• Net Sales: $146 million in the first half of 2024, a 34% increase year-over-year.
• Q2 Net Revenues: $75.3 million, a 7% increase from Q1.
• US Market Growth: 11% growth in Q2 compared to Q1.
• Market Share: Approximately 65% market share in the US for KIMMTRAK.
• Net Loss: $36.1 million for the first half of 2024, or $0.72 per share.
• Cash and Marketable Securities: $860 million as of June 30, 2024.
• SG&A and R&D Expenses: Increased 31% in the first half of 2024 compared to the same period in 2023.

• Warning! GuruFocus has detected 3 Warning Signs with IMCR.

Release Date: August 08, 2024

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

Positive Points

• Immunocore Holdings PLC (NASDAQ:IMCR) reported a 34% increase in net sales for the first half of 2024, driven by strong US performance.
• The company has successfully launched KIMMTRAK in 19 countries, expanding its global footprint.
• IMCR is pursuing label expansion for KIMMTRAK in late-line cutaneous melanoma and adjuvant uveal melanoma, potentially benefiting up to 6,000 patients.
• The company is advancing nine clinical programs, including three Phase 3 trials, showcasing a robust pipeline.
• IMCR's AI-enabled patient finding tool has improved patient identification in lower density community centers, enhancing market penetration without increasing field force.

Negative Points

• The reimbursement environment in Europe remains challenging, impacting revenue growth and requiring increased rebate reserves.
• Despite strong US sales, European demand for KIMMTRAK flattened in Q2, with a decline in net revenues due to increased rebate reserves.
• R&D and SG&A expenses increased by 31% in the first half of 2024 compared to the same period in 2023.
• The company faces uncertainties in the HIV program, with ongoing dose escalation and a need for more data to confirm biological activity.
• IMCR's growth in Europe is expected to be incremental, with significant challenges in market access and reimbursement negotiations.

Q & A Highlights

Q: Can you explain the $6.7 million reserve adjustment in Europe for KIMMTRAK and its impact on future quarters? A: Ralph Torbay, SVP Commercial, explained that the reserve adjustment was based on the latest assumptions from negotiations, primarily with France and Germany. It is expected to be a one-time adjustment, and future adjustments should not simply add the $6.7 million as it involves both backward and forward-looking erosion.

Q: Could you expand on the HIV program and the decision to enroll more patients at a higher dose? A: David Berman, EVP Research & Development, stated that the HIV program is in the dose escalation phase, reaching up to 300 micrograms. They see evidence of biological activity, which is promising given the low target density in this setting. More patients will be enrolled to better characterize the activity and explore higher doses.

Q: What are the expectations for the ovarian cancer update at ESMO? A: David Berman noted that the update will include a similar number of patients as the melanoma dataset at ASCO, with a focus on monotherapy and some combination data. The key questions are around monotherapy activity, combinability with intended partners, and confidence in meeting registrational endpoints.

Q: What is the potential market ceiling for KIMMTRAK in uveal melanoma? A: Ralph Torbay mentioned that while the US market shows strong growth, the European market faces challenges. The potential for label expansions through ongoing trials could significantly increase the patient base, potentially benefiting up to 6,000 patients.

Q: How do you see the competitive landscape for uveal melanoma evolving, and what gives you confidence in KIMMTRAK's continued success? A: David Berman highlighted KIMMTRAK's established global standard of care status in the metastatic setting and the well-designed ATOM trial for adjuvant settings. The AI-enabled patient finder tool is also helping to identify patients in low-density areas, supporting commercial efforts.

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