☒ | ANNUAL REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware
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52-2154066
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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2910 Seventh Street, Berkeley,
California 94710
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(510) 204-7200
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(Address of principal executive offices, including zip code)
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(Telephone number)
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Title of each class
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Name of each exchange on which registered
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Common Stock, $0.0075 par value Preferred Stock Purchase Rights
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The NASDAQ Stock Market, LLC
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PART I
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Item 1.
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1
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Item 1A.
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20
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Item 1B.
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38
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Item 2.
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38
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Item 3.
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38
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Item 4.
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38
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38
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PART II
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Item 5.
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39
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Item 6.
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41
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Item 7.
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42
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Item 7A.
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60
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Item 8.
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61
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Item 9.
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61
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Item 9A.
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61
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Item 9B.
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62
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PART III
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Item 10.
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64
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Item 11.
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64
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Item 12.
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64
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Item 13.
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64
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Item 14.
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64
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PART IV
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Item 15.
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65
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66
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F-1
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i
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· | Complete pivotal clinical development for gevokizumab, our lead product candidate, in Behçet’s disease uveitis, a rare ocular indication. Upon the receipt of successful primary endpoint data from the EYEGUARD-B study in patients with Behçet’s disease uveitis, we will seek guidance from the FDA to determine the requirements necessary to support a BLA in this rare indication. We believe positive EYEGUARD-B results, combined with the results obtained by Servier and our independent Phase 2 studies, will be compelling and warrant the submission of a BLA for Behçet’s disease uveitis. The FDA may require us to conduct a confirmatory study in patients with Behçet’s disease uveitis to support a BLA filing in this indication; therefore we initiated the EYEGUARD-US study. Depending upon the FDA’s feedback regarding what data is required to support a BLA filing for Behçet’s disease uveitis, we hope to be able to file the application shortly after our pre-BLA meeting. This strategy was designed to accelerate our path to commercialization. |
· | Complete Phase 3 clinical development for gevokizumab in NIU. With Servier, we launched the global gevokizumab Phase 3 clinical development program, named EYEGUARD™, in 2012. The global program includes two Phase 3 trials in active and controlled NIU (EYEGUARD-A and EYEGUARD-C, respectively) and a Phase 3 trial outside the United States in patients who suffer from Behçet’s disease uveitis (EYEGUARD-B). The EYEGUARD-A study defines active NIU as a vitreous haze score of equal to or greater than two on the Standardization of Uveitis Nomenclature (“SUN”)/NEI scale. The vitreous is a normally transparent gel that fills the eyeball behind the lens, and vitreous haze is the clouding of that gel. The EYEGUARD-C study is designed to determine if physicians can reduce or eliminate corticosteroid use from NIU patients without causing their disease to flare, or exacerbate. EYEGUARD-A and -C are ongoing and continue to enroll patients. The EYEGUARD-B study is also designed to determine if physicians can reduce or eliminate corticosteroid use in Behçet’s disease patients without causing an acute exacerbation of their uveitis. In addition to establishing efficacy, we believe these trials have been designed to provide data necessary to meet the minimum FDA requirements for demonstrating safety for ophthalmic indications: at least 300 patients must be treated for at least six months and 100 patients for one year at the to-be-marketed dose. |
●
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Advance a Phase 3 program in PG, a rare skin disease classified under the broader indication of neutrophilic dermatoses.
In late 2013, we launched a pilot study to determine gevokizumab’s ability to treat acute inflammatory PG, one of several rare skin diseases classified under the broader cluster of neutrophilic dermatoses. We designed the study to enroll as many as four patients to receive gevokizumab 60mg, dosed once monthly for three months. After this cohort completed one dose, we reviewed the data and elected not to proceed to a higher dosing regimen, as the patients were responding to gevokizumab. Three patients showed improvement in ulcer size by Day 28. One patient had total resolution of the ulcer by Day 84; a second patient had 93% improvement in ulcer size by Day 56. Two additional patients were enrolled in the pilot program. Today, four of the six patients in our pilot study are enrolled in an extension study, and three have received additional therapy with gevokizumab, with similar results. One patient has not exacerbated after the initial gevokizumab treatment over one year ago. In November 2014, we launched the first of two Phase 3 clinical trials and are in the process of completing the regulatory filings and clinical site identification to initiate the second study.
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· | Continue to assess gevokizumab’s ability to treat a variety of diseases. In April 2013, NEI, a division of NIH, opened its noninfectious, active, anterior scleritis trial for patient enrollment. The open-label single-arm Phase 1/2 study is designed to assess the safety and potential efficacy of gevokizumab in up to 10 patients experiencing non-infectious, active, anterior scleritis, which is the inflammation of the sclera (the fibrous white membrane surrounding the eyeball excluding the cornea). |
· | Establish commercial-scale manufacturing for gevokizumab . In August 2012, Servier and we announced an agreement with Boehringer Ingelheim to transfer XOMA's technology and processes for the validation of our technology and processes in preparation for the commercial manufacture of gevokizumab. Boehringer Ingelheim has completed Good Manufacturing Practices (“GMP”) runs with successful biological comparability, including all process validation batches of the XOMA processes. Boehringer Ingelheim is making preparations for the production of gevokizumab commercial batches at its facility in Biberach, Germany. |
· | Advance our proprietary pipeline candidates and generate revenues from our proprietary technologies. We continue to develop assets in our proprietary pipeline, primarily focusing on the development of allosteric modulating monoclonal antibodies. Our most advanced program, which targets the insulin receptor, has generated three new classes of fully human monoclonal antibodies known as Selective Insulin Receptor Modulators (“SIRMs”) . These allosteric modulating antibodies activate (“XMetA”), sensitize (“XMetS”) or deactivate/antagonize (“XMetD”) the insulin receptor in vivo . XMetA and XMetS represent the potential for distinct, new therapeutic approaches for the treatment of patients with diabetes. Separate studies of XMetA and XMetS have demonstrated reduced fasting blood glucose levels and improved glucose tolerance in animal models of diabetes. We intend to out-license the insulin receptor-activating drug candidate(s) for development in diabetes. |
· | Complete current biodefense contracts . To date, we have been awarded four contracts totaling approximately $120 million from NIAID to support development of XOMA 3AB and several additional product candidates for the treatment of botulism poisoning with botulinum toxin serotypes A, B and E, as well as C and D. |
●
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Gevokizumab
is a proprietary
potent humanized monoclonal antibody with unique allosteric modulating properties that has the potential to treat patients with a wide variety of inflammatory diseases.
Gevokizumab binds strongly to IL-1 beta, a pro-inflammatory cytokine involved in NIU and Behçet’s disease uveitis, PG, active non-infectious anterior scleritis, AIED, cardiovascular disease, diseases under the neutrophilic dermatoses designation, Schnitzler syndrome and other diseases. By binding to IL-1 beta, gevokizumab modulates the activation of the IL-1 receptor, thereby preventing the cellular signaling events that produce inflammation. Based on its binding properties, specificity for IL-1 beta and its half-life (the time it takes for the amount administered to be reduced by one-half) in the body, gevokizumab may provide convenient dosing of once per month.
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●
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XMet: XOMA Metabolic Activating, Sensitizing and Deactivating/Antagonizing Antibodies.
Insulin receptor-activating antibodies, such as XMetA, are designed to provide long-acting reduction of hyperglycemia in Type 2 diabetic patients, potentially reducing the advancement to a number of insulin injections needed to control their blood glucose levels. Insulin receptor-sensitizing antibodies, such as XMetS, are being evaluated to reduce insulin resistance and could enable diabetic patients to use their own insulin more effectively to control blood glucose levels. Insulin receptor-deactivating/antagonizing antibodies, such as XOMA 358, are in development to treat several diseases that result from the over-production or abnormal regulation to insulin. There are three rare disease indications that may benefit from XOMA 358 that are of greatest interest to us:
CHI, post-meal hypoglycemia in post-gastric bypass surgery patients and possibly certain insulinomas
. XOMA 358 has successfully completed Phase 1 testing, and we are exploring clinical trial designs to further advance XOMA 358.
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●
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XOMA’s antibotulinum toxin program
has multiple antibody candidates that are in development. Botulinum toxins Types A, B, C, D, and E cause paralysis and are potential bioterrorism threats. XOMA 3AB is a multi-antibody product designed to neutralize the most potent of the botulinum toxins, Type A. XOMA 3E is a multi-antibody product designed to neutralize another of the most prevalent of the botulinum toxins, Type E. XOMA CD is a multi-antibody product directed to BoNT/C and BoNT/D, and is our first divalent product directed simultaneously against two serotypes of botulinum toxin, Types C and D. The antibodies are designed to bind to each toxin, neutralize them, and enhance the clearance of the toxin from the body. The use of multiple antibodies increases the likelihood of clearing the harmful toxins by providing specific protection against each toxin type. In contrast to existing agents that treat botulism, XOMA uses advanced human monoclonal antibody technologies in an effort to achieve superior safety, potency and efficacy and avoid life-threatening immune reactions associated with animal-derived products. NIAID has completed a Phase 1 trial of XOMA 3AB
with no product-related serious adverse events.
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●
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XOMA 629
is a topical anti-bacterial formulation of a peptide derived from bactericidal/permeability-increasing protein (“BPI”), an integral part of the protective human immune system. In 2012, XOMA entered into a license agreement with Margaux Biologics, Inc. (“Margaux”), under which XOMA transferred its rights, title, and interest in BPI. As consideration for the transferred assets and licenses, Margaux issued shares of its common stock to XOMA, representing an amount of capital stock equal to 7% of the then outstanding capital stock of Margaux. Under the terms of this agreement, we may receive milestone payments aggregating up to $5.6 million and low- to mid-single-digit royalties on future sales of products subject to this license.
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●
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Preclinical Product Pipeline:
We are pursuing additional opportunities to further broaden our preclinical product pipeline, including internal discovery programs.
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· | Therapeutic Antibodies with Takeda: Since 2006, Takeda has been a collaboration partner for therapeutic monoclonal antibody discovery and development against multiple targets selected by them. In February 2009, we expanded our existing collaboration to provide Takeda with access to multiple antibody technologies, including a suite of research and development technologies and integrated information and data management systems. We may receive potential milestones and royalties on sales of antibody products in the future. |
· | Therapeutic Antibodies with Novartis In November 2008, we restructured our product development collaboration with Novartis, which was entered into in 2004 with Novartis (then Chiron Corporation). Under the restructured agreement, Novartis received control over the two ongoing programs relating to CD40 and prolactin receptor. Control of the prolactin receptor antibody program was returned to us in 2014. We may, in the future, receive milestones and/or double-digit royalty rates for the CD40 antibody program and options to develop or receive royalties from four additional programs. |
· | ADAPT™ (Antibody Discovery Advanced Platform Technologies): proprietary phage display libraries integrated with yeast and mammalian display to enable antibody discovery; |
· | ModulX™: technology that enables positive and negative modulation of biological pathways using allosterically modulating antibodies; and |
· | OptimX™: technologies used for optimizing biophysical properties of antibodies, including affinity, immunogenicity, stability and manufacturability. |
· | Antibody Discovery Technologies: We use human antibody phage display libraries, integrated with yeast and mammalian display, which we call ADAPT™ Integrated Display, in our discovery of therapeutic candidates. We offer access to this platform, including novel phage libraries developed internally, as part of our collaboration business. We believe access to ADAPT™ Integrated Display offers a number of benefits to us and our collaboration partners because it enables us to combine the diversity of phage libraries with accelerated discovery due to rapid immunoglobulin (“IgG”) reformatting and Fluorescence-Activated Cell Sorting (“FACS”) based screening using yeast and mammalian display. This increases the probability of technical and business success in finding rare and unique functional antibodies directed to targets of interest. |
· | ModulX™ technology: ModulX™ technology allows modulation of biological pathways using monoclonal antibodies and offers insights into regulation of signaling pathways, homeostatic control, and disease biology. Using ModulX™, XOMA is generating product candidates with novel mechanisms of action that specifically alter the kinetics of interaction between molecular constituents (e.g. receptor-ligand). ModulX™ technology enables expanded target and therapeutic options and offers a unique approach in the treatment of disease. |
· | OptimX™ technologies: |
· | Flexible Manufacturing: This patented technology relates to a flexible arrangement of mobile clean rooms (“MCRs”) within a manufacturing facility, with each MCR providing a portable, self-contained environment that allows for drug development. The facility design allows MCRs to connect easily and quickly to a central supply of utilities such as air, water, and electricity. This unique arrangement facilitates flexible manufacturing and eliminates change-over downtime. This translates into significantly reduced capital expenditures, production costs, and maintenance costs while offering meaningful time advantages over conventional manufacturing facilities. When MCRs are not in use, they can be easily moved to cleaning/refurbishing areas and prepared MCRs can be "plugged in" for manufacturing. The flexible manufacturing system can be applied to fields as diverse as pharmaceuticals, biologics, and electronics. |
Product/Candidate
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Competitors
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Gevokizumab
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AbbVie Inc.
Biovitrum AB
Allergan
Novartis AG
pSivida
Regeneron Pharmaceuticals, Inc.
Santen Pharmaceutical Co., Ltd.
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XOMA 3AB
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Emergent BioSolutions, Inc.
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● | preclinical in vitro and in vivo tests, which must comply with Good Laboratory Practices (“GLP”); |
● | submission to the FDA of an IND which must become effective before clinical trials may commence, and which must be updated annually with a report on development; |
● | completion of adequate and well controlled human clinical trials to establish the safety and efficacy of the product candidate for its intended use; |
● | submission to the FDA of a BLA, which must often be accompanied by payment of a substantial user fee; |
● | FDA pre-approval inspection of manufacturing facilities for current Good Manufacturing Practices, or GMP, compliance and FDA inspection of select clinical trial sites for Good Clinical Practice (“GCP”), compliance; and |
● | FDA review and approval of the BLA and product prescribing information prior to any commercial sale. |
●
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Our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and any amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act will be available as soon as reasonably practicable after such material is electronically filed or otherwise furnished to the SEC. All reports we file with the SEC also can be obtained free of charge via EDGAR through the SEC’s website at http://www.sec.gov.
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●
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Our policies related to corporate governance, including our Code of Ethics applying to our directors, officers and employees (including our principal executive officer and principal financial and accounting officer) that we have adopted to meet the requirements set forth in the rules and regulations of the SEC and its corporate governance principles, are available.
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●
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The charters of the Audit, Compensation and Nominating & Governance Committees of our Board of Directors are available.
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· | terminate or delay clinical trials for one or more of our product candidates; reduce or eliminate certain product development efforts or commercialization efforts; |
· | further reduce our headcount and capital or operating expenditures; or |
· | curtail our spending on protecting our intellectual property. |
· | operations will generate meaningful funds; |
· | additional agreements for product development funding can be reached; |
· | strategic alliances can be negotiated; or |
· | adequate additional financing will be available for us to finance our own development on acceptable terms, or at all. |
· | In December 2010, we entered into a license and collaboration agreement with Servier, to jointly develop and commercialize gevokizumab in multiple indications. Under the terms of the agreement, Servier has worldwide rights to cardiovascular disease and diabetes indications and rights outside the United States and Japan to all other indications, including Behçet’s disease uveitis and other inflammatory and oncology indications. In late 2011, we announced Servier agreed to include the NIU Phase 3 trials under the terms of the collaboration agreement for Behçet’s disease uveitis. We retain development and commercialization rights for NIU and other inflammatory disease and oncology indications in the United States and Japan and have an option to reacquire rights to cardiovascular disease and diabetes indications from Servier in these territories. Should we exercise this option, we will be required to pay an option fee to Servier and partially reimburse a specified portion of Servier’s incurred development expenses. The agreement contains mutual customary termination rights relating to matters such as material breach by either party. Servier may terminate for safety issues, and we may terminate the agreement, with respect to a particular country or the European Patent Organization (“EPO”) member states, for any challenge to our patent rights in that country or any EPO member state, respectively, by Servier. Servier also has a unilateral right to terminate the agreement for the European Union (“EU”) or for non-EU countries, on a country-by-country basis, or in its entirety, in each case with six months’ notice. |
· | In December 2010, we entered into a loan agreement with Servier (the “Servier Loan Agreement”), which provides for an advance of up to €15.0 million and was funded fully in January 2011 with the proceeds converting to approximately $19.5 million at the January 13, 2011, Euro-to-U.S.-dollar exchange rate of 1.3020. This loan is secured by an interest in our intellectual property rights to all gevokizumab indications worldwide, excluding the United States and Japan. The loan has a final maturity date in 2016; however, after a specified period prior to final maturity, the loan is required to be repaid (1) at Servier’s option, by applying up to a significant percentage of any milestone or royalty payments owed by Servier under our collaboration agreement and (2) using a significant percentage of any upfront, milestone or royalty payments we receive from any third-party collaboration or development partner for rights to gevokizumab in the United States and/or Japan. In addition, the loan becomes immediately due and payable upon certain customary events of default. At December 31, 2014, the €15.0 million outstanding principal balance under this Servier Loan Agreement would have equaled approximately $18.2 million using the December 31, 2014 Euro-to-U.S.-dollar exchange rate of 1.216. |
· | clinical development and testing; |
· | manufacturing; |
· | labeling; |
· | storage; |
· | record keeping; |
· | promotion and marketing; and |
· | importing and exporting. |
· | our future filings will be delayed; |
· | our preclinical and clinical studies will be successful; |
· | we will be successful in generating viable product candidates to targets; |
· | we will be able to provide necessary additional data; |
· | results of future clinical trials will justify further development; or |
· | we ultimately will achieve regulatory approval for any of these product candidates. |
· | results of preclinical studies and clinical trials; |
· | information relating to the safety or efficacy of products or product candidates; |
· | developments regarding regulatory filings; |
· | announcements of new collaborations; |
· | failure to enter into collaborations; |
· | developments in existing collaborations; |
· | our funding requirements and the terms of our financing arrangements; |
· | technological innovations or new indications for our therapeutic products and product candidates; |
· | introduction of new products or technologies by us or our competitors; |
· | sales and estimated or forecasted sales of products for which we receive royalties, if any; |
· | government regulations; |
· | developments in patent or other proprietary rights; |
· | the number of shares issued and outstanding; |
· | the number of shares trading on an average trading day; |
· | announcements regarding other participants in the biotechnology and pharmaceutical industries; and |
· | market speculation regarding any of the foregoing. |
· | In March 2004, we announced we had agreed to collaborate with Chiron Corporation (now Novartis) for the development and commercialization of antibody products for the treatment of cancer. In April 2005, we announced the initiation of clinical testing of the first product candidate out of the collaboration, HCD122, an anti-CD40 antibody, in patients with advanced chronic lymphocytic leukemia. In October 2005, we announced the initiation of the second clinical trial of HCD122 in patients with multiple myeloma. In November 2008, we announced the restructuring of this product development collaboration, which involved six development programs including CD40 and prolactin receptor antibody programs. In exchange for cash and debt reduction on our existing loan facility with Novartis, Novartis received control over the CD40 and prolactin receptor antibody programs, as well as the right to expand the development of these programs into additional indications outside of oncology. Novartis has initiated clinical studies to test CFZ533, an anti-CD40 antibody arising from its collaboration with XOMA, in de novo renal transplantation and in Primary Sjögren's Syndrome. Novartis has returned control of the prolactin receptor antibody program to us, and we are evaluating options for its continued development. |
· | In March 2005, we entered into a contract with the National Institute of Allergy and Infectious Diseases (“NIAID”) to produce three monoclonal antibodies designed to protect U.S. citizens against the harmful effects of botulinum neurotoxin used in bioterrorism. In July 2006, we entered into an additional contract with NIAID for the development of an appropriate formulation for human administration of these three antibodies in a single injection. In September 2008, we announced we had been awarded an additional contract with NIAID to support our on-going development of drug candidates toward clinical trials in the treatment of botulism poisoning. In October 2011, we announced we had been awarded an additional contract with NIAID to develop broad-spectrum antitoxins for the treatment of human botulism poisoning. |
· | We have licensed our bacterial cell expression technology, a set of enabling technologies used to discover and screen, as well as develop and manufacture, recombinant antibodies and other proteins for commercial purposes, to over 60 companies. As of March 9, 2015, we were aware of three products manufactured using this technology that have received FDA approval: Genentech’s LUCENTIS® (ranibizumab injection) for treatment of neovascular wet age-related macular degeneration, Macular Edema Following Vein Occulsion, Diabetic Macular Edema, and Diabetic Retinopathy in patients with Diabetic Macular Edema; UCB’s CIMZIA® (certolizumab pegol) for treatment of Crohn’s disease and rheumatoid arthritis; and Pfizer’s TRUMENBA®, a meningococcal group B vaccine. In the third quarter of 2009, we sold our LUCENTIS royalty interest to Genentech. In the third quarter of 2010, we sold our CIMZIA royalty interest. We anticipate receiving a fraction of a percentage royalty on sales of TRUMENBA. |
· | In August 2012, Servier and we announced an agreement with Boehringer Ingelheim to transfer XOMA's technology and processes for the validation of our technology and processes in preparation for the commercial manufacture of gevokizumab. Boehringer Ingelheim has completed GMP runs with successful biological comparability, including all process validation batches of the XOMA processes. Boehringer Ingelheim is making preparations for the production of gevokizumab commercial batches at its facility in Biberach, Germany. |
· | significantly greater financial resources; |
· | larger research and development and marketing staffs; |
· | larger production facilities; |
· | entered into arrangements with, or acquired, biotechnology companies to enhance their capabilities; or |
· | extensive experience in preclinical testing and human clinical trials. |
· | Novartis markets and is developing ILARIS® (canakinumab, ACZ885), a fully human monoclonal antibody that selectively binds to and neutralizes IL-1 beta. Since 2009, canakinumab has been approved in over 50 countries for the treatment of children and adults suffering from Cryopyrin-Associated Periodic Syndrome (“CAPS”). The product is indicated in the U.S. for the treatment of CAPS in patients over four years of age, including familial cold auto-inflammatory syndrome (“FCAS”) and Muckle-Wells syndrome (“MWS”), as well as for active systemic juvenile idiopathic arthritis (“SJIA”) in patients aged two years and older. In the EU, canakinumab is indicated for the treatment of FCAS, MWS, neonatal-onset multisystem inflammatory disease (“NOMID”)/ chronic infantile neurological cutaneous articular syndrome (“CINCA syndrome”), severe forms of FCAS/familial cold urticarial (“FCU”) presenting with signs and symptoms beyond cold-induced urticaria skin rash, for the symptomatic treatment of adults with frequent gouty arthritis attacks, and for SJIA in patients aged two years and above who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs and systemic corticosteroids. In Japan, canakinumab is indicated for the treatment of CAPS and associated autoinflammatory symptoms, including FCAS, MWS and NOMID. Novartis also is pursuing other diseases in which IL-1 beta may play a prominent role, such as: systemic secondary prevention of cardiovascular events; hereditary periodic fever (familial Mediterranean fever (“FMF”)); chronic obstructive pulmonary disorder (“COPD”); osteoarthritis; urticarial vasculitis; tumor necrosis factor receptor-associated periodic syndrome (“TRAPS”); xerophthalmia; Schnitzler syndrome; polymyalgia rheumatica; hyperimmunoglobulinemia D (hyper-IgD) and periodic fever syndrome (“HIDS”); and abdominal aortic aneurysm (“AAA”). |
· | Regeneron markets and is developing ARCALYSTt® (rilonacept), an interleukin-1 blocker currently indicated in the U.S. for the treatment of CAPS, including FCAS and MWS in adults and children 12 and older. Rilonacept is also approved, but not marketed, in the EU for the same patient population. |
· | In 2008, Swedish Orphan Biovitrum obtained from Amgen the global exclusive rights to Kineret® (anakinra) for rheumatoid arthritis as currently indicated in its label. In November 2009, the agreement regarding Swedish Orphan Biovitrum’s Kineret license was expanded to include certain orphan indications. Kineret is an IL-1 receptor antagonist (IL-1ra) that has been evaluated in multiple IL- 1-mediated diseases, including indications we are considering for gevokizumab. In addition to other on-going studies, a proof-of concept clinical trial investigating Kineret in patients with a certain type of myocardial infarction, or heart attack, has been completed in the United Kingdom. In January 2013, Biovitrum obtained FDA approval for NOMID, a severe form of CAPS. In November 2013, Kineret was approved by the European Commission for the treatment of CAPS. Shanghai CP Guojian Pharmaceutical is developing an injectable formulation of recombinant human IL-1Ra, presumed to be a follow-on biologic version of anakinra, for the potential treatment of rheumatoid arthritis. In February 2010, an NDA was filed with the China Food and Drug Administration (“SFDA”); in January 2012, supplemental materials were required by the SFDA to conclude the review. |
· | The following companies have completed or are conducting or planning Phase 3 clinical trials of the following products for the treatment of noninfectious intermediate, posterior or pan-uveitis: AbbVie - HUMIRA® (adalimumab); Novartis - Myfortic® (mycophenalate sodium); Santen Pharmaceutical Co., Ltd. - Opsiria® (intravitreal sirolimus); pSivida Corp. - Fluocinolone Acetonide Intravitreal; and Allergan - Ozurdex® (dexamethasone). |
· | Emergent Biosolutions Inc. has a contract with the U.S. Department of Health & Human Services, expected to be worth $423.0 million, to manufacture and supply an equine heptavalent botulism anti-toxin. In March 2013, the product was approved by the FDA. |
· | imposition of government controls; |
· | export license requirements; |
· | political or economic instability; |
· | trade restrictions; |
· | changes in tariffs; |
· | restrictions on repatriating profits; |
· | exchange rate fluctuations; and |
· | withholding and other taxation. |
· | prevent our competitors from duplicating our products; |
· | prevent our competitors from gaining access to our proprietary information and technology; or |
· | permit us to gain or maintain a competitive advantage. |
· | whether any pending or future patent applications held by us will result in an issued patent, or that if patents are issued to us, that such patents will provide meaningful protection against competitors or competitive technologies; |
· | whether competitors will be able to design around our patents or develop and obtain patent protection for technologies, designs or methods that are more effective than those covered by our patents and patent applications; or |
· | the extent to which our product candidates could infringe on the intellectual property rights of others, which may lead to costly litigation, result in the payment of substantial damages or royalties, and/or prevent us from using technology that is essential to our business. |
· | require certain procedures to be followed and time periods to be met for any stockholder to propose matters to be considered at annual meetings of stockholders, including nominating directors for election at those meetings; and |
· | authorize our Board of Directors to issue up to 1,000,000 shares of preferred stock without stockholder approval and to set the rights, preferences and other designations, including voting rights, of those shares as the Board of Directors may determine. |
Name
|
Age
|
Title
|
||
John Varian
|
55
|
Chief Executive Officer
|
||
Patrick J. Scannon, M.D., Ph.D.
|
67
|
Executive Vice President and Chief Scientific Officer
|
||
Paul D. Rubin, M.D.
|
61
|
Senior Vice President, Research and Development and Chief Medical Officer
|
||
Fred Kurland
|
64
|
Vice President, Finance, Chief Financial Officer, and Secretary
|
||
Tom Klein
|
53
|
Vice President, Chief Commercial Officer
|
Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities |
|
Price Range
|
|||||||
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High
|
Low
|
||||||
|
|
|
||||||
2014
|
|
|
||||||
First Quarter
|
$
|
9.57
|
$
|
4.77
|
||||
Second Quarter
|
$
|
5.54
|
$
|
3.42
|
||||
Third Quarter
|
$
|
4.95
|
$
|
3.66
|
||||
Fourth Quarter
|
$
|
5.95
|
$
|
3.50
|
||||
2013
|
||||||||
First Quarter
|
$
|
3.67
|
$
|
2.43
|
||||
Second Quarter
|
$
|
4.40
|
$
|
3.02
|
||||
Third Quarter
|
$
|
5.53
|
$
|
3.61
|
||||
Fourth Quarter
|
$
|
7.45
|
$
|
3.67
|
As of
December 31, |
XOMA
Corporation
|
Nasdaq
Composite
Index
|
AMEX
Biotechnology
Index
|
|||||||||
2009
|
$
|
100.00
|
$
|
100.00
|
$
|
100.00
|
||||||
2010
|
$
|
48.86
|
$
|
116.91
|
$
|
137.73
|
||||||
2011
|
$
|
10.95
|
$
|
114.81
|
$
|
115.85
|
||||||
2012
|
$
|
22.86
|
$
|
133.07
|
$
|
164.21
|
||||||
2013
|
$
|
64.10
|
$
|
184.06
|
$
|
247.36
|
||||||
2014
|
$
|
34.19
|
$
|
208.71
|
$
|
365.04
|
|
Year Ended December 31,
|
|||||||||||||||||||
|
2014
|
2013
|
2012
|
2011
|
2010
|
|||||||||||||||
|
(In thousands, except per share amounts)
|
|||||||||||||||||||
Consolidated Statement of Operations Data
|
|
|
|
|
|
|||||||||||||||
Total revenues
(1)
|
$
|
18,866
|
$
|
35,451
|
$
|
33,782
|
$
|
58,196
|
$
|
33,641
|
||||||||||
Total operating costs and expenses
|
100,614
|
93,328
|
85,332
|
92,151
|
100,663
|
|||||||||||||||
Restructuring costs
|
84
|
328
|
5,074
|
-
|
82
|
|||||||||||||||
Loss from operations
|
(81,832
|
)
|
(58,205
|
)
|
(56,624
|
)
|
(33,955
|
)
|
(67,104
|
)
|
||||||||||
Other income (expense), net
(2)
|
43,531
|
(65,867
|
)
|
(14,515
|
)
|
1,227
|
(1,625
|
)
|
||||||||||||
Net loss before taxes
|
(38,301
|
)
|
(124,072
|
)
|
(71,139
|
)
|
(32,728
|
)
|
(68,729
|
)
|
||||||||||
Income tax benefit (expense), net
|
-
|
14
|
74
|
(15
|
)
|
(27
|
)
|
|||||||||||||
Net loss
|
$
|
(38,301
|
)
|
$
|
(124,058
|
)
|
$
|
(71,065
|
)
|
$
|
(32,743
|
)
|
$
|
(68,756
|
)
|
|||||
Basic net loss per share of common stock
|
$
|
(0.36
|
)
|
$
|
(1.43
|
)
|
$
|
(1.10
|
)
|
$
|
(1.04
|
)
|
$
|
(3.69
|
)
|
|||||
Diluted net loss per share of common stock
|
$
|
(0.67
|
)
|
$
|
(1.43
|
)
|
$
|
(1.10
|
)
|
$
|
(1.04
|
)
|
$
|
(3.69
|
)
|
December 31,
|
||||||||||||||||||||
2014
|
2013
|
2012
|
2011
|
2010
|
||||||||||||||||
(In thousands)
|
||||||||||||||||||||
Balance Sheet Data
|
|
|
|
|
|
|||||||||||||||
Cash and cash equivalents
|
$
|
78,445
|
$
|
101,659
|
$
|
45,345
|
$
|
48,344
|
$
|
37,304
|
||||||||||
Short-term investments
|
$
|
-
|
$
|
19,990
|
$
|
39,987
|
$
|
-
|
$
|
-
|
||||||||||
Current assets
|
$
|
83,842
|
$
|
127,060
|
$
|
95,837
|
$
|
62,695
|
$
|
58,880
|
||||||||||
Working capital
|
$
|
47,367
|
$
|
97,415
|
$
|
72,004
|
$
|
42,064
|
$
|
23,352
|
||||||||||
Total assets
|
$
|
89,631
|
$
|
134,782
|
$
|
105,676
|
$
|
78,036
|
$
|
74,252
|
||||||||||
Current liabilities
|
$
|
36,475
|
$
|
29,645
|
$
|
23,833
|
$
|
20,631
|
$
|
35,528
|
||||||||||
Long-term liabilities
(3)
|
$
|
50,057
|
$
|
109,124
|
$
|
60,376
|
$
|
42,394
|
$
|
15,133
|
||||||||||
Redeemable convertible preferred stock, at par value
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
1
|
||||||||||
Accumulated deficit
|
$
|
(1,119,477
|
)
|
$
|
(1,081,176
|
)
|
$
|
(957,118
|
)
|
$
|
(886,053
|
)
|
$
|
(853,310
|
)
|
|||||
Total stockholders' equity (deficit)
|
$
|
3,099
|
$
|
(3,987
|
)
|
$
|
21,467
|
$
|
15,011
|
$
|
23,591
|
(1) | 2010 includes a non-recurring fee of $4.0 million related to the sale of our CIMZIA ® royalty interest to an undisclosed buyer. |
(2) | 2014, 2013 and 2012 include $39.5 million, ($59.9) million and ($9.5) million, respectively, related to the revaluation of contingent warrant liabilities issued in connection with an equity financing in March 2012. 2010 includes a loss associated with the $4.5 million paid in the first quarter of 2010 to the holders of warrants issued in June 2009, upon modification of the terms. |
(3) | 2014, 2013 and 2012 include $26.7 million, $68.7 million and $15.0 million, respectively, related to contingent warrant liabilities in connection with an equity financing in March 2012. The balance in 2014, 2013, 2012, and 2011 includes a €15.0 million loan from Servier, which had a principal balance equal to approximately $18.2 million, $20.6 million, $19.8 million, and $19.4 million as of December 31, 2014, 2013, 2012, and 2011, respectively, and a term loan from GECC, which had a principal balance equal to $5.2 million, $9.4 million, $12.5 million, and $10.0 million as of December 31, 2014, 2013, 2012, and 2011, respectively. |
· | In February 2014, we announced gevokizumab has been granted Orphan Drug Designation by the FDA for the treatment of Pyoderma Gangrenosum. |
· | In March 2014, we reported that despite early positive results in the first of two Phase 2 programs in patients with EOA, the top-line data at Day 168 in that study, as well as data at Day 84 in the second study, were not positive. These results led to our decision not to pursue Phase 3 testing in the broad EOA population. We continue to review the data to determine if there is a subgroup of the EOA population that could benefit from gevokizumab therapy . |
· | In April 2014, we finalized our plans for our gevokizumab Phase 3 program in PG and submitted the protocols to the FDA for any further comments. Final comments from the FDA were received in the third quarter of 2014. The Phase 3 program will include two double-blind, placebo-controlled clinical studies, each of which is designed to enroll 58 patients with active PG. The primary endpoint is the complete closure of the PG target ulcer determined at Day 126 and confirmation of complete closure a minimum of two weeks later at Day 140. |
· | In September 2014, we announced we opened the EYEGUARD-US supplemental clinical study to patients at study sites located in the United States. The objective of this trial is to assess the efficacy and safety of gevokizumab in treating Behçet's disease uveitis. Upon the successful completion of SERVIER’s EYEGUARD-B study, we intend to meet with the FDA to review the Phase 3 EYEGUARD-B data together with the data from the two Behçet’s disease uveitis Phase 2 studies conducted by XOMA and Servier. Should EYEGUARD-B successfully demonstrate that Behçet’s disease uveitis patients receiving gevokizumab took longer to exacerbate than the placebo-treated patients during the tapering of administered steroids, we believe we will be in position to begin the BLA submission process. The supplemental EYEGUARD-US study may be used in one of several ways. It may not be required for the initial BLA submission so that it merely provides further information as to U.S. physicians and patients’ experiences with gevokizumab. It may be required for the FDA’s review of our submission but for informational purposes without being considered a pivotal study. In this case, the study would be unmasked at a predetermined time when we are in a position to submit the BLA. Finally, it may be required by the FDA as a second pivotal study of U.S. Behçet’s disease uveitis patients in order for the Agency to accept our submission. We’ve designed the EYEGUARD-US study to fulfill whatever directive we are given by the FDA. We are prepared to respond as quickly as possible to any of the anticipated outcomes from our pre-BLA meeting. |
· | In October 2014, we announced we have initiated dosing in our Phase 1 study exploring the safety and tolerability of single intravenous dose (“IV”) of XOMA 358, the lead compound from the our XMetD program, in healthy volunteers. The study also will explore the biologic effects of ascending single IV doses of XOMA 358 on glucose and insulin levels, as well as insulin sensitivity. |
· | In November 2014, we announced the pivotal Phase 3 gevokizumab study in patients with active PG, is open for patient enrollment. The objective of the study is to assess the efficacy and safety of gevokizumab in treating the active ulcers caused by this rare and debilitating disease. The Phase 3 randomized, placebo-controlled study will enroll 58 patients with active PG to receive gevokizumab 60 mg or placebo dosed subcutaneously once monthly, in addition to their current treatment regimen of low-dose corticosteroids and/or immunosuppressants. |
· | In July 2014, we completed the transfer of our U.S. marketing rights in ACEON to Symplmed and are no longer selling this drug product. |
· | In September 2014, we granted a non-exclusive license for our innovative design of a manufacturing facility to the Texas A&M University System. The patented technology relates to a flexible arrangement of MCRs within the manufacturing facility, with each MCR providing a portable, self-contained environment for product manufacture. The flexible manufacturing facility design allows MCRs to connect easily and quickly to a central supply of utilities such as air, water, and electricity. The unique arrangement facilitates flexible design and eliminates change-over downtime. This translates into significantly reduced capital expenditures, production costs, and maintenance costs, while offering meaningful time advantages over conventional manufacturing facilities. When MCRs are not in use, they can be easily moved to cleaning/refurbishing areas and prepared MCRs can be "plugged in" for manufacturing. The A&M System will use MCRs for certain government programs at The National Center for Therapeutics Manufacturing (“NCTM”) facility, a multidisciplinary workforce education institution and biopharmaceutical manufacturing center, located at Texas A&M University in College Station, Texas. |
· | In December 2014, we completed a registered direct offering of 8,097,165 shares of our common stock for gross proceeds of $40.0 million to select institutional investors, before deducting underwriting discounts and commissions an estimated offering expenses totaling approximately $2.3 million. In connection with the offering, we issued two year warrants to purchase up to an aggregate of 8,097,165 shares of our common stock at an exercise price of $7.90 per share. |
· | In February 2015, we entered into a Loan and Security Agreement with Hercules in which we borrowed $20.0 million. We used a portion of the proceeds received under the Hercules Loan Agreement to repay existing indebtedness, and we plan to use the remaining proceeds for general corporate purposes. In connection with the Hercules Loan Agreement, we issued a warrant to Hercules which is exercisable for an aggregate of up to 181,268 shares of XOMA common stock at an exercise price of $3.31 per share. |
Year ended December 31,
|
2013-2014
|
2012-2013
|
||||||||||||||||||
2014
|
2013
|
2012
|
Change
|
Change
|
||||||||||||||||
License and collaborative fees
|
$
|
5,683
|
$
|
11,028
|
$
|
5,727
|
$
|
(5,345
|
)
|
$
|
5,301
|
|||||||||
Contract and other revenue
|
13,183
|
24,423
|
28,055
|
(11,240
|
)
|
(3,632
|
)
|
|||||||||||||
Total revenues
|
$
|
18,866
|
$
|
35,451
|
$
|
33,782
|
$
|
(16,585
|
)
|
$
|
1,669
|
Year ended December 31,
|
2013-2014 | 2012-2013 | ||||||||||||||||||
2014
|
2013
|
2012
|
Change
|
Change
|
||||||||||||||||
Servier
|
$
|
3,523
|
$
|
13,568
|
$
|
14,529
|
$
|
(10,045
|
)
|
$
|
(961
|
)
|
||||||||
NIAID
|
9,565
|
9,098
|
11,191
|
467
|
(2,093
|
)
|
||||||||||||||
Other
|
95
|
1,757
|
2,335
|
(1,662
|
)
|
(578
|
)
|
|||||||||||||
Total revenues
|
$
|
13,183
|
$
|
24,423
|
$
|
28,055
|
$
|
(11,240
|
)
|
$
|
(3,632
|
)
|
Year ended December 31,
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
Beginning deferred revenue
|
$
|
6,323
|
$
|
9,724
|
$
|
13,234
|
||||||
Revenue deferred
|
798
|
1,478
|
5,881
|
|||||||||
Revenue recognized
|
(2,246
|
)
|
(4,879
|
)
|
(9,391
|
)
|
||||||
Deferred revenue adjustment
|
(1,847
|
)
|
-
|
-
|
||||||||
Ending deferred revenue
|
$
|
3,028
|
$
|
6,323
|
$
|
9,724
|
Year ended December 31,
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
Earlier stage programs
(1)
|
$
|
28,327
|
$
|
40,840
|
$
|
33,170
|
||||||
Later stage programs
(1)
|
52,421
|
34,011
|
35,297
|
|||||||||
Total
|
$
|
80,748
|
$
|
74,851
|
$
|
68,467
|
(1) | Certain research and development segment reclassifications have been made to previously reported amounts to conform to the current year's presentation. |
Year ended December 31,
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
Internal projects
(1)
|
$
|
51,281
|
$
|
47,489
|
$
|
30,531
|
||||||
Collaborative and contract arrangements
(1)
|
29,467
|
27,362
|
37,936
|
|||||||||
Total
|
$
|
80,748
|
$
|
74,851
|
$
|
68,467
|
(1) | Certain research and development segment reclassifications have been made to previously reported amounts to conform to the current year's presentation. |
Year ended December 31,
|
2013-2014 | 2012-2013 | ||||||||||||||||||
2014
|
2013
|
2012
|
Change
|
Change
|
||||||||||||||||
Interest expense
|
||||||||||||||||||||
Servier loan
|
$
|
2,330
|
$
|
2,152
|
$
|
2,097
|
$
|
178
|
$
|
55
|
||||||||||
GECC term loan
|
1,638
|
2,064
|
1,850
|
(426
|
)
|
214
|
||||||||||||||
Novartis note
|
312
|
362
|
397
|
(50
|
)
|
(35
|
)
|
|||||||||||||
Other
|
23
|
53
|
43
|
(30
|
)
|
10
|
||||||||||||||
Total interest expense
|
$
|
4,303
|
$
|
4,631
|
$
|
4,387
|
$
|
(328
|
)
|
$
|
244
|
Year ended December 31,
|
2013-2014 | 2012-2013 | ||||||||||||||||||
2014
|
2013
|
2012
|
Change
|
Change
|
||||||||||||||||
Other income (expense)
|
||||||||||||||||||||
Unrealized foreign exchange gain (loss)
(1)
|
$
|
2,447
|
$
|
(442
|
)
|
$
|
(329
|
)
|
$
|
2,889
|
$
|
(113
|
)
|
|||||||
Realized foreign exchange gain (loss)
|
-
|
(90
|
)
|
6
|
90
|
(96
|
)
|
|||||||||||||
Unrealized loss on foreign exchange options
|
(355
|
)
|
(127
|
)
|
(714
|
)
|
(228
|
)
|
587
|
|||||||||||
Other
|
(31
|
)
|
462
|
81
|
(493
|
)
|
381
|
|||||||||||||
Total other income (expense)
|
$
|
2,061
|
$
|
(197
|
)
|
$
|
(956
|
)
|
$
|
2,258
|
$
|
759
|
(1)
|
Unrealized foreign exchange gain (loss) for the years ended December 31, 2014, 2013, and 2012 primarily relates to the re-measurement of the €15 million Servier loan.
|
Warrant
Liabilities
|
||||
Balance at December 31, 2011
|
$
|
379
|
||
Initial fair value of warrants issued in March 2012
|
6,390
|
|||
Reclassification of contingent warrant liability to equity upon exercise of warrants
|
(940
|
)
|
||
Net increase in fair value of contingent warrant liabilities upon revaluation
|
9,172
|
|||
Balance at December 31, 2012
|
15,001
|
|||
Reclassification of contingent warrant liability to equity upon exercise of warrants
|
(6,171
|
)
|
||
Net increase in fair value of contingent warrant liabilities upon revaluation
|
61,039
|
|||
Balance at December 31, 2013
|
69,869
|
|||
Initial fair value of warrants issued in December 2014 warrant
|
10,258
|
|||
Reclassification of contingent warrant liability to equity upon exercise of warrants
|
(2,526
|
)
|
||
Net decrease in fair value of contingent warrant liabilities upon revaluation
|
(45,773
|
)
|
||
Balance at December 31, 2014
|
$
|
31,828
|
December 31,
|
2013-2014
|
|||||||||||
2014
|
2013
|
Change
|
||||||||||
Cash and cash equivalents
|
$
|
78,445
|
$
|
101,659
|
$
|
(23,214
|
)
|
|||||
Short-term investments
|
$
|
-
|
$
|
19,990
|
$
|
(19,990
|
)
|
|||||
Working Capital
|
$
|
47,367
|
$
|
97,415
|
$
|
(50,048
|
)
|
Year ended December 31,
|
2013-2014
|
2012-2013
|
||||||||||||||||||
2014
|
2013
|
2012
|
Change
|
Change
|
||||||||||||||||
Net cash used in operating activities
|
$
|
(78,282
|
)
|
$
|
(45,915
|
)
|
$
|
(40,765
|
)
|
$
|
(32,367
|
)
|
$
|
(5,150
|
)
|
|||||
Net cash provided by (used in) investing activities
|
19,675
|
18,840
|
(42,016
|
)
|
835
|
60,856
|
||||||||||||||
Net cash provided by financing activities
|
35,560
|
83,389
|
79,782
|
(47,829
|
)
|
3,607
|
||||||||||||||
Effect of exchange rate changes on cash
|
(167
|
)
|
-
|
-
|
(167
|
)
|
-
|
|||||||||||||
Net (decrease) increase in cash and cash equivalents
|
$
|
(23,214
|
)
|
$
|
56,314
|
$
|
(2,999
|
)
|
$
|
(79,528
|
)
|
$
|
59,313
|
Contractual Obligations
|
Total
|
Less than 1
year
|
1 to 3 years
|
3 to 5 years
|
More than 5
years
|
|||||||||||||||
Operating leases
(1)
|
$
|
28,923
|
$
|
3,428
|
$
|
7,167
|
$
|
7,594
|
$
|
10,733
|
||||||||||
Debt Obligations
(2)
|
||||||||||||||||||||
Principal
|
36,797
|
18,565
|
18,232
|
-
|
-
|
|||||||||||||||
Interest
|
1,926
|
1,711
|
215
|
-
|
-
|
|||||||||||||||
Total
|
$
|
67,646
|
$
|
23,704
|
$
|
25,614
|
$
|
7,594
|
$
|
10,733
|
|
Maturity
|
Carrying
Amount
(in thousands) |
Fair Value
(in thousands) |
Weighted
Average Interest Rate |
||||||||||||
December 31, 2014
|
|
|
|
|||||||||||||
Cash and cash equivalents
|
Daily to 90 days
|
$
|
78,445
|
$
|
78,445
|
0.07
|
%
|
|||||||||
December 31, 2013
|
||||||||||||||||
Cash, cash equivalents, and short-term investments
|
Daily to 90 days
|
$
|
121,649
|
$
|
121,649
|
0.08
|
%
|
Item 9B. | Other Information |
Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters |
(a) | The following documents are included as part of this Annual Report on Form 10-K: |
(1) | Financial Statements: |
(2) | Financial Statement Schedules: |
(3) | Exhibits: |
XOMA CORPORATION
|
||
By:
|
/s/ JOHN VARIAN
|
|
John Varian
Chief Executive Officer and Director
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ John Varian
|
|
Chief Executive Officer (Principal Executive Officer) and Director
|
|
March 11, 2015
|
(John Varian)
|
|
|
|
|
|
|
|
|
|
/s/ Fred Kurland
|
|
Vice President, Finance, Chief Financial Officer and Secretary
|
|
March 11, 2015
|
(Fred Kurland)
|
|
(Principal Financial and Principal Accounting Officer) |
|
|
|
|
|
|
|
/s/ Patrick J. Scannon
|
|
Executive Vice President and Chief Scientific Officer and Director
|
|
March 11, 2015
|
(Patrick J. Scannon)
|
|
|
|
|
|
|
|
|
|
/s/ W. Denman Van Ness
|
|
Chairman of the Board of Directors
|
|
March 11, 2015
|
(W. Denman Van Ness)
|
|
|
|
|
|
|
|
|
|
/s/ William K. Bowes, Jr.
|
|
Director
|
|
March 11, 2015
|
(William K. Bowes, Jr.)
|
|
|
|
|
|
|
|
|
|
|
Director
|
|
March 11, 2015
|
|
(Peter Barton Hutt)
|
|
|
|
|
|
|
|
|
|
/s/ Joseph M. Limber
|
|
Director
|
|
March 11, 2015
|
(Joseph M. Limber)
|
|
|
|
|
|
|
|
|
|
/s/ Kelvin M. Neu
|
|
Director
|
|
March 11, 2015
|
(Kelvin M. Neu)
|
|
|
|
|
|
|
|
|
|
/s/ Timothy P. Walbert
|
|
Director
|
|
March 11, 2015
|
(Timothy P. Walbert)
|
|
|
|
|
|
|
|
|
|
|
Director
|
|
March 11, 2015
|
|
(Jack L. Wyszomierski)
|
|
|
|
|
Report of Independent Registered Public Accounting Firm
|
F-2
|
Consolidated Balance Sheets
|
F-3
|
Consolidated Statements of Comprehensive Loss
|
F-4
|
Consolidated Statements of Stockholders' Equity (Deficit)
|
F-5
|
Consolidated Statements of Cash Flows
|
F-6
|
Notes to the Consolidated Financial Statements
|
F-7
|
Year Ended December 31,
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
Revenues:
|
|
|
|
|||||||||
License and collaborative fees
|
$
|
5,683
|
$
|
11,028
|
$
|
5,727
|
||||||
Contract and other
|
13,183
|
24,423
|
28,055
|
|||||||||
Total revenues
|
18,866
|
35,451
|
33,782
|
|||||||||
Operating expenses:
|
||||||||||||
Research and development
|
80,748
|
74,851
|
68,467
|
|||||||||
Selling, general and administrative
|
19,866
|
18,477
|
16,865
|
|||||||||
Restructuring
|
84
|
328
|
5,074
|
|||||||||
Total operating expenses
|
100,698
|
93,656
|
90,406
|
|||||||||
Loss from operations
|
(81,832
|
)
|
(58,205
|
)
|
(56,624
|
)
|
||||||
Other income (expense):
|
||||||||||||
Interest expense
|
(4,303
|
)
|
(4,631
|
)
|
(4,387
|
)
|
||||||
Other income (expense), net
|
2,061
|
(197
|
)
|
(956
|
)
|
|||||||
Revaluation of contingent warrant liabilities
|
45,773
|
(61,039
|
)
|
(9,172
|
)
|
|||||||
Net loss before taxes
|
(38,301
|
)
|
(124,072
|
)
|
(71,139
|
)
|
||||||
Benefit from income taxes
|
-
|
14
|
74
|
|||||||||
Net loss
|
$
|
(38,301
|
)
|
$
|
(124,058
|
)
|
$
|
(71,065
|
)
|
|||
Basic net loss per share of common stock
|
$
|
(0.36
|
)
|
$
|
(1.43
|
)
|
$
|
(1.10
|
)
|
|||
Diluted net loss per share of common stock
|
$
|
(0.67
|
)
|
$
|
(1.43
|
)
|
$
|
(1.10
|
)
|
|||
Shares used in computing basic net loss per share of common stock
|
107,435
|
86,938
|
64,629
|
|||||||||
Shares used in computing diluted net loss per share of common stock
|
115,333
|
86,938
|
64,629
|
|||||||||
Other comprehensive loss:
|
||||||||||||
Net loss
|
$
|
(38,301
|
)
|
$
|
(124,058
|
)
|
$
|
(71,065
|
)
|
|||
Net unrealized gain (loss) on available-for-sale securities
|
1
|
(9
|
)
|
8
|
||||||||
Comprehensive loss
|
$
|
(38,300
|
)
|
$
|
(124,067
|
)
|
$
|
(71,057
|
)
|
Common Stock
|
Paid-In
|
Accumulated Comprehensive
|
Accumulated
|
Total Stockholders'
(Deficit) Equity
|
||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Income
|
Deficit
|
||||||||||||||||||||
Balance, December 31, 2011
|
35,107
|
$
|
263
|
$
|
900,801
|
$
|
─
|
$
|
(886,053
|
)
|
$
|
15,011
|
||||||||||||
Exercise of stock options, contributions to 401(k) and incentive plans
|
1,089
|
8
|
1,323
|
─
|
─
|
1,331
|
||||||||||||||||||
Release of restricted stock units
|
397
|
─
|
─
|
─
|
─
|
─
|
||||||||||||||||||
Stock-based compensation expense
|
─
|
─
|
4,284
|
─
|
─
|
4,284
|
||||||||||||||||||
Sale of shares of common stock
|
45,288
|
340
|
75,960
|
─
|
─
|
76,300
|
||||||||||||||||||
Issuance of warrants
|
─
|
─
|
(6,335
|
)
|
─
|
─
|
(6,335
|
)
|
||||||||||||||||
Exercise of warrants
|
566
|
4
|
1,929
|
─
|
─
|
1,933
|
||||||||||||||||||
Net loss
|
─
|
─
|
─
|
─
|
(71,065
|
)
|
(71,065
|
)
|
||||||||||||||||
Other comprehensive income
|
─
|
─
|
─
|
8
|
─
|
8
|
||||||||||||||||||
Balance, December 31, 2012
|
82,447
|
615
|
977,962
|
8
|
(957,118
|
)
|
21,467
|
|||||||||||||||||
Exercise of stock options, contributions to 401(k) and incentive plans
|
933
|
7
|
2,213
|
─
|
─
|
2,220
|
||||||||||||||||||
Release of restricted stock units
|
801
|
6
|
(6
|
)
|
─
|
─
|
─
|
|||||||||||||||||
Stock-based compensation expense
|
─
|
─
|
5,099
|
─
|
─
|
5,099
|
||||||||||||||||||
Sale of shares of common stock
|
19,661
|
147
|
82,799
|
─
|
─
|
82,946
|
||||||||||||||||||
Exercise of warrants
|
1,544
|
12
|
8,336
|
─
|
─
|
8,348
|
||||||||||||||||||
Net loss
|
─
|
─
|
─
|
─
|
(124,058
|
)
|
(124,058
|
)
|
||||||||||||||||
Other comprehensive loss
|
─
|
─
|
─
|
(9
|
)
|
─
|
(9
|
)
|
||||||||||||||||
Balance, December 31, 2013
|
105,386
|
787
|
1,076,403
|
(1
|
)
|
(1,081,176
|
)
|
(3,987
|
)
|
|||||||||||||||
Exercise of stock options, contributions to 401(k) and incentive plans
|
1,065
|
11
|
4,515
|
─
|
─
|
4,526
|
||||||||||||||||||
Release of restricted stock units
|
981
|
7
|
(7
|
)
|
─
|
─
|
─
|
|||||||||||||||||
Stock-based compensation expense
|
─
|
─
|
10,772
|
─
|
─
|
10,772
|
||||||||||||||||||
Sale of shares of common stock
|
8,097
|
61
|
37,725
|
─
|
─
|
37,786
|
||||||||||||||||||
Issuance of warrants
|
(10,258
|
)
|
(10,258
|
)
|
||||||||||||||||||||
Exercise of warrants
|
363
|
3
|
2,557
|
─
|
─
|
2,560
|
||||||||||||||||||
Net loss
|
─
|
─
|
─
|
─
|
(38,301
|
)
|
(38,301
|
)
|
||||||||||||||||
Other comprehensive income
|
─
|
─
|
─
|
1
|
─
|
1
|
||||||||||||||||||
Balance, December 31, 2014
|
115,892
|
$
|
869
|
$
|
1,121,707
|
$
|
-
|
$
|
(1,119,477
|
)
|
$
|
3,099
|
Year Ended December 31,
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
Cash flows from operating activities:
|
|
|
|
|||||||||
Net loss
|
$
|
(38,301
|
)
|
$
|
(124,058
|
)
|
$
|
(71,065
|
)
|
|||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||||||
Depreciation
|
1,856
|
2,575
|
4,124
|
|||||||||
Common stock contribution to 401(k)
|
870
|
828
|
1,134
|
|||||||||
Stock-based compensation expense
|
10,772
|
5,099
|
4,284
|
|||||||||
Accrued interest on interest bearing obligations
|
(1,444
|
)
|
2,284
|
1,186
|
||||||||
Revaluation of contingent warrant liabilities
|
(45,773
|
)
|
61,039
|
9,172
|
||||||||
Restructuring charge related to long-lived assets
|
-
|
-
|
2,460
|
|||||||||
Amortization of debt discount, final payment fee on debt, and debt issuance costs
|
2,707
|
2,470
|
1,958
|
|||||||||
Loss on sale and retirement of property and equipment
|
-
|
281
|
29
|
|||||||||
Unrealized loss on foreign currency exchange
|
(2,280
|
)
|
662
|
295
|
||||||||
Unrealized loss on foreign exchange options
|
355
|
127
|
714
|
|||||||||
Other non-cash adjustments
|
(9
|
)
|
(20
|
)
|
(11
|
)
|
||||||
Changes in assets and liabilities:
|
||||||||||||
Trade and other receivables, net
|
472
|
4,486
|
4,064
|
|||||||||
Prepaid expenses and other assets
|
(662
|
)
|
481
|
(158
|
)
|
|||||||
Accounts payable and accrued liabilities
|
(3,774
|
)
|
2,901
|
4,485
|
||||||||
Deferred revenue
|
(2,983
|
)
|
(3,399
|
)
|
(3,511
|
)
|
||||||
Other liabilities
|
(88
|
)
|
(1,671
|
)
|
75
|
|||||||
Net cash used in operating activities
|
(78,282
|
)
|
(45,915
|
)
|
(40,765
|
)
|
||||||
Cash flows from investing activities:
|
||||||||||||
Purchase of investments
|
-
|
(19,991
|
)
|
(56,970
|
)
|
|||||||
Proceeds from maturities of investments
|
20,000
|
40,000
|
17,000
|
|||||||||
Purchase of property and equipment
|
(325
|
)
|
(1,169
|
)
|
(2,509
|
)
|
||||||
Proceeds from sale of property and equipment
|
-
|
-
|
463
|
|||||||||
Net cash provided by (used in) investing activities
|
19,675
|
18,840
|
(42,016
|
)
|
||||||||
Cash flows from financing activities:
|
||||||||||||
Proceeds from issuance of common stock, net of issuance costs
|
41,442
|
84,338
|
76,498
|
|||||||||
Proceeds from exercise of warrants
|
35
|
2,176
|
993
|
|||||||||
Proceeds from issuance of long-term debt, net of issuance costs
|
-
|
-
|
4,434
|
|||||||||
Principal payments of debt
|
(5,917
|
)
|
(3,125
|
)
|
(2,143
|
)
|
||||||
Net cash provided by financing activities
|
35,560
|
83,389
|
79,782
|
|||||||||
Effect of exchange rate changes on cash
|
(167
|
)
|
-
|
-
|
||||||||
Net (decrease) increase in cash and cash equivalents
|
(23,214
|
)
|
56,314
|
(2,999
|
)
|
|||||||
Cash and cash equivalents at the beginning of the year
|
101,659
|
45,345
|
48,344
|
|||||||||
Cash and cash equivalents at the end of the year
|
$
|
78,445
|
$
|
101,659
|
$
|
45,345
|
||||||
Supplemental Cash Flow Information:
|
||||||||||||
Cash paid during the year for:
|
||||||||||||
Interest
|
$
|
3,009
|
$
|
1,262
|
$
|
1,035
|
||||||
Non-cash investing and financing activities:
|
||||||||||||
Issuance of warrants
|
$
|
10,258
|
$
|
-
|
$
|
6,390
|
||||||
Reclassification of contingent warrant liability to equity upon exercise of warrants
|
$
|
(2,526
|
)
|
$
|
(6,171
|
)
|
$
|
(940
|
)
|
|||
Interest added to principal balances on long-term debt
|
$
|
313
|
$
|
935
|
$
|
1,160
|
||||||
Investment in Symplmed Pharmaceuticals, LLC
|
$
|
-
|
$
|
171
|
$
|
-
|
||||||
Discount on long-term debt
|
$
|
-
|
$
|
-
|
$
|
(55
|
)
|
1. | Description of Business |
2. | Basis of Presentation and Significant Accounting Policies |
December 31,
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
Options for common stock
|
6,666
|
7,087
|
5,603
|
|||||||||
Warrants for common stock
|
2,073
|
15,839
|
13,840
|
|||||||||
Total
|
8,739
|
22,926
|
19,443
|
December 31,
|
||||
2014
|
||||
Numerator
|
|
|||
Net loss before taxes
|
|
|||
Basic
|
$
|
(38,301
|
)
|
|
Adjustment for revaluation of contingent warrant liabilities
|
(39,512
|
)
|
||
Diluted
|
$
|
(77,813
|
)
|
|
Denominator
|
||||
Weighted average shares outstanding used for basic net loss per share
|
107,435
|
|||
Effect of dilutive warrants
|
7,898
|
|||
Weighted average shares outstanding for dilutive net loss per share
|
115,333
|
3. | Consolidated Financial Statement Detail |
December 31,
|
||||||||
2014
|
2013
|
|||||||
Trade receivables, net
|
$
|
2,993
|
$
|
3,731
|
||||
Other receivables
|
316
|
50
|
||||||
Total
|
$
|
3,309
|
$
|
3,781
|
December 31,
|
||||||||
2014
|
2013
|
|||||||
Equipment and furniture
|
$
|
28,638
|
$
|
28,365
|
||||
Buildings, leasehold and building improvements
|
9,343
|
9,316
|
||||||
Construction-in-progress
|
337
|
225
|
||||||
Land
|
310
|
310
|
||||||
38,628
|
38,216
|
|||||||
Less: Accumulated depreciation and amortization
|
(33,508
|
)
|
(31,760
|
)
|
||||
Property and equipment, net
|
$
|
5,120
|
$
|
6,456
|
December 31,
|
||||||||
2014
|
2013
|
|||||||
Incentive compensation
|
$
|
4,295
|
$
|
4,386
|
||||
Accrued payroll and other benefits
|
3,061
|
3,009
|
||||||
Accrued clinical trial costs
|
1,424
|
878
|
||||||
Other
|
1,112
|
1,661
|
||||||
Total
|
$
|
9,892
|
$
|
9,934
|
4. | Collaborative, Licensing and Other Arrangements |
5. | Restructuring Charges |
Facility
Charges
(1)
|
||||
Balance at December 31, 2013
|
$
|
21
|
||
Restructuring charges
|
84
|
|||
Cash payments
|
(128
|
)
|
||
Adjustments
|
23
|
|||
Balance at December 31, 2014
|
$
|
-
|
Facility
Charges
(1)
|
||||
Balance at December 31, 2012
|
$
|
75
|
||
Restructuring charges
|
328
|
|||
Cash payments
|
(434
|
)
|
||
Adjustments
|
52
|
|||
Balance at December 31, 2013
|
$
|
21
|
(1) | Includes moving and relocation costs, and lease payments, net of sublease payments. |
6. | Available-for-Sale and Fair Value Measurements |
December 31,
2014
|
December 31,
2013
|
|||||||
Money Market funds
|
$
|
67,569
|
$
|
82,759
|
||||
U.S. treasury securities
|
-
|
19,989
|
||||||
$
|
67,569
|
$
|
102,748
|
Fair Value Measurements at December 31, 2014 Using
|
||||||||||||||||
Quoted Prices in
Active Markets
for Identical
Assets
|
Significant
Other
Observable
Inputs
|
Significant
Unobservable
Inputs
|
||||||||||||||
(Level 1)
|
(Level 2)
|
(Level 3)
|
Total
|
|||||||||||||
Assets:
|
||||||||||||||||
Money market funds
(1)
|
$
|
67,569
|
$
|
-
|
$
|
-
|
$
|
67,569
|
||||||||
Foreign exchange options
|
-
|
6
|
-
|
6
|
||||||||||||
Total
|
$
|
67,569
|
$
|
6
|
$
|
-
|
$
|
67,575
|
||||||||
Liabilities:
|
||||||||||||||||
Contingent warrant liabilities
|
$
|
-
|
$
|
-
|
$
|
31,828
|
$
|
31,828
|
Fair Value Measurements at December 31, 2013 Using
|
||||||||||||||||
Quoted Prices in
Active Markets
for Identical
Assets
|
Significant
Other
Observable
Inputs
|
Significant
Unobservable
Inputs
|
||||||||||||||
(Level 1)
|
(Level 2)
|
(Level 3)
|
Total
|
|||||||||||||
Assets:
|
||||||||||||||||
Money market funds
(1)
|
$
|
82,759
|
$
|
-
|
$
|
-
|
$
|
82,759
|
||||||||
U.S. treasury securities
|
19,989
|
-
|
-
|
19,989
|
||||||||||||
Foreign exchange options
|
-
|
361
|
-
|
361
|
||||||||||||
Total
|
$
|
102,748
|
$
|
361
|
$
|
-
|
$
|
103,109
|
||||||||
Liabilities:
|
||||||||||||||||
Contingent warrant liabilities
|
$
|
-
|
$
|
-
|
$
|
69,869
|
$
|
69,869
|
(1) | Included in cash and cash equivalents |
December 31,
2014
|
December 31,
2013
|
|||||||
Expected volatility
|
69.6% - 72.9
|
%
|
66.1% - 86.6
|
%
|
||||
Risk-free interest rate
|
0.03% - 0.67
|
%
|
0.10% - 0.80
|
%
|
||||
Expected term
|
0.09 - 2.19 years
|
0.90 - 3.20 years
|
Warrant
Liabilities
|
||||
Balance at December 31, 2011
|
$
|
379
|
||
Initial fair value of warrants issued in March 2012
|
6,390
|
|||
Reclassification of contingent warrant liability to equity upon exercise of warrants
|
(940
|
)
|
||
Net increase in fair value of contingent warrant liabilities upon revaluation
|
9,172
|
|||
Balance at December 31, 2012
|
15,001
|
|||
Reclassification of contingent warrant liability to equity upon exercise of warrants
|
(6,171
|
)
|
||
Net increase in fair value of contingent warrant liabilities upon revaluation
|
61,039
|
|||
Balance at December 31, 2013
|
69,869
|
|||
Initial fair value of warrants issued in December 2014 warrant
|
10,258
|
|||
Reclassification of contingent warrant liability to equity upon exercise of warrants
|
(2,526
|
)
|
||
Net decrease in fair value of contingent warrant liabilities upon revaluation
|
(45,773
|
)
|
||
Balance at December 31, 2014
|
$
|
31,828
|
December 31, 2014
|
December 31, 2013
|
|||||||||||||||
Carrying Amount
|
Fair Value
|
Carrying Amount
|
Fair Value
|
|||||||||||||
Outstanding debt
|
$
|
35,537
|
$
|
36,461
|
$
|
40,985
|
$
|
41,813
|
7. | Loans and Other Arrangements |
Year Ending December 31,
|
Total
|
|||
2015
|
$
|
20,276
|
||
2016
|
18,447
|
|||
38,723
|
||||
Less: interest, final payment and discount
|
(3,186
|
)
|
||
35,537
|
||||
Less: current portion
|
(19,247
|
)
|
||
Total
|
$
|
16,290
|
Year ended December 31,
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
Interest expense
|
||||||||||||
Servier loan
|
$
|
2,330
|
$
|
2,152
|
$
|
2,097
|
||||||
GECC term loan
|
1,638
|
2,064
|
1,850
|
|||||||||
Novartis note
|
312
|
362
|
397
|
|||||||||
Other
|
23
|
53
|
43
|
|||||||||
Total interest expense
|
$
|
4,303
|
$
|
4,631
|
$
|
4,387
|
8. | Income Taxes |
Year ended December 31,
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
Federal income tax (benefit) provision
|
$
|
-
|
$
|
(14
|
)
|
$
|
(74
|
)
|
||||
Total
|
$
|
-
|
$
|
(14
|
)
|
$
|
(74
|
)
|
Year ended December 31,
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
Federal tax at statutory rate
|
34
|
%
|
34
|
%
|
34
|
%
|
||||||
Warrant valuation
|
40
|
%
|
-17
|
%
|
-4
|
%
|
||||||
Permanent items and other
|
-1
|
%
|
0
|
%
|
-1
|
%
|
||||||
Valuation allowance
|
-73
|
%
|
-17
|
%
|
-29
|
%
|
||||||
Total
|
0
|
%
|
0
|
%
|
0
|
%
|
December 31,
|
||||||||
2014
|
2013
|
|||||||
Capitalized research and development expenses
|
$
|
50.9
|
$
|
49.4
|
||||
Net operating loss carryforwards
|
105.0
|
78.4
|
||||||
Research and development and other credit carryforwards
|
12.1
|
8.8
|
||||||
Other
|
22.1
|
23.5
|
||||||
Total deferred tax assets
|
190.1
|
160.1
|
||||||
Valuation allowance
|
(190.1
|
)
|
(160.1
|
)
|
||||
Net deferred tax assets
|
$
|
-
|
$
|
-
|
2014
|
2013
|
2012
|
||||||||||
Balance at January 1
|
$
|
4,274
|
$
|
4,104
|
$
|
-
|
||||||
Increase related to current year tax position
|
720
|
164
|
49
|
|||||||||
Increase related to prior year tax position
|
509
|
6
|
4,055
|
|||||||||
Balance at December 31
|
$
|
5,503
|
$
|
4,274
|
$
|
4,104
|
9. | Compensation and Other Benefit Plans |
2014
|
2013
|
2012
|
||||||||||||||||||||||
Number of
Shares
|
Weighted
Average
Exercise
Price
|
Number of
Shares
|
Weighted
Average
Exercise
Price
|
Number of
Shares
|
Weighted
Average
Exercise
Price
|
|||||||||||||||||||
Outstanding at beginning of year
|
7,216,041
|
$
|
8.42
|
6,788,383
|
$
|
8.99
|
5,053,435
|
$
|
12.55
|
|||||||||||||||
Granted
|
1,891,989
|
6.69
|
1,168,203
|
3.13
|
2,351,445
|
2.59
|
||||||||||||||||||
Exercised
|
(915,911
|
)
|
3.91
|
(589,355
|
)
|
2.26
|
(90,252
|
)
|
1.68
|
|||||||||||||||
Forfeited, expired or cancelled
|
(489,810
|
)
|
14.36
|
(151,190
|
)
|
17.46
|
(526,245
|
)
|
15.84
|
|||||||||||||||
Outstanding at end of year
|
7,702,309
|
8.15
|
7,216,041
|
8.42
|
6,788,383
|
8.99
|
||||||||||||||||||
Exercisable at end of year
|
4,908,925
|
9.98
|
4,814,926
|
11.14
|
4,276,834
|
12.42
|
||||||||||||||||||
Weighted average grant date fair value
|
$
|
4.49
|
$
|
2.27
|
$
|
1.89
|
Number of
Shares
|
Weighted
Average Grant
Date Fair Value
|
|||||||
Unvested awards at December 31, 2013
|
1,738,037
|
$
|
2.73
|
|||||
Granted
|
1,506,194
|
7.03
|
||||||
Vested
|
(1,099,701
|
)
|
3.51
|
|||||
Forfeited
|
(190,651
|
)
|
4.22
|
|||||
Unvested awards at December 31, 2014
|
1,953,879
|
5.46
|
Year Ended December 31,
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
Dividend yield
|
0
|
%
|
0
|
%
|
0
|
%
|
||||||
Expected volatility
|
92
|
%
|
92
|
%
|
92
|
%
|
||||||
Risk-free interest rate
|
1.72
|
%
|
0.89
|
%
|
0.82
|
%
|
||||||
Expected term
|
5.6 years
|
5.6 years
|
5.6 years
|
Year Ended December 31,
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
Research and development
|
$
|
5,557
|
$
|
2,358
|
$
|
2,391
|
||||||
Selling, general and administrative
|
5,215
|
2,741
|
1,893
|
|||||||||
Total stock-based compensation expense
|
$
|
10,772
|
$
|
5,099
|
$
|
4,284
|
10.
|
Capital Stock
|
11. | Commitments and Contingencies |
Operating
Leases
|
||||
2015
|
$
|
3,428
|
||
2016
|
3,531
|
|||
2017
|
3,637
|
|||
2018
|
3,742
|
|||
2019
|
3,852
|
|||
Thereafter
|
10,733
|
|||
Minimum lease payments
|
$
|
28,923
|
12. | Concentration of Risk, Segment and Geographic Information |
Year ended December 31,
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
United States
|
$
|
11,756
|
$
|
19,955
|
$
|
14,134
|
||||||
Europe
|
5,510
|
15,396
|
18,454
|
|||||||||
Asia Pacific
|
1,600
|
100
|
1,194
|
|||||||||
Total
|
$
|
18,866
|
$
|
35,451
|
$
|
33,782
|
13. | Subsequent Events |
14.
|
Quarterly Financial Information (unaudited)
|
Consolidated Statements of Operations
|
||||||||||||||||
Quarter Ended
|
||||||||||||||||
March 31
|
June 30
|
September 30
|
December 31
|
|||||||||||||
(In thousands, except per share amounts)
|
||||||||||||||||
2014
|
||||||||||||||||
Total revenues
|
$
|
3,410
|
$
|
5,973
|
$
|
5,136
|
$
|
4,347
|
||||||||
Total operating costs and expenses
(1)
|
(26,884
|
)
|
(24,750
|
)
|
(25,589
|
)
|
(23,475
|
)
|
||||||||
Other income (expense), net
(2)
|
18,787
|
6,880
|
6,054
|
11,810
|
||||||||||||
Income tax benefit
|
-
|
-
|
-
|
-
|
||||||||||||
Net loss
|
$
|
(4,687
|
)
|
$
|
(11,897
|
)
|
$
|
(14,399
|
)
|
$
|
(7,318
|
)
|
||||
Basice net loss per share of common stock
|
$
|
(0.04
|
)
|
$
|
(0.11
|
)
|
$
|
(0.13
|
)
|
$
|
(0.07
|
)
|
||||
Diluted net loss per share of common stock
|
$
|
(0.21
|
)
|
$
|
(0.17
|
)
|
$
|
(0.17
|
)
|
$
|
(0.12
|
)
|
||||
2013
|
||||||||||||||||
Total revenues
|
$
|
9,453
|
$
|
7,151
|
$
|
6,312
|
$
|
12,535
|
||||||||
Total operating costs and expenses
|
(20,777
|
)
|
(21,230
|
)
|
(23,535
|
)
|
(28,114
|
)
|
||||||||
Other (expense) income, net
(2)
|
(13,563
|
)
|
(3,169
|
)
|
(12,416
|
)
|
(36,719
|
)
|
||||||||
Income tax benefit (expense)
|
-
|
-
|
15
|
(1
|
)
|
|||||||||||
Net loss
|
$
|
(24,887
|
)
|
$
|
(17,248
|
)
|
$
|
(29,624
|
)
|
$
|
(52,299
|
)
|
||||
Basic and diluted net loss per share of common stock
|
$
|
(0.30
|
)
|
$
|
(0.21
|
)
|
$
|
(0.34
|
)
|
$
|
(0.55
|
)
|
(1) | In 2014, the Company corrected an immaterial error driven by certain stock-based compensation expense in the fourth quarter of 2014, resulting in a decrease to operating expenses and net loss by $1.6 million and a decrease to basic and diluted loss per share of $0.01 and $0.02, respectively, for the three months ended December 31, 2014. Refer to Note 2, Basis of Presentation and Significant Accounting Policies - Correction of an Immaterial Error |
(2) | Fluctuations in 2014 and 2013 primarily relate to (losses) gains on the revaluation of the contingent warrant liabilities. |
Incorporation By Reference
|
|||||
Exhibit
Number |
Exhibit Description
|
Form
|
SEC File No.
|
Exhibit
|
Filing Date
|
3.1
|
Certificate of Incorporation of XOMA Corporation
|
8-K
|
000-14710
|
3.1
|
01/03/2012
|
3.2A
|
Certificate of Amendment of Certificate of Incorporation of XOMA Corporation
|
8-K
|
000-14710
|
3.1
|
05/31/2012
|
3.2B
|
Certificate of Amendment of Certificate of Incorporation of XOMA Corporation
|
8-K
|
000-14710
|
3.1
|
05/28/2014
|
3.3
|
By-laws of XOMA Corporation
|
8-K
|
000-14710
|
3.2
|
01/03/2012
|
4.1
|
Reference is made to Exhibits 3.1, 3.2 and 3.3
|
||||
4.2
|
Specimen of Common Stock Certificate
|
8-K
|
000-14710
|
4.1
|
01/03/2012
|
4.3
|
Form of Certificate of Designations of Series A Preferred Stock
|
8-K
|
000-14710
|
3.1
|
01/03/2012
|
4.4
|
Form of Amended and Restated Warrant (June 2009 Warrants)
|
8-K
|
000-14710
|
10.6
|
02/02/2010
|
4.5
|
Form of Warrant (February 2010 Warrants)
|
8-K
|
000-14710
|
10.2
|
02/02/2010
|
4.6
|
Form of Warrant (December 2011 Warrants)
|
10-K
|
000-14710
|
4.9
|
03/14/2012
|
4.7
|
Form of Warrant (March 2012 Warrants)
|
8-K
|
000-14710
|
4.1
|
03/07/2012
|
4.8
|
Form of Warrant (September 2012 Warrants)
|
8-K
|
000-14710
|
4.10
|
10/03/2012
|
4.9
|
Registration Rights Agreement, dated June 12, 2014, by and among XOMA Corporation, 667, L.P., Baker Brothers Life Sciences, L.P., and 14159, L.P.
|
8-K
|
000-14710
|
4.1
|
06/12/2014
|
4.10
|
Form of Warrants (December 2014 Warrants)
|
8-K
|
000-14710
|
4.1
|
12/09/2014
|
10.1*
|
1981 Share Option Plan as amended and restated
|
S-8
|
333-171429
|
10.1
|
12/27/2010
|
10.2*
|
Form of Share Option Agreement for 1981 Share Option Plan
|
10-K
|
000-14710
|
10.1A
|
03/11/2008
|
10.3*
|
Restricted Share Plan as amended and restated
|
S-8
|
333-171429
|
10.1
|
12/27/2010
|
10.4*
|
Form of Share Option Agreement for Restricted Share Plan
|
10-K
|
000-14710
|
10.2A
|
03/11/2008
|
10.5*
|
2007 CEO Share Option Plan
|
8-K
|
000-14710
|
10.7
|
08/07/2007
|
10.6*
|
1992 Directors Share Option Plan as amended and restated
|
S-8
|
333-171429
|
10.1
|
12/27/2010
|
10.7*
|
Form of Share Option Agreement for 1992 Directors Share Option Plan (initial grants)
|
10-K
|
000-14710
|
10.3A
|
03/11/2008
|
10.8*
|
Form of Share Option Agreement for 1992 Directors Share Option Plan (subsequent grants)
|
10-K
|
000-14710
|
10.3B
|
03/11/2008
|
10.9*
|
2002 Director Share Option Plan
|
S-8
|
333-151416
|
10.10
|
06/04/2008
|
10.10*
|
XOMA Corporation Amended and Restated 2010 Long Term Incentive and Stock Award Plan
|
S-8
|
000-14710
|
99.1
|
09/12/2014
|
10.11*
|
Form of Stock Option Agreement for Amended and Restated 2010 Long Term Incentive and Stock Award Plan
|
10-K
|
000-14710
|
10.6A
|
03/14/2012
|
10.12*
|
Form of Restricted Stock Unit Agreement for Amended and Restated 2010 Long Term Incentive and Stock Award Plan
|
10-K
|
000-14710
|
10.6B
|
03/14/2012
|
10.13*
|
Management Incentive Compensation Plan as amended and restated
|
8-K
|
000-14710
|
10.3
|
11/06/2007
|
10.14*
|
CEO Incentive Compensation Plan
|
10-K
|
000-14710
|
10.4A
|
03/11/2008
|
10.15*
|
Amendment No. 1 to CEO Incentive Compensation Plan
|
10-K
|
000-14710
|
10.7B
|
03/14/2012
|
10.16*
|
Bonus Compensation Plan
|
10-K
|
000-14710
|
10.4B
|
03/11/2008
|
10.17*
|
Amended and Restated 1998 Employee Stock Purchase Plan
|
POS AM
|
333-174730
|
10.2
|
01/03/2012
|
10.18
|
Form of Amended and Restated Indemnification Agreement for Officers
|
10-K
|
000-14710
|
10.6
|
03/08/2007
|
10.19
|
Form of Amended and Restated Indemnification Agreement for Employee Directors
|
10-K
|
000-14710
|
10.7
|
03/08/2007
|
10.20
|
Form of Amended and Restated Indemnification Agreement for Non-employee Directors
|
10-K
|
000-14710
|
10.8
|
03/08/2007
|
10.21*
|
Employment Agreement entered into between XOMA (US) LLC and Fred Kurland, dated as of December 29, 2008
|
10-K/A
|
000-14710
|
10.7B
|
12/27/2010
|
10.22*
|
Amended and Restated Employment Agreement entered into between XOMA (US) LLC and Charles C. Wells, dated as of December 30, 2008
|
10-K/A
|
000-14710
|
10.7D
|
12/27/2010
|
10.23
|
Officer Employment Agreement dated March 19, 2013 between XOMA Corporation and Paul Rubin
|
10-K
|
000-14710 | 10.23 |
03/12/2014
|
10.24*
|
Employment Agreement effective as of January 4, 2012 between XOMA (US) LLC and John Varian
|
10-K
|
000-14710
|
10.10G
|
03/14/2012
|
10.25
|
Officer Employment Agreement dated March 10, 2014 between XOMA Corporation and Pat Scannon
|
10-K |
000-14710
|
10.25 | 03/12/2014 |
10.26*
|
Form of Change of Control Severance Agreement entered into between XOMA Ltd. and certain of its executives
|
10-K
|
000-14710
|
10.12
|
03/10/2011
|
10.27*
|
Change of Control Agreement entered into between XOMA Ltd. and John Varian, dated January 4, 2012
|
10-K
|
000-14710
|
10.12A
|
03/14/2012
|
10.28
|
Retention Benefit Agreement entered into between XOMA Corporation and John Varian, dated March 11, 2014
|
10-K
|
000-14710
|
10.28 | 03/12/2014 |
10.29
|
Lease of premises at 804 Heinz Street, Berkeley, California dated February 13, 2013
|
10-K
|
000-14710
|
10.29 | 03/12/2014 |
10.30
|
Lease of premises at 2910 Seventh Street, Berkeley, California dated February 13, 2013
|
10-K
|
000-14710
|
10.30 | 03/12/2014 |
10.31
|
First amendment to lease of premises at 2910 Seventh Street, Berkeley, California dated February 22, 2013
|
10-K
|
000-14710
|
10.31 | 03/12/2014 |
10.32
|
Lease of premises at 5860 and 5864 Hollis Street, Emeryville, California dated February 13, 2013
|
10-K
|
000-14710
|
10.32 | 03/12/2014 |
10.33
|
Lease of premises at 2850 Seventh Street, Second Floor, Berkeley, California dated as of December 28, 2001 (with addendum and guaranty)
|
10-K
|
000-14710
|
10.20
|
04/01/2002
|
10.34†
|
Second Amended and Restated Collaboration Agreement dated January 12, 2005, by and between XOMA (US) LLC and Genentech, Inc.
|
10-K
|
000-14710
|
10.26C
|
03/15/2005
|
10.35†
|
Agreement related to LUCENTIS® License Agreement and RAPTIVA® Collaboration Agreement dated September 9, 2009, by and between XOMA (Bermuda) Ltd., XOMA (US) LLC and Genentech, Inc.
|
10-Q
|
000-14710
|
10.18A
|
11/09/2009
|
10.36†
|
License Agreement by and between XOMA Ireland Limited and MorphoSys AG, dated as of February 1, 2002
|
10-K
|
000-14710
|
10.43
|
02/01/2002
|
10.37A†
|
License Agreement, dated as of December 29, 2003, by and between Diversa Corporation (n/k/a BP Biofuels Advanced Technology Inc.) and XOMA Ireland Limited
|
8-K/A
|
000-14710
|
2
|
03/19/2004
|
10.37B
|
First Amendment, dated October 28, 2014, to the License Agreement between XOMA (US) LLC (assigned to it by XOMA Ireland Limited) and BP Biofuels Advanced Technology Inc. (previously Diversa Corporation, previously Verenium Corporation).
|
10-Q
|
000-14710
|
10.3
|
11/06/2014
|
10.38†
|
GSSM License Agreement, effective as of May 2, 2008, by and between Verenium Corporation (n/k/a BP Biofuels Advanced Technology Inc.) and XOMA Ireland Limited
|
10-K
|
000-14710
|
10.25A
|
03/10/2011
|
10.39†
|
Secured Note Agreement, dated as of May 26, 2005, by and between Chiron Corporation and XOMA (US) LLC
|
10-Q
|
000-14710
|
10.3
|
08/08/2005
|
10.40†
|
Amended and Restated Research, Development and Commercialization Agreement, executed November 7, 2008, by and between Novartis Vaccines and Diagnostics, Inc. (formerly Chiron Corporation) and XOMA (US) LLC
|
10-K
|
000-14710
|
10.24C
|
03/11/2009
|
10.41†
|
Amendment No. 1 to Amended and Restated Research, Development and Commercialization Agreement, effective as of April 30, 2010, by and between Novartis Vaccines and Diagnostics, Inc. and XOMA (US) LLC
|
10-K
|
000-14710
|
10.25B
|
03/14/2012
|
10.42
|
Manufacturing and Technology Transfer Agreement, executed December 16, 2008, by and between Novartis Vaccines and Diagnostics, Inc. (formerly Chiron Corporation) and XOMA (US) LLC
|
10-K
|
000-14710
|
10.24D
|
03/11/2009
|
10.43
|
Agreement dated March 8, 2005, between XOMA (US) LLC and the National Institute of Allergy and Infectious Diseases
|
10-K
|
000-14710
|
10.53
|
03/15/2005
|
10.44
|
Agreement dated July 28, 2006, between XOMA (US) LLC and the National Institute of Allergy and Infectious Diseases
|
10-K
|
000-14710
|
10.60
|
08/09/2006
|
10.45†
|
Agreement dated September 15, 2008, between XOMA (US) LLC and the National Institute of Allergy and Infectious Diseases
|
10-Q
|
000-14710
|
10.39
|
11/10/2008
|
10.46
|
Second Amendment to Agreement dated September 15, 2008, between XOMA (US) LLC and the National Institute of Allergy and Infectious Diseases
|
10-Q
|
000-14710
|
10.24C
|
11/04/2010
|
10.47
|
Agreement dated September 30, 2011, between XOMA (US) LLC and the National Institute of Allergy and Infectious Diseases
|
S-4
|
000-14710
|
10.28D
|
10/04/2011
|
10.48†
|
Collaboration Agreement, dated as of November 1, 2006, between Takeda Pharmaceutical Company Limited and XOMA (US) LLC
|
10-K
|
000-14710
|
10.46
|
03/08/2007
|
10.49
|
First Amendment to Collaboration Agreement, effective as of February 28, 2007, between Takeda Pharmaceutical Company Limited and XOMA (US) LLC
|
10-Q/A
|
000-14710
|
10.48
|
03/05/2010
|
10.50
|
Second Amendment to Collaboration Agreement, effective as of February 9, 2009, among Takeda Pharmaceutical Company Limited and XOMA (US) LLC
|
10-K
|
000-14710
|
10.31B
|
03/11/2009
|
10.51†
|
License Agreement, effective as of August 27, 2007, by and between Pfizer Inc. and XOMA Ireland Limited
|
8-K
|
000-14710
|
2
|
09/13/2007
|
10.52
|
Common Share Purchase Agreement, dated as of July 23, 2010, by and between XOMA Ltd. and Azimuth Opportunity Ltd.
|
8-K
|
000-14710
|
10.1
|
07/23/2010
|
10.53
|
Securities Purchase Agreement dated June 5, 2009, between XOMA Ltd. and the investors named therein
|
8-K
|
000-14710
|
10.1
|
06/10/2009
|
10.54
|
Engagement Letter dated June 4, 2009
|
8-K
|
000-14710
|
10.3
|
06/10/2009
|
10.55†
|
Discovery Collaboration Agreement dated September 9, 2009, by and between XOMA Development Corporation and Arana Therapeutics Limited
|
10-Q/A
|
000-14710
|
10.35
|
03/05/2010
|
10.56
|
Amendment to At Market Issuance Sales Agreement dated December 31, 2011, between XOMA Corporation and McNicoll, Lewis & Vlak LLC
|
POS AM
|
333-172197
|
1.2
|
01/03/2012
|
10.57
|
Form of Warrant Amendment Agreement dated February 2, 2010 (June 2009 Warrants)
|
8-K
|
000-14710
|
10.3
|
02/02/2010
|
10.58†
|
Royalty Purchase Agreement, dated as of August 12, 2010, by and among XOMA CDRA LLC, XOMA (US) LLC, XOMA Ltd. and the buyer named therein
|
10-Q/A
|
000-14710
|
10.38
|
04/13/2011
|
10.59†
|
Collaboration and License Agreement dated as of December 30, 2010, by and between XOMA Ireland Limited, Les Laboratoires Servier and Institut de Recherches Servier
|
10-K
|
000-14710
|
10.42
|
03/10/2011
|
10.60†
|
Amended and Restated Collaboration and License Agreement dated as of February 14, 2012, by and between XOMA Ireland Limited, Les Laboratoires Servier and Institut de Recherches Servier
|
10-K
|
000-14710
|
10.41A
|
03/14/2012
|
10.61†
|
Loan Agreement dated as of December 30, 2010, by and between XOMA Ireland Limited and Les Laboratoires Servier
|
10-K/A
|
000-14710
|
10.42A
|
05/26/2011
|
10.62
|
Foreign Exchange and Options Master Agreement (FEOMA) dated as of May 16, 2011, between Royal Bank of Canada and XOMA Ltd., with letter agreement dated May 17, 2011
|
10-Q
|
000-14710
|
10.1
|
08/04/2011
|
10.63†
|
Loan Agreement dated as of December 30, 2011, among XOMA (US) LLC, as Borrower, XOMA Ltd., as Parent, each other loan party from time to time party thereto, General Electric Capital Corporation, as Agent, and each other lender from time to time party thereto
|
10-K
|
000-14710
|
10.43
|
03/14/2012
|
10.64†
|
Guaranty, Pledge and Security Agreement dated as of December 30, 2011, among XOMA (US) LLC, each other guarantor from time to time party thereto and General Electric Capital Corporation, as Agent
|
10-K
|
000-14710
|
10.43A
|
03/14/2012
|
10.65†
|
Amended and Restated License and Commercialization Agreement effective as of January 11, 2012, by and between Les Laboratoires Servier and XOMA Ireland Limited
|
10-K
|
000-14710
|
10.44
|
03/14/2012
|
10.66†
|
Amended and Restated Trademark License Agreement entered into as of January 11, 2012, between Biofarma and XOMA Ireland Limited
|
10-K
|
000-14710
|
10.44A
|
03/14/2012
|
10.67†
|
Master Services Agreement dated as of November 9, 2009, between Medpace, Inc. and XOMA (US) LLC
|
10-K
|
000-14710
|
10.45
|
03/14/2012
|
10.68†
|
Amendment No. 1 to Master Services Agreement dated as of October 4, 2011, between Medpace, Inc. and XOMA (US) LLC
|
10-K
|
000-14710
|
10.45A
|
03/14/2012
|
†
|
Confidential treatment has been granted with respect to certain portions of this exhibit. This exhibit omits the information subject to this confidentiality request. Omitted portions have been filed separately with the SEC.
|
*
|
Indicates a management contract or compensation plan or arrangement.
|
+
|
Filed herewith
|
(1)
|
This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.
|
1. | Definitions . All capitalized terms not otherwise defined herein shall have the meanings assigned to them in the Loan Agreement, except if they are otherwise defined in this Amendment, in which case they shall have the meaning ascribed to them in this Amendment. |
2. | General . Except as expressly set forth herein, the Loan Agreement shall continue in full force and effect and, as modified or amended, is hereby ratified, confirmed and approved. No provision of this Amendment N°1 may be modified or amended except expressly in a writing signed by both Parties nor shall any terms be waived except expressly in a writing signed by both Parties charged therewith. |
ARTICLE 1 | AMENDMENT OF THE DEFINITION OF “MATURITY DATE” SET OUT IN ARTICLE 1 OF THE LOAN AGREEMENT |
ARTICLE 2 | AMENDMENT OF SECTIONS 3.2 AND 3.3 OF THE LOAN AGREEMENT |
(a) | three million euros (€3,000,000) on January 15, 2016, |
(b) | five million euros (€5,000,000) on January 15, 2017, and |
(c) | seven million euros (€7,000,000) on the Maturity Date. |
ARTICLE 3
|
OTHER PROVISIONS
|
/s/
Pascal Touchon
|
/s/ James R. Neal
|
|
LES LABORATOIRES SERVIER
|
XOMA (US) LLC
|
|
By: Mr. Pascal Touchon
|
By: James R. Neal
|
|
Title: Proxy
|
Name: James R. Neal
|
|
Title: VP, Business Development
|
||
Dated: January 9, 2015
|
||
/s/ Marie-Christine Larcher
|
||
INSTITUT DE RECHERCHES SERVIER
|
||
By: Mrs. Marie-Christine Larcher
|
||
Title: Proxy
|
1. | Definitions . All capitalized terms not otherwise defined herein shall have the meanings assigned to them in the Collaboration Agreement, except if they are otherwise defined in this Amendment, in which case they shall have the meaning ascribed to them in this Amendment. |
2. | General . Except as expressly set forth herein, the Collaboration Agreement shall continue in full force and effect and, as modified or amended, is hereby ratified, confirmed and approved. No provision of this Amendment N°2 may be modified or amended except expressly in a writing signed by both parties nor shall any terms be waived except expressly in a writing signed by both parties charged therewith. |
ARTICLE1
:
|
AMENDMENT OF SECTION 8.7 OF THE ORIGINAL AGREEMENT ENTITLED “
REGULATORY MILESTONES FOR REMAINING FIELD INDICATIONS
”
|
[*]
|
Milestone Event
|
Milestone Payment
|
[*]
|
Acceptance for filing of MAA by EMA
|
€[*]
|
Regulatory Approval by EMA
|
€[*]
|
|
[*]
|
Acceptance for filing of MAA by EMA
|
€[*]
|
Regulatory Approval by EMA
|
€[*]
|
|
[*]
|
Acceptance for filing of MAA by EMA
|
€[*]
|
Regulatory Approval by EMA
|
€[*]
|
|
[*]
|
Acceptance for filing of MAA by EMA
|
€[*]
|
Regulatory Approval by EMA
|
€[*]
|
ARTICLE 2: | OTHER PROVISIONS |
/s/
Pascal Touchon
|
/s/ James R. Neal
|
|
LES LABORATOIRES SERVIER
|
XOMA (US) LLC
|
|
By: Mr. Pascal Touchon
|
By: James R. Neal
|
|
Title: Proxy
|
Name: James R. Neal
|
|
Title: VP, Business Development
|
||
Dated:
January 9, 2015
|
||
/s/ Marie-Christine Larcher
|
||
INSTITUT DE RECHERCHES SERVIER
|
||
By: Mrs. Marie-Christine Larcher
|
||
Title: Proxy
|
A. | SERVIER is a pharmaceutical company committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human medicine. |
B. | XOMA owns and controls certain intellectual property related to, and has conducted clinical trials with respect to, its proprietary IL-1β antibody designated as XOMA 052. |
C. | SERVIER and XOMA have established a collaboration for the continued development, regulatory approval and commercialization of products containing XOMA 052, with XOMA retaining certain exclusive development and commercialization rights in the U.S. and in Japan and Servier having exclusive development and commercialization rights in the rest of the world, in accordance with the terms and conditions set forth in that certain Amended and Restated Collaboration and License Agreement, dated as of February 14, 2012, by and among SERVIER, on the first part, and XOMA Ireland Limited, a company with limited liability organized under the laws of the Republic of Ireland (“ XOMA Ireland ”), on the second part (the “ Restated Agreement ”). Pursuant to an Asset Transfer Agreement and an Assignment and Assumption Agreement effective as of August 12, 2013, the Restated Agreement was, with SERVIER’s consent, assigned by XOMA Ireland to XOMA . |
D. | Pursuant to the Restated Agreement, as summarized in Section 2.1 thereof, Servier is granted exclusive rights to the Product with respect to all indications (i.e., the Remaining Field and the Cardiometabolic Field) in the Licensed Territory and the Cardiometabolic Indications in the Retained Territory, XOMA having an option to re-acquire such rights in the Retained Territory. |
E. | Notwithstanding provisions related to the principle set out in the Restated Agreement that SERVIER would be responsible for all Development activities in the Licensed Territory, XOMA has exceptionally proposed, and SERVIER has accepted, that XOMA conduct certain Unsponsored Work, as defined in Section 3.8 of the Restated Agreement, consisting of phase 3 clinical trials in “Pyoderma Gangrenosum” (study X052173 and extension study X052171) as sole sponsor in certain countries, listed in Annex 1 , of the Licensed Territory (the “ PG Trials ”). |
E. | Therefore, the Parties wish hereby to set out certain terms and conditions with respect to the PG Trials, some of which are exceptions to the terms and conditions of the Restated Agreement, including matters related to their respective responsibilities and liabilities concerning regulatory matters and pharmacovigilance with respect to the PG Trials. |
1) | Definitions . All capitalized terms not otherwise defined herein shall have the meanings assigned to them in the Restated Agreement, except if they are otherwise defined in this Amendment, in which case they shall have the meaning ascribed to them in this Amendment. |
2) | General . The Parties agree that the PG Trials constitute Unsponsored Work, as contemplated in Section 3.8(b) of the Restated Agreement, and that the provisions of Section 3.8(b) shall govern the PG Trials. For the purposes of Section 3.8(b), XOMA is the proposing Party and SERVIER the non-proposing Party for the PG Trials. It has been agreed between the Parties that the PG Trials shall be conducted by XOMA at its own expense and acting as sponsor in the countries of the Licensed Territory listed in Annex 1 as well as in the Retained Territory (together, the “ PG Trial Countries ”). For the avoidance of doubt, SERVIER’s right to use the Information resulting from the PG Trials, including all such Information generated in the PG Trial Countries located in the Licensed Territory, shall be subject to the terms and conditions of Section 3.8(b), and XOMA shall not pursuant to this Amendment obtain any Commercialization rights in the Pyoderma Gangrenosum indication in the Licensed Territory, including in those countries where the PG Trials are conducted. |
3) | Sponsor Obligations . Notwithstanding Article 4 of the Restated Agreement, XOMA shall be the sponsor of, and lead regulatory Party for, the PG Trials, including in the Licensed Territory PG Trial Countries, and as such shall own the Regulatory Materials specific thereto, comply with all the obligations of a sponsor of clinical trials in the PG Trial Countries, and endorse solely all sponsor responsibilities in those countries. |
4) | Indemnification by XOMA . The following shall be added as a second paragraph at the end of Section 13.2 of the Restated Agreement: |
5) | Other Provisions . |
a) | It is hereby understood among the Parties that, except with respect to XOMA’s Development of the Product in the PG Trials in the PG Trial Countries, this Agreement does not otherwise limit the rights of SERVIER set forth in Section 7.1 of the Restated Agreement. This Amendment is not intended to and does not modify or amend the terms or conditions of the Restated Agreement or the SDEA except to the limited extent as provided in this Amendment to enable XOMA to conduct the PG Trials in the PG Trial Countries. |
b) | This Amendment shall inure to the benefit of and shall be binding upon the parties hereto and their respective successors, transferees and assigns. |
c) | This Agreement may be executed in one or more counterparts, each of which shall be deemed an original, but all of which, when taken together, shall constitute one and the same instrument. |
d) | If any one or more of the provisions of this Agreement shall be held to be invalid, illegal or unenforceable, the validity, legality or enforceability of the remaining provisions hereof shall not in any way be affected or impaired thereby. In the event any provisions hereof shall be held invalid, illegal or unenforceable, the parties shall use commercially reasonable efforts to substitute a valid, legal and enforceable provision, which, insofar as practical, implements the purposes hereof. |
/s/ Christian Bazantay
|
/s/ James R. Neal
|
|
LES LABORATOIRES SERVIER
|
XOMA (US) LLC
|
|
By: Christian Bazantay
|
By: James R. Neal
|
|
Name:
|
Name:
|
|
Title: Proxy
|
Title: VP, Business Development
|
|
11/4/2014
|
||
/s/ Pascal Touchon
|
||
By: Pascal Touchon
|
||
Name:
|
||
Title: Proxy
|
||
/s/ Emmanuel Canet
|
||
INSTITUT DE RECHERCHES SERVIER
|
||
By: Emmanuel Canet
|
||
Name:
|
||
Title: President of R&D
|
✓ | Australia |
✓ | Argentina |
✓ | Canada |
✓ | Israel |
✓ | Mexico |
✓ | Colombia |
Ø | XOMA Ireland issued a Promissory Note to SERVIER on January 13, 2011 with a principal amount equal to the Advance (the “ Original Note ”); |
Ø | XOMA Ireland and SERVIER entered into a Fixed Charge (the “ Fixed Equitable Charge ”) dated January 13, 2011 pursuant to which XOMA Ireland charged certain contractual and intellectual property rights (the “ Collateral ”) related to its proprietary IL-1β antibody designated gevokizumab (formerly known as XOMA 052 and/or S-78989, “ GEVO ”) as a security for the benefit of SERVIER to guarantee the repayment of the amounts due to SERVIER pursuant to the Loan Agreement; |
Ø | the Fixed Equitable Charge was registered with the Irish Companies Registry on January 25, 2011; |
Ø | XOMA Ltd., XOMA Ireland’s parent company organized under the laws of Bermuda, issued a Guarantee to SERVIER on December 30, 2010, to guarantee the payment by XOMA Ireland to SERVIER of all amounts due under the Loan Agreement (the “ XOMA Ltd. Guarantee ”); and |
Ø | XOMA US issued a Guarantee to SERVIER on December 30, 2010, to guarantee the payment by XOMA Ireland to SERVIER of all amounts due under the Loan Agreement (the “ XOMA US Guarantee ”). |
1.1 | Subject to Section 3.1, SERVIER hereby irrevocably consents to the transfer of all of XOMA Ireland’s rights and obligations under the Loan Agreement to XOMA US. |
1.2 | Effective as of the Transfer Completion Date, all references to XOMA Ireland in the Loan Agreement shall be deemed to refer to XOMA US and XOMA Ireland shall have no further obligations under the Loan Agreement. |
1.3 | XOMA US hereby irrevocably agrees effective as of the Transfer Completion Date to assume all of XOMA Ireland’s obligations under the Loan Agreement and shall perform and discharge all such obligations in accordance with the terms thereof. |
1.4 | The representations and warranties contained in Article 5 of the Loan Agreement, shall be true and correct as of the Transfer Completion Date, provided that: (a) each reference in such provisions to XOMA Ireland shall be deemed to refer to XOMA US, and (b) for purposes of Sections 5.1 and 5.4 of the Loan Agreement, each representation and warranty by XOMA Ireland as an Irish limited company shall mean and refer to XOMA US, a Delaware limited liability company, with all such representations and warranties meaning and referring to XOMA US as such. |
2.1 | Termination and Replacement of the Fixed Equitable Charge. |
2.1.1 | Subject to Section 3.1, XOMA Ireland, SERVIER and XOMA US agree that the Fixed Equitable Charge shall be cancelled and released effective as of the Transfer Completion Date. |
2.1.2 | Subject to Section 3.1, SERVIER shall at the latest on the Transfer Completion Date deliver to XOMA US a Deed of Release in substantially the form attached as Exhibit 3 hereto dated as of the date hereof giving effect to SERVIER’s cancellation and release of the Fixed Equitable Charge. |
2.1.3 | The definition “Fixed Equitable Charge” in Section 1.2 of the Loan Agreement shall be deleted in its entirety and replaced by the definition of “Security Agreement” set out in Section 3.1 hereof. All references to the term “Fixed Equitable Charge” in the Loan Agreement shall thereinafter be understood as referring to the Security Agreement. |
2.2 | Cancellation and Replacement of the Note. |
2.2.1 | Subject to Section 3.1, the Original Note shall be cancelled and of no further effect and validity effective as of the Transfer Completion Date, and replaced by the XOMA US Note (as defined in Section 3.1 hereof) in accordance with terms hereof. Upon receipt of the XOMA US Note, SERVIER shall deliver to XOMA Ireland the cancelled Original Note. |
2.2.2 | All references to the term “Note” in the Loan Agreement shall thereinafter refer to the XOMA US Note. |
2.3 | Cancellation of the XOMA US Guarantee to SERVIER. |
2.3.1 | Subject to Section 3.1, the XOMA US Guarantee shall be terminated and of no further effect effective as of the Transfer Completion Date. |
2.4 | Tax Cooperation. |
2.4.1 | Effective as of the Transfer Completion Date, the first three sentences of Section 3.10(a) of the Loan Agreement shall be deleted in their entirety and replaced by the following text: |
2.4.2 | Effective as of the Transfer Completion Date, Section 3.10(b) of the Loan Agreement shall be deleted in its entirety and replaced by the following text: |
2.5 | Effective as of the Transfer Completion Date, Section 9.4 (Notices) of the Loan Agreement shall be amended by including the following as XOMA US’ address and designated contact person for notices: |
2.6 | Effective as of the Transfer Completion Date, all references to the Republic of Ireland in the Loan Agreement shall be amended to refer to the State of Delaware. |
2.7 | Effective as of the Transfer Completion Date, all references in the Loan Agreement toBelgium law and Belgium choice of law shall be changed to New York law and NewYork choice of law; and Sections 9.6 (Governing Law) and 9.7 (Binding Arbitration) of the Loan Agreement shall be deleted and replaced by Section 9 of the Security Agreement, which shall be incorporated by reference to the Loan Agreement and apply thereto mutatis mutandis . |
2.8 | Effective as of the Transfer Completion Date, the definition of “Collateral” set forth in Section 1.1 of the Loan Agreement shall be deleted in its entirety and replaced by the following text: |
3.1 | Conditions to Effectiveness. |
3.1.1 | XOMA Ireland and XOMA US acknowledge and agree that, pursuant to the terms of the Loan Agreement, SERVIER’s consent is required prior to any transfer of the Loan Agreement, and that SERVIER’s consent given in this Loan Transfer Consent and the amendments in Article 2 hereof are subject to the prior satisfaction of the Conditions. Upon the satisfaction of the Conditions, SERVIER undertakes to deliver to XOMA Ireland and XOMA US a written confirmation of the Conditions having been satisfied, in substantially the form set out in Exhibit 4 hereto. |
3.1.2 | Subject to the satisfaction of the Conditions, SERVIER acknowledges and agrees that neither the consummation of the Asset Transfer Agreement and the GEVO Asset Transfer nor the transfer of the Collateral to XOMA US in accordance with the terms and conditions of the Asset Transfer Agreement and this Loan Transfer Consent shall constitute a breach or default under the Loan Agreement. |
3.2 | Release. Subject to the satisfaction of the Conditions, SERVIER consequently releases XOMA Ireland from any and all obligations towards SERVIER under the Loan Agreement as of the Transfer Completion Date. Similarly, subject to the satisfaction of the Conditions, XOMA Ireland consequently releases SERVIER from any and all obligations towards XOMA Ireland under the Loan Agreement as of the Transfer Completion Date. |
4.1 | Reimbursement of Costs. XOMA US covenants to pay or reimburse the reasonable fees and out-of-pocket expenses of outside counsel incurred by SERVIER in connection with the preparation, execution and delivery of this Loan Transfer Consent and the related agreements. |
4.2 | Patent Transfer Registration. Following the Transfer Completion Date (within three (3) months for European Union countries and within six (6) months for all other countries listed below), XOMA US (or an appropriate affiliate) and XOMA Ireland shall carry out all formalities that are necessary or helpful to register with the relevant regional or national patent offices in the countries / regions listed below the transfer to XOMA US of the rights in the patent applications or patents, as applicable, that are transferred to XOMA US in connection with the transactions contemplated by the Asset Transfer Agreement. XOMA US and XOMA Ireland shall thereafter use their respective best efforts to have this transfer registered promptly after the filing of such transfer request. |
5.1 | Further Assurances. XOMA Ireland, XOMA US and SERVIER hereby covenant that each will, at any time and from time to time upon request by any other, and without the assumption of any additional liability thereby, execute and deliver such further documents and do such further acts as such party may reasonably request in order to fully effect the purpose of this Loan Transfer Consent |
5.2 | Counterparts. This Loan Transfer Consent may be executed in any number of counterparts, each of which shall be deemed an original, but all of which when taken together shall constitute but one and the same agreement. |
5.3 | Governing Law - Arbitration. This Loan Transfer Consent shall be governed by, and construed and enforced in accordance with, the laws of the State of New York, excluding conflict of laws principles that would cause the application of laws of any other jurisdiction. The provisions of Section 9 of the Security Agreement are hereby incorporated by reference and this Agreement and the parties hereto shall otherwise be subject to all of the terms and conditions of Section 9 of the Security Agreement, mutatis mutandis . |
5.4 | All capitalized terms used but not defined in this Loan Transfer Consent shall have the meanings ascribed thereto in the Loan Agreement. |
5.5 | Except as explicitly amended hereby, the Loan Agreement remains in full force and effect. |
XOMA Ireland Limited
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XOMA (US) LLC
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By: /s/ Alan Kane
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By: /s/ James R. Neal
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Name: Alan Kane
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Name: James R. Neal
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Title: Director
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Title: VP, Business Development
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LES LABORATOIRES SERVIER
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By: /s/ Marie Christine Larcher
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Name: Marie Christine Larcher
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Title: Legal Affairs Director
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Debtor:
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Secured Party:
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XOMA (US) LLC
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LES LABORATOIRES SERVIER
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By:
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By:
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Name:
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Name:
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Title:
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Title:
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DEBTOR: | XOMA (US) LLC |
SECURED PARTY: | LES LABORATOIRES SERVIER |
Title: | IL1-Beta binding antibodies and fragments thereof |
Inventors: | Linda Masat; Mary Haak-Frendscho; Gang Chen; Arnold Horwitz; Marina Roell |
COUNTRY
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APPLICATION NO.
|
FILE DATE
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PATENT/PUBLICATION
|
US Provisional
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61/692,830
|
06/21/05
|
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PCT
|
PCT/US06/024261
|
06/21/06
|
WO2007/002261
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Australia
|
2006 262179
|
06/21/06
|
2006262179 B2
|
Brazil
|
PI0612273-6
|
06/21/06
|
BRPI0612273 A2
|
Canada
|
2,612,760
|
06/21/06
|
CA2612760 A1
|
China
|
2006 80026551.9
|
06/21/06
|
CN101228188 A
|
China
|
201210157441.3
|
05/18/12
|
CN
102775493A
|
EP (all countries):
|
06773749.4
|
06/21/06
|
1899378
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Austria
|
06773749.4
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06/21/06
|
1899378
|
Belgium
|
06773749.4
|
06/21/06
|
1899378
|
Bulgaria
|
06773749.4
|
06/21/06
|
1899378
|
Cyprus
|
06773749.4
|
06/21/06
|
1899378
|
Czech Republic
|
06773749.4
|
06/21/06
|
1899378
|
Denmark
|
06773749.4
|
06/21/06
|
1899378
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Estonia
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06773749.4
|
06/21/06
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E004059
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Finland
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06773749.4
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06/21/06
|
1899378
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France
|
06773749.4
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06/21/06
|
1899378
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Germany
|
06773749.4
|
06/21/06
|
60 2006 010 072.8-08
|
Greece
|
06773749.4
|
06/21/06
|
3070850
|
Hungary
|
06773749.4
|
06/21/06
|
E 007716
|
Iceland
|
06773749.4
|
06/21/06
|
1899378
|
Ireland
|
06773749.4
|
06/21/06
|
1899378
|
Italy
|
06773749.4
|
06/21/06
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73749BE/2009
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Latvia
|
06773749.4
|
06/21/06
|
1899378
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Lithuania
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06773749.4
|
06/21/06
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1899378
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Luxembourg
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06773749.4
|
06/21/06
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1899378
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Monaco
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06773749.4
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06/21/06
|
1899378
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Netherlands
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06773749.4
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06/21/06
|
1899378
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Poland
|
06773749.4
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06/21/06
|
1899378
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Portugal
|
06773749.4
|
06/21/06
|
1899378
|
Romania
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06773749.4
|
06/21/06
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RO/EP 1 899 378
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Slovak Republic
|
06773749.4
|
06/21/06
|
1899378
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Slovenia
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06773749.4
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06/21/06
|
1899378
|
Spain
|
06773749.4
|
06/21/06
|
1899378
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Sweden
|
06773749.4
|
06/21/06
|
1899378
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Switzerland
|
06773749.4
|
06/21/06
|
1899378
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Turkey
|
06773749.4
|
06/21/06
|
TR 2009 09878 T4
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United Kingdom
|
06773749.4
|
06/21/06
|
1899378
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EP
|
09 174 190.0
|
10/27/09
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2 163 562 A2
|
EP
|
10 179 088.9
|
09/23/10
|
2314623 B1
|
Austria
|
10 179 088.9
|
09/23/10
|
2314623 B1
|
Belgium
|
10 179 088.9
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09/23/10
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2314623 B1
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Bulgaria
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10 179 088.9
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09/23/10
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2314623 B1
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Cyprus
|
10 179 088.9
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09/23/10
|
2314623 B1
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Czech Republic
|
10 179 088.9
|
09/23/10
|
2314623 B1
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Denmark
|
10 179 088.9
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09/23/10
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2314623 B1
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Estonia
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10 179 088.9
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09/23/10
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2314623 B1
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Finland
|
10 179 088.9
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09/23/10
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2314623 B1
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France
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10 179 088.9
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09/23/10
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2314623 B1
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Germany
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10 179 088.9
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09/23/10
|
2314623 B1
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Greece
|
10 179 088.9
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09/23/10
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2314623 B1
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Hungry
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10 179 088.9
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09/23/10
|
2314623 B1
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Iceland
|
10 179 088.9
|
09/23/10
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2314623 B1
|
Ireland
|
10 179 088.9
|
09/23/10
|
2314623 B1
|
Italy
|
10 179 088.9
|
09/23/10
|
2314623 B1
|
Latvia
|
10 179 088.9
|
09/23/10
|
2314623 B1
|
Lithuania
|
10 179 088.9
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09/23/10
|
2314623 B1
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Liechtenstein
|
10 179 088.9
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09/23/10
|
2314623 B1
|
Luxembourg
|
10 179 088.9
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09/23/10
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2314623 B1
|
Monaco
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10 179 088.9
|
09/23/10
|
2314623 B1
|
Netherlands
|
10 179 088.9
|
09/23/10
|
2314623 B1
|
Poland
|
10 179 088.9
|
09/23/10
|
2314623 B1
|
Portugal
|
10 179 088.9
|
09/23/10
|
2314623 B1
|
Romania
|
10 179 088.9
|
09/23/10
|
2314623 B1
|
Spain
|
10 179 088.9
|
09/23/10
|
2314623 B1
|
Sweden
|
10 179 088.9
|
09/23/10
|
2314623 B1
|
Slovenia
|
10 179 088.9
|
09/23/10
|
2314623 B1
|
Slovak Republic
|
10 179 088.9
|
09/23/10
|
2314623 B1
|
Switzerland
|
10 179 088.9
|
09/23/10
|
2314623 B1
|
Turkey
|
10 179 088.9
|
09/23/10
|
2314623 B1
|
United Kingdom
|
10 179 088.9
|
09/23/10
|
2314623 B1
|
EP
|
10 179 089.7
|
09/23/10
|
2 322 552 A2
|
Hong Kong
|
09100795.8
|
06/21/06
|
1123560
|
Hong Kong
|
10107181.2
|
07/27/10
|
1140781A
|
Hong Kong
|
11111525.8
|
10/26/11
|
1157351 B
|
Hong Kong
|
11112428.4
|
11/17/11
|
1158218A
|
Israel
|
188094
|
06/21/06
|
188094
|
Israel
|
202630
|
12/09/09
|
202630
|
India
|
320/CHENP/2008
|
06/21/06
|
|
Korea
|
10-2008-7001520
|
06/21/06
|
KR 20080039875 A
|
Mexico
|
MX/a/2007/016032
|
06/21/06
|
282003
|
Mexico
|
MX/a/2010/002638
|
03/08/10
|
|
New Zealand
|
565138
|
06/21/06
|
565138
|
Philippines
|
1-2007-502895
|
06/21/06
|
1-2007-502895
|
Russian Federation
|
2008102135
|
06/21/06
|
RU 2008102135 A
|
Singapore
|
200718904-6
|
06/21/06
|
140638
|
South Africa
|
2008/00555
|
06/21/06
|
2008/00555
|
Title: | Methods for Treatment of IL-1Beta Related Diseases |
Inventors: | Alan M. Solinger; Patrick J. Scannon; Robert J. Bauer; David Alleva |
Brazil
|
PI 0720928-2
|
12/20/07
|
|
Canada
|
2,673,592
|
12/20/07
|
|
China
|
200780051536.4
|
12/20/07
|
CN 101616690A
|
Hong Kong
|
10102012.8
|
02/25/10
|
1135323A
|
India
|
4626/DELNP/2009
|
12/20/07
|
|
Indonesia
|
W00 2009 01721
|
12/20/07
|
050.2064A
|
Mexico
|
MX/a/2009/006709
|
12/20/07
|
299543
|
Russia
|
2009127066
|
12/20/07
|
|
South Africa
|
2009/04660
|
12/20/07
|
2009/04660
|
Title: | Methods for Treatment of Gout |
Inventors: | Alan M. Solinger |
Title: | Methods for the Treatment of Rheumatoid Arthritis |
Inventors: | Alan M. Solinger, Alexander Owyang |
COUNTRY
|
APPLICATION NO.
|
FILE DATE
|
PATENT/PUBLICATION
|
US Provisional
|
61/059,711
|
06/06/08
|
|
US Provisional
|
61/095,232
|
09/08/08
|
|
PCT
|
PCT/US09/46441
|
06/05/09
|
WO 2009/149370
|
Canada
|
2,727,171
|
12/06/10
|
|
Australia
|
2009256072
|
12/14/10
|
|
Europe:
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Austria
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Belgium
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Bulgaria
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Croatia
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Cyprus
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Czech Repub
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Denmark
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Estonia
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Finland
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
France
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Germany
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Greece
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Hungary
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Iceland
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Ireland
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Italy
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Latvia
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Lithuania
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Luxembourg
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Macedonia
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Malta
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Monaco
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Netherlands
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Norway
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Poland
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Portugal
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Romania
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Slovak Repub
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Slovenia
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Spain
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Sweden
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Switzerland/
Liechtenstein
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Turkey
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
UK
|
09 759 528.4
|
12/22/10
|
2293816 B1
|
Title: | Methods for Treating or Preventing IL-1Beta Related Diseases |
Inventors: | Patrick J. Scannon, Alan M. Solinger, Robert J. Bauer |
COUNTRY
|
APPLICATION NO.
|
FILE DATE
|
PATENT/PUBLICATION
|
US Provisional
|
61/094,842
|
09/05/08
|
|
US Provisional
|
61/121,451
|
12/10/08
|
|
PCT
|
PCT/US09/56086
|
09/04/09
|
WO 2010/028275
|
Australia
|
2009289547
|
03/03/11
|
|
Canada
|
2,735,940
|
03/02/11
|
|
Europe
|
09 812 306.0
|
04/04/11
|
2 341 936 A1
|
Title: | METHODS FOR IMPROVEMENT OF BETA CELL FUNCTION |
Inventors: | Patrick J. Scannon, Alan M. Solinger, Robert J. Bauer |
COUNTRY
|
APPLICATION NO.
|
FILE DATE
|
PATENT/PUBLICATION
|
US Provisional
|
61/094,857
|
09/05/08
|
|
US Provisional
|
61/121,486
|
12/10/08
|
|
PCT
|
PCT/US09/56084
|
09/04/09
|
WO 2010/028273
|
Australia
|
2009289545
|
03/03/11
|
|
Canada
|
2,735,939
|
03/02/11
|
|
Europe
|
09 812 304.5
|
04/04/11
|
2 341 935 A1
|
Title: | CARDIOVASCULAR RELATED USES OF IL-1 β ANTIBODIES AND BINDING FRAGMENTS THEREOF |
Inventors: | Patrick J. Scannon, Alan M. Solinger, Jeffrey D. Feldstein |
COUNTRY
|
APPLICATION NO.
|
FILE DATE
|
PATENT/PUBLICATION
|
US Provisional
|
61/182,679
|
05/29/09
|
|
US Provisional
|
61/252,571
|
10/16/09
|
|
US Provisional
|
61/313,001
|
03/11/10
|
|
PCT
|
PCT/US10/36761
|
05/28/10
|
WO 2010/138939
|
Australia
|
2010253924
|
05/28/10
|
|
Australia
|
2013203560
|
04/10/13
|
|
Brazil
|
PI1011228-6
|
11/29/11
|
|
Canada
|
2,763,161
|
05/28/10
|
|
China
|
201080033031.7
|
05/28/10
|
CN 102573893A
|
EPO
|
10 781 360.2
|
12/20/11
|
EP 2 435 073 A1
|
Eurasia
|
201101643
|
12/15/11
|
|
Hong Kong
|
12108509.3
|
08/XX/12
|
1167814A
|
India
|
9944/DELNP/2011
|
12/16/11
|
|
Indonesia
|
W00 2011 04690
|
12/21/11
|
2012/01714 A
|
Israel
|
216660
|
11/28/11
|
|
Korea
|
10-2011-7031198
|
12/27/11
|
10-2012-006104
|
Mexico
|
MX/a/2011/012666
|
11/28/11
|
|
New Zealand
|
597024
|
11/12/11
|
|
Philippines
|
1-2011-502479
|
11/28/11
|
|
Singapore
|
201108772-3
|
11/28/11
|
|
South Africa
|
2011/09050
|
12/08/11
|
Title: | Methods for the treatment of IL-1Beta related conditions |
Inventors: | Alan M. Solinger, Ahmet Gül |
COUNTRY
|
APPLICATION NO.
|
FILE DATE
|
PATENT/PUBLICATION
|
US Provisional
|
61/332,658
|
05/07/10
|
|
US Provisional
|
61/334,125
|
05/12/10
|
|
US Provisional
|
61/444,638
|
02/18/11
|
|
PCT
|
PCT/US11/35646
|
05/06/11
|
WO 2011/140522
|
Australia
|
2011249854
|
05/06/11
|
|
Australia
|
2013203214
|
04/09/13
|
|
Brazil
|
BR 11 2012 028557 2
|
05/06/11
|
|
Canada
|
2,797,846
|
05/06/11
|
|
China
|
201180022684.X
|
05/06/11
|
2013-509314
|
Europe
|
11778465.2
|
05/06/11
|
2 566 520 A
|
Eurasia
|
201201526
|
05/06/11
|
|
India
|
9496/DELNP/2012
|
05/06/11
|
|
Indonesia
|
W00201204922
|
05/06/11
|
|
Israel
|
222890
|
05/06/11
|
|
Korea
|
10-2012-7031454
|
05/06/11
|
|
Mexico
|
MX/a/2012/012901
|
05/06/11
|
|
New Zealand
|
603191
|
05/06/11
|
|
Philippines
|
1-2012-502143
|
05/06/11
|
|
Singapore
|
201208230-1
|
05/06/11
|
|
South Africa
|
2012/08172
|
05/06/11
|
Title: | METHODS FOR TREATING ACNE |
Inventors: | Paul Rubin |
COUNTRY
|
APP. NO.
|
FILE DATE
|
PATENT/PUBLICATION
|
US Provisional
|
61/577,450
|
12/19/11
|
|
PCT
|
PCT/US12/70734
|
12/19/12
|
Borrower
|
XOMA (US) LLC
|
|
By:
|
||
Printed Name:
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Title:
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1. | DEFINITIONS AND INTERPRETATION |
2. | DISCHARGE AND RELEASE |
2.1.1. | RELEASES and DISCHARGES unto the Chargor, to the extent charged by way of security in favour of the Chargee pursuant to the Fixed Charge, all rights, interests and titles in and to the Transfer Agreement present or future; |
2.1.2. | RELEASES and DISCHARGES unto the Chargor, to the extent charged by way of security in favour of the Chargee pursuant to the Fixed Charge, all rights, interests and titles in and to the Intellectual Property Rights, including without limitation, all Intellectual Property Rights specified in the schedule attached to the Fixed Charge; and |
2.1.3. | RELEASES and DISCHARGES the Chargor from all obligations, absolute and contingent, pursuant to the Fixed Charge and all claims and demands thereunder, so that such obligations, claims and demands are, with effect from the execution and delivery of this Deed, discharged and of no further effect. |
3. | INVALIDITY |
3.1.1. | the legality, validity or enforceability in that jurisdiction of any other provision of this Deed; or |
3.1.2. | the legality, validity or enforceability in any other jurisdiction of that or any other provision of this Deed. |
4. | REPRESENTATIONS AND WARRANTIES |
4.1.1. | it has full power and authority to execute, deliver and perform its obligations under this Deed; and |
4.1.2. | this Deed constitutes its legal, valid and binding obligations enforceable against it in accordance with its terms. |
5. | FURTHER ASSURANCES |
6. | COUNTERPARTS |
7. | GOVERNING LAW |
By:
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Name:
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Title:
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For and on behalf of LES LABORATOIRES SERVIER
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By:
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Name:
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Title:
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Date:
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Subsidiaries of the Company
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Jurisdiction of Organization
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XOMA Ireland Limited
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Ireland
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XOMA Technology Ltd.
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Bermuda
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XOMA (US) LLC
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Delaware
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XOMA Commercial LLC
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Delaware
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XOMA CDRA LLC
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Delaware
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XOMA UK Limited
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United Kingdom
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1. | I have reviewed this annual report on Form 10-K of XOMA Corporation; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f))) for the registrant and we have: |
a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. |
c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function): |
a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: March 11, 2015
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/s/ JOHN VARIAN
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John Varian
Chief Executive Officer
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1. | I have reviewed this annual report on Form 10-K of XOMA Corporation; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f))) for the registrant and we have: |
a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. |
c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function): |
a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: March 11, 2015
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/s/ FRED KURLAND
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Fred Kurland
Vice President, Finance, Chief Financial Officer and Secretary
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/s/ JOHN VARIAN
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John Varian
Chief Executive Officer
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/s/ FRED KURLAND
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Fred Kurland
Vice President, Finance, Chief Financial Officer and Secretary
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· | Advanced all gevokizumab clinical studies, including initiating the Phase 3 EYEGUARD™-US study in U.S. patients with Behçet’s disease uveitis and the Phase 3 study in patients with pyoderma gangrenosum. |
· | Completed enrollment of eight patients in the gevokizumab open-label proof of concept clinical trial in patients with active, non-infectious, anterior scleritis being conducted under Dr. Nida Sen’s leadership at The National Eye Institute (NEI). The study objectives were to evaluate the safety and possible efficacy of gevokizumab in patients with active scleral inflammation at baseline. Although the study is still ongoing, 6 of the 8 study participants had a positive response in the first 16 weeks of gevokizumab treatment, based on a standardized scale. The Company will be working with NEI to design a possible multi-center controlled trial in this difficult to treat condition. |
· | Successfully completed the Phase 1 clinical study of XOMA 358, a fully human, allosteric monoclonal antibody that inhibits both the binding of insulin to its receptor and downstream insulin signaling. The results from this Phase 1 study, presented at ENDO 2015, show XOMA 358 down-regulates the insulin receptor and its downward signaling. XOMA 358 is being evaluated for the treatment of non-drug-induced, endogenous hyperinsulinemic hypoglycemia (low blood glucose caused by excessive insulin produced endogenously). |
· | Strengthened the Company’s financial position by raising $37.7 million, after deducting offering costs and out-of-pocket expenses, through the sale of units at a price of $4.94. Each unit includes a share of common stock and an accompanying warrant with a term of two years to purchase one additional share of common stock at an exercise price of $7.90 per share. |
· | Renegotiated terms of the SERVIER loan agreement. The loan now will be repaid in three annual payments, beginning on January 15, 2016, and ending January 15, 2018, rather than being due in its entirety on January 15, 2016. |
· | Obtained a $20.0 million secured loan from Hercules Technology III, L.P., as lender, and affiliate of Hercules Technology Growth Capital, Inc., as agent; a portion of the proceeds from which were used to repay a portion of existing indebtedness with the remaining proceeds to be used for general corporate purposes. |
· | Announced the promotion of Thomas Burns to Chief Financial Officer and the retirement of Fred Kurland. |
Three months ended
December 31,
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Twelve months ended
December 31,
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2014
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2013
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2014
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2013
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Revenues:
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License and collaborative fees
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$
|
1,069
|
$
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8,450
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$
|
5,683
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$
|
11,028
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Contract and other
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3,279
|
4,084
|
13,183
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24,423
|
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Total revenues
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4,348
|
12,534
|
18,866
|
35,451
|
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Operating expenses:
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Research and development
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19,378
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22,946
|
80,748
|
74,851
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Selling, general and administrative
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4,097
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5,049
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19,866
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18,477
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Restructuring
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-
|
119
|
84
|
328
|
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Total operating expenses
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23,475
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28,114
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100,698
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93,656
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Loss from operations
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(19,127
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)
|
(15,580
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)
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(81,832
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)
|
(58,205
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)
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Other income (expense):
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Interest expense
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(1,008
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)
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(1,137
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)
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(4,303
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)
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(4,631
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)
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Other income (expense), net
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729
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(287
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)
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2,061
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(197
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)
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Revaluation of contingent warrant liabilities
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12,088
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(35,294
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)
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45,773
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(61,039
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)
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Net loss before taxes
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(7,318
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)
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(52,298
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)
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(38,301
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)
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(124,072
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)
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Provision for income tax (expense) benefit
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-
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(1
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)
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-
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14
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Net loss
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$
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(7,318
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)
|
$
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(52,299
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)
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$
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(38,301
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)
|
$
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(124,058
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)
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Basic net loss per share of common stock
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$
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(0.07
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)
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$
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(0.55
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)
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$
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(0.36
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)
|
$
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(1.43
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)
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Diluted net loss per share of common stock
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$
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(0.12
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)
|
$
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(0.55
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)
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$
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(0.67
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)
|
$
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(1.43
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)
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Shares used in computing basic net loss per share of common stock
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109,415
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95,048
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107,435
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86,938
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Shares used in computing diluted net loss per share of common stock
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116,563
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95,048
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115,333
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86,938
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Other comprehensive loss:
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Net loss
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$
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(7,318
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)
|
$
|
(52,299
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)
|
$
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(38,301
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)
|
$
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(124,058
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)
|
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Net unrealized gain (loss) on available-for-sale securities
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-
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(1
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)
|
1
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(9
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)
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Comprehensive loss
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$
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(7,318
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)
|
$
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(52,300
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)
|
$
|
(38,300
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)
|
$
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(124,067
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)
|
December 31,
2014
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December 31,
2013
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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78,445
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$
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101,659
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Short-term investments
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-
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19,990
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||||||
Trade and other receivables, net
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3,309
|
3,781
|
||||||
Prepaid expenses and other current assets
|
2,088
|
1,630
|
||||||
Total current assets
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83,842
|
127,060
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Property and equipment, net
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5,120
|
6,456
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||||||
Other assets
|
669
|
1,266
|
||||||
Total assets
|
$
|
89,631
|
$
|
134,782
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LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
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||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
5,990
|
$
|
9,616
|
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Accrued and other liabilities
|
9,892
|
9,934
|
||||||
Deferred revenue - current
|
1,089
|
2,218
|
||||||
Interest bearing obligations – current
|
19,247
|
5,835
|
||||||
Accrued interest on interest bearing obligations – current
|
257
|
2,042
|
||||||
Total current liabilities
|
36,475
|
29,645
|
||||||
Deferred revenue – long-term
|
1,939
|
4,105
|
||||||
Interest bearing obligations – long-term
|
16,290
|
35,150
|
||||||
Contingent warrant liabilities
|
31,828
|
69,869
|
||||||
Total liabilities
|
86,532
|
138,769
|
||||||
Stockholders’ equity (deficit):
|
||||||||
Common stock, $0.0075 par value, 277,333,332 and 138,666,666 shares authorized at December 31, 2014 and 2013, respectively, 115,892,450 and 105,386,216 shares issued and outstanding at December 31, 2014 and 2013, respectively
|
869
|
787
|
||||||
Additional paid-in capital
|
1,121,707
|
1,076,403
|
||||||
Accumulated comprehensive loss
|
-
|
(1
|
)
|
|||||
Accumulated deficit
|
(1,119,477
|
)
|
(1,081,176
|
)
|
||||
Total stockholders’ equity (deficit)
|
3,099
|
(3,987
|
)
|
|||||
Total liabilities and stockholders’ equity (deficit)
|
$
|
89,631
|
$
|
134,782
|