Interim Report Q2, 2023: Calliditas Therapeutics
- Calliditas has filed for full approval of TARPEYO, which could positively impact the stock price. The company expects significant revenue growth in the US, with estimated net sales of USD 100-120 million for 2023.
- None.
Filing for full approval of TARPEYO
FINANCIAL SUMMARY FOR THE GROUP
Key Figures
April 1 - June 30, 2023
- Net sales amounted to
SEK 269.4 million , of which TARPEYO® net sales amounted toSEK 259.2 million , for the three months ended June 30, 2023. For the three months ended June 30, 2022, net sales amounted toSEK 64.0 million , of which TARPEYO net sales amounted toSEK 63.6 million . - Operating loss amounted to
SEK 75.2 million andSEK 209.8 million for the three months ended June 30, 2023, and 2022, respectively. - Loss per share before and after dilution amounted to
SEK 1.71 andSEK 3.62 for the three months ended June 30, 2023, and 2022, respectively. - Cash amounted to
SEK 866.2 million andSEK 846.8 million as of June 30, 2023, and 2022, respectively.
January 1 - June 30, 2023
- Net sales amounted to
SEK 460.7 million , of which TARPEYO net sales amounted toSEK 444.9 million , for the six months ended June 30, 2023. For the six months ended June 30, 2022, net sales amounted toSEK 113.8 million , of which TARPEYO net sales amounted toSEK 81.6 million . - Operating loss amounted to
SEK 255.2 million andSEK 418.2 million for the six months ended June 30, 2023, and 2022, respectively. - Loss per share before and after dilution amounted to
SEK 5.21 andSEK 7.57 for the six months ended June 30, 2023, and 2022, respectively.
Significant Events in Q2 2023, in Summary
- In June 2023, Calliditas had two oral presentations and two abstracts reflecting top line data and analyses from the NeflgArd Phase 3 Study, evaluating Nefecon® (TARPEYO® (budesonide) delayed release capsules/Kinpeygo®) in patients with IgA nephropathy (IgAN), at the European Renal Association (ERA) Congress in
Milan, Italy . - In June 2023, Calliditas announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking full approval of TARPEYO (budesonide) delayed release capsules (developed under the project name Nefecon) for the entire study population evaluated in the Phase 3 NeflgArd study. The sNDA submission was based on the full data set from the Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study which assessed the efficacy and safety of Nefecon dosed at 16 mg once daily versus placebo on a background of optimized RASi therapy in adult patients with primary IgAN. The trial met its primary endpoint of kidney function, with Nefecon demonstrating a highly statistically significant benefit over placebo (p value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year period of 9 months of treatment with Nefecon or placebo and 15 months of follow-up off drug.
Key Takeaways:
- Late breaking data from the Phase 3 NefIgArd study presented at the ERA EDTA Conference in June 2023.
- sNDA submitted to the FDA in June 2023 for full approval in the entire study population of NefIgArd.
- In August Calliditas Therapeutics announced full results from the NefIgArd Phase 3 trial published in The Lancet.
Updated 2023 Outlook
For 2023, Calliditas expects revenue growth in the US where: Net sales from TARPEYO are estimated to be
Investor Presentation August 17, 2023, 14:30 CET
Audio cast with teleconference, Q2 2023
Webcast: https://ir.financialhearings.com/calliditas-therapeutics-q2-2023
Teleconference: SWE +46 (8) 525 07 003, US +1 774 450 99 00,
For further information, please contact:
Åsa Hillsten, Head of Investor Relations, Calliditas
Phone.: +46 764 03 35 43, E mail: asa.hillsten@calliditas.com
The information is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Market Act. The information was sent for publication, through the agency of the contact person set out above, on August 17, 2023, at 7:00 a.m. CET.
About Calliditas
Calliditas Therapeutics is a commercial stage biopharma company based in
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 Calliditas' strategy, commercialization efforts, business plans, regulatory submissions, clinical development plans, revenue and product sales projections or forecasts 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 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, 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 or forecasts, including 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:
Q2_2023_Calliditas_ENG | |
https://mb.cision.com/Public/16574/3818917/8a11e8b30d37e817.pdf | Q2 2023 PR ENG |
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SOURCE Calliditas Therapeutics
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