​

​

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

For the month of August 2021

(Commission File No. 001-39308)

CALLIDITAS THERAPEUTICS AB

(Translation of registrant’s name into English)

Kungsbron 1, C8

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): ☐

​

​

​

Enclosed hereto is a copy of an interim report and announcement published by Calliditas Therapeutics AB on August 19, 2021.

​

The information contained in this Form 6-K, including Exhibit 99.1, 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

​

​

​

​

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.

​

​

​

​

​

Exhibit 99.1

​

​

CALLIDITAS THERAPEUTICS AB (publ)

Interim Report January 1 – June 30, 2021

Filing of Marketing Authorisation Application on accelerated basis with EMA

Key Figures

​

​

Significant events during the period April 1 – June 30, 2021, in summary

​

​

​

Significant events after the reporting period, in summary

Investor presentation August 19, 14:30 CET

Audio cast with teleconference, Q2 2021, August 19, 2021, 14:30 (Europe/Stockholm)

Webcast: https://tv.streamfabriken.com/calliditas-therapeutics-q2-2021

Teleconference: SE: +46850558356 UK: +443333009266 US: +16467224903

​

​

​

CEO Statement

Execution, execution, execution.…

Following the filing for accelerated approval with the FDA in Q1, we filed our submission for conditional approval with EMA in May.  Both applications are being processed on an accelerated basis and we look forward to receiving first round of questions from EMA during Q3.  In the U.S our target PDUFA date is September 15th, and it is an adrenaline filled and exciting time as we are getting closer to a potential approval of the first ever drug specifically developed for IgA nephropathy.  However, as we all know, regulatory processes are complex and multifaceted, so we can only continue to work hard and prepare the organisation whilst we await the decision by the agency.

During the 2nd quarter we significantly ramped up our pre commercial activities in the US following the strengthening of the team announced in Q1. We have added significant internal resources as well as entered into some key partnerships, in order to ensure that we are well positioned to initiate commercialization in Q4, subject to a positive outcome of the FDA approval process.  We have also continued to do work around pricing and reimbursement in the US, which will be completed in Q3 and form the basis for our decision related to pricing which will be communicated in conjunction with a potential approval.  Other workstreams have focused on systems, processes and structures, which are required to be in place, tested and integrated in advance of commercial sales.  All of these activities have been carried out in parallel with ongoing clinical, regulatory and CMC related activities related to the initiation of new clinical trials with setanaxib in the second half of this year, as well as the ongoing Phase 3 trial, NefIgArd, and interactions with the FDA.  Focus in Q2 therefore has been on execution across all aspects of our business.

During Q2 we also explored avenues to non-dilutive financing by way of a competitive process in order to provide the company with access to additional capital in advance of, as well as post a potential regulatory approval.  In parallel we also ran a successful competitive process focused on securing a strong European commercial partner for Nefecon.  Both of these processes obviously required significant commitments across the organisation as discussions regarding fit, diligence and structuring were conducted with a number of parties.  I applaud the commitment, focus and solutions orientation of each and every member of the organisation who worked tirelessly over the quarter to ensure that both of these processes were able to be successfully concluded in early Q3.  The result of these processes which was announced in Q3 resulted in over $100m of non- dilutive capital potentially being available to the company, divided between approximately $50m available pre-approval with the remainder becoming available post FDA and EMA approvals and subsequent US commercialization. These processes, together with the accelerated book building procedure raising approximately gross $37m (SEK 324 million) which we completed in Q3, have significantly enhanced our financial strength after the close of Q2. We are delighted with the outcome and excited to welcome our new partners to the Calliditas team.

​

​

A glass half full

There have been many harrowing scenes and deep personal losses experienced by many over the last 18 months due to the pandemic.  In addition, healthcare workers across the globe have been carrying a heavy load, with any intermittent relief primarily reflecting the regional vaccination rate. On the other  side, enormous scientific progress have been made over a very short time resulting in significant reductions in terms of hospitalisations and mortality.

One thing which strikes me however is the difference in how people, organisations and institutions interpret and react to this shift in statistics and the daily coverage of Covid 19.  It has already since many months become a dominant force in daily news and on social media platforms, not to mention in conversations at home, in transit and at the workplace (for those who have had the opportunity to actually go to work).  Despite a significantly reduced rate of hospitalisations and deaths as a percentage of the reported number of infections across Europe, primarily driven by high levels of vaccinations, the detailed focus remains. Covid-19, as any virus, has the potential ablity to mutate and hence clearly there can be no guarantee of a definitive, lasting solution, something which we humans are ill prepared to know how to deal with as uncertainty is difficult to manage.  We prefer absolutes and well defined outcomes.

So therefore we continue to spend enormous amount of energy on worrying about what potentially will happen next, remaining transfixed by the pandemic. What else migth drive this? One reason is probably habit, which clearly is a very strong driver of human behaviour. Once a daily routine is established, we tend to seek the familiarity of looking up the same sites, reading the same news sources and performing the same rituals.  Another, perhaps somewhat less attractive side of human nature is our fascination with disasters and tragedies.

According to the psychologist Dr. John Mayer, we are hardwired to stop and look at disasters.  It is part of our survival process, which require us to analyse these kinds of situations and to assess whether or not it affects us directly and if we should react, by fleeing or fighting for example.  Another reason for this behaviour according to psychiatrist Dr. David Henderson is that by continuing to stare at disasters and witness violence and destruction whether it is a movie or in real life, is a way for us to face our fears without risking immediate harm.  We play out different scenarios in our head and try to reconcile the uncontrollable with our need to remain in control.  Studies have concluded that we humans have a negative bias, meaning that we have a tendency to automatically give more attention to negative events and information than positive.  It also shows that we learn more from our negative experiences than our positive ones.   Also, looking at disasters stimulates our empathy and we are hard wired to be empathetic – it is a key psychosocial condition that makes us social human beings.

The other side of that coin however is that repeat exposure to disasters can drive anxiousness and fear, leading to illness and trauma.  This therefore indicates that we should be careful and limit our exposure to avalanches of bad news and disasters or risk falling victim to an overload of anxiety and mental stress.

So as the pandemic seems to, at least for the moment, wane in terms of mortality and hospitalisations in Europe compared to the winter and early spring, perhaps we need to grasp the opportunity to also look at things which are full of hope, beauty or promise in our close environment.  Maybe our minds, at least for a little while, need a bit less exposure to those who consistently look at the glass half empty, actively promoting a gloomy outlook, always at the ready to predict a turn for the worse and a looming disaster around the corner, and a little bit more to those who talk of achievements to date, building on our sucesses and striving for the light…a glass half full. Perhaps we need to turn down the daily noise and seek out positive thoughts at least for a while in order to build reserves for whatever might come in the future. This doesn’t mean that we stop caring, or that we go into denial, but rather believe that, just as with a chronic disease, we can achieve more by taking one step at a time in a positive direction, rather than focus only on the negative and be defeated and defined by it.

Renée Aguiar-Lucander, CEO

​

​

​

​

Business Overview

Nefecon – An Overview

Calliditas is a clinical-stage biopharmaceutical company 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 candidate, Nefecon, is a downregulator of Iga1 for the treatment of the autoimmune renal disease IgA nephropathy (IgAN). IgAN is a progressive, chronic disease, for which there is a high unmet medical need and no approved treatments. Over time, it results in deterioration of kidney function in patients, many of whom end up at risk of developing end-stage renal disease (ESRD) with the need for dialysis or kidney transplant. Nefecon targets the ileum, the distal region of the small intestine, which is the presumed origin of the pathogenesis of IgAN. The ileum is the location of the highest concentration of the Peyer’s patches, which are responsible for the production of the secretory immunoglobulin A (IgA) antibodies that are found in elevated levels in patients with IgAN.

Nefecon is designed to release a high dose of a locally acting immunosuppressive agent in the ileum to reduce the formation of, and/or the leakiness of secretory galactose-deficient IgA antibodies into the blood. Nefecon’s active ingredient, budesonide, has demonstrated efficacy and safety in other indications. After the active ingredient has been released and had its effect in the intestinal mucosa, it enters the liver, where 90% is cleared in first pass metabolism, resulting in the inactivation of a majority of the active ingredient before the substance reaches the systemic circulation. This high metabolism limits systemic immunosuppressive activity and thereby limits concerning side effects related to systemic immunosuppression.

Calliditas has been granted orphan drug designation for the treatment of IgAN in the United States and the European Union. We retain worldwide rights to Nefecon other than in Europe, Greater China, and Singapore, and – subject to approval by the FDA – we intend to commercialize Nefecon for IgAN on our own in the United States. In July 2021, Calliditas partnered with STADA to register and commercialize Nefecon in the European Economic Area (EEA) member states, Switzerland and the UK. The deal is valued at a total of EUR 97.5 million ($115m) in initial upfront and potential milestone payments, plus tiered royalties on net sales expressed as a percentage between the low twenties and the low thirties. Calliditas has also out-licensed the development and commercialization of Nefecon in Greater China and Singapore to Everest Medicines.

The NefIgArd study

NefIgArd is a double-blind, placebo-controlled, two-part Phase 3 clinical trial designed to evaluate the same endpoint used in our previously completed Phase 2b NEFIGAN clinical trial. We randomized our first patient in NefIgArd in November 2018. The first part of NefIgArd, which we refer to as Part A, is a pivotal efficacy and safety trial. The primary endpoint of Part A is the reduction in proteinuria in the first 200 randomized and dosed patients, and a key secondary endpoint is the difference in kidney function between treated and placebo patients as measured by eGFR. In November 2020, we reported positive top-line data from Part A of the trial. On the basis of these results, we filed for regulatory approval with the FDA and the EMA in early 2021.

Treatment with Nefecon was associated with a statistically significant and clinically relevant reduction of proteinuria and stabilization of kidney function. The primary endpoint analysis showed a 31% mean reduction in the 16 mg arm versus baseline, with placebo showing a 5% mean reduction versus baseline, resulting in a 27% mean reduction at nine months of the 16 mg arm versus placebo (p=0.0005). The key secondary endpoint, eGFR, showed a treatment benefit of 7% versus placebo at nine 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. In addition, the trial showed that Nefecon was generally well-tolerated and in keeping with the Phase 2b safety profile.

​

​

On the basis of the positive results from Part A of NefIgArd, Calliditas submitted a New Drug Application (NDA) on March 15, 2021 to the United States Food and Drug Administration (FDA). We sought accelerated approval under Subpart H for the 505(b)(2) application, and also applied for priority review. On April, 28, 2021, Calliditas announced that the FDA had accepted the submission and granted Priority Review for Nefecon, setting a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021.

In April, Nefecon was also granted accelerated assessment procedure by the European Medicine Agency’s (EMA) Committee for Human Medicinal Products (CHMP), reducing the maximum timeframe for review of the application to 150 days (excluding clock-stops). Calliditas submitted a Marketing Authorisation Application (MAA) for conditional approval to the EMA in May, 2021. If approved, Nefecon could be available to patients in Europe in first half of 2022.

The second part of the NefIgArd study, which we refer to as Part B, is a post-approval confirmatory trial designed to provide evidence of long-term renal benefit. In January 2021, we completed the enrolment of all 360 patients in NefIgArd, which includes the 200 patients previously enrolled in Part A. Part B will assess the difference in kidney function between treated and placebo patients, as measured by eGFR, over a two-year period. 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. We intend to report data from Part B in early 2023, subject to any impact from the COVID-19 pandemic to our business. We believe that the key secondary endpoint in Part A, a measure of eGFR over a nine-month period, is informative of the primary endpoint of Part B.

If approved by the FDA, we intend to market and commercialize Nefecon ourselves in the United States as a treatment specifically designed to have a disease-modifying effect for IgAN by preserving kidney function and thereby delaying or avoiding progression to ESRD.

IgA Nephropathy – an orphan disease with great unmet medical need

IgAN, sometimes referred to as Berger’s disease, is a serious progressive autoimmune disease of the kidney, in which up to 50% of patients end up at risk of developing 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.

Although IgAN manifests in the kidney, most scientific studies have found that the pathogenesis of IgAN begins in the ileum, where masses of lymphatic tissue, known as Peyer’s patches, are predominantly found. Peyer’s patches produce secretory IgA antibodies, which play a key role in the immune system by protecting the body from foreign substances such as food-derived factors, bacteria and viruses.

Patients with IgAN have elevated levels of a subclass of IgA antibodies produced in the gut that lack units of galactose, a type of sugar, at their hinge region. The hinge region is a flexible amino acid stretch in the central part of the heavy chains of the IgA antibody. In IgAN patients, a combination of genetic predisposition and environmental, bacterial or dietary factors are presumed to lead to an increased production of these galactose-deficient IgA antibodies which, potentially in combination with increased intestinal permeability, leads to these antibodies appearing in the blood. The galactose-deficient IgA antibodies are immunogenic when found in the circulation and trigger autoantibodies, which are antibodies created by the body in response to a constituent of its own tissue. This in turn leads to the formation of pathogenic immune complexes, or clusters of antibodies, which deposit in the membranes of the glomeruli, the kidney’s filtration apparatus. These trapped immune complexes initiate an inflammatory cascade that damages the membranes, resulting in protein and blood leaking into the urine. Ultimately the glomeruli are destroyed, reducing the kidney’s ability to remove waste products from the blood. As the disease progresses, waste products that are normally removed from the blood accumulate, resulting in potentially life-threatening complications that in many patients will lead to the need for dialysis or kidney transplant.

​

​

Despite a need for new therapies, there have been few new drugs developed for chronic kidney diseases during the last decade and there is currently no approved therapy for IgAN. Initially, patients with IgAN are typically given antihypertensive medications, as recommended by the non-profit organization Kidney Disease: Improving Global Outcome (KDIGO). This treatment regimen attempts to manage the symptoms of IgAN by decreasing blood pressure and reducing proteinuria but does not address the underlying cause of IgAN. Over time, as a significant proportion of patients experience continued deterioration of kidney function and with no approved treatment options currently available, physicians attempt to control disease progression with a variety of off-label treatments.

For IgAN patients whose disease has progressed, clinicians may treat patients with systemic immunosuppressive agents, primarily consisting of high doses of systemic corticosteroids, such as prednisone, prednisolone and methylprednisolone. While some published reports indicate that these agents may reduce proteinuria, this high dosing of systemic corticosteroids is also associated with a wide range of adverse events, including high blood pressure, weight gain, diabetes, serious infections and osteoporosis. Also, recent clinical studies indicate that this treatment may not be associated with any benefit with regards to the underlying kidney function.

IgAN is an orphan disease that we estimate affects approximately 130,000 to 150,000 people in the United States and approximately 200,000 people in Europe. A significantly higher prevalence has been observed in Asia, including Greater China, where IgAN has historically been a leading cause of ESRD. We estimate that IgAN affects approximately two million people in Greater China. Calliditas estimates the U.S. target market opportunity for Nefecon to be approximately $4.5 billion to $5.0 billion annually, based on our estimate of the prevalence of the disease in the United States and primary market research conducted by IQVIA that Calliditas commissioned to assess preliminary reimbursement levels perceived acceptable by U.S.-based payors.

Pipeline: A NOX Inhibitor Platform

Through our recent acquisition of a controlling interest in Genkyotex, we have acquired access to a novel NOX inhibitor platform that includes the lead compound setanaxib. Setanaxib has completed a Phase 2 trial in PBC and recently received orphan drug designation for the treatment of PBC in the United States and Europe. Based on its Phase 2 results, which indicated clinically relevant anti-fibrotic activity despite failing to achieve the primary endpoint GGT, Genkyotex had interactions with the FDA during 2020 regarding the clinical development pathway for setanaxib in PBC. In January 2021, Genkyotex reported positive data from its Phase 1 clinical trial to evaluate the safety and pharmacokinetics of setanaxib at dosages up to 1,600 mg/day. Based on this positive data, we plan to initiate a Phase 2/3 trial in PBC in the second half of 2021, incorporating higher dosing than that used in the Phase 2 trial and using alkaline phosphatase, or ALP, as a primary endpoint. The final design and protocol are subject to further feedback and commentary by the FDA.

PBC is a progressive and chronic autoimmune disease in which the small bile ducts that drain bile from the liver are damaged. This damage can result in cholestasis and the destruction of the bile ducts, which leads to liver cell damage and ultimately liver failure and the need for a liver transplant. PBC is an orphan disease and, based on its known prevalence rates, we estimate that there are approximately 140,000 patients in the United States. There are currently no approved therapies that specifically address the autoimmune response that is believed to drive PBC or the inflammatory consequences of this autoimmune response.

We also intend to explore oncology indications involving fibrotic components such as CAFs using setanaxib administered with checkpoint inhibitors to address tumour drug resistance related to fibroblasts. To this end, we plan to initiate a Phase 2 proof-of-concept study in head and neck cancer in 2021, which will study administration of setanaxib in conjunction with immunotherapy targeting CAFs.

​

​

*(ILS) Investigator lead studies

Calliditas has also exclusively in-licensed Budenofalk 3 mg oral capsules for the U.S. market from the German pharmaceutical company Falk Pharma. Our license covers all indications for the United States market, excluding orphan indications outside of liver targets. Budenofalk is a formulation of budesonide originally developed to treat Crohn’s disease, and has been approved for the treatment of Crohn’s disease and acute episodes of collagenous colitis in several countries in Europe. It has also been tested in a large randomized, controlled clinical trial in AIH patients and is approved for the treatment of AIH in several countries in Europe, but there has been no clinical development or regulatory approval in the United States. We therefore believe Budenofalk also has the potential to address AIH for patients in the United States, where there are currently no approved therapies for the treatment of this disease, and to complement our activities in that geography.

AIH is a rare disease associated with chronic inflammation of the liver. Based on the current knowledge of AIH’s pathophysiology, the origin of the autoimmune response is believed to be production of cytotoxic T-cells and B-cell derived autoantibodies directed towards liver cells or their components, resulting in inflammation that eventually destroys the liver cells and leads to fibrosis. AIH often presents as a slow progressing disease of the liver, leading to cirrhosis at variable rates with complications such as liver failure and liver cancer. AIH is an orphan disease and, based on its known prevalence rates, we estimate that there are approximately 50,000 to 80,000 patients in the United States.

We have received orphan drug designation for the treatment of AIH using budesonide by the FDA, and have discussed the development plans with the FDA for AIH during 2020. However, additional interaction is required before establishing any definitive clinical development plans.

Significant Events During the Period January 1 – June 30, 2021

​

​

Calliditas also provided selected data from the recently concluded Part A of the Phase 3 study NefIgArd. The data presented included overall baseline characteristics, rate of discontinuation of study treatment (9.5%) and rate of discontinuation from the study (3.5%). It was also confirmed that no adverse clinical effects were seen with regards to weight gain, blood pressure or HbA1c, reflecting a safety profile in keeping with the Phase 2b trial.

Significant Events After the Reporting Period

​

​

​

Financial Overview

Key Figures

​

​

¹ Alternative performance measure, see definitions on page 27.

​

January – June 2021

Revenue

No net sales were recognized for the three months ended June 30, 2021 and 2020, respectively. No net sales were recognized for the six months ended June 30, 2021. Net sales for the six months ended June 30, 2020 amounted to SEK 0.5 million and derived from the delivery of Nefecon to China as part of the license agreement with Everest Medicines. For additional information see Note 4.

Total Operating Expenses

Total operating expenses amounted to SEK 159.4 million and SEK 66.6 million for the three months ended June 30, 2021 and 2020, respectively. For the six months ended June 30, 2021 and 2020, total operating expenses amounted to SEK 310.2 million and SEK 139.4 million, respectively.

Research and Development Expenses

Research and development expenses amounted to SEK 75.0 million and SEK 48.4 million for the three months ended June 30, 2021 and 2020, respectively. For the six months ended June 30, 2021 and 2020, research and development expenses amounted to SEK 165.1 million and SEK 102.5 million, respectively. The increase of SEK 26.6 million for the second quarter and SEK 62.6 million for the six months ended June 30, 2021 is primarily due to increased cost of the NefIgArd studies and the preparation and product development for the upcoming setanaxib trials, compared to the same period last year

​

​

Administrative and Selling Expenses

Administrative and selling expenses amounted to SEK 84.4 million and SEK 18.8 million for the three months ended June 30, 2021 and 2020, respectively. For the six months ended June 30, 2021 and 2020, administrative and selling expenses amounted to SEK 143.2 million and SEK 36.8 million, respectively. The increase of SEK 65.6 million for the second quarter and SEK 106.4 million for the six months ended June 30, 2021 is mainly due to intensified commercial preparations and medical affairs activities in the US and an increased cost for administration, compared to the same period last year.

Other Operating Incomes/Expenses

Other operating income amounted to SEK 0.4 million and SEK 0.6 million for the three months ended June 30, 2021 and 2020, respectively. For the six months ended June 30, 2021 and 2020, other operating income amounted to SEK 0.4 million and SEK 0.8 million, respectively.

Other operating expenses amounted to SEK 0.4 million for the three months ended June 30, 2021. No other operating expenses were recognized for the three months ended June 30, 2020. Other operating expenses amounted to SEK 2.3 million and SEK 0.8 million for the six months ended June 30, 2021 and 2020, respectively.

Net Financial Income and Expenses

Net financial income and (expenses) amounted to SEK (5.8) million and SEK 5.3 million for the three months ended June 30, 2021 and 2020, respectively. For the six months ended June 30, 2021 and 2020, net financial income and (expenses) amounted to SEK 8.8 million and SEK 14.0 million, respectively. The decrease of SEK 11.1 million for second quarter are primarily derived by unrealized foreign currency transaction losses on cash accounts and the decrease of SEK 5.2 million for the six months ended June 30, 2021 are primarily derived by decreased unrealized foreign currency transaction gains on cash accounts.

Tax

Deferred tax assets of SEK 11.4 million have been recognized in the six months ended June 30, 2021 due to future temporary differences that such losses can be used to offset and are related to Genkyotex. The Groups tax losses accumulated have otherwise not 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 June 30, 2021 and 2020 the Group had a net loss of SEK 163.1 million and SEK 61.3 million, respectively and corresponding loss per share before and after dilution amounted to SEK 3.20 and SEK 1.50 for the three months ended, respectively.

For the six months ended June 30, 2021 and 2020 the Group had a net loss of SEK 289.9 million and SEK 125.0 million, respectively and the corresponding loss per share before and after dilution amounted to SEK 5.71 and SEK 3.14, respectively.

The decrease in the result for the periods is mainly due to the increased activities in R&D and the pre-commercial activities in the US.

​

​

Cash Flow and Cash Position

Cash flow used in operating activities amounted to SEK 132.9 million and SEK 67.0 million for the three months ended June 30, 2021 and 2020, respectively. For the six months ended June 30, 2021 and 2020, cash flow used in operating activities amounted to SEK 267.1 million and SEK 85.8 million, respectively. The cash flow used in operating activities during these periods is according to plan and is explained by the Group’s increased clinical activities as well as work within the Group’s administrative and commercial functions.

Cash flow used in investing activities amounted to SEK 18.6 million for the three months ended June 30, 2021. For the six months ended June 30, 2021, cash flow used in investing activities amounted to SEK 18.8. The cash flow used in investing activities amounted for both the three month period and six month period ending June 30, 2021, are mainly derived from a EUR 1.5 million milestone payment for the Budenofalk license. The Group had non-material cash flows used in investing activities for both the three months ended and the six months ended June 30, 2020.

Cash flow from/(used in) in financing activities amounted to SEK (0.7) million and SEK 791.2 million for the three months ended June 30, 2021 and 2020, respectively. For the six months ended June 30, 2021 and 2020, cash flow from/(used in) financing activities amounted to SEK (10.3) million and SEK 777.7 million, respectively. The cash used in financing activities for the six months ending June 30, 2021 are related to purchase of minority shares in Genkyotex.

Net increase/(decrease) in cash amounted to SEK (152.2) million and SEK 724.2 million for the three months ended June 30, 2021 and 2020, respectively. For the six months ended June 30, 2021 and 2020, net increase/(decrease) in cash amounted to SEK (296.2) million and SEK 691.9 million, respectively. Cash amounted to SEK 709.3 million and SEK 1,459.6 million as of June 30, 2021 and 2020, respectively.

Changes in Shareholders’ Equity and Number of Shares

Equity attributable to equity holders of the Parent Company amounted to SEK 937.8 million and SEK 1,425.1 million as of June 30, 2021 and 2020, respectively. The number of shares amounted to 49,941,584 and 47,938,408 as of June 30, 2021 and 2020, respectively. The increase in number of shares between the periods is due to the exercise of the partial over-allotment option from the IPO of 0.7 million new common shares in July 2020 and the exercise of the Warrant Program 2017/2020 of 1.3 million new common shares.

Employees

The number of employees were 54 and 21 employees as of June 30, 2021 and 2020, respectively. The total number of full-time equivalent (FTE), including the consultants, were 61 and 30 people as of June 30, 2021 and 2020, respectively. The average number of employees were 44 and 20 employees for the three months ended June 30, 2021 and 2020, respectively and 40 and 18 for the six months ended June 30, 2021 and 2020, respectively.

Incentive Programs

For the three months ended June 30, 2021, an allocation of 510,000 employee stock options have been made for the ESOP 2021 program and an allocation of 26,968 share awards have been made for the Board LTIP 2021 program. For more information on incentive programs, see Note 10.

Parent Company

Since the operations for the Parent Company are consistent with those of the Group in all material respects, the comments for the Group are also relevant for the Parent Company.

​

​

Auditor's Review

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

Declaration by the Board of Directors

The Board of Directors and CEO declare that the interim report for the six months ended June 30, 2021 gives a fair view of the business development, financial position and result of operation of the Parent Company and the Group and describes significant risks and uncertainties that the Parent Company and its subsidiaries are facing.

Stockholm August 19, 2021

Board of Directors

​

​

​

​

Financial Statements

Condensed Consolidated Statements of Income

​

​

​

​

​

Condensed Consolidated Statements of Comprehensive Income

​

​

​

​

​

Condensed Consolidated Statements of Financial Position

​

​

​

​

Condensed Consolidated Statements of Changes in Equity

​

​

​

​

​

​

Condensed Consolidated Statements of Cash Flows

​

​

​

​

​

​

Condensed Parent Company Statements of Income

​