Immunocore Holdings Plc
Immunocore Holdings Plc Q2 FY2022 earnings call
August 10, 2022 · fiscal period ended 2022-06
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2022-08-10
Management highlights
Commercial Launch - The commercial team has executed well: KIMMTRAK launched strongly in the U.S., with EU approval in February, followed by launches in Germany, France, U.K., Australia, and Canada. Year-to-date revenue from KIMMTRAK is over $45 million. - Reimbursement efforts are ongoing, with progress in the U.S. and Europe, and plans to expand to additional European countries in 2023 and 2024. ### Pipeline - Expanding KIMMTRAK beyond uveal melanoma: Presented data in cutaneous melanoma at ASCO with promising 1-year survival, and initiated a registrational Phase II/III trial in melanoma excluding uveal melanoma. - PRAME and MAGE-A4 programs: PRAME Phase I data to be presented at ESMO in September, and MAGE-A4 Phase I dose escalation continues. - Infectious Disease Programs: First patient dosed in HIV functional cure program, and early HBV data presented at EASL. ### Financial Runway - Secured $140 million PIPE transaction, resulting in an adjusted cash position of $393 million, solidifying financial runway through 2025.
Segment performance
In the second quarter of 2022, Immunocore reported total net revenue of $33.7 million. The U.S. contributed $22.1 million in KIMMTRAK sales, and Europe added $7.1 million. Year-to-date, revenue from KIMMTRAK exceeds $45 million. KIMMTRAK's commercial launch has been strong, with approvals in the EU, U.K., Australia, and Canada, and it has generated significant revenue as it continues to reach new patients.
Guidance
Financial - Expect product revenue primarily from U.S., Germany, and France in 2022. - Development costs are expected to increase in 2023 as the clinical development portfolio expands. ### Pipeline - To present PRAME Phase I data as an oral presentation at ESMO in September. - To present an update on MAGE-A4 data in the fourth quarter. - First patient dosed in HIV functional cure program. - Capital from PIPE to fund the company through 2025 and into 2026.
Risks
No specific risks explicitly detailed in the transcript, but general biotech risks such as clinical trial uncertainties, regulatory approval challenges, and market adoption risks apply.
Q&A highlights
Q: On the commercial front, although early in launch, do you expect steady growth in following quarters beyond EAP people, and on pipeline, framing expectations for PRAME given it's an active target?
A: Ralph Torbay noted it's too early to comment on commercial growth as launch is in early stages, but expects team to continue good work; David Berman stated PRAME is a good target with platform showing durable benefit, tumor shrinkage, and ctDNA reduction, and data will be shared at ESMO.
Q: In the U.S., how many legacy EAP patients were still on KIMMTRAK at end of 2Q, and directional on treatment duration?
A: Ralph Torbay said 40% of KIMMTRAK patients are in first line, discontinuations are in line with expectations, but too early to comment definitively on duration.
Q: On cutaneous melanoma trial design, does 1-year survival benefit analysis separate more, and impact of control arm?
A: David Berman said historical 1-year survival is lower for the patient population, and control arm patients can be enrolled in other trials, not expected to impact study powering.
Q: European KIMMTRAK launches in 2023-2024 and HBV program details?
A: Ralph Torbay said launches depend on reimbursement negotiations, and David Berman discussed HBV program markers observed, unexpected surface antigen change, and program combinable with other therapies.
Q: Patterns between first-line or second-line KIMMTRAK treated patients?
A: Ralph Torbay noted second-line patients tend to be sicker, focus is on establishing KIMMTRAK as first-line standard of care.
Q: Expectations for PRAME data at ESMO and modality differentiation?
A: David Berman highlighted platform differentiation with validated survival benefit, durable benefit, rapid onset of effect, and good safety profile, and PRAME data to be shared in a month.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-0.17 | $-0.72 | +76.4% | — |
| Revenue | $38.8M | $25.5M | +52.5% | — |
Transcript
August 10, 2022Full transcript unavailable for redistribution
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