Switzerland
|
| |
2834
|
| |
Not Applicable
|
(State or other jurisdiction of
incorporation or organization)
|
| |
(Primary Standard Industrial
Classification Code Number)
|
| |
(I.R.S. Employer
Identification No.)
|
Deanna L. Kirkpatrick
Yasin Keshvargar
Davis Polk & Wardwell LLP
450 Lexington Avenue
New York, NY 10017
(212) 450-4000
|
| |
Dieter Gericke
Benjamin Leisinger
Homburger AG
Hardstrasse 201
CH-8005 Zurich,
Switzerland
+41 43 222 10 00
|
| |
Jacques Iffland
Lenz & Staehelin
Route de Chêne 30
CH-1211 Geneva 6,
Switzerland
+41 58 450 70 00
|
| |
Divakar Gupta
Richard C. Segal
Alison A. Haggerty
Cooley LLP
55 Hudson Yards
New York, NY 10001
(212) 479-6000
|
Title of each class of securities to be registered
|
| |
Proposed maximum
aggregate offering price(1)(2)
|
| |
Amount of
registration fee
|
Common shares, par value CHF 0.08 per share
|
| |
$287,787,500
|
| |
$37,354.82
|
(1)
|
Estimated solely for the purpose of computing the amount of the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended.
|
(2)
|
Includes 825,000 common shares granted pursuant to the underwriters’ option to purchase additional common shares.
|
|
| |
PER SHARE
|
| |
TOTAL
|
Public offering price
|
| |
$
|
| |
$
|
Underwriting discounts and commissions(1)
|
| |
$
|
| |
$
|
Proceeds, before expenses, to us
|
| |
$
|
| |
$
|
(1)
|
See “Underwriters” for a description of all compensation payable to the underwriters.
|
MORGAN STANLEY
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| |
BofA SECURITIES
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| |
COWEN
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•
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Cytotoxic Potency. The PBD dimer warheads used in our ADCs have been shown preclinically to be approximately 100 times more potent than other warheads used in currently marketed ADCs, such as auristatin, maytansine and calicheamicin.
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•
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Activity in Tumors with Low-Expressing Targets. The high potency of our PBD-based warheads means that, compared to other warheads, fewer molecules of warhead should be needed to be internalized into the cancer cell to kill it. We believe that the potency of our PBD-based warheads may allow us to develop ADCs that target antigens with low expression levels in the tumor microenvironment, potentially increasing the range of cancers amenable to treatment with ADCs.
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•
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Durable Responses. Our PBD-based ADCs create interstrand cross-links in the target cells’ DNA. As PBD cross-links are non-distortive, they are designed to be able to evade the cells’ DNA repair mechanisms that result in limited clinical responses and relapses. We believe that this may contribute to the frequency and durability of responses in heavily pre-treated and primary refractory patients that we have observed in our clinical trials.
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•
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Bystander Effect. Since our PBD-based warheads are cell-permeable, they may be able to diffuse into adjacent cells and kill them in an antigen-independent manner. We believe that this may allow us to develop ADCs that target antigens with heterogeneous expression levels in the tumor microenvironment, potentially increasing the range of cancers amenable to treatment with ADCs.
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•
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Immunogenic Cell Death. PBD warheads have been observed to induce immunogenic cell death, whereby a cancer cell’s death expresses certain stress signals that induce the body’s anti-tumor immune response through the activation of T cells and antigen-presenting cells. This opens up the potential for combining our ADCs with other therapies, particularly with immuno-oncology therapies such as checkpoint inhibitors, that are specifically designed to activate the patient’s own immune system to combat cancer.
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•
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We retain exclusive worldwide development and commercialization rights to Lonca. We intend to commercialize Lonca in the United States through our own infrastructure and may selectively pursue strategic collaborations and licensing opportunities in other geographies.
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•
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On September 21, 2020, we submitted a BLA to the FDA for Lonca for the treatment of relapsed or refractory DLBCL and commenced a confirmatory clinical trial of Lonca in combination with rituximab, which, if successful, we believe will support an sBLA for Lonca to be used as a second-line therapy for the treatment of relapsed or refractory DLBCL in transplant-ineligible patients.
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•
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We completed enrollment of a 145-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory DLBCL.
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○
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As of April 2020, we observed a 48.3% ORR and a 24.1% CRR in 145 heavily pre-treated patients who had received a median of three prior lines of therapy. The median duration of response was 10.25 months.
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○
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Lonca’s significant clinical activity was observed across a broad patient population in this clinical trial, including patients with primary refractory disease, bulky disease, double-hit or triple-hit disease and transformed disease, as well as elderly patients and patients who did not respond to any prior therapy.
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•
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Lonca is also being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of relapsed or refractory DLBCL and MCL.
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○
|
As of April 6, 2020, at the dose being used in the pivotal Phase 2 part of the clinical trial, we observed a 75.0% ORR and a 58.3% CRR in heavily pre-treated evaluable DLBCL patients who had received a median of two prior lines of therapy.
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•
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We also intend to commence an additional pivotal Phase 2 clinical trial of Lonca for the treatment of FL in the first half of 2021.
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○
|
In the Phase 1 clinical trial of Lonca for the treatment of relapsed or refractory B-cell lineage NHL (“B-NHL”), we observed a 78.6% ORR and a 64.3% CRR in heavily pre-treated patients with relapsed or refractory FL who had received a median of four prior lines of therapy.
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•
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Favorable clinical activity across a broad patient population, including transplant eligible and ineligible patients, patients who have not responded to first-line therapy or any prior therapy and patients with bulky disease, double-hit and triple-hit disease and transformed disease;
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•
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Significant single-agent clinical activity while maintaining a manageable tolerability profile with a low incidence of febrile neutropenia;
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•
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Activity in heavily pretreated patients, including those who had received prior CD19 therapies, including CAR T-cell therapy (“CAR-T”), and stem cell transplant (“SCT”);
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•
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Promising clinical activity observed in our combination clinical trial with ibrutinib, which we believe demonstrates the opportunity to advance Lonca into earlier lines of therapy in combination with other therapies such as ibrutinib and rituximab; and
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•
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30-minute intravenous infusions once every three weeks.
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•
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Our successful recruitment of an experienced Chief Commercial Officer and senior commercial leadership team, including a Vice President of Sales, a Vice President of Marketing and a Vice President of Market Access, with broader organizational recruitment underway;
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•
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Our successful recruitment of a Vice President of Medical Affairs, with broader organizational recruitment underway, including field-based medical science liaisons;
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Investing resources to assess the competitive landscape, supporting our differentiated profile and accelerating our launch readiness efforts;
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•
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Increased scientific interactions with Key Opinion Leaders; and
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•
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Our plans to build a highly talented and efficient U.S. customer-facing organization of more than 65 cross-functional employees, which we believe has the potential to capture more than 80% of the DLBCL commercial opportunity.
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•
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We retain worldwide development and commercialization rights to Cami, subject to our collaboration and license agreement with Genmab.
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•
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We are advancing Cami through clinical development to support a BLA submission for the treatment of relapsed or refractory HL.
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•
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Cami is being evaluated in a 100-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory HL, for which we anticipate reporting top-line response rate data in the first half of 2021.
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○
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As of June 30, 2020, 47 patients have been enrolled in this pivotal Phase 2 clinical trial.
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•
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Enrollment has been completed in a 133-patient Phase 1 clinical trial of Cami for the treatment of relapsed or refractory HL and NHL, including 77 patients with relapsed or refractory HL. In this clinical trial, Cami demonstrated significant clinical activity across a broad patient population and maintained a tolerability profile that we believe was manageable. More specifically, as of April 2019, we observed:
|
○
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At the initial dose for our pivotal Phase 2 clinical trial, an 86.5% ORR and a 48.6% CRR in heavily pre-treated patients with relapsed or refractory HL who had received a median of five prior lines of therapy, including patients who were relapsed or refractory to any or all of brentuximab vedotin, checkpoint inhibitors and stem cell transplant; and
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○
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A 44.0% ORR and an 8.0% CRR in heavily pre-treated patients with relapsed or refractory T-cell lymphoma who had received a median of four prior lines of therapy.
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•
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Cami is also being evaluated in a Phase 1b clinical trial for the treatment of selected advanced solid tumors by targeting CD25-expressing regulatory T cells (“Tregs”).
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○
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In paired biopsies from three of six patients in the Phase 1b clinical trial, we have observed a significant increase in the ratio of T effector cells (“Teffs”) to Tregs.
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○
|
Preliminary pharmacokinetics/pharmacodynamics (“PK/PD”) data indicate that treatment with Cami was associated with clinically relevant modulation of immune cells, both in the circulation and in tumor tissue.
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•
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At the initial dose for our pivotal Phase 2 clinical trial, an 86.5% ORR and a 48.6% CRR in heavily pre-treated patients with relapsed or refractory HL who were relapsed or refractory to any or all of brentuximab vedotin, checkpoint inhibitors and stem cell transplant;
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•
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Tolerability profile that we believe is manageable;
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•
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The potential opportunity to advance Cami into earlier lines of therapy as a monotherapy or in combination with other therapies;
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•
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Novel immuno-oncology approach targeting Tregs for the treatment of various advanced solid tumors; and
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•
|
30-minute intravenous infusions once every three weeks.
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•
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Continue to prepare for the near-term commercial launch of Lonca, if approved.
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•
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Expand the potential market opportunity by advancing Lonca into earlier lines of therapy and for multiple indications.
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•
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Advance our second lead product candidate, Cami, to support BLA submission.
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•
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Advance our two clinical-stage solid tumor product candidates to address multiple indications in areas of high unmet medical need.
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•
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Continue to build a diverse and balanced portfolio of product candidates to address high unmet medical needs in oncology by leveraging our R&D strengths, our disciplined approach to target selection and our preclinical and clinical development strategy.
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•
|
Maximize the commercial potential of our product candidates through both our own commercial organization and strategic collaborations and licensing opportunities in select markets.
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•
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The pivotal Phase 2 clinical trial of Lonca in relapsed or refractory DLBCL has completed enrollment. Patients continue in follow-up, and data are being collected. On September 21, 2020, we submitted a BLA to the FDA for Lonca for the treatment of relapsed or refractory DLBCL.
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•
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We have not experienced any material impact of the COVID-19 pandemic on our clinical trial enrollment, timelines or expenses for our other clinical-stage product candidates. However, the ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change.
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•
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We have incurred net losses during all fiscal periods since our inception, have no products approved for commercial sale and anticipate that we will continue to incur substantial net losses for the foreseeable future.
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•
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Our $115.0 million Facility Agreement with Deerfield Partners, L.P. and certain of its affiliates (the ‘‘Facility Agreement”) and the associated restrictive covenants thereunder could adversely affect our financial condition and will restrict our ability to raise capital.
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•
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We have concentrated our research and development efforts on PBD-based ADCs, and our future success depends heavily on the successful development of this therapeutic approach.
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•
|
Our current product candidates are in various stages of development, and it is possible that none of our product candidates will ever become commercial products.
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•
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In the past, certain of our clinical trials, including our pivotal Phase 2 clinical trial of Cami for the treatment of relapsed or refractory HL, have been subject to clinical holds prior to the dosing of the first patient and partial clinical holds after the dosing of the first patient. A clinical hold on any of our clinical trials will result in delays of our clinical development timeline.
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•
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Our product candidates may cause undesirable side effects or have other properties that may delay or prevent their development or regulatory approval or limit their commercial potential.
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•
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The regulatory review and approval processes of the FDA, the European Medicines Agency (“EMA”) and comparable regulatory authorities in other jurisdictions are lengthy, time-consuming and inherently unpredictable. If we are unable to obtain, or if there are delays in obtaining, regulatory approval for our product candidates, we will not be able to commercialize our product candidates and our ability to generate revenue will be materially impaired.
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•
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As a company, we have never commercialized a product. We currently have no active sales force and we are in the process of building our commercial infrastructure. We may lack the necessary expertise, personnel and resources to successfully commercialize our product candidates.
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•
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We face substantial competition, which may result in others discovering, developing or commercializing products, treatment methods and/or technologies before or more successfully than we do.
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•
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Our rights to Cami are subject to our collaboration and license agreement with Genmab, and there can be no assurance that we will maintain the rights to develop or commercialize Cami.
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•
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We rely on third parties for the manufacture, production, storage and distribution of our product candidates. Our dependence on these third parties may impair the clinical advancement and commercialization of our product candidates.
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•
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Issued patents covering one or more of our product candidates or technologies, including Lonca, Cami or the technology we use in our product candidates, could be found invalid or unenforceable if challenged in court.
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•
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If we fail to attract and retain senior management and key scientific personnel or fail to adequately plan for succession, we may be unable to successfully develop our product candidates, conduct our clinical trials and commercialize our product candidates.
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•
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Our business could be adversely affected by the effects of health epidemics, including the COVID-19 pandemic, in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations.
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•
|
We have identified material weaknesses in our internal control over financial reporting. If we are unable to remediate these material weaknesses or otherwise fail to maintain an effective system of internal controls, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business and the price of our common shares.
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•
|
a requirement to have only two years of audited financial statements in addition to any required interim financial statements and correspondingly reduced disclosure in the Management’s Discussion and Analysis of Financial Condition and Results of Operations disclosure in the registration statement of which this prospectus forms a part;
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•
|
an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”); and
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•
|
to the extent that we no longer qualify as a foreign private issuer, (i) reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and (ii) exemptions from the requirements of holding a non-binding advisory vote on executive compensation, including golden parachute compensation.
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•
|
the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act;
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•
|
the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time; and
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•
|
the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specified information, or current reports on Form 8-K, upon the occurrence of specified significant events.
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•
|
3,247,523 common shares issuable upon the exercise of options outstanding under our 2019 Equity Incentive Plan as of June 30, 2020, at a weighted-average exercise price of $20.55 per share;
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•
|
436,976 common shares issuable upon the exercise of options outstanding under our 2019 Equity Incentive Plan granted after June 30, 2020, at a weighted-average exercise price of $43.04 per share;
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•
|
149,984 common shares issued pursuant to restricted share units granted to certain of our executive officers under our 2019 Equity Incentive Plan after June 30, 2020;
|
•
|
7,820,000 common shares reserved for future issuance under our 2019 Equity Incentive Plan, which include the common shares described in the three preceding items;
|
•
|
54,148 common shares we hold in treasury; and
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•
|
common shares issuable upon the conversion of the senior secured convertible notes issued or to be issued under the Facility Agreement.
|
•
|
no exercise of the option granted to the underwriters to purchase up to 825,000 additional common shares in connection with this offering;
|
•
|
a public offering price of $45.50 per common share, which was the last reported sale price of our common shares on the NYSE on September 18, 2020;
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•
|
no purchase of common shares in this offering by directors, officers or existing shareholders;
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•
|
no exercise of outstanding options described above; and
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•
|
no conversion of the senior secured convertible notes issued under the Facility Agreement.
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|
| |
Six Months Ended June 30,
|
| |
Year Ended December 31,
|
||||||
|
| |
2020
|
| |
2019
|
| |
2019(2)
|
| |
2018
|
Consolidated Income Statement Data:
|
| |
(in USD thousands except for share and per share data)
|
|||||||||
Contract revenue
|
| |
—
|
| |
2,340
|
| |
2,340
|
| |
1,140
|
Research and development expense
|
| |
(61,325)
|
| |
(46,572)
|
| |
(107,537)
|
| |
(118,313)
|
General and administrative expense
|
| |
(27,509)
|
| |
(6,592)
|
| |
(14,202)
|
| |
(8,768)
|
Operating loss
|
| |
(88,834)
|
| |
(50,824)
|
| |
(119,399)
|
| |
(125,941)
|
Other income
|
| |
278
|
| |
—
|
| |
1,655
|
| |
—
|
Convertible loans, derivatives, increase in fair value
|
| |
(79,261)
|
| |
—
|
| |
—
|
| |
—
|
Convertible loans, first tranche, derivative, transaction costs
|
| |
(1,571)
|
| |
—
|
| |
—
|
| |
—
|
Financial income
|
| |
569
|
| |
1,306
|
| |
2,253
|
| |
2,856
|
Financial expense
|
| |
(939)
|
| |
(73)
|
| |
(156)
|
| |
—
|
Exchange differences
|
| |
(71)
|
| |
(68)
|
| |
(255)
|
| |
213
|
Loss before taxes
|
| |
(169,829)
|
| |
(49,659)
|
| |
(115,902)
|
| |
(122,872)
|
Income tax expense
|
| |
(204)
|
| |
(199)
|
| |
(582)
|
| |
(224)
|
Loss for the period
|
| |
(170,033)
|
| |
(49,858)
|
| |
(116,484)
|
| |
(123,096)
|
Basic and diluted loss per share(1)
|
| |
(2.97)
|
| |
(1.05)
|
| |
(2.36)
|
| |
(2.64)
|
Weighted-average number of shares used to compute basic and diluted loss per share(1)
|
| |
57,225,939
|
| |
47,297,859
|
| |
49,279,961
|
| |
46,600,000
|
(1)
|
See Note 28 to our audited consolidated financial statements and Note 15 to our unaudited condensed consolidated interim financial statements, each included elsewhere in this prospectus for a description of the method used to compute basic and diluted net loss per share.
|
(2)
|
On January 1, 2019, we adopted IFRS 16 “Leases,” the impact of which is described in Note 17 to our audited consolidated financial statements.
|
|
| |
As of June 30, 2020
|
|||
|
| |
Actual
|
| |
As Adjusted(1)
|
Consolidated Balance Sheet Data:
|
| |
(in USD thousands)
|
|||
Cash and cash equivalents
|
| |
348,593
|
| |
580,028
|
Total assets
|
| |
373,842
|
| |
605,277
|
Total liabilities(2)
|
| |
177,540
|
| |
177,540
|
Share capital
|
| |
5,795
|
| |
6,282
|
Share premium
|
| |
792,605
|
| |
1,023,553
|
Accumulated losses
|
| |
(618,602)
|
| |
(618,602)
|
Total equity
|
| |
196,302
|
| |
427,737
|
(1)
|
The as-adjusted information gives effect to our issuance and sale of 5,500,000 common shares in this offering based on the assumed public offering price of $45.50 per common share, which was the last reported sale price of our common shares on the NYSE on September 18, 2020, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. The as-adjusted information is illustrative only and will change based on the actual public offering price and other terms of this offering determined at pricing. Each $1.00 increase or decrease in the assumed public offering price would increase or decrease the as-adjusted amount of each of cash and cash equivalents, total assets and total equity by $5.1 million, assuming that the number of common shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. Each 1,000,000 share increase or decrease in the number of common shares offered by us would increase or decrease the as-adjusted amount of each of cash and cash equivalents, total assets and total equity by $42.3 million, assuming the assumed public offering price remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
|
(2)
|
See Notes 3 and 11 to our unaudited condensed consolidated interim financial statements included elsewhere in this prospectus for further information related to the Facility Agreement and accounting for the convertible loans and associated derivative instruments.
|
•
|
seek regulatory approval for Lonca and our other product candidates from applicable regulatory authorities;
|
•
|
conduct a confirmatory clinical trial of Lonca in combination with rituximab for the treatment of relapsed or refractory DLBCL;
|
•
|
conduct pivotal Phase 2 clinical trials of our product candidates, including the pivotal Phase 2 clinical trial of Lonca for the treatment of relapsed or refractory FL;
|
•
|
the Phase 1/2 clinical trial of Lonca in combination with ibrutinib for the treatment of relapsed or refractory DLBCL and MCL and the pivotal Phase 2 clinical trial of Cami for the treatment of relapsed or refractory HL;
|
•
|
conduct Phase 1 clinical trials of our current and future product candidates;
|
•
|
conduct any required confirmatory clinical trials of any of our product candidates in anticipation of potential accelerated approval from the FDA or similar conditional approval from the EMA or comparable regulatory agencies in other jurisdictions;
|
•
|
expand our research and development efforts for our preclinical product candidates and research pipeline;
|
•
|
invest in our late-stage clinical development, manufacturing and commercialization activities, including launching commercial sales, marketing and distribution operations;
|
•
|
continue to prepare, file, prosecute, maintain, protect and enforce our intellectual property rights and claims;
|
•
|
add clinical, scientific, operational, financial and management information systems and personnel; and
|
•
|
continue to operate as a public company.
|
•
|
the outcome, timing and costs of obtaining regulatory approvals for Lonca and for our other product candidates if the requisite clinical trials are successful;
|
•
|
the progress, results and costs of our confirmatory clinical trial of Lonca in combination with rituximab for the treatment of relapsed or refractory DLBCL;
|
•
|
the progress, results and costs of our Phase 1 and potentially pivotal Phase 2 clinical trials of our product candidates;
|
•
|
the progress, results and costs of any required confirmatory clinical trials of any product candidates that receive accelerated approval from the FDA or similar conditional approval from the EMA or comparable regulatory agencies in other jurisdictions;
|
•
|
the scope, progress, results and costs of researching and developing product candidates in our research pipeline, including conducting preclinical studies and clinical trials of such product candidates;
|
•
|
the costs of outsourced manufacturing of our product candidates, which are complex biological molecules, for clinical trials and in preparation for regulatory approval and commercialization;
|
•
|
the size of the markets for approved indications in territories in which we receive regulatory approval, if any;
|
•
|
the timing and costs of commercialization activities for our product candidates, if any are approved for sale, including establishing our sales and marketing capabilities and engaging in the marketing, sales and distribution of our product candidates;
|
•
|
the revenue, if any, received from the commercialization of our product candidates, if any are approved for sale;
|
•
|
our ability to maintain and establish collaboration, licensing or other arrangements and the financial terms of such agreements;
|
•
|
the costs involved in preparing, filing, prosecuting, maintaining, protecting and enforcing our intellectual property rights and claims, including any litigation costs and the outcome of such litigation;
|
•
|
the costs associated with potential product liability claims, including the costs associated with obtaining insurance against such claims and with defending against such claims;
|
•
|
the timing and amount of milestone payments we receive under our collaboration agreements;
|
•
|
the costs involved in maintaining and improving the technology we use in our product candidates;
|
•
|
our efforts to enhance operational systems and hire additional personnel, including personnel to support the development and commercialization of our product candidates and to satisfy our obligations as a public company;
|
•
|
the effect of competing technological and market developments; and
|
•
|
the types of available sources of private and/or public market financing.
|
•
|
require us to dedicate a substantial portion of cash and cash equivalents to the payment of interest on, and principal of, the indebtedness, which will reduce the amounts available to fund working capital, capital expenditures, product development efforts and other general corporate purposes;
|
•
|
oblige us to comply with negative covenants restricting our activities, including limitations on dispositions, mergers or acquisitions, encumbering our intellectual property, incurring indebtedness or liens, paying dividends, making investments and engaging in certain other business transactions;
|
•
|
limit our flexibility in planning for, or reacting to, changes in our business and our industry;
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•
|
place us at a competitive disadvantage compared to our competitors who have less debt or competitors with comparable debt at more favorable interest rates; and
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•
|
limit our ability to borrow additional amounts for working capital, capital expenditures, research and development efforts, acquisitions, debt service requirements, execution of our business strategy and other purposes and otherwise restrict our financing options.
|
•
|
negative preclinical data;
|
•
|
delays in receiving the required regulatory clearance from the appropriate regulatory authorities to commence clinical trials or amend clinical trial protocols, including any objections to our INDs or protocol amendments from the FDA;
|
•
|
delays in reaching, or a failure to reach, a consensus with regulatory authorities on study design;
|
•
|
delays in reaching, or a failure to reach, an agreement on acceptable terms with prospective clinical research organizations (“CROs”) and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;
|
•
|
difficulties in obtaining required Institutional Review Board (“IRB”) or ethics committee approval at each clinical trial site;
|
•
|
challenges in recruiting and enrolling suitable patients that meet the study criteria to participate in clinical trials;
|
•
|
the inability to enroll a sufficient number of patients in clinical trials to ensure adequate statistical power to detect statistically significant treatment effects;
|
•
|
imposition of a clinical hold by regulatory authorities or IRBs for any reason, including safety concerns and non-compliance with regulatory requirements;
|
•
|
failure by CROs, other third parties or us to adhere to clinical trial requirements;
|
•
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failure to perform in accordance with the FDA’s good clinical practices (“GCP”) or applicable regulatory guidelines in other jurisdictions;
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the inability to manufacture adequate quantities of a product candidate or other materials necessary in accordance with current Good Manufacturing Practices (“cGMPs”) to conduct clinical trials, including, for example, quality issues and delays in the testing, validation, manufacturing delays or failures at our CROs and delivery of the product candidates to the clinical trial sites;
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lower than anticipated patient retention rates;
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difficulties in maintaining contact with patients after treatment, resulting in incomplete data;
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ambiguous or negative interim results;
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our CROs or clinical trial sites failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, deviating from the protocol or dropping out of a clinical trial;
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unforeseen safety issues, including occurrence of treatment emergent adverse events (“TEAEs”) associated with the product candidate that are viewed to outweigh the product candidate’s potential benefits;
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changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;
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lack of adequate funding to continue the clinical trial; or
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delays and disruptions as a result of the COVID-19 pandemic.
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the size and nature of the patient population;
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the severity of the disease under investigation;
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the eligibility criteria for the study in question, including any misjudgment of, and resultant adjustment to, the appropriate ranges applicable to the exclusion and inclusion criteria;
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the number of clinical trial sites and the proximity of prospective patients to those sites;
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the nature, severity and frequency of adverse side effects associated with our product candidates;
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the standard of care in the diseases under investigation;
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the commitment of our clinical investigators to identify eligible patients;
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competing studies or trials with similar eligibility criteria;
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the patient referral practices of physicians;
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clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including perception of ADCs generally and of PBD-based ADCs specifically; and
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disruptions as a result of the COVID-19 pandemic.
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we may encounter delays or difficulties in enrolling patients for our clinical trials due to a negative perception of our product candidates’ safety and tolerability profile;
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we and/or regulatory authorities may temporarily or permanently put our clinical trials on hold;
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we may be unable to obtain regulatory approval for our product candidates;
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regulatory authorities may withdraw or limit their approvals of our product candidates;
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regulatory authorities may require the addition of labeling statements, such as a contraindication, boxed warnings or additional warnings;
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the FDA may require development of a Risk Evaluation and Mitigation Strategy with Elements to Assure Safe Use as a condition of approval;
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we may decide to remove our product candidates from the marketplace;
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we may be subject to regulatory investigations and government enforcement actions;
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we could be sued and held liable for harm caused to patients, including as a result of hospital errors; and
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our reputation may suffer.
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the FDA, EMA or comparable regulatory authorities in other jurisdictions may disagree with the number, design or implementation of our clinical trials;
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the population studied in the clinical trial may not be considered sufficiently broad or representative to assure safety in the full population for which we seek approval;
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the FDA, EMA or comparable regulatory authorities in other jurisdictions may disagree with our interpretation of data from preclinical studies or clinical trials;
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the data collected from clinical trials of our product candidates may not meet the level of statistical or clinical significance required by the FDA, EMA or comparable regulatory authorities in other jurisdictions or may otherwise not be sufficient to support the submission of a BLA, Marketing Authorization Application (“MAA”) or other submission or to obtain regulatory approval in the United States, the European Union or elsewhere;
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the FDA, EMA or comparable regulatory authorities in other jurisdictions may not accept data generated by our preclinical service providers and clinical trial sites;
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the FDA, EMA or comparable regulatory authorities in other jurisdictions may require us to conduct additional preclinical studies and clinical trials;
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we may be unable to demonstrate to the FDA, EMA or comparable regulatory authorities in other jurisdictions that a product candidate’s response rate, duration of response (“DoR”) or risk-benefit ratio for its proposed indication is acceptable;
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the FDA, EMA or comparable regulatory authorities in other jurisdictions may fail to approve the manufacturing processes, test procedures and specifications applicable to the manufacture of our product candidates, the facilities of third-party manufacturers with which we contract for clinical or commercial supplies may fail to maintain a compliance status acceptable to the FDA, EMA or comparable regulatory authorities or the EMA or comparable regulatory authorities may fail to approve facilities of third-party manufacturers with which we contract for clinical and commercial supplies;
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we or any third-party service providers may be unable to demonstrate compliance with cGMPs to the satisfaction of the FDA, EMA or comparable regulatory authorities in other jurisdictions, which could result in delays in regulatory approval or require us to withdraw or recall products and interrupt commercial supply of our products;
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the approval policies or regulations of the FDA, EMA or comparable regulatory authorities in other jurisdictions may change in a manner rendering our clinical data insufficient for approval; or
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political factors surrounding the approval process, such as government shutdowns and political instability.
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the clinical trial(s) required to verify the predicted clinical benefit of a product candidate fails to verify such benefit or does not demonstrate sufficient clinical benefit to justify the risks associated with the product candidate;
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other evidence demonstrates that a product candidate is not shown to be safe or effective under the conditions of use;
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we fail to conduct any required post-marketing confirmatory clinical trial with due diligence; or
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we disseminate false or misleading promotional materials relating to the relevant product candidate.
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restrictions on the marketing or manufacturing of the product;
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withdrawal of the product from the market or voluntary or mandatory product recalls;
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fines, restitution or disgorgement of profits or revenues;
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warning or untitled letters;
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requirements to conduct post-marketing studies or clinical trials;
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holds on clinical trials;
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refusal by the FDA, EMA or comparable regulatory authorities in other jurisdictions to approve pending applications or supplements to approved applications filed by us, or suspension or revocation of product license approvals;
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product seizure or detention;
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refusal to permit the import or export of products; and
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injunctions or the imposition of civil or criminal penalties.
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the safety and efficacy of the product, as demonstrated in clinical trials;
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the indications for which the product is approved and the labeling approved by regulatory authorities for use with the product, including any warnings that may be required in the labeling;
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our ability to offer our products for sale at competitive prices;
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the perceptions of physicians, patients and patient advocacy groups of ADCs generally and PBD-based ADCs specifically;
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the treatment’s cost, safety, efficacy, convenience and ease of administration compared to that of alternative treatments;
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acceptance by physicians, patients and patient advocacy groups of the product as a safe and effective treatment;
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the availability of coverage and adequate reimbursement by third-party payors, including cost-sharing programs such as copays and deductibles;
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patients’ willingness to pay out-of-pocket in the absence of coverage and/or adequate reimbursement from third-party payors;
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the effectiveness of our and our competitors’ sales and marketing efforts;
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our ability to establish sales, marketing and commercial product distribution capabilities or to partner with third parties with such capabilities;
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the effectiveness of pre-launch activities to raise awareness of our company and our product candidates;
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the nature, severity and frequency of adverse side effects;
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any restrictions on the use of our products together with other medications;
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publication of any post-approval data on the safety and effectiveness of the product; and
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the success of randomized post-marketing commitment studies to confirm the benefit-risk ratio of the product.
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a covered benefit under its health plan;
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safe, effective and medically necessary;
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appropriate for the specific patient;
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cost-effective; and
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neither experimental nor investigational.
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increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program;
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established a branded prescription drug fee that pharmaceutical manufacturers of certain branded prescription drugs must pay to the federal government;
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expanded the list of covered entities eligible to participate in the 340B drug pricing program by adding new entities to the program;
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established a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;
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extended manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;
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expanded eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability;
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created a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our product candidates, that are inhaled, infused, instilled, implanted or injected;
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established a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
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established a Center for Medicare and Medicaid Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending; and
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created a licensure framework for follow-on biologic products.
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the demand for any products for which we may obtain regulatory approval;
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our ability to set a price that we believe is fair for our products;
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our ability to obtain coverage and reimbursement approval for a product;
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our ability to generate revenues and achieve or maintain profitability; and
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the level of taxes that we are required to pay.
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advance the technology we use in our product candidates;
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obtain, maintain, protect and enforce intellectual property protection for our technologies and product candidates;
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obtain required government and other public and private approvals on a timely basis;
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attract and retain key personnel;
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execute our research and development plans;
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commercialize effectively;
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obtain and maintain coverage and reimbursement for our products in approved indications;
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obtain adequate funding for our activities;
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comply with applicable laws, regulations and regulatory requirements and restrictions with respect to the commercialization of our products, including with respect to any changed or increased regulatory restrictions; and
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enter into additional strategic collaborations and licensing opportunities to advance the development and commercialization of our product candidates.
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have staffing difficulties;
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fail to comply with contractual obligations;
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experience regulatory compliance issues;
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undergo changes in priorities or become financially distressed; or
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form relationships with other entities, some of which may be our competitors.
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delays or stoppages in product shipments for our product candidates, including loss shipments and cross-border logistical complications, resulting in delayed and lost shipments;
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delays to the development timelines for our product candidates;
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an inability to commence or continue clinical trials of product candidates under development;
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interruption of supply resulting from modifications to a CMO’s operations;
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delays or stoppage in manufacturing or shipment due to a CMO’s bankruptcy, winding up, reorganization or similar corporate failures or financial distress;
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delays in product manufacturing or shipments resulting from uncorrected defects, reliability or stability issues, or a CMO’s variation in a component;
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a lack of long-term arrangements for key components;
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inability to obtain adequate supply in a timely manner, or to obtain adequate supply on commercially reasonable terms;
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difficulty and cost associated with locating and qualifying alternative CMOs for our components or raw materials in a timely manner;
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production delays related to the evaluation and testing of components from alternative CMOs, and corresponding regulatory qualifications;
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delay in delivery due to our CMOs’ prioritizing other customer orders over ours;
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damage to our reputation caused by defective product candidates produced by our CMOs; and
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potential price increases.
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the scope of rights granted under the license agreement and other interpretation-related issues;
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the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;
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the sublicensing of patent and other rights under our existing collaborative development relationships and any collaboration relationships we might enter into in the future;
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our diligence obligations under the license agreement and what activities satisfy those diligence obligations;
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the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our current and future licensors and us; and
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the priority of invention of patented technology.
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others may be able to make products that are similar to any product candidates we may develop or utilize similar technology but that are not covered by the claims of the patents that we license or may own in the future;
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we, or our license partners or current or future collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that we license or may own in the future;
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we, or our license partners or current or future collaborators, might not have been the first to file patent applications covering certain of our or their inventions;
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others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights;
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it is possible that our pending licensed patent applications or those that we may own in the future will not lead to issued patents;
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issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors;
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our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;
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we may not develop additional proprietary technologies that are patentable;
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the patents of others may harm our business; and
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we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.
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our available capital resources or capital constraints we experience;
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the rate of progress, costs and results of our clinical trials and research and development activities, including the extent of scheduling conflicts with participating clinicians and collaborators;
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our ability to identify and enroll patients who meet clinical trial eligibility criteria;
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our receipt of approvals by the FDA, EMA and comparable regulatory authorities in other jurisdictions, and the timing thereof;
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other actions, decisions or rules issued by regulators;
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our ability to access sufficient, reliable and affordable supplies of materials used in the manufacture of our product candidates;
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our ability to manufacture and supply clinical trial materials to our clinical sites on a timely basis;
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the efforts of our collaborators with respect to the commercialization of our products; and
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the securing of, costs related to, and timing issues associated with, commercial product manufacturing as well as sales and marketing activities.
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The federal Anti-Kickback Statute, which prohibits any person or entity from, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of an item or service reimbursable, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include anything of value. The federal Anti-Kickback Statute has also been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary managers on the other hand. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, but the exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection.
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Federal civil and criminal false claims laws, such as the False Claims Act (“FCA”), which can be enforced by private citizens through civil qui tam actions, and civil monetary penalty laws prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, false, fictitious or fraudulent claims for payment of federal funds, and knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government. For example, pharmaceutical companies have been prosecuted under the FCA in connection with their alleged off-label promotion of drugs, purportedly concealing price concessions in the pricing information submitted to the government for government price reporting purposes, and allegedly providing free product to customers with the expectation that the customers would bill federal healthcare programs for the product. In addition, a claim including items or services resulting from a violation of the federal
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HIPAA, among other things, imposes criminal liability for executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and creates federal criminal laws that prohibit knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services.
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HIPAA, as amended by HITECH, and their implementing regulations, which impose privacy, security and breach reporting obligations with respect to individually identifiable health information upon entities subject to the law, such as health plans, healthcare clearinghouses and certain healthcare providers, known as covered entities, and their respective business associates that perform services for them that involve individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in U.S. federal courts to enforce HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.
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Federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers.
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The federal transparency requirements under the Physician Payments Sunshine Act, created under the Health Care Reform Act, which requires, among other things, certain manufacturers of drugs, devices, biologics and medical supplies reimbursed under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to CMS information related to payments and other transfers of value provided to physicians, as defined by such law, and teaching hospitals and physician ownership and investment interests, including such ownership and investment interests held by a physician’s immediate family members.
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State and foreign laws that are analogous to each of the above federal laws, such as anti-kickback and false claims laws, that may impose similar or more prohibitive restrictions, and may apply to items or services reimbursed by non-governmental third-party payors, including private insurers.
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State and foreign laws that require pharmaceutical companies to implement compliance programs, comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or to track and report gifts, compensation and other remuneration provided to physicians and other healthcare providers; state laws that require the reporting of marketing expenditures or drug pricing, including information pertaining to and justifying price increases; state and local laws that require the registration of pharmaceutical sales representatives; state laws that prohibit various marketing-related activities, such as the provision of certain kinds of gifts or meals; state laws that require the posting of information relating to clinical trials and their outcomes; and other federal, state and foreign laws that govern the privacy and security of health information or personally identifiable information in certain circumstances, including state health information privacy and data breach notification laws which govern the collection, use, disclosure, and protection of health-related and other personal information, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus requiring additional compliance efforts.
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decreased demand for our product candidates or products that we may develop;
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injury to our reputation and significant negative media attention;
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withdrawal of clinical trial sites and/or study participants;
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significant costs to defend the related litigations;
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a diversion of management’s time and our resources to pursue our business strategy;
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substantial monetary awards to study participants or patients;
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•
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product recalls, withdrawals or labeling, marketing or promotional restrictions;
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loss of revenue;
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•
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the inability to commercialize our product candidates that we may develop; and
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•
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a decline in the price of our common shares.
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high acquisition costs;
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the need to incur substantial debt or engage in dilutive issuances of equity securities to pay for acquisitions;
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the potential disruption of our historical business and our activities under our collaboration agreements;
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the strain on, and need to expand, our existing operational, technical, financial and administrative infrastructure;
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our lack of experience in late-stage product development and commercialization;
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the difficulties in assimilating employees and corporate cultures;
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the difficulties in hiring qualified personnel and establishing necessary development and/or commercialization capabilities;
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the failure to retain key management and other personnel;
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•
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the challenges in controlling additional costs and expenses in connection with and as a result of the acquisition;
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•
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the need to write down assets or recognize impairment charges;
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the diversion of our management’s attention to integration of operations and corporate and administrative infrastructures; and
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any unanticipated liabilities for activities of or related to the acquired business or its operations, products or product candidates.
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economic weakness, including inflation, or political instability in particular non-U.S. economies and markets;
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global trends towards pharmaceutical pricing;
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differing regulatory requirements for drug approvals in non-U.S. countries;
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differing reimbursement, pricing and insurance regimes;
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•
|
potentially reduced protection for, and complexities and difficulties in obtaining, maintaining, protecting and enforcing, intellectual property rights;
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•
|
difficulties in compliance with non-U.S. laws and regulations;
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•
|
changes in non-U.S. regulations and customs, tariffs and trade barriers;
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•
|
changes in non-U.S. currency exchange rates and currency controls;
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•
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changes in a specific country’s or region’s political or economic environment;
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•
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trade protection measures, economic sanctions and embargoes, import or export licensing requirements or other restrictive actions by U.S. or non-U.S. governments;
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negative consequences from changes in tax laws;
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compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
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workforce uncertainty in countries where labor unrest is more common than in the United States;
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•
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difficulties associated with staffing and managing international operations, including differing labor relations;
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•
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production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;
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business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires; and
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•
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the impact of public health epidemics on employees and the global economy, such as the COVID-19 pandemic.
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results and timing of preclinical studies and clinical trials of our product candidates;
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results of clinical trials of our competitors’ products;
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public concern relating to the commercial value or safety of any of our product candidates;
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our inability to adequately protect our proprietary rights, including patents, trademarks and trade secrets;
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our inability to raise additional capital and the terms on which we raise it;
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commencement or termination of any strategic collaboration or licensing arrangement;
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•
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regulatory developments, including actions with respect to our products or our competitors’ products;
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actual or anticipated fluctuations in our financial condition and operating results;
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•
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publication of research reports by securities analysts about us or our competitors or our industry;
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our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market;
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additions and departures of key personnel;
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strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy;
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the passage of legislation or other regulatory developments affecting us or our industry, including changes in the structure of healthcare payment systems;
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fluctuations in the valuation of companies perceived by investors to be comparable to us;
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sales of our common shares by us, our insiders or our other shareholders;
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speculation in the press or investment community;
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•
|
announcement or expectation of additional financing efforts;
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any default under the Facility Agreement or the timing of any conversion of the convertible notes issued thereunder into common shares;
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changes in market conditions for biopharmaceutical stocks; and
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changes in general market and economic conditions.
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if any of our product candidates receives regulatory approval, the timing and the terms of such approval and market acceptance and demand for such product candidates;
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variations in the level of expense related to the ongoing development of our product candidates or research pipeline;
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results of clinical trials, or the addition or termination of clinical trials or funding support by us, or existing or future collaborators or licensing partners;
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|
our execution of any additional collaboration, licensing or similar arrangements, and the timing of payments we may make or receive under existing or future arrangements, or the termination or modification of any such existing or future arrangements;
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developments or disputes concerning patents or other proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our products;
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any intellectual property infringement lawsuit or any opposition, interference, cancellation or other intellectual-property-related proceeding in which we may become involved;
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|
additions and departures of key personnel;
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•
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strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy;
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fluctuations in the price of our common shares;
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regulatory developments affecting our product candidates or those of our competitors; and
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changes in general market and economic conditions.
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the non-Swiss court had jurisdiction pursuant to the PILA;
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the judgment of such non-Swiss court has become final and non-appealable;
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the judgment does not contravene Swiss public policy;
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|
the court procedures and the service of documents leading to the judgment were in accordance with the due process of law; and
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no proceeding involving the same parties and the same subject matter was first brought in Switzerland, or adjudicated in Switzerland, or was earlier adjudicated in a third state, and this decision is recognizable in Switzerland.
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in certain cases, allow our board of directors to place, upon the completion of this offering, up to 26,500,000 common shares and rights to acquire an additional 32,000,000 common shares with affiliates or third parties, without existing shareholders having statutory pre-emptive rights in relation to this share placement;
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allow our board of directors not to record any acquirer of common shares, or several acquirers acting in concert, in our share register as a shareholder with voting rights with respect to more than 15% of our share capital as set forth in the commercial register;
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limit the size of our board of directors to 11 members; and
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require two-thirds of the votes represented at a shareholder meeting for amending or repealing the above-mentioned voting and recording restrictions, for amending the provision setting a maximum board size or providing for indemnification of our directors and members of our executive committee and for removing the chairman or any member of the board of directors before the end of his or her term of office.
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the commencement, timing, progress and results of our research and development programs, preclinical studies and clinical trials;
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the timing of IND, BLA, sBLA, MAA and other regulatory submissions with the FDA, EMA or comparable regulatory authorities in other jurisdictions;
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•
|
the proposed clinical development pathway for our lead product candidates, Lonca and Cami, and our other product candidates, and the acceptability of the results of clinical trials for regulatory approval of such product candidates by the FDA, EMA or comparable regulatory authorities in other jurisdictions;
|
•
|
assumptions relating to the identification of serious adverse, undesirable or unacceptable side effects related to our product candidates;
|
•
|
the timing of and our ability to obtain and maintain regulatory approval for our product candidates;
|
•
|
our plan for the commercialization of Lonca and, subject to our collaboration and license agreement with Genmab, of Cami, if approved;
|
•
|
our expectations regarding the size of the patient populations amenable to treatment with our product candidates, if approved, as well as the treatment landscape of the indications that we are targeting with our product candidates;
|
•
|
assumptions relating to the rate and degree of market acceptance of any approved product candidates;
|
•
|
the pricing and reimbursement of our product candidates;
|
•
|
our ability to identify and develop additional product candidates;
|
•
|
the ability of our competitors to discover, develop or commercialize competing products before or more successfully than we do;
|
•
|
our competitive position and the development of and projections relating to our competitors or our industry;
|
•
|
our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing;
|
•
|
our ability to raise capital when needed in order to continue our research and development programs or commercialization efforts;
|
•
|
assumptions regarding the receipt of the second disbursement under the Facility Agreement;
|
•
|
our ability to identify and successfully enter into strategic collaborations or licensing opportunities in the future, and our assumptions regarding any potential revenue that we may generate thereunder;
|
•
|
our ability to obtain, maintain, protect and enforce intellectual property protection for our product candidates, and the scope of such protection;
|
•
|
our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of third parties;
|
•
|
our expectations regarding the impact of the COVID-19 pandemic;
|
•
|
our ability to attract and retain qualified key management and technical personnel; and
|
•
|
our expectations regarding the time during which we will be an emerging growth company under the JOBS Act and a foreign private issuer.
|
•
|
approximately $115 million to advance the clinical development of Lonca for the treatment of multiple hematological malignancies, including ongoing and new clinical trials;
|
•
|
approximately $30 million to advance the clinical development of Cami for the treatment of both hematological malignancies and solid tumors;
|
•
|
approximately $25 million to advance the clinical development of ADCT-602 for the treatment of relapsed or refractory ALL as well as ADCT-601 and ADCT-901 for the treatment of select advanced solid tumors, and to fund the research and development of our preclinical product candidates and preclinical pipeline;
|
•
|
approximately $60 million to commercialize Lonca in the United States, if approved; and
|
•
|
the remainder for working capital and other general corporate purposes.
|
•
|
on an actual basis;
|
•
|
on an as-adjusted basis to give effect to our issuance and sale of common shares in this offering based on the assumed public offering price of $45.50 per common share, which was the last reported sale price of our common shares on the NYSE on September 18, 2020, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
|
|
| |
June 30, 2020
|
|||
|
| |
Actual
|
| |
As Adjusted(1)
|
|
| |
(in USD thousands except for share,
par value per share and per share data)
|
|||
Cash and cash equivalents
|
| |
348,593
|
| |
580,028
|
Convertible loans, short- and long-term
|
| |
35,968
|
| |
35,968
|
Convertible loans, derivatives
|
| |
107,058
|
| |
107,058
|
Shareholders’ equity:
|
| |
|
| |
|
Common shares, par value CHF 0.08 per share; 70,715,852 shares outstanding, actual; 76,215,852 shares outstanding, as adjusted
|
| |
5,795
|
| |
6,282
|
Share premium
|
| |
792,605
|
| |
1,023,553
|
Treasury shares
|
| |
(4)
|
| |
(4)
|
Other reserves
|
| |
16,654
|
| |
16,654
|
Cumulative translation adjustments
|
| |
(146)
|
| |
(146)
|
Accumulated losses
|
| |
(618,602)
|
| |
(618,602)
|
Total equity
|
| |
196,302
|
| |
427,737
|
Total capitalization
|
| |
339,328
|
| |
570,763
|
(1)
|
The as-adjusted information is illustrative only and will change based on the actual public offering price and other terms of this offering determined at pricing. Each $1.00 increase or decrease in the assumed public offering price would increase or decrease the as-adjusted amount of each of cash and cash equivalents, total equity and total capitalization by $5.1 million, assuming that the number of common shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. Each 1,000,000 share increase or decrease in the number of common shares offered by us, as set forth on the cover page of this prospectus, would increase or decrease the as-adjusted amount of each of cash and cash equivalents, total equity and total capitalization by $42.3 million, assuming the assumed public offering price remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.
|
Assumed public offering price per common share
|
| |
|
| |
$45.50
|
Historical net tangible book value per share as of June 30, 2020
|
| |
$2.65
|
| |
|
Increase in net tangible book value per share attributable to new investors participating in this offering
|
| |
2.85
|
| |
|
As-adjusted net tangible book value per common share after giving effect to this offering
|
| |
|
| |
5.50
|
Dilution per common share to investors participating in this offering
|
| |
|
| |
$40.00
|
|
| |
Six Months Ended June 30,
|
| |
Year Ended December 31,
|
||||||
|
| |
2020
|
| |
2019
|
| |
2019(2)
|
| |
2018
|
Consolidated Income Statement Data:
|
| |
(in USD thousands except for share and per share data)
|
|||||||||
Contract revenue
|
| |
—
|
| |
2,340
|
| |
2,340
|
| |
1,140
|
Research and development expense
|
| |
(61,325)
|
| |
(46,572)
|
| |
(107,537)
|
| |
(118,313)
|
General and administrative expense
|
| |
(27,509)
|
| |
(6,592)
|
| |
(14,202)
|
| |
(8,768)
|
Operating loss
|
| |
(88,834)
|
| |
(50,824)
|
| |
(119,399)
|
| |
(125,941)
|
Other income
|
| |
278
|
| |
—
|
| |
1,655
|
| |
—
|
Convertible loans, derivatives, increase in fair value
|
| |
(79,261)
|
| |
—
|
| |
—
|
| |
—
|
Convertible loans, first tranche, derivative, transaction costs
|
| |
(1,571)
|
| |
—
|
| |
—
|
| |
—
|
Financial income
|
| |
569
|
| |
1,306
|
| |
2,253
|
| |
2,856
|
Financial expense
|
| |
(939)
|
| |
(73)
|
| |
(156)
|
| |
—
|
Exchange differences
|
| |
(71)
|
| |
(68)
|
| |
(255)
|
| |
213
|
Loss before taxes
|
| |
(169,829)
|
| |
(49,659)
|
| |
(115,902)
|
| |
(122,872)
|
Income tax expense
|
| |
(204)
|
| |
(199)
|
| |
(582)
|
| |
(224)
|
Loss for the period
|
| |
(170,033)
|
| |
(49,858)
|
| |
(116,484)
|
| |
(123,096)
|
Basic and diluted loss per share(1)
|
| |
(2.97)
|
| |
(1.05)
|
| |
(2.36)
|
| |
(2.64)
|
Weighted-average number of shares used to compute basic and diluted loss per share(1)
|
| |
57,225,939
|
| |
47,297,859
|
| |
49,279,961
|
| |
46,600,000
|
(1)
|
See Note 28 to our audited consolidated financial statements and Note 15 to our unaudited condensed consolidated interim financial statements, each included elsewhere in this prospectus for a description of the method used to compute basic and diluted net loss per share.
|
(2)
|
On January 1, 2019, we adopted IFRS 16 “Leases,” the impact of which is described in Note 17 to our audited consolidated financial statements.
|
|
| |
As of June 30,
|
| |
As of December 31,
|
|||
|
| |
2020
|
| |
2019
|
| |
2018
|
Consolidated Balance Sheet Data:
|
| |
(in USD thousands)
|
||||||
Cash and cash equivalents
|
| |
348,593
|
| |
115,551
|
| |
138,807
|
Total assets
|
| |
373,842
|
| |
137,682
|
| |
150,558
|
Total liabilities(1)
|
| |
177,540
|
| |
26,526
|
| |
24,315
|
Share capital
|
| |
5,795
|
| |
4,361
|
| |
401
|
Share premium
|
| |
792,605
|
| |
549,922
|
| |
452,268
|
Accumulated losses
|
| |
(618,602)
|
| |
(448,569)
|
| |
(332,085)
|
Total equity
|
| |
196,302
|
| |
111,156
|
| |
126,243
|
(1)
|
See Notes 3 and 11 to our unaudited condensed consolidated interim financial statements included elsewhere in this prospectus for further information related to the Facility Agreement and accounting for the convertible loans and associated derivative instruments, which were a significant cause of the increase in our total liabilities as of June 30, 2020 from December 31, 2019.
|
•
|
seek regulatory approval for Lonca and our other product candidates from applicable regulatory authorities;
|
•
|
conduct a confirmatory clinical trial of Lonca in combination with rituximab for the treatment of relapsed or refractory DLBCL;
|
•
|
conduct pivotal Phase 2 clinical trials of our product candidates, including the pivotal Phase 2 clinical trial of Lonca for the treatment of relapsed or refractory FL, the Phase 1/2 clinical trial of Lonca in combination with ibrutinib for the treatment of relapsed or refractory DLBCL and MCL and the pivotal Phase 2 clinical trial of Cami for the treatment of relapsed or refractory HL;
|
•
|
conduct Phase 1 clinical trials of our current and future product candidates;
|
•
|
conduct any required confirmatory clinical trials of any of our product candidates in anticipation of potential accelerated approval from the FDA or similar conditional approval from the EMA or comparable regulatory agencies in other jurisdictions;
|
•
|
expand our research and development efforts for our preclinical product candidates and research pipeline;
|
•
|
invest in our late-stage clinical development, manufacturing and commercialization activities, including launching commercial sales, marketing and distribution operations;
|
•
|
continue to prepare, file, prosecute, maintain, protect and enforce our intellectual property rights and claims;
|
•
|
add clinical, scientific, operational, financial and management information systems and personnel; and
|
•
|
continue to operate as a public company.
|
•
|
salaries for research and development staff and related expenses, including share-based compensation expense;
|
•
|
costs for production of preclinical and clinical-stage product candidates by CMOs;
|
•
|
fees and other costs paid to contract research organizations in connection with the performance of preclinical studies and clinical trials;
|
•
|
costs of related facilities, materials and equipment;
|
•
|
costs associated with depreciation of right-of-use assets;
|
•
|
costs associated with obtaining and maintaining patents and other intellectual property; and
|
•
|
amortization and depreciation of tangible and intangible fixed assets used to develop our product candidates.
|
•
|
Lonca. Our pivotal Phase 2 clinical trial of Lonca for the treatment of relapsed or refractory DLBCL and our Phase 1/2 clinical trial of Lonca in combination with ibrutinib for the treatment of relapsed or refractory DLBCL and MCL.
|
•
|
Cami. Our pivotal Phase 2 clinical trial of Cami for the treatment of relapsed or refractory HL and our Phase 1b clinical trial of Cami for the treatment of selected advanced solid tumors.
|
•
|
Other development programs. Our other research and development expenses related to our Phase 1/2 clinical trial of ADCT-602 for the treatment of relapsed or refractory ALL, ADCT-601 for the treatment of selected advanced solid tumors and our preclinical studies of ADCT-701 and ADCT-901 for the treatment of selected advanced solid tumors. The expenses mainly consist of salaries, costs for production of our product candidates and costs paid to contract research organizations in conjunction with clinical trials and preclinical studies.
|
•
|
the scope, rate of progress, results and cost of our clinical trials, preclinical studies and other related activities;
|
•
|
the cost of manufacturing clinical supplies, and establishing commercial supplies, of any product candidates;
|
•
|
the number and characteristics of product candidates that we pursue;
|
•
|
the cost, timing and outcomes of regulatory approvals;
|
•
|
the cost and timing of establishing sales, marketing and distribution capabilities; and
|
•
|
the terms and timing of any collaboration, licensing or other arrangements that we may establish, including any required milestone and royalty payments thereunder.
|
•
|
The embedded conversion option derivative has been initially measured at fair value and is subsequently re-measured to fair value at each reporting date. Under IAS 32, this derivative could have
|
•
|
The convertible loan’s initial fair value is the residual amount of the consideration received, net of attributable costs, after separating out the fair value of the embedded conversion option derivative. The loan is subsequently measured at its amortized cost in accordance with IFRS 9. It is presented in the consolidated balance sheet as a financial liability.
|
|
| |
Six Months Ended June 30,
|
| |
|
|||
|
| |
2020
|
| |
2019
|
| |
Change
|
|
| |
(in USD thousands)
|
||||||
Contract revenue
|
| |
—
|
| |
2,340
|
| |
(2,340)
|
Research and development expense
|
| |
(61,325)
|
| |
(46,572)
|
| |
(14,753)
|
General and administrative expense
|
| |
(27,509)
|
| |
(6,592)
|
| |
(20,917)
|
Operating loss
|
| |
(88,834)
|
| |
(50,824)
|
| |
(38,010)
|
Other income
|
| |
278
|
| |
—
|
| |
278
|
Convertible loans, derivatives, increase in fair value
|
| |
(79,261)
|
| |
—
|
| |
(79,261)
|
Convertible loans, first tranche, derivative, transaction costs
|
| |
(1,571)
|
| |
—
|
| |
(1,571)
|
|
| |
Six Months Ended June 30,
|
| |
|
|||
|
| |
2020
|
| |
2019
|
| |
Change
|
|
| |
(in USD thousands)
|
||||||
Financial income
|
| |
569
|
| |
1,306
|
| |
(737)
|
Financial expense
|
| |
(939)
|
| |
(73)
|
| |
(866)
|
Exchange differences
|
| |
(71)
|
| |
(68)
|
| |
(3)
|
Loss before taxes
|
| |
(169,829)
|
| |
(49,659)
|
| |
(120,170)
|
Income tax expense
|
| |
(204)
|
| |
(199)
|
| |
(5)
|
Loss for the year
|
| |
(170,033)
|
| |
(49,858)
|
| |
(120,175)
|
|
| |
Six Months Ended June 30,
|
| |
|
|||
|
| |
2020
|
| |
2019
|
| |
Change
|
|
| |
(in USD thousands)
|
||||||
Research and development expense, share-based compensation
|
| |
3,974
|
| |
93
|
| |
3,881
|
General and administrative expense, share-based compensation
|
| |
12,550
|
| |
47
|
| |
12,503
|
Convertible loans, derivatives, increase in fair value
|
| |
79,261
|
| |
—
|
| |
79,261
|
Convertible loans, first tranche, derivative, transaction costs
|
| |
1,571
|
| |
—
|
| |
1,571
|
|
| |
Six Months Ended June 30,
|
| |
|
|||
|
| |
2020
|
| |
2019
|
| |
Change
|
|
| |
(in USD thousands)
|
||||||
External costs(1)
|
| |
42,300
|
| |
36,041
|
| |
6,259
|
Employee expense(2)
|
| |
19,025
|
| |
10,531
|
| |
8,494
|
Research and development expense
|
| |
61,325
|
| |
46,572
|
| |
14,753
|
(1)
|
External costs include depreciation expense.
|
(2)
|
Employee expense includes share-based compensation expense.
|
|
| |
Six Months Ended June 30,
|
| |
|
|||
|
| |
2020
|
| |
2019
|
| |
Change
|
|
| |
(in USD thousands)
|
||||||
Lonca
|
| |
27,753
|
| |
18,820
|
| |
8,933
|
Cami
|
| |
19,655
|
| |
13,880
|
| |
5,775
|
ADCT-602
|
| |
1,471
|
| |
563
|
| |
908
|
ADCT-601
|
| |
2,400
|
| |
2,937
|
| |
(537)
|
Preclinical product candidates and research pipeline
|
| |
7,979
|
| |
9,177
|
| |
(1,198)
|
Not allocated to specific programs
|
| |
2,067
|
| |
1,195
|
| |
872
|
Research and development expense
|
| |
61,325
|
| |
46,572
|
| |
14,753
|
|
| |
Six Months Ended June 30,
|
| |
|
|||
|
| |
2020
|
| |
2019
|
| |
Change
|
|
| |
(in USD thousands)
|
||||||
External costs(1)
|
| |
8,401
|
| |
4,062
|
| |
4,339
|
Employee expense(2)
|
| |
19,108
|
| |
2,530
|
| |
16,578
|
General and administrative expense
|
| |
27,509
|
| |
6,592
|
| |
20,917
|
(1)
|
External costs include depreciation expense.
|
(2)
|
Employee expense includes share-based compensation expense.
|
|
| |
Six Months Ended June 30,
|
| |
|
|||
|
| |
2020
|
| |
2019
|
| |
Change
|
|
| |
(in USD thousands)
|
||||||
Other income
|
| |
278
|
| |
—
|
| |
278
|
Convertible loans, derivatives, increase in fair value
|
| |
(79,261)
|
| |
—
|
| |
(79,261)
|
Convertible loans, first tranche, derivative, transaction costs
|
| |
(1,571)
|
| |
—
|
| |
(1,571)
|
Financial income
|
| |
569
|
| |
1,306
|
| |
(737)
|
Financial expense
|
| |
(939)
|
| |
(73)
|
| |
(866)
|
Exchange differences
|
| |
(71)
|
| |
(68)
|
| |
(3)
|
Total other income (expense)
|
| |
(80,995)
|
| |
1,165
|
| |
(82,160)
|
|
| |
Year Ended December 31,
|
| |
|
|||
|
| |
2019
|
| |
2018
|
| |
Change
|
|
| |
(in USD thousands)
|
||||||
Contract revenue
|
| |
2,340
|
| |
1,140
|
| |
1,200
|
Research and development expense
|
| |
(107,537)
|
| |
(118,313)
|
| |
10,776
|
General and administrative expense
|
| |
(14,202)
|
| |
(8,768)
|
| |
(5,434)
|
Operating loss
|
| |
(119,399)
|
| |
(125,941)
|
| |
6,542
|
Other income
|
| |
1,655
|
| |
—
|
| |
1,655
|
Financial income
|
| |
2,253
|
| |
2,856
|
| |
(603)
|
Financial expense
|
| |
(156)
|
| |
—
|
| |
(156)
|
Exchange differences
|
| |
(255)
|
| |
213
|
| |
(468)
|
Loss before taxes
|
| |
(115,902)
|
| |
(122,872)
|
| |
6,970
|
Income tax expense
|
| |
(582)
|
| |
(224)
|
| |
(358)
|
Loss for the year
|
| |
(116,484)
|
| |
(123,096)
|
| |
6,612
|
|
| |
Year Ended December 31,
|
| |
|
|||
|
| |
2019
|
| |
2018
|
| |
Change
|
|
| |
(in USD thousands)
|
||||||
External costs
|
| |
81,363
|
| |
98,493
|
| |
(17,130)
|
Employee expenses
|
| |
24,916
|
| |
19,246
|
| |
5,670
|
Depreciation of property, plant and equipment
|
| |
407
|
| |
330
|
| |
77
|
Depreciation of right-of-use assets
|
| |
837
|
| |
—
|
| |
837
|
Amortization of intangible assets
|
| |
14
|
| |
17
|
| |
(3)
|
Impairment of intangible assets
|
| |
—
|
| |
227
|
| |
(227)
|
Research and development expense
|
| |
107,537
|
| |
118,313
|
| |
(10,776)
|
|
| |
Year Ended December 31,
|
| |
|
|||
|
| |
2019
|
| |
2018
|
| |
Change
|
|
| |
(in USD thousands)
|
||||||
Lonca
|
| |
42,123
|
| |
45,701
|
| |
(3,578)
|
Cami
|
| |
31,839
|
| |
29,374
|
| |
2,465
|
ADCT-602
|
| |
3,374
|
| |
6,162
|
| |
(2,788)
|
ADCT-601
|
| |
7,183
|
| |
14,250
|
| |
(7,067)
|
MEDI3726
|
| |
915
|
| |
2,389
|
| |
(1,474)
|
Preclinical product candidates and research pipeline
|
| |
22,103
|
| |
20,437
|
| |
1,666
|
Total
|
| |
107,537
|
| |
118,313
|
| |
(10,776)
|
|
| |
Year Ended December 31,
|
| |
|
|||
|
| |
2019
|
| |
2018
|
| |
Change
|
|
| |
(in USD thousands)
|
||||||
Employee expenses
|
| |
5,135
|
| |
4,936
|
| |
199
|
External costs
|
| |
8,668
|
| |
3,628
|
| |
5,040
|
General and administrative costs charged by related parties
|
| |
11
|
| |
38
|
| |
(27)
|
Depreciation of property, plant and equipment
|
| |
145
|
| |
158
|
| |
(13)
|
Depreciation of right-of-use assets
|
| |
227
|
| |
—
|
| |
227
|
Amortization of intangible assets
|
| |
16
|
| |
8
|
| |
8
|
General and administrative expenses
|
| |
14,202
|
| |
8,768
|
| |
5,434
|
|
| |
Six Months Ended June 30,
|
| |
|
|||
|
| |
2020
|
| |
2019
|
| |
Change
|
|
| |
(in USD thousands)
|
||||||
Net cash provided by (used in):
|
| |
|
| |
|
| |
|
Operating activities
|
| |
(72,688)
|
| |
(55,688)
|
| |
(17,000)
|
Investing activities
|
| |
(634)
|
| |
(1,907)
|
| |
1,273
|
Financing activities
|
| |
306,494
|
| |
100,931
|
| |
205,563
|
Net change in cash and cash equivalents
|
| |
233,172
|
| |
43,336
|
| |
189,836
|
|
| |
Year Ended December 31,
|
| |
|
|||
|
| |
2019
|
| |
2018
|
| |
Change
|
|
| |
(in USD thousands)
|
||||||
Net cash provided by (used in):
|
| |
|
| |
|
| |
|
Operating activities
|
| |
(121,581)
|
| |
(121,362)
|
| |
(219)
|
Investing activities
|
| |
(2,248)
|
| |
(2,506)
|
| |
258
|
Financing activities
|
| |
100,512
|
| |
(24)
|
| |
100,536
|
Net change in cash and cash equivalents
|
| |
(23,317)
|
| |
(123,892)
|
| |
100,575
|
•
|
the outcome, timing and costs of obtaining regulatory approvals for Lonca and for our other product candidates if the requisite clinical trials are successful;
|
•
|
the progress, results and costs of our confirmatory clinical trial of Lonca in combination with rituximab for the treatment of relapsed or refractory DLBCL;
|
•
|
the progress, results and costs of our Phase 1 and potentially pivotal Phase 2 clinical trials of our product candidates;
|
•
|
the progress, results and costs of any required confirmatory clinical trials of any product candidates that receive accelerated approval from the FDA or similar conditional approval from the EMA or comparable regulatory agencies in other jurisdictions;
|
•
|
the scope, progress, results and costs of researching and developing product candidates in our research pipeline, including conducting preclinical studies and clinical trials of such product candidates;
|
•
|
the costs of outsourced manufacturing of our product candidates, which are complex biological molecules, for clinical trials and in preparation for regulatory approval and commercialization;
|
•
|
the size of the markets for approved indications in territories in which we receive regulatory approval, if any;
|
•
|
the timing and costs of commercialization activities for our product candidates, if any are approved for sale, including establishing our sales and marketing capabilities and engaging in the marketing, sales and distribution of our product candidates;
|
•
|
the revenue, if any, received from the commercialization of our product candidates, if any are approved for sale;
|
•
|
our ability to maintain and establish collaboration, licensing or other arrangements and the financial terms of such agreements;
|
•
|
the costs involved in preparing, filing, prosecuting, maintaining, protecting and enforcing our intellectual property rights and claims, including any litigation costs and the outcome of such litigation;
|
•
|
the costs associated with potential product liability claims, including the costs associated with obtaining insurance against such claims and with defending against such claims;
|
•
|
the timing and amount of milestone payments we receive under our collaboration agreements;
|
•
|
the costs involved in maintaining and improving the technology we use in our product candidates;
|
•
|
our efforts to enhance operational systems and hire additional personnel, including personnel to support the development and commercialization of our product candidates and to satisfy our obligations as a public company;
|
•
|
the effect of competing technological and market developments; and
|
•
|
the types of available sources of private and/or public market financing.
|
|
| |
Payments Due By Period(1)
|
||||||||||||
|
| |
Total
|
| |
Less than
1 year
|
| |
1-3
years
|
| |
3-5
years
|
| |
More than
5 years
|
|
| |
(in USD thousands)
|
||||||||||||
Trade accounts payable
|
| |
3,329
|
| |
3,329
|
| |
—
|
| |
—
|
| |
—
|
Lease liabilities
|
| |
5,370
|
| |
1,246
|
| |
1,859
|
| |
1,204
|
| |
1,061
|
Total(2)
|
| |
8,699
|
| |
4,575
|
| |
1,859
|
| |
1,204
|
| |
1,061
|
(1)
|
The amounts of contractual obligations set forth in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts. The table does not include obligations under agreements that we can cancel without a significant penalty.
|
(2)
|
Excludes collaboration agreements described in the preceding paragraphs above.
|
•
|
including any market performance conditions;
|
•
|
excluding the impact of any service and non-market performance vesting conditions; and
|
•
|
including the impact of any non-vesting conditions.
|
|
| |
Six Months Ended
June 30, 2020
|
| |
Year Ended
December 31, 2019
|
Weighted average share price (in USD)
|
| |
15.95-34.99
|
| |
16.31
|
Strike price (in USD)
|
| |
18.75-34.99
|
| |
18.75
|
Expected volatility (%)
|
| |
85-206
|
| |
176.6
|
Award life (years)
|
| |
5.02-5.85
|
| |
5.65
|
Expected dividend yield (%)
|
| |
—
|
| |
—
|
Risk-free interest rate (%)
|
| |
0.36-0.70
|
| |
1.67
|
•
|
the amount of the initial measurement of lease liability;
|
•
|
any lease payments made at or before the commencement date less any lease incentives received;
|
•
|
any initial direct costs; and
|
•
|
restoration costs.
|
(i)
|
the first tranche of convertible loans in the amount of $65.0 million upon the completion of our initial public offering, and satisfaction of certain other conditions; and
|
(ii)
|
the second tranche of convertible loans in the amount of $50.0 million upon the receipt of regulatory approval for a specified product candidate, and satisfaction of certain other conditions.
|
•
|
The embedded conversion option derivative has been initially measured at fair value and is subsequently re-measured to fair value at each reporting date. Under IAS 32, this derivative could have been classified as a component of equity only if in all cases the contract would be settled by us delivering a fixed number of its own equity instruments in exchange for a fixed amount of cash or debt redemption. However, the agreement foresees, in the event of a major transaction, the payment of “make-whole” amounts that would have to be computed in the light of the circumstances and are therefore not fixed. As a result, the derivative is presented in the balance sheet as a liability and classified as non-equity in accordance with IFRS 9. Changes in the fair value (gains or losses) of the derivative at the end of each period are recorded in the consolidated statement of income.
|
•
|
The convertible loan’s initial fair value is the residual amount of the consideration received, net of attributable costs, after separating out the fair value of the embedded conversion option derivative. The loan is subsequently measured at its amortized cost in accordance with IFRS 9. It is presented in the consolidated balance sheet as a financial liability.
|
•
|
We are a pioneer in developing highly potent and targeted PBD-based ADCs. We believe that our team, with decades of experience in this field, is well positioned to develop and commercialize PBD-based ADCs for the benefit of patients with cancer.
|
•
|
Our two lead product candidates, Lonca and Cami, have consistently demonstrated robust single-agent clinical activity across a broad population of heavily pre-treated patients, while maintaining tolerability profiles that we believe are manageable. We submitted a BLA to the FDA for Lonca and are advancing the clinical development of Cami to support BLA submission.
|
•
|
We are advancing a broad pipeline of four clinical-stage product candidates and two preclinical product candidates addressing multiple areas of unmet medical need across hematological malignancies and solid tumors, leveraging our R&D strengths, our disciplined approach to target selection and our preclinical and clinical development strategy.
|
•
|
We retain exclusive worldwide development and commercialization rights to all of our product candidates other than Cami, for which we have a collaboration and license agreement with Genmab. Our commercial organization has initiated pre-launch market activities and is leveraging our team’s deep industry experience to maximize the commercial potential of any approved products.
|
•
|
Our experienced CMC team is highly proficient in the manufacturing of PBD-based ADCs and has developed a validated commercial supply chain that has been able to consistently produce Lonca at commercial scale.
|
•
|
Continue to prepare for the near-term commercial launch of Lonca, if approved. On September 21, 2020, we submitted a BLA to the FDA for Lonca for the treatment of relapsed or refractory DLBCL. If we receive accelerated approval, we intend to commence the commercial launch of Lonca in 2021. To prepare for commercial launch, we have successfully recruited an experienced Chief Commercial Officer and senior commercial leadership team. We intend to continue to prepare for the commercial launch of Lonca by further enhancing our commercial team and commercial capabilities, including by building a highly talented and efficient U.S. customer-facing organization of more than 65 cross-functional employees, which we believe has the potential to capture more than 80% of the DLBCL commercial opportunity.
|
•
|
Expand the potential market opportunity by advancing Lonca into earlier lines of therapy and for multiple indications. Based on the significant single-agent clinical activity and promising combination data with ibrutinib observed in clinical trials to date, we believe that Lonca has the opportunity to advance into earlier lines of therapy in combination with other therapies, including into first-line therapy. On September 21, 2020, we commenced a confirmatory clinical trial of Lonca in combination with rituximab, which, if successful, we believe will support an sBLA for Lonca to be used as a second-line therapy for the treatment of relapsed or refractory DLBCL in transplant-ineligible patients. In addition, to further expand Lonca’s potential market opportunity, we are conducting a Phase 1/2 clinical trial of Lonca in combination with ibrutinib for the treatment of relapsed or refractory DLBCL and MCL and intend to commence a pivotal Phase 2 clinical trial of Lonca for the treatment of relapsed or refractory FL in the first half of 2021.
|
•
|
Advance our second lead product candidate, Cami, to support BLA submission. Based on promising results from our 133-patient Phase 1 clinical trial, we are currently evaluating Cami in a pivotal Phase 2 clinical trial for the treatment of relapsed or refractory HL that, if successful, we believe will form the basis for a BLA submission.
|
•
|
Advance our two clinical-stage solid tumor product candidates to address multiple indications in areas of high unmet medical need. Our PBD-based ADCs have multiple mechanisms of action that we believe make them suitable for targeting solid tumors. We are therefore evaluating Cami, which targets the CD25-expressing Tregs that are part of the immunosuppressive tumor microenvironment, as a novel immuno-oncology approach for the treatment of various advanced solid tumors. We are also evaluating ADCT-601, which targets AXL-expressing solid tumors, for the treatment of various advanced solid tumors.
|
•
|
Continue to build a diverse and balanced portfolio of product candidates to address high unmet medical needs in oncology by leveraging our R&D strengths, our disciplined approach to target selection and our preclinical and clinical development strategy. In addition to the lead indications that we are pursuing for Lonca and Cami, we are also evaluating these two product candidates in various other disease settings, such as MCL and FL and, in the case of Cami, multiple solid tumors, both as monotherapies and when used in combination with other therapies. Furthermore, we are advancing our other product candidates, including ADCT-601 and ADCT-602, and research programs through preclinical and clinical development. To strike an optimized risk-reward balance, we intend to address both hematological malignancies and solid tumors, across both clinically validated and novel cancer targets.
|
•
|
Maximize the commercial potential of our product candidates through both our own commercial organization and strategic collaborations and licensing opportunities in select markets. We currently hold exclusive worldwide development and commercialization rights to all of our product candidates other than Cami, for which we have a collaboration and license agreement with Genmab. We intend to commercialize Lonca in the United States through our own infrastructure and may selectively pursue strategic collaborations and licensing opportunities in other geographies. We have an experienced team with substantial expertise in the commercialization of oncology products to support our commercialization efforts for Lonca, if approved, which will also serve as the foundation of our U.S. commercialization efforts for our other product candidates in our hematology franchise.
|
•
|
Selective Targeting. Traditional chemotherapies are unable to distinguish between healthy cells and tumor cells. As a result, these therapies typically have a narrow therapeutic window (i.e., the dose range that can treat disease effectively without causing unacceptable toxic side effects). In contrast, ADCs, through their use of antigen-specific antibodies, target tumor cells or other cells in the tumor microenvironment with greater selectivity than do traditional chemotherapies. This selective targeting allows ADCs to use potent cytotoxins at dose levels that otherwise would not be tolerable. As a result, ADCs can represent a highly effective treatment approach while maintaining manageable side effects.
|
•
|
Wide Addressable Patient Population. ADCs represent a treatment approach that expands the treatment options available to cancer patients. Many therapies are not appropriate for certain patient populations. For example, surgery is not used when the cancer is widespread, chemotherapy may not be appropriate when the patient is too sick to tolerate or does not respond to available chemotherapeutics, stem cell transplant may not be appropriate when the patient is frail, and some novel targeted therapies such as CAR-T (i.e., a type of treatment in which a patient’s T cells are modified in the laboratory so they will attack cancer cells) may not be appropriate when there is significant comorbidity. As a result of these limitations, there remains a significant unmet medical need for patients for whom other treatment options are inappropriate or ineffective.
|
•
|
Potential in Relapsed or Refractory Patients. Traditional therapies typically have limited effectiveness for patients who exhibit relapsed (i.e., the cancer returns after an initial positive response to treatment) or refractory (i.e., the cancer is resistant to treatment) cancers. In contrast, some ADCs have proven efficacious in such patient populations while maintaining a manageable tolerability profile. Therefore, ADCs represent an important part of the cancer treatment paradigm, expanding the treatment options available to patients suffering from relapsed or refractory cancers.
|
•
|
Cytotoxic Potency. The PBD dimer warheads used in our ADCs have been shown preclinically to be approximately 100 times more potent than warheads used in currently marketed ADCs, such as auristatin, maytansine and calicheamicin. The figure below shows the relative in vitro cytotoxic potency of various ADC warheads and common chemotherapeutics in comparison to a PBD dimer. Despite their potency, however, the PBD dimer warheads used in our ADCs have demonstrated a manageable tolerability profile in our preclinical studies and clinical trials to date.
|
•
|
Activity in Tumors with Low-Expressing Targets. Tumor cells typically require a threshold number of warhead molecules to be internalized for efficient cell killing. The high potency of our PBD-based warheads means that, compared to other warheads, fewer molecules of warhead should be needed to be internalized into the cancer cell to kill it. In cancer cells with low levels of antigen expression, ADCs with less potent warheads cannot bind in sufficient quantities to be effective. We believe that the potency of our PBD-based warheads may allow us to develop ADCs that target antigens with low expression levels in the tumor microenvironment, potentially increasing the range of cancers amenable to treatment with ADCs.
|
•
|
Durable Responses. Cross-links in DNA occur when an agent reacts with two nucleotides of DNA, forming a covalent linkage between them. The cross-links can occur in the same strand (i.e., intrastrand) or between opposite strands of DNA (i.e., interstrand). Our PBD-based ADCs create interstrand cross-links in the target cells’ DNA. These interstrand cross-links persist in target cells and can lie dormant, potentially for weeks. We believe that this allows our ADCs to target slowly proliferating cancer cells, including cancer stem cells. The persistence of the interstrand cross-links is explained by the fact that these cross-links do not distort the DNA helix. Cells have natural DNA repair mechanisms that detect structural changes to DNA, including those caused by cytotoxic warheads, and repair the DNA back to its original state. Warheads that create intrastrand cross-links, and even some warheads that create interstrand cross-links such as calicheamicin, distort the DNA helix, triggering the cells’ DNA repair mechanisms, thereby reducing their efficacy and leading to drug resistance. As PBD cross-links are non-distortive, they are designed to be able to evade the cells’ DNA repair mechanisms. In addition, tumor cells also induce the expression of certain transporter proteins (i.e., proteins that are able to transport warheads across the membrane outside the tumor cell) or the activation of detoxifying mechanisms that lead to inactive toxins. These potential resistance mechanisms limit traditional ADCs’
|
•
|
Bystander Effect. The bystander effect occurs when a released warhead is able to diffuse into and kill neighboring cells in the tumor microenvironment, irrespective of those cells’ antigen expression. Upon binding to the target antigen and internalization of our ADCs into the tumor cell, the warhead is designed to induce apoptosis. This is followed by the release of free PBD dimers into the tumor microenvironment. Since our PBD-based warheads are cell-permeable, they may be able to diffuse into adjacent cells and kill them in an antigen-independent manner. We believe that this may allow us to develop ADCs that target antigens with heterogeneous expression levels in the tumor microenvironment, potentially increasing the range of cancers amenable to treatment with ADCs. Once the PBD is released into circulation outside the tumor microenvironment, it is rapidly excreted with a short half-life, thus limiting overall systemic toxicity. We believe that this results in our ADCs’ bystander effect being controlled and generally limited to tumor cells.
|
•
|
Immunogenic Cell Death. PBD warheads have been observed to induce immunogenic cell death, whereby a cancer cell’s death expresses certain stress signals that induce the body’s anti-tumor immune response through the activation of T cells and antigen-presenting cells. This opens up the potential for combining our ADCs with other therapies, particularly with immuno-oncology therapies such as checkpoint inhibitors, that are specifically designed to activate the patient’s own immune system to combat cancer.
|
•
|
analysis of the relative overexpression of the target antigen on the membrane of cancer cells (as compared to healthy cells) and other target characteristics, such as internalization (i.e., how rapidly the antigen migrates from the membrane to the inside of the cell), recycling (i.e., whether or not the antigen recycles back to the membrane once internalized) and shedding (i.e., whether the antigen is cleaved off from the membrane to form a soluble antigen sink in the extracellular space and/or circulation) properties;
|
•
|
review of whether an ADC that targets the antigen has the potential to address a clear unmet medical need and whether there is an established development path with the potential for accelerated regulatory approval;
|
•
|
extensive in-house research and development focused on identifying preclinical in vivo activity and on- and off-target toxicity to determine the therapeutic index of a PBD-based ADC aimed at the antigen target; and
|
•
|
determination of the potential product candidate’s placement in the overall risk-reward profile of our portfolio.
|
•
|
selecting the clinical product candidate that represents the optimal combination of antibody, linker and PBD dimer. We compare multiple candidates with different combinations of the target-specific antibodies, linkers and linker positions, conjugation chemistry and the PBD warhead. Our objective is to nominate product candidates that exhibit the optimal balance between efficacy and safety in preclinical models.
|
•
|
advancing our product candidates through IND-enabling preclinical studies, focusing on rapid execution of required pharmacology studies, non-clinical toxicology and pharmacokinetic studies and cGMP manufacturing of Phase 1 clinical material. Our efficient approach to preclinical development is evidenced by the following:
|
○
|
We have consistently completed IND-enabling preclinical studies in 13 to 22 months following selection of the clinical product candidate.
|
○
|
Since 2015, we have submitted five INDs and worked with our collaborators to submit two additional INDs for our product candidates.
|
•
|
designing clinical trials to efficiently advance our product candidates towards regulatory submission and potential approval. Our clinical trials have the following features:
|
○
|
Our Phase 1 clinical trials enroll patients with different cancers that express the target antigen on the tumor cells or other cells in the tumor microenvironment. This allows us to conduct small dose-expansion studies simultaneously with dose-escalation studies, enabling signal searching and dose selection prior to concluding Phase 1 clinical trials. We have successfully used this method in our Phase 1 clinical trials of Lonca and Cami, which resulted in the early identification of DLBCL and HL as the initial indications to pursue in our pivotal Phase 2 clinical trials, respectively.
|
○
|
Our approach allows us to identify opportunities that may expand the market opportunity for our product candidates. For example, while we are pursuing DLBCL as the lead indication for Lonca, the data generated from the Phase 1 clinical trial has allowed us to efficiently advance pivotal clinical trials of Lonca for the treatment of other indications, such as MCL and FL.
|
○
|
Our Phase 1 clinical trials involve a wide range of dosing regimens. Because the PBD cross-links persist in tumor cells, it is important to find the dose levels and intervals that result in optimal tumor shrinkage while minimizing cumulative toxicities due to accumulation of the cross-links between doses. The wide range of dosing regimens in our Phase 1 clinical trials enables us to select the dose level to be used in pivotal clinical trials without the need for separate dose-range finding studies.
|
○
|
Our clinical trials are designed to balance risk and reward by enrolling patients with both cancers that are difficult to treat and those that are more responsive to treatment.
|
•
|
encouraging close collaboration between our preclinical and clinical teams. For example, when our clinical team provides emerging pharmacokinetic data to our preclinical team, this strengthens the predictive value of our preclinical animal models when switching between indications, such as from hematological tumors to solid tumors with Cami. Our preclinical team also analyze biomarkers that correlate with patient outcomes taken by our clinical team to monitor their pharmacodynamics effects and to inform patient selection and dosing strategies.
|
Patient Characteristics
|
| |
Polatuzumab vedotin (Polivy®)
in combination with rituximab
plus bendamustine
|
| |
Tafasitamab (Monjuvi®)
in combination with
lenalidomide
|
Median Number of Prior Lines of Therapy
|
| |
2
|
| |
2
|
SCT eligible
|
| |
Not Included
|
| |
Not Included
|
Primary refractory disease
|
| |
*
|
| |
Not Included***
|
Double-hit and triple-hit DLBCL
|
| |
Not Included
|
| |
Not Included
|
Transformed disease
|
| |
Not Included
|
| |
*
|
Bulky disease
|
| |
Included
|
| |
*
|
Prior treatment with CAR-T
|
| |
*
|
| |
Not Included
|
Prior treatment with SCT
|
| |
Included
|
| |
Included
|
Best Overall Response (%)
|
| |
Polatuzumab
vedotin
(Polivy®)**
|
| |
Tafasitamab
(Monjuvi®)**
|
| |
Polatuzumab
vedotin
(Polivy®) in
combination
with rituximab
plus bendamustine
|
| |
Tafasitamab
(Monjuvi®)
in combination
with lenalidomide
|
| |
Selinexor
(XPOVIO®)
|
Complete response (CR)
|
| |
15%
|
| |
6%
|
| |
50%
|
| |
37%
|
| |
13%
|
Partial response (PR)
|
| |
37%
|
| |
20%
|
| |
13%
|
| |
18%
|
| |
16%
|
Overall response rate (CR + PR)
|
| |
52%
|
| |
26%
|
| |
63%
|
| |
55%
|
| |
29%
|
Common Grade ≥3
TEAEs reported in ≥5% of patients (%)
|
| |
Polatuzumab
vedotin
(Polivy®)**
|
| |
Tafasitamab
(Monjuvi®)**
|
| |
Polatuzumab
vedotin
(Polivy®) in
combination
with rituximab
plus bendamustine
|
| |
Tafasitamab
(Monjuvi®)
in combination
with lenalidomide
|
| |
Selinexor
(XPOVIO®)
|
Neutropenia
|
| |
40%
|
| |
17%
|
| |
42%
|
| |
49%
|
| |
*
|
Anemia
|
| |
11%
|
| |
9%
|
| |
24%
|
| |
7%
|
| |
*
|
Peripheral sensory neuropathy
|
| |
9%
|
| |
26%
|
| |
*
|
| |
*
|
| |
*
|
Thrombocytopenia
|
| |
*
|
| |
6%
|
| |
40%
|
| |
17%
|
| |
*
|
Lymphopenia
|
| |
*
|
| |
*
|
| |
13%
|
| |
*
|
| |
*
|
Febrile neutropenia
|
| |
*
|
| |
*
|
| |
11%
|
| |
12%
|
| |
*
|
Pneumonia
|
| |
*
|
| |
*
|
| |
16%
|
| |
7%
|
| |
*
|
Fatigue
|
| |
*
|
| |
*
|
| |
*
|
| |
*
|
| |
15%
|
Nausea
|
| |
*
|
| |
*
|
| |
*
|
| |
*
|
| |
6%
|
TEAEs leading to treatment discontinuation
|
| |
*
|
| |
*
|
| |
31%
|
| |
15%
|
| |
17%
|
|
| |
Duvelisib
(Copiktra®)
|
| |
Copanlisib
(Aliqopa®)
|
| |
Idelalisib
(Zydelig®)
|
| |
Obinutuzumab
(Gazyva®) in
combination with
bendamustine
|
| |
Lenalidomide
(Revlimid®) in
combination
with rituximab
|
Complete response (CR)
|
| |
1.2%
|
| |
14.4%
|
| |
8.3%
|
| |
15.5%
|
| |
35%-46%
|
Partial response (PR)
|
| |
41.0%
|
| |
44.2%
|
| |
45.8%
|
| |
63.2%
|
| |
28%-46%
|
Overall response rate (CR + PR)
|
| |
42.2%
|
| |
58.7%
|
| |
54.2%
|
| |
78.7%
|
| |
74%-80%
|
Median duration of response
|
| |
*
|
| |
12.2 months
|
| |
not reached
|
| |
not reached
|
| |
36.6 months -
not reached
|
•
|
We retain exclusive worldwide development and commercialization rights to Lonca. We intend to commercialize Lonca in the United States through our own infrastructure and may selectively pursue strategic collaborations and licensing opportunities in other geographies.
|
•
|
On September 21, 2020, we submitted a BLA to the FDA for Lonca for the treatment of relapsed or refractory DLBCL and commenced a confirmatory clinical trial of Lonca in combination with rituximab, which, if successful, we believe will support an sBLA for Lonca to be used as a second-line therapy for the treatment of relapsed or refractory DLBCL in transplant-ineligible patients.
|
•
|
We completed enrollment of a 145-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory DLBCL.
|
○
|
As of April 2020, we observed a 48.3% ORR and a 24.1% CRR in 145 heavily pre-treated patients who had received a median of three prior lines of therapy. The median duration of response was 10.25 months.
|
○
|
Lonca’s significant clinical activity was observed across a broad patient population in this clinical trial, including patients with primary refractory disease, bulky disease, double-hit or triple-hit disease and transformed disease, as well as elderly patients and patients who did not respond to any prior therapy.
|
•
|
Lonca is also being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of relapsed or refractory DLBCL and MCL.
|
○
|
As of April 6, 2020, at the dose being used in the pivotal Phase 2 part of the clinical trial, we observed a 75.0% ORR and a 58.3% CRR in heavily pre-treated evaluable DLBCL patients who had received a median of two prior lines of therapy.
|
•
|
We also intend to commence an additional pivotal Phase 2 clinical trial of Lonca for the treatment of FL in the first half of 2021.
|
○
|
In the Phase 1 clinical trial of Lonca for the treatment of relapsed or refractory B-NHL, we observed a 78.6% ORR and a 64.3% CRR in heavily pre-treated patients with relapsed or refractory FL who had received a median of four prior lines of therapy.
|
•
|
Favorable clinical activity across a broad patient population, including transplant eligible and ineligible patients, patients who have not responded to first-line therapy or any prior therapy and patients with bulky disease, double-hit and triple-hit disease and transformed disease;
|
•
|
Significant single-agent clinical activity while maintaining a manageable tolerability profile with a low incidence of febrile neutropenia;
|
•
|
Activity in heavily pretreated patients, including those who had received prior CD19 therapies, including CAR-T, and SCT;
|
•
|
Promising clinical activity observed in our combination clinical trial with ibrutinib, which we believe demonstrates the opportunity to advance Lonca into earlier lines of therapy in combination with other therapies such as ibrutinib and rituximab; and
|
•
|
30-minute intravenous infusions once every three weeks.
|
•
|
Our successful recruitment of an experienced Chief Commercial Officer and senior commercial leadership team, including a Vice President of Sales, a Vice President of Marketing and a Vice President of Market Access, with broader organizational recruitment underway;
|
•
|
Our successful recruitment of a Vice President of Medical Affairs, with broader organizational recruitment underway, including field-based medical science liaisons;
|
•
|
Investing resources to assess the competitive landscape, supporting our differentiated profile and accelerating our launch readiness efforts;
|
•
|
Increased scientific interactions with Key Opinion Leaders; and
|
•
|
Our plans to build a highly talented and efficient U.S. customer-facing organization of more than 65 cross-functional employees, which we believe has the potential to capture more than 80% of the DLBCL commercial opportunity.
|
•
|
CD19 is a clinically validated target for the treatment of B cell malignancies.
|
•
|
CD19 is expressed in B cell lineage at an earlier stage compared to CD20, which is another well-known target for the treatment of hematological malignancies.
|
•
|
The CD19 antigen is rapidly internalized by the cell. Therefore, it is an effective target for ADC therapy since ADCs bind only to antigens on the cell surface and the ADCs must be internalized to release the warhead inside the cell.
|
•
|
The CD19 antigen does not shed into the circulation. Therefore, there are no, or very low, levels of soluble CD19 to compete for binding of the ADC.
|
Patient Characteristics
|
| |
|
| |
|
|||
Age, median (minimum, maximum)
|
| |
63
|
| |
(20, 87)
|
|||
Number of previous systemic therapies received, median (minimum, maximum)
|
| |
3
|
| |
(1, 13)
|
|||
Response to first-line systemic therapy, n (%)
|
| |
Relapsed
|
| |
115
|
| |
(62.8)
|
|
| |
Refractory
|
| |
43
|
| |
(23.5)
|
Response to last-line prior systemic therapy, n (%)
|
| |
Relapsed
|
| |
66
|
| |
(36.1)
|
|
| |
Refractory
|
| |
109
|
| |
(59.6)
|
Prior stem cell transplant, n (%)
|
| |
Yes
|
| |
42
|
| |
(23.0)
|
|
| |
No
|
| |
141
|
| |
(77.0)
|
•
|
The MTD was not reached in the dose escalation stage.
|
•
|
Grade ≥3 TEAEs were reported in 108 patients, or 77.7% of patients. The table below presents the most common Grade ≥3 TEAEs that were reported in more than 5% of patients.
|
Grade ≥3 TEAEs*, n (%)
|
| |
Dose Levels
|
||||||||||||
|
≤90 µg/kg
(n=10)
|
| |
120 µg/kg
(n=32)
|
| |
150 µg/kg
(n=70)
|
| |
200 µg/kg
(n=27)
|
| |
All Doses
(n=139)
|
||
Neutrophil count decreased**
|
| |
2 (20.0)
|
| |
10 (31.2)
|
| |
26 (37.1)
|
| |
15 (55.6)
|
| |
53 (38.1)
|
Platelet count decreased**
|
| |
1 (10.0)
|
| |
7 (21.9)
|
| |
18 (25.7)
|
| |
11 (40.7)
|
| |
37 (26.6)
|
Gamma-glutamyltransferase increased
|
| |
1 (10.0)
|
| |
7 (21.9)
|
| |
12 (17.1)
|
| |
7 (25.9)
|
| |
27 (19.4)
|
Anemia
|
| |
2 (20.0)
|
| |
3 (9.4)
|
| |
11 (15.7)
|
| |
3 (11.1)
|
| |
19 (13.7)
|
Disease progression
|
| |
0 (0.0)
|
| |
2 (6.3)
|
| |
8 (11.4)
|
| |
0 (0.0)
|
| |
10 (7.2)
|
Hypokalemia
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
8 (11.4)
|
| |
1 (3.7)
|
| |
9 (6.5)
|
Alkaline phosphatase increased
|
| |
1 (10.0)
|
| |
3 (9.4)
|
| |
3 (4.3)
|
| |
1 (3.7)
|
| |
8 (5.8)
|
Lymphocyte count decreased
|
| |
0 (0.0)
|
| |
2 (6.3)
|
| |
4 (5.7)
|
| |
2 (7.4)
|
| |
8 (5.8)
|
Alanine aminotransferase increased
|
| |
0 (0.0)
|
| |
2 (6.3)
|
| |
3 (4.3)
|
| |
2 (7.4)
|
| |
7 (5.0)
|
Fatigue
|
| |
0 (0.0)
|
| |
2 (6.3)
|
| |
2 (2.9)
|
| |
3 (11.1)
|
| |
7 (5.0)
|
White blood cell count decreased
|
| |
0 (0.0)
|
| |
2 (6.3)
|
| |
3 (4.3)
|
| |
2 (7.4)
|
| |
7 (5.0)
|
Patients with any Grade ≥3 TEAEs
|
| |
4 (40.0)
|
| |
24 (75.0)
|
| |
56 (80.0)
|
| |
24 (88.9)
|
| |
108 (77.7)
|
•
|
TEAEs in 26 patients, or 18.7% of patients, led to treatment discontinuation.
|
•
|
Across all dose levels, 32 patients, or 23.4% of patients, achieved a complete response and another 26 patients, or 19.0% of patients, achieved a partial response, resulting in a 42.3% ORR. At dose levels ≥120 μg/kg, 31 patients, or 24.4% of patients, achieved a complete response and another 25 patients, or 19.7% of patients, achieved a partial response, resulting in a 44.1% ORR. The table below shows the response rate data from this clinical trial.
|
Best Overall Response, n (%)
|
| |
Dose Levels
|
||||||||||||
|
≤90 µg/kg
(n=10)
|
| |
120 µg/kg
(n=32)
|
| |
150 µg/kg
(n=70)
|
| |
200 µg/kg
(n=25)
|
| |
All Doses
(n=137)
|
||
Complete response (CR)
|
| |
1 (10.0)
|
| |
6 (18.8)
|
| |
15 (21.4)
|
| |
10 (40.0)
|
| |
32 (23.4)
|
Partial response (PR)
|
| |
1 (10.0)
|
| |
8 (25.0)
|
| |
14 (20.0)
|
| |
3 (12.0)
|
| |
26 (19.0)
|
Stable disease
|
| |
2 (20.0)
|
| |
7 (21.9)
|
| |
12 (17.1)
|
| |
2 (8.0)
|
| |
23 (16.8)
|
Progressive disease
|
| |
6 (60.0)
|
| |
10 (31.3)
|
| |
28 (40.0)
|
| |
10 (40.0)
|
| |
54 (39.4)
|
Not evaluable
|
| |
0 (0.0)
|
| |
1 (3.1)
|
| |
1 (1.4)
|
| |
0 (0.0)
|
| |
2 (1.5)
|
Overall response rate (CR + PR)
|
| |
2 (20.0)
|
| |
14 (43.8)
|
| |
29 (41.4)
|
| |
13 (52.0)
|
| |
58 (42.3)
|
•
|
In our post-hoc subset analysis that excluded patients with double-hit or triple-hit disease and patients with primary refractory and early relapsed disease, at dose levels ≥120 μg/kg, 18 patients, or 45.0% of patients, achieved a complete response and another eight patients, or 20.0% of patients, achieved a partial response, resulting in a 65.0% ORR.
|
•
|
Lonca’s favorable clinical activity was observed across a broad patient population in this clinical trial, including transplant eligible and ineligible patients, patients who have not responded to first-line
|
Tumor Characteristics
|
| |
Overall Response Rate,
responders/total (%)
|
Bulky disease*
|
| |
4/18 (22.2), including 2/18 (11.1) CR
|
Double-hit or triple-hit disease**
|
| |
5/22 (22.7), including 3/22 (13.6) CR
|
Transformed disease***
|
| |
16/31 (51.6), including 9/31 (29.0) CR
|
Age
|
| |
Overall Response Rate,
responders/total (%)
|
Less than 65
|
| |
25/69 (36.2), including 16/69 (23.2) CR
|
65-74
|
| |
18/36 (50.0), including 11/36 (30.6) CR
|
More than 74
|
| |
13/22 (59.1), including 4/22 (18.2) CR
|
Response to Prior Therapy
|
| |
Overall Response Rate,
responders/total (%)
|
|||
Response to first-line systemic therapy
|
| |
Complete response
|
| |
32/49 (65.3)
|
|
| |
Partial response
|
| |
12/33 (36.4)
|
|
| |
Any response
|
| |
44/82 (53.7)
|
|
| |
No response
|
| |
12/44 (27.3)
|
Response to last-line prior systemic therapy
|
| |
Complete response
|
| |
16/21 (76.2)
|
|
| |
Partial response
|
| |
9/24 (37.5)
|
|
| |
Any response
|
| |
25/45 (55.6)
|
|
| |
No response
|
| |
31/82 (37.8)
|
•
|
Across all dose levels, the median DoR was not reached for patients who achieved a complete response (indicating that more than half of the patients continued to show a complete response as of their most recent assessment) and 2.86 months for patients who achieved a partial response, for an overall DoR of 4.47 months. At dose levels ≥120 µg/kg, the median DoR was not reached for patients who achieved a complete response (indicating that more than half of the patients continued to show a complete response as of their most recent assessment) and was 2.69 months for patients who achieved a partial response, for an overall DoR of 4.17 months. The figure below shows the DoR by response at dose levels ≥120 µg/kg.
|
•
|
In our post-hoc subset analysis that excluded patients with double-hit or triple-hit disease and patients with primary refractory and early relapsed disease, at dose levels ≥120 μg/kg, the median DoR was 10.6 months for patients who achieved a complete response and was 2.1 months for patients who achieved a partial response, for an overall DoR of 4.1 months.
|
•
|
Across all dose levels, five patients, or 33.3% of patients, achieved a complete response and another two patients, or 13.3% of patients, achieved a partial response, resulting in a 46.7% ORR.
|
•
|
The median DoR was not reached (indicating that more than half of the patients continued to show a complete response as of their most recent assessment).
|
•
|
Across all dose levels, nine patients, or 64.3% of patients, achieved a complete response and another two patients, or 14.3% of patients, achieved a partial response, resulting in a 78.6% ORR.
|
•
|
The median DoR was not reached (indicating that more than half of the patients continued to show a complete response as of their most recent assessment).
|
Patient Characteristics
|
| |
|
| |
|
|||
Age, median (minimum, maximum)
|
| |
66
|
| |
(23, 94)
|
|||
Histology, n (%)
|
| |
DLBCL Not otherwise specified
|
| |
127
|
| |
(87.6)
|
|
| |
HGBCL*
|
| |
11
|
| |
(7.6)
|
|
| |
PMBCL**
|
| |
7
|
| |
(4.8)
|
Cancer characteristic, n (%)
|
| |
Double-hit or triple-hit disease***
|
| |
15
|
| |
(10.3)
|
|
| |
Double/triple expressor
|
| |
20
|
| |
(13.8)
|
|
| |
Transformed disease****
|
| |
29
|
| |
(20.0)
|
Disease stage*****, n (%)
|
| |
I-II
|
| |
33
|
| |
(22.8)
|
|
| |
III-IV
|
| |
112
|
| |
(77.2)
|
Number of previous systemic therapies received, median (minimum, maximum)
|
| |
3
|
| |
(2, 7)
|
|||
Response to first-line systemic therapy, n (%)
|
| |
Relapsed
|
| |
99
|
| |
(68.3)
|
|
| |
Refractory
|
| |
29
|
| |
(20.0)
|
Response to last-line prior systemic therapy, n (%)
|
| |
Relapsed
|
| |
43
|
| |
(29.7)
|
|
| |
Refractory
|
| |
84
|
| |
(57.9)
|
Refractory to all prior systemic therapies, n (%)
|
| |
Yes
|
| |
25
|
| |
(17.2)
|
|
| |
No
|
| |
115
|
| |
(79.3)
|
Prior stem cell transplant, n (%)
|
| |
Autologous stem cell transplant
|
| |
21
|
| |
(14.5)
|
|
| |
Allogeneic stem cell transplant
|
| |
2
|
| |
(1.4)
|
|
| |
Both autologous and allogeneic stem cell transplant
|
| |
1
|
| |
(0.7)
|
|
| |
No
|
| |
121
|
| |
(83.4)
|
•
|
Grade ≥3 TEAEs were reported in 105 patients, or 72.4% of patients. The table below presents the most common Grade ≥3 TEAEs that were reported in more than 10% of patients.
|
Grade ≥3 TEAEs*, n (%)
|
| |
All Patients
(n=145)
|
Neutropenia
|
| |
37 (25.5)
|
Thrombocytopenia
|
| |
26 (17.9)
|
Gamma-glutamyltransferase increased
|
| |
24 (16.6)
|
Anemia
|
| |
15 (10.3)
|
Patients with any Grade ≥3 TEAEs
|
| |
105 (72.4)
|
•
|
Thirty-five patients, or 24.1% of patients, achieved a complete response and another 35 patients, or 24.1% of patients, achieved a partial response, resulting in a 48.3% ORR. The table below shows the response rate data.
|
|
| |
Histology
|
|||||||||
Best Overall Response, n (%)
|
| |
DLBCL-NOS
(n=127)
|
| |
HGBCL
(n=11)
|
| |
PMBCL
(n=7)
|
| |
All Patients
(n=145)
|
Complete response (CR)
|
| |
30 (23.6)
|
| |
5 (45.5)
|
| |
0 (0.0)
|
| |
35 (24.1)
|
Partial response (PR)
|
| |
34 (26.8)
|
| |
0 (0.0)
|
| |
1 (14.3)
|
| |
35 (24.1)
|
Stable disease
|
| |
20 (15.7)
|
| |
1 (9.1)
|
| |
1 (14.3)
|
| |
22 (15.2)
|
Progressive disease
|
| |
23 (18.1)
|
| |
4 (36.4)
|
| |
3 (42.9)
|
| |
30 (20.7)
|
Not evaluable
|
| |
20 (15.7)
|
| |
1 (9.1)
|
| |
2 (28.6)
|
| |
23 (15.9)
|
Overall response rate (CR + PR)
|
| |
64 (50.4)
|
| |
5 (45.5)
|
| |
1 (14.3)
|
| |
70 (48.3)
|
•
|
Lonca’s favorable clinical activity was observed across a broad patient population in this clinical trial, including transplant eligible and ineligible patients, patients who have not responded to first-line therapy or any prior therapy, patients with bulky disease, double-hit and triple-hit disease and transformed disease and patients who had received prior CD19 therapies and SCT. The tables below show the effect of tumor characteristics, age, response to prior therapy and prior therapy (i.e., stem cell transplant or CAR-T) on response rate data.
|
Tumor Characteristics
|
| |
Overall Response Rate,
responders/total (%)
|
Double-hit or triple-hit disease
|
| |
5/15 (33.3)
|
Transformed disease
|
| |
13/29 (44.8)
|
Double/triple expressor
|
| |
10/20 (50.0)
|
Germinal center B-cell DLBCL
|
| |
26/48 (54.2)
|
Activated B-cell DLBCL
|
| |
11/23 (47.8)
|
Age
|
| |
Overall Response Rate,
responders/total (%)
|
Less than 65
|
| |
32/65 (49.2)
|
More than or equal to 65
|
| |
38/80 (47.5)
|
Response to Prior Therapy
|
| |
Overall Response Rate,
responders/total (%)
|
|||
Response to first-line systemic therapy
|
| |
Refractory
|
| |
11/29 (37.9), including 5/29 (17.2) CR
|
|
| |
Relapsed
|
| |
53/99 (53.5)
|
Response to prior last-line systemic therapy
|
| |
Refractory
|
| |
31/84 (36.9), including 10/84 (11.9) CR
|
|
| |
Relapsed
|
| |
29/43 (67.4)
|
Response to any prior line systemic therapy
|
| |
Refractory
|
| |
9/25 (36.0)
|
|
| |
Relapsed
|
| |
60/115 (52.2)
|
Prior Therapy
|
| |
Overall Response Rate,
responders/total (%)
|
Stem cell transplant
|
| |
14/24 (58.3)
|
•
|
The median DoR was 10.25 months for patients who achieved a response. The figure below shows the DoR.
|
Patient Characteristics
|
| |
|
|||
Age, median (minimum, maximum)
|
| |
69 (39, 87)
|
|||
ECOG performance status*, n (%)
|
| |
0
|
| |
14 (56.0)
|
|
| |
1
|
| |
8 (32.0)
|
|
| |
2
|
| |
3 (12.0)
|
NHL subtype, n (%)
|
| |
Double-hit or triple-hit DLBCL**
|
| |
1 (4.0)
|
|
| |
Double expressor
|
| |
3 (12.0)
|
|
| |
Transformed DLBCL***
|
| |
2 (8.0)
|
|
| |
Total DLBCL
|
| |
23 (92.0)
|
|
| |
MCL
|
| |
2 (8.0)
|
Disease stage****, n (%)
|
| |
Stage II
|
| |
3 (12.0)
|
|
| |
Stage III
|
| |
3 (12.0)
|
|
| |
Stage IV
|
| |
19 (76.0)
|
Number of previous systemic therapies received, median (minimum, maximum)
|
| |
2 (1, 5)
|
|||
Response to first-line systemic therapy, n (%)
|
| |
Relapsed
|
| |
18 (72.0)
|
|
| |
Refractory
|
| |
5 (20.0)
|
Response to last-line systemic therapy, n (%)
|
| |
Relapsed
|
| |
11 (44.0)
|
|
| |
Refractory
|
| |
12 (48.0)
|
Prior stem cell transplant, n (%)
|
| |
Autologous stem cell transplant
|
| |
1 (4.0)
|
|
| |
Allogeneic stem cell transplant
|
| |
2 (8.0)
|
|
| |
No
|
| |
22 (88.0)
|
•
|
Grade ≥3 TEAEs were reported in 14 patients, or 56.0% of patients. The table below presents the most common Grade ≥3 TEAEs that were reported in more than 5% of patients.
|
Grade ≥3 TEAEs*, n (%)
|
| |
All Doses
(n=25)
|
Thrombocytopenia
|
| |
5 (20.0)
|
Anemia
|
| |
3 (12.0)
|
Patients with any Grade ≥3 TEAEs
|
| |
14 (56.0)
|
•
|
TEAEs in four patients, or 16.0% of patients, led to treatment discontinuation.
|
•
|
One DLT of Death Not Otherwise Specified was observed in a patient treated with Lonca at the 90 µg/kg dose level in combination with ibrutinib, which the investigator assessed as unlikely to be related to Lonca and as possibly being related to ibrutinib, the disease and/or comorbidities. One DLT of anemia and thrombocytopenia was observed in a patient treated with Lonca at the 90 µg/kg dose level in combination with ibrutinib, which the investigator assessed as possibly being related to Lonca, ibrutinib, the disease and/or comorbidities.
|
•
|
Across all dose levels, nine patients, or 50.0% of patients, achieved a complete response and another three patients, or 16.7% of patients, achieved a partial response, resulting in a 66.7% ORR. At the 60 μg/kg dose level, which is being used in the pivotal Phase 2 portion of the clinical trial, seven patients, or 58.3% of patients, achieved a complete response and another two patients, or 16.7% of patients, achieved a partial response, resulting in a 75.0% ORR. The table below shows the response rate data from this clinical trial.
|
|
| |
Dose Levels
|
||||||
Best Overall Response, n (%)
|
| |
Lonca 60 µg/kg
+ ibrutinib
(n=12)
|
| |
Lonca 90 µg/kg
+ ibrutinib
(n=6)
|
| |
All Doses
(n=18)
|
Complete response (CR)
|
| |
7 (58.3)
|
| |
2 (33.3)
|
| |
9 (50.0)
|
Partial response (PR)
|
| |
2 (16.7)
|
| |
1 (16.7)
|
| |
3 (16.7)
|
Stable disease
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Progressive disease
|
| |
3 (25.0)
|
| |
3 (50.0)
|
| |
6 (33.3)
|
Overall response rate (CR + PR)
|
| |
9 (75.0)
|
| |
3 (50.0)
|
| |
12 (66.7)
|
•
|
The graph below shows the time to response for each patient.
|
•
|
We retain worldwide development and commercialization rights to Cami, subject to our collaboration and license agreement with Genmab.
|
•
|
We are advancing Cami through clinical development to support a BLA submission for the treatment of relapsed or refractory HL.
|
•
|
Cami is being evaluated in a 100-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory HL, for which we anticipate reporting top-line response rate data in the first half of 2021.
|
○
|
As of June 30, 2020, 47 patients have been enrolled in this pivotal Phase 2 clinical trial.
|
•
|
Enrollment has been completed in a 133-patient Phase 1 clinical trial of Cami for the treatment of relapsed or refractory HL and NHL, including 77 patients with relapsed or refractory HL. In this clinical trial, Cami demonstrated significant clinical activity across a broad patient population and maintained a tolerability profile that we believe was manageable. More specifically, as of April 2019, we observed:
|
○
|
At the initial dose for our pivotal Phase 2 clinical trial, an 86.5% ORR and a 48.6% CRR in heavily pre-treated patients with relapsed or refractory HL who had received a median of five prior lines of therapy, including patients who were relapsed or refractory to any or all of brentuximab vedotin, checkpoint inhibitors and stem cell transplant; and
|
○
|
A 44.0% ORR and an 8.0% CRR in heavily pre-treated patients with relapsed or refractory T-cell lymphoma who had received a median of four prior lines of therapy.
|
•
|
Cami is also being evaluated in a Phase 1b clinical trial for the treatment of selected advanced solid tumors by targeting Tregs.
|
○
|
In paired biopsies from three of six patients in the Phase 1b clinical trial, we have observed a significant increase in the ratio of Teffs to Tregs.
|
○
|
Preliminary PK/PD data indicate that treatment with Cami was associated with clinically relevant modulation of immune cells, both in the circulation and in tumor tissue.
|
•
|
At the initial dose for our pivotal Phase 2 clinical trial, an 86.5% ORR and a 48.6% CRR in heavily pre-treated patients with relapsed or refractory HL who were relapsed or refractory to any or all of brentuximab vedotin, checkpoint inhibitors and stem cell transplant;
|
•
|
Tolerability profile that we believe is manageable;
|
•
|
The potential opportunity to advance Cami into earlier lines of therapy as a monotherapy or in combination with other therapies;
|
•
|
Novel immuno-oncology approach targeting Tregs for the treatment of various advanced solid tumors; and
|
•
|
30-minute intravenous infusions once every three weeks.
|
•
|
CD25 expression in healthy human tissue is mainly limited to activated T cells and activated B cells.
|
•
|
CD25 is expressed in a wide range of hematological malignancies.
|
•
|
The importance of CD25 overexpression as a prognosticator in hematological malignancies has been shown in multiple indications, including DLBCL.
|
•
|
CD25 positive Treg cells have been shown to play a role in undermining anti-tumor immune functions.
|
•
|
The safety profiles of monoclonal antibodies directed against CD25 have been well characterized.
|
•
|
Clinical proof of concept for treatment of CD25 positive malignancies has been established using radio-immunoconjugates and immunotoxins incorporating the anti-CD25 antibodies.
|
Patient Characteristics
|
| |
|
| |
|
| |
|
Age, median (minimum, maximum)
|
| |
52
|
| |
(19, 88)
|
|||
Number of previous systemic therapies received, median (minimum, maximum)
|
| |
5
|
| |
(1, 15)
|
|||
Prior stem cell transplant, n (%)
|
| |
Yes
|
| |
57
|
| |
(44.5)
|
|
| |
No
|
| |
71
|
| |
(55.5)
|
Patient Characteristics of HL Patients
|
| |
|
| |
|
| |
|
Age, median (minimum, maximum)
|
| |
38
|
| |
(19, 80)
|
|||
Number of previous systemic therapies received, median (minimum, maximum)
|
| |
5
|
| |
(2, 15)
|
|||
Prior stem cell transplant, n (%)
|
| |
Autologous stem cell transplant
|
| |
39
|
| |
(50.6)
|
|
| |
Allogeneic stem cell transplant
|
| |
3
|
| |
(3.9)
|
|
| |
Both autologous and allogeneic stem cell transplant
|
| |
5
|
| |
(6.5)
|
|
| |
No
|
| |
30
|
| |
(39.0)
|
•
|
The MTD was not reached in the dose escalation stage.
|
•
|
Grade ≥3 TEAEs were reported in 51 patients, or 66.2% of patients. The table below presents the most common Grade ≥3 TEAEs that are reported in more than 5% of patients.
|
Grade ≥3 TEAEs, n (%)
|
| |
Dose Levels
|
||||||||||||
|
≤20 µg/kg
(n=3)
|
| |
30 µg/kg
(n=20)
|
| |
45 µg/kg
(n=37)
|
| |
≥60 µg/kg
(n=17)
|
| |
All Doses
(n=77)
|
||
Gamma-glutamyltransferase increased
|
| |
1 (33.3)
|
| |
2 (10.0)
|
| |
3 (8.1)
|
| |
7 (41.2)
|
| |
13 (16.9)
|
Maculopapular rash
|
| |
1 (33.3)
|
| |
2 (10.0)
|
| |
8 (21.6)
|
| |
2 (11.8)
|
| |
13 (16.9)
|
Alanine aminotransferase increased
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
3 (8.1)
|
| |
4 (23.5)
|
| |
7 (9.1)
|
Anemia
|
| |
1 (33.3)
|
| |
2 (10.0)
|
| |
3 (8.1)
|
| |
0 (0.0)
|
| |
6 (7.8)
|
Aspartate aminotransferase increased
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
1 (2.7)
|
| |
4 (23.5)
|
| |
5 (6.5)
|
Guillain–Barré syndrome/polyradiculopathy
|
| |
0 (0.0)
|
| |
1 (5.0)
|
| |
3 (8.1)
|
| |
1 (5.9)
|
| |
5 (6.5)
|
Lipase increased
|
| |
0 (0.0)
|
| |
1 (5.0)
|
| |
3 (8.1)
|
| |
0 (0.0)
|
| |
4 (5.2)
|
Patients with any Grade ≥3 TEAEs
|
| |
2 (66.7)
|
| |
12 (60.0)
|
| |
25 (67.6)
|
| |
12 (70.6)
|
| |
51 (66.2)
|
•
|
TEAEs in 20 patients, or 26.0% of patients, led to treatment discontinuation.
|
•
|
Across all dose levels, 30 patients, or 40.0% of patients, achieved a complete response and another 23 patients, or 30.7% of patients, achieved a partial response, resulting in a 70.7% ORR. At the 45 µg/kg dose level, 18 patients, or 48.6% of patients, achieved a complete response and another 14 patients, or 37.8% of patients achieved a partial response, resulting in an 86.5% ORR. The table below shows the response rate data from this clinical trial.
|
Best Overall Response, n (%)
|
| |
Dose Levels
|
||||||||||||
|
≤20 µg/kg
(n=3)
|
| |
30 µg/kg
(n=18)
|
| |
45 µg/kg
(n=37)
|
| |
≥60 µg/kg
(n=17)
|
| |
All Doses
(n=75)
|
||
Complete response (CR)
|
| |
0 (0.0)
|
| |
5 (27.8)
|
| |
18 (48.6)
|
| |
7 (41.1)
|
| |
30 (40.0)
|
Partial response (PR)
|
| |
1 (33.3)
|
| |
4 (22.2)
|
| |
14 (37.8)
|
| |
4 (23.5)
|
| |
23 (30.7)
|
Stable disease
|
| |
1 (33.3)
|
| |
6 (33.3)
|
| |
0 (0.0)
|
| |
1 (5.9)
|
| |
8 (10.7)
|
Progressive disease
|
| |
0 (0.0)
|
| |
2 (11.1)
|
| |
5 (13.5)
|
| |
4 (23.5)
|
| |
11 (14.7)
|
Not evaluable
|
| |
1 (33.3)
|
| |
1 (5.6)
|
| |
0 (0.0)
|
| |
1 (5.9)
|
| |
3 (4.0)
|
Overall response rate (CR + PR)
|
| |
1 (33.3)
|
| |
9 (50.0)
|
| |
32 (86.5)
|
| |
11 (64.7)
|
| |
53 (70.7)
|
•
|
Cami’s favorable clinical activity was observed across a broad patient population in this clinical trial, including elderly patients and patients who have failed SCT. The table below shows the effect of age, prior therapy and response to prior therapy on response rate data at the 45 µg/kg dose level.
|
Age
|
| |
Overall Response Rate,
responders/total (%)
|
Less than or equal to 55
|
| |
25/28 (89.3), including 14/28 (50.0) CR
|
More than 55
|
| |
7/9 (77.8), including 4/9 (44.4) CR
|
Prior Therapy
|
| |
Overall Response Rate,
responders/total (%)
|
Brentuximab vedotin
|
| |
32/37 (86.5)
|
Brentuximab vedotin and checkpoint inhibitor
|
| |
23/26 (88.5)
|
Stem cell transplant
|
| |
16/18 (88.9)
|
Brentuximab vedotin, checkpoint inhibitor and stem cell transplant
|
| |
13/14 (92.9)
|
Response to Prior Therapy
|
| |
|
| |
Overall Response Rate,
responders/total (%)
|
Response to first-line therapy
|
| |
Refractory
|
| |
11/13 (84.6), including 6/13 (46.2) CR
|
|
| |
Relapsed
|
| |
21/24 (87.5), including 12/24 (50.0) CR
|
Response to most recent therapy
|
| |
Refractory
|
| |
22/25 (88.0), including 11/25 (44.0) CR
|
|
| |
Relapsed
|
| |
8/10 (80.0), including 6/10 (60.0) CR
|
•
|
Across all dose levels, the median DoR was 8.1 months for patients who achieved a complete response and 5.1 months for patients who achieved a partial response, for an overall DoR of 6.4 months. At the 45 µg/kg dose level, the median DoR was 7.2 months for patients who achieved a complete response and 5.6 months for patients who achieved a partial response, for an overall DoR of 6.6 months. The figure below shows the DoR by response at the 45 µg/kg dose level.
|
•
|
The MTD was not reached in the dose escalation stage.
|
•
|
Grade ≥3 TEAEs were reported in 23 patients, or 79.3% of patients. The most common Grade ≥3 TEAEs, reported in more than 5% of patients, included hypercalcemia (10.3%), acute kidney injury (6.9%), back pain (6.9%), dehydration (6.9%), gamma-glutamyltransferase increased (6.9%), lung infection (6.9%), platelet count decreased (6.9%), pyrexia (6.9%), rash (6.9%) and maculopapular rash (6.9%).
|
•
|
TEAEs in two patients, or 6.9% of patients, led to treatment discontinuation.
|
•
|
Across all dose levels, two patients, or 8.0% of patients, achieved a complete response and another nine patients, or 36.0% of patients, achieved a partial response, resulting in a 44.0% ORR.
|
•
|
The CD22 antigen is rapidly internalized by the cell.
|
•
|
An increasing number of reports describe the outgrowth of CD19-negative tumor cells in patients who initially respond to CD19-targeted therapy. We believe that given CD22’s broad and favorable expression profile, it may be a viable alternative B cell marker to CD19 for the targeted delivery of highly potent cytotoxic drugs.
|
|
| |
n (%)
|
|||||||||
Response
|
| |
ADCT-602
0.3 mg/kg
(n=10)
|
| |
ADCT-602
1 mg/kg
(n=10)
|
| |
Non-Targeted ADC
1 mg/kg
(n=10)
|
| |
Vehicle Control
(n=10)
|
Complete response
|
| |
0 (0.0)
|
| |
10 (100.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Partial response
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Tumor-free survivor
|
| |
0 (0.0)
|
| |
9 (90.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
•
|
Sur301 exhibited strong and durable anti-tumor activity that is superior to that achieved by an anti-PD1 antibody;
|
•
|
Sur301 exhibited strong synergistic effects when tested at a low dose level in combination with an anti-PD1 regimen;
|
•
|
Sur301’s observed anti-tumor activity was dependent on CD8 Teffs, and a statistically significant increase in the ratio of intratumoral CD8+ Teffs to Tregs was observed after administration of Sur301; and
|
•
|
Sur301 was associated with immunological memory in our re-challenge of tumor-free survivors.
|
•
|
ADCT-601 uses GlycoconnectTM site-specific conjugation technology, which allows for fast and stable conjugation of the warhead to the antibody.
|
•
|
The PBD payload of ADCT-601 contains a unique spacer, HydraspaceTM, which we have shown to provide an additional improvement in therapeutic index in preclinical models.
|
•
|
AXL is highly overexpressed or ectopically expressed in a multitude of solid tumors, including in lung, breast, prostate, pancreas, glioma and esophageal cancers. Its overexpression is maintained in both primary tumors and metastasis.
|
•
|
AXL expression in healthy tissues is significantly lower than that in tumor cells.
|
•
|
AXL is expressed on M2 macrophages, which are part of the immunosuppressive tumor microenvironment.
|
•
|
Expression and activation of AXL is associated with poor clinical prognosis in many tumor indications and several studies suggest that expression of AXL is induced by both targeted and chemotherapy drugs. Therefore, AXL-based therapies may be efficacious even where traditional therapies have failed.
|
•
|
AXL is prevalent in tumors resistant to anti-PD1 therapy, and pre-clinical data have shown the benefit of combining AXL-targeted therapies with immunotherapies.
|
•
|
The extracellular portion of AXL can be cleaved off from the membrane to generate soluble AXL (“sAXL”), which can be detected in serum. Recent studies suggest that sAXL can be a potential circulating biomarker in certain tumors, representing a potentially attractive biomarker for clinical use.
|
Response
|
| |
n (%)
|
||||||
|
ADCT-601
1 mg/kg
(n=10)
|
| |
Non-Targeted ADC
1 mg/kg
(n=10)
|
| |
Vehicle Control
(n=10)
|
||
Complete response
|
| |
4 (40.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Partial response
|
| |
5 (50.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Tumor-free survivor
|
| |
4 (40.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Response
|
| |
n (%)
|
||||||
|
ADCT-601
1 mg/kg
(n=8)
|
| |
Non-Targeted ADC
1 mg/kg
(n=8)
|
| |
Vehicle Control
(n=8)
|
||
Complete response
|
| |
2 (25.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Partial response
|
| |
5 (62.5)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Tumor-free survivor
|
| |
2 (25.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
|
| |
n (%)
|
|||||||||||||||
Response
|
| |
ADCT-601
0.075 mg/kg
(n=8)
|
| |
ADCT-601
0.15 mg/kg
(n=8)
|
| |
ADCT-601
0.3 mg/kg
(n=8)
|
| |
AXL-107-MMAE
0.3 mg/kg
(n=8)
|
| |
AXL-107-MMAE
4 mg/kg
(n=8)
|
| |
Vehicle Control
(n=8)
|
Complete response
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
3 (37.5)
|
| |
0 (0.0)
|
| |
8 (100.0)
|
| |
0 (0.0)
|
Partial response
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
1 (12.5)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Tumor-free survivor
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
3 (37.5)
|
| |
0 (0.0)
|
| |
8 (100.0)
|
| |
0 (0.0)
|
|
| |
n (%)
|
||||||
Response
|
| |
ADCT-901
1 mg/kg
(n=8)
|
| |
Non-Targeted ADC
1 mg/kg
(n=8)
|
| |
Vehicle Control
(n=8)
|
Complete response
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Partial response
|
| |
7 (87.5)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Tumor-free survivor
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
|
| |
n (%)
|
||||||||||||
Response
|
| |
ADCT-701
0.1 mg/kg
(n=8)
|
| |
ADCT-701
0.3 mg/kg
(n=8)
|
| |
ADCT-701
1 mg/kg
(n=8)
|
| |
Non-Targeted ADC
1 mg/kg
(n=8)
|
| |
Vehicle Control
(n=8)
|
Complete response
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
2 (37.5)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Partial response
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
3 (62.5)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
Tumor-free survivor
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
| |
0 (0.0)
|
•
|
completion of extensive preclinical laboratory and animal studies in accordance with applicable regulations, including studies conducted in accordance with GLP requirements;
|
•
|
submission to the FDA of an IND, which must become effective before human clinical trials may begin;
|
•
|
approval by an IRB or independent ethics committee at each clinical trial site before each clinical trial may be commenced;
|
•
|
performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, GCP requirements and other clinical trial-related regulations to establish the safety and efficacy of the investigational product for each proposed indication;
|
•
|
submission to the FDA of a BLA;
|
•
|
a determination by the FDA within 60 days of its receipt of a BLA to accept the filing for review;
|
•
|
satisfactory completion of one or more FDA pre-approval inspections of the manufacturing facility or facilities where the biologic, or components thereof, will be produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the biologic’s identity, strength, quality and purity;
|
•
|
satisfactory completion of any potential FDA audits of the clinical trial sites that generated the data in support of the BLA to assure compliance with GCPs and integrity of the clinical data;
|
•
|
payment of any user fees for FDA review of the BLA;
|
•
|
FDA review and approval of the BLA, including consideration of the views of any FDA advisory committee; and
|
•
|
compliance with any post-approval requirements, including REMS, where applicable, and post-approval studies required by the FDA as a condition of approval.
|
•
|
Phase 1 clinical trials generally involve a small number of healthy volunteers or disease-affected patients who are initially exposed to a single dose and then multiple doses of the product candidate. The primary purpose of these clinical trials is to assess the metabolism, pharmacokinetics, pharmacologic action, side effect tolerability, safety of the product candidate, and, if possible, early evidence of effectiveness. Phase 1 clinical trials may be designated as Phase 1a, which may involve dose escalation to determine the maximum tolerated dose, or Phase 1b, which may involve dose expansion at one or more dose levels to determine the recommended dose level for Phase 2 clinical trials.
|
•
|
Phase 2 clinical trials generally involve studies in disease-affected patients to evaluate proof of concept and/or determine the dosing regimen(s) for subsequent investigations. At the same time, safety and further pharmacokinetic and pharmacodynamic information is collected, possible adverse effects and safety risks are identified, and a preliminary evaluation of efficacy is conducted.
|
•
|
Phase 3 clinical trials generally involve a large number of patients at multiple sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk relationship of the product, and provide an adequate basis for product labeling. In most cases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of the biologic.
|
•
|
restrictions on the marketing or manufacturing of the product, suspension of the approval, complete withdrawal of the product from the market or product recalls;
|
•
|
fines, warning or other enforcement-related letters or holds on post-approval clinical studies;
|
•
|
refusal of the FDA to approve pending BLAs or supplements to approved BLAs, or suspension or revocation of product license approvals;
|
•
|
product seizure or detention, or refusal to permit the import or export of products; or
|
•
|
injunctions or the imposition of civil or criminal penalties.
|
•
|
preclinical laboratory tests, animal studies and formulation studies all performed in accordance with the applicable EU Good Laboratory Practice regulations;
|
•
|
submission to the relevant national authorities of a clinical trial application (“CTA”) for each trial in humans, which must be approved before the trial may begin in each country where patient enrollment is planned;
|
•
|
performance of adequate and well-controlled clinical trials to establish the safety and efficacy of the product for each proposed indication;
|
•
|
submission to the relevant competent authorities of a MAA, which includes the data supporting safety and efficacy as well as detailed information on the manufacture and composition of the product in clinical development and proposed labelling;
|
•
|
satisfactory completion of an inspection by the relevant national authorities of the manufacturing facility or facilities, including those of third parties, at which the product is produced to assess compliance with strictly enforced cGMP;
|
•
|
potential audits of the non-clinical and clinical trial sites that generated the data in support of the MAA; and
|
•
|
review and approval by the relevant competent authority of the MAA before any commercial marketing, sale or shipment of the product.
|
•
|
The federal Anti-Kickback Statute, which prohibits any person or entity from, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration, directly or indirectly,
|
•
|
Federal civil and criminal false claims laws, such as the FCA, which can be enforced by private citizens through civil qui tam actions, and civil monetary penalty laws prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, false, fictitious or fraudulent claims for payment of federal funds, and knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government. For example, pharmaceutical companies have been prosecuted under the FCA in connection with their alleged off-label promotion of drugs, purportedly concealing price concessions in the pricing information submitted to the government for government price reporting purposes, and allegedly providing free product to customers with the expectation that the customers would bill federal healthcare programs for the product. In addition, a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand” for money or property presented to the U.S. government. In addition, manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims.
|
•
|
HIPAA, among other things, imposes criminal liability for executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and creates federal criminal laws that prohibit knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services.
|
•
|
HIPAA, as amended by HITECH, and their implementing regulations, which impose privacy, security and breach reporting obligations with respect to individually identifiable health information upon entities subject to the law, such as health plans, healthcare clearinghouses and certain healthcare providers, known as covered entities, and their respective business associates that perform services for them that involve individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in U.S. federal courts to enforce HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.
|
•
|
Federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers.
|
•
|
The federal transparency requirements under the Physician Payments Sunshine Act, created under the Health Care Reform Act, which requires, among other things, certain manufacturers of drugs, devices, biologics and medical supplies reimbursed under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to CMS information related to payments and other transfers of value provided to physicians, as defined by such law, and teaching hospitals and physician ownership and investment interests, including such ownership and investment interests held by a physician’s immediate family members.
|
•
|
State and foreign laws that are analogous to each of the above federal laws, such as anti-kickback and false claims laws, that may impose similar or more prohibitive restrictions, and may apply to items or services reimbursed by non-governmental third-party payors, including private insurers.
|
•
|
State and foreign laws that require pharmaceutical companies to implement compliance programs, comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or to track and report gifts, compensation and other remuneration provided to physicians and other healthcare providers; state laws that require the reporting of marketing expenditures or drug pricing, including information pertaining to and justifying price increases; state and local laws that require the registration of pharmaceutical sales representatives; state laws that prohibit various marketing-related activities, such as the provision of certain kinds of gifts or meals; state laws that require the posting of information relating to clinical trials and their outcomes; and other federal, state and foreign laws that govern the privacy and security of health information or personally identifiable information in certain circumstances, including state health information privacy and data breach notification laws which govern the collection, use, disclosure, and protection of health-related and other personal information, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus requiring additional compliance efforts.
|
•
|
increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program;
|
•
|
established a branded prescription drug fee that pharmaceutical manufacturers of certain branded prescription drugs must pay to the federal government;
|
•
|
expanded the list of covered entities eligible to participate in the 340B drug pricing program by adding new entities to the program;
|
•
|
established a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;
|
•
|
extended manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;
|
•
|
expanded eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability;
|
•
|
created a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our product candidates, that are inhaled, infused, instilled, implanted or injected;
|
•
|
established a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
|
•
|
established a Center for Medicare and Medicaid Innovation at the CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending; and
|
•
|
created a licensure framework for follow-on biologic products.
|
•
|
a covered benefit under its health plan;
|
•
|
safe, effective and medically necessary;
|
•
|
appropriate for the specific patient;
|
•
|
cost-effective; and
|
•
|
neither experimental nor investigational.
|
Location
|
| |
Primary Function
|
| |
Approximate Size
|
Biopôle
Route de la Corniche 3B
1066 Epalinges
Switzerland
|
| |
Office
|
| |
518 m2
|
|
| |
|
| |
|
430 Mountain Avenue, 4th Floor
Murray Hill, New Jersey 07974
United States
|
| |
Office
|
| |
1038 m2
|
|
| |
|
| |
|
42 New Road
London, E1 2AX
United Kingdom
|
| |
Office and laboratory
|
| |
284 m2
|
|
| |
|
| |
|
1510 Fashion Island Boulevard, Suite 205
San Mateo, California 94404
United States
|
| |
Office
|
| |
390 m2
|
Name
|
| |
Position(s)
|
| |
Age
|
Executive Officers and Directors
|
| |
|
| |
|
Christopher Martin
|
| |
Chief Executive Officer and Director
|
| |
62
|
Michael Forer(1)
|
| |
Executive Vice President and Vice Chairman of the Board of Directors
|
| |
55
|
Jennifer Creel
|
| |
Chief Financial Officer
|
| |
49
|
Jay Feingold
|
| |
Senior Vice President, Chief Medical Officer & Head of Oncology
|
| |
64
|
Dominique Graz(1)
|
| |
General Counsel and Company Secretary
|
| |
59
|
Peter Greaney
|
| |
Head of Corporate Development
|
| |
41
|
Jennifer Herron
|
| |
Senior Vice President, Chief Commercial Officer
|
| |
50
|
Richard Onyett
|
| |
Vice President, Business Development
|
| |
73
|
Kimberly Pope
|
| |
Senior Vice President, Chief Human Resources Officer
|
| |
54
|
Susan Romanus
|
| |
Chief Compliance Officer
|
| |
55
|
Robert A. Schmidt
|
| |
Vice President, Corporate Controller & Chief Accounting Officer
|
| |
43
|
Patrick van Berkel
|
| |
Senior Vice President, Research and Development
|
| |
52
|
Non-Executive Directors
|
| |
|
| |
|
Ron Squarer
|
| |
Chairman of the Board of Directors
|
| |
53
|
Peter B. Corr
|
| |
Director
|
| |
72
|
Stephen Evans-Freke
|
| |
Director
|
| |
68
|
Peter Hug
|
| |
Director
|
| |
61
|
Thomas Pfisterer
|
| |
Director
|
| |
38
|
Thomas M. Rinderknecht
|
| |
Director
|
| |
66
|
Tyrell J. Rivers
|
| |
Director
|
| |
47
|
Victor Sandor
|
| |
Director
|
| |
54
|
Jacques Theurillat
|
| |
Director
|
| |
60
|
(1)
|
Mr. Graz has notified us of his decision to resign as General Counsel and Secretary to pursue a new opportunity, effective September 30, 2020. Mr. Forer will, in addition to his current positions, assume the General Counsel role effective October 1, 2020.
|
•
|
pre-approve the audit services and non-audit services (including the fees and terms thereof) to be provided by the independent auditor pursuant to pre-approval policies and procedures;
|
•
|
evaluate the independent auditor’s qualifications, performance and independence, and present its conclusions with respect to the independent auditor to the board of directors on at least an annual basis;
|
•
|
confirm and evaluate the rotation of the audit partners on the audit engagement team as required by law;
|
•
|
at least annually, review management’s plans with respect to the responsibilities, budget and staffing of the internal audit function and its plans for the implementation of the internal audit function, if any;
|
•
|
review and discuss with management and the independent auditor the annual audited consolidated and stand-alone financial statements and unaudited quarterly financial statements;
|
•
|
review with management, personnel responsible for the design and implementation of the internal audit function and the independent auditor (i) any analyses or other written communications prepared by management and/or the independent auditor setting forth significant financial reporting issues and judgments made in connection with the preparation of the financial statements, (ii) the Company’s critical accounting policies and practices, (iii) the effect of regulatory and accounting initiatives, as well as off-balance sheet transactions and structures, on the Company’s financial statements and (iv) any major issues regarding accounting principles and financial statement presentations;
|
•
|
review the type and presentation of information included in the earnings press releases, as well as financial information and earnings guidance provided to analysts and rating agencies, and may review earnings press releases prior to public dissemination;
|
•
|
in conjunction with the chief executive officer and chief financial officer, review disclosure controls and procedures and internal control over financial reporting;
|
•
|
review policies and practices with respect to risk assessment and risk management; and
|
•
|
review any major litigation or investigations against the Company that may have a material impact on the Company’s financial statements.
|
•
|
regularly review and make recommendations to the board of directors regarding our compensation and benefits strategy and guidelines;
|
•
|
prepare the proposals to the shareholders’ meeting regarding the compensation of the members of the board of directors and the executive committee;
|
•
|
regularly review and make recommendations to the board of directors regarding the compensation of the members of the board of directors and of the executive committee;
|
•
|
review and approve the recommendation of our chief executive officer regarding the fixed and variable compensation, including incentive plan participation and benefits, of the members of the management team other than members of the executive committee;
|
•
|
review and make recommendations to the board of directors regarding our compensation and benefits plans (cash and/or equity-based plans) and, where appropriate or required, make recommendations to adopt, amend and terminate such plans;
|
•
|
to the extent not delegated by the compensation committee to a different body or a third party, administer our compensation and benefits plans (other than equity-based plans); and
|
•
|
review and assess risks arising from our employee compensation policies and practices and whether any such risks are reasonably likely to have a material adverse effect on us.
|
•
|
determine selection criteria for the succession of the members of the board of directors and board committees, our chief executive officer, our chief financial officer and our executive vice president, and establish such succession planning (including for the event of the incapacitation, retirement or removal of such individuals) by making recommendations to the board of directors;
|
•
|
oversee searches and identify qualified individuals for membership on the board of directors and for the position of chief executive officer;
|
•
|
recommend individuals for membership on the board of directors and board committees and for the position of chief executive officer;
|
•
|
at least annually, prepare the board of directors’ assessment of the performance of the board of directors and board committees and of our chief executive officer and review the recommendations of the other board committees based on their evaluation of their own performance;
|
•
|
review the recommendations of the other board committees based on their self-evaluations and discuss its self-evaluation with the board of directors;
|
•
|
monitor and assess developments and trends in corporate governance to the extent that these do not have an impact on the activities and tasks of the audit and finance committee or the compensation committee;
|
•
|
review proposals to be made to the board of directors for the amendment of our articles of association, our organizational regulations, any other rules or regulations and the Code of Conduct;
|
•
|
periodically review and reassess the adequacy of the Code of Conduct and recommend any proposed changes to the board of directors;
|
•
|
periodically review and assess the adequacy of the charter of the nomination and corporate governance committee and recommend any proposed changes to the board of directors for approval;
|
•
|
if it deems advisable, develop and recommend to the board of directors corporate governance guidelines for the Company, and, if such guidelines are adopted, periodically review and reassess the adequacy of such guidelines, consider any requests for waivers of such guidelines and make recommendations to the board of directors regarding amendments and requests for waivers; and
|
•
|
oversee compliance with the Code of Conduct and report on such compliance to the board of directors.
|
•
|
review and make recommendations to the board of directors regarding our preclinical and clinical research and development activities, including related CMC activities;
|
•
|
review and make recommendations to the board of directors regarding preclinical and clinical research and development strategies;
|
•
|
review and make recommendations to the board of directors regarding our preclinical and clinical research guidelines;
|
•
|
provide strategic advice to the board of directors regarding emerging science and technology issues and trends;
|
•
|
examine periodically our measures to keep the research and development personnel motivated, productive and entrepreneurially oriented;
|
•
|
ensure, through regular review and consultation with the Chief Executive Officer and his team, that appropriate research and development objectives are in place that are aligned with our overall research and development strategy, and that progress against these objectives is being appropriately assessed; and
|
•
|
ensure that appropriate market potential assessments are being conducted.
|
•
|
Exemption from the requirement that a majority of the board of directors be comprised of independent directors and that there be regularly scheduled meetings with only the independent directors present. Swiss law does not have such a requirement.
|
•
|
Exemption from the requirements that the compensation committee and the nomination and corporate governance committee be comprised of independent directors. Swiss law does not have such requirements.
|
•
|
Exemption from quorum requirements applicable to meetings of shareholders. Swiss law does not require such quorum requirements.
|
•
|
Exemption from the requirement that independent directors meet at regularly scheduled executive sessions. Swiss law does not have such a requirement.
|
•
|
Exemption from the requirement that listed companies adopt and disclose corporate governance guidelines that cover certain minimum specified subjects related to director qualifications and responsibilities. Swiss law does not require the adoption or disclosure of such guidelines.
|
•
|
Exemption from the requirement to disclose within four business days of any determination to grant a waiver of the Code of Conduct to directors and executive officers. Although we will require approval by our board of directors for any such waiver, we may choose not to disclose the waiver in the manner set forth in the NYSE listing standards.
|
•
|
Exemption from the requirement to obtain shareholder approval for certain issuances of securities, including shareholder approval of share option plans. Our articles of association provide that our board of directors is authorized, in certain instances, to issue a certain number of common shares without re-approval by our shareholders.
|
•
|
each person, or group of affiliated persons, known by us to own beneficially 5% or more of our outstanding common shares, including the Selling Shareholders;
|
•
|
each of our executive officers and directors and persons nominated to serve in such positions; and
|
•
|
all executive officers and directors and persons nominated to serve in such positions as a group.
|
|
| |
Number of Common Shares
Beneficially Owned
|
| |
Percentage of Common Shares Beneficially Owned
|
|||
Principal Shareholders
|
| |
Before This Offering
|
| |
After This Offering
|
|||
5% Shareholders
|
| |
|
| |
|
| |
|
Entities affiliated with Auven Therapeutics GP Ltd.(1)
|
| |
23,093,730
|
| |
32.7%
|
| |
30.3%
|
AstraZeneca UK Limited(2)
|
| |
4,011,215
|
| |
5.7%
|
| |
5.3%
|
HPWH TH AG(3)
|
| |
7,450,000
|
| |
10.5%
|
| |
9.8%
|
Executive Officers and Directors
|
| |
|
| |
|
| |
|
Peter B. Corr(4)
|
| |
23,093,730
|
| |
32.7%
|
| |
30.3%
|
Jennifer Creel
|
| |
*
|
| |
*
|
| |
*
|
Stephen Evans-Freke(4)
|
| |
23,093,730
|
| |
32.7%
|
| |
30.3%
|
Jay Feingold
|
| |
*
|
| |
*
|
| |
*
|
Michael Forer(5)
|
| |
864,678
|
| |
1.2%
|
| |
1.1%
|
Dominique Graz
|
| |
*
|
| |
*
|
| |
*
|
Peter Greaney
|
| |
*
|
| |
*
|
| |
*
|
Jennifer Herron
|
| |
*
|
| |
*
|
| |
*
|
Peter Hug
|
| |
*
|
| |
*
|
| |
*
|
Christopher Martin(6)
|
| |
1,131,745
|
| |
1.6%
|
| |
1.5%
|
Richard Onyett
|
| |
*
|
| |
*
|
| |
*
|
Thomas Pfisterer
|
| |
*
|
| |
*
|
| |
*
|
Kimberly Pope
|
| |
*
|
| |
*
|
| |
*
|
Thomas M. Rinderknecht
|
| |
*
|
| |
*
|
| |
*
|
Tyrell J. Rivers(7)
|
| |
*
|
| |
*
|
| |
*
|
Susan Romanus
|
| |
*
|
| |
*
|
| |
*
|
Victor Sandor
|
| |
*
|
| |
*
|
| |
*
|
Robert A. Schmidt
|
| |
*
|
| |
*
|
| |
*
|
Ron Squarer
|
| |
*
|
| |
*
|
| |
*
|
Jacques Theurillat
|
| |
*
|
| |
*
|
| |
*
|
Patrick van Berkel(8)
|
| |
*
|
| |
*
|
| |
*
|
All executive officers and directors as a group (21 persons)
|
| |
26,559,131
|
| |
37.6%
|
| |
34.8%
|
*
|
Less than 1% of our total outstanding common shares.
|
(1)
|
This information is presented as of the date of this prospectus. A.T. Holdings II Sàrl (“A.T. Holdings”) holds a 73.77% interest in ADC Products Switzerland Sàrl (“ADC Products”) and is a wholly-owned subsidiary of C.T. Phinco Sàrl (“C.T. Phinco”), which is a wholly-owned subsidiary of Auven Therapeutics Holdings L.P. (“Auven Therapeutics”). Auven Therapeutics General L.P. (“Auven Therapeutics General”) is the general partner of Auven Therapeutics. Auven Therapeutics GP Ltd. (“Auven Therapeutics GP”) is the general partner of Auven Therapeutics General. Peter B. Corr and Stephen Evans-Freke are directors and principals of Auven Therapeutics. All common shares held by A.T. Holdings have been pledged pursuant to lending arrangements. The address of each of A.T. Holdings and ADC Products is Biopôle, Route de la Corniche 3B, 1066 Epalinges, Switzerland. The address of C.T. Phinco is 6 Rue Eugene Ruppert, L-2453 Luxembourg, Luxembourg. The address of each of Auven Therapeutics, Auven Therapeutics General and Auven Therapeutics GP is 171 Main Street, Road Town, Tortola, British Virgin Islands VG1110. The address of each of Mr. Corr and Mr. Evans-Freke is 6501 Redhook Plaza, Suite 201, St. Thomas, U.S. Virgin Islands 00802. If the underwriters exercise in full their option to purchase additional common shares, entities affiliated with Auven Therapeutics GP Ltd. will hold an aggregate of 22,268,730 common shares, or 29.2% beneficial ownership of our outstanding common shares.
|
(2)
|
AstraZeneca UK Limited (“AstraZeneca”) is a wholly-owned subsidiary of AstraZeneca plc, a public limited company organized under the laws of the United Kingdom, which may be deemed to have sole voting and investment power. The address of AstraZeneca is 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, United Kingdom, CB2 0AA.
|
(3)
|
This information is based on a Schedule 13D filed with the SEC on September 14, 2020 by HPWH TH AG (“HPWH”), HP WILD Holding AG (“HPW Holding”), Hans-Peter Wild and Thomas Pfisterer. The principal business of HPWH is holding investment rights in, directly or indirectly, ADC Therapeutics. HPW Holding is an intermediary holding company. Dr. Wild is the chairman of HPWH and HPW Holding. Mr. Pfisterer is a board member of HPWH and an investment manager. By reason of a stockholders’ agreement by and among Mr. Pfisterer and HPW Holding and their joint indirect minority equity interest in HPWH via their joint ownership of HPWH MH AG (“MH”), which owns a 12.5% interest in HPWH, Mr. Pfisterer may be deemed to have shared voting and investment
|
(4)
|
As described in footnote (1), as the directors and principals of Auven Therapeutics, Mr. Corr and Mr. Evans-Freke, may be deemed to have shared voting and investment power with respect to the common shares held by Auven Therapeutics.
|
(5)
|
Does not include common shares held by Dune Capital Inc., a company which is wholly-owned by a trust whose beneficiaries include Mr. Forer and his family. Mr. Forer does not exercise investment or voting control over the trust, and therefore such shares do not appear in the table above.
|
(6)
|
Does not include common shares held of record by Tuula Martin, spouse of Christopher Martin. Dr. Martin does not exercise investment or voting control over such shares, and therefore such shares do not appear in the table above.
|
(7)
|
Dr. Rivers is an executive director within AstraZeneca’s corporate development group and disclaims beneficial ownership of common shares held by AstraZeneca, except to the extent of his pecuniary interest in such shares, if any. See footnote (2).
|
(8)
|
Includes common shares held by Betulamab B.V., a Dutch private limited liability company of which Dr. van Berkel is beneficial owner. The address of Betulamab B.V. is Neerdyck 3, 3601 CZ Maarssen, The Netherlands.
|
Name of Shareholders
|
| |
Number of Common Shares Purchased
|
HPWH TH AG(1)
|
| |
950,000
|
(1)
|
Based solely on a Schedule 13D filed with the SEC on September 14, 2020 by HPWH TH AG, HP WILD Holding AG, Hans-Peter Wild and Thomas Pfisterer.
|
Name of Shareholders
|
| |
Number of Class E Preferred
Shares (Number of Common Shares
After Giving Effect to the Share Capital
Reorganization) Purchased(1)
|
|||
A.T. Holdings II Sàrl
|
| |
105.0000
|
| |
(1,312,500.0000)
|
ADC Products Switzerland Sàrl
|
| |
56.0000
|
| |
(700,000.0000)
|
Michael Forer
|
| |
0.7709
|
| |
(9,636.2500)
|
Tuula Martin(2)
|
| |
1.5418
|
| |
(19,272.5000)
|
Thomas Rinderknecht
|
| |
3.3421
|
| |
(41,776.2500)
|
Jacques Theurillat
|
| |
1.5815
|
| |
(19,768.7500)
|
Barrie Ward(3)
|
| |
0.4667
|
| |
(5,833.7500)
|
(1)
|
Includes shares and fractional shares held by nominees on behalf of the shareholders set out in the table.
|
(2)
|
Tuula Martin is the spouse of Christopher Martin, who is a member of our board of directors and CEO.
|
(3)
|
Barrie Ward was a member of our board of directors from September 2014 to April 2020.
|
Name of Shareholders
|
| |
Number of Class E Preferred Shares
(Number of Common Shares
After Giving Effect to the Share Capital
Reorganization) Purchased(1)
|
|||
A.T. Holdings II Sàrl(2)
|
| |
62.0000
|
| |
(775,000.0000)
|
Michael Forer
|
| |
0.4286
|
| |
(5,357.5000)
|
Dominique Graz
|
| |
0.5700
|
| |
(7,125.0000)
|
Stéphane Henchoz
|
| |
0.1000
|
| |
(1,250.0000)
|
Thomas Rinderknecht
|
| |
1.0000
|
| |
(12,500.0000)
|
Jacques Theurillat
|
| |
0.1800
|
| |
(2,250.0000)
|
Tuula Martin(3)
|
| |
0.4300
|
| |
(5,375.0000)
|
Barrie Ward(4)
|
| |
0.0200
|
| |
(250.0000)
|
(1)
|
Includes shares and fractional shares held by nominees on behalf of the shareholders set out in the table.
|
(2)
|
Includes 29.0000 Class E preferred shares (which is equal to 362,500.0000 common shares after giving effect to the Share Capital Reorganization) originally acquired by ADC Products Switzerland Sàrl and later transferred to A.T. Holdings II Sàrl.
|
(3)
|
Tuula Martin is the spouse of Christopher Martin, who is a member of our board of directors and CEO.
|
(4)
|
Barrie Ward was a member of our board of directors from September 2014 to April 2020.
|
Name of Shareholders
|
| |
Number of Shares Transferred
(After Giving Effect to the Share
Capital Reorganization)
|
ADC Products Switzerland Sàrl
|
| |
0.7727
|
Betulamab B.V.(1)
|
| |
0.4000
|
Michael Forer
|
| |
1.2801
|
Dominique Graz
|
| |
0.8000
|
Peter Greaney
|
| |
0.4000
|
Stéphane Henchoz
|
| |
0.9429
|
Peter Hug
|
| |
0.2000
|
Christopher Martin
|
| |
0.2000
|
Thomas Pfisterer
|
| |
0.2000
|
Thomas Rinderknecht
|
| |
1.5540
|
Jacques Theurillat
|
| |
1.1891
|
Tuula Martin(2)
|
| |
0.2458
|
(1)
|
Betulamab B.V. is a Dutch private limited liability company of which Dr. van Berkel, who is our Senior Vice President, Research and Development, is beneficial owner.
|
(2)
|
Tuula Martin is the spouse of Christopher Martin, who is a member of our board of directors and CEO.
|
Name of Director or Executive Officer
|
| |
Largest Amount
Previously Outstanding
(in USD thousands)
|
Michael Forer
|
| |
3,307
|
Dominique Graz
|
| |
207
|
Peter Greaney
|
| |
71
|
Stéphane Henchoz
|
| |
336
|
Peter Hug
|
| |
229
|
Christopher Martin
|
| |
4,148
|
Thomas Pfisterer
|
| |
341
|
Thomas M. Rinderknecht
|
| |
472
|
Jacques Theurillat
|
| |
472
|
Patrick van Berkel
|
| |
472
|
Barrie Ward(1)
|
| |
385
|
(1)
|
Barrie Ward was a member of our board of directors from September 2014 to April 2020.
|
•
|
On October 11, 2017, our share capital as registered with the Commercial Register on October 12, 2017, was increased by issuing 588 Class E preferred shares;
|
•
|
On October 24, 2017, our share capital as registered with the Commercial Register on October 30, 2017, was increased by issuing 22 Class E preferred shares;
|
•
|
On November 10, 2017, our share capital as registered with the Commercial Register on November 16, 2017, was increased by issuing 7 Class E preferred shares;
|
•
|
On June 19, 2018, our share capital as registered with the Commercial Register on June 29, 2018, was increased by issuing 3 Class A common shares;
|
•
|
On December 10, 2018, our share capital as registered with the Commercial Register on December 14, 2018, was increased by issuing 33 Class A common shares;
|
•
|
On January 30, 2019, our share capital as registered with the Commercial Register on February 6, 2019, was increased by issuing 6 Class A common shares;
|
•
|
On June 4, 2019, our share capital as registered with the Commercial Register on June 7, 2019, was increased by issuing 216 Class E preferred shares;
|
•
|
On June 7, 2019, our share capital as registered with the Commercial Register on June 14, 2019, was increased by issuing 2 Class E preferred shares;
|
•
|
On June 28, 2019, our share capital as registered with the Commercial Register on July 5, 2019, was increased by issuing 77 Class E preferred shares;
|
•
|
On August 22, 2019, our share capital as registered with the Commercial Register on August 28, 2019, was increased by an aggregate amount of CHF 3,714,300 through an increase of the par value of each of our Class A common shares and Class B, C, D and E preferred shares from CHF 100 to CHF 1,000;
|
•
|
On September 19, 2019, our share capital as registered with the Commercial Register on September 19, 2019, was increased by issuing 140 Class A common shares;
|
•
|
In the one-to-15,625 share split of all issued shares effected on September 19, 2019, each of our issued shares was split into 15,625 shares of the same class with a par value of CHF 0.064 per share;
|
•
|
In the five-to-four reverse share split of all issued shares effected on April 24, 2020, each of our issued shares was consolidated into 0.8 shares of the same class with a par value of CHF 0.08 per share, and an aggregate of 44 common shares were converted into 6 Class C preferred shares, 12 Class D preferred shares and 26 Class E preferred shares, each with a par value of CHF 0.08; and
|
•
|
On May 15, 2020, our share capital as registered with the Commercial Register on May 15, 2020, was increased by issuing 17,432,500 common shares with a par value of CHF 0.08 per share.
|
•
|
conditional share capital (capital-actions conditionnel) for the purpose of issuing shares in connection with, among other things, (i) option and conversion rights granted in connection with warrants and convertible bonds of the Company or one of our subsidiaries or (ii) grants of rights to employees, members of our board of directors or consultants or to our subsidiaries or other persons providing services to the Company or a subsidiary to subscribe for new shares (conversion or option rights); or
|
•
|
authorized share capital (capital-actions autorisé) to be utilized by the board of directors within a period determined by the shareholders but not exceeding two years from the date of the shareholder approval.
|
•
|
if the issue price of the new registered shares is determined by reference to the market price;
|
•
|
for raising of capital (including private placements) in a fast and flexible manner, which would not be possible, or might only be possible with great difficulty or delays or at significantly less favorable conditions, without the exclusion of the statutory pre-emptive subscription rights of the existing shareholders;
|
•
|
for the acquisition of an enterprise, parts of an enterprise or participations, for the acquisition of products, intellectual property or licenses by or for investment projects of the Company or any of its group companies, or for the financing or refinancing of any of such transactions through a placement of shares;
|
•
|
for purposes of broadening the shareholder constituency of the Company in certain geographic, financial or investor markets, for purposes of the participation of strategic partners, or in connection with the listing of new shares on domestic or foreign stock exchanges;
|
•
|
for purposes of granting an over-allotment option or an option to purchase additional shares in a placement or sale of shares to the respective initial purchaser(s) or underwriter(s);
|
•
|
for the participation of members of the board of directors, members of the executive committee, employees, contractors, consultants or other persons performing services for the benefit of the Company or any of its group companies;
|
•
|
following a shareholder or a group of shareholders acting in concert having accumulated shareholdings in excess of 20% of our share capital registered in the Commercial Register without having submitted to all other shareholders a takeover offer recommended by the board of directors;
|
•
|
for the defense of an actual, threatened or potential takeover bid, that the board of directors, upon consultation with an independent financial adviser retained by it, has not recommended to the shareholders acceptance on the basis that the board of directors has not found the takeover bid to be financially fair to the shareholders or not to be in the Company’s interest; or
|
•
|
for other valid grounds in the sense of Article 652b para. 2 of the CO.
|
•
|
for the purpose of financing or refinancing, or the payment for, the acquisition of enterprises, parts of enterprises, participations, intellectual property rights, licenses or investments;
|
•
|
if the issuance occurs in domestic or international capital markets, including private placements;
|
•
|
following a shareholder or a group of shareholders acting in concert having accumulated shareholdings in excess of 20% of the share capital registered in the Commercial Register without having submitted to all other shareholders a takeover offer recommended by the board of directors; or
|
•
|
for the defense of an actual, threatened or potential takeover bid that the board of directors, upon consultation with an independent financial adviser retained by it, has not recommended to the shareholders to accept on the basis that the board of directors has not found the takeover bid to be financially fair to the shareholders or not to be in the Company’s interest.
|
•
|
adopting and amending the articles of association, including the change of a company’s purpose or domicile;
|
•
|
electing the members of the board of directors, the chairman of the board of directors, the members of the compensation committee, the auditors and the independent proxy;
|
•
|
approving the business report, the annual statutory and consolidated financial statements, and deciding on the allocation of profits as shown on the balance sheet, in particular with regard to dividends;
|
•
|
approving the aggregate amount of compensation of members of the board of directors and the executive committee;
|
•
|
discharging the members of the board of directors and the executive committee from liability with respect to their conduct of business;
|
•
|
dissolving a company with or without liquidation; and
|
•
|
deciding matters reserved to the general meeting of shareholders by law or the articles of association or submitted to it by the board of directors.
|
•
|
amending the Company’s corporate purpose;
|
•
|
creating shares with preference rights;
|
•
|
cancelling or amending the transfer restrictions of shares;
|
•
|
creating authorized or conditional share capital;
|
•
|
increasing share capital out of equity, against contributions in-kind or for the purpose of acquiring specific assets and granting specific benefits;
|
•
|
limiting or withdrawing shareholder’s pre-emptive subscription rights;
|
•
|
changing a company’s domicile;
|
•
|
amending or repealing the voting and recording restrictions, the provision setting a maximum board size or the indemnification provision for the board of directors and the executive committee set forth in our articles of association;
|
•
|
converting registered shares into bearer shares;
|
•
|
removing the chairman or any member of the board of directors before the end of his or her term of office; and
|
•
|
dissolving or liquidating the Company.
|
•
|
a brief description of the business desired to be brought before the general meeting of shareholders and the reasons for conducting such business at the general meeting of shareholders;
|
•
|
the motions regarding the agenda item;
|
•
|
the name and address, as they appear in the share register, of the shareholder proposing such business;
|
•
|
the number of shares which are beneficially owned by such shareholder (including documentary support of such beneficial ownership);
|
•
|
the dates upon which the shareholder acquired such shares;
|
•
|
any material interest of the proposing shareholder in the proposed business;
|
•
|
a statement in support of the matter; and
|
•
|
all other information required under the applicable laws and stock exchange rules.
|
•
|
a core part of our business is sold without which it is economically impracticable or unreasonable to continue to operate the remaining business;
|
•
|
our assets, after the divestment, are not invested in accordance with our corporate purpose as set forth in the articles of association; and
|
•
|
the proceeds of the divestment are not earmarked for reinvestment in accordance with our corporate purpose but, instead, are intended for distribution to our shareholders or for financial investments unrelated to our corporate purpose.
|
•
|
the ultimate direction of the business of the Company and issuing of the relevant directives;
|
•
|
laying down the organization of the Company;
|
•
|
formulating accounting procedures, financial controls and financial planning;
|
•
|
nominating and removing persons entrusted with the management and representation of the Company and regulating the power to sign for the Company;
|
•
|
the ultimate supervision of those persons entrusted with management of the Company, with particular regard to adherence to law, our articles of association, and regulations and directives of the Company;
|
•
|
issuing the business report and the compensation report, and preparing for the general meeting of shareholders and carrying out its resolutions; and
|
•
|
informing the court in case of over-indebtedness.
|
•
|
severance payments (compensation due until the termination of a contractual relationship does not qualify as severance payment);
|
•
|
advance compensation;
|
•
|
incentive fees for the acquisition or transfer of companies, or parts thereof, by the Company or by companies being, directly or indirectly, controlled by us;
|
•
|
loans, other forms of indebtedness, pension benefits not based on occupational pension schemes and performance-based compensation not provided for in the articles of association; and
|
•
|
equity-based compensation not provided for in the articles of association.
|
•
|
the maximum aggregate amount of compensation of the board of directors for the term of office until the next annual general meeting of shareholders; and
|
•
|
the maximum aggregate amount of fixed compensation of the executive committee for the following financial year; and
|
•
|
the maximum aggregate amount of variable compensation of the executive committee for the current financial year.
|
DELAWARE CORPORATE LAW
|
| |
SWISS CORPORATE LAW
|
Mergers and similar arrangements
|
|||
|
| |
|
Under the Delaware General Corporation Law, with certain exceptions, a merger, consolidation, sale, lease or transfer of all or substantially all of the assets of a corporation must be approved by the board of directors and a majority of the outstanding shares entitled to vote thereon. A shareholder of a Delaware corporation participating in certain major corporate transactions may, under certain circumstances, be entitled to appraisal rights pursuant to which such shareholder may receive cash in the amount of the fair value of the shares held by such shareholder (as determined by a court) in lieu of the consideration such shareholder would otherwise receive in the transaction. The Delaware General Corporation Law also provides that a parent corporation, by resolution of its board of directors, may merge with any subsidiary, of which it owns at least 90.0% of each class of capital stock without a vote by the shareholders of such subsidiary. Upon any such merger, dissenting shareholders of the subsidiary would have appraisal rights.
|
| |
Under Swiss law, with certain exceptions, a merger or a demerger of the corporation or a sale of all or substantially all of the assets of a corporation must be approved by two-thirds of the voting rights represented at the respective general meeting of shareholders as well as the absolute majority of the par value of shares represented at such general meeting of shareholders. A shareholder of a Swiss corporation participating in a statutory merger or demerger pursuant to the Swiss Merger Act (Loi sur la fusion) can file a lawsuit against the surviving company. If the consideration is deemed “inadequate,” such shareholder may, in addition to the consideration (be it in shares or in cash) receive an additional amount to ensure that such shareholder receives the fair value of the shares held by such shareholder. Swiss law also provides that if the merger agreement provides only for a compensation payment, at least 90.0% of all members in the transferring legal entity, who are entitled to vote, shall approve the merger agreement.
|
|
| |
|
Shareholders’ suits
|
|||
|
| |
|
Class actions and derivative actions generally are available to shareholders of a Delaware corporation for, among other things, breach of fiduciary duty, corporate waste and actions not taken in accordance with applicable law. In such actions, the court has discretion to permit the winning party to recover attorneys’ fees incurred in connection with such action.
|
| |
Class actions and derivative actions as such are not available under Swiss law. Nevertheless, certain actions may have a similar effect. A shareholder is entitled to bring suit against directors for breach of their duties and claim the payment of the company’s losses or damages to the corporation and, in some cases, to the individual shareholder. Likewise, an appraisal lawsuit won by a shareholder may indirectly compensate all shareholders. In addition, to the extent that U.S. laws and regulations provide a basis for liability and U.S. courts have jurisdiction, a class action may be available.
|
|
| |
|
|
| |
Under Swiss law, the winning party is generally entitled to recover a limited amount of attorneys’ fees incurred in connection with such action. The court has discretion to permit the shareholder who lost the lawsuit to recover attorneys’ fees incurred to the extent that he acted in good faith.
|
|
| |
|
DELAWARE CORPORATE LAW
|
| |
SWISS CORPORATE LAW
|
believed to be in, or not opposed to, the best interests of the corporation; and the director or officer, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful.
Unless ordered by a court, any foregoing indemnification is subject to a determination that the director or officer has met the applicable standard of conduct:
• by a majority vote of the directors who are not
parties to the proceeding, even though less than a
quorum;
• by a committee of directors designated by a
majority vote of the eligible directors, even though
less than a quorum;
• by independent legal counsel in a written opinion
if there are no eligible directors, or if the eligible
directors so direct; or
• by the shareholders.
Moreover, a Delaware corporation may not indemnify a director or officer in connection with any proceeding in which the director or officer has been adjudged to be liable to the corporation unless and only to the extent that the court determines that, despite the adjudication of liability but in view of all the circumstances of the case, the director or officer is fairly and reasonably entitled to indemnity for those expenses which the court deems proper.
|
| |
Also, a corporation may enter into and pay for directors’ and officers’ liability insurance, which may cover negligent acts as well.
|
|
| |
|
Directors’ fiduciary duties
|
|||
|
| |
|
A director of a Delaware corporation has a fiduciary duty to the corporation and its shareholders. This duty has two components:
• the duty of care; and
• the duty of loyalty.
The duty of care requires that a director act in good faith, with the care that an ordinarily prudent person would exercise under similar circumstances. Under this duty, a director must inform himself or herself of, and disclose to shareholders, all material information reasonably available regarding a significant transaction.
|
| |
The board of directors of a Swiss corporation manages the business of the corporation, unless responsibility for such management has been duly delegated to the executive committee based on organizational rules. However, there are several non-transferable duties of the board of directors:
• the overall management of the corporation and the
issuing of all necessary directives;
• determination of the corporation’s organization;
• the organization of the accounting, financial
control and financial planning systems as required
for management of the corporation;
|
DELAWARE CORPORATE LAW
|
| |
SWISS CORPORATE LAW
|
provisions in the governing documents. A special meeting may be called by the board of directors or any other person authorized to do so in the governing documents, but shareholders may be precluded from calling special meetings.
|
| |
proposals relating to the agenda items that were not duly notified. Unless the articles of association provide for a lower threshold or for additional shareholders’ rights:
• shareholders together representing at least 10% of
the share capital may demand that a general meeting
of shareholders be called for specific agenda items
and specific proposals; and
• shareholders together representing shares with a par
value of at least CHF 1.0 million or 10% of the
share capital, whichever is lower, may demand that
an agenda item including a specific proposal be put
on the agenda for a scheduled general meeting of
shareholders, provided such request is made with
appropriate lead time.
Any shareholder can propose candidates for election as directors or make other proposals within the scope of an agenda item without prior written notice.
In addition, any shareholder is entitled, at a general meeting of shareholders and without advance notice, to (i) request information from the board of directors on the affairs of the company (note, however, that the right to obtain such information is limited), (ii) request information from the auditors on the methods and results of their audit, (iii) request that the general meeting of shareholders resolve to convene an extraordinary general meeting, or (iv) request that the general meeting of shareholders resolve to appoint an examiner to carry out a special examination (“contrôle spécial”).
|
|
| |
|
Cumulative voting
|
|||
|
| |
|
Under the Delaware General Corporation Law, cumulative voting for elections of directors is not permitted unless the corporation’s certificate of incorporation provides for it.
|
| |
Cumulative voting is not permitted under Swiss corporate law. Pursuant to Swiss law, shareholders can vote for each proposed candidate, but they are not allowed to cumulate their votes for single candidates. An annual individual election of (i) all members of the board of directors, (ii) the chairperson of the board of directors, (iii) the members of the compensation committee, (iv) the election of the independent proxy for a term of office of one year (i.e., until the following annual general meeting of shareholders), as well as the vote on the aggregate amount of compensation of the members of the board of directors, of the executive committee and of the members of any advisory board, is mandatory for listed companies. Re-election is permitted.
|
|
| |
|
DELAWARE CORPORATE LAW
|
| |
SWISS CORPORATE LAW
|
Amendment of governing documents
|
|||
|
| |
|
A Delaware corporation’s governing documents may be amended with the approval of a majority of the outstanding shares entitled to vote, unless the certificate of incorporation provides otherwise.
|
| |
The articles of association of a Swiss corporation may be amended with a resolution passed by a majority of the shares represented at a general meeting of shareholders, unless otherwise provided in the articles of association.
There are a number of resolutions, such as an amendment of the stated purpose of the corporation, the introduction of authorized and conditional capital and the introduction of shares with preferential voting rights that require the approval by two-thirds of the votes and an absolute majority of the par value of the shares represented at such general meeting of shareholders. The articles of association may increase these voting thresholds.
|
|
| |
|
Inspection of books and records
|
|||
|
| |
|
Shareholders of a Delaware corporation, upon written demand under oath stating the purpose thereof, have the right during the usual hours for business to inspect for any proper purpose, and to obtain copies of list(s) of shareholders and other books and records of the corporation and its subsidiaries, if any, to the extent the books and records of such subsidiaries are available to the corporation.
|
| |
Shareholders of a Swiss corporation may only inspect books and records if the general meeting of shareholders or the board of directors approved such inspection. The information may be refused where providing it would jeopardize the corporation’s trade secrets or other interests warranting protection. A shareholder is only entitled to receive information to the extent required to exercise his or her rights as a shareholder, subject to the interests of the corporation. A shareholder’s right to inspect the share register is limited to the right to inspect his or her own entry in the share register.
|
|
| |
|
Payment of dividends
|
|||
|
| |
|
The board of directors may approve a dividend without shareholder approval. Subject to any restrictions contained in its certificate of incorporation, the board may declare and pay dividends upon the shares of its capital stock either:
• out of its surplus, or
• in case there is no such surplus, out of its net
profits for the fiscal year in which the dividend is
declared and/or the preceding fiscal year.
Shareholder approval is required to authorize capital stock in excess of that provided in the charter. Directors may issue authorized shares without shareholder approval.
|
| |
Dividend payments are subject to the approval of the general meeting of shareholders. The board of directors may propose to shareholders that a dividend shall be paid but cannot itself authorize the distribution.
Payments out of a corporation’s share capital (in other words, the aggregate par value of the corporation’s registered share capital) in the form of dividends are not allowed and may be made only by way of a share capital reduction. Dividends may be paid only from the profits of the previous business year or brought forward from previous business years or if the corporation has distributable reserves, each as evidenced by the corporation’s audited stand-alone statutory balance sheet prepared pursuant to Swiss law and after allocations to reserves required by Swiss law and the articles of association have been deducted.
|
|
| |
|
DELAWARE CORPORATE LAW
|
| |
SWISS CORPORATE LAW
|
Creation and issuance of new shares
|
|||
|
| |
|
All creation of shares require the board of directors to adopt a resolution or resolutions, pursuant to authority expressly vested in the board of directors by the provisions of the company’s certificate of incorporation.
|
| |
All creation of shares require a shareholders’ resolution. The creation of authorized or contingent share capital requires at least two-thirds of the voting rights represented at the general meeting of shareholders and an absolute majority of the par value of shares represented at such meeting. The board of directors may issue shares out of the authorized share capital during a period of up to two years. Shares are created and issued out of contingent share capital through the exercise of options or of conversion rights that the board of director may grant in relation to, e.g., debt instruments or employees.
|
•
|
1% of the number of our common shares then outstanding, which will equal approximately 762,158 common shares immediately after this offering; or
|
•
|
the average weekly trading volume of our common shares on the NYSE during the four calendar weeks preceding the filing of a notice on Form 144 with respect to the sale;
|
•
|
certain banks, insurance companies and other financial institutions;
|
•
|
brokers, dealers or traders in securities who use a mark-to-market method of tax accounting;
|
•
|
persons holding common shares as part of a straddle, wash sale, conversion transaction or other integrated transaction or persons entering into a constructive sale with respect to the common shares;
|
•
|
persons whose functional currency for U.S. federal income tax purposes is not the U.S. dollar;
|
•
|
entities or arrangements classified as partnerships or S corporations for U.S. federal income tax purposes;
|
•
|
tax-exempt entities, including “individual retirement accounts” or “Roth IRAs,” and governmental entities;
|
•
|
real estate investment trusts or regulated investment companies;
|
•
|
former U.S. citizens or long-term residents of the United States;
|
•
|
persons subject to Section 451(b) of the Code;
|
•
|
persons that own or are deemed to own 10% or more of the voting power or value of our shares; or
|
•
|
persons holding common shares in connection with a trade or business conducted outside of the United States or in connection with a permanent establishment or other fixed place of business outside of the United States.
|
•
|
a citizen or individual resident of the United States;
|
•
|
a corporation, or other entity taxable as a corporation, created or organized in or under the laws of the United States, any state therein or the District of Columbia; or
|
•
|
an estate or trust the income of which is subject to U.S. federal income taxation regardless of its source.
|
Underwriter
|
| |
Number of Common
Shares
|
Morgan Stanley & Co. LLC
|
| |
|
BofA Securities, Inc.
|
| |
|
Cowen and Company, LLC
|
| |
|
Total
|
| |
5,500,000
|
|
| |
|
| |
Total
|
|||
|
| |
Per Share
|
| |
No Exercise
|
| |
Full Exercise
|
Public offering price
|
| |
$
|
| |
$
|
| |
$
|
Underwriting discounts and commissions to be paid by:
|
| |
|
| |
|
| |
|
Us
|
| |
$
|
| |
$
|
| |
$
|
The Selling Shareholders
|
| |
$
|
| |
$
|
| |
$
|
Proceeds, before expenses, to us
|
| |
$
|
| |
$
|
| |
$
|
Proceeds, before expenses, to the Selling Shareholders
|
| |
$
|
| |
$
|
| |
$
|
•
|
offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, lend or otherwise transfer or dispose of, directly or indirectly, any common shares or any securities convertible into or exercisable or exchangeable for common shares;
|
•
|
file any registration statement with the SEC relating to the offering of any common shares or any securities convertible into or exercisable or exchangeable for common shares; or
|
•
|
enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the common shares,
|
(i)
|
transactions relating to common shares or any security convertible into common shares acquired in this offering or in open market transactions after the completion of the offering;
|
(ii)
|
transfers or distributions as a bona fide gift or for bona fide estate planning purposes or to a charitable organization or educational institution;
|
(iii)
|
transfers or distributions to any immediate family member of such person, affiliate or any trust or trustee or beneficiary thereof for the direct or indirect benefit of such person or the immediate family of such person (for this purpose, “immediate family” means any relationship by blood, marriage, domestic partnership or adoption, not more remote than first cousin);
|
(iv)
|
transfers or distributions to any corporation, partnership, limited liability company or other entity or affiliate of such person or the immediate family of such person;
|
(v)
|
transfers or distributions (a) by will, other testamentary document or intestate succession to the legal representative, heir, beneficiary or a member of the immediate family of such person upon the death of such person; (b) by operation of law pursuant to a domestic order or negotiated divorce settlement;
|
(vi)
|
transfers or distributions to another corporation, member, partnership, limited liability company, trust or other entity that is a direct or indirect affiliate (as defined under Rule 12b-2 of the Exchange Act), or to an investment fund or other entity that controls or manages, or is under common control with, such person, or distributions to partners, members, shareholders, beneficiaries or other equity holders of such person;
|
(vii)
|
transfers or distributions to us in connection with the repurchase of such securities with respect to the termination of such person’s employment with us;
|
(viii)
|
transfers or distributions (including through a “cashless” exercise or on a “net exercise basis”) to us in connection with the conversion of any convertible security into, or the exercise of any option or warrant for, common shares (including to satisfy withholding obligations or the payment of taxes in connection therewith); provided that (a) any such common shares received by such person shall be subject to the lock-up agreement and (b) no filing under Section 16(a) of the Exchange Act (or its foreign equivalent) reporting a reduction in beneficial ownership of common shares shall be required or shall be voluntarily made during the restricted period;
|
(ix)
|
transfers or distributions to a nominee or custodian of a person or entity to whom a disposition or transfer would be permissible under clauses (i) through (viii) above, provided that any common shares shall be subject to the terms of the lock-up agreement;
|
(x)
|
any pledge or transfer by such person (or any permitted transferee) of common shares or any security convertible into common shares pursuant to agreements governing indebtedness or commitments relating to indebtedness of such person (or any permitted transferee) or its affiliates (other than us and our subsidiaries) in effect on the date thereof (and any refinancing or replacement thereof) and described in this prospectus and any transfer upon foreclosure, provided that any required filing under Section 16(a) of the Exchange Act (or its foreign equivalent) reporting a reduction in beneficial ownership by such person or any party (pledgor or pledgee) shall indicate by footnote disclosure or otherwise the nature of the transfer and if any filing is required to be made under Section 16(a) of the Exchange Act (or its foreign equivalent) during the restricted period, and such person shall provide the representatives prior written notice informing them of such report;
|
(xi)
|
the establishment of a trading plan pursuant to Rule 10b5-1 under the Exchange Act (or its foreign equivalent) for the transfer of common shares, provided that (a) such plan does not provide for the transfer of common shares during the restricted period and (b) to the extent a public announcement or filing under the Exchange Act (or its foreign equivalent), if any, is required of or voluntarily made by or on behalf of such person or us regarding the establishment of such plan, such announcement or filing shall include a statement to the effect that no transfer of common shares may be made under such plan during the restricted period;
|
(xii)
|
transfers or dispositions pursuant to a bona fide tender offer for our capital shares, merger, consolidation or other similar transaction made to all holders of our securities involving a change of control of us (including without limitation, the entering into of any lock-up, voting or similar agreement pursuant to which such person may agree to transfer, sell, tender or otherwise dispose of common shares or any security convertible into common shares in connection with such transaction) that has been approved by our board of directors; provided that, in the event that such change of control transaction is not consummated, this paragraph shall not be applicable and such person’s shares and other securities shall remain subject to the lock-up agreement (for this purpose, “change of control” means the transfer whether by tender offer, merger, consolidation or other similar transaction), in one transactions or a series of related transactions, to a person or group of affiliated persons (other than the underwriters pursuant to this offering), of our voting securities if, after such transfer, such person or group of affiliated persons would hold greater than 50% of our outstanding voting securities);
|
(xiii)
|
the conversion, exercise or exchange of options to purchase common shares, warrants or any security convertible into common shares described in this prospectus; provided that any such securities shall remain subject to the lock-up agreement;
|
(xiv)
|
the common shares to be sold in this offering; or
|
(xv)
|
in the case of entities affiliated with Auven Therapeutics GP Ltd., up to $16.0 million of common shares in a private sale to HPWH TH AG,
|
(i)
|
the common shares to be sold in this offering;
|
(ii)
|
the issuance by us of shares of common shares upon the exercise of an option or warrant or the conversion of a security outstanding on the date of this prospectus of which the underwriters have been advised in writing;
|
(iii)
|
the grant of any options to purchase common shares, restricted shares or restricted units under an incentive compensation plan in effect or approved by our board of directors on the date of this prospectus and described in this prospectus;
|
(iv)
|
our filing of any registration statement on Form S-8 or a successor form relating to the common shares granted pursuant to or reserved for issuance under an incentive compensation plan described in this prospectus;
|
(v)
|
the offer or issuance of common shares in connection with an acquisition, joint venture, commercial or collaborative relationship, or an acquisition or license by us of assets of another person or entity or pursuant to an employee benefit plan assumed by us in connection with any such acquisition, provided that (1) the aggregate number of shares issued does not exceed 5% of the total number of outstanding shares of our common shares immediately following the closing of this offering and (2) the recipient of any such shares during the restricted period enters into a lock-up agreement;
|
(vi)
|
facilitating the establishment of a trading plan on behalf of one of our shareholders, officers or directors pursuant to Rule 10b5-1 under the Exchange Act for the transfer of common shares, provided that such plan does not provide for the transfer of common shares during the restricted period and, to the extent a public announcement or filing under the Exchange Act is required of or voluntarily made by us regarding the establishment of such plan, such announcement or filing shall include a statement to the effect that no transfer of common shares may be made under such plan during the restricted period;
|
(vii)
|
the issuance and sale of securities convertible into common shares pursuant to the Facility Agreement and the issuance of common shares upon the conversion of such securities; or
|
(viii)
|
the confidential submission and public filing and any amendments thereto, and the effectiveness, of a registration statement with the SEC with respect to common shares issued and issuable upon the conversion of securities described in clause (vii) above exclusively as a result of contractual obligations contained in the Registration Rights Agreement that was entered into in connection with the Facility Agreement.
|
(a)
|
to any legal entity which is a qualified investor as defined in the Prospectus Regulation;
|
(b)
|
to fewer than 150 natural or legal persons (other than qualified investors as defined in the Prospectus Regulation), subject to obtaining the prior consent of the representatives for any such offer; or
|
(c)
|
in any other circumstances falling within Article 1(4) of the Prospectus Regulation,
|
(a)
|
a corporation (which is not an accredited investor (as defined in Section 4A of the SFA)) the sole business of which is to hold investments and the entire share capital of which is owned by one or more individuals, each of whom is an accredited investor; or
|
(b)
|
a trust (where the trustee is not an accredited investor) whose sole purpose is to hold investments and each beneficiary of the trust is an individual who is an accredited investor,
|
(a)
|
to an institutional investor or to a relevant person defined in Section 275(2) of the SFA, or to any person arising from an offer referred to in Section 275(1A) or Section 276(4)(i)(B) of the SFA;
|
(b)
|
where no consideration is or will be given for the transfer;
|
(c)
|
where the transfer is by operation of law;
|
(d)
|
as specified in Section 276(7) of the SFA; or
|
(e)
|
as specified in Regulation 37A of the Securities and Futures (Offers of Investments) (Securities and Securities-based Derivatives Contracts) Regulations 2018 of Singapore.
|
(a)
|
it has only communicated or caused to be communicated and will only communicate or cause to be communicated an invitation or inducement to engage in investment activity (within the meaning of Section 21 of the Financial Services and Markets Act 2000 (“FSMA”) received by it in connection with the issue or sale of our common shares in circumstances in which Section 21(1) of the FSMA does not apply to us; and
|
(b)
|
it has complied and will comply with all applicable provisions of the FSMA with respect to anything done by it in relation to our common shares in, from or otherwise involving the United Kingdom.
|
Expenses
|
| |
Amount
|
SEC registration fee
|
| |
$37,355
|
FINRA filing fee
|
| |
43,669
|
Printing and engraving expenses
|
| |
50,000
|
Legal fees and expenses
|
| |
590,000
|
Accounting fees and expenses
|
| |
210,000
|
Stamp duty
|
| |
2,502,500
|
Miscellaneous costs
|
| |
366,476
|
Total
|
| |
$3,800,000
|
•
|
the non-Swiss court had jurisdiction pursuant to the PILA;
|
•
|
the judgment of such non-Swiss court has become final and non-appealable;
|
•
|
the judgment does not contravene Swiss public policy;
|
•
|
the court procedures and the service of documents leading to the judgment were in accordance with the due process of law; and
|
•
|
no proceeding involving the same position and the same subject matter was first brought in Switzerland, or adjudicated in Switzerland, or was earlier adjudicated in a third state and this decision is recognizable in Switzerland.
|
|
| |
|
| |
For the Three Months
Ended June 30,
|
| |
For the Six Months
Ended June 30,
|
||||||
|
| |
Note
|
| |
2020
|
| |
2019
|
| |
2020
|
| |
2019
|
Contract revenue
|
| |
6
|
| |
—
|
| |
1,962
|
| |
—
|
| |
2,340
|
Operating expense
|
| |
|
| |
|
| |
|
| |
|
| |
|
Research and development
|
| |
7
|
| |
(25,950)
|
| |
(21,760)
|
| |
(61,325)
|
| |
(46,572)
|
General and administrative
|
| |
8
|
| |
(18,999)
|
| |
(4,089)
|
| |
(27,509)
|
| |
(6,592)
|
Total operating expense
|
| |
|
| |
(44,949)
|
| |
(25,849)
|
| |
(88,834)
|
| |
(53,164)
|
Loss from operations
|
| |
|
| |
(44,949)
|
| |
(23,887)
|
| |
(88,834)
|
| |
(50,824)
|
Other income (expense)
|
| |
|
| |
|
| |
|
| |
|
| |
|
Other income
|
| |
|
| |
130
|
| |
—
|
| |
278
|
| |
—
|
Convertible loans, derivatives, increase in fair value
|
| |
11
|
| |
(79,261)
|
| |
—
|
| |
(79,261)
|
| |
—
|
Convertible loans, first tranche, derivative, transaction costs
|
| |
11
|
| |
(1,571)
|
| |
—
|
| |
(1,571)
|
| |
—
|
Financial income
|
| |
|
| |
195
|
| |
659
|
| |
569
|
| |
1,306
|
Financial expense
|
| |
|
| |
(897)
|
| |
(36)
|
| |
(939)
|
| |
(73)
|
Exchange differences
|
| |
|
| |
(100)
|
| |
10
|
| |
(71)
|
| |
(68)
|
Total other income (expense)
|
| |
|
| |
(81,504)
|
| |
633
|
| |
(80,995)
|
| |
1,165
|
Loss before taxes
|
| |
|
| |
(126,453)
|
| |
(23,254)
|
| |
(169,829)
|
| |
(49,659)
|
Income tax expense
|
| |
|
| |
(104)
|
| |
(94)
|
| |
(204)
|
| |
(199)
|
Net loss
|
| |
|
| |
(126,557)
|
| |
(23,348)
|
| |
(170,033)
|
| |
(49,858)
|
Net loss attributable to:
|
| |
|
| |
|
| |
|
| |
|
| |
|
Owners of the parent
|
| |
|
| |
(126,557)
|
| |
(23,348)
|
| |
(170,033)
|
| |
(49,858)
|
Net loss per share, basic and diluted
|
| |
15
|
| |
(2.01)
|
| |
(0.49)
|
| |
(2.97)
|
| |
(1.05)
|
|
| |
For the Three Months
Ended June 30,
|
| |
For the Six Months
Ended June 30,
|
||||||
|
| |
2020
|
| |
2019
|
| |
2020
|
| |
2019
|
Net Loss
|
| |
(126,557)
|
| |
(23,348)
|
| |
(170,033)
|
| |
(49,858)
|
Other comprehensive income
|
| |
|
| |
|
| |
|
| |
|
Items that will not be reclassified to profit and loss
|
| |
|
| |
|
| |
|
| |
|
Remeasurements of defined benefit plan
|
| |
—
|
| |
(16)
|
| |
—
|
| |
(7)
|
Total items that will not be reclassified to profit and loss
|
| |
—
|
| |
(16)
|
| |
—
|
| |
(7)
|
Items that may be reclassified to profit and loss
|
| |
|
| |
|
| |
|
| |
|
Currency translation differences
|
| |
(13)
|
| |
(42)
|
| |
(215)
|
| |
(8)
|
Total items that may be reclassified to profit and loss
|
| |
(13)
|
| |
(42)
|
| |
(215)
|
| |
(8)
|
Other comprehensive loss for the period
|
| |
(13)
|
| |
(58)
|
| |
(215)
|
| |
(15)
|
Total comprehensive loss for the period
|
| |
(126,570)
|
| |
(23,406)
|
| |
(170,248)
|
| |
(49,873)
|
Total comprehensive loss attributable to:
|
| |
|
| |
|
| |
|
| |
|
Owners of the parent
|
| |
(126,570)
|
| |
(23,406)
|
| |
(170,248)
|
| |
(49,873)
|
|
| |
Note
|
| |
June 30,
2020
|
| |
December 31,
2019
|
ASSETS
|
| |
|
| |
|
| |
|
Current assets
|
| |
|
| |
|
| |
|
Cash and cash equivalents
|
| |
9
|
| |
348,593
|
| |
115,551
|
Other current assets
|
| |
|
| |
10,532
|
| |
7,055
|
Total current assets
|
| |
|
| |
359,125
|
| |
122,606
|
Non-current assets
|
| |
|
| |
|
| |
|
Property, plant and equipment
|
| |
|
| |
1,260
|
| |
1,376
|
Right-of-use assets
|
| |
|
| |
4,248
|
| |
4,898
|
Intangible assets
|
| |
10
|
| |
8,825
|
| |
8,434
|
Other long-term assets
|
| |
|
| |
384
|
| |
368
|
Total non-current assets
|
| |
|
| |
14,717
|
| |
15,076
|
Total assets
|
| |
|
| |
373,842
|
| |
137,682
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
| |
|
| |
|
| |
|
Current liabilities
|
| |
|
| |
|
| |
|
Accounts payable
|
| |
|
| |
6,797
|
| |
3,329
|
Other current liabilities
|
| |
|
| |
20,211
|
| |
15,430
|
Lease liabilities, short-term
|
| |
|
| |
1,099
|
| |
1,132
|
Current income tax payable
|
| |
|
| |
148
|
| |
52
|
Convertible loans, short-term
|
| |
11
|
| |
3,113
|
| |
—
|
Total current liabilities
|
| |
|
| |
31,368
|
| |
19,943
|
Non-current liabilities
|
| |
|
| |
|
| |
|
Convertible loans, long-term
|
| |
11
|
| |
32,855
|
| |
—
|
Convertible loans, derivatives
|
| |
11
|
| |
107,058
|
| |
—
|
Lease liabilities, long-term
|
| |
|
| |
3,334
|
| |
3,899
|
Defined benefit pension liabilities
|
| |
|
| |
2,925
|
| |
2,684
|
Total non-current liabilities
|
| |
|
| |
146,172
|
| |
6,583
|
Total liabilities
|
| |
|
| |
177,540
|
| |
26,526
|
Equity attributable to owners of the parent
|
| |
|
| |
|
| |
|
Share capital
|
| |
13
|
| |
5,795
|
| |
4,361
|
Share premium
|
| |
13
|
| |
792,605
|
| |
549,922
|
Treasury shares
|
| |
13
|
| |
(4)
|
| |
(100)
|
Other reserves
|
| |
|
| |
16,654
|
| |
5,473
|
Cumulative translation adjustment
|
| |
|
| |
(146)
|
| |
69
|
Accumulated losses
|
| |
|
| |
(618,602)
|
| |
(448,569)
|
Total equity attributable to owners of the parent
|
| |
|
| |
196,302
|
| |
111,156
|
Total liabilities and equity
|
| |
|
| |
373,842
|
| |
137,682
|
For the three and six months ended June 30, 2019
|
||||||||||||||||||||||||
|
| |
Note
|
| |
Share
Capital
|
| |
Share
Premium
|
| |
Other
Reserves
|
| |
Shares to
be issued
|
| |
Cumulative
Translation
Adjustments
|
| |
Accumulated
Losses
|
| |
Total
Equity
|
January 1, 2019
|
| |
|
| |
401
|
| |
452,268
|
| |
5,702
|
| |
—
|
| |
(43)
|
| |
(332,085)
|
| |
126,243
|
Loss for the period
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(26,510)
|
| |
(26,510)
|
Translation adjustment
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
34
|
| |
—
|
| |
34
|
Remeasurement of defined benefit pension liability
|
| |
|
| |
—
|
| |
—
|
| |
9
|
| |
—
|
| |
—
|
| |
—
|
| |
9
|
Total other comprehensive income / (loss)
|
| |
|
| |
—
|
| |
—
|
| |
9
|
| |
—
|
| |
34
|
| |
—
|
| |
43
|
Total comprehensive income / (loss) for the period
|
| |
|
| |
—
|
| |
—
|
| |
9
|
| |
—
|
| |
34
|
| |
(26,510)
|
| |
(26,467)
|
Issuance of share capital
|
| |
13
|
| |
1
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
1
|
Transaction costs
|
| |
13
|
| |
—
|
| |
(19)
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(19)
|
Share-based compensation expense
|
| |
12
|
| |
—
|
| |
—
|
| |
84
|
| |
—
|
| |
—
|
| |
—
|
| |
84
|
Total transactions with owners
|
| |
|
| |
1
|
| |
(19)
|
| |
84
|
| |
—
|
| |
—
|
| |
—
|
| |
66
|
March 31, 2019
|
| |
|
| |
402
|
| |
452,249
|
| |
5,795
|
| |
—
|
| |
(9)
|
| |
(358,595)
|
| |
99,842
|
Loss for the period
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(23,348)
|
| |
(23,348)
|
Translation adjustment
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(42)
|
| |
—
|
| |
(42)
|
Remeasurement of defined benefit pension liability
|
| |
|
| |
—
|
| |
—
|
| |
(16)
|
| |
—
|
| |
—
|
| |
—
|
| |
(16)
|
Total other comprehensive loss
|
| |
|
| |
—
|
| |
—
|
| |
(16)
|
| |
—
|
| |
(42)
|
| |
—
|
| |
(58)
|
Total comprehensive loss for the period
|
| |
|
| |
—
|
| |
—
|
| |
(16)
|
| |
—
|
| |
(42)
|
| |
(23,348)
|
| |
(23,406)
|
Issuance of share capital
|
| |
13
|
| |
22
|
| |
76,277
|
| |
—
|
| |
26,950
|
| |
—
|
| |
—
|
| |
103,249
|
Transaction costs
|
| |
13
|
| |
—
|
| |
(1,443)
|
| |
—
|
| |
(309)
|
| |
—
|
| |
—
|
| |
(1,752)
|
Share-based compensation expense
|
| |
12
|
| |
—
|
| |
—
|
| |
56
|
| |
—
|
| |
—
|
| |
—
|
| |
56
|
Total transactions with owners
|
| |
|
| |
22
|
| |
74,834
|
| |
56
|
| |
26,641
|
| |
—
|
| |
—
|
| |
101,553
|
June 30, 2019
|
| |
|
| |
424
|
| |
527,083
|
| |
5,835
|
| |
26,641
|
| |
(51)
|
| |
(381,943)
|
| |
177,989
|
For the three and six months ended June 30, 2020
|
||||||||||||||||||||||||
|
| |
Note
|
| |
Share
Capital
|
| |
Share
Premium
|
| |
Other
Reserves
|
| |
Treasury
Shares
|
| |
Cumulative
Translation
Adjustments
|
| |
Accumulated
Losses
|
| |
Total
Equity
|
January 1, 2020
|
| |
|
| |
4,361
|
| |
549,922
|
| |
5,473
|
| |
(100)
|
| |
69
|
| |
(448,569)
|
| |
111,156
|
Loss for the period
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(43,476)
|
| |
(43,476)
|
Translation adjustment
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(202)
|
| |
—
|
| |
(202)
|
Total other comprehensive loss
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(202)
|
| |
—
|
| |
(202)
|
Total comprehensive loss for the period
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(202)
|
| |
(43,476)
|
| |
(43,678)
|
Share-based compensation expense
|
| |
12
|
| |
—
|
| |
—
|
| |
3,790
|
| |
—
|
| |
—
|
| |
—
|
| |
3,790
|
Total transactions with owners
|
| |
|
| |
—
|
| |
—
|
| |
3,790
|
| |
—
|
| |
—
|
| |
—
|
| |
3,790
|
March 31, 2020
|
| |
|
| |
4,361
|
| |
549,922
|
| |
9,263
|
| |
(100)
|
| |
(133)
|
| |
(492,045)
|
| |
71,268
|
Loss for the period
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(126,557)
|
| |
(126,557)
|
Translation adjustment
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(13)
|
| |
—
|
| |
(13)
|
Total other comprehensive loss
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(13)
|
| |
—
|
| |
(13)
|
Total comprehensive loss for the period
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(13)
|
| |
(126,557)
|
| |
(126,570)
|
Shares surrendered to redeem share purchase plan promissory notes
|
| |
13
|
| |
—
|
| |
11,208
|
| |
—
|
| |
(11,208)
|
| |
—
|
| |
—
|
| |
—
|
Issuance of shares through capitalization of reserves
|
| |
13
|
| |
393
|
| |
(393)
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Issuance of shares to be held as treasury shares
|
| |
13
|
| |
34
|
| |
—
|
| |
—
|
| |
(34)
|
| |
—
|
| |
—
|
| |
—
|
Grant of shares to settle 2014 incentive plan awards
|
| |
13
|
| |
—
|
| |
(29)
|
| |
—
|
| |
29
|
| |
—
|
| |
—
|
| |
—
|
Issuance of shares at initial public offering
|
| |
13
|
| |
1,007
|
| |
231,661
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
232,668
|
Sale of shares under greenshoe option
|
| |
13
|
| |
—
|
| |
23,591
|
| |
—
|
| |
11,309
|
| |
—
|
| |
—
|
| |
34,900
|
Transaction costs, initial public offering and greenshoe option
|
| |
13
|
| |
—
|
| |
(23,355)
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(23,355)
|
Share-based compensation expense
|
| |
12
|
| |
—
|
| |
—
|
| |
7,391
|
| |
—
|
| |
—
|
| |
—
|
| |
7,391
|
Total transactions with owners
|
| |
|
| |
1,434
|
| |
242,683
|
| |
7,391
|
| |
96
|
| |
—
|
| |
—
|
| |
251,604
|
June 30, 2020
|
| |
|
| |
5,795
|
| |
792,605
|
| |
16,654
|
| |
(4)
|
| |
(146)
|
| |
(618,602)
|
| |
196,302
|
|
| |
|
| |
For the Six Months
Ended June 30,
|
|||
|
| |
Note
|
| |
2020
|
| |
2019
|
Cash used in operating activities
|
| |
|
| |
|
| |
|
Loss for the period
|
| |
|
| |
(170,033)
|
| |
(49,858)
|
Adjustments for non-monetary items:
|
| |
|
| |
|
| |
|
Share-based compensation expense
|
| |
12
|
| |
11,181
|
| |
140
|
Depreciation of property, plant and equipment
|
| |
|
| |
294
|
| |
269
|
Amortization of intangible assets
|
| |
|
| |
17
|
| |
13
|
Depreciation of right-of-use assets
|
| |
|
| |
569
|
| |
513
|
Change in defined benefit pension liability
|
| |
|
| |
189
|
| |
158
|
Convertible loans, derivatives, increase in fair value
|
| |
11
|
| |
79,261
|
| |
—
|
Financial income
|
| |
|
| |
(569)
|
| |
(852)
|
Interest expense on convertible loans
|
| |
11
|
| |
868
|
| |
—
|
Exchange differences
|
| |
|
| |
—
|
| |
(2)
|
Income taxes
|
| |
|
| |
204
|
| |
199
|
Changes in assets and liabilities:
|
| |
|
| |
|
| |
|
Decrease in trade accounts receivable
|
| |
|
| |
—
|
| |
182
|
(Increase) in other current assets
|
| |
|
| |
(3,569)
|
| |
(277)
|
(Decrease) in contract liability
|
| |
6
|
| |
—
|
| |
(2,340)
|
Increase / (Decrease) in accounts payable
|
| |
|
| |
3,468
|
| |
(5,579)
|
Increase in other liabilities
|
| |
|
| |
4,781
|
| |
906
|
Cash used in operating activities
|
| |
|
| |
(73,339)
|
| |
(56,528)
|
Interest received
|
| |
|
| |
588
|
| |
970
|
Interest expense on lease obligations
|
| |
|
| |
61
|
| |
73
|
Tax refunded (paid)
|
| |
|
| |
2
|
| |
(203)
|
Net cash used in operating activities
|
| |
|
| |
(72,688)
|
| |
(55,688)
|
Cash used in investing activities
|
| |
|
| |
|
| |
|
Payment for purchase of property, plant and equipment
|
| |
|
| |
(226)
|
| |
(150)
|
Payment for purchase of intangible assets
|
| |
10
|
| |
(408)
|
| |
(1,757)
|
Net cash used in investing activities
|
| |
|
| |
(634)
|
| |
(1,907)
|
Cash from financing activities
|
| |
|
| |
|
| |
|
Proceeds from capital contributions, net of transaction costs
|
| |
|
| |
—
|
| |
74,838
|
Proceeds from public offering of common shares, net of underwriting fees and other transaction costs
|
| |
13
|
| |
244,213
|
| |
—
|
Proceeds from convertible loans, net
|
| |
11
|
| |
62,896
|
| |
—
|
Proceeds from shares to be issued, net of transaction costs
|
| |
|
| |
—
|
| |
26,641
|
Principal payments of lease obligations
|
| |
|
| |
(615)
|
| |
(548)
|
Net cash from financing activities
|
| |
|
| |
306,494
|
| |
100,931
|
Net increase in cash and cash equivalents
|
| |
|
| |
233,172
|
| |
43,336
|
Exchange gain / (losses) on cash and cash equivalents
|
| |
|
| |
(130)
|
| |
13
|
Cash and cash equivalents at beginning of the period
|
| |
|
| |
115,551
|
| |
138,807
|
Cash and cash equivalents at end of the period
|
| |
|
| |
348,593
|
| |
182,156
|
Corporate information
|
•
|
establish and maintain a strong patent position and protection;
|
•
|
enter into collaborations with partners in the pharmaceutical industry;
|
•
|
acquire and retain key personnel; and
|
•
|
acquire additional funding to support its operations.
|
2.
|
Basis of preparation
|
|
| |
Six Months Ended June 30,
|
|||
|
| |
2020
|
| |
2019
|
USD / GBP
|
| |
|
| |
|
Closing rate, GBP 1
|
| |
1.23272
|
| |
1.26898
|
Weighted average exchange rate, GBP 1
|
| |
1.23277
|
| |
1.29507
|
|
| |
Ownership Interest
|
|||
|
| |
June 30, 2020
|
| |
June 30, 2019
|
ADC Therapeutics America, Inc. (“ADCT America”)
|
| |
100%
|
| |
100%
|
ADC Therapeutics (UK) Ltd (“ADCT UK”)
|
| |
100%
|
| |
100%
|
3.
|
Significant accounting policies
|
(i)
|
an initial disbursement of convertible loans in the amount of USD 65 million upon the completion of the IPO, and satisfaction of certain other conditions (the “first tranche”) and
|
(ii)
|
a subsequent disbursement of convertible loans amounting to USD 50 million upon the receipt of regulatory approval for a specified product candidate, and satisfaction of certain other conditions (the “second tranche”).
|
(i)
|
The embedded conversion option derivative has been initially measured at fair value and is subsequently remeasured to fair value at each reporting date. Under IAS 32, this derivative could have been classified as a component of equity only if in all cases the contract would be settled by the Company delivering a fixed number of its own equity instruments in exchange for a fixed amount of cash or debt redemption. However, the agreement foresees, in the event of a major transaction, the payment of “make-whole” amounts that would have to be computed in the light of the circumstances and are therefore not fixed. As a result, the derivative is presented in the balance sheet as a liability and classified as non-equity in accordance with IFRS 9. Changes in the fair value (gains or losses) of the derivative at the end of each period are recorded in the consolidated statement of income.
|
(ii)
|
The convertible loan’s initial fair value is the residual amount of the consideration received, net of attributable costs, after separating out the fair value of the embedded conversion option derivative. The loan is subsequently measured at its amortized cost in accordance with IFRS 9. It is presented in the unaudited condensed consolidated interim balance sheet as a financial liability.
|
4.
|
Financial risk management
|
4.1
|
Financial risk factors
|
4.2
|
Fair value estimation
|
•
|
Cash and cash equivalents
|
•
|
Trade accounts payable
|
5.
|
Segment information
|
6.
|
Contract Revenue
|
|
| |
Three months ended
|
|||
in KUSD
|
| |
2020
|
| |
2019
|
April 1,
|
| |
—
|
| |
1,962
|
Recognized as contract revenue
|
| |
—
|
| |
(1,962)
|
June 30,
|
| |
—
|
| |
—
|
|
| |
Six months ended
|
|||
in KUSD
|
| |
2020
|
| |
2019
|
January 1,
|
| |
—
|
| |
2,340
|
Recognized as contract revenue
|
| |
—
|
| |
(2,340)
|
June 30,
|
| |
—
|
| |
—
|
7.
|
Research and development expense
|
|
| |
Three months ended June 30,
|
|||
in KUSD
|
| |
2020
|
| |
2019
|
External costs(1)
|
| |
16,161
|
| |
16,415
|
Employee expense(2)
|
| |
9,789
|
| |
5,345
|
Research and development expense
|
| |
25,950
|
| |
21,760
|
(1)
|
Includes depreciation expense
|
(2)
|
Includes share-based compensation expense
|
|
| |
Six months ended June 30,
|
|||
in KUSD
|
| |
2020
|
| |
2019
|
External costs(1)
|
| |
42,300
|
| |
36,041
|
Employee expense(2)
|
| |
19,025
|
| |
10,531
|
Research and development expense
|
| |
61,325
|
| |
46,572
|
(1)
|
Includes depreciation expense
|
(2)
|
Includes share-based compensation expense
|
8.
|
General and administrative expense
|
|
| |
Three months ended June 30,
|
|||
in KUSD
|
| |
2020
|
| |
2019
|
External costs(1)
|
| |
4,421
|
| |
2,843
|
Employee expense(2)
|
| |
14,578
|
| |
1,246
|
General and administrative expense
|
| |
18,999
|
| |
4,089
|
(1)
|
Includes depreciation expense
|
(2)
|
Includes share-based compensation expense
|
|
| |
Six months ended June 30,
|
|||
in KUSD
|
| |
2020
|
| |
2019
|
External costs(1)
|
| |
8,401
|
| |
4,062
|
Employee expense(2)
|
| |
19,108
|
| |
2,530
|
General and administrative expense
|
| |
27,509
|
| |
6,592
|
(1)
|
Includes depreciation expense
|
(2)
|
Includes share-based compensation expense
|
9.
|
Cash and cash equivalents
|
10.
|
Intangible Assets
|
•
|
An amount of KUSD 250 relating to a license agreement with a third party to acquire an antibody to be used in research, development, manufacturing and commercialization was capitalized as intangible assets.
|
•
|
An amount of KUSD 125 relating to a license agreement with a third party to use their technology to generate antibody-drug conjugates for up to five antibodies was capitalized as intangible assets.
|
11.
|
Convertible Loans
|
|
| |
As of
|
|||
|
| |
June 30, 2020
|
| |
April 24, 2020
|
Exercise price, in USD
|
| |
24.70
|
| |
22.10
|
Forced conversion price, in USD
|
| |
67.93
|
| |
60.78
|
Share price in USD
|
| |
46.81
|
| |
17.00
|
Risk-free interest rate
|
| |
0.3%
|
| |
0.4%
|
Expected volatility
|
| |
75%
|
| |
82%
|
|
| |
As of
|
|||
|
| |
June 30, 2020
|
| |
April 24, 2020
|
Expected term
|
| |
58 months
|
| |
61 months
|
Dividend yield
|
| |
—
|
| |
—
|
Recovery rate
|
| |
5%
|
| |
5%
|
Implied bond yield
|
| |
17.1%
|
| |
21.0%
|
in KUSD
|
| |
Embedded
derivative
|
| |
Residual
loan
|
| |
Total
|
Gross proceeds
|
| |
27,797
|
| |
37,203
|
| |
65,000
|
Less: transaction costs
|
| |
(1,571)
|
| |
(2,102)
|
| |
(3,673)
|
Net
|
| |
26,226
|
| |
35,101
|
| |
61,327
|
in KUSD
|
| |
|
Liability related to embedded derivative as of April 24, 2020
|
| |
27,797
|
Increase in fair value of embedded derivative
|
| |
57,450
|
Liability related to embedded derivative as of June 30, 2020
|
| |
85,247
|
|
| |
As of
June 30, 2020
|
Exercise price, in USD
|
| |
28.50
|
Forced conversion price, in USD
|
| |
78.38
|
Share price in USD
|
| |
46.81
|
Risk-free interest rate
|
| |
0.3%
|
Expected volatility
|
| |
75%
|
Expected term
|
| |
11 months
|
Dividend yield
|
| |
—
|
Recovery rate
|
| |
5%
|
Implied bond yield
|
| |
9.9%
|
|
| |
As of
|
|||
in KUSD
|
| |
June 30,
2020
|
| |
December 31,
2019
|
First tranche, embedded derivative
|
| |
85,247
|
| |
—
|
Second tranche, derivative
|
| |
21,811
|
| |
—
|
|
| |
107,058
|
| |
—
|
|
| |
Three and six months ended
|
|||
in KUSD
|
| |
June 30,
2020
|
| |
June 30,
2019
|
First tranche, embedded derivative
|
| |
57,450
|
| |
—
|
Second tranche, derivative
|
| |
21,811
|
| |
—
|
|
| |
79,261
|
| |
—
|
12.
|
Share-based compensation
|
|
| |
Average strike
price per share
in USD
|
| |
Number of
awards
|
| |
Weighted average
remaining life in
years
|
December 31, 2019
|
| |
18.75
|
| |
1,020,434
|
| |
9.96
|
Granted
|
| |
21.26
|
| |
2,247,074
|
| |
9.76
|
Forfeited
|
| |
18.83
|
| |
(19,985)
|
| |
—
|
June 30, 2020
|
| |
20.55
|
| |
3,247,523
|
| |
9.69
|
|
| |
Three Months Ended
|
| |
Six Months Ended
|
||||||
|
| |
June 30, 2020
|
| |
June 30, 2019
|
| |
June 30, 2020
|
| |
June 30, 2019
|
Weighted average share price
|
| |
$15.95 - $34.99
|
| |
—
|
| |
$15.95 - $34.99
|
| |
—
|
Strike price
|
| |
$18.75 - $34.99
|
| |
—
|
| |
$18.75 - $34.99
|
| |
—
|
Expected volatility
|
| |
85% - 206%
|
| |
—
|
| |
85% - 206%
|
| |
—
|
Award life
|
| |
$5.02 - $5.85
|
| |
—
|
| |
$5.02 - $5.85
|
| |
—
|
Expected dividends
|
| |
0%
|
| |
—
|
| |
0%
|
| |
—
|
Risk-free interest rate
|
| |
0.36% - 0.47%
|
| |
—
|
| |
0.36% - 0.70%
|
| |
—
|
|
| |
Three months ended
|
| |
Six months ended
|
||||||
in KUSD
|
| |
June 30, 2020
|
| |
June 30, 2019
|
| |
June 30, 2020
|
| |
June 30, 2019
|
Share Purchase Plan 2013
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Incentive Plan 2014
|
| |
179
|
| |
10
|
| |
361
|
| |
23
|
Share Purchase Plan 2016
|
| |
6,425
|
| |
46
|
| |
7,417
|
| |
117
|
Equity Incentive Plan 2019
|
| |
6,130
|
| |
—
|
| |
8,746
|
| |
—
|
Tax and social charge deductions - Incentive Plan 2014
|
| |
(5,343)
|
| |
—
|
| |
(5,343)
|
| |
—
|
Total
|
| |
7,391
|
| |
56
|
| |
11,181
|
| |
140
|
13.
|
Share Capital, share premium and treasury shares
|
|
| |
|
| |
Issued
share
capital
|
| |
Share
premium
|
| |
Treasury
shares
|
| |
Increase /
(Decrease)
in net
assets
|
| |
Price
per
share
|
| |
Issued
share
capital
|
| |
Treasury
shares
|
| |
Outstanding
share capital
|
|
| |
|
| |
In KUSD
|
| |
|
| |
Number of
shares
issued
|
| |
Number of
shares (held
or received) /
delivered
|
| |
Number of
shares
outstanding
|
|||||||||
April 15, 2020
|
| |
Shares surrendered by Share Purchase Plan 2013 and Share Purchase Plan 2016 participants to settle share purchase plan promissory notes (see note 12)
|
| |
—
|
| |
11,208
|
| |
(11,208)
|
| |
—
|
| |
USD 18.75
|
| |
—
|
| |
(597,774)
|
| |
(597,774)
|
April 16, 2020
|
| |
Issuance of shares per shareholders' agreement addendum through capitalization of reserves
|
| |
393
|
| |
(393)
|
| |
—
|
| |
—
|
| |
CHF 0.08
|
| |
4,777,996
|
| |
—
|
| |
4,777,996
|
April 24, 2020
|
| |
Elimination of fractional shareholdings
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
CHF 0.08
|
| |
—
|
| |
51
|
| |
51
|
May 15, 2020
|
| |
Issuance of shares to be held as treasury shares
|
| |
34
|
| |
—
|
| |
(34)
|
| |
—
|
| |
CHF 0.08
|
| |
408,873
|
| |
(408,873)
|
| |
—
|
May 15, 2020
|
| |
Grant of shares to settle Incentive Plan 2014 awards, net (see note 12)
|
| |
—
|
| |
(29)
|
| |
29
|
| |
—
|
| |
CHF 0.08
|
| |
—
|
| |
356,144
|
| |
356,144
|
May 15, 2020
|
| |
Issuance of shares at IPO
|
| |
1,007
|
| |
231,661
|
| |
—
|
| |
232,668
|
| |
USD 19.00
|
| |
12,245,631
|
| |
—
|
| |
12,245,631
|
May 15, 2020
|
| |
Sale of shares under greenshoe option
|
| |
—
|
| |
23,591
|
| |
11,309
|
| |
34,900
|
| |
USD 19.00
|
| |
—
|
| |
1,836,844
|
| |
1,836,844
|
May 15, 2020
|
| |
Transaction costs, IPO and greenshoe option
|
| |
—
|
| |
(23,355)
|
| |
—
|
| |
(23,355)
|
| |
|
| |
—
|
| |
—
|
| |
—
|
|
| |
Movements in the period
|
| |
1,434
|
| |
242,683
|
| |
96
|
| |
244,213
|
| |
|
| |
17,432,500
|
| |
1,186,392
|
| |
18,618,892
|
December 31, 2019
|
| |
Balances reported at December 31, 2019, revised for share consolidation
|
| |
4,361
|
| |
549,922
|
| |
(100)
|
| |
|
| |
|
| |
53,337,500
|
| |
(1,240,540)
|
| |
52,096,960
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
| |
Balance at June 30, 2020
|
| |
5,795
|
| |
792,605
|
| |
(4)
|
| |
|
| |
|
| |
70,770,000
|
| |
(54,148)
|
| |
70,715,852
|
14.
|
Related parties
|
|
| |
Three months ended
|
| |
Six months ended
|
||||||
in KUSD
|
| |
June 30, 2020
|
| |
June 30, 2019
|
| |
June 30, 2020
|
| |
June 30, 2019
|
Salaries and other short-term employee costs
|
| |
1,666
|
| |
1,242
|
| |
3,254
|
| |
2,477
|
Pension costs
|
| |
107
|
| |
98
|
| |
256
|
| |
183
|
Share-based compensation expense
|
| |
6,025
|
| |
42
|
| |
7,599
|
| |
107
|
Other compensation
|
| |
22
|
| |
—
|
| |
83
|
| |
—
|
Total
|
| |
7,820
|
| |
1,382
|
| |
11,192
|
| |
2,767
|
15.
|
Loss per share
|
|
| |
Three Months Ended
|
| |
Six Months Ended
|
||||||
(in KUSD, except per share amounts)
|
| |
June 30, 2020
|
| |
June 30, 2019
|
| |
June 30, 2020
|
| |
June 30, 2019
|
Loss attributable to owners
|
| |
(126,557)
|
| |
(23,348)
|
| |
(170,033)
|
| |
(49,858)
|
Weighted average number of shares outstanding(1)
|
| |
62,863,866
|
| |
47,654,258
|
| |
57,225,939
|
| |
47,297,859
|
Basic and diluted loss per share
|
| |
(2.01)
|
| |
(0.49)
|
| |
(2.97)
|
| |
(1.05)
|
(1)
|
Share data have been revised to give effect to the share split and share consolidation as explained in note 2, “Share split and share consolidation”.
|
|
| |
Three Months Ended June 30,
|
| |
Six Months Ended June 30,
|
||||||
|
| |
2020
|
| |
2019
|
| |
2020
|
| |
2019
|
Share options under the Incentive Plan 2014
|
| |
—
|
| |
2,137,437
|
| |
—
|
| |
2,130,967
|
Shares under the Share Purchase Plan 2016
|
| |
—
|
| |
962,500
|
| |
—
|
| |
962,500
|
Share options under the Equity Incentive Plan 2019
|
| |
2,784,467
|
| |
—
|
| |
1,999,022
|
| |
—
|
Conversion of the principal amount of convertible loans into the Company’s common shares
|
| |
1,766,917
|
| |
—
|
| |
888,340
|
| |
—
|
|
| |
4,551,384
|
| |
3,099,937
|
| |
2,887,362
|
| |
3,093,467
|
Events after the reporting date
|
|
| |
Note
|
| |
Year ended
December 31,
2019
|
| |
Year ended
December 31,
2018
|
Contract revenue
|
| |
7
|
| |
2,340
|
| |
1,140
|
Research and development expenses
|
| |
9/11
|
| |
(107,537)
|
| |
(118,313)
|
General and administrative expenses
|
| |
11
|
| |
(14,202)
|
| |
(8,768)
|
Operating loss
|
| |
|
| |
(119,399)
|
| |
(125,941)
|
Other income
|
| |
8
|
| |
1,655
|
| |
—
|
Financial income
|
| |
|
| |
2,253
|
| |
2,856
|
Financial expense
|
| |
|
| |
(156)
|
| |
—
|
Exchange differences
|
| |
|
| |
(255)
|
| |
213
|
Loss before taxes
|
| |
|
| |
(115,902)
|
| |
(122,872)
|
Income tax expenses
|
| |
12
|
| |
(582)
|
| |
(224)
|
Loss for the year
|
| |
|
| |
(116,484)
|
| |
(123,096)
|
|
| |
|
| |
|
| |
|
Attributable to:
|
| |
|
| |
|
| |
|
Owners of the parent
|
| |
|
| |
(116,484)
|
| |
(123,096)
|
|
| |
|
| |
|
| |
|
Loss per share
|
| |
|
| |
|
| |
|
Basic and diluted loss per share (in USD)
|
| |
28
|
| |
(2.36)
|
| |
(2.64)
|
|
| |
Note
|
| |
Year ended
December 31,
2019
|
| |
Year ended
December 31,
2018
|
Loss for the year
|
| |
|
| |
(116,484)
|
| |
(123,096)
|
|
| |
|
| |
|
| ||
Other comprehensive (loss) / profit:
|
| |
|
| |
|
| |
|
Items that will not be reclassified to profit or loss
|
| |
|
| |
|
| |
|
Remeasurements of defined benefit plan
|
| |
22
|
| |
(1,346)
|
| |
(193)
|
Total items that will not be reclassified to profit or loss
|
| |
|
| |
(1,346)
|
| |
(193)
|
Items that may be reclassified subsequently to profit or loss
|
| |
|
| |
|
| |
|
Currency translation differences
|
| |
|
| |
112
|
| |
(79)
|
Total items that may be reclassified subsequently to profit or loss
|
| |
|
| |
112
|
| |
(79)
|
|
| |
|
| |
|
| |
|
Other comprehensive loss for the year
|
| |
|
| |
(1,234)
|
| |
(272)
|
|
| |
|
| |
|
| |
|
Total comprehensive loss for the year
|
| |
|
| |
(117,718)
|
| |
(123,368)
|
|
| |
|
| |
|
| |
|
Attributable to:
|
| |
|
| |
|
| |
|
Owners of the parent
|
| |
|
| |
(117,718)
|
| |
(123,368)
|
|
| |
Note
|
| |
December 31,
2019
|
| |
December 31,
2018
|
ASSETS
|
| |
|
| |
|
| |
|
Current assets
|
| |
|
| |
|
| |
|
Cash and cash equivalents
|
| |
19
|
| |
115,551
|
| |
138,807
|
Trade accounts receivable
|
| |
13/19/27
|
| |
—
|
| |
192
|
Other current assets
|
| |
14
|
| |
7,055
|
| |
3,081
|
Total current assets
|
| |
|
| |
122,606
|
| |
142,080
|
Non-current assets
|
| |
|
| |
|
| |
|
Property, plant and equipment
|
| |
16
|
| |
1,376
|
| |
1,540
|
Right-of-use assets
|
| |
4/17
|
| |
4,898
|
| |
—
|
Intangible assets
|
| |
18
|
| |
8,434
|
| |
6,674
|
Other long-term assets
|
| |
|
| |
368
|
| |
264
|
Total non-current assets
|
| |
|
| |
15,076
|
| |
8,478
|
|
| |
|
| |
|
| |
|
Total assets
|
| |
|
| |
137,682
|
| |
150,558
|
|
| |
|
| |
|
| |
|
LIABILITIES AND EQUITY
|
| |
|
| |
|
| |
|
Current liabilities
|
| |
|
| |
|
| |
|
Trade accounts payable
|
| |
19a/27
|
| |
3,329
|
| |
6,750
|
Accrued liabilities and other payables
|
| |
21
|
| |
15,430
|
| |
13,650
|
Contract liability (short-term)
|
| |
7
|
| |
—
|
| |
1,765
|
Lease liabilities (short-term)
|
| |
4/17
|
| |
1,132
|
| |
—
|
Current income tax payable
|
| |
|
| |
52
|
| |
189
|
Total current liabilities
|
| |
|
| |
19,943
|
| |
22,354
|
Non-current liabilities
|
| |
|
| |
|
| |
|
Contract liability (long-term)
|
| |
7
|
| |
—
|
| |
575
|
Lease liabilities (long-term)
|
| |
4/17
|
| |
3,899
|
| |
—
|
Defined benefit pension liabilities
|
| |
22
|
| |
2,684
|
| |
1,386
|
Total non-current liabilities
|
| |
|
| |
6,583
|
| |
1,961
|
|
| |
|
| |
|
| |
|
Total liabilities
|
| |
|
| |
26,526
|
| |
24,315
|
|
| |
|
| |
|
| |
|
Equity attributable to owners of the parent
|
| |
|
| |
|
| |
|
Share capital
|
| |
24
|
| |
4,361
|
| |
401
|
Share premium
|
| |
24
|
| |
549,922
|
| |
452,268
|
Treasury shares
|
| |
24
|
| |
(100)
|
| |
—
|
Other reserves
|
| |
22/23
|
| |
5,473
|
| |
5,702
|
Cumulative translation adjustments
|
| |
|
| |
69
|
| |
(43)
|
Accumulated losses
|
| |
|
| |
(448,569)
|
| |
(332,085)
|
Total equity
|
| |
|
| |
111,156
|
| |
126,243
|
|
| |
|
| |
|
| |
|
Total liabilities and equity
|
| |
|
| |
137,682
|
| |
150,558
|
|
| |
|
| |
Attributable to owners of the parent
|
||||||||||||||||||
|
| |
Note
|
| |
Share
capital
|
| |
Share
premium
|
| |
Other
reserves
|
| |
Treasury
shares
|
| |
Cumulative
translation
adjustment
|
| |
Accumulated
losses
|
| |
Total
|
January 1, 2018
|
| |
|
| |
397
|
| |
452,296
|
| |
5,426
|
| |
—
|
| |
36
|
| |
(208,989)
|
| |
249,166
|
Loss for the year
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(123,096)
|
| |
(123,096)
|
Translation adjustment
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(79)
|
| |
—
|
| |
(79)
|
Remeasurements of defined benefit pension
|
| |
22
|
| |
—
|
| |
—
|
| |
(193)
|
| |
—
|
| |
—
|
| |
—
|
| |
(193)
|
Total other comprehensive loss
|
| |
|
| |
—
|
| |
—
|
| |
(193)
|
| |
—
|
| |
(79)
|
| |
—
|
| |
(272)
|
Total comprehensive loss for the year
|
| |
|
| |
—
|
| |
—
|
| |
(193)
|
| |
—
|
| |
(79)
|
| |
(123,096)
|
| |
(123,368)
|
Issue of share capital
|
| |
24
|
| |
4
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
4
|
Transaction costs
|
| |
24
|
| |
—
|
| |
(28)
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(28)
|
Share-based compensation expense
|
| |
23
|
| |
—
|
| |
—
|
| |
469
|
| |
—
|
| |
—
|
| |
—
|
| |
469
|
Total transactions with owners
|
| |
|
| |
4
|
| |
(28)
|
| |
469
|
| |
—
|
| |
—
|
| |
—
|
| |
445
|
December 31, 2018
|
| |
|
| |
401
|
| |
452,268
|
| |
5,702
|
| |
—
|
| |
(43)
|
| |
(332,085)
|
| |
126,243
|
Loss for the year
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(116,484)
|
| |
(116,484)
|
Translation adjustment
|
| |
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
112
|
| |
—
|
| |
112
|
Remeasurements of defined benefit pension
|
| |
22
|
| |
—
|
| |
—
|
| |
(1,346)
|
| |
—
|
| |
—
|
| |
—
|
| |
(1,346)
|
Total other comprehensive loss
|
| |
|
| |
—
|
| |
—
|
| |
(1,346)
|
| |
—
|
| |
112
|
| |
—
|
| |
(1,234)
|
Total comprehensive loss for the year
|
| |
|
| |
—
|
| |
—
|
| |
(1,346)
|
| |
—
|
| |
112
|
| |
(116,484)
|
| |
(117,718)
|
Issue of share capital / capital contributions
|
| |
24
|
| |
171
|
| |
103,221
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
103,392
|
Transaction costs
|
| |
24
|
| |
—
|
| |
(1,778)
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
(1,778)
|
Transfer from share premium for par value increase
|
| |
24
|
| |
3,789
|
| |
(3,789)
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Purchase of treasury shares
|
| |
24
|
| |
—
|
| |
—
|
| |
—
|
| |
(141)
|
| |
—
|
| |
—
|
| |
(141)
|
Sale of treasury shares
|
| |
24
|
| |
—
|
| |
—
|
| |
—
|
| |
41
|
| |
—
|
| |
—
|
| |
41
|
Share-based compensation expense
|
| |
23
|
| |
—
|
| |
—
|
| |
1,117
|
| |
—
|
| |
—
|
| |
—
|
| |
1,117
|
Total transactions with owners
|
| |
|
| |
3,960
|
| |
97,654
|
| |
1,117
|
| |
(100)
|
| |
—
|
| |
—
|
| |
102,631
|
December 31, 2019
|
| |
|
| |
4,361
|
| |
549,922
|
| |
5,473
|
| |
(100)
|
| |
69
|
| |
(448,569)
|
| |
111,156
|
|
| |
Note
|
| |
Year ended
December 31,
2019
|
| |
Year ended
December 31,
2018
|
Cash used in operating activities
|
| |
|
| |
|
| |
|
Loss for the year
|
| |
|
| |
(116,484)
|
| |
(123,096)
|
Adjustments for non-monetary items:
|
| |
|
| |
|
| |
|
Share-based compensation expense
|
| |
23
|
| |
1,117
|
| |
469
|
Depreciation of property, plant and equipment
|
| |
16
|
| |
552
|
| |
488
|
Depreciation of right-of-use assets
|
| |
17
|
| |
1,064
|
| |
—
|
Amortization and impairment of intangible assets
|
| |
18
|
| |
30
|
| |
252
|
Change in defined benefit pension liabilities
|
| |
22
|
| |
(53)
|
| |
119
|
Change in fair value measurement
|
| |
|
| |
557
|
| |
1,009
|
Accrued withholding tax
|
| |
|
| |
626
|
| |
711
|
Accrued R&D credit
|
| |
|
| |
(437)
|
| |
—
|
Financial income
|
| |
|
| |
(2,253)
|
| |
(2,856)
|
Financial expense (including interest on lease obligations)
|
| |
|
| |
156
|
| |
—
|
Exchange differences
|
| |
|
| |
128
|
| |
(29)
|
Income taxes
|
| |
12
|
| |
582
|
| |
224
|
Operating loss before working capital changes
|
| |
|
| |
(114,415)
|
| |
(122,709)
|
Decrease in trade accounts receivable
|
| |
|
| |
192
|
| |
895
|
(Increase) in other current assets
|
| |
|
| |
(4,030)
|
| |
(1,678)
|
(Decrease) in contract liability (short and long term)
|
| |
|
| |
(2,340)
|
| |
(1,140)
|
(Decrease) in trade accounts payable
|
| |
|
| |
(3,425)
|
| |
(858)
|
Increase in accrued liabilities and other payables
|
| |
|
| |
1,720
|
| |
3,262
|
Cash used in operating activities
|
| |
|
| |
(122,298)
|
| |
(122,228)
|
|
| |
|
| |
|
| |
|
Interest received
|
| |
|
| |
1,164
|
| |
1,051
|
Interest paid
|
| |
|
| |
(157)
|
| |
—
|
Tax paid
|
| |
|
| |
(290)
|
| |
(185)
|
Net cash used in operating activities
|
| |
|
| |
(121,581)
|
| |
(121,362)
|
|
| |
|
| |
|
| |
|
Cash used in investing activities
|
| |
|
| |
|
| |
|
Payment for purchases of property, plant and equipment
|
| |
16
|
| |
(358)
|
| |
(944)
|
Payment for purchases of intangible assets
|
| |
18
|
| |
(1,790)
|
| |
(1,526)
|
Payment for rent deposits
|
| |
|
| |
(100)
|
| |
(36)
|
Net cash used in investing activities
|
| |
|
| |
(2,248)
|
| |
(2,506)
|
|
| |
|
| |
|
| |
|
Cash from / (used in) financing activities
|
| |
|
| |
|
| |
|
Proceeds from capital contributions, net of transaction costs
|
| |
24
|
| |
101,614
|
| |
(24)
|
Acquisition of treasury shares
|
| |
24
|
| |
(141)
|
| |
—
|
Sale of treasury shares
|
| |
24
|
| |
41
|
| |
—
|
Principal portion of lease obligations payments
|
| |
17
|
| |
(1,002)
|
| |
—
|
Net cash from / (used in) financing activities
|
| |
|
| |
100,512
|
| |
(24)
|
|
| |
|
| |
|
| |
|
Net decrease in cash and cash equivalents
|
| |
|
| |
(23,317)
|
| |
(123,892)
|
Exchange gains / (losses) on cash and cash equivalents
|
| |
|
| |
61
|
| |
(53)
|
Cash and cash equivalents at beginning of year
|
| |
|
| |
138,807
|
| |
262,752
|
Cash and cash equivalents at end of year
|
| |
|
| |
115,551
|
| |
138,807
|
Corporate information
|
2.
|
Basis of preparation
|
-
|
establish and maintain a strong patent position and protection;
|
-
|
enter into collaborations with partners in the pharmaceutical industry;
|
-
|
acquire and retain key personnel; and
|
-
|
acquire additional funding to support its operations.
|
3.
|
Significant accounting policies
|
3.1
|
Consolidation
|
3.2
|
Foreign currency translation
|
(i)
|
assets and liabilities for each balance sheet presented are translated at the closing rate at the date of that balance sheet;
|
(ii)
|
income and expenses for each income statement are translated at monthly average exchange rates; and
|
(iii)
|
all resulting exchange differences are recognized in other comprehensive income, under “Cumulative translation adjustments”.
|
3.3
|
Cash and cash equivalents
|
3.4
|
Property, plant and equipment
|
Leasehold improvements
|
| |
3 to 10 years
|
Laboratory equipment
|
| |
5 years
|
Office equipment
|
| |
5 years
|
Hardware
|
| |
3 years
|
3.5
|
Intangible assets
|
3.6
|
Impairment of non-financial assets
|
3.7
|
Employee benefits
|
-
|
including any market performance conditions;
|
-
|
excluding the impact of any service and non-market performance vesting conditions; and
|
-
|
including the impact of any non-vesting conditions.
|
3.8
|
Share capital and share premium
|
3.9
|
Treasury shares
|
3.10
|
Leases
|
-
|
the amount of the initial measurement of lease liability;
|
-
|
any lease payments made at or before the commencement date less any lease incentives received;
|
-
|
any initial direct costs, and
|
-
|
restoration costs.
|
-
|
periods covered by an option to extend the lease if the Company is reasonably certain to exercise that option; and
|
-
|
periods covered by an option to terminate the lease if the Company is reasonably certain not to exercise that option.
|
3.11
|
Revenue recognition
|
3.12
|
Research and development expenses
|
3.13
|
Current, deferred income tax and tax credit
|
3.14
|
Segment reporting
|
3.15
|
Loss per share
|
4.
|
New and amended IFRS standards
|
(in KUSD)
|
| |
December 31,
2019
|
| |
January 1,
2019
|
Properties (offices)
|
| |
4,820
|
| |
5,399
|
Vehicles
|
| |
78
|
| |
24
|
Total right-of-use assets
|
| |
4,898
|
| |
5,423
|
5.
|
Financial risk management
|
5.1
|
Financial risk factors
|
-
|
forecast costs denominated in a currency other than the entity’s functional currency;
|
-
|
recognized assets and liabilities denominated in a currency other than the entity's functional currency; and
|
-
|
net investments in foreign operations.
|
December 31
|
| |
2019
in KL/C(1)
|
| |
2019
in KUSD
|
| |
2018
in KL/C(1)
|
| |
2018
in KUSD
|
In USD
|
| |
109,939
|
| |
109,939
|
| |
135,451
|
| |
135,451
|
In CHF
|
| |
457
|
| |
472
|
| |
1,143
|
| |
1,160
|
In GBP
|
| |
3,529
|
| |
4,654
|
| |
929
|
| |
1,179
|
In EUR
|
| |
433
|
| |
486
|
| |
889
|
| |
1,017
|
|
| |
|
| |
115,551
|
| |
|
| |
138,807
|
(1)
|
Thousands Local Currencies
|
(in KUSD)
|
| |
Note
|
| |
Less than
3 months
|
| |
Between 3
months and
1 year
|
| |
Between 1
year and
3 years
|
| |
More than
3 years
|
Trade accounts payable
|
| |
|
| |
3,266
|
| |
63
|
| |
—
|
| |
—
|
Lease liabilities
|
| |
17
|
| |
311
|
| |
935
|
| |
1,859
|
| |
2,265
|
At December 31, 2019
|
| |
|
| |
3,577
|
| |
998
|
| |
1,859
|
| |
2,265
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
Trade accounts payable
|
| |
|
| |
6,597
|
| |
153
|
| |
—
|
| |
—
|
Lease liabilities
|
| |
17
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
At December 31, 2018
|
| |
|
| |
6,597
|
| |
153
|
| |
—
|
| |
—
|
5.2
|
Capital management
|
5.3
|
Fair value estimation
|
-
|
Cash and cash equivalents
|
-
|
Trade accounts receivable
|
-
|
Trade accounts payable
|
6
|
Critical accounting estimates and judgements
|
7.
|
Contract revenue and contract liability
|
(in KUSD)
|
| |
2019
|
| |
2018
|
January 1
|
| |
2,340
|
| |
3,480
|
Recognized as contract revenue
|
| |
(2,340)
|
| |
(1,140)
|
December 31
|
| |
—
|
| |
2,340
|
|
| |
|
| |
|
of which:
|
| |
|
| |
|
Contract liability (short term)
|
| |
—
|
| |
1,765
|
Contract liability (long term)
|
| |
—
|
| |
575
|
Contract liability (total)
|
| |
—
|
| |
2,340
|
8.
|
Other Income
|
(in KUSD):
|
| |
|
| |
|
Years
|
| |
December 31,
2019
|
| |
December 31,
2018
|
2016
|
| |
296
|
| |
—
|
2017
|
| |
350
|
| |
—
|
2018
|
| |
477
|
| |
—
|
2019
|
| |
532
|
| |
—
|
|
| |
1,655
|
| |
—
|
9.
|
Research and development expenses
|
10
|
Employee expenses
|
(in KUSD)
|
| |
Note
|
| |
Year ended
December 31,
2019
|
| |
Year ended
December 31,
2018
|
|
| |
|
| |
|
| |
|
Wages, salaries and other costs
|
| |
|
| |
24,061
|
| |
19,245
|
Social security costs
|
| |
|
| |
3,871
|
| |
3,452
|
Share-based compensation expense
|
| |
23
|
| |
1,117
|
| |
469
|
Defined benefit plan - pension costs
|
| |
22
|
| |
462
|
| |
535
|
Defined contribution plan - pension costs
|
| |
|
| |
540
|
| |
481
|
Employee expenses
|
| |
|
| |
30,051
|
| |
24,182
|
11
|
Expenses by nature
|
(in KUSD)
|
| |
Note
|
| |
Year ended
December 31,
2019
|
| |
Year ended
December 31,
2018
|
R&D
|
| |
|
| |
|
| |
|
External costs
|
| |
|
| |
81,363
|
| |
98,493
|
Employee expenses
|
| |
10
|
| |
24,916
|
| |
19,246
|
Depreciation of property, plant and equipment
|
| |
16
|
| |
407
|
| |
330
|
Depreciation of right-of-use assets
|
| |
17
|
| |
837
|
| |
—
|
Amortization of intangible assets
|
| |
18
|
| |
14
|
| |
17
|
Impairment of intangible assets
|
| |
18
|
| |
—
|
| |
227
|
Research and development expenses
|
| |
|
| |
107,537
|
| |
118,313
|
|
| |
|
| |
|
| |
|
G&A
|
| |
|
| |
|
| |
|
External costs
|
| |
|
| |
8,668
|
| |
3,628
|
Employee expenses
|
| |
10
|
| |
5,135
|
| |
4,936
|
General and administrative costs charged by related parties
|
| |
27
|
| |
11
|
| |
38
|
Depreciation of property, plant and equipment
|
| |
16
|
| |
145
|
| |
158
|
Depreciation of right-of-use assets
|
| |
17
|
| |
227
|
| |
—
|
Amortization of intangible assets
|
| |
18
|
| |
16
|
| |
8
|
General and administrative expenses
|
| |
|
| |
14,202
|
| |
8,768
|
Total expenses by nature
|
| |
|
| |
121,739
|
| |
127,081
|
12
|
Income tax expenses
|
(in KUSD)
|
| |
Year ended
December 31,
2019
|
| |
Year ended
December 31,
2018
|
Current income taxes for the year
|
| |
572
|
| |
218
|
Current income taxes related to prior years
|
| |
10
|
| |
6
|
Income tax expenses
|
| |
582
|
| |
224
|
(in KUSD)
|
| |
Year ended
December 31,
2019
|
| |
Year ended
December 31,
2018
|
Loss before taxes
|
| |
115,902
|
| |
122,872
|
Tax calculated at tax domestic rates applicable to profits in the respective countries
|
| |
(12,332)
|
| |
(13,321)
|
|
| |
|
| |
|
Tax effects of:
|
| |
|
| |
|
- Tax losses for which no deferred income tax asset was recognized
|
| |
13,187
|
| |
13,766
|
- Utilization of R&D tax credit (USA)
|
| |
(436)
|
| |
(310)
|
- Income not subject to tax / (expenses not deductible for tax purposes)
|
| |
156
|
| |
83
|
- Tax relating to prior years
|
| |
10
|
| |
6
|
- Other
|
| |
(3)
|
| |
—
|
Income tax expenses
|
| |
582
|
| |
224
|
13.
|
Trade accounts receivable
|
(in KUSD)
|
| |
December 31,
2019
|
| |
December 31,
2018
|
Trade accounts receivable
|
| |
—
|
| |
192
|
Less: Allowance for doubtful accounts
|
| |
—
|
| |
—
|
Trade accounts receivable, net
|
| |
—
|
| |
192
|
14.
|
Other current assets
|
(in KUSD)
|
| |
December 31,
2019
|
| |
December 31,
2018
|
VAT receivable, net
|
| |
471
|
| |
549
|
Withholding tax receivable
|
| |
626
|
| |
968
|
Prepaid expenses
|
| |
4,215
|
| |
1,384
|
UK R&D expenditure credits
|
| |
891
|
| |
—
|
Other
|
| |
852
|
| |
180
|
|
| |
7,055
|
| |
3,081
|
15.
|
Non-current assets by geographic area
|
(in KUSD):
|
| |
|
| |
|
Country
|
| |
December 31,
2019
|
| |
December 31,
2018
|
Switzerland
|
| |
10,903
|
| |
7,112
|
United Kingdom
|
| |
2,032
|
| |
885
|
United States
|
| |
1,773
|
| |
217
|
|
| |
14,708
|
| |
8,214
|
16.
|
Property, plant and equipment
|
(in KUSD)
|
| |
Leasehold
improve-
ments
|
| |
Laboratory
equipment
|
| |
Office
equipment
|
| |
Hardware
|
| |
Total
|
Cost
|
| |
|
| |
|
| |
|
| |
|
| |
|
January 1, 2018
|
| |
291
|
| |
671
|
| |
340
|
| |
388
|
| |
1,690
|
Additions
|
| |
226
|
| |
327
|
| |
277
|
| |
114
|
| |
944
|
Disposals and scrapping
|
| |
—
|
| |
—
|
| |
(7)
|
| |
—
|
| |
(7)
|
Exchange difference
|
| |
(3)
|
| |
(59)
|
| |
(13)
|
| |
(5)
|
| |
(80)
|
December 31, 2018
|
| |
514
|
| |
939
|
| |
597
|
| |
497
|
| |
2,547
|
Additions
|
| |
17
|
| |
131
|
| |
93
|
| |
118
|
| |
359
|
Exchange difference
|
| |
2
|
| |
41
|
| |
8
|
| |
3
|
| |
54
|
December 31, 2019
|
| |
533
|
| |
1,111
|
| |
698
|
| |
618
|
| |
2,960
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
Accumulated depreciation
|
| |
|
| |
|
| |
|
| |
|
| |
|
January 1, 2018
|
| |
(70)
|
| |
(168)
|
| |
(136)
|
| |
(174)
|
| |
(548)
|
Depreciation charge
|
| |
(57)
|
| |
(159)
|
| |
(118)
|
| |
(154)
|
| |
(488)
|
Disposals and scrapping
|
| |
—
|
| |
—
|
| |
7
|
| |
—
|
| |
7
|
Exchange difference
|
| |
1
|
| |
17
|
| |
2
|
| |
2
|
| |
22
|
December 31, 2018
|
| |
(126)
|
| |
(310)
|
| |
(245)
|
| |
(326)
|
| |
(1,007)
|
Depreciation charge
|
| |
(82)
|
| |
(204)
|
| |
(149)
|
| |
(117)
|
| |
(552)
|
Exchange difference
|
| |
(1)
|
| |
(19)
|
| |
(3)
|
| |
(2)
|
| |
(25)
|
December 31, 2019
|
| |
(209)
|
| |
(533)
|
| |
(397)
|
| |
(445)
|
| |
(1,584)
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
Net book amount
|
| |
|
| |
|
| |
|
| |
|
| |
|
December 31, 2018
|
| |
388
|
| |
629
|
| |
352
|
| |
171
|
| |
1,540
|
December 31, 2019
|
| |
324
|
| |
578
|
| |
301
|
| |
173
|
| |
1,376
|
(in KUSD)
|
| |
Year ended
December 31,
2019
|
| |
Year ended
December 31,
2018
|
Research and development expenses
|
| |
407
|
| |
330
|
General and administrative expenses
|
| |
145
|
| |
158
|
|
| |
552
|
| |
488
|
17.
|
Leases
|
(in KUSD)
|
| |
December 31,
2019
|
| |
January 1,
2019
|
Properties (offices)
|
| |
4,820
|
| |
5,399
|
Vehicles
|
| |
78
|
| |
24
|
Total right-of-use assets
|
| |
4,898
|
| |
5,423
|
(in KUSD)
|
| |
December 31,
2019
|
| |
January 1,
2019
|
Lease liabilities (short-term)
|
| |
1,132
|
| |
924
|
Lease liabilities (long-term)
|
| |
3,899
|
| |
4,499
|
Total lease liabilities
|
| |
5,031
|
| |
5,423
|
(in KUSD)
|
| |
Year ended
December 31,
2019
|
| |
Year ended
December 31,
2018
|
Research and development expenses
|
| |
837
|
| |
—
|
General and administrative expenses
|
| |
227
|
| |
—
|
|
| |
1,064
|
| |
—
|
(in KUSD)
|
| |
|
| |
|
| |
|
Lease liabilities
|
| |
Offices
|
| |
Vehicles
|
| |
Total
|
January 1, 2019
|
| |
5,399
|
| |
24
|
| |
5,423
|
Additions
|
| |
466
|
| |
78
|
| |
544
|
Disposals
|
| |
—
|
| |
(12)
|
| |
(12)
|
Cash outflow (including interest)
|
| |
(1,130)
|
| |
(13)
|
| |
(1,143)
|
Interest
|
| |
140
|
| |
1
|
| |
141
|
Exchange difference
|
| |
78
|
| |
—
|
| |
78
|
December 31, 2019
|
| |
4,953
|
| |
78
|
| |
5,031
|
|
| |
|
| |
|
| |
|
Lease liabilities (short-term)
|
| |
1,114
|
| |
18
|
| |
1,132
|
Lease liabilities (long-term)
|
| |
3,839
|
| |
60
|
| |
3,899
|
Total lease liabilities
|
| |
4,953
|
| |
78
|
| |
5,031
|
18.
|
Intangible assets
|
(in KUSD)
|
| |
Licenses
|
| |
Software
|
| |
Total
|
Cost
|
| |
|
| |
|
| |
|
January 1, 2018
|
| |
6,009
|
| |
44
|
| |
6,053
|
Additions
|
| |
1,481
|
| |
45
|
| |
1,526
|
Exchange difference
|
| |
—
|
| |
(2)
|
| |
(2)
|
December 31, 2018
|
| |
7,490
|
| |
87
|
| |
7,577
|
Additions
|
| |
1,731
|
| |
59
|
| |
1,790
|
Exchange difference
|
| |
—
|
| |
1
|
| |
1
|
December 31, 2019
|
| |
9,221
|
| |
147
|
| |
9,368
|
Accumulated amortization
|
| |
|
| |
|
| |
|
January 1, 2018
|
| |
(626)
|
| |
(26)
|
| |
(652)
|
Amortization charge
|
| |
—
|
| |
(25)
|
| |
(25)
|
Impairment loss
|
| |
(227)
|
| |
—
|
| |
(227)
|
Exchange difference
|
| |
—
|
| |
1
|
| |
1
|
December 31, 2018
|
| |
(853)
|
| |
(50)
|
| |
(903)
|
Amortization charge
|
| |
—
|
| |
(30)
|
| |
(30)
|
Exchange difference
|
| |
—
|
| |
(1)
|
| |
(1)
|
December 31, 2019
|
| |
(853)
|
| |
(81)
|
| |
(934)
|
|
| |
|
| |
|
| |
|
Net book amount
|
| |
|
| |
|
| |
|
December 31, 2018
|
| |
6,637
|
| |
37
|
| |
6,674
|
December 31, 2019
|
| |
8,368
|
| |
66
|
| |
8,434
|
(in KUSD)
|
| |
Year ended
December 31,
2019
|
| |
Year ended
December 31,
2018
|
Research and development expenses
|
| |
14
|
| |
17
|
General and administrative expenses
|
| |
16
|
| |
8
|
|
| |
30
|
| |
25
|
-
|
An amount of KUSD 1,000 relating to a license agreement with a third party to acquire an antibody to be used in pre-clinical formalization, clinical testing, manufacturing and commercialization was capitalized as intangible assets.
|
-
|
An amount of KUSD 500 relating to a license agreement with a third party to use their technology to generate antibody-drug conjugates for up to five antibodies was capitalized as intangible assets.
|
-
|
An amount of KUSD 231 relating to a license agreement with a third party to use their technology for the production of antibodies was capitalized as intangible assets.
|
-
|
An amount of KUSD 231 relating to a license agreement with a third party to use their technology for the production of antibodies was capitalized as intangible assets.
|
-
|
An amount of KUSD 750 relating to a license agreement with a third party to use their technology to generate antibody-drug conjugates for up to five antibodies was capitalized as intangible assets.
|
-
|
An amount of KUSD 250 relating to a license agreement with a third party to use their technology to generate antibody-drug conjugates for up to five antibodies was capitalized as intangible assets.
|
-
|
An amount of KUSD 250 relating to a license agreement with a third party to acquire an antibody to be used in pre-clinical formalization, clinical testing, manufacturing and commercialization was capitalized as intangible assets.
|
-
|
Historical expenditure on clinical trials, future contractual commitments and internal budgets approved by the Board of Directors for ongoing and future trials;
|
-
|
Consideration of the progress of clinical trials, including obtaining primary endpoint readout data, discussions with regulatory authorities for new trials and enrollment status for ongoing clinical trials;
|
-
|
Consideration of market potential, supported where available by external market studies, and assessments of competitor products and product candidates.
|
19a.
|
Financial instruments by class and by category
|
(in KUSD)
|
| |
Note
|
| |
December 31,
2019
|
| |
December 31,
2018
|
Financial assets - financial assets at amortized cost
|
| |
|
| |
|
| |
|
Cash and cash equivalents
|
| |
|
| |
115,551
|
| |
138,807
|
Trade accounts receivable
|
| |
13
|
| |
—
|
| |
192
|
Other current assets (excluding prepaid expenses)
|
| |
14
|
| |
2,840
|
| |
1,697
|
Other long-term assets
|
| |
|
| |
368
|
| |
264
|
Total financial assets
|
| |
|
| |
118,759
|
| |
140,960
|
(in KUSD)
|
| |
Note
|
| |
December 31,
2019
|
| |
December 31,
2018
|
Financial liabilities - financial liabilities at amortized cost
|
| |
|
| |
|
| |
|
Trade accounts payable
|
| |
|
| |
3,329
|
| |
6,750
|
Accrued liabilities and other payables
|
| |
21
|
| |
15,430
|
| |
13,650
|
Lease liabilities
|
| |
17
|
| |
5,031
|
| |
—
|
Total financial liabilities
|
| |
|
| |
23,790
|
| |
20,400
|
|
| |
|
| |
|
| |
|
Net financial position
|
| |
|
| |
94,969
|
| |
120,560
|
19b.
|
Credit quality of financial assets
|
(in KUSD)
|
| |
December 31,
2019
|
| |
December 31,
2018
|
Cash and cash equivalents
|
| |
|
| |
|
A+ UBS
|
| |
51,983
|
| |
71,493
|
A+ Credit Suisse
|
| |
62,652
|
| |
66,066
|
A+ JP Morgan Chase
|
| |
916
|
| |
1,248
|
|
| |
115,551
|
| |
138,807
|
20.
|
Deferred income taxes and tax credit
|
(in KUSD)
|
| |
December 31,
2019
|
| |
December 31,
2018
|
Deductible temporary differences, unused tax losses and unused tax credits for which no deferred tax assets have been recognized are attributable to the following:
|
| |
|
| |
|
Taxes losses
|
| |
437,013
|
| |
329,254
|
Unused tax credit
|
| |
10,765
|
| |
6,009
|
Deductible temporary differences related to the retirement benefit plan
|
| |
2,684
|
| |
1,386
|
Deductible temporary differences related to IFRS 16
|
| |
(39)
|
| |
—
|
Offset of recognized temporary differences related to intangible assets
|
| |
(2,364)
|
| |
(2,364)
|
Total
|
| |
448,059
|
| |
334,285
|
Years of expiry
|
| |
December 31,
2019
|
| |
December 31,
2018
|
2019
|
| |
—
|
| |
6,209
|
2020
|
| |
14,735
|
| |
14,966
|
2021
|
| |
19,889
|
| |
20,200
|
2022
|
| |
31,128
|
| |
31,615
|
2023
|
| |
38,441
|
| |
39,042
|
Beyond 2024
|
| |
332,820
|
| |
217,222
|
|
| |
437,013
|
| |
329,254
|
Years of expiry
|
| |
December 31,
2019
|
| |
December 31,
2018
|
2036
|
| |
783
|
| |
783
|
2037
|
| |
1,839
|
| |
1,839
|
2038
|
| |
3,387
|
| |
3,387
|
2039
|
| |
4,756
|
| |
—
|
|
| |
10,765
|
| |
6,009
|
21.
|
Accrued liabilities and other payables
|
(in KUSD)
|
| |
December 31,
2019
|
| |
December 31,
2018
|
Payroll and social charges
|
| |
5,726
|
| |
4,939
|
Research and development costs
|
| |
8,922
|
| |
8,124
|
Other
|
| |
782
|
| |
587
|
|
| |
15,430
|
| |
13,650
|
22.
|
Pension obligations
|
(in KUSD)
|
| |
December 31,
2019
|
| |
December 31,
2018
|
Present value of defined benefit obligation for funded plan
|
| |
7,880
|
| |
4,372
|
Fair value of plan assets
|
| |
(5,196)
|
| |
(2,986)
|
Deficit of funded plan: liability on the balance sheet
|
| |
2,684
|
| |
1,386
|
(in KUSD)
|
| |
Present value
of obligation
|
| |
Fair value of
plan assets
|
| |
Total
|
January 1, 2018
|
| |
3,070
|
| |
(1,994)
|
| |
1,076
|
Defined benefit plan - pension costs:
|
| |
|
| |
|
| |
|
Current service cost
|
| |
527
|
| |
—
|
| |
527
|
Interest cost / (income)
|
| |
23
|
| |
(15)
|
| |
8
|
Defined benefit plan - pension costs
|
| |
550
|
| |
(15)
|
| |
535
|
Employee contributions
|
| |
208
|
| |
(208)
|
| |
—
|
Employer contributions
|
| |
—
|
| |
(416)
|
| |
(416)
|
Transfers from joiners' previous plans
|
| |
382
|
| |
(382)
|
| |
—
|
|
| |
590
|
| |
(1,006)
|
| |
(416)
|
Exchange differences
|
| |
(12)
|
| |
10
|
| |
(2)
|
Remeasurements:
|
| |
|
| |
|
| |
|
Change in financial assumptions
|
| |
(99)
|
| |
—
|
| |
(99)
|
Other actuarial losses
|
| |
295
|
| |
—
|
| |
295
|
Plan asset losses
|
| |
—
|
| |
5
|
| |
5
|
Exchange differences
|
| |
(22)
|
| |
14
|
| |
(8)
|
Remeasurements
|
| |
174
|
| |
19
|
| |
193
|
December 31, 2018
|
| |
4,372
|
| |
(2,986)
|
| |
1,386
|
(in KUSD)
|
| |
Present value
of obligation
|
| |
Fair value of
plan assets
|
| |
Total
|
Defined benefit plan - pension costs:
|
| |
|
| |
|
| |
|
Current service cost
|
| |
769
|
| |
—
|
| |
769
|
Impact of plan changes
|
| |
(319)
|
| |
—
|
| |
(319)
|
Interest cost / (income)
|
| |
37
|
| |
(25)
|
| |
12
|
Defined benefit plan - pension costs
|
| |
487
|
| |
(25)
|
| |
462
|
Employee contributions
|
| |
257
|
| |
(257)
|
| |
—
|
Employer contributions
|
| |
—
|
| |
(515)
|
| |
(515)
|
Transfers from joiners' previous plans
|
| |
1,302
|
| |
(1,302)
|
| |
—
|
|
| |
1,559
|
| |
(2,074)
|
| |
(515)
|
Exchange differences
|
| |
74
|
| |
(69)
|
| |
5
|
Remeasurements:
|
| |
|
| |
|
| |
|
Change in financial assumptions
|
| |
686
|
| |
—
|
| |
686
|
Other actuarial losses
|
| |
609
|
| |
—
|
| |
609
|
Plan asset gains
|
| |
—
|
| |
(2)
|
| |
(2)
|
Exchange differences
|
| |
93
|
| |
(40)
|
| |
53
|
Remeasurements
|
| |
1,388
|
| |
(42)
|
| |
1,346
|
December 31, 2019
|
| |
7,880
|
| |
(5,196)
|
| |
2,684
|
|
| |
2019
|
| |
2018
|
Discount rate
|
| |
0.20%
|
| |
0.85%
|
Interest credited on savings accounts
|
| |
0.20%
|
| |
1.00%
|
Future salary increases
|
| |
1.50%
|
| |
1.50%
|
Future pension increases
|
| |
0.00%
|
| |
0.00%
|
|
| |
2019
|
| |
2018
|
Male
|
| |
22.61
|
| |
22.50
|
Female
|
| |
25.64
|
| |
25.53
|
2019
|
| |
Increase in
assumption
|
| |
Impact on
defined
benefit
obligation
and service
cost
|
| |
Decrease in
assumption
|
| |
Impact on
defined
benefit
obligation
and service
cost
|
Discount rate
|
| |
0.25%
|
| |
(5.40%)
|
| |
(0.25%)
|
| |
5.90%
|
Future salary increases
|
| |
0.50%
|
| |
0.90%
|
| |
(0.50%)
|
| |
(0.90%)
|
Interest credited on savings accounts
|
| |
0.50%
|
| |
3.20%
|
| |
(0.50%)
|
| |
(3.00%)
|
Future pension increases
|
| |
0.50%
|
| |
7.00%
|
| |
(0.50%)
|
| |
(6.30%)
|
2018
|
| |
Increase in
assumption
|
| |
Impact on
defined
benefit
obligation
and service
cost
|
| |
Decrease in
assumption
|
| |
Impact on
defined
benefit
obligation
and service
cost
|
Discount rate
|
| |
0.25%
|
| |
(5.40%)
|
| |
(0.25%)
|
| |
5.90%
|
Future salary increases
|
| |
0.50%
|
| |
1.00%
|
| |
(0.50%)
|
| |
(1.00%)
|
Interest credited on savings accounts
|
| |
0.50%
|
| |
3.20%
|
| |
(0.50%)
|
| |
(3.10%)
|
Future pension increases
|
| |
0.50%
|
| |
6.20%
|
| |
(0.50%)
|
| |
(5.60%)
|
|
| |
December 31,
2019
|
| |
December 31,
2018
|
Cash
|
| |
155
|
| |
65
|
Bonds
|
| |
3,065
|
| |
1,919
|
Shares
|
| |
329
|
| |
147
|
Real estates and mortgages
|
| |
1,303
|
| |
720
|
Alternative investments
|
| |
344
|
| |
135
|
|
| |
5,196
|
| |
2,986
|
(in KUSD)
|
| |
2019
|
| |
2018
|
January 1
|
| |
(1,043)
|
| |
(850)
|
Remeasurements of defined benefit pension plan
|
| |
(1,346)
|
| |
(193)
|
December 31
|
| |
(2,389)
|
| |
(1,043)
|
23.
|
Share-based compensation expense
|
|
| |
2019
|
| |
2018
|
||||||
|
| |
Average
strike
price in
USD
per share
|
| |
Number of
awards
|
| |
Average
strike
price in
USD
per share
|
| |
Number of
awards
|
At the beginning of the year
|
| |
12.5
|
| |
1,982,375
|
| |
11.8
|
| |
1,882,125
|
Granted
|
| |
26.6
|
| |
226,666
|
| |
25.9
|
| |
100,250
|
Forfeited
|
| |
9.8
|
| |
(183,509)
|
| |
—
|
| |
—
|
At the end of the year
|
| |
14.3
|
| |
2,025,532
|
| |
12.5
|
| |
1,982,375
|
Grant date
|
| |
Expiry date
|
| |
Strike
price
in
USD
|
| |
Awards
December 31,
2019
|
| |
Awards
December 31,
2018
|
Feb - Sep 2014
|
| |
2024
|
| |
9.3
|
| |
602,375
|
| |
602,375
|
Mar - Jul 2015
|
| |
2025
|
| |
9.3
|
| |
144,875
|
| |
144,875
|
Oct - Nov 2015
|
| |
2025
|
| |
11.2
|
| |
11,875
|
| |
11,875
|
Jan - Jul 2016
|
| |
2026
|
| |
11.2
|
| |
151,375
|
| |
151,375
|
Jan - Oct 2017
|
| |
2027
|
| |
13.4
|
| |
938,250
|
| |
938,250
|
Nov - Dec 2017
|
| |
2027
|
| |
25.9
|
| |
33,375
|
| |
33,375
|
Jan - Dec 2018
|
| |
2028
|
| |
25.9
|
| |
100,250
|
| |
100,250
|
Jan - Apr 2019
|
| |
2029
|
| |
25.9
|
| |
155,062
|
| |
|
Jul - Sep 2019
|
| |
2029
|
| |
28.0
|
| |
71,604
|
| |
|
Jul 2019 forfeited
|
| |
|
| |
|
| |
(183,509)
|
| |
|
Total
|
| |
|
| |
|
| |
2,025,532
|
| |
1,982,375
|
Weighted average remaining contractual life of awards outstanding at end of period
|
| |
|
| |
|
| |
6.64 years
|
| |
7.17 years
|
|
| |
|
| |
Year ended
December 31,
2019
|
| |
Year ended
December 31,
2018
|
a) weighted average share price
|
| |
in USD
|
| |
0.80 to 27.50
|
| |
0.79 to 1.91
|
b) strike price
|
| |
in USD
|
| |
26.00 to 28.00
|
| |
25.94
|
c) expected volatility
|
| |
in %
|
| |
201.9 to 4,612.8
|
| |
146.4 to 201.9
|
d) award life
|
| |
in # of years
|
| |
0.08 to 1.02
|
| |
1.02 to 1.75
|
e) expected dividends
|
| |
in %
|
| |
0
|
| |
0
|
f) risk-free interest rate
|
| |
in %
|
| |
2.08 to 2.57
|
| |
1.84 to 2.57
|
|
| |
2019
|
| |
2018
|
||||||
|
| |
Average
strike
price in
USD
per share
|
| |
Number of
awards
|
| |
Average
strike
price in
USD
per share
|
| |
Number of
awards
|
At the beginning of the year
|
| |
2.7
|
| |
2,762,500
|
| |
2.7
|
| |
2,312,500
|
Granted
|
| |
2.5
|
| |
584,460
|
| |
2.6
|
| |
450,000
|
Forfeited
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
At the end of the year
|
| |
2.6
|
| |
3,346,960
|
| |
2.7
|
| |
2,762,500
|
Grant date
|
| |
Expiry date
|
| |
Strike
price
in
USD
|
| |
Awards
December 31,
2019
|
| |
Awards
December 31,
2018
|
May 2014
|
| |
2024
|
| |
2.8
|
| |
63,750
|
| |
63,750
|
Sep 2014
|
| |
2024
|
| |
2.8
|
| |
102,500
|
| |
102,500
|
May 2015
|
| |
2025
|
| |
2.7
|
| |
1,047,375
|
| |
1,047,375
|
Sep 2015
|
| |
2025
|
| |
2.7
|
| |
160,500
|
| |
160,500
|
May 2016
|
| |
2026
|
| |
2.7
|
| |
101,125
|
| |
101,125
|
May 2016
|
| |
2026
|
| |
2.7
|
| |
160,500
|
| |
160,500
|
Oct 2016
|
| |
2026
|
| |
2.6
|
| |
112,500
|
| |
112,500
|
Dec 2016
|
| |
2026
|
| |
2.6
|
| |
564,250
|
| |
564,250
|
Jun 2018
|
| |
2028
|
| |
2.6
|
| |
37,500
|
| |
37,500
|
Dec 2018
|
| |
2028
|
| |
2.6
|
| |
412,500
|
| |
412,500
|
Jan 2019
|
| |
2029
|
| |
2.6
|
| |
75,000
|
| |
|
Dec 2019
|
| |
2029
|
| |
2.5
|
| |
509,460
|
| |
|
Total
|
| |
|
| |
|
| |
3,346,960
|
| |
2,762,500
|
Weighted average remaining contractual life of awards outstanding at end of period
|
| |
|
| |
|
| |
6.97 years
|
| |
7.37 years
|
|
| |
|
| |
Year ended
December 31,
2019
|
| |
Year ended
December 31,
2018
|
a) weighted average share price
|
| |
in USD
|
| |
0.51 to 16.31
|
| |
0.50 to 1.25
|
b) strike price
|
| |
in USD
|
| |
2.50 to 2.56
|
| |
2.58 to 2.63
|
c) expected volatility
|
| |
in %
|
| |
176.6 to 233.1
|
| |
170.0 to 233.1
|
d) award life
|
| |
in # of years
|
| |
0.83 to 1.29
|
| |
0.83 to 1.33
|
e) expected dividends
|
| |
in %
|
| |
0
|
| |
0
|
f) risk-free interest rate
|
| |
in %
|
| |
1.55 to 2.60
|
| |
2.32 to 2.60
|
|
| |
2019
|
| |
2018
|
||||||
|
| |
Average
strike
price in
USD
per share
|
| |
Number of
awards
|
| |
Average
strike
price in
USD
per share
|
| |
Number of
awards
|
At the beginning of the year
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Granted
|
| |
18.8
|
| |
1,020,434
|
| |
—
|
| |
—
|
Forfeited
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
At the end of the year
|
| |
18.8
|
| |
1,020,434
|
| |
—
|
| |
—
|
Grant date
|
| |
Expiry date
|
| |
Strike price
in USD
|
| |
Awards
December 31,
2019
|
| |
Awards
December 31,
2018
|
Dec 2019
|
| |
2029
|
| |
18.8
|
| |
1,020,434
|
| |
—
|
Total
|
| |
|
| |
|
| |
1,020,434
|
| |
—
|
Weighted average remaining contractual life of awards outstanding at end of period
|
| |
|
| |
|
| |
9.96 years
|
| |
—
|
|
| |
|
| |
Year
ended
December 31,
2019
|
| |
Year
ended
December 31,
2018
|
a) weighted average share price
|
| |
in USD
|
| |
16.31
|
| |
—
|
b) strike price
|
| |
in USD
|
| |
18.75
|
| |
—
|
c) expected volatility
|
| |
in %
|
| |
176.6
|
| |
—
|
d) award life
|
| |
in # of years
|
| |
5.65
|
| |
—
|
e) expected dividends
|
| |
in %
|
| |
0
|
| |
—
|
f) risk-free interest rate
|
| |
in %
|
| |
1.67
|
| |
—
|
(in KUSD)
|
| |
2019
|
| |
2018
|
January 1
|
| |
6,745
|
| |
6,276
|
Share Purchase Plan 2013
|
| |
—
|
| |
—
|
Incentive Plan 2014
|
| |
437
|
| |
108
|
Share Purchase Plan 2016
|
| |
332
|
| |
361
|
Equity Incentive Plan 2019
|
| |
348
|
| |
—
|
December 31
|
| |
7,862
|
| |
6,745
|
24.
|
Share capital
|
|
| |
Number of
shares
issued
Common
|
| |
Number of
shares
issued
Class B
|
| |
Number of
shares
issued
Class C
|
| |
Number of
shares
issued
Class D
|
| |
Number of
shares
issued
Class E
|
| |
Number of
shares
issued
Total
|
January 1, 2018
|
| |
9,487,500
|
| |
14,262,500
|
| |
8,075,000
|
| |
7,837,500
|
| |
7,712,500
|
| |
47,375,000
|
Issuance of share capital / capital contributions
|
| |
450,000
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
450,000
|
December 31, 2018
|
| |
9,937,500
|
| |
14,262,500
|
| |
8,075,000
|
| |
7,837,500
|
| |
7,712,500
|
| |
47,825,000
|
Issuance of share capital / capital contributions
|
| |
1,825,000
|
| |
—
|
| |
—
|
| |
—
|
| |
3,687,500
|
| |
5,512,500
|
December 31, 2019
|
| |
11,762,500
|
| |
14,262,500
|
| |
8,075,000
|
| |
7,837,500
|
| |
11,400,000
|
| |
53,337,500
|
of which, treasury shares:
|
| |
1,240,540
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
| |
Share
capital
(in KUSD)
|
| |
Share
premium
(in KUSD)
|
| |
Treasury
shares
(in KUSD)
|
| |
Total
(in KUSD)
|
January 1, 2018
|
| |
397
|
| |
452,296
|
| |
—
|
| |
452,693
|
Issuance of share capital /capital contributions
|
| |
4
|
| |
(28)
|
| |
—
|
| |
(24)
|
December 31, 2018
|
| |
401
|
| |
452,268
|
| |
—
|
| |
452,669
|
Issuance of share capital /capital contributions
|
| |
171
|
| |
101,443
|
| |
—
|
| |
101,614
|
Change in par value
|
| |
3,789
|
| |
(3,789)
|
| |
|
| |
—
|
Treasury shares - additions
|
| |
—
|
| |
—
|
| |
(141)
|
| |
(141)
|
Treasury shares - disposals
|
| |
—
|
| |
—
|
| |
41
|
| |
41
|
December 31, 2019
|
| |
4,361
|
| |
549,922
|
| |
(100)
|
| |
554,183
|
1.
|
First, to the Class E shareholders, an amount equal to the total price paid for the Class E shares, plus an 8% per annum return;
|
2.
|
Second, to the Class D shareholders, an amount equal to the total price paid for the Class D shares, plus an 8% per annum return;
|
3.
|
Third, to the Class C shareholders, an amount equal to the total price paid for the Class C shares;
|
4.
|
Fourth, pari passu, to the Class B shareholders, an amount equal to the total price paid for the Class B shares, plus an 8% per annum return, and, to the Class C shareholders, an 8% per annum return on the total price paid for the Class C shares; and
|
5.
|
Thereafter, to all shareholders, the remaining proceeds in proportion to the nominal value of their shares.
|
|
| |
2019
|
| |
2018
|
||||||||||||
|
| |
Price
(in USD)
|
| |
Number of
treasury
shares
|
| |
Value
(in KUSD)
|
| |
Price
(in USD)
|
| |
Number of
treasury
shares
|
| |
Value
(in KUSD)
|
At the beginning of the year
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
| |
—
|
Additions
|
| |
0.08
|
| |
1,750,000
|
| |
141
|
| |
—
|
| |
—
|
| |
—
|
Disposals
|
| |
0.08
|
| |
(509,460)
|
| |
(41)
|
| |
—
|
| |
—
|
| |
—
|
At the end of the year
|
| |
0.08
|
| |
1,240,540
|
| |
100
|
| |
—
|
| |
—
|
| |
—
|
25.
|
Commitments
|
(in KUSD):
|
| |
|
| |
|
R&D Phase
|
| |
December 31,
2019
|
| |
December 31,
2018
|
Pre-clinical
|
| |
192,290
|
| |
275,602
|
Phase I
|
| |
116,115
|
| |
49,959
|
Phase II
|
| |
15,568
|
| |
5,569
|
|
| |
323,973
|
| |
331,130
|
(in KUSD)
|
| |
December 31,
2018
|
Not later than 1 year
|
| |
1,084
|
Later than 1 year and not later than 5 years
|
| |
3,163
|
More than 5 years
|
| |
131
|
|
| |
4,378
|
26.
|
Contingent liabilities
|
27.
|
Related parties
|
(in KUSD)
|
| |
Year ended
December 31,
2019
|
| |
Year ended
December 31,
2018
|
Salaries and other short-term employee benefits
|
| |
5,364
|
| |
4,512
|
Pension costs
|
| |
407
|
| |
299
|
Share-based compensation expenses
|
| |
396
|
| |
341
|
Other compensation
|
| |
73
|
| |
183
|
|
| |
6,240
|
| |
5,335
|
28.
|
Loss per share
|
Year Ended December 31, 2019
|
| |
Common
Shares
|
| |
Class B
Preferred
Shares
|
| |
Class C
Preferred
Shares
|
| |
Class D
Preferred
Shares
|
| |
Class E
Preferred
Shares
|
Net loss attributable to shareholders (in KUSD)
|
| |
(22,137)
|
| |
(33,713)
|
| |
(19,087)
|
| |
(18,526)
|
| |
(23,021)
|
Weighted average number of shares in issue
|
| |
9,365,406
|
| |
14,262,500
|
| |
8,075,000
|
| |
7,837,500
|
| |
9,739,555
|
Basic and diluted loss per share (in USD)
|
| |
(2.36)
|
| |
(2.36)
|
| |
(2.36)
|
| |
(2.36)
|
| |
(2.36)
|
Year Ended December 31, 2018
|
| |
Common
Shares
|
| |
Class B
Preferred
Shares
|
| |
Class C
Preferred
Shares
|
| |
Class D
Preferred
Shares
|
| |
Class E
Preferred
Shares
|
Net loss attributable to shareholders (in KUSD)
|
| |
(23,014)
|
| |
(37,676)
|
| |
(21,330)
|
| |
(20,703)
|
| |
(20,373)
|
Weighted average number of shares in issue
|
| |
8,712,500
|
| |
14,262,500
|
| |
8,075,000
|
| |
7,837,500
|
| |
7,712,500
|
Basic and diluted loss per share (in USD)
|
| |
(2.64)
|
| |
(2.64)
|
| |
(2.64)
|
| |
(2.64)
|
| |
(2.64)
|
29.
|
Foreign currency exchange rate
|
USD / GBP
|
| |
|
| |
Year ended
December 31,
2019
|
| |
Year ended
December 31,
2018
|
Closing rate, GBP 1
|
| |
USD
|
| |
1.31858
|
| |
1.26902
|
Weighted average exchange rate, GBP 1
|
| |
USD
|
| |
1.27468
|
| |
1.35009
|
Events after the reporting date
|
Item 6.
|
Indemnification of Directors and Officers
|
Item 7.
|
Recent Sales of Unregistered Securities
|
Name or Class of Purchasers
|
| |
Date of Issuance
|
| |
Title of Securities
|
| |
Number of
Securities
|
| |
Consideration
(in USD thousands)
|
Deerfield Partners, L.P. and certain of its affiliates
|
| |
May 19, 2020
|
| |
Senior secured convertible notes
|
| |
$65,000,000
principal amount
|
| |
65,000
|
|
| |
|
| |
|
| |
|
| |
|
Directors, officers, employees and consultants
|
| |
December 16, 2019
|
| |
Common shares
|
| |
636,825
|
| |
1,274
|
|
| |
|
| |
|
| |
|
| |
|
A.T. Holdings II Sàrl (for the creation of treasury shares to settle share grants and equity-linked instruments for directors, officers employees and consultants)
|
| |
September 19, 2019
|
| |
Class A common shares
|
| |
140
|
| |
141
|
|
| |
|
| |
|
| |
|
| |
|
Various private equity investment funds, institutional investors and other persons
|
| |
June 7, 2019
June 14, 2019
July 5, 2019
|
| |
Class E preferred shares
|
| |
295
|
| |
103,250
|
|
| |
|
| |
|
| |
|
| |
|
Name or Class of Purchasers
|
| |
Date of Issuance
|
| |
Title of Securities
|
| |
Number of
Securities
|
| |
Consideration
(in USD thousands)
|
Directors and officers
|
| |
June 29, 2018
December 14, 2018
February 6, 2019
|
| |
Class A common shares
|
| |
42
|
| |
1,314
|
|
| |||||||||||
Various private equity investment funds, institutional investors and other persons
|
| |
October 12, 2017
October 30, 2017
November 16, 2017
|
| |
Class E preferred shares
|
| |
617
|
| |
200,088
|
Item 8.
|
Exhibits and Financial Statement Schedules
|
Item 9.
|
Undertakings
|
(a)
|
for purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective;
|
(b)
|
for the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof;
|
(c)
|
insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that, in the opinion of the SEC, such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer, or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless, in the opinion of its counsel, the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question of whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue; and
|
(d)
|
to provide to the underwriters at the closing specified in the underwriting agreement, certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.
|
| |
Form of Underwriting Agreement
|
|
| |
Articles of Association of ADC Therapeutics SA
|
|
| |
Opinion of Homburger AG, Swiss counsel of ADC Therapeutics SA, as to the validity of the common shares
|
|
| |
Second Amended and Restated License Agreement among ADC Products (UK) Limited, ADC Therapeutics SA and MedImmune Limited, dated May 9, 2016 (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Registration Statement on Form F-1 (File No. 333-237841), filed with the SEC on April 24, 2020)
|
|
| |
Amendment #1 to the Second Amended and Restated License Agreement among ADC Products (UK) Limited, ADC Therapeutics SA and MedImmune Limited, dated September 19, 2018 (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Registration Statement on Form F-1 (File No. 333-237841), filed with the SEC on April 24, 2020)
|
|
| |
Collaboration and License Agreement between ADC Therapeutics Sarl and Genmab A/S, dated June 14, 2013 (incorporated herein by reference to Exhibit 10.3 to the Registrant’s Registration Statement on Form F-1 (File No. 333-237841), filed with the SEC on April 24, 2020)
|
|
| |
Amendment to the Collaboration and License Agreement between ADC Therapeutics Sarl and Genmab A/S, dated November 20, 2013 (incorporated herein by reference to Exhibit 10.4 to the Registrant’s Registration Statement on Form F-1 (File No. 333-237841), filed with the SEC on April 24, 2020)
|
|
| |
Second Amendment to the Collaboration and License Agreement between ADC Therapeutics SA and Genmab A/S, dated April 16, 2020 (incorporated herein by reference to Exhibit 10.5 to the Registrant’s Registration Statement on Form F-1 (File No. 333-237841), filed with the SEC on April 24, 2020)
|
|
| |
Third Amendment to the Collaboration and License Agreement between ADC Therapeutics SA and Genmab A/S, dated August 10, 2020
|
|
| |
Lease Relating to Suite 5, 1st Floor, The Queen Mary BioEnterprises Innovation Centre between Queen Mary Bioenterprises Limited and ADC Therapeutics (UK) Limited, dated September 14, 2017 (incorporated herein by reference to Exhibit 10.6 to the Registrant’s Registration Statement on Form F-1 (File No. 333-237841), filed with the SEC on April 24, 2020)
|
|
| |
Lease Relating to Lab 11b, Suite 11 Write Up Space and Suite 12, 1st Floor, The Queen Mary BioEnterprises Innovation Centre between Queen Mary Bioenterprises Limited and ADC Therapeutics (UK) Limited, dated December 20, 2017 (incorporated herein by reference to Exhibit 10.7 to the Registrant’s Registration Statement on Form F-1 (File No. 333-237841), filed with the SEC on April 24, 2020)
|
|
| |
Counterpart Lease Relating to Suite 8, First Floor, The Queen Mary BioEnterprises Innovation Centre between Queen Mary Bioenterprises Limited and ADC Therapeutics (UK) Limited, dated July 9, 2018 (incorporated herein by reference to Exhibit 10.8 to the Registrant’s Registration Statement on Form F-1 (File No. 333-237841), filed with the SEC on April 24, 2020)
|
|
| |
Deed of Variation Relating to Lease of Suite 5, 1st Floor, The Queen Mary BioEnterprises Innovation Centre between Queen Mary Bioenterprises Limited and ADC Therapeutics (UK) Limited, dated July 1, 2019 (incorporated herein by reference to Exhibit 10.9 to the Registrant’s Registration Statement on Form F-1 (File No. 333-237841), filed with the SEC on April 24, 2020)
|
|
| |
Deed of Variation Relating to Lease of Lab 11b, Suite 11 Write Up Space and Suite 12, 1st Floor, The Queen Mary BioEnterprises Innovation Centre between Queen Mary Bioenterprises Limited and ADC Therapeutics (UK) Limited, dated July 1, 2019 (incorporated herein by reference to Exhibit 10.10 to the Registrant’s Registration Statement on Form F-1 (File No. 333-237841), filed with the SEC on April 24, 2020)
|
|
| |
Deed of Variation Relating to Lease of Suite 8, First Floor, The Queen Mary BioEnterprises Innovation Centre between Queen Mary Bioenterprises Limited and ADC Therapeutics (UK) Limited, dated July 1, 2019 (incorporated herein by reference to Exhibit 10.11 to the Registrant’s Registration Statement on Form F-1 (File No. 333-237841), filed with the SEC on April 24, 2020)
|
|
| |
Form of Indemnity Agreement with directors and officers (incorporated herein by reference to Exhibit 10.12 to the Registrant’s Registration Statement on Form F-1 (File No. 333-237841), filed with the SEC on April 24, 2020)
|
| |
2019 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.16 to the Registrant’s Registration Statement on Form F-1 (File No. 333-237841), filed with the SEC on April 24, 2020)
|
|
| |
Facility Agreement among ADC Therapeutics SA, the other Loan Parties party thereto, the Lenders and Deerfield Partners, L.P., as agent for itself and the Secured Parties thereto, dated April 24, 2020 (incorporated herein by reference to Exhibit 10.17 to the Registrant’s Registration Statement on Form F-1 (File No. 333-237841), filed with the SEC on April 27, 2020)
|
|
| |
Form of Senior Secured Convertible Note (incorporated herein by reference to Exhibit 99.1 to the Registrant’s Report on Form 6-K (File No. 001-39071), filed with the SEC on May 19, 2020)
|
|
| |
Registration Rights Agreement between ADC Therapeutics SA and Deerfield Partners, L.P. and Deerfield Private Design Fund IV, L.P., dated May 19, 2020
|
|
| |
List of subsidiaries
|
|
| |
Consent of PricewaterhouseCoopers SA
|
|
| |
Consent of Homburger AG, Swiss counsel of ADC Therapeutics SA (included in Exhibit 5.1)
|
|
| |
Powers of attorney (included on signature page to the registration statement)
|
#
|
Portions of this exhibit have been omitted because they are both (i) not material and (ii) would likely cause competitive harm to the Company if publicly disclosed.
|
|
| |
ADC THERAPEUTICS SA
|
||||||
|
| |
|
| |
|
| |
|
|
| |
By:
|
| |
/s/ Christopher Martin
|
|||
|
| |
|
| |
Name:
|
| |
Christopher Martin
|
|
| |
|
| |
Title:
|
| |
Chief Executive Officer
|
Name
|
| |
|
| |
Title
|
|
| |
|
| |
|
/s/ Christopher Martin
|
| |
|
| |
Chief Executive Officer and Director
(principal executive officer)
|
Christopher Martin
|
| |
|
| ||
|
| |
|
| |
|
/s/ Jennifer Creel
|
| |
|
| |
Chief Financial Officer
(principal financial officer)
|
Jennifer Creel
|
| |
|
| ||
|
| |
|
| ||
/s/ Robert A. Schmidt
|
| |
|
| |
Corporate Controller and Chief Accounting Officer (principal accounting officer)
|
Robert A. Schmidt
|
| |
|
| ||
|
| |
|
| ||
/s/ Ron Squarer
|
| |
|
| |
Chairman of the Board of Directors
|
Ron Squarer
|
| |
|
| ||
|
| |
|
| |
|
/s/ Michael Forer
|
| |
|
| |
Vice Chairman of the Board of Directors
|
Michael Forer
|
| |
|
| |
|
|
| |
|
| |
|
/s/ Peter B. Corr
|
| |
|
| |
Director
|
Peter B. Corr
|
| |
|
| ||
|
| |
|
| |
|
/s/ Stephen Evans-Freke
|
| |
|
| |
Director
|
Stephen Evans-Freke
|
| |
|
| ||
|
| |
|
| |
|
/s/ Peter Hug
|
| |
|
| |
Director
|
Peter Hug
|
| |
|
| ||
|
| |
|
| |
|
/s/ Thomas Pfisterer
|
| |
|
| |
Director
|
Thomas Pfisterer
|
| |
|
| ||
|
| |
|
| |
|
/s/ Thomas M. Rinderknecht
|
| |
|
| |
Director
|
Thomas M. Rinderknecht
|
| |
|
| ||
|
| |
|
| |
|
/s/ Tyrell J. Rivers
|
| |
|
| |
Director
|
Tyrell J. Rivers
|
| |
|
| ||
|
| |
|
| |
|
/s/ Victor Sandor
|
| |
|
| |
Director
|
Victor Sandor
|
| |
|
|
c/o |
Morgan Stanley & Co. LLC
1585 Broadway New York, New York 10036 |
c/o |
BofA Securities, Inc.
One Bryant Park New York, New York 10036 |
c/o |
Cowen and Company, LLC
599 Lexington Avenue New York, New York 10022 |
Very truly yours,
|
|||
ADC Therapeutics SA
|
|||
By:
|
|||
Name:
|
|||
Title:
|
A.T. Holdings II Sàrl
|
|||
By:
|
|||
Name:
|
|||
Title:
|
ADC Products Switzerland Sàrl
|
|||
By:
|
|||
Name:
|
|||
Title:
|
The Selling Shareholders named in
Schedule I hereto, acting severally
|
||
By:
|
||
Attorney-in- Fact
|
||
By:
|
Morgan Stanley & Co. LLC
|
||
By:
|
|||
Name:
|
|||
Title:
|
By:
|
BofA Securities, Inc.
|
||
By:
|
|||
Name:
|
|||
Title:
|
By:
|
Cowen and Company, LLC
|
||
By:
|
|||
Name:
|
|||
Title:
|
Selling Shareholder
|
Number of Additional Shares
To Be Sold
|
|||
A.T. Holdings II Sàrl
|
[•
|
]
|
||
ADC Products Switzerland Sàrl
|
[•
|
]
|
||
Total:
|
[•
|
]
|
Underwriter
|
Number of Firm Shares
To Be Purchased
|
|||
Morgan Stanley & Co. LLC
|
[-
|
]
|
||
BofA Securities, Inc.
|
[-
|
]
|
||
Cowen and Company, LLC.
|
[-
|
]
|
||
Total:
|
[-
|
]
|
1. |
Preliminary Prospectus dated [•], 2020
|
2. |
Price per share to the public: $[•]
|
By:
|
Morgan Stanley & Co. LLC
|
||
By:
|
|||
Name:
|
|||
Title:
|
Section 1
Name, Registered Office, Purpose and Duration of the Company
|
Section 1
Raison sociale, siège, but de la société, durée
|
|||
Article 1
|
Article 1
|
|||
Name, Place of In-
corporation
|
Under the name ADC Therapeutics SA (ADC Therapeutics AG) (ADC Therapeutics Ltd) (the Company) shall exist a corporation with its registered office in Epalinges, canton of Vaud.
|
Raison sociale,
siège
|
Sous la raison sociale ADC Therapeutics SA (ADC Therapeutics AG), (ADC Therapeutics Ltd) (la Société) existe une société anonyme avec siège à Epalinges,
canton de Vaud.
|
|
Article 2
|
Article 2
|
|||
Purpose
|
1 The Company's purpose is to research, develop, produce and sell products in the fields of biotechnology, pharmaceutics, medical technology, diagnosis and
therapy as well as to purchase, sell and use patents and licenses in these fields. The Company may engage in all types of transactions that appear appropriate to promote the purpose of the Company or that are related thereto.
|
But
|
1 La Société a pour but la recherche, le développement, la production et la vente de produits dans les domaines de la biotechnologie, de la pharmaceutique, de
la technologie médicale, du diagnostic et de la thérapie ainsi que l’acquisition, la vente et l'utilisation de brevets et de licences dans ces domaines. La Société peut exercer toutes activités aptes à favoriser son but ou en rapport avec ce
dernier.
|
|
2 The Company may open branch offices and subsidiaries in Switzerland and abroad. It may also acquire participations or otherwise invest in other companies in
Switzerland and abroad.
|
2 La Société peut constituer des succursales et des filiales en Suisse et à l'étranger et participer à ou investir autrement dans d'autres entreprises en
Suisse et à l'étranger.
|
|||
3 The Company may acquire, hold, manage, mortgage, exploit and sell real estate and intellectual property rights in Switzerland and abroad and may also
finance other companies.
|
3 La Société peut acquérir, détenir, gérer, gager, mettre en valeur et aliéner des immeubles et des droits de propriété intellectuelle en Suisse et à
l'étranger, ainsi que financer d'autres sociétés.
|
|||
Article 3
|
Article 3
|
|||
Duration
|
The duration of the Company shall be unlimited.
|
|
Durée
|
La durée de la Société est illimitée.
|
Section 2
Share Capital, Shares, Restrictions of Transferability
|
Section 2
Capital-actions, actions et restrictions à la transmissibilité
|
|||
Article 4
|
Article 4
|
|||
Share Capital
|
The share capital of the Company is CHF 5,661,600 and is divided into 70,770,000 fully paid in registered shares with a par value of CHF 0.08 each.
|
|
Capital-actions
|
Le capital-actions de la Société s'élève à CHF 5,661,600 et est divisé en 70,770,000 actions nominatives entièrement libérées d'une valeur nominale de CHF 0.08 chacune.
|
Article 4a
|
Article 4a
|
|||
Authorized Share
Capital
|
1 The Board of Directors shall be authorized to increase the share capital at any time, including in connection with an intended takeover, until April 23,
2022 by a maximum amount of CHF 32,000,000 by issuing a maximum of 2,560,000 fully paid in registered shares with a par value of CHF 0.08 each. Increases in partial amounts shall be permissible.
|
Capital-actions auto-risé
|
1 Le Conseil d'administration est autorisé à augmenter le capital-actions d'un montant maximum de CHF 2'560'000, en tout temps, y inclus en lien avec une
future offre publique d'acquisition, mais jusqu'au 23 avril 2022 au plus tard, par l'émission d'un maximum de 32'000'000 actions nominatives d'une valeur nominale de CHF 0.08 chacune, qui doivent être intégralement libérées. Des augmentations
par montants partiels sont autorisées.
|
|
2 The subscription and acquisition of the new shares as well as any subsequent transfer of the shares shall be subject to the restrictions pursuant to Article
6 of these articles of association.
|
2 La souscription et l'acquisition des nouvelles actions ainsi que tout transfert ultérieur des actions sont assujettis aux restrictions à la transmissibilité
conformément à l'article 6 des présents statuts.
|
|||
3 The Board of Directors shall determine the issue price, the type of contribution, the date of issue, the conditions for the exercise of pre-emptive rights
and the beginning date for dividend entitlement. In this regard, the Board of Directors may issue new shares by means of a firm underwriting through a financial institution, a syndicate of financial institutions or another third party and a
subsequent offer of these shares to the existing shareholders or third parties (if the pre-emptive rights of the existing shareholders have been withdrawn or have not been duly exercised). The Board of Directors is entitled to permit, to
restrict or to exclude the trading of pre-emptive rights. It may permit the expiration of pre-emptive rights that have not been exercised, or it may place such rights or shares as to which pre-emptive rights have been granted, but not
exercised, at market conditions or may use them otherwise in the interest of the Company.
|
3 Le Conseil d'administration détermine le prix d'émission, la nature des apports, le moment de l'émission, les conditions de l'exercice du droit de
souscription préférentiel et le moment à partir duquel les actions donneront droit à des dividendes. A cet effet, le Conseil d'administration peut émettre des nouvelles actions par voie de prise ferme par un établissement financier, un
consortium bancaire ou un tiers et d'offre subséquente de ces actions aux actionnaires actuels ou à des tiers (si les droits de souscription préférentiels des actionnaires actuels ont été supprimés ou qu'ils n'ont pas été valablement
exercés). Le Conseil d'administration est en droit d'autoriser, de limiter ou d'exclure le négoce des droits de souscription préférentiels. Le Conseil d'administration peut laisser s'éteindre les droits de souscription préférentiels non
exercés; il peut aussi aliéner ceux-ci, respectivement les actions pour lesquelles des droits de souscription ont été accordés sans toutefois être exercés, aux conditions du marché ou les utiliser autrement dans l'intérêt de la Société.
|
4 The Board of Directors is further authorized to withdraw or restrict pre-emptive rights of existing shareholders and to allocate such rights to third
parties, the Company or any of its group companies:
|
4 Le Conseil d'administration peut aussi exclure ou limiter les droits de souscription préférentiels des actionnaires actuels et les attribuer à des tiers, à
la Société ou à une des sociétés du groupe:
|
|||
(a) if the issue price of the new shares is determined by reference to the market price; or
|
(a) si le prix d'émission des nouvelles actions est déterminé en fonction du prix du marché; ou
|
|||
(b) for raising capital in a fast and flexible manner, which would not be possible, or might only be possible with great difficulty or delays or at significantly less favorable
conditions, without the exclusion of the pre-emptive rights of existing shareholders; or
|
(b) pour créer des fonds de manière rapide et flexible, ce qui ne serait pas possible ou possible qu'avec difficulté ou tardivement ou à des conditions nettement plus défavorables sans
l'exclusion des droits de souscription préférentiels des actionnaires actuels; ou
|
|||
(c) for the acquisition of companies, part(s) of companies or participations, for the acquisition of products, intellectual property or licenses by or for investment projects of the
Company or any of its group companies, or for the financing or refinancing of any of such transactions through a placement of shares; or
|
(c) pour l'acquisition de sociétés, de partie(s) de sociétés ou de participations, pour l'acquisition de produits, de droits de propriété intellectuelle, ou licences par ou pour des
projets d'investissement de la Société ou de l'une des sociétés du groupe, ou pour le financement ou le refinancement de telles transactions par le placement d'actions; ou
|
|||
(d) for purposes of broadening the shareholder constituency of the Company in certain geographic, financial or investor markets, for purposes of the participation of strategic partners,
or in connection with the listing of new shares on domestic or foreign stock exchanges; or
|
(d) pour élargir le cercle des actionnaires de la Société dans certains marchés géographiques, financiers ou d'investisseurs, pour permettre la participation de
partenaires stratégiques, ou en relation avec la cotation de nouvelles actions sur des bourses nationales ou étrangères; ou
|
(e) for purposes of granting an over-allotment option (Greenshoe) or an option to subscribe for additional shares in a placement or sale of
shares to the respective initial purchaser(s) or underwriter(s); or
|
(e) pour octroyer une option de surallocation (Greenshoe) ou une option de souscription d'actions supplémentaires lors d'un placement ou de la
vente d'actions à un ou plusieurs acheteurs initiaux ou souscripteurs; ou
|
|||
(f) for the participation of members of the Board of Directors, members of the executive management, employees, contractors, consultants or other persons performing services for the
benefit of the Company or any of its group companies; or
|
(f) pour la participation de membres du Conseil d'administration, de membres de la direction, d'employés, de co-contractants, de consultants ou d'autres personnes exerçant des services
au bénéfice de la Société ou de l'une des sociétés du groupe; ou
|
|||
(g) following a shareholder or a group of shareholders acting in concert having accumulated shareholdings in excess of 20% of the share capital registered in the commercial register
without having submitted to all other shareholders a takeover offer recommended by the Board of Directors; or
|
(g) si un actionnaire ou un groupe d'actionnaires agissant de concert a acquis ou réuni une participation de plus de 20% du capital-actions inscrit au registre du commerce sans avoir
présenté à tous les autres actionnaires une offre publique d'achat dont l'acceptation a été recommandée par le Conseil d'administration; ou
|
|||
(h) for the defense of an actual, threatened or potential takeover bid that the Board of Directors, upon consultation with an independent financial adviser retained by it, has not
recommended or will not recommend to the shareholders to accept on the basis that the Board of Directors does not find such takeover bid to be financially fair to the shareholders or not to be in the Company's interest.
|
(h) pour se défendre contre une offre publique d'achat hostile présentée, menaçante ou potentielle dont le rejet est, respectivement sera, recommandé par le Conseil d'administration,
après consultation d'un conseiller financier indépendant qu'il aura choisi, dans la mesure où le Conseil d'administration estime que l'offre publique d'achat n'est pas équitable d'un point de vue financier vis-à-vis des actionnaires ou n'est
pas dans l'intérêt de la Société.
|
Article 4b
|
Article 4b
|
|||
Conditional Share
Capital for Em
ployee Participation
|
1 The share capital may be increased in an amount not to exceed CHF 936,000 through the issuance of up to 11,700,000 fully paid in registered shares with a
par value of CHF 0.08 per share through the direct or indirect issuance of shares, options or related subscription rights to members of the Board of Directors, members of the executive management, employees, contractors or consultants of the
Company or its group companies, or other persons providing services to the Company or its group companies.
|
Capital-actions
conditionnel pour
la participation
des employés
|
1 Le capital-actions peut être augmenté d'un montant maximum de CHF 936'000 par l'émission de 11'700'000 actions nominatives au plus, d'une valeur nominale
de CHF 0.08 chacune, qui doivent être intégralement libérées, par l'émission directe ou indirecte d'actions, d'options ou de droits de souscription y relatifs, octroyés aux membres du Conseil d'administration, aux membres de la direction, ou
aux employés, co-contractants ou consultants de la Société ou de l'une des sociétés du groupe, ou d'autres personnes exerçant des services au bénéfice de la Société ou de l'une des sociétés du groupe.
|
|
2 The pre-emptive rights and advance subscription rights of the shareholders of the Company shall be excluded in connection with the issuance of any shares,
options, other rights to receive shares, or subscription rights therefor. Shares, options, other rights to receive shares, or subscription rights therefor shall be issued pursuant to one or more regulations to be issued by the Board of
Directors or, to the extent delegated to it, the Compensation Committee, and to the extent applicable, taking into account the compensation principles pursuant to Article 28 of these articles of association. Shares,
options, other rights to receive shares, or subscription rights therefor may be issued at a price or with an exercise price lower than the market price.
|
2 Le droit de souscription préférentiel ainsi que le droit de souscription préalable des actionnaires de la Société sont exclus en relation avec l'émission de
toutes actions, options, autres droits à recevoir des actions ou des droits de souscription qui y sont attachés. L'émission d'actions, d'options, d'autres droits à recevoir des actions ou des droits de souscription qui y sont attachés est
faite selon un ou plusieurs règlements adoptés par le Conseil d'administration ou le Comité de rémunération, dans la mesure où cette compétence lui a été déléguée, et le cas échéant en tenant compte des principes de rémunération selon
l'article 28 des présents statuts. L'émission d'actions, d'options, d'autres droits à recevoir des actions ou des droits de souscription qui y sont attachés peut se faire à un prix ou avec un prix d'exercice en-dessous du prix du marché.
|
|||
3 The direct or indirect acquisition of the new shares by persons listed in paragraph 1 in connection with an employee participation program and any
subsequent transfer of such shares shall be subject to the restrictions of Article 6 of these articles of association.
|
3 L'acquisition directe ou indirecte de nouvelles actions par des personnes mentionnées à l'alinéa 1 dans le cadre d'un programme de participation des
collaborateurs ainsi que le transfert subséquent de ces actions sont assujettis aux restrictions à la transmissibilité conformément à l'article 6 des présents statuts.
|
Article 4c
|
Article 4c
|
|||
Conditional Share
Capital for Financing,
Acquisitions and other
Purposes
|
1 The share capital may be increased including in connection with an intended takeover in an amount not to exceed CHF 1,624,000 through the issuance of up to
20,300,000 fully paid in registered shares with a par value of CHF 0.08 per share through the exercise or mandatory exercise of conversion, exchange, option, warrant or similar rights or obligations for the subscription of shares granted to
shareholders or third parties on a stand-alone basis or in connection with bonds, notes, options, warrants or other securities or contractual obligations of the Company or any of its group companies, including without limitation a convertible
debenture to be entered into by the Company, as may be amended or novated from time to time (hereinafter collectively, the Financial Instruments).
|
Capital-actions
conditionnel aux
fins de financement,
acquisitions ou
d'autres buts
|
1 Le capital-actions peut être augmenté, y compris en lien avec une future offre publique d'acquisition, d'un montant maximum de CHF 1'624'000 par l'émission
de 20'300'000 actions nominatives au plus, d'une valeur nominale de CHF 0.08 chacune, qui doivent être intégralement libérées par l'exercice ou l'exercice obligatoire de droits de conversion, d'échange, d'option, de warrant ou d'autres droits
ou obligations similaires pour la souscription d'actions octroyés aux actionnaires ou à des tiers de manière autonome ou en rapport avec des obligations, effets, options, warrants ou autres instruments financiers ou obligations contractuelles
de la Société ou de l'une des sociétés du groupe, y compris, mais sans s'y limiter, une débenture convertible de la société, laquelle peut être amenée à être modifiée ou actualisée (ci-après désignés collectivement les Instruments Financiers).
|
|
2 The pre-emptive rights of shareholders shall be excluded for the exercise of any Financial Instruments in connection with the issuance of shares. The
then-current owners of such Financial Instruments shall be entitled to acquire the new shares issued upon conversion, exchange or exercise of any Financial Instruments. The key conditions of the Financial Instruments shall be determined by
the Board of Directors.
|
2 Le droit de souscription préférentiel des actionnaires est exclu en relation avec l'émission d'actions à l'occasion de l'exercice d'Instruments Financiers.
Les personnes qui détiendront alors de tels Instruments Financiers seront en droit d'acquérir les nouvelles actions émises à l'occasion de la conversion, de l'échange ou de l'exercice d'Instruments Financiers. Le Conseil d'administration
détermine les principales conditions des Instruments Financiers.
|
3 The Board of Directors shall be authorized to restrict or withdraw advance subscription rights of shareholders in connection with the issuance of Financial
Instruments by the Company or one of its group companies (1) if the issuance is for purposes of financing or refinancing, or the payment for, the acquisition of companies, parts of a company, participations, intellectual property rights,
licenses or investments, (2) if the issuance occurs in domestic or international capital markets or through a private placement, (3) following a shareholder or a group of shareholders acting in concert having accumulated shareholdings in
excess of 20% of the share capital registered in the commercial register without having submitted to all other shareholders a takeover offer recommended by the Board of Directors, or (4) for the defense of an actual, threatened or potential
takeover bid that the Board of Directors, upon consultation with an independent financial adviser retained by it, has not recommended or will not recommend to the shareholders to accept on the basis that the Board of Directors does not find
such takeover bid to be financially fair to the shareholders or not in the Company's interest. If the advance subscription rights are neither granted directly nor indirectly by the Board of Directors, the following shall apply:
|
3 Le Conseil d'administration est autorisé à limiter ou retirer le droit de souscription préalable des actionnaires en relation avec l'émission d'Instruments
Financiers par la Société ou une des sociétés du groupe (1) si l'émission a pour but le financement, le refinancement ou le paiement de l'acquisition d'entreprises, de parties d'une entreprise, de participations, de droits de propriété
intellectuelle, de licences ou d'investissements, (2) si l'émission a lieu sur les marchés de capitaux nationaux ou internationaux ou par le biais d'un placement privé, (3) si un actionnaire ou un groupe d'actionnaires agissant de concert a
acquis ou réuni une participation de plus de 20% du capital-actions inscrit au registre du commerce sans avoir présenté à tous les autres actionnaires une offre publique d'achat dont l'acceptation a été recommandée par le Conseil
d'administration, ou (4) pour se défendre contre une offre publique d'achat hostile présentée, menaçante ou potentielle dont le rejet est, respectivement sera, recommandé par le Conseil d'administration, après consultation d'un conseiller
financier indépendant qu'il aura choisi, dans la mesure où le Conseil d'administration estime que l'offre publique d'achat n'est pas équitable d'un point de vue financier vis-à-vis des actionnaires ou n'est pas dans l'intérêt de la Société.
Si le droit de souscription préalable n'est pas accordé, de manière directe ou indirecte, par le Conseil d'administration, les règles suivantes s'appliquent:
|
|||
(a) the Financial Instruments shall be issued or entered into at market conditions;
|
(a) les Instruments Financiers sont émis ou conclus aux conditions du marché;
|
|||
(b) the Financial Instruments may be converted, exchanged or exercised during a maximum period of 10 years from the date of issuance or contract conclusion; and
|
(b) les Instruments Financiers peuvent être convertis, échangés ou exercés durant une période maximale de 10 ans suivant la date de l'émission ou de la conclusion du contrat; et
|
|||
(c) the conversion, exchange or exercise price of the Financial Instruments shall be set with reference to, and/or shall be subject to change
based upon, the valuation of the Company's equity and/or market conditions.
|
(c) le prix de conversion, d'échange ou d'exercice des Instruments Financiers est fixé en prenant en compte, et/ou peut être modifié en fonction, de la valorisation des fonds propres de
la société et/ou des conditions du marché.
|
|||
4 The direct or indirect acquisition of the new shares acquired through the exercise of Financial Instruments and any subsequent transfer of such shares
shall be subject to the restrictions of Article 6 of these articles of association.
|
4 L'acquisition de nouvelles actions acquises directement ou indirectement par l'exercice d'Instruments Financiers ainsi que le transfert subséquent de ces
actions sont assujettis aux restrictions à la transmissibilité conformément à l'article 6 des présents statuts.
|
Article 5
|
Article 5
|
|||
Share Certificates and Intermediated Securities
|
1 The Company may issue its registered shares in the form of single certificates, global certificates and uncertificated securities. Subject to applicable
law, the Company may convert its registered shares from one form into another form at any time and without the approval of the shareholders. The Company shall bear the cost associated with any such conversion.
|
|
Certificats d'actions et titres intermédiés
|
1 La Société émet ses actions nominatives sous forme de certificats individuels, de certificats globaux ou de droits-valeurs. La Société est libre, dans les
limites du droit applicable, en tout temps et sans l'approbation des actionnaires, de convertir ses actions nominatives émises sous l'une des formes ci-dessus, en une autre forme. La Société supporte les coûts d'une telle conversion.
|
2 A shareholder has no right to request a conversion of the registered shares issued in one form into another form. Each shareholder may, however, at any time
request from the Company a written confirmation of the registered shares held by such shareholder, as reflected in the share register.
|
2 Un actionnaire n'a pas le droit de réclamer la conversion d'actions nominatives émises sous une certaine forme en une autre forme. Chaque actionnaire peut
toutefois exiger en tout temps que la Société établisse une attestation relative aux actions nominatives qu'il détient selon le registre des actions.
|
|||
3 Intermediated securities based on registered shares of the Company cannot be transferred by way of assignment. A security interest in any such intermediated
securities also cannot be granted by way of assignment.
|
3 Les titres intermédiés fondés sur des actions nominatives de la Société ne peuvent pas être transférés par cession. Il ne peut pas non plus être constitué
de sûretés par cession sur ces titres intermédiés.
|
|||
Article 6
|
Article 6
|
|||
Share Register, Re
strictions on Regis
tration, Nominees
|
1 The Company shall maintain, itself or through a third party, a share register for the registered shares that lists the surname and name (the name of the
company in case of a legal entity), the address and domicile (the registered office in case of a legal entity) of the shareholders or usufructuaries. A person registered in the share register shall notify the share registrar of any change of
address. Until such notification has occurred, all written communications from the Company to persons registered in the share register shall be deemed to have validly been made if sent to the address previously recorded in the share register.
|
|
Registre des ac
tions, limitations à
l'inscription, Nomin
ees
|
1 La Société ou un tiers mandaté par elle tient un registre des actions qui mentionne le nom et le prénom (la raison sociale pour les personnes morales),
l'adresse et le domicile (le siège pour les personnes morales) des propriétaires et des usufruitiers. Si une personne inscrite au registre des actions change d'adresse, elle doit le communiquer à la personne en charge de la tenue du registre.
Aussi longtemps que cette communication n'a pas eu lieu, toutes les communications écrites de la Société aux personnes inscrites au registre des actions seront valablement envoyées à l'adresse inscrite au registre des actions.
|
2 Persons acquiring shares shall be registered in the share register as shareholders with voting rights upon their request if they expressly declare to have
acquired these shares in their own name and for their own account. Subject to paragraph 4 of this Article 6 and article 685d para. 3 of the Swiss Code of Obligations, no person or entity shall be
registered in the share register as a shareholder with voting rights for, and no person or entity may directly or indirectly, formally, constructively or beneficially own, or otherwise control alone or together with third parties voting
rights (whether exercisable or not) with respect to more than 15% of the share capital as set forth in the commercial register as a shareholder with voting rights. This restriction shall also apply to persons or entities who hold some or all
of their shares through Nominees (as defined in paragraph 4 of this Article 6).
|
2 Les personnes qui acquièrent des actions sont inscrites dans le registre des actions, à leur demande, comme actionnaires avec droit de vote, pour autant
qu'ils déclarent expressément avoir acquis les actions en leur nom et pour leur propre compte. Sous réserve de l'alinéa 4 du présent article 6 et de l'article 685d al. 3 du Code des obligations, aucune personne physique ou morale ne peut être
inscrite au registre des actions comme actionnaire avec droit de vote et aucune personne physique ou morale ne peut détenir, directement ou indirectement, formellement, de fait ou comme ayant droit économique, ou contrôler autrement, seul ou
avec des tiers, des droits de vote (exerçables ou non), par rapport à plus de 15% du capital-actions inscrit au registre du commerce en tant qu'actionnaire avec droit de vote. Cette restriction s'applique également aux personnes ou entités
qui détiennent tout ou partie de leurs actions par l'intermédiaire de Nominees (tels que définis à l'alinéa 4 du présent article 6).
|
|||
3 Subject to Art. 652b para. 3 of the Swiss Code of Obligations, this transfer restriction also applies in the case of the acquisition of shares by the
exercise of subscription, option and conversion rights. The transfer restriction does not apply to acquisitions by inheritance, division of an estate or matrimonial property law.
|
3 Sous réserve de l'art. 652b al. 3 CO, les restrictions au transfert s'appliquent également lors de l'acquisition d'actions dans le cadre de l'exercice d'un
droit de souscription, d'option ou de conversion. Les restrictions au transfert ne s'appliquent pas lors d'acquisitions par succession, partage successoral ou en vertu du droit matrimonial.
|
|||
4 The Board of Directors may, in its own discretion, register persons who declare in the registration application that they hold the shares as nominees (each
a Nominee) on behalf of third party beneficiaries (each a Beneficial Owner) in the share register as shareholders with voting rights. If, however, any
Beneficial Owner should as a result of such registration being made or upheld, directly or indirectly, formally, constructively or beneficially own, or otherwise control or direct, alone or together with third parties, voting rights (whether
exercisable or not) with respect to more than 15% of the share capital as set forth in the commercial register, the Board of Directors may cancel the registration of the Nominee holding shares for the account of such Beneficial Owner with
respect to any shares in excess of such limit. The Board of Directors may make the registration with voting rights of the shares held by a Nominee subject to conditions, limitations and reporting requirements or may impose or adjust such
conditions, limitations and requirements once registered.
|
4 Le Conseil d'administration peut, à son entière discretion inscrire les personnes qui déclarent dans leur requête d'inscription qu'elles détiennent les
actions en tant que nominees (chacun un Nominee) pour le compte de tiers ayants droit économiques (chacun un Ayant Droit Economique) en tant qu'actionnaires
avec droit de vote. Toutefois, si suite à l'inscription ou à la confirmation de l'inscription, un Ayant Droit Economique détient directement ou indirectement, formellement, de fait ou comme ayant droit économique, ou contrôle ou dirige
autrement, seul ou avec des tiers, des droits de votes (exerçables ou non) par rapport à plus de 15% du capital-actions inscrit au registre du commerce, le Conseil d'administration peut annuler l'inscription du Nominee détenant les actions
pour le compte d'un tel Ayant Droit Economique pour les actions dépassant cette limite. Le Conseil d'administration peut soumettre l'inscription avec droit de vote des actions détenues par un Nominee à des conditions, limitations, exigences
de rapports ou peut imposer de telles conditions, limitiations ou exigences suite à l'inscription.
|
5 Legal entities and partnerships or other groups of persons or joint owners who are interrelated to one another through capital ownership, voting rights,
uniform management or are otherwise linked, as well as individuals or legal entities or partnerships who act in concert or otherwise act in a coordinated manner or acquire shares indirectly, thereby circumventing the restrictions or limits
pursuant to paragraph 2 or 4 of this article 6 shall be treated as one single person, entity, Nominee or as a person acquiring shares, as applicable, for purposes of paragraphs 2 and 4 of this article 6.
|
5 Les personnes morales et communautés de personnes ou autres groupes de personnes ou de copropriétaires qui sont liés par le capital, les droits de vote, la
gestion commune ou de toute autre manière, de même que les personnes physiques ou morales ou communautés de personnes qui agissent de concert ou de manière coordonnée ou acquièrent indirectement des actions, et contournent ainsi les
restrictions ou limites visées aux alinéas 2 ou 4 du présent article 6 sont traités comme une seule personne, personne morale, Nominee ou comme une personne acquérant des actions, selon le cas, aux fins des alinéas 2 et 4 du présent article
6.
|
|||
6 The Board of Directors may grant exceptions from the restrictions or limits pursuant to paragraph 2 or 4 of this article 6 for justified reasons with the
majority vote of two thirds of all its members. A justified reason may include the situation where a person extends an offer to purchase with respect to all other shares of the Company, which the Board of Directors, after having consulted an
independent financial advisor, recommends to the shareholders. Shareholders, other than Nominees, already being registered directly or through a Nominee with more than 15% at the time that this article takes effect remain registered with
voting rights for such shares.
|
6 Le Conseil d'administration peut octroyer des dérogations aux restrictions et limites mentionnées aux alinéas 2 ou 4 du présent article 6 pour des raisons
justifiées, à la majorité des deux tiers de l'ensemble de ses membres. Peut aussi être considérée comme une raison justifiée le fait qu'une personne étende une offre d'achat par rapport à l'ensemble des autres actions de la Société et que le
Conseil d'administration, après avoir consulté un conseiller financier indépendant, recommande aux actionnaires d'accepter cette offre. Les actionnaires autres que les Nominees déjà inscrits directement ou par l'intermédiaire d'un Nominee
pour plus de 15% au moment où le présent article entre en vigueur demeurent enregistrés avec droit de vote pour ces actions.
|
7 After hearing the registered shareholder or Nominee, the Board of Directors may cancel such person's registration in the share register with retroactive
effect as of the date of registration if such registration was made based on false or misleading information or if such information becomes untrue or misleading. The relevant shareholder or Nominee shall be promptly informed of the
cancellation.
|
7 Le Conseil d'administration peut, après avoir entendu l'actionnaire ou le Nominee, radier du registre des actions l'inscription qui a été faite sur la base
d'informations fausses ou trompeuses données par l'acquéreur, ou si les informations deviennent fausses ou trompeuses. L'actionnaire ou le Nominee doit être informé immédiatement de la radiation.
|
|||
8 The Board of Directors shall regulate all details and issue the instructions necessary to ensure compliance with the preceding provisions. The Board of
Directors may delegate its duties.
|
8 Le Conseil d'administration règle les détails et prend les mesures nécessaires au respect des dispositions ci-dessus. Le Conseil d'administration peut
déléguer ses tâches.
|
|||
Article 7
|
Article 7
|
|||
Exercise of Rights
|
1 The Company shall only accept one representative per share.
|
|
Exercice des droits
|
1 La Société ne reconnaît qu'un représentant par action.
|
2 The voting right and the rights associated therewith may be exercised vis-à-vis the Company by a shareholder, usufructuary or Nominee only to the extent
that such person is registered in the share register with voting rights.
|
2 Le droit de vote et les droits y relatifs ne peuvent être exercés à l'égard de la Société que par un actionnaire, un usufruitier ou un Nominee uniquement
dans la mesure où celui-ci est inscrit avec droit de vote au registre des actions.
|
Section 3
Corporate Bodies
|
Section 3
Organes
|
|||
A. The General Meeting of Shareholders
|
A. L'Assemblée générale
|
|||
Article 8
|
Article 8
|
|||
|
1 The General Meeting of Shareholders is the supreme corporate body of the Company.
|
|
|
1 L'Assemblée générale est l'organe suprême de la Société.
|
Powers of the Gen
eral Meeting of
Shareholders
|
2 The General Meeting of Shareholders shall have the following inalienable powers:
|
Pouvoirs de
l'Assemblée géné
rale
|
2 L'Assemblée générale a le droit inaliénable:
|
|
1. the adoption and amendment of these articles of association;
|
1. d'adopter et de modifier les présents statuts;
|
|||
2. the election of the members of the Board of Directors, the Chairman of the Board of Directors and the members of the Compensation Committee;
|
2. de nommer les membres du Conseil d'administration, le président du Conseil d'administration et les membres du Comité de rémunération;
|
|||
3. the election of the Auditors;
|
3. de nommer l'organe de révision;
|
|||
4. the election of the independent voting rights representative;
|
4. de nommer le représentant indépendant;
|
|||
5. the approval of the annual management report and the consolidated financial statements;
|
5. d’approuver le rapport annuel et les comptes consolidés;
|
|||
6. the approval of the annual financial statements as well as the resolution on the allocation of profit shown on the balance sheet, in particular the determination of dividends;
|
6. d'approuver les comptes annuels et de déterminer l'emploi du bénéfice résultant du bilan, en particulier de fixer le dividende;
|
|||
7. the discharge from liability of the members of the Board of Directors and the persons entrusted with management;
|
7. de donner décharge aux membres du Conseil d'administration et aux personnes chargées de la gestion;
|
|||
8. the approval of the compensation of the Board of Directors and of the Executive Committee pursuant to Article 26 of these articles of association; and
|
8. d'approuver la rémunération du Conseil d'administration et de la Direction exécutive selon l'article 26 des présents statuts; et
|
|||
9. the adoption of resolutions on matters that are reserved to the General Meeting of Shareholders by law or these articles of association or that are, subject to article 716a CO,
submitted to the General Meeting of Shareholders by the Board of Directors.
|
9. de prendre toutes les décisions qui lui sont réservées par la loi ou les présents statuts ou qui lui sont soumises par le Conseil d’administration, sous réserve de l’article 716a CO.
|
|||
Article 9
|
Article 9
|
|||
Ordinary and Ex
traordinary General
Meetings of Share
holders
|
1 The Ordinary General Meeting of Shareholders shall be held each year within six months of the close of the financial year of the Company.
|
Assemblées géné
rales ordinaires et
extraordinaires
|
1 L'Assemblée générale ordinaire a lieu chaque année dans les six mois qui suivent la clôture de l'exercice de la Société.
|
|
2 Extraordinary General Meetings of Shareholders shall be held if
|
2 Des Assemblées générales extraordinaires ont lieu lorsque
|
|||
(a) the Board of Directors or the Auditors deem it necessary;
|
(a) le Conseil d'administration ou l'organe de révision l'estime nécessaire;
|
|||
(b) so resolved by a General Meeting of Shareholders; or
|
(b) une Assemblée générale le décide; ou
|
|||
(c) shareholders who hold, alone or together, shares representing at least 10% of the share capital so request in writing, indicating the matters to be discussed and the corresponding
proposals and, in case of elections, the names of the nominated candidates.
|
(c) des actionnaires représentant seuls ou ensemble 10% au moins du capital-actions le requièrent par écrit en indiquant les objets de discussion et les propositions, et en cas
d'élections, les noms des candidats proposés.
|
|||
Article 10
|
Article 10
|
|||
Notice
|
1 Notice of a General Meeting of Shareholders shall be given by the Board of Directors or, if necessary, by the Auditors, no later than 20 calendar days
prior to the date of the meeting. Liquidators and representatives of bond-holders are also entitled to call a General Meeting of Shareholders.
|
|
Convocation
|
1 L'Assemblée générale est convoquée par le Conseil d'administration ou, si nécessaire, par l'organe de révision au plus tard 20 jours calendaires avant le
jour de l'assemblée. Les liquidateurs et les représentants de détenteurs d'obligations ont également le droit de convoquer l'Assemblée générale.
|
2 Notice of the General Meeting of Shareholders shall be given by way of a single announcement in the official means of publication of the Company pursuant to
Article 36 of these articles of association. Registered shareholders may in addition be notified in writing.
|
2 La convocation à l'Assemblée générale a lieu par une annonce unique dans l'organe de publication de la Société selon l'article 36 des présents statuts. La convocation peut également être envoyée par écrit aux actionnaires inscrits.
|
|||
3 The annual report, the compensation report and the Auditors' reports shall be made available for inspection by the shareholders at the registered office of
the Company no later than 20 calendar days prior to the Ordinary General Meeting of Shareholders. Registered shareholders shall be informed in writing in the notice.
|
3 Le rapport de gestion, le rapport de rémunération et les rapports de révision sont mis à la disposition des actionnaires au siège de la Société au plus
tard 20 jours calendaires avant l'Assemblée générale ordinaire. Les actionnaires inscrits doivent en être informés par écrit dans la convocation.
|
4 The notice shall specify the items on the agenda as well as the proposals of the Board of Directors and the shareholder(s) who requested that a General
Meeting of Shareholders be held or an item be included on the agenda and, in the event of elections, the names of the proposed candidates.
|
4 La convocation mentionne les objets portés à l'ordre du jour ainsi que les propositions du Conseil d'administration et du ou des actionnaires qui ont
demandé la convocation de l'Assemblée générale ou l'inscription d'un objet à l'ordre du jour et, en cas d'élections, les noms des candidats proposés.
|
|||
Article 11
|
Article 11
|
|||
Agenda
|
1 Shareholders who, alone or together, either hold shares with a par value of at least CHF 1,000,000 or who represent at least 10% of the share capital may
request that an item be included on the agenda. Such request must be made in writing and be received at the registered office of the Company at least 45 calendar days prior to the General Meeting of
Shareholders, specifying the agenda item and the proposals of the shareholders.
|
|
Objets à l'ordre du
jour
|
1 Des actionnaires qui représentent seuls ou ensemble des actions totalisant une valeur nominale d'au moins CHF 1'000'000 ou qui représentent au moins 10% du
capital-actions peuvent requérir l'inscription d'un objet à l'ordre du jour. La demande doit être faite par écrit et reçue au siège de la Société au moins 45 jours calendaires avant l'Assemblée générale avec indication des objets à l'ordre du
jour et des propositions des actionnaires.
|
2 No resolutions may be passed at a General Meeting of Shareholders on proposals concerning agenda items for which proper notice was not given. This provision
shall not apply, however, to proposals made during a General Meeting of Shareholders to convene an Extraordinary General Meeting of Shareholders or to initiate a special audit. Each request for inclusion of an item on the agenda shall include
(i) a brief description of the agenda item and the reason for which it is to be discussed at the meeting; (ii) the motions regarding the agenda item; (iii) the name and address, as they appear on the Company’s register of shareholders, of the
shareholder proposing such business; (iv) the number of shares of the Company which are beneficially owned by such shareholder; (v) the dates upon which the shareholder acquired such shares; (vi) documentary support for any claim of
beneficial ownership; (vii) any material interest of such shareholder in including the item in the agenda; (viii) a statement in support of the matter; and (ix) all other information required under applicable law and stock exchange rules.
|
2 Aucune décision ne peut être prise par l'Assemblée générale sur des objets qui n'ont pas été dûment portés à l'ordre du jour, à l'exception des propositions
de convoquer une Assemblée générale extraordinaire et d'instituer un contrôle spécial. Toute requête visant l'inscription d'un objet à l'ordre du jour doit inclure (i) une brève description de cet objet et la raison pour laquelle il doit être
discuté lors de l'Asemblée générale; (ii) les propositions relatives à cet objet; (iii) le nom et l'adresse, tels qu'ils apparaissent dans le registre des actions, de l'actionnaire proposant un tel objet; (iv) le nombre d'actions de la
Société dont cet actionnaire est ayant droit économique; (v) les dates auxquelles l'actionnaire a acquis ces actions; (vi) les pièces justificatives démontrant le statut d'ayant droit économique; (vii) l'intérêt important de l'actionnaire à
l'inscription de l'objet à l'ordre du jour; (viii) une déclaration à l'appui de la requête; et (ix) toute autre information requise par la loi ou les règles boursières applicables.
|
3 No prior notice is required to bring motions related to items already on the agenda or for the discussion of matters on which no resolution is to be taken.
|
3 En revanche, il n'est pas nécessaire d'annoncer à l'avance les propositions entrant dans le cadre des objets portés à l'ordre du jour ni les délibérations
qui ne doivent pas être suivies d'un vote.
|
|||
Article 12
|
Article 12
|
|||
Chairman, Vote
Counters, Minutes
|
1 The Chairman of the Board of Directors shall chair the General Meeting of Shareholders. In his absence, the Vice-Chairman of the Board of Directors,
another member or a person designated by the Board of Directors shall chair the General Meeting of Shareholders. If no member of the Board of Directors is available and no other person has been designated by the Board of Directors, the acting
chair shall be elected by the General Meeting of Shareholders.
|
|
Présidence, scruta
teurs, procès-verbal
|
1 Le président du Conseil d'administration préside l'Assemblée générale. En son absence, le vice-président du Conseil d'administration, un autre membre ou
une personne désignée par le Conseil d'administration préside l'Assemblée générale. Si aucun membre du Conseil d'administration n'est disponible et aucune personne n'a été désignée par le Conseil d'administration, l'Assemblée générale élit
son président.
|
2 The acting chair of the General Meeting of Shareholders shall appoint the secretary and the vote counter(s), none of whom need be shareholders. The minutes
shall be signed by the acting chair of the General Meeting of Shareholders and the secretary.
|
2 Le président de l'Assemblée générale désigne un rédacteur du procès-verbal et le ou les scrutateurs, qui ne doivent pas nécessairement être des
actionnaires. Le procès-verbal doit être signé par le président de l'Assemblée générale et le secrétaire.
|
|||
3 The acting chair of the General Meeting of Shareholders shall have all powers and authority necessary and appropriate to ensure the orderly conduct of the
General Meeting of Shareholders.
|
3 Le président de l'Assemblée générale a tous les pouvoirs nécessaires et appropriés pour s'assurer de la conduite régulière de l'Assemblée générale.
|
Article 13
|
Article 13
|
|||
Voting Rights, Rep
resentation
|
1 Each share shall convey the right to one vote. The voting rights are subject to the conditions of Articles 6 and 7 of these articles of association.
|
|
Droit de vote, repré
sentation |
1 Chaque action donne droit à une voix. Les droits de vote sont soumis aux conditions des articles 6 et 7 des
présents statuts.
|
2 The Board of Directors shall issue the rules regarding the participation in and representation at the General Meeting of Shareholders and determine the
requirements as to proxies and instructions. A shareholder may only be represented at the General Meeting of Shareholders by the independent voting rights representative, its legal representative or, by means of a written proxy, by another
shareholder with the right to vote. All shares held by a shareholder may only be represented by one person.
|
2 Le Conseil d'administration prend les dispositions relatives à la participation et à la représentation à l'Assemblée générale et détermine les exigences
applicables aux procurations et instructions. Un actionnaire ne peut être représenté à l'Assemblée générale que par le représentant indépendant, par son représentant légal ou, au moyen d'une procuration écrite, par un autre actionnaire ayant
droit de vote. Toutes les actions détenues par un actionnaire ne peuvent être représentées que par une seule personne.
|
|||
3 The General Meeting of Shareholders shall elect the independent voting rights representative for a term of office until completion of the next Ordinary
General Meeting of Shareholders. Re-election is possible.
|
3 L'Assemblée générale nomme le représentant indépendant pour une durée de fonctions s’achevant à la fin de l’Assemblée générale ordinaire suivante. La
réélection est possible.
|
|||
4 If the Company does not have an independent voting rights representative, the Board of Directors shall appoint the independent voting rights representative
for the next General Meeting of Shareholders.
|
4 Dans le cas où la Société n'a pas de représentant indépendant, le Conseil d'administration nommera le représentant indépendant pour l'Assemblée générale
suivante.
|
|||
Article 14
|
Article 14
|
|||
Resolutions, Elec
tions
|
1 The General Meeting of Shareholders shall pass its resolutions and decide its elections by the absolute majority of the votes attached to the shares
represented, unless required otherwise by law or these articles of association. In the event of a tie, the resolution shall be deemed refused.
|
|
Décisions, élections
|
1 Les décisions de l'Assemblée générale sont prises à la majorité absolue des voix attribuées aux actions représentées, à moins que la loi ou les présents
statuts n'en disposent autrement. En cas d'égalité de voix, la décision est refusée.
|
2 Two thirds of the votes represented and the absolute majority of the par value of shares represented shall be required for the General Meeting of
Shareholders to adopt resolutions on the following matters:
|
2 Une décision de l'Assemblée générale recueillant au moins les deux tiers des voix attribuées aux actions représentées et la majorité absolue des valeurs
nominales représentées est nécessaire pour:
|
|||
1. the amendment of the purpose of the Company;
|
1. la modification du but social de la Société;
|
|||
2. the creation of shares with privileged voting rights;
|
2. l'introduction d'actions à droit de vote privilégié;
|
|||
3. the restriction on the transferability of registered shares or their registration with voting rights and the cancelation of such a restriction;
|
3. la restriction de la transmissibilité des actions nominatives ou leur inscription avec droit de vote ainsi que la suppression d'une telle restriction;
|
|||
4. an authorized or conditional increase in share capital;
|
4. l'augmentation autorisée ou conditionnelle du capital-actions;
|
|||
5. an increase in share capital through the conversion of equity surplus, against contributions in kind or for purposes of an acquisition of assets, or the granting of special benefits;
|
5. l'augmentation du capital-actions au moyen de la conversion de fonds propres, contre apport en nature ou en vue d'une reprise de biens et l'octroi d'avantages particuliers;
|
|||
6. the limitation or withdrawal of pre-emptive rights;
|
6. la limitation ou la suppression du droit de souscription préférentiel;
|
|||
7. the relocation of the registered office of the Company;
|
7. le transfert du siège de la Société;
|
|||
8. the dissolution of the Company;
|
8. la dissolution de la Société;
|
|||
9. mergers, demergers and conversions pursuant to the Merger Act;
|
9. une fusion, scission ou transformation conformément à la Loi sur la fusion;
|
|||
10. the conversion of registered shares into bearer shares;
|
10. la conversion d'actions nominatives en actions au porteur;
|
|||
11. the removal of any member of the Board of Directors or of its Chairman before the end of his or her term of office; and
|
11. la révocation de tout membre du Conseil d'administration ou de son président avant la fin de son mandat; et
|
|||
12. the amendment or repeal of the following provisions of these articles of association, with the exception of editorial amendments that do not effectively change their content:
|
12. la modification ou la suppression des dispositions suivantes des présents statuts, à l'exception des modifications rédactionnelles qui ne modifient pas effectivement leur contenu:
|
(i) article 6;
(ii) article 14;
(iii) article 15; and
(iv) article 18.
|
(i) article 6;
(ii) article 14;
(iii) article 15; et
(iv) article 18.
|
|||
3 Resolutions and elections shall be decided by open ballot, unless the acting chair of the General Meeting of Shareholders decides that a secret ballot be
held or that it be voted by electronic means. The acting chair may at any time order that a resolution or election be repeated if he considers the vote to be in doubt. The resolution or election previously held shall then be deemed not to
have taken place.
|
3 Les décisions et élections ont lieu à main levée, à moins qu'un vote à bulletins secrets ou électronique ne soit ordonné par le président de l'Assemblée
générale. Le président peut en tout temps ordonner qu'une décision ou élection soit répétée s'il estime qu'il existe des doutes sur le résultat. Dans ce cas, la décision ou l'élection précédente est réputée ne pas avoir eu lieu.
|
|||
B. The Board of Directors
|
B. Le Conseil d'administration
|
|||
Article 15
|
Article 15
|
|||
Number of Directors
|
The Board of Directors shall consist of not less than 3 and no more than 11 members.
|
|
Nombre de membres
|
Le Conseil d'administration se compose de 3 membres au moins et de 11 membres au plus.
|
Article 16
|
Article 16
|
|||
Election and Term
of Office
|
1 The General Meeting of Shareholders shall elect the members of the Board of Directors and the Chairman of the Board of Directors individually and for a
term of office until the completion of the next Ordinary General Meeting of Shareholders. Re-election is possible.
|
|
Élection et durée
des fonctions
|
1 Les membres du Conseil d’administration et le président du Conseil d’administration sont élus individuellement par l’Assemblée générale pour une durée de
fonctions s’achevant à la fin de l’Assemblée générale ordinaire suivante. La réélection est possible.
|
2 If the office of the Chairman of the Board of Directors is vacant, the Board of Directors shall appoint a new Chairman from among its members for a term of
office extending until completion of the next Ordinary General Meeting of Shareholders.
|
2 Lorsque la fonction de président du Conseil d’administration est vacante, le Conseil d’administration désigne un nouveau président parmi ses membres pour
une durée de fonctions s’achevant à la fin de l’Assemblée générale ordinaire suivante.
|
Article 17
|
Article 17
|
|||
Organization of the
Board of Directors
|
1 Except for the election of the Chairman of the Board of Directors and the members of the Compensation Committee by the General Meeting of Shareholders, the
Board of Directors shall constitute itself. The Board of Directors may elect one or several Vice-Chairmen. The Board of Directors shall further appoint a secretary who need not be member of the Board of Directors.
|
|
Organisation du
Conseil d'adminis
tration
|
1 A l'exception de l'élection par l'Assemblée générale du président du Conseil d'administration et des membres du Comité de rémunération, le Conseil
d'administration se constitue lui-même. Il peut désigner au besoin, un ou plusieurs vice-présidents. Le Conseil d'administration désigne en outre un secrétaire, qui ne doit pas nécessairement être membre du Conseil d'administration.
|
2 Subject to these articles of association, the Board of Directors shall regulate its organization and the adoption of resolutions in the organizational
regulations.
|
2 Le Conseil d'administration règle en outre son organisation et la manière de prendre des décisions dans un règlement d'organisation, sous réserve des
présents statuts.
|
|||
Article 18
|
Article 18
|
|||
Reimbursement of
Expenses, Indemni
fication
|
1 The members of the Board of Directors shall be entitled to the reimbursement of all expenses incurred in the interest of the Company.
|
|
Remboursement
des frais, indemni
sation
|
1 Les membres du Conseil d'administration ont droit au remboursement de tous les frais engagés dans l'intérêt de la Société.
|
2 To the extent not included in insurance coverage or paid by third parties, the Company shall indemnify and hold harmless, to the extent permitted by law,
the existing and former members of the Board of Directors and Executive Committee, and their heirs, executors and administrators, out of the assets of the Company from and against all threatened, pending or completed actions, suits or
proceedings – whether civil, criminal, administrative or investigative – and all costs, charges, losses, damages, and expenses which they or any of them, their heirs, executors or administrators, shall or may incur or sustain by or by reason
of any actual or alleged actions, consents or omissions in or about the execution of their duty, or alleged duty, or by reason of the fact that he is or was a member of the Board of Directors or Executive Committee of the Company or one of
its subsidiaries, or, while serving as a member of the Board of Directors or Executive Committee of the Company, is or was serving at the request of the Company as a director, member of the executive management, employee or agent of another
corporation, partnership, joint venture, trust or other enterprise; provided, however, that this indemnity shall not extend to any matter in which any of said persons is found, in a final judgment or decree of a court or governmental or
administrative authority of competent jurisdiction not subject to appeal, to have committed an intentional or grossly negligent breach of his statutory duties as a member of the Board of Directors or Executive Committee.
|
2 Dans la mesure où la loi le permet, la Société indemnisera, à concurrence de la portion non couverte par une assurance ou payée par un tiers, sur ses
propres biens les membres actuels et passés du Conseil d'administration et de la Direction exécutive ainsi que leurs héritiers, masse en faillite ou masse successorale contre toutes actions, procès ou poursuites, menaçants, en cours ou
terminés, de nature civile, pénale, administrative ou autre, et tous les coûts, dépenses, pertes, dommages et frais qu'ils (ou leurs héritiers, masse en faillite ou masse successorale) subiraient ou pourraient subir en raison d'actions,
consentements ou omissions, effectifs ou présumés, en relation avec l'exercice de leurs fonctions, leurs fonctions supposées ou en raison du fait d'être ou d'avoir été membres du Conseil d'administration ou de la Direction exécutive de la
Société ou de l'une de ses filiales ou, sur instruction de la Société en tant que membres du Conseil d'administration ou de la Direction exécutive, en raison du fait d'être ou d'avoir été administrateur, membre de la direction, employé ou
mandataire d'une autre société, entreprise, coentreprise, personne morale dénuée de la personnalité ou trust. L'obligation d'indemnisation s'éteint dès qu'un jugement définitif et exécutoire d'un tribunal ou d'une autorité compétente a décidé
que la personne en question a violé, volontairement ou par grave négligence, ses devoirs de membre du Conseil d'administration ou de la Direction exécutive.
|
3 Without limiting the foregoing paragraph 2 of this Article 18, the Company shall advance costs and expenses idemnifiable thereunder to the existing and
former members of the Board of Directors and Executive Committee to the extent not included in insurance coverage or advanced by third parties. The Company may however recover such advanced costs if any of said persons is found, in a final
judgment or decree of a court or governmental or administrative authority of competent jurisdiction not subject to appeal, to have committed an intentional or grossly negligent breach of his statutory duties as a member of the Board of
Directors or Executive Committee.
|
3 Sans préjudice de l'alinéa 2 du présent article 18, la Société avancera les frais et les coûts indemnisables en vertu de la disposition précitée aux
membres actuels et passés du Conseil d'administration et de la Direction exécutive, à concurrence de la portion non couverte par une assurance ou payée par un tiers. La Société peut cependant recouvrer ces avances de frais si l'une de ces
personnes a été reconnue coupable de violation intentionnelle ou par négligence grave de ses devoirs de membre du Conseil d'administration ou de la Direction exécutive par un jugement ou une décision final et exécutoire d'un tribunal ou d'une
autorité gouvernementale ou administrative compétente.
|
|||
Article 19
|
Article 19
|
|||
Convening of Meet
ings, Resolutions,
Minutes
|
1 The Board of Directors shall meet at the invitation of its Chairman or, if not available, of the Vice-Chairman or of another member of the Board of
Directors as often as the business of the Company shall require or if a member requests it in writing or via telefax, e-mail or another form of electronic communication, indicating the reasons.
|
|
Convocation, déci
sions, procès-verbal
|
1 Le Conseil d'administration est convoqué par son président ou, en cas d'empêchement de ce dernier, par son vice-président ou par un autre membre du Conseil
d'administration, aussi souvent que cela apparaît nécessaire ou lorsqu'un membre du Conseil d'administration le demande par écrit, par télécopie, courriel ou par un autre moyen de communication électronique, avec indication des motifs.
|
2 Unless the organizational regulations adopted by the Board of Directors or a board resolution taken with the applicable attendance quorum provide otherwise,
the Board of Directors shall only have a quorum if a majority of the members of the Board of Directors is present. No attendance quorum shall be required for resolutions of the Board of Directors providing for the amendment and ascertainment
of a capital increase.
|
2 A moins que le contraire ne résulte d'une disposition du règlement d'organisation adopté par le Conseil d'administration ou d'une décision du Conseil
d'administration prise conformément aux dispositions applicables au quorum de présence, la majorité des membres du Conseil d'administration doivent être présents afin de pouvoir prendre une décision. Ce quorum de présence n'est pas nécessaire
pour les décisions de modification et de constatation du Conseil d'administration en lien avec les augmentations du capital-actions.
|
|||
3 The Board of Directors shall adopt its resolutions by a majority of votes cast. In the case of a tie, the Chairman of the Board of Directors shall have the
casting vote.
|
3 Les décisions du Conseil d'administration sont prises à la majorité des voix exprimées. En cas d'égalité des voix, la voix du président du Conseil
d'administration prévaut.
|
|||
4 Resolutions may also be adopted by way of written consent or by approval via telefax, e-mail or another form of electronic communication, unless a member
requests discussion thereof.
|
4 Les décisions du Conseil d'administration peuvent également être prises par voie de circulation ou être adoptées par télécopie, courriel ou par un autre
moyen de communication électronique, à moins qu'une discussion ne soit requise par l'un des membres du Conseil d'administration.
|
|||
5 The decisions of the Board of Directors shall be recorded in minutes to be signed by the acting chair and the secretary.
|
5 Les décisions du Conseil d'administration sont consignées dans un procès-verbal signé par le président et par le secrétaire.
|
|||
Article 20
|
Article 20
|
|||
Powers of the Board
of Directors
|
1 The Board of Directors may pass resolutions with respect to all matters which are not delegated to another corporate body of the Company by law, by these
articles of association or by regulations.
|
|
Attributions du Con
seil d'administration
|
1 Le Conseil d'administration peut prendre des décisions sur toutes les affaires qui ne sont pas attribuées à un autre organe de la Société par la loi, les
présents statuts ou un règlement.
|
2 It shall have the following non-transferable and inalienable duties:
|
2 Il a les attributions intransmissibles et inaliénables suivantes:
|
1. the ultimate management of the Company and the issuance of necessary instructions;
|
1. exercer la haute direction de la Société et établir les instructions nécessaires;
|
|||
2. the determination of the organization of the Company;
|
2. fixer l'organisation de la Société;
|
|||
3. the structuring of the accounting system, of the financial controls and of the financial planning;
|
3. fixer les principes de la comptabilité et du contrôle financier ainsi que le plan financier;
|
|||
4. the appointment and dismissal of the persons entrusted with management and representation of the Company, and issuance of rules on the signature authority;
|
4. nommer et révoquer les personnes chargées de la gestion et de la représentation de la Société et réglementer le droit de signature;
|
|||
5. the ultimate supervision of the persons entrusted with management, in particular in view of compliance with the law, these articles of association, regulations and directives;
|
5. exercer la haute surveillance sur les personnes chargées de la gestion pour s'assurer notamment qu'elles observent la loi, les présents statuts, les règlements et les instructions
données;
|
|||
6. the preparation of the annual report and the compensation report;
|
6. établir le rapport de gestion et le rapport de rémunération;
|
|||
7. the preparation of the General Meeting of Shareholders and the implementation of its resolutions;
|
7. préparer l'Assemblée générale et exécuter ses décisions;
|
|||
8. the adoption of resolutions on the increase of the share capital to the extent that such power is vested in the Board of Directors, the ascertainment of capital increases, the
preparation of the report on the capital increase, and the respective amendments of the articles of association (including deletions);
|
8. prendre les décisions relatives aux augmentations du capital-actions, dans la mesure où elles sont de la compétence du Conseil d'administration, ainsi que les décisions relatives à
la constatation d'augmentations de capital, à l'établissement du rapport d'augmentation du capital-actions et aux modifications des statuts qui en résultent (radiation comprise);
|
|||
9. the non-transferable and inalienable duties and powers of the Board of Directors pursuant to the Merger Act;
|
9. les attributions et compétences intransmissibles et inaliénables du Conseil d'administration selon la Loi sur la fusion;
|
|||
10. the notification of the judge if liabilities exceed assets; and
|
10. informer le juge en cas de surendettement; et
|
Article 23
|
Article 23
|
|||
Organization of the
Compensation
Committee
|
1 The Compensation Committee shall constitute itself. Unless the organizational regulations provide otherwise, the Board of Directors shall elect a chairman
from among the Compensation Committee's members.
|
|
Organisation du Co
mité de rémunéra
tion
|
1 Le Comité de rémunération se constitue lui-même. A moins que le règlement d'organisation n'en dispose autrement, le Conseil d'administration élit le
Président du Comité de rémunération parmi les membres du Comité de rémunération.
|
2 The Board of Directors shall issue regulations establishing the organization and decision-making process of the Compensation Committee, which may be part of
the organizational regulations.
|
2 Le Conseil d'administration établit un règlement concernant l'organisation et le processus de décision du Comité de rémunération, qui peut être intégré au
règlement d'organisation.
|
|||
Article 24
|
Article 24
|
|||
Duties and Powers
|
1 The Compensation Committee shall support the Board of Directors in establishing and reviewing the compensation strategy and guidelines as well as in
preparing the proposals to the General Meeting of Shareholders regarding the compensation of the Board of Directors and the Executive Committee. It may submit proposals to the Board of Directors in other compensation-related issues.
|
Attributions
|
1 Le Comité de rémunération assiste le Conseil d'administration dans l'établissement et la révision de la stratégie et des directives de rémunération, ainsi
que dans la préparation des propositions à soumettre à l'Assemblée générale concernant la rémunération du Conseil d'administration et de la Direction exécutive. Il peut soumettre au Conseil d'administration des propositions en toutes autres
matières relatives à la rémunération.
|
|
2 The Board of Directors shall determine in regulations for which positions of the Board of Directors, the Executive Committee and other member of management
(if any) the Compensation Committee shall submit proposals for the performance metrics, target values and/or the compensation of the members of the Board of Directors and the Executive Committee, and
for which positions it shall itself determine, in accordance with these articles of association and the compensation guidelines established by the Board of Directors, such performance metrics, target values and/or the compensation.
|
2 Le Conseil d'administration détermine dans un règlement pour quelles fonctions du Conseil d'administration, de la Direction exécutive et d'autres membres
de la direction (si applicable) le Comité de rémunération proposera au Conseil d'administration les mesures de performances, les valeurs cibles et/ou la rémunération des membres du Conseil d'administration et de la Direction exécutive, et
pour quelles fonctions il aura la compétence de déterminer de son propre chef, en accord avec les statuts et les directives de rémunération établies par le Conseil d'administration, les mesures de performances, les valeurs cibles et/ou la
rémunération.
|
3 The Board of Directors may delegate further tasks to the Compensation Committee.
|
3 Le Conseil d’administration peut déléguer d'autres tâches au Comité de rémunération.
|
|||
D. The Auditors
|
D. L'organe de révision
|
|||
Article 25
|
Article 25
|
|||
1 The General Meeting of Shareholders shall elect the Auditors for a term of office until the completion of the next Ordinary General Meeting of
Shareholders. Re-election is possible.
|
1 L'Assemblée générale élit l'organe de révision pour une durée de fonctions s’achevant à la fin de l’Assemblée générale ordinaire suivante. La réélection
est possible.
|
|||
2 The Auditors shall have the powers and duties vested in them by law.
|
2 L'organe de révision a les pouvoirs et obligations que lui confère la loi.
|
|||
3 The Board of Directors may mandate the Auditors at any time to perform special investigations, in particular interim audits, and to prepare a report on
their findings.
|
3 Le Conseil d'administration peut en tout temps charger l'organe de révision de procéder à des contrôles spéciaux, notamment des révisions intermédiaires,
et de lui en soumettre un rapport.
|
|||
Section 4
Compensation of the Members of the Board of Directors and the Executive Committee and Related Matters
|
Section 4
Rémunération des membres du Conseil d'administration et de la Direction exécutive et affaires connexes
|
|||
Article 26
|
Article 26
|
|||
Approval of the
Compensation by
the General Meeting
of Shareholders
|
1 The General Meeting of Shareholders shall approve the proposals of the Board of Directors in relation to the aggregate amounts of:
|
Approbation de la
rémunération par
l'Assemblée géné
rale
|
1 L'Assemblée générale approuve les propositions du Conseil d'administration en relation avec les montants maximaux suivants:
|
|
1. the maximum compensation of the Board of Directors until the completion of the next Ordinary General Meeting of Shareholders;
|
1. la rémunération maximale du Conseil d'administration jusqu'à la fin de l'Assemblée générale ordinaire des actionnaires suivante;
|
2. the maximum fixed compensation of the Executive Committee for the following financial year; and
|
2. la rémunération fixe maximale de la Direction exécutive pour l'année comptable suivante; et
|
|||
3. the maximum variable compensation of the Executive Committee for the current financial year.
|
3. la rémunération variable maximale de la Direction exécutive pour l'exercice en cours.
|
|||
2 The Board of Directors may submit for approval by the General Meeting of Shareholders deviating, additional or conditional proposals relating to the
maximum aggregate amount or maximum partial amounts for the same or different periods and/or specific compensation components and/or in relation to additional amounts for specific compensation components.
|
2 Le Conseil d'administration peut soumettre à l'approbation de l'Assemblée générale des propositions divergentes, supplémentaires ou conditionnelles
concernant le montant maximal total ou les montants maximaux partiels pour les mêmes périodes ou des périodes différentes et/ou des éléments de rémunération spécifiques et/ou en relation avec des montants additionnels pour des éléments de
rémunération spécifiques.
|
|||
3 In the event that the General Meeting of Shareholders does not approve a proposal of the Board of Directors, the Board of Directors shall determine, taking
into account all relevant factors, the respective (maximum) aggregate amount or (maximum) partial amounts, and submit the amount(s) so determined for approval by a General Meeting of Shareholders.
|
3 Si l'Assemblée générale n'approuve pas une proposition du Conseil d'administration, le Conseil d'administration détermine, en prenant en compte tous les
critères pertinents, le montant (maximal) total ou des montants (maximaux) partiels respectifs, et soumet le(s) montant(s) ainsi déterminé(s) à l'approbation d'une Assemblée générale.
|
|||
4 The Company or companies controlled by it may pay or grant compensation prior to approval by the General Meeting of Shareholders, subject to subsequent
approval.
|
4 La rémunération peut être versée ou octroyée par la Société ou les sociétés qu'elle contrôle avant l'approbation de l'Assemblée générale, sous réserve
d'une approbation ultérieure.
|
|||
Article 27
|
Article 27
|
|||
Supplementary
Amount for
Changes to the Ex
ecutive Committee
|
If the maximum aggregate amount of compensation already approved by the General Meeting of Shareholders is not sufficient to also cover the compensation of one or more persons who become members of the Executive Committee or are being
promoted within the Executive Committee after the General Meeting of Shareholders has approved the compensation of the Executive Committee for the relevant period, then the Company or companies controlled by it shall be authorized to pay such
member(s) a supplementary amount during the compensation period(s) already approved. The supplementary amount per compensation period per member shall not exceed 100% of the aggregate amount of (maximum) compensation of the Executive
Committee last approved.
|
Montant complé
mentaire en cas de
changements au
sein de la Direction
exécutive
|
Si le montant global maximal de la rémunération déjà approuvé par l'Assemblée générale n'est pas suffisant pour couvrir également la rémunération d'une ou plusieurs personnes devenant membre(s) de la Direction exécutive ou étant promue(s)
au sein de la Direction exécutive après que l'Assemblée générale a approuvé la rémunération de la Direction exécutive pour la période visée, la Société ou toute autre société qu'elle contrôle est alors autorisée à verser à ce(s) membre(s) un
montant complémentaire au cours de la (ou les) période(s) de rémunération déjà approuvée(s). Le montant complémentaire par période de compensation par membre ne doit pas dépasser 100% du montant global
de la rémunération (maximale) de la Direction exécutive approuvée en dernier.
|
Article 28
|
Article 28
|
|||
General Compensa
tion Principles
|
1 The compensation of the non-executive members of the Board of Directors may consist of fixed and variable compensation elements. Total compensation shall
take into account the position and level of responsibility of the recipient.
|
Principes généraux
de rémunération
|
1 La rémunération des membres non-exécutifs du Conseil d'administration peut être constituée d'éléments de rémunérations fixes et variables. La rémunération
totale prend en compte la position et le niveau de responsabilité du bénéficiaire.
|
|
2 The compensation of the members of the Executive Committee may consist of fixed and variable compensation elements. Fixed compensation comprises the base
salary and may consist of other compensation elements. Variable compensation may take into account the achievement of specific performance targets. Total compensation shall take into account the position and level of responsibility of the
recipient.
|
2 La rémunération des membres de la Direction exécutive peut être constituée d'éléments de rémunération fixes et variables. La rémunération fixe comprend le
salaire de base et peut être constituée d'autres éléments de rémunération. La rémunération variable peut prendre en compte l'accomplissement d'objectifs de performance spécifiques. La rémunération totale prend en compte la position et le
niveau de responsabilité du bénéficiaire.
|
|||
3 The performance targets may include individual targets, targets of the Company, group or parts thereof or targets in relation to the market, other
companies or comparable benchmarks, taking into account the position and level of responsibility of the recipient. The Board of Directors or, to the extent delegated to it, the Compensation Committee shall determine the relative weight of the
performance targets and the respective target values.
|
3 Les objectifs de performance peuvent comprendre des objectifs personnels, des objectifs liés à la performance de la Société ou de tout ou partie du groupe
ou des buts en relation avec le marché, d'autres sociétés ou d'autres repères comparables, prenant en compte la position et le niveau de responsabilité du bénéficiaire. Le Conseil d'administration ou le Comité de rémunération, dans la mesure
où cette compétence lui est déléguée, détermine le poids relatif des objectifs de performance et les valeurs cibles respectives.
|
4 Compensation may be paid in the form of cash, shares, options or other share-based instruments or units, or in the form of other types of benefits. The
Board of Directors or, to the extent delegated to it, the Compensation Committee shall determine grant, vesting, exercise, restriction and forfeiture conditions and periods. In particular, they may provide for continuation, acceleration or
removal of vesting, exercise, restriction and forfeiture conditions and periods, for payment or grant of compensation based upon assumed target achievement, or for forfeiture, in each case in the event of pre-determined events such as a
change of control or termination of an employment or mandate agreement. The Company may procure the required shares or other securities through purchases in the market, from treasury shares or by using conditional or authorized share capital.
|
4 La rémunération peut être versée en espèces, sous forme d'actions, d'options ou d'instruments ou unités sur base d'actions ou d'autres types de
prestations. Le Conseil d'administration ou le Comité de rémunération, dans la mesure où cette compétence lui a été déléguée, détermine les conditions et périodes d'octroi, d'acquisition (vesting),
d'exercice, de restriction et de péremption. Ils peuvent en particulier prévoir la continuation, l'accélération ou la suppression des conditions ou périodes d'acquisition (vesting), d'exercice, de
restriction et de péremption, le versement ou l'octroi d'une rémunération supposant l'atteinte des objectifs ou encore la déchéance des droits, dans chaque cas lors d'événements prédéterminés tels que, notamment, un changement de contrôle ou
la fin d'un contrat de travail ou de mandat. La Société peut se procurer les actions ou autres instruments des marchés financiers requis par le biais d'achats sur le marché ou d'actions propres, ou en utilisant son capital-actions
conditionnel ou autorisé.
|
|||
5 Compensation may be paid by the Company or companies controlled by it.
|
5 La rémunération peut être versée par la Société ou tout autre société qu'elle contrôle.
|
|||
Article 29
|
Article 29
|
|||
Agreements with
Members of the
Board of Directors
and the Executive
Committee
|
1 The Company or companies controlled by it may enter into agreements with non-executive members of the Board of Directors relating to their compensation for
a fixed term or for an indefinite term. The duration and termination are subject to the term of office and the law.
|
Contrats avec les
membres du Con
seil d'administration
et de la Direction
exécutive
|
1 La Société, ou toute société qu'elle contrôle, peut conclure des contrats de durée déterminée ou indéterminée avec les membres non-exécutifs du Conseil
d'administration en relation avec leur rémunération. La durée et la résiliation doivent être conformes avec la durée des fonctions ainsi qu'avec les dispositions légales applicables.
|
|
2 The Company or companies controlled by it may enter into employment agreements with executive members of the Board of Directors and other members of the
Executive Committee for a fixed term or for an indefinite term. Fixed term agreements may have a maximum duration of one year; renewal is possible. Agreements for an indefinite term may have a notice period of maximum twelve months.
|
2 La Société, ou toute société qu'elle contrôle, peut conclure des contrats de travail de durée déterminée ou indéterminée avec les membres exécutifs du
conseil d'administration et les autres membres de la Direction exécutive. Les contrats de durée déterminée peuvent avoir une durée maximale d'une année; le renouvellement est possible. Les contrats de durée indéterminée peuvent prévoir un
délai de congé d'au maximum douze mois.
|
3 The Company or companies controlled by it may enter into non-compete agreements with members of the Executive Committee for the time after termination of
employment. Their duration shall not exceed two years, and consideration paid per year for such non-compete undertaking shall not exceed the sum of the total annual compensation of such member last paid or payable for the first time.
|
3 La Société, ou toute société qu'elle contrôle, peut conclure des accords de non-concurrence avec les membres de la Direction exécutive pour la période
suivant la fin des rapports de travail. Leur durée ne peut excéder deux ans, et l'indemnisation par an versée en contrepartie d'un tel accord de non concurrence ne peut excéder la somme de la dernière rémunération annuelle totale versée ou à
verser pour la première fois au membre concerné.
|
|||
Article 30
|
Article 30
|
|||
Mandates Outside
of the Group
|
1 The number of mandates on the board of directors or the executive committee of legal entities that have to be registered in a Swiss commercial register or a
similar foreign register outside the group is limited:
|
Mandats en dehors
du groupe
|
1 Le nombre de mandats d'administrateur et/ou au sein de la Direction exécutive d'entités juridiques tenues d'être inscrites au registre du commerce suisse
ou dans un registre similaire étranger est limité:
|
|
(a) for members of the Executive Committee, to seven mandates, of which no more than two in a listed company; and
|
(a) pour les membres de la Direction exécutive, à sept mandats, dont pas plus de deux au sein de sociétés cotées; et
|
|||
(b) for members of the Board of Directors, to fifteen mandates, of which no more than five in listed companies.
|
(b) pour les membres du Conseil d'administration à quinze mandats, dont pas plus de cinq au sein de sociétés cotées.
|
|||
2 Mandates in different legal entities being part of the same group or for the same group are deemed to be one mandate.
|
2 Les mandats dans différentes entités juridiques appartenant au même groupe ou assumés pour le même groupe sont considérés comme un mandat.
|
|||
3 Mandates in associations, charitable organizations, family trusts and foundations relating to post-retirement benefits are not subject to the above
limitations. No member of the Board of Directors or the Executive Committee shall hold more than 10 such mandates.
|
3 Les mandats dans des associations, organisations caritatives, fondations de famille et fondations de prévoyance professionnelle ne sont pas soumis aux
limites mentionnées ci-dessus. Aucun membre du Conseil d'administration ou de la Direction exécutive ne peut exercer plus de 10 mandats de ce genre.
|
Article 31
|
Article 31
|
|||
Post-Retirement
Benefits
|
The Company or companies controlled by it may grant to members of the Board of Directors and the Executive Committee post-retirement benefits beyond the occupational benefit schemes which do not exceed the annual compensation of the
respective member of the Board of Directors or the Executive Committee last paid or payable for the first time.
|
Prestations de re
traite
|
La Société ou toute société qu'elle contrôle peut octroyer aux membres du Conseil d'administration et de la Direction exécutive des prestations de retraite allant au-delà du régime de prévoyance professionnelle n'excédant pas la
rémunération annuelle du membre du Conseil d'administration ou de la Direction exécutive concerné versée ou à verser pour la première fois.
|
|
Section 5
Financial Year, Profit Allocation
|
Section 5
Exercice, répartition du bénéfice
|
|||
Article 32
|
Article 32
|
|||
Financial Year, An
nual and Compen
sation Report
|
1 The Company's financial year shall be determined by the Board of Directors.
|
Exercice social, rap
port de gestion et de
rémunération
|
1 L'exercice est fixé par le Conseil d'administration.
|
|
2 The Board of Directors shall prepare an annual report for each financial year, comprising the annual financial statements, if required, the management
report and the consolidated financial statements, as well as a compensation report.
|
2 Le Conseil d'administration établit pour chaque exercice un rapport de gestion, qui se compose des comptes annuels et, cas échéant, du rapport annuel et des
comptes de groupe, ainsi qu'un rapport de rémunération.
|
|||
Article 33
|
Article 33
|
|||
Allocation of Profit
Shown on the Bal
ance Sheet, Re
serves
|
1 The General Meeting of Shareholders shall resolve on the allocation of the profit as shown on the balance sheet in accordance with applicable law. The
Board of Directors shall submit its proposals to the General Meeting of Shareholders.
|
Utilisation du béné
fice résultant du
bilan, réserves
|
1 L'Assemblée générale détermine l'emploi du bénéfice résultant du bilan, sous réserve des prescriptions légales concernant la répartition du bénéfice. Le
Conseil d'administration lui soumet ses propositions.
|
|
2 In addition to the reserves required by law, the General Meeting of Shareholders may create other reserves.
|
2 En sus des réserves légales, l'Assemblée générale peut constituer des réserves supplémentaires.
|
3 Dividends that have not been collected within five years after their payment date shall inure to the Company and be allocated to the general statutory
reserves.
|
3 Les dividendes qui n'ont pas été perçus dans un délai de cinq ans après leur date de paiement sont prescrits et sont alloués aux réserves statutaires de la
Société.
|
|||
Section 6
Dissolution, Liquidation
|
Section 6
Dissolution, liquidation
|
|||
Article 34
|
Article 34
|
|||
Dissolution, Liquida
tion
|
1 The General Meeting of Shareholders may at any time resolve to dissolve and liquidate the Company in accordance with the law and the provisions set forth
in these articles of association.
|
Dissolution, liquida
tion
|
1 L'Assemblée générale peut décider en tout temps de la dissolution et de la liquidation de la Société en conformité avec les prescriptions légales et
statutaires.
|
|
2 The liquidation shall be effected by the Board of Directors, unless the General Meeting of Shareholders appoints other persons as liquidators.
|
2 La liquidation a lieu par les soins du Conseil d'administration, à moins que l'Assemblée générale ne désigne d'autres liquidateurs.
|
|||
3 The liquidation of the Company shall be effected pursuant to applicable law. The liquidators shall be entitled to sell assets (real estate included) in
private transactions.
|
3 La liquidation de la Société s'effectue conformément au droit applicable. Les liquidateurs sont autorisés à vendre des actifs (immeubles y compris) de gré
à gré.
|
|||
4 Upon discharge of all liabilities of the Company, the assets shall be distributed to the shareholders in proportion to the share capital, unless these
articles of association provide otherwise.
|
4 Après paiement des dettes de la Société, l'actif est réparti entre les actionnaires au prorata du capital-actions, à moins que les présents statuts n'en
disposent autrement.
|
Section 7
Notices, Communications
|
Section 7
Communications, organe de publication
|
|||
Article 35
|
Article 35
|
|||
Notices, Communi
cations
|
1 The official means of publication of the Company shall be the Swiss Official Gazette of Commerce.
|
Communications,
organe de publica
tion
|
1 L'organe de publication de la Société est la Feuille officielle suisse du commerce.
|
|
2 To the extent that personal notification is not mandated by law, all communications to the shareholders shall be deemed valid if published in the Swiss
Official Gazette of Commerce. Written communications by the Company to its shareholders shall be sent by ordinary mail to the last address of the shareholder or authorized recipient entered in the share register. If neither these articles of
association nor the law mandatorily require a communication to be in written form, the Company can validly send communications to the shareholders to the last e-mail address of the shareholder or authorized recipient communicated to the
Company, through the banking system, electronically, by publication in the Swiss Official Gazette of Commerce or in any other way. To comply with a written form, a facsimile or electronic copy of a signature shall be sufficient.
|
2 Dans la mesure où la loi n’exige pas de notification personnelle, toutes les communications aux actionnaires publiées dans la Feuille officielle suisse du
commerce seront réputées valides. Les communications écrites adressées par la Société à ses actionnaires seront envoyées par courrier ordinaire à la dernière adresse de l’actionnaire ou de son bénéficiaire autorisé qui figure sur le registre
des actions. Si ni la loi ni les présents statuts n'imposent qu'une communication revête la forme écrite, la Société peut valablement envoyer une telle communication aux actionnaires par courriel, à la dernière adresse e-mail de l’actionnaire
ou de son bénéficiaire autorisé communiquée à la Société, par l'intermédiraire du système bancaire, électroniquement, par publication dans la Feuille officielle suisse du commerce ou de toute autre manière. Un téléfax ou une copie
électronique de la signature suffisent pour se conformer à la forme écrite.
|
|||
Section 8
Authoritative Language
|
Section 8
Langue faisant foi
|
|||
Article 36
|
Article 36
|
|||
Authoritative Lan
guage
|
In the event of discrepancies between the French and English version of these articles of association, the French version shall prevail.
|
Langue faisant foi
|
En cas de désaccord entre la version française et la version anglaise, la version française des présents statuts prévaut.
|
ADC Therapeutics SA
|
Homburger AG
|
Biopôle
|
Prime Tower
|
Route de la Corniche 3 B
|
Hardstrasse 201 | CH–8005 Zurich
|
1066 Epalinges
|
|
Switzerland
|
T +41 43 222 10 00
|
F +41 43 222 15 00
|
|
lawyers@homburger.ch
|
|
I. |
Basis of Opinion
|
(i) |
an electronic copy of the Registration Statement; and
|
(ii) |
an electronic copy of the articles of association (statuts) of the Company, the form of which is filed as Exhibit 3.1 to the Registration Statement (the Articles of
Association).
|
|
II. |
Assumptions
|
(a) |
all documents produced to us as originals are authentic and complete, and all documents produced to us as copies (including, without limitation, electronic copies) conform to the original;
|
(b) |
all documents produced to us as originals and the originals of all documents produced to us as copies were duly executed and certified, as applicable, by the individuals purported to have executed or certified, as the case may be, such
documents;
|
(c) |
all documents produced to us in draft form will be executed in the form of the draft submitted to us;
|
(d) |
each party to the Documents is a corporation or other legal entity duly organized and validly existing and in good standing (if applicable) under the laws of the jurisdiction of its incorporation and|or establishment and none of the
parties to the Documents (other than the Company) has passed or, until the issuance of all Common Shares, will have passed a voluntary winding-up resolution; no petition has been, or, until the issuance of all Common Shares, will be presented
or order made by a court for the winding-up, dissolution, bankruptcy or administration of any party (other than the Company); and no receiver, trustee in bankruptcy, administrator or similar officer has been or, until the issuance of all
Common Shares, will have been appointed in relation to any of the parties (other than the Company) or any of their assets or revenues;
|
(e) |
to the extent relevant for purposes of this opinion, any and all information contained in the Docu-ments is and will be true, complete and accurate at all relevant times;
|
(f) |
no laws (other than those of Switzerland) affect any of the conclusions stated in this opinion;
|
(g) |
the Registration Statement is unchanged and correct, complete and up-to-date and in full force and effect as of the date hereof and no changes have been made which should have been or should be reflected in the Registration Statement as of
the date hereof;
|
(h) |
prior to the issuance of any Common Shares, the board of directors of the Company will have duly authorized the issuance and sale of such Common Shares and will have validly excluded the pre-emptive rights of the existing shareholders for
purposes of offering and selling the Common Shares as contemplated in the Registration Statement, and such authorization will not have been amended and will be in full force and effect until the issuance of all Common Shares;
|
(i) |
the Company has not entered and will not enter into any transaction which could be construed as repayment of share capital (réstitution des versements) and has not undertaken and will not undertake
an acquisition in kind (reprise des biens) or intended acquisition in kind (reprise des biens envisagée) without complying with the formal procedure set forth
in article 628 of the Swiss Code of Obligations; and
|
(j) |
all authorizations, approvals, consents, licenses, exemptions, other than as required by mandatory Swiss law applicable to the Company or the Articles of Association, and other requirements for the filing of the Registration Statement or
for any other activities carried on in view of, or in connection with, the performance of the obligations expressed to be undertaken by the Company in the Registration Statement have been duly obtained or fulfilled in due time and are and
will remain in full force and effect, and any related conditions to which the parties thereto are subject have been satisfied.
|
|
III. |
Opinion
|
|
IV. |
Qualifications
|
(a) |
The lawyers of our firm are members of the Zurich bar and do not hold themselves out to be experts in any laws other than the laws of Switzerland. Accordingly, we are opining herein as to Swiss law only and we express no opinion with
respect to the applicability or the effect of the laws of any other jurisdiction to or on the matters covered herein.
|
(b) |
The exercise of voting rights and rights related thereto with respect to any Common Shares is only permissible after registration in the Company’s share register as a shareholder with voting rights in accordance with the provisions of, and
subject to the limitations provided in, the Articles of Association.
|
(c) |
We express no opinion as to whether the Registration Statement is accurate, true, correct, complete or not misleading. In particular, and without limitation to the foregoing, we express no opinion on whether the Registration Statement
provides sufficient information for investors to reach an informed assessment of the Company, any companies within the Company’s consolidation perimeter and the Common Shares.
|
(d) |
We express no opinion as to regulatory matters or as to any commercial, accounting, calculating, auditing or other non-legal matter.
|
ADC Therapeutics SA
|
||
By:
|
/s/ Michael Forer
|
|
Name:
|
Michael Forer
|
|
Title:
|
Vice Chairman & EVP
|
|
Genmab A/S
|
||
By:
|
/s/ Birgitte Stephensen
|
|
Name:
|
Birgitte Stephensen
|
|
Title:
|
SVP, IPR & Legal
|
COMPANY:
|
||
ADC THERAPEUTICS SA
|
||
By:
|
/s/ Michael Forer
|
|
Name:
|
Michael Forer | |
Title:
|
Vice Chairman & EVP
|
INVESTORS:
|
|||
DEERFIELD PARTNERS, L.P.
|
|||
By:
|
Deerfield Mgmt, L.P.,
|
||
its General Partner
|
|||
By:
|
J.E. Flynn Capital, LLC,
|
||
its General Partner
|
|||
By:
|
/s/ David J. Clark
|
||
Name:
|
David J. Clark
|
||
Title:
|
Authorized Signatory
|
DEERFIELD PRIVATE DESIGN FUND IV, L.P.
|
|||
By: Deerfield Mgmt IV, L.P., General Partner
|
|||
By: J.E. Flynn Capital IV, LLC, General Partner
|
|||
By:
|
/s/ David J. Clark
|
||
Name:
|
David J. Clark
|
||
Title:
|
Authorized Signatory
|
Name of Subsidiary
|
Jurisdiction of Organization
|
ADC Therapeutics America, Inc.
|
United States
|
ADC Therapeutics (UK) Limited
|
England
|