Immunocore reports fourth quarter and full year 2023 financial results and provides a business update
KIMMTRAK (tebentafusp) net revenues of $67.6 million in Q4 2023 and $238.7 million in 2023; increasing commercial access to KIMMTRAK globally, and pursuing future growth opportunities with two registrational trials in advanced cutaneous melanoma and adjuvant uveal melanoma
Clinical trial collaboration and supply agreement with Bristol Myers Squibb to evaluate IMC-F106C (PRAME HLA-A02) with nivolumab in registrational Phase 3 first-line advanced cutaneous melanoma trial; PRISM-MEL301 trial to start in 1Q 2024
Multiple clinical readouts expected to start in 2Q 2024 for IMC-F106C from Phase 1/2 clinical trial monotherapy and combination arms; CTA/IND submission for IMC-P115C (PRAME HLA-A02 HLE) and
IMC-T119C (PRAME HLA-A24) programs on track for 2024
IMC-R117C, a first-in-class ImmTAC targeting PIWIL1, to begin Phase 1 trial in colorectal and other gastrointestinal cancers in 2H 2024
Data from IMC-M113V Phase 1 clinical trial in people living with HIV expected in 2H 2024
Advancing novel TCR bispecific clinical candidates for autoimmune diseases
Cash and cash equivalents of $442.6 million as of December 31, 2023; subsequent February 2024 Convertible Senior Notes offering adds $389.3 million net proceeds
Conference call today, February 28th at 8:00 AM ET, 1:00 PM GMT
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 28 February 2024) Immunocore Holdings plc (NASDAQ:IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, today announced its financial results for the fourth quarter and year ended December 31, 2023 and provided a business update.
“In the last 5 years, Immunocore has transformed from a research organization to a revenue-generating, sustainable company,” said Bahija Jallal, CEO of Immunocore. “We look forward to the next 5 years, when we maximize the potential of KIMMTRAK, expect to launch our PRAME ImmTAC therapy, and advance our clinical candidates across oncology, infectious diseases and autoimmune diseases.”
“Throughout the last year, we expanded the reach of KIMMTRAK in metastatic uveal melanoma with additional approvals, launches, and sales growth across all territories,” said Ralph Torbay, Head of Commercial. “We believe KIMMTRAK, the world’s first approved TCR therapy, could benefit thousands more patients and look forward to broadening indications with ongoing late-stage clinical trials in cutaneous and adjuvant uveal melanoma.”
Full Year and Fourth Quarter 2023 Highlights (including post-period)
Financial Results
Total net product revenue (or “net sales) arising from the sales of KIMMTRAK (tebentafusp) was $67.6 million in the fourth quarter of 2023, of which $49.1 million was generated in the United States, $18.3 million in Europe and $0.2 million in international regions. For the year ended December 31, 2023, the Company generated net sales from the sale of KIMMTRAK in the amount of $238.7 million, of which $169.8 million was in the United States, $67.6 million in Europe and $1.3 million in international regions.
Research & development expenses for the year 2023 were $163.5 million, compared to $101.9 million for the year 2022. Selling, general and administrative (SG&A) expenses for the year 2023 were $144.5 million, compared to $123.1 million for the year 2022.
Net loss for the fourth quarter of 2023 was $19.7 million compared to a net loss of $30.0 million in the same period in 2022, and full year net loss for 2023 was $55.3 million compared to a full year net loss of $52.5 million in 2022.
The fourth quarter basic and diluted loss per share was $0.40, compared to $0.64 for the fourth quarter of 2022. Basic and diluted loss per share for 2023 was $1.13, compared to $1.15 for 2022.
Cash and cash equivalents at December 31, 2023 were $442.6 million. In February 2024, the Company raised net cash proceeds of $389.3 million from an offering of convertible notes with a six-year term and 2.50% interest rate (Convertible Notes).
KIMMTRAK expansion strategy
KIMMTRAK® (tebentafusp-tebn) for metastatic uveal melanoma
Since the start of the 2024, KIMMTRAK has been launched in two additional countries (Australia and Canada), for a total of 12 launched and 38 approved countries. KIMMTRAK continues to be the standard of care for HLA-A02+ patients with metastatic uveal melanoma (mUM) in all of the countries in which it has been launched. In 2024, the Company plans to reach more patients in the United States, Europe and globally, as it continues to drive global launches and focuses on supporting early patient identification and treatment.
KIMMTRAK Phase 2/3 clinical trial in 2L+ advanced cutaneous melanoma
The Company also continues to enroll patients into a Phase 2/3 clinical trial (TEBE-AM) to investigate the potential of KIMMTRAK in 2L+ advanced cutaneous melanoma. Topline data from the Phase 2 portion of the trial is expected to be available by the fourth quarter of 2024.
KIMMTRAK Phase 3 clinical trial in adjuvant uveal (or ocular) melanoma
In 2023, the Company signed an agreement for a European Organisation for Research and Treatment of Cancer (EORTC)-sponsored trial to study KIMMTRAK as adjuvant therapy for uveal (or ocular) melanoma (ATOM). The Company anticipates that the EORTC will randomize the first patient in the second half of 2024.
PRAME franchise
PRISM-MEL301 – First PRAME Phase 3 clinical trial with IMC-F106C in first-line advanced cutaneous melanoma
In February 2024, the Company entered into a clinical trial collaboration and supply agreement with Bristol Myers Squibb (NYSE:BMY) to investigate Immunocore’s ImmTAC bispecific TCR candidate targeting PRAME HLA-A02, IMC-F106C, in combination with Bristol Myers Squibb’s nivolumab, in first-line advanced cutaneous melanoma. Under the terms of the collaboration, Immunocore will sponsor and fund the registrational Phase 3 clinical trial of IMC-F106C in combination with nivolumab in first-line advanced cutaneous melanoma (PRISM-MEL-301), and Bristol Myers Squibb will provide nivolumab.
In August 2023, the Company announced plans to start a registrational Phase 3 clinical trial with IMC-F106C in first-line advanced cutaneous melanoma (CM). The Company decided to advance IMC-F106C into a Phase 3 first-line CM clinical trial in combination with nivolumab with a primary endpoint of progression-free survival (PFS), based on the Company’s analysis of the ongoing Phase 1 data in previously treated CM which demonstrated monotherapy clinical activity including partial responses (PR), durable tumor reduction, disease control (PR and SD), PFS and circulating tumor DNA (ctDNA) reduction (consistent with prior reported data for IMC-F106C and tebentafusp). Additional rationale includes safety in combination with checkpoints (from the ongoing Phase 1 data and prior experience with tebentafusp) and evidence from across the platform for increased clinical activity in earlier line patients compared to later line. As such, PRISM-MEL-301, the first PRAME Phase 3 clinical trial with IMC-F106C, will randomize patients with HLA-A*02:01-positive, first-line advanced CM to IMC-F106C + nivolumab versus a control arm of either nivolumab or nivolumab + relatlimab, depending on the country where the patient is enrolled. The Company plans to randomize the first patient in this trial in the first quarter of 2024.
Phase 1/2 clinical trial of IMC-F106C targeting PRAME-A02 in multiple solid tumors
In addition to progressing IMC-F106C into a registrational trial in cutaneous melanoma, the Company is continuing to enroll patients in the monotherapy and combination arms of the Phase 1/2 clinical trial across multiple tumor types, including expansion arms for patients with advanced ovarian, non-small cell lung, and endometrial carcinoma. The initial data from the Phase 1 clinical trial of IMC-F106C, the first PRAME x CD3 ImmTAC bispecific protein, was presented at the 2022 European Society for Medical Oncology (ESMO) Congress in September 2022. Durable Response Evaluation Criteria in Solid Tumors (RECIST) responses and reduction in ctDNA were observed across multiple solid tumors. In August 2023, the Company provided an updated analysis of the original 18 melanoma patients (initially presented at ESMO in September 2022), which continued to show promising durability of the clinical activity (range of duration of partial response from 6 months to 17 months). The Company expects to report clinical data from the ongoing monotherapy and combination cohorts throughout 2024 including cutaneous melanoma (expected in Q2 2024), ovarian (expected by Q3 2024), and non-small cell lung carcinoma (expected by Q4 2024).
IMC-P115C (PRAME HLA-A02 Half-Life Extended) & IMC-T119C (PRAME HLA-A24)
The Company is expanding the PRAME franchise with two new PRAME ImmTAC candidates, IMC-P115C (PRAME HLA-A02 HLE) and IMC-T119C (PRAME HLA-A24) for solid tumors, which are both on track for investigational new drug (IND) or clinical trial application (CTA) submissions for IMC-P115C in the middle of 2024 and the fourth quarter of 2024 for IMC-T119C.
IMC-R117C (PIWIL1) for colorectal and other gastrointestinal cancers
The Company has leveraged its proprietary peptide (ImmSPECT) 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 other gastrointestinal cancers. PIWIL1 is also reported to be a negative prognostic marker and the Company believes IMC-R117C is the first PIWIL1-targeted immunotherapy. The Company submitted a CTA to regulatory authorities in December 2023, and expects the trial to start in the second half of 2024.
Enrolling ImmTAV candidates for a functional cure in infectious diseases
The Company continues to enroll people living with HIV in the multiple ascending dose (MAD) part of a Phase 1 clinical trial with IMC-M113V, to identify a safe and tolerable dosing schedule. This trial will also test whether IMC-M113V could lead to reduction in the viral reservoir and, after stopping all therapies (antiretroviral therapies and IMC-M113V), delay or prevent HIV rebound (known as functional cure). The MAD part of the trial will enroll up to 28 participants. The Company expects to present a data update from the Phase 1 clinical trial in the second half of 2024.
In 2023, the Company amended the design of the ongoing Phase 1 clinical trial with IMC-I109V for people living with HBV to include HBV-positive hepatocellular carcinoma. The Company continues to enroll patients into the single ascending dose portion of the trial in 2024.
Tissue-specific down modulation of the immune system for autoimmune diseases
The Company is expanding its platform into autoimmune diseases with two first-in-class new bispecific candidates entering the Company’s pipeline. The key differentiator of the ImmTAAI platform is tissue-specific down modulation of the immune system. When tethered to the tissue of interest, the new candidates supress pathogenic T cells via PD1 receptor agonism.
The first candidate, IMC-S118AI (PPIxPD1), is targeted specifically to pancreatic beta cells and is intended for disease-modifying treatment in type 1 diabetes. IMC-S118AI recognizes a peptide from pre-proinsulin presented by HLA-A02 on beta cells coupled with a PD1 agonist effector arm. IMC-S118AI is advancing towards GMP manufacturing in 2024.
The second target is present in the skin and intended to treat inflammatory dermatological diseases. The candidate is an antigen presenting cell (APC) tethered ImmTAAI and is not HLA restricted (e.g. universal for all populations).
Financial Results
Basic and diluted loss per share was $0.40 and $1.13 for the quarter and year ended December 31, 2023, respectively, as compared to a basic and diluted loss per share of $0.64 and $1.15, respectively, for the same periods in 2022. Net loss for the quarter and year ended December 31, 2023, was $19.7 million and $55.3 million, respectively, as compared to $30.0 million and $52.5 million, respectively, for the same periods in 2022.
For the fourth quarter and year ended December 31, 2023, we generated net sales of $67.6 million and $238.7 million, respectively, due to the sale of KIMMTRAK and tebentafusp, of which $49.1 million and $169.8 million, respectively was in the United States, $18.3 million and $67.6 million, respectively, was in Europe, and $0.2 million and $1.3 million, respectively, was in the international regions. The increase in net sales was due primarily to increased volume in the United States and global country expansion, as we continued our commercialization efforts.
For the fourth quarter and year ended December 31, 2023, our research and development (R&D) expenses were $45.6 million and $163.5 million, respectively as compared to $31.1 million and $101.9 million for the quarter and year ended December 31, 2022. These increases were driven by expenses incurred for our PRAME programs, increases in headcount-related expenses as a result of higher number of employees and associated staff costs, increases related to consumables and facilities costs, and decreased R&D tax credits due to us no longer qualifying as a ‘small and medium enterprise’ (SME) under the UK R&D tax regulations. 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, 2023, our SG&A expenses were $41.4 million and $144.5 million, respectively, compared to $35.4 million and $123.1 million for the quarter and year ended December 31, 2022. These increases were related to an increase in headcount costs, higher selling and distribution costs following regulatory approval of KIMMTRAK, and costs associated with expansion as a growing publicly listed and commercial company.
Cash and cash equivalents were $442.6 million as of December 31, 2023, as compared to $402.5 million as of December 31, 2022. In February 2024, the Company raised net cash proceeds of $389.3 million from a Convertible Notes offering with a six-year term and 2.50% interest rate. The Company plans to use $50 million from the net proceeds to repay its existing Pharmakon loan by the end of 2024. The Company estimates Pro Forma for the net cash proceeds from the Convertible Notes offering in February 2024, and the Pharmakon loan repayment, its cash and cash equivalents at year-end 2023, were approximately $782 million.
As of December 31, 2023, the Company no longer qualified as a foreign private issuer for U.S. publicly company reporting purposes. Effective January 1, 2024, it now files periodic reports on U.S. domestic filer forms with the Securities and Exchange Commission (SEC) and comply with other rules as required, including but not limited to presenting its financial results in press releases and Annual Report on Form 10-K in accordance with U.S. GAAP, with such change being applied retrospectively. See the Company’s Annual Report on Form 10-K filed today with the SEC for more information.
Audio Webcast
Immunocore will host a conference call today, February 28, 2024 at 8:00 A.M. ET/ 1:00 PM GMT, to discuss the fourth quarter and full year 2023 financial results and provide a business update. The call will also be available via webcast by visiting the Events & …