Calliditas Year-end report, January - December 2023

Rhea-AI Summary

Calliditas Therapeutics AB (CALT) achieved full approval for TARPEYO in the US in 2023, marking a successful year. Net sales and operating income increased in Q4 2023 compared to Q4 2022. Cash decreased, but net sales and TARPEYO sales saw significant growth in 2023. The company anticipates revenue growth in 2024.

Positive

• 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

Negative

• None.

Financial Analyst

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.

Medical Research Analyst

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.

Market Research Analyst

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.

STOCKHOLM, Feb. 21, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq Stockholm: CALTX)

2023: Full approval for TARPEYO in the US; a year of successes

OCTOBER – DECEMBER 2023 (COMPARED TO OCTOBER – DECEMBER 2022)                           Net sales amounted to SEK 451.6 million, of which TARPEYO® net sales amounted to SEK 347.3 million, for the three months ended December 31, 2023. For the three months ended December 31, 2022, net sales amounted to SEK 429.0 million, of which TARPEYO net sales amounted to SEK 167.3 million. Operating income amounted to SEK 41.8 million and SEK 32.5 million for the three months ended December 31, 2023, and 2022, respectively. Loss per share before and after dilution amounted to SEK 0.34 and SEK 0.07 for the three months ended December 31, 2023, and 2022, respectively. Cash amounted to SEK 973.7 million and SEK 1,249.1 million as of December 31, 2023, and 2022, respectively.

JANUARY – DECEMBER 2023 (COMPARED TO JANUARY –DECEMBER 2022)              Net sales amounted to SEK 1,206.9 million, of which TARPEYO net sales amounted to SEK 1,075.8 million, for the year ended December 31, 2023. For the year ended December 31, 2022, net sales amounted to SEK 802.9 million, of which TARPEYO net sales amounted to SEK 372.2 million. Operating loss amounted to SEK 373.1 million and SEK 421.9 million for the year ended December 31, 2023, and 2022, respectively. Loss per share before and after dilution amounted to SEK 8.69 and SEK 7.78 for the year ended December 31, 2023, and 2022, respectively. For the year ended December 31, 2023, no dividend is proposed.

"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

In November, Calliditas' partner Everest Medicines announced that China's National Medical Products Administration (NMPA) had approved Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. In November, Calliditas announced the initiation of a Phase 2 clinical study to evaluate setanaxib in Alport syndrome. In December, Calliditas received approval (Notice of Allowance) regarding a US patent application for TARPEYO®. In the first quarter of 2024, notice was issued regarding the patent, which provides patent in the US through 2043. In December, the United States (US) Food and Drug Administration (FDA) granted Calliditas full approval of TARPEYO® for reduction of kidney loss in adult IgAN patients at risk of disease progression.

Read out of the Nefecon Open label Phase 3 extension trial, which will provide data on retreatment with Nefecon. The transfer of the Marketing Authorization Holder (MAH) approval to Everest Medicines and commercial launch of Nefecon in China. European Commission decision regarding a potential full approval for Kinpeygo for Calliditas' partner STADA. Full data read out of the setanaxib Phase 2 trial in head and neck cancer.

OUTLOOK FOR 2024

Calliditas expects continued revenue growth:

Total net sales are estimated to be USD 150-180 million for the year ending December 31, 2024

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:

https://mb.cision.com/Main/16574/3932653/2618214.pdf	Calliditas interim report Q4 2023_ENG
https://mb.cision.com/Public/16574/3932653/b208fe02f5312ac1.pdf	Q4 Press Release - ENG

 

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SOURCE Calliditas Therapeutics

What was the net sales for TARPEYO in Q4 2023 compared to Q4 2022?

In Q4 2023, TARPEYO net sales amounted to SEK 347.3 million, compared to SEK 167.3 million in Q4 2022.

What was the operating income for Q4 2023 and Q4 2022?

Operating income amounted to SEK 41.8 million in Q4 2023 and SEK 32.5 million in Q4 2022.

What was the cash amount as of December 31, 2023, compared to December 31, 2022?

Cash amounted to SEK 973.7 million on December 31, 2023, and SEK 1,249.1 million on December 31, 2022.

What was the net sales for TARPEYO in 2023 compared to 2022?

In 2023, TARPEYO net sales amounted to SEK 1,075.8 million, compared to SEK 372.2 million in 2022.

What is the outlook for total net sales in 2024?

Calliditas expects total net sales to be USD 150-180 million for the year ending December 31, 2024.