Loading...
•
Dec 31, 2021
Tarsus Q4 2021 Earnings Report
Tarsus Pharmaceuticals reported full-year 2021 financial results and business achievements.
Key Takeaways
Tarsus Pharmaceuticals reported a full-year net loss of $13.8 million, with research and development expenses at $41.7 million and general and administrative expenses at $25.4 million. The company's cash, cash equivalents, and marketable securities totaled $171.8 million as of December 31, 2021. They anticipate topline data for the Saturn-2 Phase 3 trial in April 2022 and an NDA submission this year for TP-03.
Completed enrollment in the Saturn-2 Phase 3 trial for TP-03, with topline data expected in April 2022.
Reported positive pivotal Saturn-1 trial results, highlighting TP-03's potential as a standard of care for Demodex blepharitis patients.
Advanced TP-05 into the Callisto Phase 1b trial for Lyme disease prevention, with data expected in the second half of 2022.
Secured a $175 million non-dilutive credit facility and anticipate receiving $30 million in milestones in 2022 from the TP-03 out-license in Greater China.
Tarsus
Tarsus
Forward Guidance
Tarsus Pharmaceuticals anticipates several milestones in 2022, including topline data from the Saturn-2 trial and an NDA submission for TP-03. They also plan to initiate Phase 2 trials for TP-03 and TP-04, and expect Phase 1b data for TP-05.
Positive Outlook
- TP-03 Topline Pivotal Data (Saturn-2) for Demodex blepharitis anticipated in H1 2022
- TP-03 Initiate Phase 2 (Ersa) for Meibomian Gland Disease anticipated in H1 2022
- TP-03 NDA Submission for Demodex blepharitis anticipated in H2 2022
- TP-04 Initiate Phase 2 (Galatea) for Rosacea anticipated in H2 2022
- TP-05 Phase 1b Data (Callisto) for Lyme disease prevention anticipated in H2 2022
Challenges Ahead
- Tarsus has incurred significant losses and negative cash flows from operations since inception and anticipates that it will continue to incur significant expenses and losses for the foreseeable future
- Tarsus may need to obtain additional funding to complete the development and any commercialization of its product candidates, if approved
- Tarsus is heavily dependent on the success of its lead product candidate, TP-03 for the treatment of Demodex blepharitis
- The COVID-19 pandemic may affect Tarsus’ ability to initiate and complete preclinical studies and clinical trials, disrupt regulatory activities, disrupt manufacturing and supply chain or have other adverse effects on Tarsus’ business and operations
- Even if TP-03, TP-05, or any other product candidate that Tarsus develops receives marketing approval, Tarsus may not be successful in educating healthcare professionals and the market about the need for treatments specifically for Demodex blepharitis, Lyme disease, and/or other diseases or conditions targeted by Tarsus’ products