Corporate Presentation
March 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, 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 and forecasts 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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A commercial stage biopharma company focused on novel treatments in orphan indications, with an initial focus on
renal and hepatic diseases with significant unmet needs
- Pioneers in immunoglobulin A nephropathy (IgAN)
- Positive Phase 2b results published in The Lancet
- Successful top-line data read out from the ongoing Phase 3 NefIgArd trial in November 2020
- Both clinical trials met primary and key secondary endpoints
- Dec 2021 the first and only FDA approved medication for IgAN, launched Jan 2022
- Jul 2022 the first and only EC approved medication for IgAN, launched Sept 2022
- Strong pipeline in orphan liver and kidney indications; platform of first-in-class NOX Inhibitors
- Actively expanding through in-licensing and/or acquisition of product candidates
Headquartered: Stockholm
OMX NASDAQ (CALTX)
Exchange
NASDAQ (CALT)
Key Institutional Shareholders
BVF Capital
Linc
Polar Capital
Sofinnova Partners
Cash (31/12/22): SEK 1,249m (~$119m)
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Financial Overview - Key Takeaways from 2022; significant growth!
- Total revenues of SEK 802.9 million ($79.3m) for the year of 2022 - 250% growth year over year
- TARPEYO net sales for 2022 amounted to $36.8m (SEK 372.2 million) for initial 11 months of commercialization
- Operating expense for the year amounted to SEK 1,210 M
- Positive Q4 cash flow from operations of SEK 230 M driven by partner payments and TARPEYO sales.
- Calliditas is well funded with a cash position of SEK 1,249 M as of end of December.
- we believe that we are, based on our guidance for TARPEYO, funded to profitability and well prepared to capitalize on growth and opportunities in 2023.
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Our Pipeline
Preclinical
Phase 1
Phase 2
Phase 3
Marketed
Rights
Commercial
Region
Upcoming Milestones
IgAN | * | United States |
IgAN | Europe, UK, | |
Switzerland | ||
NEFECON | China, HK, Macau, | |
IgAN | ||
Taiwan, Singapore, | ||
S. Korea | ||
IgAN | Japan |
PBC
SCCHN
SETANAXIB
IPF
Alport
Mid March target for top line data readout of Part B of NefIgArd study
NDA accepted and FTD received in China. Decision expected in 2H 2023
Q2 2023: Trial Launch
Commercial: | Ongoing Trial: | Planned Trial: | Investigator Led Trial: |
- Approved under accelerated approval in the USA under the tradename TARPEYO. TARPEYOTM (budesonide) delayed release capsules is a prescription medicine used to reduce levels of protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at high risk of rapid disease progression, generally UPCR ≥ 1.5g/g
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Calliditas Therapeutics AB published this content on 07 March 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 07 March 2023 14:03:04 UTC.