Calliditas Year-end report, January - December 2023
- Full approval for TARPEYO in the US in 2023
- Net sales increased in Q4 2023 compared to Q4 2022
- Operating income rose in Q4 2023
- Significant growth in net sales and TARPEYO sales in 2023
- Expected revenue growth in 2024
- None.
Insights
The financial results of Calliditas Therapeutics AB, particularly the significant increase in TARPEYO® net sales from SEK 167.3 million in Q4 2022 to SEK 347.3 million in Q4 2023, indicate a robust market acceptance and an effective commercialization strategy. The year-over-year growth, with net sales jumping from SEK 802.9 million in 2022 to SEK 1,206.9 million in 2023, demonstrates a strong revenue trajectory. However, despite the revenue growth, the company reported an operating loss, although reduced from SEK 421.9 million in 2022 to SEK 373.1 million in 2023. This suggests that the company is still in an investment phase, focusing on expanding its market reach and product development. The loss per share has increased year-over-year, which could be a point of concern for shareholders and potential investors. The cash position has decreased, signaling significant cash burn that is common in biotech firms during periods of growth and product rollout. The lack of dividend proposal aligns with the company's stage of reinvestment for growth. Stakeholders should monitor the company's ability to manage expenses and achieve profitability.
The full approval of TARPEYO® by the FDA for reducing kidney loss in adult patients with IgAN marks a pivotal milestone in Calliditas Therapeutics' development. IgAN, being a rare disease with limited treatment options, represents a significant market opportunity for Calliditas. The Notice of Allowance for a US patent that extends through 2043 strengthens the company's intellectual property position and could be a substantial barrier to entry for competitors. The upcoming readout of the Nefecon Open label Phase 3 extension trial will be crucial in understanding the long-term efficacy and safety of the treatment, which could further solidify TARPEYO®'s market position. Additionally, the initiation of a Phase 2 clinical study for setanaxib in Alport syndrome and the full data readout of the setanaxib trial in head and neck cancer could diversify the company's portfolio and open new revenue streams. The transfer of the MAH approval to Everest Medicines and the commercial launch of Nefecon in China is a strategic move to tap into the Asian market, potentially increasing global revenue.
The projected total net sales for 2024, estimated between USD 150-180 million, reflect Calliditas Therapeutics' optimistic outlook and confidence in continued revenue growth. The company's strategic partnerships, such as with Everest Medicines for the commercialization of Nefecon in China and STADA for Kinpeygo, could play a critical role in expanding its global footprint. The European Commission's decision on Kinpeygo's full approval will be a key event to watch, as it could significantly impact the company's market presence in Europe. The successful commercialization of TARPEYO® in the US and potential approvals in other regions are likely to drive investor interest. However, investors should be mindful of the inherent risks associated with the biopharmaceutical industry, including regulatory hurdles, market competition and the execution of commercialization strategies. The upcoming investor presentation and conference call could provide valuable insights into the company's future plans and address investor queries.
2023: Full approval for TARPEYO in the US; a year of successes
OCTOBER – DECEMBER 2023
| JANUARY – DECEMBER 2023
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"In December we were granted full approval by the FDA for TARPEYO - a crowning achievement after many years of striving to bring an approved disease modifying treatment to patients with primary IgAN."
CEO Renée Aguiar-Lucander
KEY TAKEAWAYS FROM Q4, 2023 | EXPECTED KEY EVENTS UPCOMING 6 MONTHS |
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OUTLOOK FOR 2024
Calliditas expects continued revenue growth:
Total net sales are estimated to be
INVESTOR PRESENTATION
February 21, 2024, 14:30 CET
Link to webcast: https://ir.financialhearings.com/calliditas-therapeutics-q4-report-2023
To participate via conference call register via this link: https://conference.financialhearings.com/teleconference/?id=50046870
For further information, please contact:
Åsa Hillsten, Head of IR & Sustainability, Calliditas
Tel.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com
The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact person set out above, on February 21, 2024, at 07:00 a.m. CET.
The following files are available for download:
Calliditas interim report Q4 2023_ENG | |
https://mb.cision.com/Public/16574/3932653/b208fe02f5312ac1.pdf | Q4 Press Release - ENG |
View original content:https://www.prnewswire.com/news-releases/calliditas-year-end-report-january--december-2023-302066984.html
SOURCE Calliditas Therapeutics
FAQ
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