Calliditas Q1 report, January - March 2024

Rhea-AI Summary

Calliditas Therapeutics reported significant growth in Q1 2024 compared to Q1 2023. Net sales increased to SEK 295.5 million, with TARPEYO® contributing SEK 278.3 million. The company faced an operating loss of SEK 203.8 million and a loss per share of SEK 4.59. Cash reserves decreased to SEK 810.3 million from SEK 1,013.6 million. Key achievements include a 27% increase in enrollments, a new TARPEYO patent valid until 2043, and FDA's orphan drug exclusivity until 2030. Despite a USD 4.7 million revenue impact due to a cyberattack, future revenue is expected to remain stable. Upcoming events include European Commission decisions and Phase 2 trial results.

Positive

• Net sales increased to SEK 295.5 million in Q1 2024, up from SEK 191.4 million in Q1 2023.
• TARPEYO® net sales grew to SEK 278.3 million from SEK 185.7 million year-over-year.
• Record quarter with 705 enrollments, a 27% increase over Q4.
• New patent for TARPEYO valid until 2043 was issued by USPTO.
• FDA granted a seven-year orphan drug exclusivity for TARPEYO until December 2030.
• Positive preliminary net sales for Q2 amounting to USD 25.5 million.
• Positive results from Nefecon Phase 3 extension trial and setanaxib Phase 2 trial.
• Commercial launch of Nefecon in China by partner Everest Medicines.

Negative

• Operating loss increased to SEK 203.8 million in Q1 2024 from SEK 180.1 million in Q1 2023.
• Loss per share rose to SEK 4.59 from SEK 3.49 year-over-year.
• Cash reserves decreased to SEK 810.3 million from SEK 1,013.6 million as of March 31, 2024.
• Negative impact on TARPEYO revenues by approximately USD 4.7 million due to a cyberattack.

Insights

Financial Analyst

Financial Performance: Calliditas' net sales for Q1 2024 are SEK 295.5 million, a notable increase from SEK 191.4 million in Q1 2023. This represents a 54% year-over-year growth. The company's flagship product, TARPEYO, made up a significant portion of these sales, demonstrating its importance to Calliditas' revenue stream. However, it's critical to highlight the operating loss which increased from SEK 180.1 million in Q1 2023 to SEK 203.8 million in Q1 2024. This indicates higher expenses which, without further detail, could be attributed to increased marketing or R&D costs. The loss per share also widened from SEK 3.49 to SEK 4.59, reflecting these increased costs and the potential dilution effect. Although the revenue growth is promising, the increasing losses should be monitored closely.

Cash Reserves: The cash balance dropped from SEK 1,013.6 million in March 2023 to SEK 810.3 million in March 2024. This decline could be due to operating losses or investments in growth initiatives. Maintaining a healthy cash reserve is essential for sustaining operations, particularly in high-growth phases. Investors should watch for any signs of cash burn acceleration which might necessitate additional capital raising.

Rating: 0

Market Research Analyst

Market Expansion: The expansion of TARPEYO’s market with a new US patent and FDA orphan drug exclusivity is significant. The patent protection until 2043 provides a long-term competitive edge, reducing the threat of generic competition. The orphan drug exclusivity till 2030 adds another layer of market protection, potentially leading to premium pricing and exclusive marketing rights. These factors can drive sustained revenue from TARPEYO, providing a robust growth outlook.

Enrollment and Prescriber Growth: The record 27% increase in enrollments and the addition of 354 new prescribers indicate strong market acceptance and expanding physician endorsement. These metrics are critical for long-term growth as they suggest increasing market penetration and demand.

Rating: 1

Medical Research Analyst

Clinical Trial Results: The positive outcomes from the Nefecon Open label Phase 3 extension trial and the setanaxib Phase 2 trial in head and neck cancer are promising. Successful trial results are important for further FDA approvals, which can open new revenue streams and expand the market share. For instance, positive Phase 2 results often lead to larger Phase 3 trials and eventual market approval, increasing the product pipeline's potential.

Implications of Upcoming Events: The upcoming European Commission decision regarding Kinpeygo's full approval could significantly impact European market dynamics. Full approval would enhance the product’s credibility and accessibility across Europe, boosting sales. Additionally, the updated KDIGO guidelines might influence clinical practices and therefore prescription patterns, potentially favoring Calliditas products if included favorably.

Cyberattack Impact: The reported USD 4.7 million negative impact on quarterly revenues due to a cyberattack is a concerning vulnerability. However, the company's assurance that these revenues will be captured in the subsequent quarters mitigates immediate concerns. Still, the event stresses the need for robust cybersecurity measures, especially in healthcare sectors dealing with sensitive data.

Rating: 1

STOCKHOLM, May 23, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALTX) (STOCKHOLM: CALTX):

Target market expansion following full approval in the US

JANUARY - MARCH 2024 (COMPARED TO JANUARY - MARCH 2023)

• Net sales amounted to SEK 295.5 million, of which TARPEYO® net sales amounted to SEK 278.3 million, for the three months ended March 31, 2024. For the three months ended March 31, 2023, net sales amounted to SEK 191.4 million, of which TARPEYO net sales amounted to SEK 185.7 million.
• Operating loss amounted to SEK 203.8 million and SEK 180.1 million for the three months ended March 31, 2024, and 2023, respectively.
• Loss per share before and after dilution amounted to SEK 4.59 and SEK 3.49 for the three months ended March 31, 2024, and 2023, respectively.
• Cash amounted to SEK 810.3 million and SEK 1,013.6 million as of March 31, 2024, and 2023, respectively.

"In Q1 we generated another record quarter in terms of demand with 705 enrollments and 354 new prescribers. We are very excited over this positive trend, and we continue to see strong demand in Q2." - CEO Renée Aguiar-Lucander.

KEY TAKEAWAYS FROM Q1, 2024                             

• Calliditas had a record quarter with 705 enrollments, representing a 27% increase over Q4.
• In February, the United States Patent and Trademark Office (USPTO) issued patent no. 11896719, entitled "New Pharmaceutical Compositions". This was Calliditas' second patent for TARPEYO in the United States and provides product protection until 2043.
•  In March, the FDA granted an orphan drug exclusivity period of seven years for TARPEYO®, expiring in December 2030, based on when the company obtained full approval with a new indication for this drug product.
• There was a negative impact on net TARPEYO revenues in the quarter of approximately USD 4.7 million due to a cyberattack on Change Health. The revenues we were not able to record in Q1 because of this technical issue are not lost, but are expected to roll forward over the next several months. This is not expected to have any impact on annual revenues.

KEY EVENTS AFTER THE REPORTING PERIOD                                   

• Preliminary net sales from TARPEYO for the second quarter to date amounts to USD 25.5 million.
• Positive read out of the Nefecon Open label Phase 3 extension trial. 
• Positive topline results from the setanaxib Phase 2 trial in head and neck cancer. 
• Commercial launch of Nefecon in China by partner Everest Medicines.

KEY EVENTS UPCOMING 6 MONTHS                                    

• European Commission decision regarding a potential full approval for Kinpeygo for Calliditas' partner STADA.
• Full data read out of Phase 2 trial in Primary Biliary Cholangitis.
• Updated KDIGO guidelines expected in 2024.

Outlook for 2024: Unchanged

Calliditas expects continued revenue growth:

Total net sales from the Nefecon franchise, including milestones, are estimated to be USD 150-180 million for the year ending December 31, 2024.

Investor Presentation:

May 23, 2024 14:30 CET

Link to webcast: Calliditas Therapeutics Q1 Report 2024 (financialhearings.com)

To participate via conference call register via this link:  Call Access (financialhearings.com)

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 report 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 May 23, 2024, at 7:00 a.m. CET.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/calliditas-therapeutics/r/calliditas-q1-report--january---march-2024,c3986496

The following files are available for download:

https://mb.cision.com/Main/16574/3986496/2816066.pdf	Q1 2024 Calliditas ENG
https://mb.cision.com/Public/16574/3986496/8e28fb584e477801.pdf	Q1 Press Release - ENG

 

View original content:https://www.prnewswire.com/news-releases/calliditas-q1-report-january--march-2024-302153820.html

SOURCE Calliditas Therapeutics

FAQ

What were Calliditas Therapeutics' net sales for Q1 2024?

Net sales for Q1 2024 were SEK 295.5 million, with TARPEYO® contributing SEK 278.3 million.

What was Calliditas Therapeutics' operating loss in Q1 2024?

The operating loss for Q1 2024 was SEK 203.8 million.

What was Calliditas Therapeutics' loss per share in Q1 2024?

The loss per share for Q1 2024 was SEK 4.59.

How much did Calliditas Therapeutics' cash reserves decrease in Q1 2024?

Cash reserves decreased to SEK 810.3 million from SEK 1,013.6 million.

What was the impact of the cyberattack on Calliditas Therapeutics' TARPEYO revenues in Q1 2024?

The cyberattack negatively impacted TARPEYO revenues by approximately USD 4.7 million.

What are the key achievements of Calliditas Therapeutics in Q1 2024?

Key achievements include a new TARPEYO patent valid until 2043, FDA orphan drug exclusivity until 2030, and a 27% increase in enrollments.

What are the expected upcoming events for Calliditas Therapeutics?

Upcoming events include the European Commission's decision on Kinpeygo approval and full data readout of the Phase 2 trial in Primary Biliary Cholangitis.