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Jun 30, 2023
Tarsus Q2 2023 Earnings Report
Tarsus reported a net loss for Q2 2023, alongside the FDA approval of XDEMVY and progress in clinical trials.
Key Takeaways
Tarsus Pharmaceuticals reported a net loss of $31.4 million for the second quarter of 2023, compared to a net loss of $5.7 million for the same period in 2022. The company achieved FDA approval for XDEMVY for Demodex blepharitis and completed enrollment in a Phase 2a trial for Rosacea.
XDEMVY (lotilaner ophthalmic solution) 0.25% received FDA approval for the treatment of Demodex blepharitis.
On track to have XDEMVY and sales force in market by the end of August 2023.
Completed enrollment of Galatea, a Phase 2a trial evaluating TP-04 for Rosacea, with topline data expected in 1H 2024.
Strengthened balance sheet with $100 million public equity offering in August 2023.
Tarsus
Tarsus
Forward Guidance
Tarsus anticipates launching XDEMVY later in August 2023, expects rapid adoption among eye care providers, and foresees meaningful prescription volume in the early days following XDEMVY’s entrance into the market.
Positive Outlook
- FDA approval of XDEMVY for the treatment of Demodex blepharitis.
- First and only approved therapeutic for DB, a highly prevalent eyelid disease that impacts approximately 25 million eye care patients in the U.S.
- Actively engaging in contracting discussions with all the top commercial and Medicare accounts and expect to secure commercial coverage sequentially throughout 2024 and Medicare coverage in 2025
- Established unique distribution model leveraging high touch retail and digital pharmacies to offer broad patient access with a potential 2x fill rate compared to traditional approaches
- Active disease education continuing to drive awareness and encouraging eye care providers (ECPs) to proactively diagnose DB
Challenges Ahead
- 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
- Tarsus may need to obtain additional funding to complete the development and commercialization of its product candidates, if approved
- Tarsus is heavily dependent on the success of its lead product, XDEMVY for the treatment of Demodex blepharitis
- the development and commercialization of Tarsus products is dependent on intellectual property it licenses from Elanco Tiergesundheit AG
- the sizes of the market opportunity for Tarsus’ product candidates, particularly XDEMVY for the treatment of Demodex blepharitis, TP-03 for the treatment of MGD, TP-04 for the treatment of Rosacea, as well as TP-05 for the prevention of Lyme disease, have not been established with precision and may be smaller than estimated