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Calliditas Therapeutics provides business update ahead of JP Morgan conference

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Calliditas Therapeutics AB (CALT) provided a business update for the fourth quarter of 2023, reporting strong Q4 preliminary product revenue growth with net TARPEYO revenues of $31 – 33m for the quarter, representing significant growth over Q3. Preliminary Net TARPEYO revenues of $100 – 102m for 2023, representing over 170% year over year growth compared to 2022. Preliminary Total revenues reaching $110 – 113m for 2023, as a result of milestone payments and royalty income from the Nefecon franchise outside the US. The company also achieved a record quarter in terms of enrollments with 555 new TARPEYO prescriptions in the 4th quarter.
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Insights

The reported preliminary revenue figures for Calliditas Therapeutics AB indicate a robust performance, particularly in the fourth quarter of 2023. The substantial year-over-year growth of over 170% in net TARPEYO revenues is a strong signal for investors, reflecting the company's ability to scale its commercial operations effectively. The growth trajectory is impressive, especially considering it is only the second year of commercialization for their product.

From a financial perspective, the growth in product revenue, complemented by milestone payments and royalty income, suggests a diversifying revenue stream, which could be appealing to investors seeking companies with multiple income sources. It's important to note that these figures are preliminary and unaudited, which means they are subject to change upon finalization of financial statements. However, the double-digit million-dollar range in revenue growth points towards a positive trend that could impact the company's valuation and investor sentiment.

Calliditas Therapeutics' performance in the rare disease market appears to be gaining significant momentum, as evidenced by the record number of new TARPEYO prescriptions. The rare disease space is known for high barriers to entry due to the need for specialized research and development, but it offers substantial rewards for companies that successfully navigate these challenges. The reported increase in enrollments suggests that TARPEYO is gaining traction among prescribers and patients, which is crucial for sustained long-term growth.

Understanding the market dynamics, such as the competitive landscape, pricing strategies and reimbursement policies, is essential for projecting the future market performance of TARPEYO. The preliminary data provided indicates that Calliditas may be effectively capitalizing on its market strategy, which could lead to increased market share and further revenue growth. Stakeholders will be interested in the company's ability to maintain this growth and expand its market presence in the coming years.

The impressive growth in TARPEYO prescriptions suggests that Calliditas' product is meeting a significant unmet need within the rare disease community. This could indicate that the efficacy and safety profile of TARPEYO aligns well with patient and clinician expectations, which is a critical factor in the adoption of new therapies. For stakeholders, the underlying data on patient outcomes, as well as any ongoing clinical trials, will be key determinants in assessing the long-term potential of TARPEYO.

Furthermore, the milestone payments and royalty income from the Nefecon franchise outside the US highlight the potential for international expansion and the value of global partnerships. As the company continues to navigate regulatory environments and seeks approvals in various markets, the ability to leverage such partnerships will be instrumental in driving global growth and mitigating risks associated with market concentration.

STOCKHOLM, Jan. 8, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas"), a commercial biopharma company focused on rare diseases today provided a business update for the fourth quarter of 2023 and certain preliminary, unaudited key financial information for the fourth quarter and full year 2023, as follows:

  • Strong Q4 preliminary product revenue growth with net TARPEYO revenues of $31 – 33m for the quarter, representing significant growth over Q3.
  • Preliminary Net TARPEYO revenues of $100 – 102m for 2023, representing over 170% year over year growth compared to 2022.
  • Preliminary Total revenues reaching $110 – 113m for 2023, as a result of milestone payments and royalty income from the Nefecon franchise outside the US.  
  • Record quarter in terms of enrollments with 555 new TARPEYO prescriptions in the 4th quarter.

The information above reflects our preliminary estimates with respect to such results based on currently available information. We have provided ranges, rather than specific amounts, for the preliminary results described above primarily because our financial closing procedures are not yet complete and, as a result, our final results may vary from the preliminary estimates.

"We are very pleased with the preliminary outcome of the 2023 fiscal year, generating product sales in excess of $100 million in our second year of commercialisation. This is a very strong result and we are very excited about 2024 based on the recent full approval of TARPEYO in the US, strengthened product protection and the record growth seen in enrollments in Q4. This result, in combination with our successful debt refinancing and strengthening our US leadership team, puts us in an optimal position to drive growth and profitability in 2024 and build a high growth, durable franchise in the rare disease space." said CEO Renée Aguiar-Lucander. 

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 persons set out above, on January 8, 2024 at 8.15 am CET.

The above unaudited, estimated results for the quarter and year ended December 31, 2023 are preliminary financial information, remain subject to completion, and were prepared by management based upon estimates, a number of assumptions and currently available information, and are subject to revision based upon, among other things, quarter-end closing procedures and/or adjustments, the completion of our financial statements and other operational procedures. Our actual results could be materially different from this preliminary financial information, which should not be regarded as a representation by us as to our actual results for the quarter and year ended December 31, 2023. In addition, our independent registered public accounting firm has not audited, reviewed, compiled or performed any procedures with respect to this preliminary financial information and does not express an opinion or any other form of assurance with respect to this preliminary financial information. During the course of the preparation of our financial statements and related notes as of and for the quarter and year ended December 31, 2023, we may identify items that would require us to make material adjustments to this preliminary financial information.

About Calliditas

Calliditas Therapeutics is a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan indications with significant unmet medical needs. Calliditas' common shares are listed on Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT). Visit Calliditas.com for further information.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the development of Calliditas' pipeline. 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 press release 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 press release, including, without limitation, any related to Calliditas' business, operations, clinical trials, intellectual property of the NEFECON franchise globally, competition from other companies, pipeline development, revenue and product sales projections or forecasts, 2023 revenue guidance  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 press release represent Calliditas' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

 

The following files are available for download:

https://mb.cision.com/Main/16574/3905241/2525263.pdf

Preannouncement_JPM ENG

 

Cision View original content:https://www.prnewswire.com/news-releases/calliditas-therapeutics-provides-business-update-ahead-of-jp-morgan-conference-302028160.html

SOURCE Calliditas Therapeutics

FAQ

What was Calliditas Therapeutics AB's business update for the fourth quarter of 2023?

Calliditas Therapeutics AB reported strong Q4 preliminary product revenue growth with net TARPEYO revenues of $31 – 33m for the quarter, representing significant growth over Q3.

What were the preliminary Net TARPEYO revenues for 2023?

Preliminary Net TARPEYO revenues of $100 – 102m for 2023, representing over 170% year over year growth compared to 2022.

What were the preliminary Total revenues for 2023?

Preliminary Total revenues reached $110 – 113m for 2023, as a result of milestone payments and royalty income from the Nefecon franchise outside the US.

How many new TARPEYO prescriptions were enrolled in the 4th quarter of 2023?

Calliditas Therapeutics AB achieved a record quarter in terms of enrollments with 555 new TARPEYO prescriptions in the 4th quarter of 2023.

Calliditas Therapeutics AB American Depositary Shares

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