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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: May 20, 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 ☒    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): ☐

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INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

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Company Announcement and Interim Report

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On May 18, 2022, the Company announced its unaudited results for the three months ended March 31, 2022, which are further described in the Company’s Interim Report Q1 2022 and press release, copies of which are attached hereto as Exhibits 99.1 and 99.2, respectively, and are incorporated by reference herein.

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The Company also presented an updated Investor Presentation on a webcast which is available on the Company’s website and a copy of which is attached hereto as Exhibit 99.3 and incorporated by reference herein.

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Additional Company Announcements

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On May 17, 2022, the Company announced that the first patient was randomized in its Phase 2 clinical trial of setanaxib in head and neck cancer. This press release is attached hereto as Exhibit 99.4 and incorporated by reference herein.

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On May 19, 2022, the Company announced the Committee for Medicinal Products for Human Use of the European Medicines Agent adopted a positive opinion recommending the granting of a conditional marketing authorization for Kinpeygo^TM for the treatment of primary immunoglobulin A nephropathy in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio ≥1.5 g/gram. This press release is attached hereto as Exhibit 99.5 and incorporated by reference herein.

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2022 Annual General Meeting

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The Company held its 2022 annual general meeting of shareholders on May 19, 2022. Attached as Exhibit 99.6 is a bulletin with the results of the meeting which is incorporated herein by reference.

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EXHIBIT INDEX

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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.

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Exhibit 99.1

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INTERIM REPORT JANUARY 1^ST – MARCH 31^ST 2022

Start of TARPEYO™ Commercial Launch

Financial summary for the Group

Key Figures

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January 1 - March 31, 2022

Significant events in Q1 2022

In January 2022, Calliditas announced commercial availability and initial sales of TARPEYO (budesonide) delayed release capsules, the first and only FDA approved treatment for IgA nephropathy, indicated for reduction of proteinuria in adults with primary IgA nephropathy (IgAN) at risk of rapid disease progression, generally considered a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g.

In February 2022, Calliditas announced that the first patient had been randomized in the company’s pivotal phase 2b/3 TRANSFORM study in patients with primary biliary cholangitis (PBC).

In March 2022, Calliditas expanded its licensing agreement with Everest to extend the territory covered to include South Korea.

Significant events after the reporting period

In May 2022, Calliditas announced that the first patient had been randomized in the company’s proof-of-concept Phase 2 study in patients with squamous cell carcinoma of the head and neck (SCCHN) with the NOX 1 and 4 inhibitor, setanaxib.

Investor Presentation May 18, 2022 14:30 CET

Audio cast with teleconference, Q1 2022

Webcast: https://tv.streamfabriken.com/calliditas-therapeutics-q1-2022

Teleconference: SE: +46856642706 UK: +443333009034 US: +16467224956

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CEO STATEMENT

Successful Start of the Commercial Launch

During the first quarter Calliditas launched its first commercial product, TARPEYO, in the US, supported by 40 experienced specialty sales executives who were trained and in the field in late January.

Our commercial product was already available to ship to patients at the end of January, reflecting the great collaboration between our CMC group and our commercial team in the US.

Our transformation from a primarily R&D based company to a commercial stage, fully integrated business has been a journey, which first started 3 years ago when we brought onboard our first employee in the US. Under the guidance of a small but highly experienced senior team, we started to build our medical affairs and market access teams in preparation for a future regulatory approval. Medical education and interactions to raise awareness about the pathophysiology of IgA nephropathy (IgAN) were conducted at conferences and congresses, as well as on a one to one basis with nephrologists across the country. Market research was undertaken to understand the existing treatment paradigms in detail, verify the unmet medical need and truly understand the patient journey and burden of disease. In addition, a substantial amount of work was carried out over an extended period relating to the perceived health economic burden of IgAN and the value associated with TARPEYO, (developed under the name of Nefecon), initially based on available Phase 2b clinical data and then further refined when Phase 3 data became available in November 2020.

Over time and as a potential approval drew nearer, US operations added critical resources related to IT, legal, HR and finance, as well as highly experienced sales and marketing expertise and additional key resources in market access and medical affairs. With a fully integrated operation and a streamlined supply and distribution chain in place, the US organization had grown significantly and was by mid-2021 ready for the final step, onboarding of the sales force. When accelerated approval of TARPEYO was granted by the FDA, the entire organization was well prepared and ready. TARPEYO Touchpoints^TM was available within hours and prescribers were able to access details regarding the product, the indication and could write prescriptions for appropriate patients. There was hope at last for IgAN patients in the US, as an approved product became available for the first time.

We believe the combination of significant proteinuria reduction at 9 months, positive impact on eGFR and the significant decline in proteinuria (-52%) observed in patients who had reached 12 months at the time of the data cut-off are all supportive of the differentiated approach of TARPEYO in targeting the origin of the disease. This is obviously just the very beginning of the journey, but we are very encouraged by the strong interest and early successes we have experienced, which have resulted in net product revenues of $1.9M (SEK 18.0M) for the first couple of months of commercial availability, and we remain fully committed to continuing to build the TARPEYO franchise.

The first quarter also saw the dosing of the first patient in our pivotal study in PBC, TRANSFORM, and the initiation of our Phase 2 clinical trial in head and neck cancer, both of which will investigate the efficacy and safety of setanaxib, the lead candidate from our proprietary NOX platform. Our experienced clinical team has yet again proven its expertise by preparing and supporting both of these trials simultaneously in collaboration with our CRO partners, and in times still defined by COVID 19 and its aftermath.

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Setting up and running another global trial, similar in size to NefIgArd, is a major achievement under these circumstances. Recruitment will, as always, be subject to the overall accessibility to appropriate patients, as well as macro factors outside of our control such as global conflicts and pandemics, but we are very excited to have reached these milestones and look forward to progressing these trials as rapidly as possible.

Finally, in Q1 we continued our constructive interactions with EMA regarding a potential approval in IgAN in Europe, and we are targeting an opinion in Q2. We also expanded our licensing collaboration with Everest Medicines to include South Korea. We look forward to continue working with Everest and STADA, our commercial partner in Europe, as we work towards addressing the unmet need of IgAN patients across the world.

Renée Aguiar-Lucander, CEO

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BUSINESS OVERVIEW

TARPEYO

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 (developed under the project name NEFECON) is the first and only FDA-approved treatment for IgA nephropathy.

TARPEYO is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. TARPEYO was 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 cause IgA nephropathy.

TARPEYO was approved by the FDA under the accelerated approval pathway, based on achieving its primary endpoint of reduction in proteinuria. The effect of TARPEYO was assessed in patients with biopsy-proven IgAN, eGFR ≥35 mL/min/1.73m2, and proteinuria (defined as ≥1 g/day) 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. The second part of the NefIgArd study, Part B, is a confirmatory validation study in which no TARPEYO treatment is administered and where eGFR is the primary outcome measure. 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 of the ongoing randomized, double-blind, placebo controlled multicenter NefIgArd study 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 United States on its own.

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TARPEYO Commercial Launch

The first sale of TARPEYO took place on January 28, 2022. The experience, dedication and hard work of the entire US commercial organization ensured that we were fully prepared to execute an efficient and effective launch within about a month from receiving approval, including the Christmas and New Year holiday period. We are encouraged by our early success and the strong interest expressed in our product by both patients and nephrologists.

Prior to approval, Calliditas focused its pre-commercial efforts on disease education, market access and patient advocacy, with the goal of facilitating access to TARPEYO for the appropriate patients for which it can fulfil an unmet medical need. Our medical science liaison team was out in the field beginning in 2020, with the aim of educating and raising awareness about IgA nephropathy and the pathophysiology of the disease. As a result, there was significant awareness of TARPEYO amongst nephrologists, and research demonstrated that those familiar with our product profile rated themselves as ‘extremely likely’ to prescribe TARPEYO for 70% of their patients¹.

We also made sure that our trade and distribution partners and national account managers were in place and operational well in advance of approval. Furthermore, we established a highly successful support service to make the process of prescribing and obtaining our product as seamless as possible. Our patient support services program, TARPEYO Touchpoints, was fully operational from day one of approval, allowing physicians and patients to have access to dedicated case managers and a designated Rare Pod Team – including nurses, pharmacists, and a fulfilment and distribution team – as well as a financial assistance program where appropriate. Since approval, we have seen a continuous increase in inbound traffic and engagement with TARPEYO Touchpoints from all audiences and we continue to work closely via this platform to maximise access to our product.

Our immediate focus upon approval was to officially onboard and train our rare and specialty experienced sales team of 40 sales reps, 70% of whom join us directly from existing work in the nephrology market. We began promoting to physicians at the end of January, and our sales reach as of March 31st was well over four thousand nephrologists. Our sales efforts since the product became available in late January have resulted in 134 enrolments from 111 unique prescribers resulting in net sales for the first quarter of $1.9M (SEK 18.0 million).

¹ Spherix Global Insights, RealWorld Dynamix IgA Nephropathy 2021 with 188 nephrologists (note Nefecon was the product name used in the research)

We also built on and continued our engagement with payers, with a focus on key targeted accounts that cover most commercial lives and key federal/state payers. While the average payer takes typically six to nine months to review a newly launch product for coverage and formulary placement, we have made significant progress early in the process. By the end of March, 11 of our targeted accounts, including Cigna, Express Script, and Humana were covering TARPEYO on their predominant formularies. As a result, we estimate about one third of commercial lives had coverage at the end of the first quarter. In addition, TARPEYO is covered by Medicare Part D beginning at launch (as it is the only FDA approved treatment in IgA nephropathy) and for Medicaid patients with the mandatory coverage date of April 1st. In the meantime, our full-service patient and provider support program, TARPEYO Touchpoints is helping patients and prescribers navigate the medical exception process, to allow appropriate patients to receive access to the medication during the review process. To date we have had only one enrolled patient cancel due to payer coverage.

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In summary, we are extremely pleased with our execution and result at the end of the first quarter. As expected, the IgA nephropathy market is unsatisfied and eager for a treatment specifically designed to target the cause of the disease.

NEFECON

Calliditas is advancing its delayed, targeted-release formulation of budesonide under the development name “NEFECON®” outside of the USA.

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 supported by the Phase 2b NEFIGAN study, which also met both its primary endpoint of proteinuria reduction and key secondary endpoint of eGFR stabilization. Calliditas read out topline data from Part A of the study in November 2020. Patients taking NEFECON showed a statistically significant 31% reduction in proteinuria from baseline vs 5% in the placebo cohort at 9 months. Furthermore, in the intention to treat (ITT) population, the reduction at 9 months was 34%, and for patients who had reached 12 months at the time of the data cut-off the continued proteinuria reduction was 52%. The key secondary endpoint, eGFR, showed a treatment benefit of 7% versus placebo at 9 months, reflecting stabilization in the treatment arm and a 7% decline of eGFR in the placebo arm (p=0.0029). This reflected an absolute decline of 4.04 ml/min/1.73m² in the placebo group over 9 months compared to a 0.17 ml/min/1.73m² decline in the treatment arm. The trial also demonstrated that NEFECON was well-tolerated.

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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 assessment of the MAA for NEFECON under standard procedure assessment timelines. Calliditas expects a CHMP opinion in the second quarter of 2022.

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In July 2021, Calliditas and STADA Arzneimittel AG entered into a license agreement to register and commercialize NEFECON® for the treatment of the IgA nephropathy in Europe. 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.

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 incentives 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.

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Calliditas also has a commercial partner in China and Singapore, having entered into a license agreement to develop and commercialize NEFECON for IgAN in those markets with Everest Medicines in 2019. Calliditas received an initial upfront payment of 15M USD upon signing, as well as future payments linked to development, regulatory and commercialization milestones up to an additional 106M USD, plus royalties. In March 2022, this agreement was expanded to include South Korea. Everest will look to file with regulators in China in 2022, with a view to target potential approval in 2023.

IgA Nephropathy

An orphan disease with great unmet medical need.

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.

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 material 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 significantly higher prevalence of IgAN has been observed in Asia, including in Greater China, where it has historically 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-associated lymphoid tissue in the ileum, have been identified as a major source of mucosal-type IgA antibodies. IgA 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 identical 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 polymeric and are galactose deficient. In IgAN patients, a combination of a genetic predisposition and of environmental, bacterial and dietary factors is presumed to lead to an increased production of these galactose-deficient IgA antibodies. This increased production, 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 circulation. 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. Treatment via RAS inhibition is supportive only, and does not address the underlying cause of IgAN.

In the absence of approved treatments, some physicians 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 inconclusive 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.

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Pipeline: NOX Inhibitor Platform

Calliditas’ pipeline contains development programs based on a first in class, novel NOX inhibitor platform. The lead compound, setanaxib, is the first NOX inhibitor to reach the clinical trial stage. 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 dinucleotide 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 signaling 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 mechanism 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.

Setanaxib in Primary Biliary Cholangitis

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 approximately 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 epithelial 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, osteoporosis, 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.

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 anticholestatic. UDCA is a bile acid analogue which is incorporated into the bile acid pool, replacing other more toxic bile acids and reducing inflammation and 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 modified 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.

Pipeline: NOX Inhibitor Platform

Promising Phase 2 Data in PBC

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.

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Setanaxib 400mg BID achieved significant reduction in ALP of 12.9% vs placebo over the 24-week treatment period (p<0.002). 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).

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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.

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. Following the favourable safety data from the Phase 1 study, this trial will evaluate two dosing regimens of 1200mg/daily and 1600mg/daily. 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 will determine which dose of setanaxib will be used for the Phase 3 part of the study, and the trial is expected to read out final data in late 2024 or early 2025. In August 2021, Calliditas received FDA Fast Track Designation for setanaxib in PBC.

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*Dose of 1200 mg daily administered as 800 mg AM and 400 mg PM

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ǂDose of 1600 mg daily administered as 800 mg AM and 800 mg PM

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Pipeline: NOX Inhibitor Platform

Setanaxib in Scquamous Cell Carcinoma of the Head & Neck

Calliditas also intends to evaluate 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-associated fibroblasts (CAFs) in the tumour. A relationship between cancer associated fibroblasts (CAFs) and prognosis 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%).

Using a CAF-rich tumour model in mice, administration of setanaxib + pembrolizumab (versus either treatment alone) resulted in:

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Proof-of-concept study in head and neck cancer

Calliditas is planning a Phase 2 proof-of-concept study in patients with head and neck cancer, which will investigate administration of setanaxib in conjunction with immunotherapy targeting CAFs.

The study will likely involve around 50 patients, and the first patient was randomised in Q2 2022, with an interim readout expected in late 2022 and final data read out expected in H2 2023.

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Our Pipeline

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Significant events,

January 1 – March 31, 2022

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Significant events after the reporting period

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Financial Overview

Key Figures

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January – March 2022

Revenue

Net sales amounted to SEK 49.7 million for the three months ended March 31, 2022. No net sales were recorded for the three months ended March 31, 2021. The net sales for the three months ended March 31, 2022 primarily originates from a USD 3.0 million milestone fee from Everest for the extension of the license agreement for South Korea and SEK 18.0 million in net sales of TARPEYO in the U.S. For additional information see Note 4.

Total Operating Expenses

Total operating expenses amounted to SEK 257.5 million and SEK 150.8 million for the three months ended March 31, 2022 and 2021, respectively.

Research and Development Expenses

Research and development expenses amounted to SEK 113.3 million and SEK 90.1 million for the three months ended March 31, 2022 and 2021, respectively. The increase of SEK 23.2 million for the first quarter is primarily due to the setanaxib trials and the development of setanaxib.

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Marketing and Selling Expenses

Marketing and selling expenses amounted to SEK 93.9 million and SEK 19.4 million for the three months ended March 31, 2022 and 2021, respectively. The increase of SEK 74.5 million for the first quarter is primarily related to the the costs for sales and marketing of TARPEYO in the U.S. including the costs for the sales force.

Administrative Expenses

Administrative expenses amounted to SEK 48.5 million and SEK 39.4 million for the three months ended March 31, 2022 and 2021, respectively. The increase of SEK 9.1 million for the first quarter was primarily related to general cost increases due to a larger organization compared to the same period last year.

Other Operating Incomes/Expenses

Other operating income amounted to SEK 0.8 million for the three months ended March 31, 2022. No other operating income was recognized for the three months ended March 31, 2021. Other operating expenses amounted to SEK 2.5 million and SEK 1.9 million for the three months ended March 31, 2022 and 2021, respectively. The increase in other operating expenses for the three months ended March 31, 2022 was primarily related to a more disadvantageous exchange rate development on operating liabilities.

Net Financial Income and Expenses

Net financial income/(expenses) amounted to (SEK 3.1 million) and SEK 14.6 million for the three months ended March 31, 2022 and 2021, respectively. The decrease of SEK 17.7 million for the three months ended March 31, 2022 are primarily derived by interest expenses and a decrease of unrealized foreign currency transaction gains on cash accounts, compared to the same period last year.

Tax

Income tax expenses, in all material respects, primarily relates to the U.S. subsidiaries of Calliditas Therapeutics. Deferred tax assets of SEK 4.4 million have been recognized in the three months ended March 31, 2022 mainly due to future temporary differences that such losses can be used to offset and are related to Calliditas Therapeutics Suisse. The Group’s tax losses carried forward have not otherwise been valued and not recognized as deferred tax assets. Deferred tax assets will be recognized for unused tax losses to the extent that it is probable that taxable profit will be available against which the losses can be utilized.

Result for the Period

For the three months ended March 31, 2022 and 2021, loss for the period amounted to SEK 207.0 million and SEK 132.9 million, and the corresponding loss per share before and after dilution amounted to SEK 3.95 and SEK 2.62, respectively.

January – March 2022

Cash Flow and Cash Position

Cash flow used in operating activities amounted to SEK 191.4 million and SEK 134.2 million for the three months ended March 31, 2022 and 2021, respectively. The increase in cash flow used in operating activities during the three months ended March 31, 2022 are primarily explained by the increase in sales and marketing expenses for the TARPEYO sales in the U.S. and the Group’s increased clinical activities for setanaxib.

Cash flow used in investing activities amounted to SEK 2.7 million and SEK 0.2 million for the three months ended March 31, 2022 and 2021, respectively.

Cash flow from/(used in) financing activities amounted to SEK 60.1 million and (SEK 9.6 million) for the three months ended March 31, 2022 and 2021, respectively. The increase in cash flow from financing activities for the three months ended March 31, 2022, compared to the same period last year, was primarily due to payments related to the exercise of warrant program 2018/2022.

Net decrease in cash amounted to SEK 134.0 million and SEK 144.0 million for the three months ended March 31, 2022 and 2021, respectively. Cash amounted to SEK 825.4 million and SEK 867.3 million as of March 31, 2022 and 2021, respectively.

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Changes in Shareholders’ Equity and Number of Shares

Equity attributable to equity holders of the Parent Company amounted to SEK 871.1 million and SEK 1,089.5 million as of March 31, 2022 and 2021, respectively. The number of registered and outstanding shares amounted to 53,172,170 and 49,941,584 as of March 31, 2022 and 2021, respectively. The increase in number of shares between the periods is due to a new share issue in August 2021 of 2.4 million shares and the ongoing issue of 830,586 shares.

Personnel

The number of employees were 71 and 46 employees as of March 31, 2022 and 2021, respectively. The total number of full-time equivalent (FTE), including consultants, were 131 and 64 as of March 31, 2022 and 2021, respectively. The average number of employees were 71 and 41 for the three months ended March 31, 2022 and 2021, respectively.

Incentive Programs

During the three months ended March 31, 2022 a total allocation of 650,000 employee options have been issued. For more information on incentive programs, see Note 10.

Parent Company

Net sales for the Parent Company, Calliditas Therapeutics AB, amounted to SEK 31.8 million for the three months ended March 31, 2022. No net sales were recognized for the three months ended March 31, 2021. The increase was primarily derived from out-licensing Nefecon with STADA for Europe by SEK 3.0 million and the extension of the Everest Medicine agreement to South Korea by SEK 28.8 million. Operating loss amounted to SEK 102.5 million and SEK 127.9 million for the three months ended March 31, 2022 and 2021, respectively. The decrease was primarily derived from other operating income, which referred to intercompany pass-through to Calliditas Therapeutics Suisse regarding setanaxib trails. Non-current financial assets have increased by SEK 92.5 million to SEK 645.4 million as of March 31, 2022 compared to December 31, 2021, which was primarily derived from intercompany transactions.

Auditor’s Review

This report has not been reviewed by the company’s auditor.

Stockholm, May 18, 2022

Renée Aguiar-Lucander

CEO

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FINANCIAL STATEMENTS

Condensed Consolidated Statements of Income

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Condensed Consolidated Statements of Comprehensive Income

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Condensed Consolidated Statements of Financial Position

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Condensed Consolidated Statements of Changes in Equity

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Condensed Consolidated Statements of Cash Flows

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Condensed Parent Company Statements of Income

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Condensed Parent Company Statements of Comprehensive Income

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Condensed Parent Company Balance Sheet

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