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Sep 30, 2022
Lexicon Pharmaceuticals Q3 2022 Earnings Report
Reported financial results for the third quarter of 2022 and provided a business update.
Key Takeaways
Lexicon Pharmaceuticals reported a net loss of $23.4 million for Q3 2022, with R&D expenses decreasing and SG&A expenses increasing compared to the same period in 2021. The NDA for sotagliflozin remains on track for a May 2023 PDUFA date.
FDA mid-cycle review meeting held for sotagliflozin NDA for heart failure, remains on track for May 2023 PDUFA date.
Data for sotagliflozin presented at American Heart Association Scientific Sessions 2022, showing reduced cardiovascular mortality and hospital readmissions.
Final data from RELIEF-DPN-1 study of LX9211 in painful diabetic neuropathy to be presented at the 16th Annual Pain Therapeutics Summit.
Enrollment completed in RELIEF-PHN-1 study of LX9211 in post-herpetic neuralgia, with top-line data expected before year-end.
Lexicon Pharmaceuticals
Lexicon Pharmaceuticals
Forward Guidance
Lexicon is focused on the clinical development and regulatory filings for sotagliflozin and LX9211, as well as the discovery and development of other potential drug candidates.
Positive Outlook
- Sotagliflozin NDA remains on track for May 2023 PDUFA date.
- Positive data presented for sotagliflozin at medical conferences.
- Final data from RELIEF-DPN-1 study of LX9211 to be presented.
- Enrollment completed in RELIEF-PHN-1 study of LX9211.
- Lexicon has a pipeline of promising drug candidates in development.
Challenges Ahead
- Lexicon's ability to meet its capital requirements.
- Successfully conduct preclinical and clinical development of drug candidates.
- Obtain necessary regulatory approvals of drug candidates on anticipated timelines.
- Successfully commercialize any products for which it obtains regulatory approval.
- Achieve its operational objectives.