Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Phathom Pharmaceuticals Inc (PHAT, Financial) successfully launched VOQUEZNA for non-erosive GERD, achieving significant market penetration with over 143,000 prescriptions filled since launch.
- The company secured FDA approval for VOQUEZNA as a treatment for non-erosive GERD, expanding its addressable market to approximately 22 million U.S. adults.
- Phathom Pharmaceuticals Inc (PHAT) achieved over 80% commercial coverage for VOQUEZNA, with inclusion in major formularies like CVS Caremark, enhancing accessibility and affordability for patients.
- The company raised $130 million in equity financing, strengthening its balance sheet and signaling investor confidence in VOQUEZNA's market potential.
- VOQUEZNA has received positive feedback from physicians and patients, with increasing brand awareness and recognition in the marketplace, including multiple industry awards for innovation.
Negative Points
- Phathom Pharmaceuticals Inc (PHAT) reported a net loss of $67.9 million for the third quarter of 2024, reflecting ongoing financial challenges.
- The company is still early in its launch phase and has not provided financial guidance for projected revenues or earnings, indicating uncertainty in future financial performance.
- There is potential volatility in gross-to-net discount rates, which could impact financial results, especially with changes in health plans and deductibles in the upcoming quarters.
- The company faces risks related to regulatory exclusivity and is engaged in discussions with the FDA regarding the Orange Book listing, which could affect market exclusivity timelines.
- Despite progress, Phathom Pharmaceuticals Inc (PHAT) acknowledges that it is still in the early stages of growth for VOQUEZNA, with significant work needed to fully capitalize on its market opportunity.
Q & A Highlights
Q: Your coverage uptake was impressively rapid. To what extent is the increased prescriptions from actual access versus the uptick from the non-erosive GERD indications? Also, what percent of prescriptions is now 60 days?
A: The growth is a mixture of both increased access and demand tied to the launch of non-erosive GERD. The 10 mg dose saw an immediate rise, indicating demand for non-erosive GERD. Most prescriptions are written for 30 days, with some for 60 or 90 days, driven by health plans and physician preferences.
Q: Can you update us on the status of your gain application for VOQUEZNA monotherapy and the exclusivity reflected in the Orange Book?
A: We are engaged in discussions with the FDA regarding the Orange Book listing. We believe VOQUEZNA should have 10 years of NCA exclusivity, protecting it from generic entries until 2032. We are evaluating the best path forward to ensure this is reflected in the Orange Book.
Q: Can you comment on what you're seeing in terms of overall refill rates compared to prescription PPIs?
A: We are seeing a large increase in new writers, indicating healthy business growth. For those who have started writing, they are doing so more frequently. Persistency is strong, with refill rates reflecting what is typically seen in the PPI prescription market.
Q: How should we think about the duration of therapy and compliance? Also, any comments on gross to net discount evolution, especially in Q1 next year?
A: We are tracking persistency, and it aligns with the PPI market, with days of therapy between 141-160 annually. The gross to net discount is within the expected 50%-65% range. We anticipate some volatility in Q1 due to plan changes and deductible resets but expect to stay within this range.
Q: Are there any observations from the H Pylori side of the label, and has there been any change in prescriber engagement for standard of care?
A: H Pylori is important, and its treatment demonstrates VOQUEZNA's potent acid suppression. Some patients may transition to non-erosive GERD treatment post-eradication. Physicians are adopting VOQUEZNA as their preferred treatment for H Pylori, appreciating its differentiation.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
