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x200B; ​ ​ ​ INTERIM REPORT JANUARY 1 ST – JUNE 30 TH 2022 European approval for Kinpeygo ® Financial Summary For the Group Key Figures April 1

Key Takeaway: INTERIM REPORT JANUARY 1ST JUNE 30TH 2022 European approval for Kinpeygo Financial Summary For the Group April 1 - June 30, 2022 January 1 - June 30, 2022 Significant Events in Q2 2022, in Summary In May 2022, Calliditas announced that the first patient has been randomized

Full Press Release Details

INTERIM REPORT JANUARY 1ST JUNE 30TH 2022
European approval for Kinpeygo
Financial Summary For the Group
April 1 - June 30, 2022
January 1 - June 30, 2022
Significant Events in Q2 2022, in Summary
In May 2022, Calliditas announced that the first patient has been randomized in the Group'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.
In May 2022, Calliditas announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a conditional marketing authorisation for Kinpeygo for the treatment of IgA nephropathy.
In May 2022, the Annual General Meeting of Calliditas was held and, among other things, the meeting decided on the election of Henrik Stenqvist and Elisabeth Bj rk to the Board of Directors and the establishment of a U.S. At-the-Market framework, pursuant to which Calliditas may, at its option, sell American Depositary Shares ( ADSs ) in the United States.
Significant Events After the Reporting Period
In July 2022, Calliditas announced that the European Commission (EC) granted conditional marketing authorization for Kinpeygo for the treatment of IgA nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) 1.5 g/gram. Kinpeygo is an orphan medicinal product and became the first and only approved treatment for IgAN in the European Economic Area (EEA). Kinpeygo will be marketed in the EEA exclusively by STADA Arzneimittel AG.
Investor Presentation August 18, 2022 14:30 CET
Audio cast with teleconference, Q2 2022
Teleconference: SE: +46856642692 UK: +443333009260 US: +16467224904
European approval for Kinpeygo
On May 19th, the European Medicines Agency (EMA) announced that it had adopted a positive opinion regarding the application for conditional approval of Kinpeygo for the treatment of IgA nephropathy, and on July 15th the European Commission issued the market authorization for Kinpeygo in Europe.
This is the first time that any drug has achieved approval for this rare disease in Europe and we are delighted that we can contribute a piece of the puzzle in the broader effort to improve care for patients with orphan diseases. We have now initiated the transfer of our market authorization to our partner, STADA, and look forward to seeing Kinpeygo being launched in Europe. Having now received approval in both the US and Europe we are looking forward to the regulatory process in China, where our partner, Everest Medicines, plans to file for approval with the NMPA in the second half of this year.
In the US we continue to have significant success in our early commercial efforts. Net revenues from TARPEYO grew by well over 250% when compared to Q1, resulting in net revenues of SEK 64 million ($6.6m) from TARPEYO for Q2. This reflects the continued strong interest from nephrologists, with unique prescribers growing from 111 in Q1 to 314 prescribers during Q2 with enrolments growing signifcantly from 134 in Q1 to 315 in Q2. This is a testament both to the unmet medical need perceived by nephrologists for this patient group as well as significant interest from prescribers generated due to the strong proteinuria and eGFR data associated with our product.
The US operation continues to grow as we add complementary resources in key areas. The multidisciplinary team continues to reach out to physicians across multiple channels in support of our commercial activities and positive momentum continues to build in the market. We believe the combination of the significant proteinuria reduction vs ACE / ARB therapy at 9 months (-31%) and the continued significant decline in proteinuria observed 3 months after withdrawal of the treatment (-52%) that we observed in the Phase 3 trial reflect the differentiated mechanism of action of TARPEYO. Its design, which specifically targets the origin of the disease, continues to drive strong interest from both patients and nephrologists, who seem especially impressed by the impact on eGFR during the 9 months of treatment. In order to fully support this growing interest, we decided post this period's end to expand our US sales force to encompass a total of 60 sales executives expected, with recruitment of an additional 20 sales executives in Q3 and who will become fully operational in Q4. We are truly excited about this development which further builds on TARPEYO's initial commercial success and our commitment to ensure that TARPEYO continues to be readily available for appropriate patients with IgA nephropathy.
The second quarter also saw the dosing of the first patient in our Phase 2 study in head and neck cancer, studying the efficacy and safety of the lead candidate from our proprietary NOX platform, setanaxib. There is significant interest in cancer associated fibroblasts (CAFs) from a variety of industry participants and we look forward to hopefully sharing biomarker data with you before the end of the year.
In Q2 we also revisited the existing credit line with Kreos regarding the final $25 million tranche under the $75 million non-dilutive loan facility we put in place mid 2021. As a result, we do not have any specific operational requirements and are thus able to draw down the last tranche at any time before the end of December, 2022. In addition, we expect to receive 12.5m (approximately SEK 130 million) in milestone payments related to the approval and commercial launch of Kinpeygo in Europe from STADA during the second half of 2022.
We are thrilled to be another step closer to bringing the first approved medication in IgAN to patients around the world and look forward to continuing to expand access for patients with an unmet medical need for the rest of the year and beyond.
Ren e Aguiar-Lucander, CEO
Our Commercial Product
Calliditas' lead product, which was granted accelerated approval by the US Food and Drug Administration (FDA) in December 2021 and conditional marketing authorization by the European Commission in July 2022, is the first treatment specifically designed to target the origin of the autoimmune kidney disease IgA Nephropathy (IgAN).
IgAN is a serious progressive disease, in which up to 50% of patients end up at risk of developing end-stage renal disease (ESRD) within ten to twenty years. This product, which was developed under the name NEFECON, is approved under the brand name TARPEYO in the United States and under the brand name Kinpeygo in Europe.
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. Patients with IgA nephropathy have elevated levels of mucosal-type IgA, which in contrast to the majority of the IgA in the blood - 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 secretory 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 form pathogenic immune complexes that deposit in the glomeruli, the kidney's filtration apparatus. The trapped immune complexes initiate an inflammatory cascade 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.
Calliditas' lead product is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. It 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 various polymers and budesonide designed to target the area with the highest concentration of Peyer's patches, with the intention of having a disease-modifying effect.
Calliditas' regulatory filings with the FDA and European Medicines Agency (EMA) were based on positive data from Part A of the NefIgArd pivotal Phase 3 study, which read out topline data 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; in the intention to treat (ITT) population, the reduction at 9 months of treated patients was 34%. Furthermore, for patients who had reached 12 months at the time of the data cut-off, the 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.
Our Commercial Product (cont.)
The product is approved under the accelerated approval pathway under the brand name TARPEYO in the United States. TARPEYO is 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. Itis the first and only FDA-approved treatment for IgA nephropathy.
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.
In July 2022, the product was granted conditional marketing authorization by the European Commission under the brand name Kinpeygo for the treatment of IgA nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) 1.5 g/ gram. Kinpeygo is an orphan medicinal product and became the first and only approved treatment for IgAN in the European Economic Area (EEA).
Kinpeygo will be marketed in the EEA exclusively by STADA Arzneimittel AG with whom Calliditas entered into a license agreement in July 2021. The deal with STADA to register and commercialize Kinpeygo in the European Economic Area (EEA) member states, Switzerland and the UK was valued at a total of EUR 97.5 million, plus royalties. Under the terms of the agreement, Calliditas received an initial upfront payment of EUR 20 million upon signing and is entitled to up to an additional EUR 77.5 million 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.
Greater China, Singapore and South Korea
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 USD 15 million upon signing, as well as future payments linked to development, regulatory and commercialization milestones up to an additional USD 106 million, plus royalties. In March 2022, this agreement was expanded to include South Korea. Everest Medicines will look to file with regulators in China in 2H 2022, with a view to target potential approval in 2023.
Building on a Successful Commercial Launch
In our second and first full quarter of sales of TARPEYO , the commercial team has continued to build on the foundation established in Q1 subsequent to TARPEYO's approval. The enthusiasm for TARPEYO from physicians and patients has been encouraging, we are pleased with the progress that has been made to date, and we remain confident in our ability to continue our growth, this year and beyond.
Since TARPEYO's launch in late January, there have been a total of 450 patient enrollments, with 235% more enrollments in Q2 compared to Q1. All patients are guided through the enrollment and procurement process with the support of our patient services program, TARPEYO Touchpoints , which has been assisting physicians and patients via a designated Rare Pod Team including nurses, pharmacists, and a fulfilment and distribution team.
The Calliditas market access team continues to engage with payers and focus on the key targeted payers that cover most American lives. While the review process for coverage and formulary placement is on-going it typically takes six to nine months. When we look at coverage, as reported by Breakaway Partners, a Komodo Health Company, well over 80% of US lives are covered for TARPEYO.
Following the required FDA review related to accelerated approved medications, we launched our branded campaign during Q2. The multimedia campaign focuses on the unique mechanism of action of TARPEYO and the efficacy and safety results achieved in the clinic. Supported by our medical affairs education and marketing campaign, the adoption of TARPEYO by physicians has been quick and after only 5 months of promotion awareness of our drug is high, with unaided awareness at 70% and aided awareness at 80%. A total of 314 prescribers to date have prescribed TARPEYO for their patients, reflecting a broad interest in the drug.
Our medical affairs team has been active at the big symposia and congresses, such as the National Kidney Foundation's yearly Spring Clinical Meetings educational event. We also continue to work with patient advocacy groups and were thrilled to continue to lend our support to the IgA Nephropathy Foundation as it worked towards hosting its yearly symposium, SPARK 2022, in July.
Our specialty sales team has continued to build on the strong results in Q1, recording net sales for the second quarter of $6.6M (SEK 64 million), more than tripling net sales compared to Q1. We are now, in light of the broad and strong demand, planning to expand our sales force with the aim of further bolstering our reach and frequency of contact, empowering our sales team to support the demand from the physician audience and increase the individual frequency of meetings and of face-to-face interactions.
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 and is a selective NOX 1 and NOX 4 inhibitor. Calliditas is presently running trials with setanaxib in Primary Biliary Cholangitis (PBC) and in Squamous Cell Carcinoma of the Head & Neck (SCCHN).
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.
At appropriate concentrations, ROS have essential functions in cellular signaling processes, but disruption of the redox homeostasis has been implicated in multiple 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.
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. 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.
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 in up to 150 investigational centres. The primary endpoint is ALP reduction, with key secondary endpoints including change in liver stiffness and effect on fatigue and pruritus (itching). Following favorable safety data from a 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. 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.
*Dose of 1200 mg daily administered as 800 mg AM and 400 mg PM
Dose of 1600 mg daily administered as 800 mg AM and 800 mg PM
Pipeline: NOX Inhibitor Platform
Setanaxib in Squamous 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:
Proof-of-concept study in head and neck cancer
Calliditas is conducting 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 approximately 50 patients. 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.
Significant Events During the Period January 1 June 30, 2022
Significant Events After the Reporting Period
Three Months Ended Six Months Ended Year Ended
June 30, June 30, December 31,
(SEK in thousands, except per share amount or as otherwise indicated) 2022 2021 2022 2021 2021
Net sales 64,047 113,781 229,347
Research and development expenses (96,290) (75,020) (209,633) (165,097) (357,485)
Research and development expenses/Total operating expenses in % 35 % 47 % 40 % 53 % 47 %
Operating loss (209,844) (159,398) (418,210) (310,179) (524,456)
Loss before income tax for the period (192,090) (165,212) (403,525) (301,386) (513,373)
Loss per share before and after dilution (3.62) (3.22) (7.57) (5.84) (9.84)
Cash flow used in operating activities (225,234) (132,910) (416,658) (267,089) (461,588)
June 30, December 31,
(SEK in thousands, except per share amount or as otherwise indicated) 2022 2021 2021
Total registered shares at the end of the period 59,106,188 49,941,584 52,341,584
Equity attributable to equity holders of the Parent Company at the end of the period 721,094 931,206 1,008,281
Equity ratio at the end of the period in % 49 % 78 % 69 %
Cash at the end of the period 846,799 709,306 955,507
Net sales amounted to SEK 64.0 million for the three months ended June 30, 2022 and for the six months ended June 30, 2022 net sales amounted to SEK 113.8 million. No net sales were recognized during the three and six months ended June 30, 2021, respectively. Net sales for the three and six months ended June 30, 2022 primarily originates from net sales of TARPEYO in the U.S., which amounted to SEK 63.6 million for the three months ended June 30, 2022 and SEK 81.6 million for the six months ended June 30, 2022. Further, for the six months ended June 30, 2022, net sales also consisted of the milestone fee from Everest Medicines for the extension of the license agreement for South Korea which amounted to SEK 28.8 million. For additional information see Note 4.
Total Operating Expenses
Total operating expenses amounted to SEK 271.5 million and SEK 159.4 million for the three months ended June 30, 2022 and 2021, respectively. For the six months ended June 30, 2022 and 2021, total operating expenses amounted to SEK 529.0 million and SEK 310.2 million, respectively.
Research and Development Expenses
Research and development expenses amounted to SEK 96.3 million and SEK 75.0 million for the three months ended June 30, 2022 and 2021, respectively. For the six months ended June 30, 2022 and 2021, research and development expenses amounted to SEK 209.6 million and SEK 165.1 million, respectively. The increase of SEK 21.3 million for the three months ended June 30, 2022 and SEK 44.5 million for the six months ended June 30, 2022 was primarily due to the setanaxib trials and the development of setanaxib compared to the corresponding periods of the prior year.
Marketing and Selling Expenses
Marketing and selling expenses amounted to SEK 113.3 million and SEK 58.4 million for the three months ended June 30, 2022 and 2021, respectively. For the six months ended June 30, 2022 and 2021, marketing and selling expenses amounted to SEK 207.2 million and SEK 77.8 million, respectively. The increase of SEK 54.9 million for the three months ended June 30, 2022 and SEK 129.4 million for the six months ended June 30, 2022 was primarily related to the costs for sales and marketing of TARPEYO in the U.S., including the costs for the sales force compared to the corresponding periods of the prior year.
Administrative Expenses
Administrative expenses amounted to SEK 58.9 million and SEK 26.0 million for the three months ended June 30, 2022 and 2021, respectively. For the six months ended June 30, 2022 and 2021, administrative expenses amounted to SEK 107.4 million and SEK 65.4 million, respectively. The increase of SEK 32.9 million for the three months ended June 30, 2022 and SEK 42.0 million for the six months ended June 30, 2022 was primarily related to general cost increases due to a larger organization and increased regulatory requirements compared to the corresponding periods in the prior year.
Other Operating Incomes/Expenses
Other operating income amounted to SEK 0.3 million and SEK 0.4 million for the three months ended June 30, 2022 and 2021, respectively. For the six months ended June 30, 2022 and 2021, other operating income amounted to SEK 1.1 million and SEK 0.4 million, respectively. Other operating expenses amounted to SEK 3.4 million and SEK 0.4 million for the three months ended June 30, 2022 and 2021, respectively. For the six months ended June 30, 2022 and 2021, other operating expenses amounted to SEK 5.9 million and SEK 2.3 million, respectively. The increase in other operating expenses for the three and six months ended June 30, 2022, was primarily related to a more disadvantageous exchange rate development on operating liabilities compared to the corresponding periods of the prior year.
Net Financial Income and Expenses
Net financial income/(expenses) amounted to SEK 17.8 million and (SEK 5.8 million) for the three months ended June 30, 2022 and 2021, respectively. For the six months ended June 30, 2022 and 2021, net financial income amounted to SEK 14.7 million and SEK 8.8 million, respectively. The increase of SEK 23.6 million for the three months ended June 30, 2022 and SEK 5.9 million for the six months ended June 30, 2022 was primarily derived by currency effect related to intercompany loan and unrealized foreign currency transaction gains on cash accounts.
Income tax expenses, in all material respects, primarily relates to the U.S. subsidiaries of Calliditas Therapeutics. Deferred tax assets of SEK 5.3 million related to Calliditas Therapeutics Suisse have been recognized in the six months ended June 30, 2022, due to future temporary differences that such losses can be used to offset. 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 June 30, 2022 and 2021, loss for the period amounted to SEK 192.4 million and SEK 164.2 million, and the corresponding loss per share before and after dilution amounted to SEK 3.62 and SEK 3.22, respectively. For the six months ended June 30, 2022 and 2021, loss for the period amounted to SEK 399.5 million and SEK 297.0 million, and the corresponding loss per share before and after dilution amounted to SEK 7.57 and SEK 5.84, respectively.
Cash Flow and Cash Position
Cash flow used in operating activities amounted to SEK 225.2 million and SEK 132.9 million for the three months ended June 30, 2022 and 2021, respectively. For the six months ended June 30, 2022 and 2021, cash flow used in operating activities amounted to SEK 416.7 million and SEK 267.1 million, respectively. The increase in cash flow used in operating activities for the three and six months ended June 30, 2022, were 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 compared to the corresponding periods of the prior year.
Cash flow used in investing activities amounted to SEK 0.1 million and SEK 18.6 million for the three months ended June 30, 2022 and 2021, respectively. For the six months ended June 30, 2022 and 2021, cash flow used in investing activities amounted to SEK 2.8 million and SEK 18.8 million, respectively. The decrease in cash flow used in investing activities for the three and six months ended June 30, 2022 were mainly derived from a EUR 1.5 million milestone payment for the Budenofalk license, which occurred the corresponding periods of the prior year.
Cash flow from/(used in) financing activities amounted to SEK 235.9 million and (SEK 0.7 million) for the three months ended June 30, 2022 and 2021, respectively. For the six months ended June 30, 2022 and 2021, cash flow from/(used in) financing activities amounted to SEK 295.9 million and (SEK 10.3 million), respectively. The increase in cash flow from financing activities for the three and six months ended June 30, 2022, compared to the corresponding periods of the prior year, was primarily due to the draw down of the second tranche of the Kreos loan facility of SEK 236.5 million. Further for the six month period, the increase in cash flow from financing activities was also derived from the payments related to the exercise of warrant program 2018/2022.
Net increase/(decrease) in cash amounted to SEK 10.5 million and (SEK 152.2 million) for the three months ended June 30, 2022 and 2021, respectively. For the six months ended June 30, 2022 and 2021, net decrease in cash amounted to SEK 123.5 million and SEK 296.2 million, respectively. Cash amounted to SEK 846.8 million and SEK 709.3 million as of June 30, 2022 and 2021, respectively.
Changes in Shareholders' Equity and Number of Shares
Equity attributable to equity holders of the Parent Company amounted to SEK 721.1 million and SEK 931.2 million as of June 30, 2022 and 2021, respectively. The number of registered shares amounted to 59,106,188 and 49,941,584 as of June 30, 2022 and 2021, respectively. The increase in number of shares between the periods was derived from a new share issue in August 2021 of 2.4 million shares, a new share issue in April and May 2022 of 856,586 shares related to the Warrant Program 2018/2022 and a new issue of 5,908,018 C-shares, which subsequently immediately was repurchased and, after the end of the period, converted to common shares.
Issuance and Repurchase of Treasury Shares
For the three months ended June 30, 2022, Calliditas resolved to carry out a new issue of 5,908,018 C-shares at a subscription price of SEK 0.04 per share and to subsequently immediately repurchased the 5,908,018 newly issued C-shares for SEK 0.04 per share and subsequently, after the end of the period, was converted into ordinary shares in accordance with the company's articles of association and held as treasury shares. The purpose of the issue and repurchase is to secure future potential delivery of shares under the company's at-the-market program. The new share issue has increased the share capital by SEK 0.2 million. See Note 10 for additional information.
The number of employees were 85 and 54 employees as of June 30, 2022 and 2021, respectively. The total number of full-time equivalent (FTE), including consultants, were 137 and 61 as of June 30, 2022 and 2021, respectively. The average number of employees were 81 and 44 employees for the three months ended June 30, 2022 and 2021, respectively and 76 and 40 employees for the six months ended June 30, 2022 and 2021, respectively.
For the three months ended June 30, 2022, an allocation of 40,706 share awards have been granted for the Board LTIP 2022 program. For more information on incentive programs, see Note 11.
Net sales for the Parent Company, Calliditas Therapeutics AB, amounted to SEK 0.4 million for the three months ended June 30, 2022 and for the six months ended June 30, 2022 net sales amounted to SEK 32.2 million. No net sales were recognized for the three and six months ended June 30, 2021, respectively. The increase was primarily derived from the extension of the Everest Medicines agreement to South Korea by SEK 28.8 million. Operating loss amounted to SEK 152.1 million and SEK 123.6 million for the three months ended June 30, 2022 and 2021, respectively. For the six months ended June 30, 2022 and 2021, operating loss amounted to SEK 254.7 and SEK 251.5 million, respectively. The decrease for both periods was primarily derived from larger organization compared to the corresponding periods of the prior year. Non-current financial assets have increased by SEK 190.2 million to SEK 743.2 million as of June 30, 2022 compared to December 31, 2021, which was primarily derived from intercompany transactions.
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, 2022 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 18, 2022
Last updated: Aug 19, 2022