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Immunocore Reports 2022 Financial Results and Provides Business Update KIMMTRAK / tebentafusp net revenues of 42 million ($51 million) in Q4 2022 and 117 million ($141 million) in 2022; approved in over 30 countries and

Key Takeaway: Immunocore has reported its financial results for Q4 2022 and the full year, highlighting KIMMTRAK's impressive net revenues of $142 million. The company continues to expand its clinical trials, including an upcoming IND for a novel therapy targeting PIWIL1. Despite its strong revenue performance and expanding international presence, Immunocore reported a net loss in 2022, reflecting increased expenses in research and development.

Market Sentiment Analysis

POSITIVE FACTORS

  • KIMMTRAK generates significant net revenues with $142 million in 2022.
  • Immunocore's products are approved in over 30 countries, expanding patient access.
  • Strong financial position with $401.6 million in cash provides a runway until 2026.

CONCERNS & RISKS

  • Net loss for 2022 was $49.8 million, indicating ongoing financial challenges.
  • R&D and administrative expenses increased significantly compared to 2021.

Full Press Release Details

Immunocore Reports 2022 Financial Results and Provides Business Update
KIMMTRAK / tebentafusp net revenues of 42 million ($51 million) in Q4 2022 and 117 million ($141 million) in 2022; approved in over 30 countries and nearly 200 patients on global early access
Enrolling IMC-F106C (PRAME-HLA-A02) in monotherapy and combination arms of Phase 1/2 clinical trial and expanding PRAME franchise, including first-in-class PRAME-HLA-A24 target and a PRAME HLA-A02
IND planned for first-in-class ImmTAC targeting PIWIL1 for colorectal and other gastrointestinal cancers in Q4 2023
Completed single ascending dose escalation part of IMC-M113V Phase 1 trial in people living with HIV and presented data at CROI 2023; multiple ascending dose portion of trial is enrolling
Cash and cash equivalents of $401.6 million as of December 31, 2022; cash runway into 2026 with projected KIMMTRAK revenues
Conference call today, March 1st at 8:00 AM ET, 1:00 PM GMT
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 1 March, 2023) Immunocore Holdings plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of
T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious diseases and autoimmune conditions, today announced its financial results for the fourth quarter and year ended December 31,
2022, and provided a business update.
"We are proud that KIMMTRAK, the world's first commercialized TCR therapy, has been approved in over 30 countries for patients with metastatic uveal melanoma. In 2023, we will make it available to even more patients
with launches planned in additional countries and through enrollment of cutaneous melanoma patients into our registrational tebentafusp trial," said Bahija Jallal, Chief Executive Officer of Immunocore. "We
are also focused on progressing our PRAME clinical programs with ongoing expansion arms in multiple tumor types. Our platform continues to deliver first-in-class oncology programs, like PIWIL1, and several infectious disease candidates."
Full Year and Fourth Quarter 2022 Highlights (including post-period)
Total net product and net pre-product revenue (or "net sales") arising from the sales of KIMMTRAK (tebentafusp) were 42.3 million (or $51.1 million) in the fourth quarter of 2022, of which 32.1 million (or $38.8
million) was in the United States, 10.1 million (or $12.2 million) in Europe and 0.1 million (or $0.1 million) in international regions. For the year ended December 31, 2022, the Company generated total revenue from the sale of KIMMTRAK and
tebentafusp in the amount of 116.8 million (or $141.1 million), of which 80.4 million (or $97.2 million) was in the United States, 35.5 million (or $42.9 million) in Europe and 0.9 million (or $1.1 million) in international regions.
R&D expenses for the year 2022 were 89.2 million (or $107.9 million), compared to 73.2 million for the year 2021. Selling and Administrative expenses for the year 2022 were 93.7 million (or $113.2 million),
compared to 88.4 million for the year 2021.
Net loss for the fourth quarter of 2022 was 25.2 million (or $30.4 million) compared to a net loss of 39.4 million in the same period in 2021, and full year net loss for 2022 was 41.24 million (or $49.8 million)
compared to a full year net loss of 131.5 million in 2021.
The fourth quarter basic and diluted loss per share for was $0.63, compared to $1.21 on December 31, 2021. Basic and diluted loss per share for the year ended December 31, 2022 was $1.09, compared to $4.19 for 2021.
Cash and cash equivalents for the year ended December 31, 2022 were 332.5 million (or $401.6 million). The Company's current cash position and projected KIMMTRAK revenue provides a projected cash runway into 2026.
KIMMTRAK (tebentafusp-tebn) for metastatic uveal melanoma
During the fourth quarter of 2022, the Company continued to add new accounts prescribing KIMMTRAK in the United States, Germany, and France. As of December 31, 2022 there were 240 new accounts prescribing KIMMTRAK in
the United States, which brings the capture rate of these accounts, according to the Company's internal estimates, to 50% of potentially eligible patients. There were 100 new accounts prescribing KIMMTRAK in Germany and France, which brings the
capture rate to approximately 80% of the eligible patient population. In the United States, Germany, and France the commercial team is focused on treating patients closer to home. In the three countries where KIMMTRAK is commercially available the
real-world mean duration of treatment for KIMMTRAK continues increasing to the 9 months observed in the Phase 2 and 3 clinical trials.
During the fourth quarter of 2022, the Company received numerous awards and positive recognitions for KIMMTRAK's clinical benefit. In November, the Company was awarded the SCRIP award in the UK in the Best New Drug'
category, and in December, the prestigious Prix Galien France 2022 award in the Medicine in Innovative Therapeutics' category, for KIMMTRAK. KIMMTRAK's clinical benefit to patients was recognized with Germany's G-BA (Gemeinsamer Bundesausschuss)
granting the therapy a considerable added benefit rating, as well as in France, where the HAS transparency committee granted an ASMR III and a SMR rating of important. These recommendations build upon the positive recommendations by American
Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) in the second quarter of 2022. KIMMTRAK was approved by the U.S. Food and Drug Administration; the European Commission; and health authorities in the United
Kingdom, Australia and Canada in the first half of 2022.
The Company is undergoing reimbursement discussions in a number of countries, including Germany and France where the Company is currently receiving revenues. The Company expects reimbursement decisions in one
additional major European country by mid-2023 and up to five smaller countries by end of 2023.
In November 2022, the Company and Medison Pharma Ltd. ("Medison") amended and restated their exclusive distribution agreement for KIMMTRAK originally entered into in September 2021. Medison is the exclusive
distribution partner for KIMMTRAK in Canada, Australia, New Zealand, Israel, Central and Eastern Europe, and following this amendment South and Central America, and the Caribbean.
Tebentafusp Phase 2/3 trial in advanced melanoma
The Company is screening patients in its Phase 2/3 clinical trial of tebentafusp in patients with previously treated advanced melanoma. The trial will enroll patients with advanced melanoma, excluding uveal melanoma,
who have progressed on an anti-PD1, received prior ipilimumab and, if applicable, received a tyrosine kinase inhibitor (TKI). Patients will be randomized to one of three arms including tebentafusp, as monotherapy or in combination with an anti-PD1,
and a control arm. The Phase 2 portion of the trial will include 40 patients per arm and has a dual primary endpoint of overall survival (OS) and circulating tumor DNA (ctDNA) reduction.
IMC-F106C targeting PRAME-A02 in multiple solid tumors
The Company's planned global expansion of the clinical trial footprint for PRAME-A02 studies is underway, with additional patients now being recruited into the Phase 1/2 monotherapy and combination expansion arms in
order to characterize the breadth of clinical activity across multiple tumor types. Initial Phase 1 data with IMC-F106C targeting PRAME (PRAME-A02) was presented at the European Society for Medical Oncology (ESMO) Congress 2022, and the Company
initiated four expansion arms-cutaneous melanoma, ovarian, non-small cell lung cancer (NSCLC), and endometrial cancers. The combinations with standards-of-care (checkpoint inhibitors, chemotherapy, and tebentafusp) will position the Company to
explore IMC-F106C in earlier lines of treatment. The Company expects to report data from the monotherapy and combination arms by the first half of 2024.
Expansion of PRAME franchise: IMC-T119C (PRAME-A24) & IMC-P115C (PRAME-A02 HLE)
In January 2023, the Company revealed the addition of two new PRAME ImmTAC candidates for solid tumors to the pipeline. Building on enthusiasm for IMC-F106C targeting PRAME HLA-A02, the Company has expanded its
franchise targeting PRAME.
IMC-F106C is an ImmTAC targeting PRAME for patients with HLA-A02, which is expressed in approximately 40% of Western populations (United States, Canada, EU). In order to expand the potential of TCR therapy targeting
PRAME, the Company is developing IMC-T119C, a first-in-class ImmTAC product candidate targeting a PRAME peptide presented by HLA-A24. HLA-24 is an HLA-type that is estimated to be present in 60% of people in Japan and 15-20% in Western populations.
In addition, the Company is developing IMC-P115C, a half-life extended (HLE) ImmTAC product candidate targeting PRAME-A02, with the aim of improving patient convenience. IMC-P115C targets the same PRAME-A02 peptide
and uses the same CD3 end and TCR specificity as IMC-F106C.
The Company plans to submit investigational new drug applications (INDs) for these two ImmTAC candidates in 2024.
First-in-class ImmTAC candidate - IMC-R117C (PIWIL1)
In January 2023, the Company announced an ImmTAC targeting a novel protein for colorectal and other gastrointestinal cancers. The Company has leveraged its proprietary peptidomic database to validate a novel target,
PIWIL1. PIWIL1 is believed to play a role in tumor progression and is expressed across a range of tumors including colorectal, which is historically insensitive to immune checkpoints, as well as gastro-esophageal, and pancreatic cancer. PIWIL1 is
also reported to be a negative prognostic marker. The Company believes IMC-R117C is the first PIWIL1 targeted immunotherapy and plans to submit an IND in the fourth quarter of 2023.
IMC-C103C targeting MAGE-A4
In December 2022, the Company presented Phase 1 data for IMC-C103C in a poster presentation at the ESMO Immuno-Oncology 2022 Congress.
In February 2023, Genentech accepted Immunocore's proposal to cease co-funding the development of MAGE-A4 HLA-A02 targeted programs, except for Immunocore's equal share of the wind-down costs of the IMC-C103C Phase 1 clinical trial. The clinical
trial with IMC-C103C is nearing completion and Immunocore does not plan to enroll additional patients. Immunocore is eligible to receive development and commercial milestone payments plus royalties from Genentech on any sales of MAGE-A4 HLA-A02
targeted products arising under the Genentech agreement.
ImmTAV clinical programs
In February 2023, the Company presented initial safety and pharmacodynamic activity data with IMC-C113V, the first soluble TCR therapy for people living with Human Immunodeficiency Virus (HIV), at the Conference on
Retroviruses and Opportunistic Infections (CROI) 2023. IMC-M113V is an immunotherapeutic approach designed to specifically eliminate CD4+ cells that are persistently infected with HIV ( reservoirs'). All doses (1.6 mcg, 5 mcg, and 15 mcg) of
IMC-M113V were well tolerated and not associated with cytokine release syndrome or neurotoxicity of any grade. There were no serious adverse events, nor significant changes in hematology or chemistry. Plasma viral load remained suppressed
throughout dosing and follow-up. In addition, transient, dose-dependent increases in serum IL6 occurred 8-24 hours post-infusion. Five out of the ten participants who received the 15-mcg dose showed a >4-fold rise in IL6, which had been
prespecified as indicative of pharmacodynamic activity based on prior experience from clinical trials with KIMMTRAK.
The Company has started enrolling people living with HIV in the multiple ascending dose (MAD) part of the trial, to identify a safe and tolerable dosing schedule that could lead to reduction in the viral reservoir
and control of HIV after stopping antiretroviral therapies (ART), or functional cure. The MAD trial will enroll up to 28 participants.
In the second quarter of 2022, the Company presented data from the first three patients in the first-in-human clinical trial of IMC-I109V for chronic hepatitis B at the EASL International Liver Congress. In this
first cohort, the three patients received a single dose of 0.8 mcg, based on the minimum anticipated biological effect level (MABEL). The dose in this initial cohort was well tolerated and was not associated with adverse events and resulted in a
transient, small decrease in serum HBsAg with concomitant minor increase in alanine transaminase (ALT). The Company is enrolling patients in the single ascending dose portion of the trial.
Corporate and financial updates
In December 2022, the Company entered into an agreement with Gadeta B.V., to develop the first gamma delta ( ) TCR ImmTAC for solid tumors, including colorectal cancer. Immunocore will collaborate with Gadeta on
201 -TCR target discovery and has an option to develop ImmTAC therapies derived from the 201 TCR as part of the research collaboration.
Basic and diluted loss per share was 0.54 (or $0.63) and 0.90 (or $1.09) for the quarter and year ended December 31, 2022, respectively, as compared to a basic and diluted loss per share of 0.90 and 3.10,
respectively, for the same periods in 2021. Total operating loss for the quarter and year ended December 31, 2022, was 22.3 million (or $27.0 million) and 39.6 million (or $47.8 million), respectively, as compared to 37.8 million and 135.2
million respectively for the same periods in 2021.
For the fourth quarter and year ended December 31, 2022, we generated total revenue from the sale of therapies of 42.3 million ($51.1 million) and 116.8 million ($141.1 million), respectively, due to the sale of
KIMMTRAK and tebentafusp, of which 32.1 million ($38.8 million) and 80.4 million ($97.2 million), respectively was in the United States, 10.1 million ($12.2 million) and 35.5 million ($42.9 million), respectively, was in Europe, and 0.1
million ($0.1 million) and 0.9 million ($1.1 million), respectively, was in the rest of the world. We received marketing approval for KIMMTRAK in the United States, Europe and other territories in the year ended December 31, 2022, and did not have
marketing approval for, and thus no product revenue from, KIMMTRAK in the year ended December 31, 2021.
For the fourth quarter and year ended December 31, 2022, our research and development ("R&D") expenses were 27.1 ($32.8 million) and 89.2 million (or $107.9 million), respectively as compared to 20.1 million
and 73.2 million for the quarter and year ended December 31, 2021. These increases were due to increased expenses in connection with our IMC-F106C program and increased headcount and laboratory costs. The Company expects R&D expenses to
increase in future periods as the Company advances its trials and further develops clinical and preclinical pipeline candidates.
For the quarter and year ended December 31, 2022, our selling and administrative expenses were 43.1 million ($52.1 million) and 93.7 million (or $113.2 million), respectively, compared to 24.4 million and 88.4
million for the quarter and year ended December 31, 2021. These increases were related to higher selling and distribution costs following regulatory approval of KIMMTRAK and an increase in headcount costs (excluding share-based payment charges,
which reduced in 2022). Our administrative expenses also increased in the fourth quarter of 2022 due to approximately $15 million of non-cash foreign exchange losses, primarily on U.S. dollar balances.
Cash and cash equivalents were 332.5 million (or $401.6 million) as of December 31, 2022, as compared to 237.9 million (or $321.1 million) as of December 31, 2021. We expect that our existing cash, along with
anticipated revenue from KIMMTRAK, will be sufficient to fund our planned operating expenses, financial commitments and other cash requirements into 2026.
We maintain our books and records in pounds sterling. For the convenience of the reader, we have translated pound sterling amounts as of and for the period ended December 31, 2022 into U.S.
dollars at a rate of 1.00 to $1.2077.
Immunocore will host a conference call today, March 1, 2023 at 8:00 A.M. ET/ 1:00 PM GMT, to discuss the fourth quarter and full year 2022 financial results and provide a business update. The call will also be
available via webcast by visiting the Events & Presentations section on Immunocore's website. A replay of this webcast will be available for 30 days.
Conference Call Details:
U.S. (toll-free): 877-405-1239
International (toll): +1 201-389-0851
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule

Frequently Asked Questions

What were Immunocore's 2022 KIMMTRAK revenues?

KIMMTRAK generated net revenues of $141 million in 2022.

How many countries approved KIMMTRAK?

KIMMTRAK has been approved in over 30 countries.

When is the IND planned for ImmTAC targeting PIWIL1?

The IND is planned for Q4 2023.

What is the current cash position of Immunocore?

Immunocore has cash and equivalents of $401.6 million.

What new trials is Immunocore expanding?

Immunocore is expanding trials for IMC-F106C targeting PRAME.

Last updated: Mar 1, 2023