UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report: April 29, 2022
(Commission File No. 001-39308)
CALLIDITAS THERAPEUTICS AB
(Translation of registrant’s name into English)
Kungsbron 1, D5
SE-111 22
Stockholm, Sweden
(Address of registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
Annual Report 2021
On April 27, 2022, Calliditas Therapeutics AB (the "Company") published its Annual Report 2021, a copy of which is attached hereto as Exhibit 99.1. In addition, on April 27, 2022, the Company published an announcement, a copy of which is attached hereto as Exhibit 99.2. The Company published an additional announcement on April 29, 2022, a copy of which is attached hereto as Exhibit 99.3. The information contained in Exhibits 99.1, 99.2 and 99.3 is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
EXHIBIT INDEX
Exhibit | Description |
99.1 | Annual Report 2021 |
99.2 | Company announcement dated April 27, 2022 |
99.3 | Company announcement dated April 29, 2022 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
CALLIDITAS THERAPEUTICS AB | ||
Date: April 29, 2022 | By: | /s/ Fredrik Johansson |
Fredrik Johansson | ||
Chief Financial Officer |
Exhibit 99.1
ANNUAL REPORT 2021 |
Calliditas Therapeutics is a commercial stage biopharma company based in Stock- holm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic dis- eases with significant unmet medical needs. Calliditas’ lead product, TARPEYO, has been approved by the FDA as the first and only treatment of IgA nephropathy (IgAN), indicated for reduction of proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a UPCR of ≥1.5g/gram. Calliditas has also filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for this drug product. Additionally, Calliditas is conducting a pivotal clinical trial with the first in class NOX inhibitor product candidate setanaxib in primary biliary cholangitis and is also initiating a Phase 2 study with setanaxib in head and neck cancer. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com for further information. About Calliditas Contents The Annual Report of Calliditas Therapeutics AB (publ), 556659-9766, is comprised of directors report, the Group's and the Parent Company's financial statements with notes and audit report (pages 28-85). About Calliditas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 03 January – December 2021 Business Highlights . . . . . . . . . . . . . . . . . . . 04 CEO Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 06 Regulatory Submissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 08 TARPEYO Approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 IgA Nephropathy Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Commercialization in the US . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Interview with Dr Brad Rovin . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Commercialization in Europe . . . . . . . . . . . . . . . . . . . . . . . . . . 17 NEFECON Milestones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Pipeline: A NOX Inhibitor Platform . . . . . . . . . . . . . . . . . . . . . . . . 20 Environmental, Social, and Corporate Governance . . . . . . . . . . . . . . . . . 24 The Share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Board of Directors' Report . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 The Group Consolidated Statements of Income . . . . . . . . . . . . . . . . . . . . . . . 36 Consolidated Statements of Comprehensive Income . . . . . . . . . . . . . . . . 37 Consolidated Statements of Financial Position . . . . . . . . . . . . . . . . . . . 38 Consolidated Statements of Changes in Equity . . . . . . . . . . . . . . . . . . . 39 Consolidated Statements of Cash Flows . . . . . . . . . . . . . . . . . . . . . 40 Notes to Consolidated Financial Statements . . . . . . . . . . . . . . . . . . . . 41 Parent Company Parent Company Statements of Income . . . . . . . . . . . . . . . . . . . . . . 68 Parent Company Statements of Comprehensive Income . . . . . . . . . . . . . . . 68 Parent Company Balance Sheet . . . . . . . . . . . . . . . . . . . . . . . . . 69 Parent Company Statements of Changes in Shareholders' Equity . . . . . . . . . . . 71 Parent Company Statements of Cash Flows . . . . . . . . . . . . . . . . . . . . 72 Notes to Financial Statements . . . . . . . . . . . . . . . . . . . . . . . . . 73 Auditor's report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 Corporate Governance Report . . . . . . . . . . . . . . . . . . . . . . . . . . 86 Board of Directors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92 Management Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 Scientific Steering Commitee . . . . . . . . . . . . . . . . . . . . . . . . . . 96 Financial Calendar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 02 03 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 |
The first patient was enrolled in November 2018, and two years later Calliditas read out positive topline data from Part A, with statistically significant results both for the primary endpoint of proteinuria reduction, as well as for eGFR at 9 months, which alongside the results of the NEFIGAN trial formed the basis for the submission of an NDA with the FDA, which sought accelerated approval under Subpart H for the 505(b)(2) application. To compile all the data and materials that had been accumulated over a decade of clinical development was an enormous undertaking: thousands of pages, graphs and tables needed to be produced, edited, reviewed and double checked. Our NDA consisted of 1,198 docu- ments which, if printed, would amount to 75,533 pages. Shortly after this submission, we also filed an MAA with the EMA. Though some of the documents used in the NDA filing could be used also for the regulatory process in Europe, many were EU specific and thus had to be created, compiled and checked separately. The MAA ultimately consisted of 576 documents amounting to a total of 38,442 pages, submitted as one electronic document with 18,896 links and 4,055 hyperlinks. Both of these submissions, which were filed on time as planned, represented a hugely significant achievement and reflected the hard work of many different people in the company, guided by our regulatory team. The FDA’s approval of our drug, TARPEYO, on December 15 2021, was the perfect culmination of this long and rigorous regulatory journey, and most impor- tantly finally brought a product to market for IgAN patients who have long been waiting for a drug specifi- cally designed and approved for this rare indication. The Biotechnology innovation organization Amplion and Biomedtracker recently published the largest study of clinical drug development success rates to date, covering 2006-2015 and a total of 9,985 clinical and regulatory phase transitions. The study aimed to measure clinical development success rates with a broad set of data to strengthen benchmarking metrics for company sponsored, FDA registration enabling drug development programs. It revealed that only 9.6% of drug development programs from start to finish successfully make it to market. In 2021 specifically, there were 95 total approvals by the FDA, and we were incredibly proud to be counted among them. It is truly exciting to be leading the field globally in this indication after many years of development and collaboration within the area of nephrology. 2021: The culmination of a long but exciting regulatory journey At the end of the year, Calliditas achieved a huge milestone when the FDA approved our drug for IgA nephropathy, an achievement that was the result of over a decade of clinical development and regulatory interaction. This journey began with discussions on how to target the origins of this autoimmune kidney disease in the 1990s between Professors Fellström and Hällgren, who patented the underlying concept to target the gut, the presumed origin of the disease. Two decades later, Calliditas submitted two landmark regulatory filings with the FDA and EMA, seeking approval in this indica- tion for the first time. The regulatory undertaking began with a Phase 2a trial in 16 Swedish patients, who were treated for six months followed by a three month follow up period, which read out positive data in 2009. The following year, Calliditas was granted US orphan drug designa- tion for this product, by then named Nefecon. This laid the foundation for the company to initiate the largest, at the time, study ever conducted in IgA nephropathy, a Phase 2b randomized double-blinded, placebo-con- trolled clinical trial assessing the safety and efficacy of two different doses of Nefecon over a nine-month treatment period. This study, named NEFIGAN, was conducted in 62 centers across 10 European countries; it originally intended to recruit 90 patients but over-re- cruitment almost doubled this number, and ultimately the study read out positive data on over 150 patients. It was at the end of Phase 2b meeting in January 2017 that Calliditas received a groundbreaking acceptance of proteinuria as a surrogate marker for accelerated approval, which marked the first time that the FDA allowed the use of this surrogate endpoint for a Phase 3 nephrology study. Calliditas helped to pioneer this regulatory pathway, collaborating on a meta-analysis – published in 2016 – with Professor Inker at Tufts University and the National Kidney Foundation that examined the correla- tion between changes in urine protein and clinical end points at individual and trial levels. Calliditas subsequently agreed with the FDA on the design for our Phase 3 NefIgArd study, which is still ongoing with a total of 360 patients as a randomized, double blinded and placebo controlled trial for confir- matory purposes, and closely echoes the NEFIGAN trial. 08 09 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 REGULATORY SUBMISSIONS |
"I was ecstatic to hear of the FDA approval of Tarpeyo. It is a beacon of light for the IgAN community, a community that has been waiting for a designated treatment of the illness, not just the symptoms, for so long. We finally have hope, and I cannot wait to see the positive impact this approval will have on our community." - Judy Patients taking TARPEYO showed a statistically signif- icant 34% reduction in proteinuria from baseline vs 5% in the placebo cohort at 9 months. The treatment effects for the primary endpoint of UPCR at 9 months were consistent across key subgroups, including key demographic and baseline disease characteristics. The second part of the NefIgArd study, Part B, is a confirmatory validation study in which no TARPEYO treatment will be administered and which will assess eGFR at two years. Each patient will be dosed for 9 months and then monitored off-drug for the remainder of the trial period, generating an aggregate of 15 months of follow-up data. Calliditas intends to complete Part B in early 2023, subject to any impact from the COVID-19 pandemic to our business. Calliditas has been granted orphan drug designation for the treatment of IgAN in the United States and is commercializing TARPEYO in the US on its own. TARPEYO: First ever approved treatment for IgAN On December 15th, 2021, the US Food and Drug Administration granted accelerated approval of Calliditas’ lead product, TARPEYO, indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally defined as a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g. TARPEYO is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that under- goes substantial first pass metabolism. TARPEYO is designed as a 4 mg delayed release capsule with an enteric coating so that it remains intact until it reaches the ileum. Each capsule contains beads coated with polymers and budesonide designed to target mucosal B-cells responsible for the production of the galactose-deficient IgA1 antibodies (Gd-Ag1) that are believed to cause IgA nephropathy. TARPEYO was approved by the FDA under the acceler- ated approval pathway, based on achieving its primary endpoint of reduction in proteinuria in Part A of the NeflgArd pivotal Phase 3 study, an ongoing, random- ized, double-blind, placebo-controlled, multi-center- study conducted to evaluate the efficacy and safety of TARPEYO 16 mg once daily vs placebo in adult patients with primary IgAN. The effect of TARPEYO was assessed in patients with biopsy-proven IgAN, eGFR ≥35 mL/min/1.73 m2, and proteinuria (defined as either ≥1 g/day or UPCR ≥0.8 g/g) who were on a stable dose of maximally-tolerated RAS inhibitor therapy. Part A of the study included a 9-month blinded treatment period and a 3-month follow-up period. The primary endpoint was UPCR, and eGFR was a secondary endpoint. “As a IGAN patient the approval of Tarpeyo finally gives hope for new treatment. I am thankful for Calliditas to see the need and spend the time to be the first company to get a treatment for FDA approval.” - John 10 11 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 »TARPEYO (developed under the project name NEFECON) is the first ever and only approved FDA-approved treatment for IgA Nephropathy« TARPEYO APPROVAL |
ronmental, bacterial and dietary factors is presumed to lead to an increased production of these galac- tose-deficient IgA antibodies. This increased produc- tion, potentially in conjunction with increased intestinal permeability, leads to these antibodies appearing in the blood. The galactose-deficient spot at the hinge region of the IgA antibodies is immunogenic when found in the circu- lation. It therefore generates an autoimmune response, attracting autoantibodies in the form of IgG or IgA and forming pathogenic immune complexes that deposit in the glomeruli, the kidney’s filtration apparatus. The trapped immune complexes initiate an inflammatory response which damages the kidney and ultimately destroys its filtration mechanism. This leads to slow, progressive deterioration of renal function, which in many patients ultimately results in the need for dialysis or kidney transplant. Treatment landscape for IgAN patients With the exception of TARPEYO, which is approved in the United States, there are currently no approved treatment options for IgAN. Kidney Disease Improving Global Outcomes 2012 (KDIGO) recommended the use of blood pressure lowering agents that inhibit or block the renin angiotensin system (RAS) using either angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs). RAS blockade reduces the pressure in the kidney glomeruli, thereby reducing leakage and protein excretion in urine. Treat- ment via RAS inhibition is supportive only, and does not address the underlying cause of IgAN. In the absence of approved treatments, some physi- cians try to control the disease progression with a variety of off-label treatments that include systemic immunosuppressive agents, usually high doses of systemic corticosteroids. However, research is incon- clusive as to whether or not it has any impact on the actual underlying kidney disease as measured by eGFR. In addition, this off label treatment is known to result in serious adverse events. There is therefore a high unmet medical need for a treatment that targets the disease origin and can also be well-tolerated by IgAN patients. IgAN Disease Background IgAN is a serious progressive autoimmune disease of the kidney, in which up to 50% of patients end up at risk of developing end-stage renal disease (ESRD) within ten to twenty years. The standard of care for ESRD is dialysis or kidney transplant, which represents a significant health economic burden as well as a mate- rial impact on patients’ quality of life. IgAN is an orphan disease that we estimate affects approximately 130,000 – 150,000 people in the US and approximately 200,000 people in Europe. A signifi- cantly higher prevalence of IgAN has been observed in Asia, including in Greater China, where it has histor- ically been a leading cause of ESRD and where we estimate that IgAN affects approximately 2,000,000 people. IgAN Pathophysiology Although IgAN manifests in the kidney, the evidence indicates that it is a disease that starts in the distal part of the intestine, specifically in the ileum. Peyer’s patches, which are concentrated within the gut-associ- ated lymphoid tissue in the ileum, have been identified as a major source of mucosal-type IgA1 antibodies. IgA1 antibodies play a key role in the immune system, protecting the body from foreign substances such as food-derived factors, bacteria and viruses. Patients with IgA nephropathy have elevated levels of mucosal-type IgA, and studies have shown that the type of IgA that deposits in the glomeruli in patients with IgAN is iden- tical to the mucosal-type IgA produced in the gut. The majority of the IgA in the blood circulation is monomeric, heavily O-galactosylated and is derived from bone-marrow-residing plasma cells. In contrast, the mucosal-type IgA antibodies produced by the Peyer’s patches are predominately dimeric or poly- meric and are galactose deficient. In IgAN patients, a combination of a genetic predisposition and of envi- Overview of the disease Hinge region IgA1 BONE MARROW Hinge region of IgA1 is monomeric, heavily glycosylated MUCOSAL SURFACES Hinge region of IgA1 is dimeric/polymeric, poorly glyco- sylated, or galactose-deficient J chain GalNAc GAL GalNAc GAL SA SA SA GalNAc GAL GalNAc SA The structure of IgA antibodies varies depending on where they are produced IgA nephropathy (IgAN) – also known as Berger’s disease – is the most common form of glomerulonephritis, a chronic inflammatory condition of the kidney, in the Western world. 12 13 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 Peyer’s patches located in the ileum (i.e. GALT) Mucosal infection primes naïve B cells IgG2,3 IgG-IC1 BAFF4 APRIL4 Glycan-specific IgG anti- bodies6 Mucosal-type IgA12,5,7 Mesangial accumulation of pathogenic IgA immune complexes deposited from the circulation and/or formed in situ in the glomerular mesangium Amplification of pathogenic IgA immune complexes Generation of reactive IgG and IgA autoantibodies Formation of pathogenic IgA immune complexes Mucosal-type IgA-IC1 Immune response Infection Cytokines IgA+ B cells mis traffic into circulation Secretion of high-levels of mucosal-type dimeric/polymeric IgA1 into the circulation Mucosal-type IgA-IC1 TLR recognition naïve B cells IGA NEPHROPATHY |
The US Market Calliditas is commercializing TARPYEO in the US with a targeted commercial infrastructure and primary focus on the specialist physicians (nephrologists) treating the IgAN patient population. We estimate the prevalence of IgAN in the US to be between 130,000 – 150,000 with up to 50% of these patients progressing and ending up at risk of developing end stage renal disease (ESRD.) Commercial Launch Readiness In 2021, Calliditas was focused on getting its commer- cial infrastructure in place in preparation for an FDA approval. Calliditas focused its pre-commercial efforts on disease education, market access and patient advo- cacy with the goal of facilitating appropriate access to TARPEYO for the patients for which it can fulfil an unmet medical need. Prior to approval, the focus was on medical education supported by unbranded disease state education and preparations, as well as market access preparations to ensure the successful commer- cialization of TARPEYO in early Q1 2022. We have an experienced medical affairs, market access, marketing, and sales leadership team, with an average tenure of over 20 years. In March, we welcomed three additional industry veterans to the Calliditas team responsible for key functional areas of Medical Affairs, Marketing and Sales. Warren Brooks, PhD, our Vice President of US Medical Affairs, joined Calliditas from Regeneron, where he served as a Senior Director, National Lead in Immunology in Medical Affairs. Teona Johnson, Head of US Marketing, joined Calliditas after spending over 10 years in leadership roles in marketing at Pfizer Inc and bringing over 15 years of marketing experience which includes a proven track record of successfully launching and growing brands in the biopharmaceutical industry. Our Head of Sales, David Ferraro, joined the team from Kyowa Kirin, Inc., a global specialty pharmaceutical company, where he served as the National Sales Director for the Oncology / Rare Disease business unit. Medical Affairs: Our medical science liaison team, which was initially formed in early 2020, continued its work in establishing relationships and collaborating with our advisory boards and with key opinion leaders (KOLs) on how to best address and educate our audience. In 2021, we were also well published and active at the relevant congresses, attending the International Symposium on IgA Nephropathy (IIGANN), the ERA EDTA Congress and the International Symposium on IgA Nephropathy (IIGANN). Calliditas also published two posters at the American Society of Nephrology Commercialization in the US (ASN) Digital Kidney Week 2021 in the ‘Glomerular Diseases: Immunology and Inflammation in IgANP, C3GP, TMA, and Nephrotic Diseases’ session. Dr Karen Molyneux from the Mayer IgA Nephropathy Laboratory at the University of Leicester presented a poster titled “Targeted Release Formulation Budesonide Selectively Reduces Circulating Levels of Chemokines Critical to Immune Cell Trafficking to Peyer Patches in IgA Nephropathy”. In addition, Laura Pérez-Alós presented research on how “Treatment with Targeted Release Formulation Budesonide Modulates the Complement System in Patients with IgA Nephropathy”. Market Access: Calliditas has done extensive work in market access over the past several years. During 2021 we developed and implemented the optimal trade and distribution path for TARPEYO. This included selecting and part- nering with two of the industry’s best in ICS from AmerisourceBergen and our exclusive specialty pharmacy Biologics, a McKesson company. Our national account managers were in the field in the months leading up to approval, holding and arranging meetings with payers to educate them on IgAN – as this marked the first time that a company approached them to treat this rare disease. TARPEYO is priced according to the value it offers patients and towards reducing IgAN disease burden on society. Value was assessed according to clinical, economic, and societal benefits, factoring in both established and innovative treatments that are currently available. We believe health insurance will provide broad coverage of TARPEYO, and Calliditas is committed to help ensure that all appropriate patients will have access to this medication. Upon approval we launched TARPEYO Touchpoints TM, a full-service patient and provider support program, offering services, assistance and resources designed to accelerate and streamline access to TARPEYO for the appropriate patients. The program utilizes Biologics by McKesson’s PharmacyElite TM model, which integrates the Hub and exclusive Specialty Pharmacy services under one roof. We have a dedicated team of Care Navigators (dedicated Case Managers), as well as a designated Rare Pod Team which contains nurses, phar- macists, and a fulfilment and distribution team. Sales Force Readiness Our Head of Sales, David Ferraro, has brought on a tenured sales management team, who spent Q2 and Q3 recruiting territory representatives based on rare disease, specialty product, and nephrology market experience. This was extremely important to us as we prepared for both in-person and remote interactions with our target audience. Calliditas had filled all sales territories with contingent offers that became effective upon FDA approval. Our field force of 40 sales repre- sentatives is sized and designed to provide the optimal reach and frequency of nephrologists treating the IgAN patient population. Our sophisticated segmentation, targeting and customer relationship management system will prepare the field force to begin face to face promotion in early Q1 2022. In summary, during 2021 we secured the necessary partnerships to ensure an efficient, timely and optimal launch strategy. Our trade, distribution and patient support services were all operational and our launch campaigns were developed and tested for both in person and remote interactions in advance of approval. We continued to build on our work with an eager, focused, and receptive nephrology and IgAN advocacy community and remained on target for a commercial launch of TARPEYO in the US in January 2022. Callid- itas officially announced the commercial availability and initial sales of TARPEYO on January 28th 2022. » During 2021 we secured the necessary partnerships to ensure an efficient, timely and optimal launch strategy.« 14 15 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 COMMERCIALIZATION PLAN MARKET ACCESS MEDICAL AFFAIRS |
Historically, what have the challenges been when approaching the treatment of IgAN? The biggest challenge is trying to tell the patient that after many years of study we still don’t know how to treat IgAN, and all that can be offered is good blood pressure control, RASi inhibition, and systemic gluco- corticoids, with all of their side effects. What does it mean broadly for nephrologists and patients to have the first approved medication for this indication? Several important points. It shows that the nephrology community, the IgAN patient community, and the FDA can all work together to make progress in this disease. I think it also give patients hope and faith in the medical research enterprise. What approach do you currently take to treating your IgAN patients? I generally start all patients on RAS inhibition as soon as the diagnosis is established. My goal is to minimize proteinuria, and while I am happy if I can get the patient below 1 g/d, I really want them below 500 mg/d. How do you think the TARPEYO approval will shift your approach to treating your patients? I am hopeful this will greatly attenuate my use of systemic glucocorticoids for IgAN patients. After giving suffi- cient time with RAS inhibition, I would pivot and add TARPEYO. Having TARPEYO available affords me the option of thinking about treatment for IgAN as multi- target. For example, if patients do not respond to RASi the way we want, we generally keep pushing the dose up and/or add another RASi, like an aldosterone antagonist. It may be better tolerated and avoid issues like hypoten- sion or increased serum creatinine to use a reasonable dose of RASi, and if blood pressure is controlled appropri- ately to move directly to a drug with a different mecha- nism of action to try and generate synergy. Interview with Dr. Brad Rovin Dr Brad Rovin is the Director of the Division of Nephrology and the Vice Chairman of Medicine for Research at the Ohio State University Wexner Medical Centre. He is also the Lee A. Hebert Distinguished Professor of Nephrology at OSU. As a nephrologist, Dr. Rovin specializes in autoimmune kidney diseases, with a focus on how the immune system interacts with the kidney and causes renal inflammation and injury. 16 17 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 COMMERCIALIZATION PLAN In July 2021, Calliditas announced a deal with STADA covering European Economic Area (EEA) member states, Switzerland and the UK valued at a total of 97.5 million EUR ($115m), plus royalties. Under the terms of the agreement, Calliditas received an initial upfront payment of 20 million EUR ($24m) upon signing and is entitled to up to an additional 77.5 million EUR ($91m) in future payments linked to pre-defined regulatory and commercialization milestones. STADA is also due to pay tiered royalties on net sales expressed as a percentage between the low twenties and the low thirties. Calliditas is advancing its delayed release formula- tion of budesonide under the development name “NEFECON®” outside of the US. Calliditas submitted a Marketing Authorization Application for NEFECON to the European Medicines Agency in May 2021. The submission was based, as was the submission to the FDA, on positive data from Part A of the NefIgArd pivotal Phase 3 study and on the Phase 2b NEFIGAN study, which also met both its primary endpoint of proteinuria reduction and key secondary endpoint of eGFR stabilization at 9 months. While Calliditas was initially granted Accelerated Assessment procedure by EMA’s Committee for Human Medicinal Products (CHMP), in September 2021 the EMA announced its decision to continue the assess- ment of the MAA for NEFECON under standard proce- dure assessment timelines. Calliditas excepts a decision from the CHMP in the second quarter of 2022. IgAN is designated as an orphan disease in both the US and Europe. In Europe, an orphan disease is defined as a disease or condition affecting no more than five in 10,000 European citizens with no satisfactory method of diagnosis, prevention or treatment. Orphan incen- tives consist of ten years of market exclusivity from the grant date of marketing approval in the EU, protocol assistance and scientific advice, fee reductions on EMA procedural activities and eligibility for EU grants. Commercialisation in Europe: STADA Deal This year, Calliditas and STADA Arzneimittel AG entered into a license agreement to register and commercialize NEFECON for the treatment of the IgA nephropathy in Europe. »In July, Calliditas announced a deal with STADA covering EEA member states, Switzerland and the UK« |
2007–2011 è The Phase 2a study is completed with positive results è Calliditas obtains orphan designation for NEFECON in the US è NEFECON becomes the lead product candidate è Calliditas gains exclusive rights to the TARGIT formulation technology to develop and manufacture NEFECON Important milestones in the development of NEFECON 2014 è NEFECON core patents are granted in the US, Europe, China and Hong Kong 2015 è Calliditas collaborates with KHI (American Society of Nephrology) on proteinuria as a surrogate endpoint in IgAN è Calliditas announces initial results from the Phase 2b study and achieves the primary endpoint in a planned interim analysis, the only placebo-controlled, randomized study in IgAN to achieve this milestone 2016 è Calliditas obtains orphan drug designation for NEFECON in Europe è Tufts Medical Center publishes the meta- analysis study related to changes of proteinuria as a surrogate endpoint in IgAN in American Journal of Kidney Disease 2017 è Publication of results from the Phase 2b study in The Lancet è Calliditas completes a number of End of Phase 2 meetings with the EMA and FDA, achieving acceptance by the FDA in January for the use of reduction in proteinuria as an approvable endpoint for a pivotal Phase 3 study 2018 è First patient is randomized in the pivotal clinical Phase 3 study NefIgArd è Poster from Professor Barratt at IIgANN 2018 demonstrates that Nefecon modifies circulating IgA-IgG immune complex levels and levels of poorly O-Galactosylated IgA è First patient is enrolled in the pivotal Phase 3 NefIgArd study 2019 è All 200 patients are enrolled in Part A (required for market approval) of the NefIgArd study è After positive interaction with the FDA, the design of Part B of the NefIgArd study is modified, significantly reducing the number of patients required in Part B, as well as reducing the overall study duration è NEFECON is outlicensed to Everest Medi- cines, covering Greater China and Singapore 2020 è Readout of positive topline data from the Phase 3 pivotal NefIgArd Trial, which confirmed the results of the Phase 2b study, providing a basis for regulatory filings. NefIgArd became the first successful randomized, double-blind, placebo-controlled Phase 3 clinical trial carried out in IgAN è Poster is presented by Dr Molyneux at ASN Kidney Week demonstrating that Nefecon has a demonstrated impact on circulating pathogenic biomarkers (BAFF, soluble BCMA and TACI) in IgAN 2021 è First patient is dosed in open label extension trial of NefIgArd è Full recruitment of 360 patients for the post-approval confirmatory part of the NefIgArd study è NDA filing with FDA for accelerated approval in IgAN è MAA filing with EMA for conditional approval in IgAN è Posters are presented at ASN Kidney Week demonstrating that NEFECON selectively reduces circulating levels of chemokines critical to immune cell trafficking to Peyer Patches in IgAN and that NEFECON modu- lates the complement system in patients with IgAN. è FDA approves Nefecon, branded as TARPEYO in the US 18 19 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 |
20 21 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 PIPELINE Calliditas is presently launching trials with setanaxib in Primary Biliary Cholangitis (PBC) and in Squamous Cell Carcinoma of the Head & Neck (SCCHN). NOX Enzymes NOX enzyme inhibitors are a set of promising novel experimental drugs in a new therapeutic class, recognised by the WHO since 2019 when it approved “naxib” as a new stem. Nicotinamide adenine dinucle- otide phosphate (NADPH) oxidases, otherwise known as NOX enzymes, are the only known enzymes that are solely dedicated to producing reactive oxygen species (ROS) as their primary and sole function. They are transmembrane enzymes that transfer electrons from NADPH in the cytoplasm across the cell membrane, which results in the formation of ROS. There are seven NOX members, each differing in composition, modes of activation and the ROS type they produce. NOX1, NOX2, NOX3, and NOX5 transfer electrons from NADPH to molecular oxygen, producing superoxide anion (O2·−). NOX4, DUOX1 and DUOX2, meanwhile, mainly produce hydrogen peroxide (H2O2). At appropriate concentrations, ROS have essential functions in cellular signalling processes, helping to regulate cell proliferation, differentiation and migration, as well as modulating the innate immune response, inflammation and fibrosis. However, disruption of the redox homeostasis has been implicated in multiple disease pathways. Oxidative stress, caused by an excess of ROS, is a likely common underlying mech- anism for many disorders, including cardiovascular diseases, neurodegenerative disorders, and cancer disease pathways. Setanaxib inhibits NOX1 and NOX4, enzymes which are implicated in inflammation and fibrosis pathways. Clinical Development of Setanaxib Setanaxib in Primary Biliary Cholangitis (PBC) PBC Disease Background PBC is a progressive and chronic autoimmune disease of the liver that causes a cycle of immune injury to biliary epithelial cells, resulting in cholestasis and fibrosis. It is an orphan disease and, based on its known prevalence rates, we estimate that there are approxi- mately 140,000 patients in the US, where the annual incidence ranges from 0.3 to 5.8 cases per 100,000. The origin of this autoimmune response is believed to be the production of cytotoxic T-cells and B-cell derived autoantibodies directed towards the epithe- lial cells of the small bile ducts in the liver, resulting in inflammation and damage to the duct cells and eventually in the destruction of the bile ducts. This destruction results in the accumulation of increased bile acid in the liver, a condition known as cholestasis, to levels that are toxic to the liver cells, which in turn results in the destruction of liver cells and formation of fibrous tissue. Early symptoms of PBC include fatigue, itchy skin, and dry eyes and mouth. As the disease progresses, symptoms range from pain in the upper right abdomen and musculoskeletal pain to oedema, jaundice, oste- oporosis, elevated cholesterol and hypothyroidism. If untreated, active liver tissue is destroyed and replaced by fibrous tissue, leading to liver failure and the need for a liver transplant. Individuals with PBC are also at a greater risk than the general population of developing hepatocellular carcinoma. Current Approved Treatments for PBC Ursodeoxycholic acid, a generic drug also known as ursodiol or UDCA, and obeticholic acid, known as Ocaliva, are the only FDA- and EMA-approved treatments for PBC. These drugs are primarily anti- cholestatic. UDCA is a bile acid analogue which is incorporated into the bile acid pool, replacing other more toxic bile acids and reducing inflammation and A NOX Inhibitor Platform Calliditas’ pipeline contains development programs based on a first in class, novel NOX inhibitor platform that includes lead compound setanaxib, the first NOX inhibitor to reach the clinical trial stage. OXYGEN O2 SUPEROXIDE ANION O2 – HYDROGEN PEROXIDE H2 O2 cholestasis. However, while it remains the first-line therapy for patients with PBC, only 40% to 60% of patients respond adequately to UDCA. Ocaliva, a modi- fied bile acid, is a farnesoid X receptor (FXR) agonist which modulates bile acid homeostasis, decreasing bile acid synthesis and increasing its clearance. However, despite these treatment options, there is still an unmet medical need among PBC patients, in particular when it comes to important quality of life outcomes. Phase 2 Trial Setanaxib previously has been investigated in a 24 week Phase 2 trial with 111 patients and has received orphan drug designation for the treatment of PBC in the United States and Europe. Although the study did not meet its primary endpoint, it met key secondary endpoints related to change in alkaline phosphatase (ALP), liver stiffness and important quality of life metrics. Setanaxib 400mg BID achieved significant reduction in ALP of 12% vs placebo over the 24-week treatment period (p<0.001). Furthermore, in a pre-defined patient population with an estimated liver fibrosis stage of F3 or higher (defined as liver stiffness of ≥9.6 kPa), setanaxib had a more pronounced effect on ALP reduction and fibrosis. Patients with elevated liver stiffness are at greater risk of disease progression. In patients with a liver stiffness score of ≥9.6 kPa, setanaxib 400mg BID achieved a 24% reduction in ALP over the 24-week treatment period, and a 22% reduction in liver stiffness as compared to a 4% increase for placebo (p=0.038). Furthermore, there was a statistically significant impact on fatigue, a very common and frequently disabling symptom of PBC which is not currently addressed by existing therapies, as well as demonstrated positive effects on emotional and social aspects of the disease. Setanaxib has also demonstrated a favourable safety profile in a Phase 1 clinical study in healthy subjects, which evaluated the safety and pharmacokinetics of the drug at doses up to 800 mg twice daily. Mean Change from Baseline (% ) Percent reducǎon in ALP at week 24 -3.1% -1.8% -3.3% -9.7% -13.7% -5.6% -12.9% -8.7% -24.3% -30.0% -25.0% -20.0% -15.0% -10.0% -5.0% 0.0% Placebo 400mg QD 400mg BID All paǎents (n=104) <9.6 kPa (n=59) ≥9.6 kPa (n=45) Median Liver sǎffness (k Pa ) Paǎents with baseline liver sǎffness ≥ 9.6 kPa 12.3 14.1 12.1 14.2 13.1 9.1 0 2 4 6 8 10 12 14 16 Placebo (n=16) 400mg QD (n=14) 400mg BID (n=9) Baseline Week 24 |
Depicts ongoing/planned clinical trial stage: Depicts Investigator Led Trial: † Open Label Expension, intended to primarily support treatment-related considerations. * Approved under accelerated approval in the USA under the tradename TARPEYO. TARPEYOTM (budesonide) delayed release capsules is a prescription medicine used to reduce levels of protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at high risk of rapid disease progression, generally UPCR ≥ 1.5g/g. Calliditas submitted a Marketing Authorization Application for NEFECON to the European Medicines Agency in May 2021. Setanaxib is also being evaluated in an investigator led trial in DKD (Diabetic Kidney Disease). Clinical Candidate NEFECON* NEFECON Setanaxib Setanaxib Setanaxib Indication / Trial IgAN/ NefIgArd IgAN / OLE† PBC SCCHN IPF Kidney Research / Preclinical Phase 1 Phase 2 Phase 3 Marketed Our pipeline 22 23 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 PIPELINE Phase 2b/3 TRANSFORM Trial Calliditas has initiated a pivotal 52-week, randomized, placebo-controlled, double-blind, trial with an adaptive Phase 2b/3 design. Calliditas announced that the first patient was randomised in the TRANSFORM study on 15th February 2022. Setanaxib will be administered to approximately 318 patients with PBC and elevated liver stiffness as well as intolerance or inadequate response to UDCA in a global trial conducted at up to 150 investigational centres. The primary endpoint is ALP reduction, with key secondary endpoints including change in liver stiffness, and effect on pruritus (itching) and fatigue. An interim analysis will be conducted once the 99th randomized patient has completed the Week 24 visit, which is expected in Q2 or Q3 2023, and the trial is expected to read out final data in late 2024 or early 2025. In August 2021, Calliditas received FDA Fast Track Desig- nation for setanaxib in PBC. » Phase 2b Phase 3 Continue blinded treatment Continue blinded treatment Setanaxib ½ 1200mg daily* ½ 1600mg dailyǂ Blinded treatment with setanaxib ~318 Patients with PBC, elevated liver stiffness, and inadequate biochemical response/ intoler- ance to UDCA 52 WEEKS 52 WEEKS 52 WEEK Extension Phase 52 WEEK Extension Phase Interim/ futility analysis after 99th patient has completed 24 weeks of treatment Dose of 1200 mg daily or 1600 mg daily, selected based on interim analysis Setanaxib 1200mg daily* Setanaxib 1600 mg dailyǂ Placebo Placebo Setanaxib dose TBD* *Dose of 1200 mg daily administered as 800 mg AM and 400 mg PM ǂDose of 1600 mg daily administered as 800 mg AM and 800 mg PM Setanaxib in Head and Neck Cancer Calliditas is also initiating a Phase 2 clinical trial to eval- uate setanaxib in head and neck cancer. The response to immuno-oncology therapies can be affected by the tumour microenvironment, in particular by the numbers of tumour-infiltrating lymphocytes (TILs) and cancer-as- sociated fibroblasts (CAFs) in the tumour. A relationship between cancer associated fibroblasts (CAFs) and prog- nosis in Squamous Cell Carcinoma of the Head & Neck (SCCHN) has been established. NOX4 is highly over-expressed in CAFs and drives myofibroblastic activation within tumours, shielding them from CD8+ TILs. Targeting CAFs with setanaxib could improve patients’ responses to immunotherapies, and function as an adjunct therapy. There is increasing use of pembrolizumab as 1st line monotherapy in patients with relapsed or metastatic SCCHN, although response rates are low (ORR approx. 20%). Setanaxib has shown promising preclinical data in mice, reversing CAF differentiation and overcoming CD8-cell exclusion in vivo. Using a CAF-rich tumour model in mice, administration of setanaxib + pembrolizumab (versus either treatment alone) resulted in: • Improved penetration of TILs into the centre of the tumour • Slowing of tumour growth • Improved survival This research paper, ‘NOX4 Inhibition Potentiates Immu- notherapy by Overcoming Cancer-Associated Fibro- blast-Mediated CD8 T-cell Exclusion from Tumors’ (DOI: 10.1158/0008-5472.CAN-19-3158), was one of the most highly cited Cancer Research articles in 2020 and 2021 and will be featured at the American Association for Cancer Research (AACR) Annual Meeting 2022. 28 days No treatment Treatment Screening Follow up ~60 Patients ≤ 28 Days Tumour accessible for tissue biopsy Positive CAF level (de- fined as CAFs level in tumours ≥5%) No treatment Randomized, Double Blind All Enrolled Patients Tumour Biopsy 9 weeks (±1 week) Pembrolizumab 200mg IV, every 3 weeks Setanaxib 800mg PO, twice daily Matching placebo CAF = Cancer Associated Fibroblast IV = Intraveneously PO = Per os (orally) Randomization Calliditas is initiating a double-blind, randomized, placebo-controlled, proof-of-concept Phase 2 study, which will investigate the effect of setanaxib 800 mg twice daily in conjunction with pembrolizumab 200mg IV, administered every 3 weeks, in up to 60 patients with relapsed or metastatic SCCHN and tumours with moderate or high levels of CAFs. A tumour biopsy will be taken prior to randomization and again after approx- imately 9 weeks of treatment. Treatment will continue until unacceptable toxicity or disease progression, in keeping with standard practice for oncology trials. The target is to start enrollment in Q2 2022, with an interim analysis of biomarker and safety data targeted for Q4 2022 and final data read out expected in H2 2023. |
24 25 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 46 86 ESG Environmental, Social, and Corporate Governance Our drive to provide access to treatment for patients with rare diseases with a high unmet medical need is the foundation of our business. As part of our mission to serve patients, we support environmental, social and corporate governance (ESG) initiatives that are aligned with our values and that can help us positively impact our patients, our employees and our planet. We are dedicated to ensuring that we act ethically and responsibly in every area of our business, with a commitment to the highest standards of clinical development and business ethics as well as the highest safety and quality standards. Our committment to our employees 2021 was yet another year where the Calliditas team grew significantly, as the company bolstered its US team in preparation for TARPEYO’s accelerated approval and formally completed our acquisition of Genkyotex, which became a wholly owned subsidiary of Calliditas in October. This growth has made our quality systems and our internal policies even more paramount, and we remain passionately committed to cultivating a productive, diverse and inclusive work environment and to maintaining a company culture that we are extremely proud of. The success of Calliditas Therapeutics is determined by our ability to operate as a unified team as we work to earn the trust and respect of our co-workers, inves- tors, and ultimately our patients. Our company is built on a foundation of creative, productive and dedicated employees and Calliditas is committed to ensuring equal opportunities for everyone to flourish and contribute to our overall mission. We look to promote ethical behaviour amongst our team through our company values and our employee code of conduct, and we view our employees as essential to helping us maintain a work environment that meets a high ethical standard. Every member of the Calliditas team is expected and encouraged to ask questions, seek guid- ance and report suspected violations of this code. We also strongly believe in cultivating engagement across the different teams in our company and encour- aging open communication. Employees have access to management, and receive regular feedback, including at yearly employee review sessions. The senior leadership team holds quarterly town hall meetings as a forum to share details about the progress made and plans for the future, and to foster an open dialogue with employees about the direction and objectives of the company. We are always seeking feedback and input to ensure that employees have the resources and support they need to be successful in their role and to contribute to the company’s mission. We also encourage an appro- priate work-life balance as we aim to maintain healthy employees and a healthy work environment. We are proud to offer a safe, inclusive, and stimulating work- place with equal development opportunities for all. Commitment to Safety and Environmental Responsibility Calliditas understands the importance of acting in OUR VALUES A gility Experti se I n t e g r i t y P i o n e e r i n g Our Vision: To leverage our interdisciplinary expertise in pharmaceutical product development to identify, develop and market high value new medicines in niche indications, in which there is a significant unmet medical need and where the company can partially or completely drive and participate in the commercialization of the product. an environmentally conscious way, and we always strive to be mindful of how our business operations could be impacting the planet. Our offices in New York and Stockholm are equipped with energy saving features like smart outlets, energy efficient lightbulbs and motion activated lights in common areas and bathrooms. While business travel is important to our company, with employees based across Europe and the United States, we are always mindful of our envi- ronmental impact, and have positioned our offices in areas with excellent transport links so as to encourage employees to utilize public transport. Calliditas is also committed to rigorous safety stan- dards, both for ourselves and our partners. Calliditas does not own or manage any manufacturing facilities, but we are rigorous and mindful about how we select our suppliers and build partnerships. All of our current appointed commercial suppliers are reputable compa- nies, located in western Europe and USA. They were chosen through a selection process strictly evaluating, among other things, quality standards, compliance with laws and regulations and all relevant permits. We hold ourselves to higher quality standards than those required by law and will always hold any partners to the same rigorous standards. Our acquisition and integration of Genkyotex has added two new offices, in France and Switzerland, and also means that as a company Calliditas is now engaged in clinical research. We strictly follow bioethics policies defined by French regulations when it comes to clinical research, which includes an internal Animal Welfare Committee and an external Ethics Committee to ensure all animal experiment project requests are accept- able from an ethical point of view. A careful regard for bioethics is embedded in all of our procedures, processes and decision-making in our clinical research. Commitment to Our Patients Since our company was founded, our mission and vision has been to focus on unmet needs in orphan indications and to bring to market treatments for those suffering from rare diseases. We continue to work with the rare disease community as we endeavour to provide access to novel and innovative treatments and see this cooperation as vital for our future develop- ment as a company, particularly now that we have an approved product on the market. We draw inspiration from our advocacy partners and all our patients, and are proud to support patient advo- cacy and disease state educational efforts in IgAN. We continued our support of the IgA Nephropathy Foun- dation, sponsoring an IgAN patient toolkit, and joined IgAN patients in events such as the American Associ- ation of Kidney Patients’ walk to raise awareness. We were also the lead sponsor of the SPARK 2021 national patient/caregiver symposium. We have a robust plan to continue to build on our partnerships with patient advocacy groups in the future and to invest in these relationships and in our patients. We also ensured we were ready to support our patients the moment that TARPEYO was approved, establishing our comprehen- sive patient and provider support program, TARPEYO Touchpoints TM. This program offers services, assis- tance, and resources designed to help patients access treatment as easily as possible. Calliditas is committed to working with payers and healthcare providers across the United States to ensure that all patients prescribed TARPEYO have access to it, and we look forward to helping as many IgAN patients as possible. We pride ourselves on being pioneers in our field and are looking forward to continuing our work to bring novel medications to our patients. Having commercially launched the first ever approved treatment for IgAN in the USA, we are excited about the possibility of also bringing an approved product to address the unmet medical need in IgAN in Europe and China, as well as the potential of our NOX inhibitor platform and first-in- class compound setanaxib, which we will be conducting two late stage clinical trial programs with in 2022. We will continue to be guided and motivated by our passion to provide medications for patients with unmet medical needs across the world. 100 80 60 40 20 0 2020 2021 Full-time equivalent (FTE) Women Men Gender Distribution: Board of Directors Sweden USA UK Geographical Distribution Switzerland France Denmark Women Men Gender Distribution: Employees |
Risk Management Calliditas’ board of directors and management work continuously to identify and assess risks for the compa- ny’s operations and take measures to reduce the effect of these. A risk management strategy is drawn up for every material risk. This work involves support from expertise in areas such as commercialization, regulatory strategies and the design and implementation of clinical trials. Risks and Uncertainties Calliditas’ operations are impacted by a number of factors that affect the Group’s earnings and financial position and that in certain respects cannot be controlled, in part or in full, by Calliditas. When assessing Calliditas’ future devel- opment, it is important alongside opportunities for profit growth to also consider these risks. The most important material risks and uncertainties in terms of the Group’s future development are listed below, without any order of precedence. Operational risks Calliditas main activities are research and development and commercialization of pharmaceuticals, which is an area that is to a large extent both risky and capi- tal-intensive. Calliditas has a product in the commercial phase, Tarpeyo, which has been approved for marketing in the USA. There is a risk that commercialization will not go according to plan and that the uptake of treating doctors will be worse than planned or that the drug will not have sufficient effect or show unwanted side effects, which may affect sales negatively. Calliditas has two product candidates in clinical development, Nefecon and setanaxib, for the treatment of IgA nephropathy and primary biliary cholangitis and head and neck cancer, respectively, and there is a risk that the projects will never reach market registration due to the risk that the drugs do not have sufficient effect or show unwanted side effects. Even after a drug has been launched, market registration can be withdrawn if serious side effects occur. Calliditas conducts clinical studies regarding its product candidates. Clinical studies are time-consuming and costly and involve risks such as difficulties in finding clinics, difficulties in recruiting suitable patients, that the cost per patient exceeds budget and shortcomings in the performance of the studies by the clinics partic- ipating in the study. Both Nefecon and setanaxib are drug candidates with orphan drug classification in IgA nephropathy and primary biliary cholangitis, respectively. The number of suitable patients for clinical trials is thus lower than for common diseases and it may be a challenge for Calliditas to recruit patients for the imple- mentation of the Phase 2/3 study for the treatment of primary biliary cholangitis and the Phase 2 study for the treatment of head and neck cancer. If competing drugs take market shares or competing research projects achieve a better effect and reach the market faster, the future value of the product portfolio may be lower than expected. Patent applications filed by Calliditas may never be approved and approved patents may be annulled, which may result in Calliditas losing patent protection. The business is also affected by government decisions such as approvals and price changes. There is an ongoing political debate on perceived overpricing of orphan drugs, especially in the United States. There is a risk that new rules will have a negative impact on orphan drug prices in the future. There are also risks regarding the manufacture of the product where the selected manufacturer may have problems delivering sufficient quality and / or quantity or lose the necessary permits to manufacture. Part of Calliditas strategy is to investigate the possibility of developing products in other indications. Callid- itas, however, has not yet finished any clinical trials in other indications. Conducting clinical trials is always associated with risks related to the implementation of the study, the results and the approval of regulatory authorities, and as a result it is currently uncertain whether Calliditas ambition to develop products for treatment for other indications will be realized. The risk of the war in Ukraine and the EU sanctions imposed on Russia and Belarus is expected to be limited and not directly impact the Group since there is no direct link or exposure to these countries or entities listed by the EU restrictive measures. Any furture enforced sanctions or development of the situation will be monitored and adressed. Liquidity risks Calliuditas manages liquidity risks by continuously monitoring cash flow so that it can reduce liquidity risk and ensure its solvency. Given that Calliditas currently does not have its own earning ability, Calliditas may be dependent on external financing and there is a risk external financing will not be available to Calliditas if and when it is needed. Financial risks A financial policy for managing financial risks has been formulated by the Board and forms a framework of guidelines and rules in the form of risk mandates and limits for financial operations. Calliditas is mainly affected by the exchange rate risk. Calliditas has most of its expected future costs in the U.S. dollars and Euros. During 2021, Calliditas holded parts of the cash and cash equivalents in Euro and US dollars to reduce future currency exposure to EURO and US dollars. The finance policy is updated at least once a year. Parent Company The Group’s Parent Company is Calliditas Therapeutics AB. Operations and accounting in the Parent Company is aligned in all material respects with the operations and accounting of the Group. Net profit for the year and the financial position of the Parent Company are aligned in all material respects with the Group’s which is why the comments for the Group are in all material respects also valid for the Parent Company. For the years ended December 31, 2021 and December 31, 2020, the Parent Company had a net loss of SEK 354.4 million and SEK 407.4 million, respectively. The Parent Company had cash of SEK 894.5 million and SEK 978.2 million as of December 31, 2021 and 2020, respectively. Outlook Calliditas drug Nefecon has great market potential. The product has been approved under the brand name TARPEYO by the FDA in the USA which has granted an accelerated approval for TARPEYO (budesonide) targeted release capsules indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progres- sion, generally described as a urine protein-to-creatine ratio (UPCR) ≥1.5g / g. TARPEYO is the first and only FDA-approved treatment for this indication and has been designed specifically to target the origin of the disease. This approval marks the transition for Calliditas to a commercial phase biopharmaceutical company. Nefecon is also in a Phase 3 clinical study for IgA nephropathy where Part B of the NefIgArd study is ongoing. With studies in PBC and head and neck cancer with setanaxib initiated, the business is capital intensive and until Nefecon/TARPEYO will bring in steady revenues that exceed the costs, external financing may be required. Calliditas cash position of SEK 955.5 million as of December 31, 2021, together with available loan facilities and subject to successful commercialization of Tarpeyo in the US, is currently considered sufficient until an operationally positive cash flow is achieved. Proposed appropriation of the company’s earnings Proposed appropriation of earnings The following earnings (TSEK) are at the disposal of the Annual General Meeting, Share premium reserve 2,420,698 Retained earnings (863,175) Net loss for the year (354,405) 1,203,117 The Board of Directors proposes that SEK 1,203,117 thousand is carried forward. Dividend policy Any future dividend and the size thereof, will be deter- mined based on long-term growth, earnings trends and capital requirements of Calliditas. It is the view of the Board of Directors that Calliditas should prioritize progression of the development program, and until the future revenues substantially exceeds the cost of the development programs, financial resources should mainly be used to finance Calliditas’ development programs. In view of company’s financial position and negative earnings, the Board of Directors does not intend to propose any dividend before the company generates long-term sustainable profits and posi- tive cash flow. Dividends shall, as far as a dividend is proposed, be balanced with regard to the business risk. The Board of Directors proposes, in view of dividend policy, that no dividend be paid for the 2021 financial year. For more information on the Group and Parent Compa- ny’s earnings and financial position, refer the following statements of income and financial position, changes in shareholders’ equity and cash flows with accompanying supplementary disclosures. 34 35 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 BOARD OF DIRECTORS’ REPORT » |
Year Ended December 31, (SEK in thousands, except per share amounts) Note 2021 2020 2019 Net sales 3 229,347 874 184,829 Research and development expenses 9,10 (357,485) (241,371) (149,826) Administrative and selling expenses 6,8,9,10 (390,232) (141,724) (62,882) Other operating income 4 259 2,501 4,385 Other operating expenses 5 (6,344) - (4,525) Operating loss 7 (524,456) (379,720) (28,019) Financial income 11 20,336 547 926 Financial expenses 12 (9,253) (56,978) (5,408) Loss before income tax (513,373) (436,151) (32,501) Income tax expense 13 3,836 (360) (77) Loss for the year (509,537) (436,511) (32,578) Attributable to: Equity holders of the Parent Company (500,293) (433,494) (32,578) Non-controlling interests (9,244) (3,017) - (509,537) (436,511) (32,578) Loss per share Before and after dilution to ordinary equity holders of the Parent Company 14 (9.84) (9.66) (0.88) Consolidated Statements of Income Consolidated Statements of Comprehensive Income Year Ended December 31, (SEK in thousands) Note 2021 2020 2019 Loss for the year (509,537) (436,511) (32,578) Other comprehensive income Other comprehensive income/(loss) that may be reclassified to profit or loss in subsequent periods: Exchange differences on translation of foreign operations 21, 25 (20,111) (9,352) (11) Other comprehensive income/(loss) that may be reclassified to profit or loss in subsequent periods (20,111) (9,352) (11) Other comprehensive income/(loss) that will not be reclassified to profit or loss in subsequent periods: Remeasurement gain on defined benefit plans 27 1,993 1,216 - Other comprehensive income/(loss) that will not be reclassified to profit or loss in subsequent periods 1,993 1,216 - Other comprehensive income/(loss) for the year (18,118) (8,137) (11) Total comprehensive loss for the year (527,655) (444,648) (32,589) Attributable to: Equity holders of the Parent Company (519,189) (438,343) (32,589) Non-controlling interests (8,466) (6,305) - (527,655) (444,648) (32,589) 36 37 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 GROUP GROUP |
Consolidated Statements of Cash Flows Year Ended December 31, (SEK in thousands) Note 2021 2020 2019 Operating activities Operating loss (524,456) (379,720) (28,019) Adjustments for non-cash items 23 66,676 15,465 2,308 Interest received 102 1,912 926 Interest paid (5,432) (393) (325) Income taxes paid (3,949) (528) - Cash flow from operating activities before changes in working capital (467,058) (363,264) (25,110) Cash flow from changes in working capital Changes in inventory (949) - - Changes in operating receivables (11,712) 8,033 (53,546) Changes in operating liabilities 18,131 46,050 7,645 Cash flow from operating activities (461,588) (309,181) (71,011) Investing activities Acquisition of a subsidiary, net of cash acquired 15 - (172,602) - Purchase of equipment 17 (6,588) - (118) Investments in non-current financial assets 18 (1,686) (5) (1,888) Purchase of intangible assets 16 (16,066) - (16,066) Cash flow from investing activities (24,340) (172,607) (18,072) Financing activities New share issue 324,000 891,388 210,317 Costs attributable to new share issue (20,909) (95,937) (12,663) Exercise of warrants - 59,251 - Premiums from warrants issuance - - 2,834 Purchase of non-controlling interests (49,303) (82,172) - Contribution from non-controlling intereset 2,282 - - New borrowings 21 199,524 - - Costs attributable to new loans (14,858) - - Repayment of lease liabilities (5,575) (3,972) (1,652) Cash flow from financing activities 435,162 768,558 198,835 Net increase/(decrease) in cash (50,766) 286,770 109,752 Cash at beginning of the year 996,304 753,540 646,175 Exchange-rate difference in cash 9,969 (44,006) (2,387) Cash at the end of the year 23 955,507 996,304 753,540 Description of Business Calliditas Therapeutics AB (publ) (“Calliditas” or the “Parent Company”), with corporate registration number 556659-9766, and its subsidiaries (collectively, the “Group”) conduct development and commercial activities in pharmaceuticals. These consolidated financial statements encompass the Group, domiciled in Stockholm, Sweden, and its subsidiaries for the year ended December 31, 2021, December 31,2020 and December 31, 2019. The group has elected to present in addition to minimum periods required under IFRS, a consolidated statement of income, consolidated statement of comprehensive income, consolidated statement of cash flows, and consolidated statement of changes in equity, for an additional comparative period. Calliditas is clinical-stage biopharmaceutical company focused on identi- fying, developing and commercializing novel treatments in orphan indica- tions, with an initial focus on renal and hepatic diseases with significant unmet medical needs. The registered address of the corporate headquar- ters is Kungsbron 1, D5, Stockholm, Sweden. Calliditas was founded as a public limited liability company under the laws of Sweden on February 20, 2004 under the name Pharmalink AB and registered with the Swedish Companies Registration Office on April 15, 2004. As of December 31, 2021, Calliditas is the Parent Company of four subsidiaries located in Sweden, France and in the United States. The Swedish subsidiary is Nefecon AB which is conducting no operating activities. The subsidiaries in the United States are Calliditas Therapeutics US Inc and Calliditas NA Enterprises Inc, who are conducting pre-commer- cialization and commercialization activites activities in the United States, respectively. The French subsidiary is Calliditas Therapeutics France SAS located in France which is conducting preclinical activities. The Board of Directors (the “Board”) approved, and authorized for issuance, these consolidated financial statements on April 27, 2022, which will be presented for adoption at the Annual General Meeting on May 19, 2022. Note 1 Significant Accounting Policies Basis for Preparation These consolidated financial statements have been prepared in accordance with the International Financial Reporting Standards (IFRS) published by the International Accounting Standards Board (IASB) as adopted by the European Union (EU). In addition, the consolidated financial statements comply with the recommendation of the Swedish Financial Reporting Board RFR 1, Supplementary Accounting Regulations for Groups. The accounting policies stated below have, unless otherwise stated, been applied consistently over all periods presented in the consolidated financial statements. The Group’s accounting policies have been applied consistently by the Group’s companies. The consolidated financial statements provide comparative information in respect of the previous period. Functional Currency and Reporting Currency The Parent Company’s functional currency is Swedish Kronor (SEK), which is also the presentation currency of the Group. This means that the finan- cial statements are presented in Swedish kronor (SEK) and all amounts, unless otherwise stated, are rounded to the nearest thousand (SEK 000s). Basis for Valuation and Current versus Non-Current Classification The consolidated financial statements have been prepared on a historical cost basis, except for certain financial assets (including derivative financial instrument) and contingent consideration that have been measured at fair value through profit or loss The Group presents assets and liabilities in the statement of financial posi- tion based on current/non-current classification. An asset is current when it is expected to be realized within twelve months after the reporting period. All other assets are classified as non-current. A liability is current when it is due to be settled within twelve months after the reporting period. The Group classifies all other liabilities as non-current. Basis for Consolidation The consolidated financial statements comprise the financial statements of the Parent Company and its subsidiaries as of December 31, 2021. Control is achieved when the Parent Company has control over the investee, the Parent Company is exposed to or has rights to variable returns from its involvement in the investee, and the Parent Company has the ability to use its power over the investee to affect the amount of the investor’s returns, which normally means that the Parent Company owns more than half of the number of votes for all of the shares and participations. The Group re-assesses whether or not it controls an investee if facts and circumstances indicate that there are changes of the control. Consolidation of a subsidiary begins when the Group obtains control over the subsidiary and ceases when the Group loses control of the subsidiary. Assets, liabilities, income and expenses of a subsidiary acquired or disposed of during the year are included in the consolidated financial statements from the date the Group gains control until the date the Group ceases to control the subsidiary. All subsidiaries are consolidated using the acquisition method. The cost of an acquisition is measured as the fair value of assets that have been provided as payment along with any liabilities taken over or which have arisen at the acquisition date. With the acquisition method, the fair value of acquired identifiable assets, assumed liabilities and contingent liabilities in a business combination, regardless of the scope of any non-controlling interest, are measured at fair value as of the acquisition date. Any surplus arising from the difference between cost and fair value of identifiable acquired assets, liabilities and contingent liabilities is recognized as good- will. If the cost amount is less than the fair value of the acquired net assets, it is recognized in the consolidated statements of income. Subsidiaries that were acquired during the financial year are included in the consolidated financial statements as soon as the controlling interest has been transferred to the Group. Subsidiaries that were disposed during the financial year are included in the consolidated financial statements up until the date when the controlling interest no longer exists. For each business combination, the Group elects whether to measure the non-controlling interests in the acquiree at fair value or at the propor- tionate share of the acquiree’s identifiable net assets. Acquisition-related costs are expensed as incurred and included in administrative and selling expenses in the consolidated statements of income. A change in the ownership interest of a subsidiary, without a loss of control, is accounted for as an equity transaction. All intra-group assets and liabilities, equity, income, expenses and cash flows relating to transactions between members of the Group are elimi- nated in full on consolidation. New and Amended Standards and Interpretations Updated standards and interpretations from IASB and IFRIC interpretations that came into effect for the year ended December 31, 2021 have had no material impact on the Group. The Group has not early adopted any standards, interpre- tations or amendments that have been issued but are not yet effective. Future Standards and New Interpretations Other future or altered standards or interpretations that the IASB has published are not expected to have any significant impact on the financial statements for the Group. Revenue The Group is in the business of identifying, developing and commercial- izing novel treatments in orphan indications. Revenue from contracts with customers is recognised when control of the goods or services are transferred to the customer at an amount that reflects the consideration to which the Group expects to be entitled in exchange for those goods or services. During 2021, the Group generated revenue from contracts for outlicensing Nefecon to Everest Medicines for the Chinese region and Singapore, a contract initially entered into in 2019, and to Stada Arzneimittel for the EEA member states, Switzerland and the UK, a contract initially entered into in 2021. The Group recognizes revenue as the identified performance obligations are performed. Outlicensing contracts consists of multiple performance obligations, as they contain multiple goods or services that could be sold on a stand-alone basis, and that are distinct within the context of the contract. Accordingly, the Group allocates the transaction price based on the relative stand-alone selling prices of the performance obligations, which requires identifying the performance obligations in the contracts, and allocating the transaction price between these. The allocation of the transaction price has a significant impact on the Group's revenue recognition, as the revenue recognition patterns differ between the performance obligations. The identification of performance obligations and the allocation of the transaction price between these is hence a significant accounting judgment and estimate. See Note 2 Significant Accounting Judgements, Estimates and Assumptions for more information. Notes to Consolidated Financial Statements (SEK in thousands, except per share amounts or as otherwise indicated) 40 41 GROUP Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 GROUP |
The Group's revenues for the financial year 2021 is allocated based on the following identified performance obligations: 1) Outlicensing of Nefecon to Everest Medicines for the Chinese region and Singapore, and to Stada Arzneimittel for the EEA region. 2) Certain regulatory services to Stada Arzneimittel related to the EU regulatory approval process. Revenue for the outlicensing of Nefecon for the Chinese region and Singa- pore, as well as the EEA region, is recognized at the point in time when control of the intellectual property is transferred. The revenue allocated to the performance obligation is based on the residual approach, and consists of the total transaction price for each contract after deducting the stand-alone selling price of all other performance obligations. Revenue for the provision of certain regulatory services to Stada is reported over time as the services are performed, and the allocation of revenue to the perfor- mance obligation is based on the expected costs to provide the service, and a profit margin based on comparable companies. In the prior year, the Group recognized revenue for a performance obligation to provide pharma- ceutical goods for clinical trials to Everest Medicines. The revenue allocated to this performance obligation was based on the expected costs to provide the goods, and a profit margin based on comparable companies. These contracts with customers consists of fixed remuneration as well as variable remuneration in the form of regulatory and commercial milestones, and sales-based royalties. Variable remuneration (for example, attributable to future regulatory milestones) are initially considered constrained, as there is significant uncertainty as to whether these will occur. Compensa- tion attributable to sales-based milestones or royalties is not recognized until the sale that results in the right to the royalties have occurred. Inventory Inventory is recognized as the lower of the acquisition cost and the net realizable value. The acquisition cost for completed goods and goods being manufactured comprises raw materials and other direct costs and appli- cable indirect manufacturing costs. The net realizable value is the estimated sale price in operating activities. By continuously monitoring inventory, we ensure that it is dispatched based on its shelf life and moving average basis. When necessary, impairment of inventory is performed within the frame of normal business operations and is recognized in costs of goods sold. Financial Income Financial income consists of interest income and foreign exchange gains. Interest income is recognized in accordance with the effective interest method. Effective interest is the interest that discounts estimated future receipts and payments during a financial instrument’s anticipated duration to the financial asset’s or liability’s recognized net value. The calculation contains all costs included in the effective interest paid by the parties to the contract, transaction costs and all other premiums and discounts. Dividends received are recognized when the right to receive a dividend has been established. Foreign exchange gains and losses are netted. Research and Development Research and development expenses consist primarily of costs incurred for the Group’s development activities, including the development of the Group’s product candidates. The Group expenses research and develop- ment costs as incurred. The Group recognizes external development costs based on an evaluation of the progress to completion of specific tasks using information provided by Calliditas’ service providers. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as a prepaid expense or accrued expense. Research and development tax credits are recognized in Sweden and in France. In Sweden tax credits are recognized on social security costs and in France tax credits are recognized on accredited suppliers. These research and development tax credits are recognized as an offset to research and development expenses in the consolidated statements of income. Administrative and Selling Administrative and selling expenses consist of salaries and other related costs for personnel in the Group’s executive, finance, corporate, market access, commercialization and business development and administrative functions. Administrative and selling expenses also include professional fees for legal, patent, accounting, auditing, tax and consulting services, related travel expenses and facility-related expenses, which include allocated expenses for rent and maintenance of facilities and other operating costs. Employee Benefits Short-term benefits Current employee benefits such as salaries, social security costs, vacation pay and bonuses are expensed during the period in which employees perform the service. Pensions The Group has both defined-contribution and defined-benefit pension plans, and most employees are covered by and recognized in the defined-contribution pension plans. Employees in France and Switzerland are covered by defined-benefit pension plans. All other employees were covered by defined-contribution pension plans. See Note 27 Pension Liabilities for more information. Defined-contribution pension plans A defined-contribution pension plan is a pension plan according to which the Group pays fixed premiums to a separate legal entity. The Group does not have any legal or informal obligation to pay further premiums if this legal entity does not have sufficient assets to pay the full remuneration to employees corresponding to their service during the current or previous periods. The Group therefore has no further risk. The Group’s obligations relating to fees for defined-contribution plans are expensed in profit or loss as they are accrued due to the employee performing services for the Group over a period. Defined-benefit pension plans In defined-benefit plans, the pension is determined as a percentage of the pensionable final salary, based on the employee’s length of service and average final salary. The Group is responsible for ensuring that the established benefits are paid out. The defined-benefit pension obligations are recognized in the consolidated statements of financial position as the net total of the estimated present value of the obligations and the fair value of the plan assets, which are recognized as a provision or a non-current financial receivable. For defined-benefit plans, pension expense and commitments are calculated using the applicable principles of IAS 19. This calculation is performed annually by independent actuaries. The Group’s obligations are measured at the present value of expected future payments. Actuarial gains and losses may arise in connection with the determination of the present value of the obligations and the fair value of plan assets. These arise either because the fair value differs from the previous assump- tion, or the assumptions change. Actuarial gains and losses are recognized in the consolidated statements of comprehensive income in the period in which they arise. Interest expense, less the estimated return on plan assets, is classified as a financial expense. Other cost items in the pension expense are charged to operating profit. Severance pay An expense for remuneration in connection with termination of employ- ment of personnel is recognized only if the Group is committed, without any realistic possibility of withdrawal, by a formal detailed plan to eliminate a position in advance of when that position would normally expire. When remuneration is paid as an offer to encourage voluntary termination of employment, the cost is recognized if it is probable that the offer will be accepted and the number of employees that will accept the offer can be reliably estimated. Share-based payments Share-based payments in the Group refers to option programs and performance-based share award programs, which are regulated by equity instruments. In cases where the fair value of the instrument exceeds what the employee paid, the difference is recognized as a personnel cost. The fair value of options is determined at the allotment date using the Black- Scholes model for pricing of options. The valuation of the performance share awards is based on a discounted model with Monte Carlo simulation of the share price’s development for the share-related parts and with estimated probabilities for the outcome of the market conditions. The cost is recognized, together with a corresponding increase in equity, during the period in which the service conditions are met, up to and including, the date on which the employees concerned are fully eligible for compensation. Social security costs attributable to equity-related instruments to employees as remuneration for purchased services shall be expensed over the periods during which the services are performed. The cost should then be measured using the same valuation model used when the options were issued. The provision recognized must be revalued at each reporting period on the basis of a calculation of the social security costs that may be paid when the instruments are resolved. Leases Lessee The Group assesses at contract inception whether a contract is, or contains, a lease. That is, if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. The Group applies a single recognition and measurement approach for all leases, except for short-term leases and leases of low-value assets. The Group recognizes lease liabilities for future remaining lease payments and right-of-use assets representing the right to use the underlying assets. Right-of-use assets The Group recognizes right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right- of-use assets are measured at cost, less any accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received. Right-of-use assets are depreciated on a straight-line basis over the estimated lease term, which currently is two to three years for the Group’s leases. Lease liabilities At the commencement date of the lease, the Group recognizes lease liabilities measured at the present value of lease payments to be made over the lease term. The lease payments include fixed payments less any lease incentives receivable and variable lease payments that depend on an index or a rate. In calculating the present value of lease payments, the Group uses its incremental borrowing rate at the commencement date, because the interest rate implicit in the lease is not readily determinable. Following the commencement date, the amount of lease liabilities is increased to reflect the accretion of interest and reduced for the lease payments made. In addition, the carrying amount of lease liabilities is remeasured if there is a modification, a change in the lease term, or a change in the lease payments (e.g., changes to future payments resulting from a change in an index or rate used to determine such lease payments). The Group’s lease liabilities are included in Non-current lease liabilities and other current liabilities in the consolidated statements of financial position (see Note 8 Leases and 20 Financial and Non-Financial Assets and Liabilities). Short-term leases and leases of low-value assets The Group applies the short-term lease recognition exemption to its short-term leases of equipment (i.e., those leases that have a lease term of twelve months or less from the commencement date). It also applies the lease of low-value assets recognition exemption to leases of office equip- ment that are considered to be low value. Lease payments on short-term leases and leases of low value assets are recognized as an expense on a straight-line basis over the lease term. Financial Expenses Financial expenses mainly consist of realized and unrealized losses on foreign exchange derivative instruments and unrealized foreign exchange losses. Foreign exchange gains and losses are netted. Taxes Income tax comprises current tax and deferred tax. Income tax is recog- nized in net profit for the year, except when the underlying transaction is recognized in other comprehensive income or equity with the related tax effect recognized in other comprehensive income and in equity. Current tax is the tax that is to be paid or received in the current year, with the application of the tax rates that have been enacted or substantively enacted by the end of the reporting period. Current tax also includes adjustments of current tax attributable to prior periods. Deferred tax is recognized on all temporary differences that arise between the tax value of assets and liabilities and their carrying amounts. Temporary differences attributable to participations in Group companies is not recognized, since it is unlikely that such a reversal will take place in the foreseeable future. The valuation of deferred tax is based on how the underlying assets or liabilities are expected to be realized or settled. Deferred tax is measured with the application of the tax rates and tax rules decided or announced on the closing date, and that are expected to apply when the deferred tax asset in question is realized or the deferred tax liability is settled. Deferred tax liabilities and deferred tax assets are offset as far as possible within the framework of local laws and regulations on taxation. Deferred tax assets on deductible temporary differences and loss carryforwards are recognized only to the extent that it is probable that it will be possible to utilize these, or to the extent that there are temporary differences which these can be utilized to offset. A provision for deferred tax assets will be recognized when it is no longer deemed probable that they can be utilized. Intangible Assets Intangible assets in the Group consist of licenses and similar rights and goodwill. Licenses and similar rights The acquisition of Genkyotex SA resulted in the Group acquiring the rights to the NOX platform as well as goodwill. The NOX platform, including the lead compound setanaxib, enables the identification of orally available small molecules which selectively inhibit specific NOX enzymes that amplify multiple disease processes such as fibrosis and inflammation. In the prior year the Group had acquired the product candidate Budeno- falk 3 mg oral capsule from the German pharmaceutical company Dr Falk Pharma GmbH for development of the pipeline portfolio related to orphan liver disease, such as AIH, in the United States. Intangible assets with a finite useful life are recognized at initial recognition at cost less accumulated amortization and any accumulated impairment losses. Intangible assets with finite lives are amortized over the useful economic life and assessed for impairment whenever there is an indication that the intangible asset may be impaired. When determining the amortized amount of the assets, the residual value of the asset is taken into account, when applicable. Goodwill Goodwill arising in a business combination comprises the difference between the cost of the business combination and the fair value of iden- tifiable assets acquired, liabilities assumed, and any contingent liabilities recognized at the acquisition date. Goodwill on business combinations is included in intangible assets and measured at cost less any accumulated impairment losses. Goodwill is allocated to the cash-generating units, which is the full Group, and tested annually for impairment requirement, or whenever there is any indication of impairment. There is no amortization of goodwill and impairment of goodwill is not reversed. Research and development expenses Development expenditures are recognized as an intangible asset when related development projects meet the criteria for capitalization. The most important criteria for capitalization are that the final product of the development process will generate future economic benefits or the ability of cost-savings capacity, including the technical feasibility of completing the intangible asset. Research and development expense are otherwise recognized as operating expenses. Full market approval has not yet been obtained for the Group’s products and, accordingly, the Group deems that the conditions for capitalizing development expenditures are not met. Amortization Amortization of the intangible assets begins when the asset can be used, that is, when it is in the place and in the condition required to be able to use it in the manner intended by the Group’s management. The Group’s expected finite useful life is: – Licenses and similar rights – 6-15 years Until market approval from regulatory authorities has been granted, amortization of “Licenses and Similar Rights” will not commence. As market approval has not yet been obtained, no other costs have been capitalized. Following market approval from regulatory authorities, “Licenses and Similar Rights” will be amortized on a straight-line basis over the expected useful life. Until a market approval of the product has been obtained, the asset is assessed for impairment at least once a year, or when there is an indication that the asset may be impaired. Equipment Equipment is recognized in the consolidated statement of financial position at cost less accumulated depreciation and impairment. Such cost includes the cost price and expenses directly attributable to the asset. Repairs and maintenance costs are expensed as incurred, while expenses for improve- ments are recognized as investments and added to the cost of the assets. An item of equipment and any significant part initially recognized is derecog- nized upon disposal (i.e., at the date the recipient obtains control) or when no future economic benefits are expected from its use or disposal. Any gain or loss arising on derecognition of the asset (calculated as the difference between the net disposal proceeds and the carrying amount of the asset) is included in the statement of income when the asset is derecognized. Depreciation Equipment is depreciated on a straight-line basis over the expected useful life. The Group’s expected useful life is: – Equipment – 5 years – Computers – 5 years The residual values, useful lives, and methods of depreciation of equipment are reviewed at each financial year and adjusted prospectively, if appro- priate. If there is an indication that an asset needs to be impaired, the asset is written down to its recoverable amount if this is lower than the carrying amount. The recoverable amount corresponds to the highest of net realiz- able value and value in use. 42 43 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 GROUP - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (SEK in thousands, except per share amounts or as otherwise indicated) » |
Impairment of Non-Financial Assets Goodwill and intangible assets not yet available for use, are not amortized but the Group assesses for impairment at each reporting date, or when there is an indication that an asset may be impaired. Equipment that is depreciated is assessed for impairment whenever events or changes in circumstances indicate that the carrying amount is not recoverable. An impairment loss is made by the amount by which the asset’s carrying amount exceeds its recoverable amount. An asset’s recoverable amount is the higher of an asset’s or cash generating units’ (“CGU”) fair value less costs of disposal and its value in use. The recoverable amount is determined for an individual asset, unless the asset does not generate cash inflows that are largely independent of those from other assets or groups of assets. When the carrying amount of an asset or CGU exceeds its recoverable amount, the asset is considered impaired and is written down to its recoverable amount. In assessing value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset. In determining fair value less costs of disposal, recent market transactions are taken into account. If no such transactions can be identified, an appropriate valuation model is used. These calculations are corroborated by valuation multiples, quoted share prices for publicly traded companies or other available fair value indicators. The Group bases its impairment measurement on intangible assets on a probability-adjusted cash flow model. The value of licenses is measured by estimating the expected future cash flows and present value adjustments to take into account the development risk. The valuation takes into account cash flow from potential commercialization during the expected useful life and does not include calculation of any residual value thereafter. The most critical assumptions mainly consist of assumptions about the timing of potential commercialization, market size, market share and probability of reaching the market. When assessing the impairment requirement for goodwill, this is grouped at the lowest levels for which there are separately identifiable cash flows. Calliditas has made the assessment that the Group’s operations as a whole comprise a cash-generating unit. Impairment losses of continuing oper- ations are recognized in the statement of income in expense categories consistent with the function of the impaired asset. A previously recognized impairment loss is reversed only if there has been a change in the assumptions used to determine the asset’s recoverable amount since the last impairment loss was recognized. The reversal is limited so that the carrying amount of the asset does not exceed its recoverable amount, nor exceed the carrying amount that would have been determined, net of depreciation, had no impairment loss been recognized for the asset in prior years. Financial Assets and Financial Liabilities A financial instrument is any contract that gives rise to a financial asset of one entity and a financial liability or equity instrument of another entity. Financial instruments are classified at initial recognition, including on the basis of the purpose for which the instrument was acquired and managed. This classification determines the valuation of the instruments. Initial recognition and measurement of financial assets The Group’s financial assets consist of long-term receivables, other current receivables and cash, all of which are classified at amortized cost. The instruments are classified into: – Amortized cost, or – Fair value through profit or loss Financial assets at amortized cost are initially measured at fair value with the addition of transaction costs. Following the initial recognition, the assets are measured at amortized cost less a provision for losses on expected credit losses. Assets classified at amortized cost are held according to the business model to collect contractual cash flows that are only payments of capital amount and interest on the outstanding capital amount. Initial recognition and measurement of financial liabilities The Group’s financial liabilities consist of contingent consideration related to business combinations, accounts payable and other current liabilities, all of which, except contingent consideration, are classified as amortized cost. Contingent consideration related to business combinations is classified at fair value through profit or loss. The instruments are classified into: – Amortized cost, or – Fair value through profit or loss Financial liabilities at amortized costs are initially measured at fair value, net of transaction costs. Subsequently periods are measured at amortized cost using the effective interest (EIR) method. Financial liabilities classified at fair value are measured both initially and in subsequent periods at fair value in the Group’s consolidated statements of financial position, where changes in fair value are recognized in the Group’s consolidated statements of income. The components of the change in fair value relating to exchange rate effects are recognized in net financial items and other changes in fair value are recognized in operating profit or loss. Recognition and derecognition A financial asset or financial liability is recognized in the consolidated state- ment of financial position when the Group becomes a party in accordance with the contractual terms of the instrument. Debt is recognized when the counterparty has performed and a contractual obligation exists to pay, even if an invoice has not yet been received. A financial asset is derecognized from the consolidated statement of financial position when the rights in the agreement are realized, expire or the Group loses control of them. A financial liability is derecognized from the consolidated statement of financial position when the contractual obligation is fulfilled or otherwise extinguished. The same applies to part of a financial asset or financial liability. Gains and losses from derecognition from the consolidated statement of financial position are recorded in the consolidated statement of income. A financial asset and financial liability are offset and recognized with a net amount in the consolidated statement of financial position only when there is a legal right to set off the amounts and that there is an intention to settle the items with a net amount or to simultaneously realize the asset and settle the debt. Impairment of financial assets The Group’s impairment model is based on expected credit losses and takes into account forward-looking information. The valuation of expected credit losses takes into account any collateral and other credit enhance- ments in the form of guarantees. See Note 21 Financial Risks for informa- tion on considerations relating to accounts receivable and deposits. Cash Cash is entirely comprised of cash at banks. Equity Common shares, other contributed capital and retained earnings are classi- fied as equity. Financial instruments that meet the criteria for classification as equity are recognized as equity even if the financial instrument is legally structured as a liability. Transaction costs that are directly attributable to the issue of new shares or options are recognized net after tax in equity as a deduction from the issue proceeds. Warrants The Group has only issued warrants that were transferred at fair value. Premiums received for warrants granted to acquire shares in companies within the Group are recorded as additions to equity, based on the warrant premium, at the date when the warrant was transferred to the counterparty. Option Program The Group has issued an option program which constitutes share-based payments. The cost for the remuneration that is recognized in a period is dependent on the original valuation that was made on the date on which the contracts with the participants in the incentive programs were concluded, the number of months of service required for vesting of their options (accruals are made over this period), the number of options that are expected to be vested under the terms of the plans and a continuous reassessment of the value of the tax benefits for the participants under the plans (for determining provisions for social security expenses). Those estimates which affect the cost in a period and the corresponding increase in equity mainly refer to inputs for the valuation of the options. All the options are classified as equity-settled, as vested options are settled in equity. When the options are exercised, the company issues new shares. Provisions A provision differs from other liabilities in that there is uncertainty about the time of payment or the amount of the amount to settle the provision. A provision is recognized in the statement of financial position when there is an existing legal or informal obligation arising from past events, and it is likely that an outflow of financial resources will be required to settle the obligation and a reliable estimate of the amount can be made. The amount recognized is the best estimate of what is required to settle the existing obligation on the balance sheet date. Where the effect of when payment is made in time is significant, provisions are calculated by discounting the expected future cash flow. Contingent Liabilities A contingent liability is disclosed when there is a possible commitment orig- inating from events that have occurred and whose occurrence is confirmed by one or several uncertain future events. An obligation arising from past events whose existence will be confirmed by the occurrence or non-occur- rence of one or more uncertain future events is not recognized as a liability or provision. Foreign Currency Transactions in foreign currency Transactions in foreign currency are translated to the functional currency at the exchange rate on the date of the transaction. Monetary assets and liabilities in foreign currency are translated to the functional currency at the exchange rate that applies on the closing date. Exchange rate differences arising on translation are recognized in net profit for the year. Foreign exchange gains and losses on operating receivables and liabilities are recognized in operating profit, while foreign exchange gains and losses on financial receivables and liabilities are recognized as financial items. Translation from foreign operations Assets and liabilities in foreign operations are translated from the func- tional currency of the operations to the Group’s presentation currency at the exchange rate applicable on the closing date. Income and expenses in a foreign operation are translated to SEK at the average exchange rate which corresponds to an approximation of the exchange rates prevailing on each individual transaction date. Translation differences arising in the translation of foreign operations’ functional currencies are recognized in the consoli- dated statements of comprehensive income. Earnings per Share The calculation of earnings per share is based on the Group’s net loss for the year and on the weighted-average number of common shares outstanding during the year. In calculating earnings per share after dilution, earnings and the average number of shares are adjusted for the dilutive effects of potential common shares. Earnings per share is not adjusted for any dilution that results in a profit per share after dilution that is higher than profit per share before dilution, or loss per share that is lower than loss per share before dilution. Cash Flow The consolidated statement of cash flows is prepared in accordance with the indirect method. The recognized cash flow includes only transactions that involve inflows and outflows, divided into operating activ- ities, investing activities and financing activities. Cash flows from inflows and outflows are recognized at gross amounts, except for transactions comprising large inflows and outflows that pertain to items that are traded quickly and have short terms. Segment Information An operating segment is a part of the Group that conducts business activities from which it can generate revenue and incur costs, and for which independent financial information is available. Identification of segments is based on internal reporting to the chief operating decision maker (“CODM”). The CODM for the Group is the Chief Executive Officer (“CEO”). The Group does not divide its operations into different segments and the CODM operates and manages the Group’s entire operations as one segment, which is consistent with the Group’s internal organization and reporting system. The Group’s revenue is attributable to the Parent Company in Sweden and the non-current assets are located in Sweden, France and Switzerland. Note 2 Significant Accounting Judgements, Estimates and Assumptions The preparation of the Group’s consolidated financial statements in accordance with IFRS requires management to make judgements, estimates and assumptions that affect the recorded amounts of revenues, expenses, assets and liabilities, and the accompanying disclosures. Uncertainty about these assumptions and estimates could result in outcomes that require a material adjustment to the carrying amount of assets or liabilities affected in future periods. Judgements, estimates and assumptions are evaluated on an ongoing basis. Changes in judgements, estimates and assumptions are recognized in the period the change has occurred if the change only affects that period, and future periods if the change affects both the current period and future periods. Revenue Recognition As described in Note 1, the Group recognizes revenue as identified perfor- mance obligations are performed. The outlicensing contracts which the company has entered into consists of multiple performance obligations, as they contain multiple goods or services that could be sold on a stand-alone basis, and that are distinct within the context of the contract. Accordingly, the Group allocates the transaction price based on the relative stand-alone selling prices of the performance obligations, which requires identifying the performance obligations in the contracts, and allocating the transaction price between these. Revenue for the outlicensing of Nefecon is recognized at the point in time when control of the intellectual property is transferred, while revenue for the provision of certain regulatory services is reported over time as the services are performed. The revenue allocated to the performance obligation for outlicensing is based on the residual approach, and consists of the total transaction price for each contract after deducting the stand- alone selling price of all other performance obligations, and the allocation of revenue to the performance obligation for regulatory services is based on the expected costs to provide the service, with the addition of a profit margin based on comparable companies. The identification of and alloca- tion of the transaction price between these performance obligations hence has a significant impact on the Group's revenue recognition, as the revenue recognition patterns differ between the performance obligations. Specifically, the significant accounting judgments and estimates within revenue recognition include determining which promises within each contract are distinct, estimating the expected costs to fulfil the perfor- mance obligations that are not based on the residual method, and determining an appropriate profit margin for these. The Group determines the expected costs to complete these performance obligations through an input model based on the expected hours of work required by the Group's personnel, as well as expected costs to be incurred from the Group's suppliers. The Group then determines an appropriate profit margin by iden- tifying comparable peer companies that provide such services separately, and bases the margin rate on these. The Group then recognizes revenue for the performance obligation to provide regulatory services as these costs are incurred. These estimates are forward-looking and could be affected by differences between expected and actual costs incurred to fulfil the perfor- mance obligations. Management's estimate of the total costs as a measure of progress to completion of the performance obligation hence requires the use of assumptions and estimates. The revenue contracts also contain variable remuneration in the form of regulatory and commercial milestones. Variable remuneration is initially considered constrained, as there is significant uncertainty as to whether the associated milestones will occur. Compensation attributable to sales-based milestones or royalties is not recognized until the sale that results in the right to the royalties have occurred. Determining whether the criteria for recognition of the variable remuneration has been met hence has signifi- cant effects on revenue recognition, and requires significant judgment by Management. Purchase Price Allocation The valuation of identifiable assets and liabilities in connection with the acquisition of subsidiaries involves that items in the acquired company’s balance sheet as well as items that have not been recognized in the acquired company’s balance sheet should be valued at fair value. The valuation of NOX platform is based on the Multiple Excess Earnings Method (MEEM). 44 45 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 GROUP - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (SEK in thousands, except per share amounts or as otherwise indicated) » |
The total cost of the outstanding option program is presented below. These costs do not affect the Groups consolidated statement of cash flows. The Group has 3,000,000 warrants which are set aside to secure the delivery of shares in connection with the utilization of the option program. For additional information see Note 25 Equity. Year Ended December 31, 2021 2020 2019 Share-based payments 24,737 5,304 - Provisions attributable to changes in social security costs (Share-based payments) 9,992 3,164 - Total 34,729 8,468 - Share-Based Payments Board LTIP 2019 This is a performance-based long-term incentive program for certain members of the Board of Directors in Calliditas. A total of 51,399 share awards is outstanding for the incentive program 2019. The share awards are gradually vested over three years until the AGM 2022 or June 1, 2022, whichever is the earliest, based on the development of Calliditas share price during the period from May 8, 2019 through on June 1, 2022. The share awards are vested by 1/3 at the end of each period, provided that the participant is still a member of the Board of Calliditas that day. In addition to these conditions for vesting, the share awards are subject to performance-based vesting based on the development of Calliditas share price. If Calliditas share price has increased by more than 60 percent, 100 percent of the share awards shall be earned, and if the share price has increased by 20 percent, 33 percent of the share awards shall be vested. In the event of an increase in the share price by between 20 and 60 percent, vesting will be linear. If the share price has increased by less than 20 percent, no vesting will take place. Each share award entitles the holder to receive a share in Calliditas free of charge, provided that the holder is still a member of the Board of Calliditas at the relevant vesting date. Changes and holdings of share awards for the Board on the opening and closing balance are presented below: Share Awards Outstanding as of Holder January 1, 2019 Change December 31, 2019 Change December 31, 2020 Change December 31, 2021 Elmar Schnee, Chairman of the Board - 23,236 23,236 - 23,236 - 23,236 Thomas Eklund, Board member (until June, 2020) - 8,449 8,449 (5,633) 2,816 - 2,816 Hilde Furberg, Board member - 8,449 8,449 - 8,449 - 8,449 Lennart Hansson, Board member - 8,449 8,449 - 8,449 - 8,449 Diane Parks, Board member - 8,449 8,449 - 8,449 - 8,449 Total - 57,032 57,032 (5,633) 51,399 - 51,399 Calculation of fair value of share-based payments (Board LTIP 2019) Fair value at grant day has been measured using a Monte Carlo simulation of future share price developments. The simulated share price trend has been used to both calculate the outcome of the program and the value of each share at the time of acquisition (present value adjusted to the grant date). Exercised Date Fair Value at Grant Date Number of Share Awards Board LTIP 2019 June 1, 2022 22.49 51 399 The total cost of the outstanding share-based payments is presented below. These costs do not affect the Groups consolidated statement of cash flows. The Group has 70,000 warrants which are set aside to secure the delivery of shares in connection with the utilization of the Board LTIP 2019. For additional information see Note 25 Equity. Year Ended December 31, 2021 2020 2019 Share-based payments 396 440 249 Provisions attributable to changes in social security costs (Share-based payments) – 1,426 175 Total 396 1,866 424 Board LTIP 2020 This is a performance-based long-term incentive program for certain members of the Board of Directors in Calliditas. A total of 31,371 share awards is outstanding for the incentive program 2020. The share awards are gradually vested over three years until the AGM 2023 or July 1, 2023, whichever is the earliest, based on the development of Calliditas share price during the period from the date the share awards are allocated (grant date) up to and including the day before the vesting date. The share awards are vested by 1/3 at the end of each period, provided that the participant is still a member of the Board of Calliditas that day. In addition to these conditions for vesting, the share awards are subject to performance-based vesting based on the development of Calliditas share price. If Calliditas share price has increased by more than 60 percent, 100 percent of the share awards shall be earned, and if the share price has increased by 20 percent, 33 percent of the share awards shall be vested. In the event of an increase in the share price by between 20 and 60 percent, vesting will be linear. If the share price has increased by less than 20 percent, no vesting will take place. Each share award entitles the holder to receive a share in Calliditas free of charge, provided that the holder is still a member of the Board of Calliditas at the relevant vesting date. Changes and holdings of share awards for the Board on the opening and closing balance are presented below: Share Awards Outstanding as of Holder January 1, 2019 Change December 31, 2019 Change December 31, 2020 Change December 31, 2021 Elmar Schnee, Chairman of the Board - - - 14,063 14,063 - 14,063 Hilde Furberg, Board member - - - 4,327 4,327 - 4,327 Lennart Hansson, Board member - - - 4,327 4,327 - 4,327 Diane Parks, Board member - - - 4,327 4,327 - 4,327 Molly Henderson, Board member - - - 4,327 4,327 - 4,327 Total - - - 31,371 31,371 - 31,371 Calculation of fair value of share-based payments (Board LTIP 2020) Fair value at grant day has been measured using a Monte Carlo simulation of future share price developments. The simulated share price trend has been used to both calculate the outcome of the program and the value of each share at the time of acquisition (present value adjusted to the grant date). Exercised Date Fair Value at Grant Date Number of Share Awards Board LTIP 2020 July 1, 2023 33.97 31,371 The total cost of the outstanding share-based payments is presented below. These costs do not affect the Groups consolidated statement of cash flows. The Group has 40,000 warrants which are set aside to secure the delivery of shares in connection with the utilization of the Board LTIP 2020. For additional information see Note 25 Equity. Year Ended December 31, 2021 2020 2019 Share-based payments 445 267 - Provisions attributable to changes in social security costs (Share-based payments) 171 207 - Total 616 474 - Board LTIP 2021 This is a performance-based long-term incentive program for certain members of the Board of Directors in Calliditas. A total of 31,371 share awards is outstanding for the incentive program 2021. The share awards are gradually vested over three years until the AGM 2024 or July 1, 2024, whichever is the earliest, based on the development of Calliditas share price during the period from the date the share awards are allocated (grant date) up to and including the day before the vesting date. The share awards are vested by 1/3 at the end of each period, provided that the participant is still a member of the Board of Calliditas that day. In addition to these conditions for vesting, the share awards are subject to performance-based vesting based on the development of Calliditas share price. If Calliditas share price has increased by more than 60 percent, 100 percent of the share awards shall be earned, and if the share price has increased by 20 percent, 33 percent of the share awards shall be vested. In the event of an increase in the share price by between 20 and 60 percent, vesting will be linear. If the share price has increased by less than 20 percent, no vesting will take place. Each share award entitles the holder to receive a share in Calliditas free of charge, provided that the holder is still a member of the Board of Calliditas at the relevant vesting date. Changes and holdings of share awards for the Board on the opening and closing balance are presented below: Share Awards Outstanding as of Holder January 1, 2019 Change December 31, 2019 Change December 31, 2020 Change December 31, 2021 Elmar Schnee, Chairman of the Board - - - - - 10,624 10,624 Hilde Furberg, Board member - - - - - 4,086 4,086 Lennart Hansson, Board member - - - - - 4,086 4,086 Diane Parks, Board member - - - - - 4,086 4,086 Molly Henderson, Board member - - - - - 4,086 4,086 Total - - - - - 26,968 26,968 Calculation of fair value of share-based payments (Board LTIP 2021) Fair value at grant day has been measured using a Monte Carlo simulation of future share price developments. The simulated share price trend has been used to both calculate the outcome of the program and the value of each share at the time of acquisition (present value adjusted to the grant date). 52 53 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 » GROUP - NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (SEK in thousands, except per share amounts or as otherwise indicated) |
Valuation of intangible assets Description Intangible assets for the Group and Parent Company amount to SEK 399,418 thousand and SEK 32,132 thousand, respectively, as of December 31, 2021. As explained in Note 1 and Note 16 of the consolidated financial statements, the Company performs an impair- ment assessment of goodwill and intangible assets not yet available for use, on an annual basis, or when there is an indication that an asset may be impaired. The Company’s evaluation of the carrying value of intan- gible assets involves the comparison of the recoverable amount of each asset or cash generating unit to their carrying values. The recoverable amount of intangible assets is esti- mated based on a probability-adjusted cash flow model, where the amount is determined by estimating the expected future cash flows and present value adjustments to take into account the development risk. Changes in assumptions used by management could have a significant impact on either the recoverable amount, the amount of any impairment charge, or both. We determined the valuation of intangible assets to be a key audit matter, as auditing the valuation of intan- gible assets was complex due to the significant judg- ments made by management to estimate the recover- able amount, including the determination of the likely timing of potential commercialization, the market size, the probability of reaching the market and the discount rate used. How our audit addressed this key audit matter We performed audit procedures related to the valua- tion of intangible assets, which included, among others, understanding management’s methodology for esti- mating the recoverable value and evaluating the appro- priateness of the discounted cash flow model utilized. In addition, we tested the inputs and assumptions utilized by management regarding potential commer- cialization, expected market size and the probability of the products reaching the market by comparing these to statistical data for the clinical indications targeted and for other development projects within the industry. We also performed a sensitivity analysis of the Company’s discounted cash flow models. With the assistance of our valuation specialists, we evaluated the discount rates used by comparing these to rates used by peers, and tested the mathematical accuracy of calculations within the impairment models. Other Information than the annual accounts and consolidated accounts This document also contains other information than the annual accounts and consolidated accounts and is found on pages 1-27 and 86-99. The Board of Directors and the Managing Director are responsible for this other information. Our opinion on the annual accounts and consolidated accounts does not cover this other information and we do not express any form of assurance conclusion regarding this other information. In connection with our audit of the annual accounts and consolidated accounts, our responsibility is to read the information identified above and consider whether the information is materially inconsistent with the annual accounts and consolidated accounts. In this procedure we also take into account our knowledge otherwise obtained in the audit and assess whether the informa- tion otherwise appears to be materially misstated. If we, based on the work performed concerning this information, conclude that there is a material misstate- ment of this other information, we are required to report that fact. We have nothing to report in this regard. Responsibilities of the Board of Directors and the Managing Director The Board of Directors and the Managing Director are responsible for the preparation of the annual accounts and consolidated accounts and that they give a fair presentation in accordance with the Annual Accounts Act and, concerning the consolidated accounts, in accordance with IFRS as adopted by the EU. The Board of Directors and the Managing Director are also responsible for such internal control as they deter- mine is necessary to enable the preparation of annual accounts and consolidated accounts that are free from material misstatement, whether due to fraud or error. In preparing the annual accounts and consolidated accounts, The Board of Directors and the Managing Director are responsible for the assessment of the company’s and the group’s ability to continue as a going concern. They disclose, as applicable, matters related to going concern and using the going concern basis of accounting. The going concern basis of accounting is however not applied if the Board of Directors and the Managing Director intends to liquidate the company, to cease operations, or has no realistic alternative but to do so. The Audit Committee shall, without prejudice to the Board of Director’s responsibilities and tasks in general, among other things oversee the company’s financial reporting process. Auditor’s responsibility Our objectives are to obtain reasonable assurance about whether the annual accounts and consolidated accounts as a whole are free from material misstate- ment, whether due to fraud or error, and to issue an auditor’s report that includes our opinions. Reasonable assurance is a high level of assurance, but is not a guar- antee that an audit conducted in accordance with ISAs and generally accepted auditing standards in Sweden will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggre- gate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these annual accounts and consolidated accounts. As part of an audit in accordance with ISAs, we exercise professional judgment and maintain professional skepti- cism throughout the audit. We also: • Identify and assess the risks of material misstate- ment of the annual accounts and consolidated accounts, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for our opinions. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal control. • Obtain an understanding of the company’s internal control relevant to our audit in order to design audit procedures that are appropriate in the circum- stances, but not for the purpose of expressing an opinion on the effectiveness of the company’s internal control. 80 81 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 AUDITOR'S REPORT » |
Report on other legal and regulatory requirements Report on the audit of the administration and the proposed appropriations of the company’s profit or loss Opinions In addition to our audit of the annual accounts and consolidated accounts, we have also audited the administration of the Board of Directors and the Managing Director of Calliditas Therapeutics AB (publ) for the year 2021 and the proposed appropriations of the company’s profit or loss. We recommend to the general meeting of shareholders that the profit be appropriated (loss be dealt with) in accordance with the proposal in the statutory admin- istration report and that the members of the Board of Directors and the Managing Director be discharged from liability for the financial year. Basis for opinions We conducted the audit in accordance with generally accepted auditing standards in Sweden. Our respon- sibilities under those standards are further described in the Auditor’s Responsibilities section. We are independent of the parent company and the group in accordance with professional ethics for accountants in Sweden and have otherwise fulfilled our ethical respon- sibilities in accordance with these requirements. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinions. Responsibilities of the Board of Directors and the Mana- ging Director The Board of Directors is responsible for the proposal for appropriations of the company’s profit or loss. At the proposal of a dividend, this includes an assessment of whether the dividend is justifiable considering the requirements which the company's and the group’s type of operations, size and risks place on the size of the parent company's and the group’s equity, consoli- dation requirements, liquidity and position in general. The Board of Directors is responsible for the company’s organization and the administration of the company’s affairs. This includes among other things continuous assessment of the company’s and the group’s financial situation and ensuring that the company's organization is designed so that the accounting, management of assets and the company’s financial affairs otherwise are controlled in a reassuring manner. The Managing Director shall manage the ongoing administration according to the Board of Directors’ guidelines and instructions and among other matters take measures that are necessary to fulfill the company’s accounting in accordance with law and handle the management of assets in a reassuring manner. Auditor’s responsibility Our objective concerning the audit of the administra- tion, and thereby our opinion about discharge from liability, is to obtain audit evidence to assess with a reasonable degree of assurance whether any member of the Board of Directors or the Managing Director in any material respect: • has undertaken any action or been guilty of any omission which can give rise to liability to the company, oror • in any other way has acted in contravention of the Companies Act, the Annual Accounts Act or the Articles of Association. Our objective concerning the audit of the proposed appropriations of the company’s profit or loss, and thereby our opinion about this, is to assess with reasonable degree of assurance whether the proposal is in accordance with the Companies Act. • Evaluate the appropriateness of accounting policies used and the reasonableness of accounting esti- mates and related disclosures made by the Board of Directors and the Managing Director. • Conclude on the appropriateness of the Board of Directors’ and the Managing Director’s use of the going concern basis of accounting in preparing the annual accounts and consolidated accounts. We also draw a conclusion, based on the audit evidence obtained, as to whether any material uncertainty exists related to events or conditions that may cast significant doubt on the company’s and the group’s ability to continue as a going concern. If we conclude that a material uncertainty exists, we are required to draw attention in our auditor’s report to the related disclosures in the annual accounts and consolidated accounts or, if such disclosures are inadequate, to modify our opinion about the annual accounts and consolidated accounts. Our conclu- sions are based on the audit evidence obtained up to the date of our auditor’s report. However, future events or conditions may cause a company and a group to cease to continue as a going concern. • Evaluate the overall presentation, structure and content of the annual accounts and consolidated accounts, including the disclosures, and whether the annual accounts and consolidated accounts repre- sent the underlying transactions and events in a manner that achieves fair presentation. • Obtain sufficient and appropriate audit evidence regarding the financial information of the entities or business activities within the group to express an opinion on the consolidated accounts. We are responsible for the direction, supervision and perfor- mance of the group audit. We remain solely respon- sible for our opinions. We must inform the Board of Directors of, among other matters, the planned scope and timing of the audit. We must also inform of significant audit findings during our audit, including any significant deficiencies in internal control that we identified. We must also provide the Board of Directors with a statement that we have complied with relevant ethical requirements regarding independence, and to communicate with them all relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, actions taken to eliminate threats or related safeguards applied. From the matters communicated with the Board of Directors, we determine those matters that were of most significance in the audit of the annual accounts and consolidated accounts, including the most important assessed risks for material misstatement, and are therefore the key audit matters. We describe these matters in the auditor’s report unless law or regulation precludes disclosure about the matter. 82 83 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 AUDITOR'S REPORT |
The auditor’s examination of the ESEF report Opinion In addition to our audit of the annual accounts and consolidated accounts, we have also examined that the Board of Directors and the Managing Director have prepared the annual accounts and consolidated accounts in a format that enables uniform electronic reporting (the Esef report) pursuant to Chapter 16, Section 4(a) of the Swedish Securities Market Act (2007:528) for Calliditas Therapeutics AB for the year 2021. Our examination and our opinion relate only to the statutory requirements. In our opinion, the ESEF report #[341fcbcf- 069d68ea293374251f9d32f9ea6474f- e708099e134a59430804f09d0] has been prepared in a format that, in all material respects, enables uniform electronic reporting. Basis for opinion We have performed the examination in accordance with FAR’s recommendation RevR 18 Examination of the ESEF report. Our responsibility under this recom- mendation is described in more detail in the Auditors’ responsibility section. We are independent of Calliditas Therapeutics AB in accordance with professional ethics for accountants in Sweden and have otherwise fulfilled our ethical responsibilities in accordance with these requirements. We believe that the evidence we have obtained is suffi- cient and appropriate to provide a basis for our opinion. Responsibilities of the Board of Directors and the Mana- ging Director The Board of Directors and the Managing Director are responsible for the preparation of the Esef report in accordance with Chapter 16, Section 4(a) of the Swedish Securities Market Act (2007:528), and for such internal control that the Board of Directors and the Managing Director determine is necessary to prepare the Esef report without material misstate- ments, whether due to fraud or error. Auditor’s responsibility Our responsibility is to obtain reasonable assurance whether the Esef report is in all material respects prepared in a format that meets the requirements of Chapter 16, Section 4(a) of the Swedish Securities Market Act (2007:528), based on the procedures performed. RevR 18 requires us to plan and execute procedures to achieve reasonable assurance that the Esef report is prepared in a format that meets these requirements. Reasonable assurance is a high level of assurance, but it is not a guarantee that an engagement carried out according to RevR 18 and generally accepted auditing standards in Sweden will always detect a material Stockholm, April 27, 2022 Ernst & Young AB Anna Svanberg Authorized Public Accountant Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accor- dance with generally accepted auditing standards in Sweden will always detect actions or omissions that can give rise to liability to the company, or that the proposed appropriations of the company’s profit or loss are not in accordance with the Companies Act. As part of an audit in accordance with generally accepted auditing standards in Sweden, we exercise professional judgment and maintain professional skep- ticism throughout the audit. The examination of the administration and the proposed appropriations of the company’s profit or loss is based primarily on the audit of the accounts. Additional audit procedures performed are based on our professional judgment with starting point in risk and materiality. This means that we focus the examination on such actions, areas and relation- ships that are material for the operations and where deviations and violations would have particular impor- tance for the company’s situation. We examine and test decisions undertaken, support for decisions, actions taken and other circumstances that are relevant to our opinion concerning discharge from liability. As a basis for our opinion on the Board of Directors’ proposed appropriations of the company’s profit or loss we exam- ined whether the proposal is in accordance with the Companies Act. misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of the Esef report. The audit firm applies ISQC 1 Quality Control for Firms that Perform Audits and Reviews of Financial Statements, and other Assurance and Related Services Engagements and accordingly maintains a comprehensive system of quality control, including documented policies and procedures regarding compliance with professional ethical requirements, professional standards and legal and regulatory requirements. The examination involves obtaining evidence, through various procedures, that the Esef report has been prepared in a format that enables uniform electronic reporting of the annual and consolidated accounts. The procedures selected depend on the auditor’s judg- ment, including the assessment of the risks of material misstatement in the report, whether due to fraud or error. In carrying out this risk assessment, and in order to design audit procedures that are appropriate in the circumstances, the auditor considers those elements of internal control that are relevant to the prepara- tion of the Esef report by the Board of Directors and the Managing Director, but not for the purpose of expressing an opinion on the effectiveness of those internal controls. The examination also includes an evaluation of the appropriateness and reasonableness of assumptions made by the Board of Directors and the Managing Director. The procedures mainly include a technical validation of the Esef report, i.e. if the file containing the Esef report meets the technical specification set out in the Commission’s Delegated Regulation (EU) 2019/815 and a reconciliation of the Esef report with the audited annual accounts and consolidated accounts. Furthermore, the procedures also include an assess- ment of whether the Esef report has been marked with iXBRL which enables a fair and complete machine-read- able version of the consolidated statement of financial performance, financial position, changes in equity and cash flow. Ernst & Young AB, Hamngatan 26, 111 47 Stockholm, was appointed auditor of Calliditas Therapeutics AB by the general meeting of the shareholders on the 27 May 2021 and has been the company’s auditor since the 15 April 2004. 84 85 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 AUDITOR'S REPORT |
Corporate Governance Report Introduction Calliditas Therapeutics AB (publ), “Calliditas” is a Swedish public limited liability company with its regis- tered office in Stockholm. The company’s share was listed on June 29, 2018 on Nasdaq Stockholm and on June 5, 2020 on Nasdaq Global Select US and is traded under the ticker CALTX and CALT, respectively. This report pertains to the financial year of 2021 and has been examined by the company’s auditors. Background Corporate governance refers to the systems through which shareholders, directly or indirectly, control the company. Good corporate governance is an essential part of efforts to generate value for Calliditas’ share- holders. Corporate governance in Calliditas is based on Swedish law, Nasdaq Stockholm’s Rule Book for Issuers and internal rules and regulations. The company also applies the Swedish Code of Corporate Governance (the “Code”). The Code applies to all Swedish compa- nies whose shares are listed on a regulated market in Sweden. The company need not comply with all of the rules of the Code as the Code itself offers an opportu- nity to deviate from the rules, on the condition that any such deviation, and the chosen alternative solution, is described and the reasons explained in the Corporate Governance Report (according to the comply or explain principle). However, the company has not deviated from any of the rules established in the Code during the year. The company is classified as a Foreign Private Issuer (FPI) in accordance with the regulations estab- lished by the US Securities and Exchange Commission (SEC) and therefore follows market practice in the domestic market, ie Swedish corporate governance. Examples of Important Rules and Regulations Important internal rules and regulations • Articles of Association • Rules of procedure of the Board of Directors and Committees • Directives for the CEO • Policy documents Important external rules and regulations • Swedish Companies Act • Swedish and international accounting legislation • Nasdaq Stockholm’s Rule Book for Issuers • Nasdaq U.S Rule Book for Issuers • Swedish Code of Corporate Governance • Sarbanes-Oxley Act Shareholders Calliditas’ shares were admitted to trading on Nasdaq Stockholm, Mid Cap, in June 2018 and on Nasdag Global Select, in June 5, 2020. At the end of 2021, the total number of shares and voting rights amounted to 52,341,584, distributed between 19,972 share- holders. The ten largest shareholders held 59.07% of shares outstanding and other shareholders 40.93%. As of December 31, 2021, three shareholders owned shares that each represented 10% or more of the total number of shares and voting rights in the company: BVF Partners LP 12.7%, Stiftelsen Industrifonden, 11.0% and Linc AB 10.5%. Dividend Policy The company has so far not paid out any dividend. Any future dividend and the size thereof, will be deter- mined based on long-term growth, earnings trends and capital requirements of Calliditas. It is the view of the Board of Directors that Calliditas should prioritize progression of the development program, and until the future revenues substantially exceeds the cost of the development programs, financial resources should mainly be used to finance Calliditas’ development programs. In view of company’s financial position and negative earnings, the Board of Directors does not intend to propose any dividend before the company generates long-term sustainable profits and posi- tive cash flow. Dividends shall, as far as a dividend is proposed, be balanced with regard to the business risk. Annual General Meeting Right to participate in the Annual General Meeting Shareholders who wish to participate in the Annual General Meeting (AGM) must be included in the share- holders’ register maintained by Euroclear Sweden on the day falling six banking days prior to the meeting, and notify the company of their participation no later than on the date stipulated in the notice convening the meeting. Shareholders may attend the shareholders’ meetings in person or by proxy and may be accom- panied by a maximum of two assistants. Typically, it is possible for a shareholder to register for the AGM in several different ways as indicated in the notice of the meeting. A shareholder may vote for all company shares owned or represented by the shareholder. Notice of the AGM shall be published in the Swedish Official Gazette and on the company’s website, within such time as set forth in the Swedish Companies Act (2005:551). It shall be announced in Svenska Dagbladet that a notice has been issued. Annual General Meeting 2022 Calliditas’ 2022 AGM will be held on Thursday, May 19, 2022. With reference to the Swedish Act (2022:121) on temporary exceptions to facilitate the execution of general meetings in companies and other associations, the Board of Directors has decided that the annual general meeting will be conducted by advance voting only, without physical presence of shareholders, proxies and third parties. The minutes from the AGM will be made available at www.calliditas.se. Participation at the Annual General Meeting Shareholders who wish to participate, through advance voting, in the meeting must: • be recorded in the share register maintained by Euroclear Sweden AB relating to the circumstances on Wednesday 11 May 2022, and • give notice of participation by casting their advance votes in accordance with the instructions under the heading “Advance voting” below, so that the advance voting form is received by Euroclear Sweden AB no later than on Wednesday 18 May 2022. Shareholders whose shares are registered in the name of a nominee through a bank or a securities institution must temporarily register their shares in their own names to be entitled to participate in the meeting. Such registration, which may be temporary (so-called voting rights registration), must be duly effected in the share register maintained by Euroclear Sweden AB on Friday 13 May 2022, and the shareholders must there- fore advise their nominees well in advance of this date. Nomination Committee Companies applying the Code shall have a Nomination Committee. According to the Code, the AGM shall appoint the members of the Nomination Committee or resolve on procedures for appointing the members. The Nomination Committee shall, pursuant to the Code, consist of at least three members of which a majority shall be independent in relation to Calliditas and the Group Management. In addition, at least one member of the Nomination Committee shall be independent in relation to the largest shareholder in terms of voting rights or group of shareholders who cooperate in terms of the company’s management. At the Extraordinary General Meeting held on September 14, 2017, it was resolved that the Nomi- nation Committee shall be composed of the Chairman of the Board of Directors together with one represen- tative of each of the three largest shareholders, based on ownership in Calliditas as of the end of the third quarter of the fiscal year. The Nomination Committee in 2022 consists of: • Patrik Swobocki, appointed by Stiftelsen Industri- fonden • Per Sjögemark, appointed by Handelsbanken Fonder • Karl Tobieson, appointed by Linc AB (Chairman) • Elmar Schnee, Chairman of the Board. Should any of the three largest shareholders renounce its right to appoint one representative to the Nomination Committee, such right shall transfer to the shareholder who then in turn, after these three, is the largest share- holder in Calliditas. The Board of Directors shall convene the Nomination Committee. The member representing the largest shareholder shall be appointed Chairman of the Nomination Committee, unless the Nomination Committee unanimously appoints someone else. Should a shareholder having appointed a representative to the Nomination Committee no longer be among the three largest shareholders at a point in time falling three months before the AGM at the latest, the representa- tive appointed by such shareholder shall resign and the shareholder who is then among the three largest share- holders shall have the right to appoint one representative to the Nomination Committee. Unless there are specific reasons otherwise, the already established composition of the Nomination Committee shall, however, remain unchanged in case such change in the ownership is only marginal or occurs during the three-month period prior to the AGM. Where a shareholder has become one of the three largest shareholders due to a material change in the ownership at a point in time falling later than three months before the AGM, such a shareholder shall however in any event have the right to take part of the work of the Nomination Committee and participate at its meetings. Should a member resign from the Nomi- nation Committee before his or her work is completed, the shareholder who has appointed such member shall appoint a new member, unless that shareholder is no longer one of the three largest shareholders, in which case the largest shareholder in turn shall appoint the substitute member. A shareholder who has appointed a representative to the Nomination Committee shall have the right to discharge such representative and appoint a new representative. Changes to the composition of the Nomination Committee shall be announced immediately. The term of the office for the Nomination Committee ends when the next Nomination Committee has been appointed. The Nomination Committee shall carry out its duties as set out in the Code. The Nomination Committee will be constituted and will meet in advance of the 2022 AGM and its proposals will be presented in the convening notice of the AGM 86 87 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 |
and on Calliditas’ website. Shareholders may submit proposals to the Nomination Committee in accor- dance with what has been published on the company’s website, www.calliditas.se, prior to the AGM. Auditor In accordance with the Articles of Association, Callid- itas must appoint a registered firm of accountants as external auditor. The 2021 AGM elected the registered firm of accountants Ernst & Young AB as auditor, up to the 2022 AGM. The Auditor-in-Charge is Anna Svan- berg. The auditor examines the Parent Company’s and the Group’s accounts and administration on behalf of the AGM. The external audit of the Parent Company’s and the Group’s accounts and the Board’s and CEO’s administration is conducted using generally accepted auditing standards in Sweden. The company entrusted the auditor to review one interim reports in 2021, which satisfies the requirements of the Code. For information about remuneration of the auditor, refer to Note 6 Auditors’ Fee. Board of Directors The Board of Directors is the second highest deci- sion-making body of the company after the AGM. According to the Swedish Companies Act, the Board of Directors is responsible for the organization of Callid- itas and the management of the company’s affairs, which means that the Board of Directors is responsible for, among other things, setting targets and strategies, securing routines and systems for evaluation of set targets, continuously assessing the financial condition and profits as well as evaluating the operating manage- ment. The Board of Directors is also responsible for ensuring that annual reports and interim reports are prepared in a timely manner. Moreover, the Board of Directors appoints the CEO. Members of the Board of Directors are normally appointed by the AGM for the period until the end of the next AGM. According to Calliditas’ Articles of Asso- ciation, the members of the Board of Directors elected by the AGM shall be not less than three and not more than ten members with no deputy members of the Board of Directors. According to the Code, the Chairman of the Board of Directors is to be elected by the AGM and have a special responsibility for leading the work of the Board of Directors and for ensuring that the work of the Board of Directors is efficiently organized. The Board of Directors applies written rules of proce- dure, which are revised annually and adopted by the inaugural board meeting every year. Among other things, the rules of procedure govern the practice of the Board of Directors, functions and the division of work between Board members and the CEO. At the inaugural board meeting, the Board of Directors also adopts instructions for the CEO, including instructions for financial reporting. The Board of Directors meets according to an annual predetermined schedule. In addition to these meetings, additional Board meetings can be convened to handle issues which cannot be postponed until the next ordi- nary board meeting. In addition to the Board meetings, the Chairman of the Board of Directors and the CEO continuously discuss the management of the company. Currently, the company’s Board of Directors consists of five ordinary members elected by the AGM. Board Independence The company satisfies the requirements of the Code as most of the Board members elected by the AGM are inde- pendent of the company and management, and that at least two of these are independent in relation to major share- holders. The table on page XX presents the independence of members at the date on which this report was published. Work of the Board in 2021 During 2021, the Board of Directors held a total of 16 CORPORATE GOVERNANCE REPORT Board members’ independence, attendance and remuneration in 2021 Independent in relation to Attendance Name Position Board member since The company and manage- ment Major share- holders Board meet- ings Audit Committee meetings Remuneration Committee meetings Total remuneration, SEK in thousand Elmar Schnee Board Chairman 2019 Yes Yes 16/16 - 3/3 1,363 Lennart Hansson Board Member 2009 Yes Yes 15/16 5/5 3/3 522 Hilde Furberg Board Member 2014 Yes Yes 15/16 5/5 - 499 Diane Parks Board Member 2019 Yes Yes 16/16 - 3/3 584 Molly Henderson Board Member 2020 Yes Yes 14/16 5/5 - 664 meetings, of which 6 were ordinary and 10 extraor- dinary meetings. Calliditas’ CEO participates in Board meetings, as does the company’s CFO and General Counsel, who was secretary at the meetings. Other employees from Calliditas have reported on particular issues at the meetings. The extraordinary meetings were a result of the company’s work with acquisition and capital raise. Board Remuneration Fees to members elected by the Annual General Meeting are decided by the Annual General Meeting. The Annual General Meeting on May 27, 2021 resolved that fees to the Board for the period up to the end of the next Annual General Meeting shall be as follows: Board fees shall be SEK 850,000 to the Chairman of the Board and SEK 300,000 to each of the other members not employed in the Group, SEK 150,000 SEK 50,000 to the Chairman of the Audit Committee and SEK 75,000 to other members of the Audit Committee who are not employees of the Group, and SEK 50,000 to the Chairman of the Remuneration Committee and SEK 25,000 to other members of the Remuneration Committee who are not employees of the Group. In addition to the fee proposed above for ordinary board work, it is proposed that a board member who is resident in the USA shall receive an extra fee of SEK 140,000 and that a board member who is resident in Europe but outside the Nordic region shall receive an extra fee of SEK 50,000. For more information regarding remuneration of Board members, refer to Note 9 Employees and Personnel Costs. Board Committees Audit Committee Calliditas has an Audit Committee consisting of three members: Molly Henderson (Chairman), Lennart Hansson and Hilde Furberg. The Audit Committee shall, without it affecting the responsibilities and tasks of the Board of Directors, monitor the company’s finan- cial reporting, monitor the efficiency of the company’s internal controls, internal auditing and risk manage- ment, keep informed of the auditing of the annual report and the consolidated accounts, review and monitor the impartiality and independence of the audi- tors and pay close attention to whether the auditors are providing other services besides audit services for the company, and assist in the preparation of proposals for the AGM’s decision on election of auditors. The Committee held five meetings in 2021. The company’s auditors took part in four of the meetings, where discussions included the auditors’ planning of the audit, their observations and examination of the company and the company’s financial statements. Remuneration Committee Calliditas has a Remuneration Committee consisting of three members: Elmar Schnee (Chairman), Lennart Hansson and Diane Parks. The Remuneration Committee shall prepare matters concerning remuner- ation principles, remuneration and other employment terms for the CEO and the executive management. The Committee held three meetings in 2021. At these meetings, the Committee discussed the current compensation system in the company, including a proposal for remuneration of the CEO and senior executives and the direction and terms of the incentive program that was approved for implementation by the Annual General Meeting on May 27, 2021. Remuneration of the CEO and Executive Management 2021 Calliditas shall offer remuneration in accordance with market practice to enable the recruitment and reten- tion of qualified executive management. Remuner- ations within Calliditas shall be based on principles of performance, competitiveness and fairness. The executive management refer to the CEO and other members of the executive management, as well as board members. The remuneration to the executive management may consist of fixed remuneration, variable remuneration, share and share-price related incentive programs, pension and other benefits. If local conditions justify variations in the remuneration princi- ples, such variations may occur. The fixed remuneration shall reflect the individual’s responsibility and experi- ence level. The fixed remuneration shall be reviewed annually. The executive management may be offered cash bonuses. Variable remuneration paid in cash may not exceed 60% of the annual fixed remuneration. Variable remunerations shall be connected to predeter- mined and measurable criteria, designed with the aim of promoting the company’s long-term value creation. Share and share-price related incentive programs shall, if resolved on, be decided by the AGM. Pension shall, where possible, be premium-based. For the CEO and other members of executive management, the premium may, in situations where premium-based pension is applicable, amount to a maximum of 30 per cent of the fixed salary. Notwithstanding the above, the Board of Directors is entitled to offer other solutions which, in terms of cost, are equivalent to the above. Evaluation of the Board and CEO Every year, the Board Chairman initiates an evaluation of the Board’s work. The evaluation aims to gain an opinion of the views of Board members on how the work of the Board is progressing and what measures can be implemented to enhance the efficiency of the Board. The aim is also to gain an opinion of the type of issues the Board believes should be offered more space and areas where further expertise may be needed on the Board. The Board of Directors continuously assesses 88 89 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 CORPORATE GOVERNANCE » CORPORATE GOVERNANCE REPORT |
the work of the CEO by monitoring the performance of the operations compared with established targets and makes a formal assessment each year. CEO and Management Team The role of the CEO is subordinate to the Board of Directors, and his or her primary task is to attend to the company’s daily management and operations in the company. The Rules of Procedure for Decision-making for the Board and instructions for the CEO present which issues that the company’s Board of Directors are to consider and decide and which are the respon- sibility of the CEO. The CEO is also responsible for preparing reports and required documentation for decision-making prior to board meetings and is the reporting person on the material at board meetings. Calliditas’ management consists of six individuals and includes, in addition to the CEO, the Chief Financial Officer, Chief Medical Officer, Vice President Opera- tions, Vice President Regulatory Affairs, and President North America. For information about current senior executives at Calliditas, when these assumed their positions, and date of birth, education, experience, shareholding in the company and current and previous assignments, refer to pages 94-95 and the company’s website, www.calliditas.se. Internal Control and Risk Management The Board of Director’s responsibility for the internal control is governed by the Swedish Companies Act, the Swedish Annual Reports Act – which requires that information about the main features of Callid- itas’ system for internal control and risk management related to financial reporting each year must be included in the corporate governance report – and the Code. The Board of Directors shall, among other tasks, ensure that Calliditas has sufficient internal control and formalized routines to ensure that established principles for financial reporting and internal control are adhered to and that there are effective systems to monitor and control the company’s operations and the risks associated with the company and its operations. The overall purpose of the internal control is to ensure that the company’s operating strategies and targets are monitored and that the owners’ investments are protected, to a reasonable degree. Furthermore, the internal control shall ensure that the external finan- cial reporting, with reasonable certainty, is reliable and prepared in accordance with generally accepted accounting practice, that applicable laws and regulations are followed, and that the requirements imposed on listed companies are complied with. The internal control primarily consists of the following five components. Control environment The Board of Directors has the overall responsibility for the internal control in relation to financial reporting. In order to create and maintain a functioning control environment, the Board of Directors has adopted a number of policies and guidelines governing financial reporting. These documents primarily comprise the rules of procedure for the Board of Directors, instruc- tions for the CEO, rules of procedure for the Audit Committee and instructions for financial reporting. The Board of Directors has also adopted a delegation of signatory authority and a treasury policy. The company also has a financial manual which contains principles, guidelines and process descriptions for accounting and financial reporting. Furthermore, the Board of Directors has established an Audit Committee whose main task is to monitor the company’s financial position, to monitor the effectiveness of the company’s internal control, internal audit and risk management, to be informed about the audit of the annual report and consolidated financial statements, and to review and monitor the auditor’s impartiality and independence. The responsi- bility for the ongoing work of the internal control over financial reporting has been delegated to the compa- ny’s CEO. The CEO regularly reports to the Board of Directors in accordance with the established instruc- tions for the CEO and the instructions for financial reporting. The Board of Directors also receives reports from the company’s auditor. The responsibility for the internal, business-specific control in the daily operations lies with the CEO. Risk assessment Risk assessment includes identifying risks that may arise if the basic requirements for the financial reporting of the company are not met. Calliditas’ management team has, in a specific risk register, identified and evaluated the risks that arise in the company’s operations, and has assessed how these risks can be managed. Calliditas’ management shall annually perform a risk assessment of strategic, operational and financial risks and present the assessment to the Audit Committee and the Board of Directors. The CEO is responsible for the presentation. The management’s risk assessment shall be reviewed on an annual basis by the CFO. Control activities Control activities limit the identified risks and ensure accurate and reliable financial reporting. The Board of Directors is responsible for the internal control and monitoring of the company’s management. This is done through both internal and external control activities, and through examination and monitoring of the company’s guidelines related to risk management. The effectiveness of the control activities are assessed annually and the results from these assessments are reported to the Board of Directors and the Audit Committee. In agreements with essential subcontractors, the company has secured the right to audit each respective subcontractors’ fulfill- ment of relevant services, including quality aspects. Monitoring Compliance with, and effectiveness of, the internal controls are constantly monitored. The CEO ensures that the Board of Directors continuously receives reports on the development of the company’s activities, including the development of the company’s results and financial position, as well as information on important events, such as research results and important contracts. The CEO also reports on these matters at each ordinary Board meeting. The compa- ny’s compliance with relevant policy’s and guidelines are assessed annually. The results from these assess- ments are compiled by the CFO in the company and then reported to the Board of Directors and the Audit Committee annually. Information and communication The company has information and communication chan- nels to promote the accuracy of the financial reporting and to facilitate reporting and feedback from operations to the Board of Directors and senior management, for example by making corporate governance documents such as internal policies, guidelines and instructions regarding the financial reporting available and known to the employees concerned. The Board of Directors has also adopted an information policy governing the compa- ny’s disclosure of information. The company has also in 2021 initiated an implementation of an inter-control structure according to the Sarbanes-Oxely Act to meet the requirements for companies listed in the USA. In addition to the abovementioned internal control, there is also internal, business-specific control of data as regards research and development, as well as quality control including systematic surveillance and evaluation of the company’s development and manufacturing operations. Internal Audit The Board of Directors has assessed the need for an internal audit function and decided that such a function is not justified in Calliditas, taking into account the scope of operations and that the Board’s monitoring of internal control is considered sufficient to ensure that internal control is effective. The Board of Directors reassess the requirement when changes take place that may give rise to a reassessment and at least once per year. Auditor’s report on the corporate governance statement To the general meeting of the shareholders of Calliditas Therapeutics AB (Publ), corporate identity number 556659-9766 Stockholm, April 27, 2022 Ernst & Young AB Anna Svanberg Authorized Public Accountant Engagement and responsibility It is the Board of Directors who is responsible for the corporate governance statement for the year 2021 on pages 86-91 and that it has been prepared in accordance with the Annual Accounts Act. The scope of the audit Our examination has been conducted in accordance with FAR’s standard RevR 16 The auditor’s examination of the corporate governance statement. This means that our examination of the corporate governance statement is different and substantially less in scope than an audit conducted in accordance with International Standards on Auditing and generally accepted auditing stan- dards in Sweden. We believe that the examination has provided us with sufficient basis for our opinions. Opinions A corporate governance statement has been prepared. Disclosures in accordance with chapter 6 section 6 the second paragraph points 2-6 the Annual Accounts Act and chapter 7 section 31 the second paragraph the same law are consistent with the annual accounts and the consolidated accounts and are in accordance with the Annual Accounts Act. 90 91 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 CORPORATE GOVERNANCE CORPORATE GOVERNANCE REPORT » CORPORATE GOVERNANCE REPORT |
Board of Directors Hilde Furberg Non-executive Director Born 1958. Board member since 2014. Education: Master of Science in Engi- neering from Oslo University, Norway. Board Committees: Member of the Audit Committee. Experience: Hilde Furberg is an indepen- dent consultant and professional Board member. She has extensive experience in leadership from her 35 years in sales, marketing, strategy and management in Pharma/Biotech. Hilde has worked for companies such as Genzyme and Baxter, she was most recently SVP and General Manger/European Head of Rare Diseases at Sanofi Genzyme. In addition to working for Genzyme/Sanofi Genzyme, Hilde has since 2005 worked as non-executive director and Board member of Probi, Pronova, Clavis, Bergenbio and Algeta. Other current assignments: She is currently an industrial advisor to Investinor and Board member of PCI Biotech, OncoZenge, Herantis Pharma and Bio-Me. Holdings in the Company: Hilde Furberg holds 44,750 shares in the company, 8,449 share awards in board LTIP 2019, 4,327 share awards in board LTIP 2020 and 4,086 share awards in LTIP 2021. Independent in relation to the Company and its manage- ment and in relation to major shareholders. Elmar Schnee Chairman Born 1959. Board member since 2019. Education: Master’s degree in marketing and management from SIB. Board Committees: Chairman of the Remuneration Committee. Experience: Elmar Schnee was previ- ously CEO of Merck Serono and was instrumental in the acquisition of Serono by Merck KGaA. He has also served as General Partner and member of the Exec- utive Board of Merck KGaA and has previ- ously held several senior global manage- ment positions with UCB and Sanofi. Other current assignments: Chairman of the board of directors of Santhera Pharmaceutical, ProCom Rx SA, Moleac Pte Lts and Noorik Biophar- maceuticals AG as well a member of the board of directors of Kuste Biopharma and Damian Pharma AG. Holdings in the Company: Elmar Schnee holds 10,000 shares in the company, 23,236 share awards in board LTIP 2019, 14,063 share awards in LTIP 2020 and 10,624 share awards in LTIP 2021. Inde- pendent in relation to the Company and its management and in relation to major shareholders. Lennart Hansson Non-executive Director Born 1956. Board member since 2009. Education: PhD in Genetics from the University of Umeå. Board Committees: Member of the Audit Committee and Remuneration Committe. Experience: Lennart Hansson has broad experience from leading positions within pharmaceutical development and busi- ness development in both biotech and pharma companies such as KabiGen AB, Symbicom AB, AstraZeneca, Biovitrum AB and as CEO of Arexis AB. Lennart was responsible for Industrifonden’s life science operations between 2008– 2016. He has worked on more than 30 company boards and is also the co-founder of two pharmaceutical development companies. Other current assignments: Chairman of the Board of Directors of Sixera Pharma AB, Ignitus AB and Cinclus Pharma Holding AB. Member of the Board of Directors of InDex Pharmaceuticals Holding AB (publ) and Medivir AB (publ). Holdings in the Company: Lennart Hansson holds 12,000 shares in the company and 8,449 share awards in board LTIP 2019, 4,327 share awards in board LTIP 2020 and 4,086 share awards in LTIP 2021. Independent in relation to the Company and its management and in relation to major shareholders. Diane Parks Non-executive Director Born 1952. Board member since 2019. Education: Master’s degree from Kansas State University and an MBA from Georgia State University. Board Committees: Member of the Remu- neration Committee. Experience: Diane Parks is a senior executive with deep sales and marketing experience from the US, where she has held positions such as Head of US Commercial for Kite Pharma, VP of Sales for Amgen and Head of Global Marketing at Pharmacyclics. Other current assignments: Board member in Kura Oncology, Soligenix and TriSalus Life Sciences. Holdings in the Company: Diane Parks holds 8,449 share awards in board LTIP 2019, 4,327 share awards in board LTIP 2020 and 4,086 share awards in LTIP 2021. Independent in relation to the Company and its management and in relation to major shareholders. Molly Henderson Non-executive Director Born 1970. Board member since 2020. Education: M.B.A. and B.S. degree from the State University of New York at Buffalo. Board Committees: Chairman of the Audit Committee. Experience: Molly Henderson has served as the CFO of several listed life science companies for over 17 years. Currently, she is the CFO of Phathom Pharmaceu- tical, Inc. She was previously the CFO of Urogen and Executive Vice President of Advaxis, Inc, the CFO of Iovance Biother- apeutics, Inc. (formerly Lion Biotech- nologies, Inc.) and before that the Chief Business and Financial Officer and Senior Vice President of VirtualScopics, Inc. Molly has also advised start-up companies in Switzerland, and was a Manager in the audit division of PricewaterhouseCoopers LLP. Other current assignments: CFO of Phathom Pharmaceuticals, Inc Holdings in the Company: Molly Henderson holds 100 shares in the company and 4,327 share awards in board LTIP 2020 and 4,086 share awards in LTIP 2021. Independent in relation to the Company and its management and in relation to major shareholders. 92 93 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 |
Management team Renee Aguiar-Lucander Chief Executive Officer Born 1962. CEO since 2017. Education: BA in Finance from Stockholm School of Economics. MBA from INSEAD. Experience: Before joining Calliditas, Renée Aguiar-Lucander was a Partner and COO of Omega Fund Management, an international venture capital company focused on invest- ments within the life science sector. Before that, she served as a Partner in the venture capital group 3i Group plc in London, where she managed the publicly quoted assets and was co-head of the global healthcare and technology portfolio. Prior to this, Renée Aguiar-Lucander was the European Group Head and Managing Director at a global investment bank and has more than 12 years’ experience in corporate finance. Prior to her career in investment banking, she was the Head of European Sales and Marketing in a company focused on the sale of software for financial services. Other current assignments: Chairman of the board of directors of Exenta Inc. Member of the board of directors of Medcap AB (publ) and RAL Capital Ltd. Holdings in the Company: Renée Aguiar-Lucander holds 593,000 shares in the Company, 195,000 warrants1 and 416,000 options2. Fredrik Johansson Chief Financial Officer Born 1977. CFO since 2017. Education: Studies in Business Law at Jönköping International Business School. Studies in Business and American law, Economics and Finance at Georgia State University, University of South Carolina and Lund University. Experience: Fredrik Johansson has exten- sive experience in executive positions, primarily within telecom and software. Previously, he was CFO and COO at Birdstep Technology/ Techstep ASA, listed on the Oslo Stock Exchange, where he, among other things, was in charge of the acquisition and reversed listing of Teki Solutions. Previous CFO positions also include Phone Family, Teligent Telecom and Wayfinder Systems. Holdings in the Company: Fredrik Johansson holds 37,750 shares in the Company, 50,000 warrants1 and 180,000 options2. Frank Bringstrup Vice President Regulatory Affairs Born 1959. VP Regulatory Affairs since 2019. Education: Medical education from the University of Copenhagen. He has a diploma in Managing Medical Product Innovation (MMPI) from the Copen- hagen School of Economics, a diploma in business administration from Warwick University, and a post graduate specialist course in public health science from the National Board of Health, Denmark. Experience: Frank Bringstrup has over 17 years of experience in the pharma- ceutical industry within regulatory affairs and health authority interactions. Prior to joining Calliditas, he worked in various positions at Novo Nordisk A/S. He started his professional career first as a clinic doctor and then Frederiksborg County Medical Advisor. Holding in the Company: Frank Bringstrup holds 6,000 share in the Company, 7,500 warrants1 and 45,000 options2. Andrew Udell President, North America Born 1970. Head of North America Commercial since 2019. Education: BSc from Lehigh University. MBA from the University of Connecticut. Experience: Andrew Udell has more than 20 years of commercial experience in the pharmaceutical industry. Before joining Calliditas, Andrew worked as Vice President of North America Commer- cial at NeuroDerm. Andrew began his career in the pharmaceutical industry at Purdue Pharma and held several sales and marketing positions, including responsible for the company’s brands and led a multi- functional team for a multi-billion pain medication franchise. Holding in the Company: Andrew Udell holds 26,000 share in the company, 20,000 warrants1 and 210,000 options2. Katayoun Welin-Berger Vice President Operations Born 1968. VP Operations since 2020. Education: PhD in Pharmacy from Uppsala University, Sweden. Experience: Katayoun Welin-Berger has more than 28 years of commercial experience in the pharmaceutical and biologics industry. Before joining Calliditas, Katayoun worked as Vice President of Operations at BioGaia. Katayoun began her career in the pharmaceutical industry at AstraZeneca and held several positions within both R&D and Operations. Holding in the Company: Katayoun Welin-Berger holds 11,000 shares through a related party, 65,000 warrants1 and 45,000 options2. Richard Philipson Chief Medical Officer Born 1964. Chief Medical Officer since 2020. Education: BSc in Biomedical Sciences at London University and MB MS, Middlesex Hospital Medical School. Member of the Royal College of Physicians and Fellow of the Faculty of Pharmaceutical Medicine. Experience: Dr. Richard Philipson is a physician with 24 years of experience in the pharmaceutical industry from both large pharmaceutical companies and smaller biotechs. He has extensive expe- rience in rare diseases, having brought several products from early development to the market. Prior to joining Callid- itas, Richard worked as CMO with the UK-based biotech company Trizell where he led the Adstiladrin® phase 3 clinical program and Biologics License Application in non-muscle invasive bladder cancer, submitted to the FDA in September 2019. Before Trizell, he worked for Takeda as an Executive Medical Director and spent 16 years at GlaxoSmithKline, where he held a number of senior positions, including Disease Area Head and Acting Chief Medical Officer for the Rare Diseases Unit. Before joining the industry, Richard worked as a physician in several clinical positions with various patient populations, including patients with IgA nephropathy. Holding in the Company: Richard Philipson holds 185,000 options2. 94 95 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 1 Holding in Warrant program 2019/2022. 2 Holding in ESOP 2020. and/or ESOP 2021 |
Scientific Steering Committee Some of the most prominent IgA nephropathy specialists in the world serve as external advisors and members of the Company’s advisory board. Brad H. Rovin Professor, Director of the Division of Nephrology and Vice Chairman of Medicine for Research at the Ohio State University Wexner Medical Center, Columbus, Ohio, US Daniel C. Cattran Professor of Medicine, University of Toronto; Senior Scien- tist, Toronto General Research Institute, Toronto, Ontario, Canada Hérnan Trimarchi Professor of Medicine, Universidad Católica Argentina; Head, Nephrology Service, Hospital Británico; Head, Kidney transplant unit, Hospital Británico, Buenos Aires, Argentina Hong Zhang Professor of Medicine and Doctoral supervisor, Nephrology Division, Peking University First Hospital, Peking University Institute of Nephrology, Beijing, China Jonathan Barratt Professor, Department of Infection, Immunity and Inflam- mation, University of Leicester; Honorary Consultant Nephrologist in the John Walls Renal Unit, Leicester General Hospital, Leicester, UK Jürgen Floege Professor, head of the Department of Renal and Hyper- tensive Diseases, Rheumatological and Immunological Diseases (Medicine II) at the Aachen University Hospital; Director of the Department of Nephrology and Clinical Immunology at the University of Aachen, Aachen, Germany Richard Lafayette Professor of Medicine (Nephrology), the Stanford University Medical Center; Director, the Stanford Glomerular Disease Center, Stanford, California, US Vladimir Tesar Professor, Head of the Department of Nephrology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic Financial calendar Interim report for the period January 1–March 31, 2022 May 18, 2022 Annual General Meeting 2022 May 19, 2022 Interim report for the period January 1–June 30, 2022 August 19, 2022 Interim report for the period January 1–September 30, 2022 November 18, 2022 Year-end report for the period January 1–December 31, 2022 February 24, 2023 96 97 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 |
Glossary ACE inhibitors (ACEIs): Angiotensin Converting Enzyme inhibitors (ACEis) are a type of blood pressure medication that work by limiting the effects of the hormone angio- tensin II, which has a constricting effect on blood vessels and stim- ulates salt and water retention in the body and thus increases blood pressure. Angiotensin II is activated by a molecule called Angiotensin Converting Enzyme (ACE,) which is blocked by ACE inhibitors Adaptive Design: An adaptive design trial is one in which the design allows for modifications to the trial and/or statistical proce- dures of the trial after its initiation without undermining its validity and integrity ALP: Alkaline phosphatase (ALP) is an enzyme which is used as a marker in PBC. A rise in ALP levels indicates impaired bile flow in the liver Angiotensin Receptor Blockers (ARBs): ARBs work by blocking the AT1 receptors that the hormone angiotensin II acts on, thereby limiting its action and lowering blood pressure Autoimmune disease: Disease that is manifested because of the immune system's harmful attack with autoantibodies on the body's own tissue. All people have some degree of autoimmunity, but when it gets too high it becomes harmful Budesonide: a potent glucocor- ticoid with rapid elimination that fits very well with local treatment where you want to minimize systemic side effects CAF: A cancer-associated fibroblast (CAF) is a key cell type within the tumor microenvironment. CAFs promote tumor growth via a variety of mechanisms, including initiating the remodelling of the extracellular matrix or secreting cytokines Corticosteroids: a class of steroid hormones and synthetic analogues. Corticosteroids are used systemi- cally for the treatment of inflamma- tory and immunological diseases, including IgA nephropathy, autoim- mune hepatitis and primary biliary cholangitis Creatinine: a chemical substance made by muscles. Measured in the blood circulation and produced in a relatively even amount. Eliminated through the kidneys. Too high a concentration in the blood is a measure of impaired kidney func- tion. It is used to calculate eGFR. High creatinine corresponds to low eGFR Dimeric: Also known as ‘polymeric’, a dimeric molecule is composed of two identical simpler molecules (monomers) DKD: Diabetic kidney disease (DKD,) also called diabetic nephro- pathy, is kidney disease that is due to Type 1 or Type 2 diabetes Double blind: A double-blind study is one in which neither the participants nor the experimenters know who is receiving a particular treatment eGFR: estimated glomerular filtra- tion rate. A measure of the kidney's ability to filter and purify the blood. When a kidney disease worsens, eGFR decreases EMA: European Medicines Agency ESRD: end-stage renal disease Enteric: relating to or occurring in the small intestine. The enteric coating on Nefecon refers to the fact that it is designed to dissolve in the ileum, which is in the distal part of the small intestine FDA: US Food and Drug Adminis- tration Galactose: a type of sugar that is similar to glucose. Antibodies such as IgA have sugar chains attached to them. These sugar chains contain, among other things, galactose Glomerulus: An anatomical struc- ture of the kidney. Blood vessel bundles where the blood is filtered to urine Glomerulonephritis: an inflamma- tion of the glomeruli, the kidney's filtration function HbA1c: HbA1c is a term commonly used in relation to diabetes and is a measure of average blood sugar levels. The term refers to glycated haemoglobin, which develops when haemoglobin joins with glucose in the blood, becoming ‘glycated’ IgA: Immunoglobulin A (an anti- body.) Also referred to as IgA1 IgA Nephropathy (IgAN): a rare autoimmune kidney inflammatory disease, within the glomerulone- phritis class Ileum: the distal end of the small intestine, also called the bowel arm, is 2–4 meters long and connects to the colon Immunoglobulin: antibodies (proteins) used by the body's immune system to detect and identify foreign substances that can cause damage Incidence: number of new patients per year in a disease Immunosuppressive agents: a class of drugs that suppress, or reduce, the strength of the body's immune system Immunotherapy: Immunotherapy is the treatment of disease by acti- vating or suppressing the immune system Investigator-Led Study: Inves- tigator led studies are clinical studies initiated and managed by a non-pharmaceutical company researchers, like individual inves- tigators, institutions, collaborative study groups or cooperative groups IPF: Idiopathic pulmonary fibrosis (IPF) is a condition in which the lungs become scarred and breathing becomes increasingly difficult, the causes of which are unclear KDIGO: Kidney Disease: Improving Global Outcomes, a non-profit organization that develops global guidelines for treatment in kidney disease Monomeric: a monomeric molecule is one that is a single unit and can be bonded to other identical mole- cules to form a polymer NADPH Oxidase: NADPH oxidase (nicotinamide adenine dinucleotide phosphate oxidase,) also known as NOX enzymes, are membrane- bound enzyme complexes, which catalyse the production of reactive oxygen species Nephrologist: a physician special- ized in kidney disease Off-label prescription: prescription of an approved drug outside the approved indication On-label: prescription of an approved drug within the approved indication Open-label: An open-label trial is one in which information about which treatment is being admin- istered is not withheld from trial participants and researchers Orphan disease: a rare disease that falls within the criteria of orphan drug law Oxidative Stress: Oxidative stress is when there is an imbalance between the production and the accumulation of reactive oxygen species (ROS) in cells and tissues and the body’ ability to detoxify these reactive products PBC: Primary biliary cholangitis, a rare autoimmune fatty liver disease Peyer's patches: lymph tissue of the ileum, the distal part of the small intestine, part of the body's immune system Prevalence: number of people in a population having a disease Proteinuria: a condition charac- terized by the presence of greater than normal amounts of protein in the urine; a measure of leakage in the kidney's filtration function Proof of Concept Trial: Proof of Concept Principle studies are an early stage of clinical drug develop- ment when a compound has shown potential in animal models and early safety testing, and often is the step between a Phase 1 and a dose ranging Phase 2 study RAS: Renin-angiotensin system, which regulates blood pressure and fluid in the body; a RAS blocker lowers blood pressure; RAS blockade is when a patient is on drugs that block RAS, which can be ACEIs and/or ARBs Randomised: A randomised trial is one in which participants are randomly assigned to 2 or more groups Reactive Oxygen Species: Reactive oxygen species are highly reactive chemical molecules formed through the electron acceptability of O₂ Redox Homeostasis: Redox homeostasis is attained by the regulation of the formation and removal of reactive oxygen species (ROS) from the body system RRT: renal replacement therapy; a treatment for terminal kidney failure where the function of the diseased kidney is replaced by dial- ysis or kidney transplantation Transient Elastography: Transient elastography (FibroScan) is an ultra- sound exam that uses pulse-echo ultrasound acquisitions to measure liver stiffness in kilopascals (kPa,) which allows for a noninvasive assessment of liver stiffness UPCR: Urine protein creatinine ratio, a measure of leakage in the kidney's filtration function 98 99 Calliditas Therapeutics | Annual Report 2021 Calliditas Therapeutics | Annual Report 2021 |
Calliditas Therapeutics AB Kungsbron 1, D5, SE-111 22 Stockholm, Sweden Phone: +46 (0)8 411 3005 Mail: info@calliditas.com Web: www.calliditas.com |
Exhibit 99.2
Stockholm, Sweden | April 27, 2022 |
Calliditas Therapeutics’ 2021 Annual Report Published
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) today announces that the Annual Report for 2021 now is available at the company’s website: www.calliditas.com.
This information is information that Calliditas Therapeutics AB is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 18:00 CET on April 27, 2022.
For further information, please contact:
Marie Galay, IR Manager, Calliditas
Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com
About Calliditas
Calliditas Therapeutics is a commercial stage biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas’ lead product, TARPEYOTM (budesonide) delayed release capsules, has been approved by the FDA and is the subject of a marketing authorization application (MAA) with the European Medicines Agency (EMA). Additionally, Calliditas is conducting a pivotal clinical trial with its NOX inhibitor product candidate setanaxib in primary biliary cholangitis and is initiating a head and neck cancer Phase 2 trial with setanaxib. Calliditas’ common shares are listed on Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT).
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding Calliditas’ strategy, commercialization efforts, business plans, regulatory submissions, clinical development plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Calliditas’ business, operations, continued EMA review and approval for NEFECON, market acceptance of NEFECON/TARPEYO, safety or efficacy of NEFECON/TARPEYO, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled “Risk Factors” in Calliditas’ reports filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
Exhibit 99.3
Stockholm, Sweden | April 29, 2022 |
Number of shares and votes in Calliditas Therapeutics
During April, Calliditas Therapeutics AB (publ) has allotted 830,586 common shares within the company’s warrant program issued in 2018. Thus, as of April 29, 2022, the number of shares and votes in the company amounts to 53,172,170.
For further information, please contact:
Mikael Widell, Investor relations
Tel.: +46 703 11 99 60, email: mikael.widell@calliditas.com
The information in the press release is such that Calliditas Therapeutics AB (publ) is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 10:00 a.m. CEST on April 29, 2022.
About Calliditas
Calliditas Therapeutics is a commercial stage biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas’ lead product, TARPEYOTM (budesonide) delayed release capsules, has been approved by the FDA and is the subject of a marketing authorization application (MAA) with the European Medicines Agency (EMA). Additionally, Calliditas is conducting a pivotal clinical trial with its NOX inhibitor product candidate setanaxib in primary biliary cholangitis and is initiating a head and neck cancer Phase 2 trial with setanaxib. Calliditas’ common shares are listed on Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT).