• Net Product Sales: $5.6 million for Ohtuvayre in the third quarter.
• Cost of Goods Sold: $500,000 for the quarter ended September 30, 2024.
• Research and Development Costs: $10.6 million for the quarter, up from $3 million in Q3 2023.
• Selling, General and Administrative Expenses: $35.2 million for the quarter, compared to $13.4 million in Q3 2023.
• Net Loss After Tax: $43 million for the quarter, compared to $14.7 million in Q3 2023.
• Loss Per Share: $0.07 per ordinary share or $0.53 per ADS for the quarter.
• Cash and Equivalents: $336 million as of September 30, 2024.

• Warning! GuruFocus has detected 2 Warning Sign with VRNA.

Release Date: November 04, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Verona Pharma PLC (NASDAQ:VRNA) successfully launched Ohtuvayre in the US for COPD treatment, achieving net product sales of $5.6 million in just seven weeks.
• Over 5,000 Ohtuvayre prescriptions were filled within 12 weeks, with more than 2,200 unique healthcare providers prescribing the medication.
• Ohtuvayre is being prescribed across a broad range of COPD patients, including those on single, dual, and triple therapy, indicating its wide acceptance and potential impact.
• The company initiated two new Phase II clinical programs, expanding its pipeline and potential future offerings.
• Verona Pharma PLC (NASDAQ:VRNA) maintains a strong financial position with $336 million in cash and equivalents, providing a runway through at least the end of 2026.

Negative Points

• The company reported a net loss of $43 million for the third quarter, a significant increase from the $14.7 million loss in the same period in 2023.
• Research and development costs rose to $10.6 million, driven by increased clinical trial expenses, impacting overall financial performance.
• Selling, general, and administrative expenses increased substantially to $35.2 million, reflecting higher people-related costs and marketing expenses.
• Despite the strong launch, Verona Pharma PLC (NASDAQ:VRNA) did not provide specific guidance for the fourth quarter, creating uncertainty about future financial performance.
• The commercialization of Ohtuvayre faces potential competition from other COPD treatments, such as Dupixent, which could impact market penetration.

Q & A Highlights

Q: Does the October net sales exceeding Q3 indicate a run rate of at least $17 million for the fourth quarter? Are there any factors like holiday periods or patient dropouts that could affect this? A: We are not providing specific guidance for Q4, but we don't foresee any slowdown in patient numbers or interest. We expect the acceleration in Ohtuvayre's use to continue, driven by strong demand and positive feedback from physicians and patients. - David Zaccardelli, CEO

Q: Can you disclose how many unique patients have been prescribed Ohtuvayre as of October? A: The majority of the over 5,000 prescriptions filled are for unique patients. Refills have started, and patient adds are increasing week-over-week. We expect this trend to continue. - David Zaccardelli, CEO

Q: Are there any emerging prescriber trends regarding combination regimens with ensifentrine? A: Prescribing is broad across single, dual, and triple therapy patients, with no specific preference for certain combinations. Nearly 50% of prescriptions are for patients on triple therapy, reflecting the high unmet need in this group. - David Zaccardelli, CEO

Q: How is the infrastructure for patient access to Ohtuvayre performing? A: Our infrastructure is working well, with a significant majority of the 5,000 dispensed scripts being paid transactions. We are seeing positive trends in payer access, consistent with our launch assumptions. - Christopher Martin, CCO

Q: Do you expect any headwinds from the recent approval of Dupixent in the COPD market? A: Dupixent targets a narrow patient population, and we don't see it impacting Ohtuvayre's commercialization. Ohtuvayre addresses a broader unmet need, and its unique mechanism could complement other treatments like Dupixent. - David Zaccardelli, CEO

For the complete transcript of the earnings call, please refer to the full earnings call transcript.