Calliditas Therapeutics : March 13, 2023 NefIgArd topline data - presentation (Presentation)

Nef-301

Summary of Full Phase 3 Trial Results

March 13, 2023

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, planned regulatory submissions, anticipated regulatory approvals and clinical development plans, timing and data readouts. 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, competitive products, clinical trials, supply chain, strategy, goals and anticipated timelines 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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(Inker et al 2019)

Primary endpoint successfully met in Phase 3 NefIgArd study

Beneficial eGFR treatment effect observed, irrespective of UPCR baseline. Primary endpoint achieved - highly statistically significant with p-value<0.0001

Supportive eGFR slope analyses over 2 years highly statistically significant. All estimates well in excess of the difference per year in 2 year eGFR total slope required to predict clinically meaningful treatment effects on the composite endpoint of ESRD, eGFR<15 mL/min/1.73 m2 or sustained doubling of serum creatinine

A single treatment course of 9 months slowed the loss of kidney function by 50% compared to placebo at 24 months

UPCR effect of 30%+ reduction shown to be durable for the entire 15 month follow up period, with maximum effect observed at 12 months (three months after final dose)

The Company believes that the dataset is supportive of filing for full regulatory approval for entire study population

3 This presentation is an investor communication and is not intended for promotional purposes

NefIgArd study design

Screening	Part A	Part B
9 months	3 month	12 months
on drug	follow-up	observation
	off drug	off drug

		TARPEYO
Verify optimized &		16 mg/day
stable RAS
blockade		Placebo

Optimized RAS inhibition

Base inclusion criteria:

• Biopsy proven IgAN; > 1 gram of proteinuria; > 35 eGFR < 90 ml/min 36o patients, including 200 from Part A
• Patients were required to have well-controlled blood pressure of <140/90 mmHg to enter into the study, to ensure no BP confounding effects on proteinuria reduction.
• No immunosuppressive drugs were permitted during the study; changes to anti-hypertensive medications were discouraged.

Part A

• 200 patients in 19 countries with >145 sites
• Primary endpoint: proteinuria
  Key secondary endpoint: eGFR
• Read out positive data in November 2020

Part B

• Post approval follow up trial design
• • confirm the long-term renal benefit of observed proteinuria reduction
• 360 patients, including 200 from Part A
• Primary endpoint: difference in kidney function as measured by eGFR over the 2-year period
• Read out positive data in March 2023

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Disposition, Demographics and Baseline Characteristics