Calliditas Therapeutics : May 23, 2024 Interim Report Q1 2024 (Report)

Q1

INTERIM REPORT JANUARY - MARCH 2024

Interim report January - March 2024

JANUARY - MARCH 2024

(COMPARED TO JANUARY - MARCH 2023)

• Net sales amounted to SEK 295.5 million, of which TARPEYO® net sales amounted to SEK 278.3 million, for the three months ended March 31, 2024. For the three months ended March 31, 2023 net sales amounted to SEK
• 1. million, of which TARPEYO net sales amounted to SEK 185.7 million.
• Operating loss amounted to SEK 203.8 million and SEK
• 1. million for the three months ended March 31, 2024 and 2023, respectively.

• Loss per share before and after dilution amounted to SEK
  4.59 and SEK 3.49 for the three months ended March 31,
  2024 and 2023, respectively.
• Cash amounted to SEK 810.3 million and SEK 1,013.6 million as of March 31, 2024 and 2023, respectively.

"In Q1 we generated another record quarter in terms of demand with 705 enrollments and 354 new prescribers. We are very excited over this positive trend and we continue to see strong demand in Q2."

Renée Aguiar-Lucander / CEO

JAN - MAR 2024

278

MSEK

TARPEYO net sales

JAN - MAR 2024

50%

TARPEYO net sales growth in SEK (vs Q1 2023)

31 MAR 2024

810

MSEK

Cash position

Key takeaways from Q1, 2024

• Calliditas had a record quarter with 705 enrollments, representing a 27% increase over Q4.
• In February, the United States Patent and Trademark
  Office (USPTO) issued patent no. 11896719, entitled "New Pharmaceutical Compositions". This was Calliditas' second patent for TARPEYO in the United States, and provides product protection until 2043.
• In March, the FDA granted an orphan drug exclusivity period of seven years for TARPEYO®, expiring in December 2030, based on when the company obtained full approval with a new indication for this drug product.
• There was a negative impact on net TARPEYO revenues in the quarter of approximately USD 4.7 million due to a cyberattack on Change Health. The revenues we were not able to record in Q1 because of this technical issue are not lost, but are expected to roll forward over the next several months. This is not expected to have any impact on annual revenues.

Key events after the reporting period

• Preliminary net sales from TARPEYO for the second quarter up until the date of this report amounts to USD 25.5 million.
• Positive read out of the Nefecon Open label Phase 3 extension trial.
• Positive topline results from the setanaxib Phase 2 trial in head and neck cancer.
• Commercial launch of Nefecon in China by partner Everest
  Medicines.

Key events in upcoming 6 months

• European Commission decision regarding a potential full approval for Kinpeygo for Calliditas' partner STADA.
• Full data read out of setanaxib Phase 2 trial in Primary
  Biliary Cholangitis.
• Updated KDIGO guidelines.

Outlook 2024: Unchanged

• Calliditas expects continued revenue growth:
  Total net sales from the Nefecon franchise, including milestones, are estimated to be USD 150-180 million for the year ending December 31, 2024.

Calliditas Therapeutics | Interim Report 2024: January - March

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Calliditas

• pioneering new treatments for rare diseases

Calliditas Therapeutics leverages scientific expertise and disease specific insights to help improve the lives of patients. We are a commercial-stage biopharma company that researches, develops and commercializes novel therapies that seek to address significant unmet needs in relation to the treatment of rare diseases. We are committed to expanding treatment options and establishing new standards of care for patients with rare diseases, reflected by our pipeline of innovative medicines that target unmet medical needs.

Our lead product provides a treatment option that has been demonstrated to be disease-modifying for IgA nephropathy (IgAN) - also known as Berger's Disease - a progressive autoimmune disease of the kidney that for many patients leads to end-stage renal disease (ESRD), requiring dialysis or organ transplantation. This drug product, developed under the name Nefecon®, was granted accelerated approval by the FDA in 2021 and full approval in December 2023, and is today marketed in the US under the brand name TARPEYO®. TARPEYO is now the first and only fully approved treatment for IgAN and is approved based on a measure of kidney function. Nefecon has also been granted conditional marketing authorisation by the European Commission under the brand name Kinpeygo®

in the European Economic Area (EEA) and in the UK. Kinpeygo is currently being reviewed for full marketing authorization by the European Commission and the MHRA.

Nefecon has been granted conditional approval in China, Singa- pore, and Macau, and is being reviewed by regulators in Hong Kong and South Korea. Nefecon was launched commercially by Everest

Medicines in China in May 2024. Calliditas has also entered into a partnership to develop and commercialize Nefecon in Japan.

IgA nephropathy is the most common primary glomerulonephritis worldwide, so the market potential for Nefecon is substantial, as evidenced by our early commercial success and out-licensing deals with potential payments exceeding USD 300 million, encompassing upfront payments and predefined milestones, as well as ongoing royalty obligations.

Our late-stage pipeline is based on a first-in-class platform of NOX inhibitors. Our lead compound, setanaxib, inhibits enzymes involved in inflammation and fibrosis pathways and is the first drug of this class to reach the clinical stage. Setanaxib is currently undergoing clinical trials targeting rare diseases characterized by inflammation and fibrosis, including Primary Biliary Cholangitis (PBC) and Alport syndrome, and there is also an investigator led trial ongoing in idiopathic pulmonary fibrosis (IPF). Calliditas read out positive data from a Phase 2 proof-of-concept trial with setanaxib in head and neck cancer in May 2024.

While our headquarter is in Stockholm, Sweden, we maintain a significant presence in the United States, with offices in New York and New Jersey. We also have offices in France and Switzerland, where our discovery team is based. Calliditas Therapeutics ordinary shares were listed on NASDAQ Stockholm in 2018 (CALTX) and subsequently American Depositary Shares representing our ordinary shares were listed on the NASDAQ Global Select Market in the United States in 2020 (CALT).

Our values

AGILITY

We are flexible and able to rapidly pivot and adapt to changing situations and requirements.

EXPERTISE

We leverage our strong internal experience and competencies while complementing our strengths through knowledge sharing and external collaborations as needed.

INTEGRITY

We take responsibility for our actions and hold ourselves to the highest ethical standards, guided by our moral principles to make the right decisions.

PIONEER

We explore novel approaches and empower each other to find new ways of operating in a compliant, innovative and pragmatic manner.

Calliditas Therapeutics | Interim Report 2024: January - March

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Investment highlights

RECENT AND ANTICIPATED DRIVERS

	Consolidating market leadership
Potential positive opinion	of TARPEYO in US following full
approval
from EMA for partner STADA

Open label extension study data readout

NEFECON

Commercial launch in China

Update to KDIGO guidelines

Growth of commercial franchise in China & Europe

H1 2024

H2 2024

Setanaxib

			Topline data
	Topline data readout
	readout of Ph2 IPF
	of Ph2b trial in PBC
Topline data readout of Ph2	trial (ILS)
trial in Solid Tumors (SCCHN)		Explore partnering
		opportunities in Oncology

Key figures

	Three Months Ended 31 March
SEK in thousands, except per share amount or as otherwise indicated	2024	2023
Net sales	295,481	191,352
Of which TARPEYO product sales	278,276	185,691
Operating income (loss)	(203,826)	(180,074)
Income (loss) before Income tax for the period	(247,324)	(208,019)
Earnings (loss) per share before and after dilution (SEK)	(4.59)	(3.49)
Cash flow from (used in) operating activities	(198,205)	(231,940)
	March 31
(SEK in thousands, except per share amount or as otherwise indicated)	2024	2023

Year Ended 31 December

2023

1,206,888

1,075,829

(373,055)

(457,017)

(8.69)

(434,655)

December 31

2023

Total registered shares, including shares held by Calliditas, at the end of the period	59,580,087	59,580,087	59,580,087
Equity attributable to equity holders of the Parent Company at the end of the period	120,151	589,403	334,806
Equity ratio at the end of the period in %	7%	33%	18%
Cash at the end of the period	810,317	1,013,600	973,733

Calliditas Therapeutics | Interim Report 2024: January - March

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CEO STATEMENT

Target market expansion following full approval in the US

Following the full approval of TARPEYO by the FDA in December of 2023, we were poised to bring the message of the disease modifying potential of TARPEYO to nephrologists. New marketing materials and training of everyone in the field to reflect the new indication and label were initiated, and in February we rolled out the new program. In Q3 of 2023 we had made the decision to expand the US field force and increase key field functions such as thought leader liaisons, medical directors and field reimbursement managers to address the larger market potential. Our new indication - reduction of kidney loss in patients with primary IgAN at risk of disease progression - now enables us to address the full adult IgAN population at risk, an important change for both patients and physicians. The potential that the drug has to provide a clinically meaningful delay in the need for dialysis or transplantation can now be discussed in interactions with treating nephrologists, as we now can share the exciting and important eGFR data from

the Phase 3 trial. It was important to us that we invested in the best possible team with the right focus in order to continue our important pioneering work for IgAN patients. In January we also announced the addition of an experienced senior executive, Maria Törnsén as President North America, who brings over a decade of expertise from the US rare disease market as well as a wealth of experience from account management, optimization of field resources, and franchise building. This was a key complement to our expanded field presence and we are delighted to already see the benefits of her expertise.

This timely expansion leverages the expertise we have built over the last two years and was instrumental in generating another record quarter in terms of enrollments. The 705 enrollments received in Q1 2024 represent a 27% increase over Q4, which in turn was a 51% increase over Q3. This continued strong growth in demand we believe is the result of our strong data and the positive patient and physician experiences with using the drug in a real-world setting, a key leading indicator of expected revenue growth in 2024. We are very excited about this positive trend and are continuing to see strong demand

in Q2. We believe that TARPEYO is poised to become the backbone treatment in IgAN as the only disease specific and disease modifying medication on the market, providing eGFR stabilization during treatment which is durable post treatment. The ability to treat when necessary to provide disease management without the high cost and potential safety-related issues of many chronic treatments is important both for patients and physicians dealing with this progressive disease, especially if it potentially can keep patients out of dialysis or transplantation in their lifetime.

Total net revenues for the quarter from TARPEYO amounted to USD

26.8 million (SEK 278 million). Revenues in Q1 were impacted by two important factors. The first was already communicated in our Q4 presentation: namely, that Q1 is typically a somewhat slower quarter due to the insurance reverification process taking place.

The second was completely unexpected, namely the cyberattack in

February on Change Health, a division of United Health, which is one of three major claims processors in the US. This significant event had a profound effect on the industry generally, and on our hub's ability to verify insurance coverage during the time that the system was down, as our specialty pharmacy exclusively utilizes Change Health. This led to a negative revenue impact of approximately USD 4.7 million for the period. The revenues we were not able to record in Q1 because of this technical issue are not lost, but are expected to roll forward over the next several months, and this is not expected to have an impact on annual revenues, which is also borne out by a strong start to Q2 in terms of TARPEYO net sales, which quarter to date already amount to approximately USD 25.5 million1 with an additional 5 weeks remaining in the quarter. Our hub manager, Biologics by McKesson, has subsequently implemented routines to better deal with this type of unexpected situation in the future.

Our interactions with payors have continued as planned, and we have had many interactions with P&T committees already. We expect the updated rules to come into effect for many of the larger plans in their next update cycle, which is slated for June/July.

Q1 also saw a significant strengthening of the product protection of TARPEYO as we received seven years of orphan drug status for the new indication, ending in late December of 2030. In addition, we complemented our existing TARPEYO patent portfolio with a new patent, expiring in 2043. We will continue to work to both broaden the patent portfolio as well as achieve greater geographical coverage.

Post period we were also very excited to report out topline data from our setanaxib Phase 2 head and neck cancer trial. The highly relevant and clinically meaningful measures of progression free survival and overall survival came out as statistically significant in the patients who received setanaxib and pembrolizumab, compared to the group receiving placebo and pembrolizumab, and in addition we could see clinical evidence of setanaxib's anti fibrotic effect given the statistical significance on T cell activity in the tumors treated with setanaxib. This was beyond our initial expectations for the trial and we are looking forward to engaging in discussions with potential partners, as well as seeing the results from the other Phase 2 trials from our rare disease pipeline.

Our cash position remains strong with SEK 810 million on the balance sheet at the end of the quarter, which we believe is sufficient to take us to profitability based on expected revenue growth of TARPEYO. We reiterate our guidance of USD 150 - 180 million of net revenues for the Nefecon franchise in 2024.

Renée Aguiar-Lucander, CEO

Calliditas Therapeutics | Interim Report 2024: January - March

1Net sales for TARPEYO are preliminary, unaudited and refer to the period April 1 - May 23.

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BUSINESS OVERVIEW

Our pipeline

Calliditas' lead product has been fully approved in the US, and has conditional approval in Europe and China. Our pipeline consists of development programs derived from a first-in-class NOX inhibitor plat- form. The lead compound, setanaxib, was designed to be a selective NOX 1 and NOX 4 inhibitor and is the first product candidate to reach the clinical stage. Calliditas read out topline data from its trial with setanaxib in squamous cell carcinoma of the head & neck (SCCHN) in May 2024, and is also presently running trials with setanaxib in primary biliary cholangitis (PBC) and Alport syndrome. There is also an ongoing investigator-led trial in idiopathic pulmonary fibrosis (IPF).

NEFECON*

Preclinical

IgAN

IgAN

IgAN

IgAN

Phase 1

Phase 2

Phase 3

Marketed

KINPEYGO 4 mg

Modified-release hard capsules budesonide

Rights

Commercial region

United States

ROW ex partnered

Europe, UK, Switzerland

China, Hong Kong, Macau,

Taiwan, Singapore,

South Korea

Japan

Setanaxib

PBC			Global
SCCHN			Global
IPF			Global
Alport			Global
Commercial	Ongoing Trial	Planned Trial	Investigator Led Trial

• Approved in the US under the tradename TARPEYO® to reduce the loss of kidney function in adults with primary IgAN at risk for disease progression, and granted condi- tional marketing authorization in the EEA and UK under the tradename Kinpeygo® for the treatment of primary IgAN in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram, and granted conditional approval in China under the tradename Nefecon®.

Exciting journey ahead

Expected commercial ramp following full approval of TARPEYO in primary IgA nephropathy for patients at risk of progression

2H 2024: Topline data read-		Potential full approval of
out of Phase 2b trial with		Kinpeygo in EU and UK
setanaxib in PBC, following
positive data from head and
neck cancer trial

Calliditas Therapeutics | Interim Report 2024: January - March

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BUSINESS OVERVIEW

Our commercial product

On December 20, 2023, Calliditas' lead product, TARPEYO, became the first and only drug granted full approval by the US Food and Drug Administration for patients affected by IgA nephropathy (IgAN). It is the only treatment specifically designed to target the origin of IgAN and to be disease- modifying.

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. It was also granted conditional approval by the European Commission under the brand name Kinpeygo® in July 2022 and by the MHRA for the UK in February 2023. Nefecon received conditional approval in China by the China NMPA in November 2023.

Disease background

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 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.

Successful Phase 3 trial readout

NefIgArd is the first Phase 3 trial in IgA nephropathy to show a statistically significant and clinically relevant kidney protective effect as measured by eGFR. Calliditas' full approval for Nefecon from the FDA was based on the strong eGFR data from this trial. The trial confirmed that targeting the origin of the disease with a non chronic approach had a significant long-term impact on kidney function.

The full Phase 3 NefIgArd trial consisted of a total of 364 patients, including 200 patients from the interim analysis, based upon which Calliditas successfully filed for accelerated approval with the FDA and for conditional approval with the European

Commission, UK MHRA, and China NMPA. The full trial included 9 months of treatment and a 15-monthpost-treatment observational period for all study participants to confirm long-term renal protection. The endpoint of the full Phase 3 trial assessed the difference in kidney function between treated and placebo patients, as measured by eGFR, over a two-year period from the start of dosing of each patient. The data read-out took place in March 2023, and in August 2023 was published in The Lancet.

The primary endpoint of the Phase 3 trial was a time-weighted average of eGFR observed at each time point over two years. The primary endpoint was successfully met with a highly statistical p value of <0.0001. At 9 months the absolute difference in eGFR of the treatment arm was an improvement of 0.7 mL/min/1.73 m2 versus a loss of 4.6 mL/min/1.73 m2 for the placebo arm. The treatment benefit was preserved during the period of observation, reflected by a loss of kidney function at two years in the placebo arm of 12.0 mL/min/1.73 m2 versus

6.1 mL/min/1.73 m2 for the treatment arm. This was also confirmed by a difference in slope of 3 mL/min/year in favor of

TARPEYO.

There was a cumulative improvement in proteinuria in patients treated with Nefecon versus placebo during the 9-month treatment period, which continued to significantly improve after end of treatment, resulting in a decline of over 50% at 12 months.

At month 24, proteinuria levels in patients who had received Nefecon were still at a reduced level, similar to that observed at the 9-month time point, reflecting the durability of the proteinuria reduction of a 9-month course of treatment.

Regulatory approvals

On the basis of this positive data, Calliditas submitted an sNDA to the FDA seeking full approval of TARPEYO for the complete study population from the Phase 3 NeflgArd study. On December 20, 2023, the FDA approved TARPEYO (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary IgAN at risk for disease progression. Marking a significant milestone, TARPEYO is now the first fully FDA-approved treatment for IgAN reflecting the impact on a measure of kidney function.

In September 2023, Calliditas' partner STADA filed with Euro- pean Commission for full marketing authorisation of Kinpeygo in the EU, and in October 2023 they also filed with the UK MHRA. Nefecon received conditional approval in China in November 2023 and approval in the Macau administrative region in October 2023. Calliditas' partner Everest Medicines will be commercialising this product in these territories.

Calliditas Therapeutics | Interim Report 2024: January - March

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BUSINESS OVERVIEW

IgA nephropathy

- a significant market opportunity

• While IgAN is a rare disease, it is the most common form of pri- mary glomerulonephritis. Prevalence is estimated to range from 130,000 to 150,000 patients in the US, to be around 200,000 patients in Europe and up to 5 million patients in China.
• In the United States, we estimate there are around 12,000 nephrologists, of which up to two thirds treat patients with IgAN. The majority of patients are seen by approximately 4,000 to 5,000 specialists. About 40% of the patients are treated in academic settings while the remaining are treated in community settings.1

• The IgAN patient population at risk of disease progression as defined by KDIGO guidelines is estimated to amount to between 45,000 and 60,000 patients in the US.2
• Today the majority of these patients are treated principally with supportive care such as generic ACEs and/or ARBs to control blood pressure, complemented with other broadly indicated cardio and kidney protective drugs.
• As availability and familiarity of approved drugs specifically indicated and approved for IgAN increase and physicians consider more active intervention to preserve kidney func- tion, we estimate the global IgAN market will grow to USD 5 - 8 billion.

Our commercial partnerships

Europe

Nefecon® was granted conditional marketing authorisation (CMA) by the European Commission in July 2022, and subsequently by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom in February 2023, under the brand name Kinpeygo® for the treatment of IgAN in adults at

risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) >1.5 g/gram, becoming the first approved treatment for IgAN in the EU. Kinpeygo is marketed in the European Economic Area (EEA), the UK and Switzerland, if approved in this jurisdiction, exclusively by STADA Arzneimittel AG, with whom Calliditas entered into a license agreement in July 2021 to register and commercialize Kinpeygo in Europe. STADA launched Kinpeygo in Germany in September 2022, with additional European countries to follow.

Following the positive data readout from the full NefIgArd trial and the submission of an sNDA to the FDA, Calliditas is collaborating with STADA to seek full approval of Kinpeygo by the European Commission and the MHRA in the full study population. An opinion from the CHMP is expected in the first half of 2024.

Greater China

In 2019, Calliditas entered into a license agreement with Everest Medicines (HKEX 1952.HK) for Everest to develop and commercialize Nefecon for IgAN in Greater China and Singapore. In March 2022, this agreement was expanded to include South Korea.

Everest first launched Nefecon in China's Hainan Boao Pilot Zone as a First-in-Disease therapy for IgA nephropathy in April 2023. This program allows innovative overseas drugs and medical devices that have been approved in other territories to be sold and used in real-world clinical settings in Hainan Province before regulatory approval by the NMPA. Several hundreds of patients signed up for this early access program, making it one of the most successful EAP programs launched in China.

Nefecon® was awarded conditional approval in IgAN by China's National Medical Products Administration (NMPA) in November 2023. Everest launched Nefecon in mainland China in May 2024.

In addition to being approved and commercially launched in Mainland China, Nefecon® has also received approval in Macau, Hong Kong and Singapore, and was successfully commercially launched and first prescribed in Macau at the end of

2023. New Drug Applications (NDA) for Nefecon® were also successfully accepted for review in Taiwan and South Korea at the end of 2023.

China has the highest prevalence of primary glomerular diseases in the world, with an estimated five million IgAN patients. Results from the Chinese subpopulation analysis of the Phase 3 NefIgArd trial, presented at the American Society of Nephrology (ASN) Kidney Week 2023, provided evidence that the treatment effect of Nefecon in the Chinese cohort was greater than in the global data set with regards to kidney function, proteinuria and microhematuria. In the Chinese cohort, the mean absolute change from baseline in eGFR at 24 months showed an approximately 66% reduction in loss of this measure of kidney function with Nefecon compared with a 50% reduction in loss of eGFR in the global data set.

Japan

At the end of 2022, Calliditas entered into a partnership to commercialize Nefecon in Japan with Viatris Pharmaceuticals Japan, a subsidiary of Viatris Inc. (Nasdaq: VTRS).

Viatris is a global healthcare company which is headquartered in the United States and has a presence in over 165 countries.

1Veeva OpenData for 2023, including all active HCPs where the primary specialty is Nephrology 2Spherix RealWorld Dynamix

Calliditas Therapeutics | Interim Report 2024: January - March

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BUSINESS OVERVIEW

TARPEYO: Moving from supportive care to treating IgAN

TARPEYO and Kinpeygo were the first-ever medications approved for IgAN by the FDA and European Commission, respectively, and the only treatments specifically designed to target the origin of IgAN and to be disease-modifying. TARPEYO is the only fully FDA-approved treatment for IgAN and the only treatment approved based on protection of kidney function.

Mechanism of action		Patient focus
Targeted B cell		In combination with
immunomodulator		optimized RASi ther-
designed to local-		apy; option of inter-
ly target origin of		mittent, rather than
disease		chronic treatment

Efficacy		Safety
Durable eGFR benefit		Well characterized
and sustained pro-		active ingredient and
teinuria disease-mod-		safety profile
ifying effects in IgAN

IgAN Patients:

• A genetic predisposition is required but not sufficient; most patients are diagnosed in their 20s and 30s
• More than 50% are at risk of developing ESRD within 10-20 years, leading to kidney transplant
• The treatment goal is to preserve eGFR - kidney function
• Recently published longitudinal data imply that disease progression is faster and outlook worse than previously thought1

1 Pitcher D, Braddon F, Hendry B, et al. Long-Term Outcomes in IgA Nephropathy. Clin J Am Soc Nephrol. 2023;18(6):727-738. doi:10.2215/CJN.000000000000013

Kwon CS, Daniele P, Forsythe A, Ngai C. A Systematic Literature Review of the Epidemiology, Health-Related Quality of Life Impact, and Economic Burden of Immunoglobulin A Nephropathy. J Health Econ Outcomes Res. 2021 Sep 1;8(2):36-45. doi: 10.36469/001c.26129. PMID: 34692885; PMCID: PMC8410133.

Calliditas Therapeutics | Interim Report 2024: January - March

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BUSINESS OVERVIEW

Strong Demand for TARPEYO in Q1

During the first quarter, the Calliditas US team focused on leveraging TARPEYO's full FDA approval and new label to inform and engage nephrology healthcare professionals, payors and patient communities regarding the latest clinical data.

In Q1 2024, TARPEYO set another quarterly record with 705 new patient enrollments, marking a substantial 27% quarter-over- quarter increase, following the 51% quarterly increase seen in

Q4. The increase in new prescribers of 354 was also a quarterly record, which is another clear indicator of market acceptance and demand for TARPEYO. The positive momentum is expected to persist throughout 2024, supported by the new label and indica- tion, further reinforcing TARPEYO's positioning as the backbone treatment option in IgAN.

The Q1 revenue was impacted by two factors: the seasonal effect of the open enrollment period in the US, with insurance changes for many patients, and a cyber-attack on the IT network of our exclusive specialty pharmacy's insurance claims processor in the US, Change Healthcare. The estimated negative impact on Q1 revenues of this unexpected disruption is ~$4.7m, which we anticipate will be recorded over the next several months. Importantly, this does not impact our revenue guidance for 2024. We are also highly encouraged by a strong start to Q2 in terms of TARPEYO net sales, which to the date of this report already amount to approximately $25.5m with an additional 5 weeks remaining in the quarter.

KEY METRICS Q1 2024

705

New Patients enrolled in Q1 27% QoQ growth

QUARTERLY HIGHLIGHTS Q1

New Label Promotional Launch

First and only product FDA-approved to reduce the loss of kidney function.

354

New Prescribers in Q1 LTD Prescribers: 1,993 17% QoQ growth

Patient Educational Webinar with IgAN

Foundation & TARPEYO

Patient Ambassadors.

$26.8M

Net sales of TARPEYO in Q1 2024

4 Presentations at WCN with analysis from NeflgArd

Phase 3 trial and QoL data.

EXCITING JOURNEY AHEAD

Continue US promotional	Drive scientific exchange
efforts to drive TARPEYO´s	and data dissemination at
positioning as a disease	major scientific congress
modifying foundational	and programs (e.g. ERA,
therapy in IgAN.	NKF,ASN).

Leverage KDIGO guidelines expected in 2024.

Educate and inform US payors on the full approval to ensure TARPEYO payor policies are reflecting new label.

Calliditas Therapeutics | Interim Report 2024: January - March

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