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Dec 31, 2020
Rhythm Pharmaceuticals Q4 2020 Earnings Report
Reported financial results for the fourth quarter and full year ended December 31, 2020, and provided a business update.
Key Takeaways
Rhythm Pharmaceuticals reported its Q4 and full-year 2020 financial results, highlighting the FDA approval of IMCIVREE™ and positive topline data from a Phase 3 trial. The company is well-funded to advance setmelanotide's development and commercialization.
Received FDA approval of IMCIVREE™ (setmelanotide) for chronic weight management in patients with obesity due to POMC, PCSK1 or LEPR deficiency.
Announced positive topline data from Phase 3 pivotal trial evaluating setmelanotide in Bardet-Biedl and Alström syndromes.
Announced data from five cohorts in Phase 2 Basket Study demonstrating proof-of-concept in HET POMC, PCSK1 or LEPR deficiencies, and obesity due to SRC1 and SH2B1 deficiencies.
Strengthened financial position with net proceeds of $98.5M from sale of Rare Pediatric Disease PRV and $161.6M from public offering, extending cash runway through at least the second half of 2023.
Forward Guidance
Rhythm expects to achieve key commercial, regulatory, and clinical milestones in 2021, including making IMCIVREE commercially available in the United States and Europe, completing regulatory submissions for setmelanotide in BBS, and initiating new clinical trials.
Positive Outlook
- Make IMCIVREE commercially available in the United States for obesity due to POMC, PCSK1 and LEPR deficiencies in the first quarter of 2021.
- Obtain regulatory approval from the European Commission and make IMCIVREE commercially available in Europe in POMC, PCSK1 and LEPR deficiency obesities in the second half of 2021.
- Complete regulatory submissions to both the FDA and the EMA seeking marketing authorization for setmelanotide for the treatment of obesity in patient with BBS in the second half of 2021.
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