Calliditas Therapeutics : February 21, 2024 Year-end report 2023 (Presentation)

Q4 2023 REPORT

February 21, 2024

Disclaimers

Important information

This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended,

including, without limitation, statements regarding Calliditas' strategy, commercialization efforts, business plans, regulatory submissions, clinical

development plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this presentation are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this presentation, including, without limitation,

any related to Calliditas' business, operations, continued and additional regulatory approvals for TARPEYO and Kinpeygo, market acceptance of

TARPEYO and Kinpeygo, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, revenue and product sales projections or forecasts, including 2024 revenue guidance, cash runway and other risks identified in the section entitled "Risk Factors" in Calliditas' reports filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements

contained in this presentation represent Calliditas' views only as of the date hereof and should not be relied upon as representing its views as of

any subsequent date.

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Q4 Highlights

On December 20th the FDA granted full approval of TARPEYO based on the submission of the full Phase 3 data set in June of 2023. The Phase 3 trial showed a highly statistically significant outcome on the primary endpoint of eGFR (p< 0.0001). Additional supportive data; slope analysis of 3ml/min/year in favour of TARPEYO versus placebo and statistically significant impact on microhaematuria and biomarkers such as IgA1

The new indication; reduction of loss of kidney function is now also indicated for the entire IgAN population at risk of disease progression.

Conditional approval of Nefecon in China was granted in November, providing access to a very large market opportunity where IgAN is not a rare disease, with estimates of up to 5 million patients.

Initiation of a Phase 2 trial in Alport syndrome in November, 2023 with setanaxib, a rare kidney disease for which there today is no approved medication.

The US PTO issued a Notice of Allowance for a new patent covering TARPEYO until 2043 on December 11th

Refinancing of existing credit line with Athyrium Capital LP on December 27th

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Commercial Highlights

Q4 saw record enrolment growth, quarter over quarter, with a 51% increase in enrolments over Q3. New prescribers also grew by 53% in Q4 over Q3, reflecting an improved familiarity with, and increased understanding of, the disease modifying potential of TARPEYO

Total revenues of SEK 452 M for the 4th quarter (USD 42.4M), out of which TARPEYO net sales represented SEK 347 M (USD 32.6M), reflecting a 22% growth over Q3 2023 and a 108% growth over Q4 2022.

Positive operating cashflow in the quarter; communicated target achieved

Expecting some initial disconnect between new US label and market access rules due to P&T committee processes - typical seasonality in Q1 also expected

Potential full EMA approval of Kinpeygo in 1st half 2024, providing impetus for continued European commercial growth

Targeted commercial launch in Q2 of 2024 in China

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Post period events

Patent covering TAREPYO

January 24th - patent issued February 13th - patent becomes valid

February 16th - FDA Orange Book is updated for TARPEYO, adding US 11,896,719

Maria Törnsen appointed as President of North America

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Key Events in 2023 - A successful year!

Successful readout of NefIgArd Phase 3 clinical study; p> 0.0001; filing for full approval with the FDA 3 months after read out

Filing for full approval of Kinpeygo with EMA

Phase 3 data published in The Lancet

Interim readout of setanaxib data from Head and Neck cancer study - exciting data

China conditional approval for Nefecon granted

Notice of Allowance for TARPEYO patent until 2043

Full approval of TARPEYO by the FDA - First and Only

Product revenues of over $100m achieved in first full year of commercialization

CATEGORY LEADER IN A GROWING MARKET!

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CMO Richard Philipson

Calliditas Recent Scientific Communications

CALLIDITAS HAD A STRONG PRESENCE AT KIDNEY WEEK, A CONFERENCE ORGANISED BY ASN (AMERICAN SOCIETY OF NEPHROLOGY) IN NOVEMBER OF 2023:

American Society of Nephrology Annual Meeting, Philadelphia; 2 - 5th November 2023 7 abstracts and presentations

Select scientific communications

• 30% reduction in eGFR or kidney failure
• Prediction of Long-term Clinical Benefit of Nefecon in a Real-World IgAN population
• Suppression of IgAN circulating autoimmune complexes

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Time to 30% reduction in eGFR or kidney failure in NefIgArd Trial

Time to 30% reduction in eGFR* or kidney failure was a secondary endpoint in the NefIgArd trial

The time to this composite endpoint was significantly delayed with Nefecon vs placebo

• Nefecon 16 mg/day versus placebo: HR 0.45 (95% CI 0.26, 0.75), p=0.0014 (1-sided)†

In a post hoc analysis‡, the Nefecon treatment effect on the risk of 30% reduction in eGFR or kidney failure was consistent, irrespective of baseline UPCR

*A 30% reduction in eGFR was confirmed by two values over ≥4 weeks. To prevent informative censoring, death from a renal-related event, patients who experienced dialysis for at least 1 month, kidney transplantation or kidney failure (defined as a sustained eGFR <15 mL/min/1.73 m2 prior to a 30% reduction) were included as having had a clinical event occurring at that time.

† In an IPCW analysis, patients who received rescue medication or other prohibited immunosuppressive medications were censored at the time of their last eGFR measurement before receiving the medication. ‡Post hoc analysis using a standard Cox model. CI, confidence interval; eGFR, estimated glomerular filtration rate; HR, hazard ratio; IPCW, inverse probability of censoring weights.

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Prediction of Long-term Clinical Benefit of Nefecon in a Real-world IgAN Population

eGFR total slope from the NefIgArd trial was used to calculate a hazard ratio (HR) for the clinical outcome, using the Inker meta-analysis1

• HR = 0.38 (95% CI 0.21, 0.63)

A matched registry cohort receiving supportive care only was used to generate a reference time to event curve

In comparison to this matched reference cohort, using the calculated HR of 0.38, the median delay to clinical outcome attributed to Nefecon was 12.8 years (95% CI 4.8, 27.9)

There was a relative reduction of approximately 50% in the proportion of patients expected to have a clinical outcome event within 10 years (24% vs 52%, Nefecon vs placebo)

1 Inker LA, et al. J Am Soc Nephrol 2019;30:1735-1745

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