Immunocore Holdings Plc
Immunocore Holdings Plc Q4 FY2022 earnings call
March 1, 2023 · fiscal period ended 2022-12
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2023-03-01
Management highlights
- KIMMTRAK is a landmark approval for unresectable or metastatic uveal melanoma, with over 500 patients treated since Phase 3 trial end and revenues over $140 million in 2022. - Q4 2022 net revenue was $51.1 million, up 25% from Q3. - Research and development teams made progress: tebentafusp is in Phase 2/3 trial for advanced melanoma; PRAME-A02 therapy showed RECIST responses, reduction in circulating tumor DNA, and durability of response at ESMO; announced 3 new pipeline candidates. - Commercial team focused on KIMMTRAK launch: over 100 accounts in Germany and France treating patients; aim to launch in more countries and make KIMMTRAK available to more patients.
Segment performance
In 2022, Immunocore's key segment was KIMMTRAK. KIMMTRAK generated over $140 million in revenue in 2022. In Q4 2022, net revenue was $51.1 million, a 25% quarter-over-quarter increase. KIMMTRAK is the first and only approved treatment for unresectable or metastatic uveal melanoma, approved in over 30 countries, and over 500 patients have been treated since the end of the Phase 3 trial.
Guidance
- In Europe, expect formal reimbursement agreement in Germany and France, and launch KIMMTRAK in one major European country midyear and up to 5 additional countries by year-end. - In the U.S., focus on increasing new community oncology accounts. - Continue clinical development: expand PRAME-A02 Phase 1/2 trial footprint across multiple tumor types and in combination with standards of care; enroll in cutaneous melanoma registrational program.
Risks
- CMS may request a rebate of portion of CMS sales for KIMMTRAK starting in Q4 2023. - Currency fluctuations, such as the $50 million currency loss on U.S. dollar reserves translated back to British pounds affecting SG&A expenses.
Q&A highlights
Q: On the KIMMTRAK sales in U.S., could you help understand the underlying demand in Q4 and growth rate in 2023?
A: Together, onetime stocking and gross to net adjustments contributed about $5 million. U.S. growth expected to be slower in 2023 as moving into community growth and another month of German discount in Q1.
Q: For PRAME, how do you think about the bar for lung cancer data?
A: Look for evidence of activity like ctDNA reductions and confidence in RECIST endpoint for response rate or PFS.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-0.63 | $-0.00 | -185194.1% | — |
| Revenue | $59.1M | $62.5M | -5.4% | — |
Transcript
March 1, 2023Full transcript unavailable for redistribution
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