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Dec 31, 2022
Tarsus Q4 2022 Earnings Report
Reported full-year 2022 financial results and recent business achievements.
Key Takeaways
Tarsus Pharmaceuticals reported full-year 2022 financial results, including TP-03 out-license revenue for greater China territory of $25.8 million and a net loss of $62.1 million. The company highlighted the acceptance of the NDA for TP-03 for Demodex blepharitis by the FDA with a PDUFA target action date of August 25, 2023, and the advancement of its pipeline with Phase 2 trials in rosacea and planned Phase 2a data readouts.
NDA for TP-03 for the treatment of Demodex blepharitis accepted by the FDA with a PDUFA target action date of August 25, 2023.
Launched an Awareness, Trial and Usage (ATU) market research survey of optometrists and ophthalmologists, with over 90% indicating they would prescribe an FDA approved therapeutic for Demodex blepharitis.
Engaged and educated more than two-thirds of target Eye Care Practitioners (ECPs) on the disease, identification and diagnosis of Demodex blepharitis.
Completed enrollment of Ersa, a Phase 2a trial evaluating TP-03 for MGD with topline data expected in 2H 2023 and initiated Galatea Phase 2a trial evaluating TP-04 for Rosacea.
Tarsus
Tarsus
Forward Guidance
Tarsus Pharmaceuticals anticipates several clinical and regulatory milestones in 2023, including the potential approval and launch of TP-03 for Demodex blepharitis, topline Phase 2a data for TP-05 in Lyme disease prevention, initiation of Phase 2b for TP-05, and topline Phase 2a data for TP-03 in Meibomian Gland Disease. The company's cash runway is anticipated into at least the second half of 2026.
Positive Outlook
- Potential approval and launch of TP-03 for Demodex blepharitis.
- Topline Phase 2a data for TP-05 in Lyme disease prevention.
- Initiation of Phase 2b for TP-05 in Lyme disease prevention.
- Topline Phase 2a data for TP-03 in Meibomian Gland Disease.
- Cash runway anticipated into at least the second half of 2026.
Challenges Ahead
- Significant losses and negative cash flows from operations since inception are expected to continue.
- Dependence on the success of TP-03 for the treatment of Demodex blepharitis.
- Potential impact of the COVID-19 pandemic on clinical trials and business operations.
- Risk that Tarsus may not be successful in educating healthcare professionals about the need for treatments specifically for Demodex blepharitis, MGD, rosacea, and Lyme disease prevention.
- The sizes of the market opportunity for Tarsus’ product candidates have not been established with precision and may be smaller than estimated.