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Immunocore Holdings plc (IMCR) Presents at Morgan Stanley 23rd Annual Global Healthcare
Seeking Alpha· 2025-09-10 20:33
Question-and-Answer SessionMaybe just to commence proceedings, we've got a couple of macro questions here we've been asking all our companies. But the first one is with China's rise in biotech innovation, how are you thinking about Immunocore's competitive position here? And will this influence your R&D and business development strategy?Travis CoyCFO, Executive VP & Head of Corporate Development Yes. First of all, Sean, thank you for having us. We appreciate it. China, it's interesting. They've made great s ...
Immunocore Holdings (NasdaqGS:IMCR) FY Conference Transcript
2025-09-10 18:52
Summary of Immunocore Holdings FY Conference Call Company Overview - **Company**: Immunocore Holdings (NasdaqGS:IMCR) - **Date of Conference**: September 10, 2025 Key Industry Insights - **Biotech Innovation in China**: China has made significant advancements in biotech, particularly in immunology and cell therapy. Immunocore views China as both a competitive threat and an opportunity for collaboration and innovation [2][2]. - **AI Integration**: Immunocore is leveraging AI to enhance business operations and R&D, particularly in T-cell receptor (TCR) target identification and clinical data analysis. AI is seen as essential for improving efficiency and accelerating drug discovery [3][4]. Regulatory Environment - **Regulatory Interactions**: The FDA's guidance is crucial for Immunocore's investment strategies and clinical trial developments. The company has not faced significant regulatory impacts recently but emphasizes the importance of clear regulatory guidance [5][6]. T-Cell Receptor (TCR) Platform - **Oncology and Autoimmune Applications**: Immunocore's TCR platform is designed to engage T-cells to target tumors and downregulate the immune system for autoimmune diseases. The platform allows for tissue-specific therapies, minimizing systemic immunosuppression [7][8]. - **KIMMTRAK**: The first approved TCR therapy, KIMMTRAK, has shown success in oncology, generating $192 million in the first half of the year with a 32% growth rate year-over-year. However, growth is expected to moderate as the product matures [11][12]. Market Penetration and Growth - **U.S. Market Penetration**: KIMMTRAK is approaching 70% penetration in the U.S., with potential for further growth, especially in community settings. Comparatively, European markets have achieved over 80% penetration [16][17]. - **International Expansion**: Immunocore is expanding KIMMTRAK's global access, having launched in 28 countries and entered distribution agreements in regions like MENA and Turkey [17][18]. Clinical Trials and Future Indications - **Advanced Melanoma Trials**: Immunocore is pursuing phase 3 trials for KIMMTRAK in advanced cutaneous melanoma, leveraging similarities with uveal melanoma. The company anticipates a significant commercial opportunity due to the larger patient population [20][30]. - **PRAME-targeted Portfolio**: The company is conducting a phase 3 study for a PRAME-targeted agent in combination with nivolumab, based on promising phase 1 results showing better disease control rates than existing therapies [34][35]. Financial Health and Strategy - **Robust Financial Position**: Immunocore has nearly $900 million in cash, allowing for continued investment in R&D and clinical trials without immediate concerns about cash flow [50][53]. - **Operational Discipline**: The company maintains a disciplined approach to operational expenses, with SG&A costs remaining stable while planning for incremental increases related to new product launches [50][51]. Pipeline and Future Outlook - **Autoimmune and Infectious Disease Programs**: Immunocore is advancing programs in autoimmune diseases, including type 1 diabetes and atopic dermatitis, with expected clinical trials starting in 2026 [45][46]. - **Long-term Growth Strategy**: The company aims to maximize KIMMTRAK's potential while continuing to innovate its platform for sustainable growth, focusing on both oncology and emerging therapeutic areas [54][55].
Immunocore Holdings (IMCR) 2025 Conference Transcript
2025-09-05 13:35
Summary of Immunocore Holdings plc Conference Call Company Overview - **Company**: Immunocore Holdings plc - **Key Product**: KIMMTRAK, the first approved T-cell receptor therapy demonstrating a survival benefit in solid tumors, specifically uveal melanoma [2][4] - **Market Position**: The company has a total enterprise value of approximately $1 billion, with KIMMTRAK achieving a $400 million run rate [4] Core Points and Arguments Product Development and Pipeline - **KIMMTRAK**: - Demonstrated a survival benefit in uveal melanoma, a type of melanoma where checkpoint inhibitors are ineffective [2] - Currently undergoing lifecycle management with two phase 3 trials [2] - Mean duration of therapy is reported at 13 months, exceeding clinical trial results [7] - The company is exploring further applications of its technology in oncology, HIV, HPV, and autoimmune diseases [3] - **Tevyam**: - A phase 3 trial for cutaneous melanoma is expected to enroll 2,000 to 4,000 patients, with data anticipated in 2026 [5][15] - The trial design includes patients who have progressed on PD-1 and other therapies, with overall survival as the primary endpoint [15][16] - **Brunetafusp PRAME**: - Aiming to combine with nivolumab in first-line cutaneous melanoma, with a focus on demonstrating superior efficacy compared to existing treatments [44][49] - The trial is designed to assess the combination's effectiveness against nivolumab monotherapy and nivolumab plus LAG3 [49] Commercial Strategy - **Market Opportunity**: - There is a high unmet need in the second-line cutaneous melanoma market, with KIMMTRAK positioned as a potentially first-line treatment option [27] - Approximately 50% of physicians treating cutaneous melanoma have experience with KIMMTRAK, which may facilitate its adoption [29] - **Exclusivity and Competition**: - The composition of matter patent for KIMMTRAK extends to 2030, with a filed extension to 2035 [10] - Anticipation of competition from newer therapies, but KIMMTRAK's established efficacy may provide a competitive edge [11] Financial Outlook - **Valuation Concerns**: - The company is perceived as undervalued despite strong performance metrics, with a focus on improving investor perception leading up to 2026 [4][5] - **Operational Goals**: - The company aims to maintain operations near break-even while advancing its pipeline and investing in growth [68] Additional Important Insights - **Real-World Evidence**: - The company plans to publish real-world evidence linking treatment beyond progression to overall survival, which may strengthen its market position [14] - **Patient Experience**: - Reports of patients remaining on KIMMTRAK for extended periods (up to seven years) suggest significant therapeutic benefits [7][12] - **Regulatory Considerations**: - The company is focused on obtaining NCCN listing and reimbursement strategies to ensure market access for new therapies [31] Conclusion Immunocore Holdings plc is positioned for significant growth with its innovative T-cell receptor therapies, particularly KIMMTRAK and upcoming products like Tevyam and brunetafusp PRAME. The company is navigating a competitive landscape while focusing on data-driven strategies to enhance its market presence and investor confidence leading into 2026.
Compared to Estimates, Immunocore (IMCR) Q2 Earnings: A Look at Key Metrics
ZACKS· 2025-08-07 14:32
Here is how Immunocore performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: View all Key Company Metrics for Immunocore here>>> Shares of Immunocore have returned -7.2% over the past month versus the Zacks S&P 500 composite's +1.2% change. The stock currently has a Zacks Rank #1 (Strong Buy), indicating that it could outperform the broader market in the near term. Geographic Revenue- United States: $64.09 million versus $59.44 million es ...
Immunocore(IMCR) - 2025 Q2 - Earnings Call Transcript
2025-08-07 13:00
Financial Data and Key Metrics Changes - For the first half of 2025, the company generated $192 million in ChemTrak revenue, representing a 32% year-over-year growth, marking a significant milestone four years post-launch [4][8] - In Q2 2025, net sales reached $98 million, a 30% increase compared to Q2 2024, and a 4% sequential increase over Q1 2025 [26][28] - The net loss decreased from $36 million to $5 million year-over-year, indicating improved financial performance as revenue growth outpaced operating expenses [29] Business Line Data and Key Metrics Changes - ChemTrak's performance in the U.S. saw net revenue of $64 million in Q2 2025, a 15% increase year-over-year, with a therapy duration of 13 months and a market penetration of approximately 68% [9][26] - In Europe, Q2 2025 net revenue was $33 million, reflecting an exceptional 115% year-over-year growth, driven by successful launches in the UK, Poland, and the Netherlands [10][26] Market Data and Key Metrics Changes - The company has launched ChemTrak in 28 countries and is approved in 39 globally, with ongoing expansion into Turkey and MENA regions through a partnership with Air Chem [6][7] - The company anticipates incremental growth from Europe as new launches mature, with expectations for continued growth in established markets [10][28] Company Strategy and Development Direction - The company's strategy focuses on three core pillars: maximizing ChemTrak's value, advancing the clinical portfolio, and innovating for sustainable growth [3][5] - The company is on track to file the CTA for its autoimmune candidates in type one diabetes by the end of 2025 and plans to start phase one trials in 2026 [5][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong performance of ChemTrak and the diversified pipeline, emphasizing the commitment to advancing clinical programs efficiently [5][31] - The company remains focused on delivering progress in lifecycle management plans for ChemTrak and enrolling patients across multiple ongoing clinical trials [31] Other Important Information - The company has a strong balance sheet with $883 million in cash and marketable securities, allowing for continued investment in innovation while maintaining financial discipline [29][30] - The company expects to pay approximately $65 million related to European rebate accruals from prior periods in 2025 [29] Q&A Session Summary Question: What happens to patients whose dose is being discontinued in the study? - Patients on the discontinued dose will continue on that dose, although the IDMC may recommend switching to the go-forward dose, but they will not be included in the ITT analysis [34][35] Question: Should the company start thinking about a breakeven point? - It is too early to consider profitability as the company continues to invest in three phase three trials and expects R&D expenses to increase [37][38] Question: Can you provide details on the growth in the U.S. and the timeline for the phase three ADAM trial? - Growth in the U.S. is driven by deeper penetration into the community, with expectations for moderate growth moving forward. The ADAM trial is in early stages of site activation, typically taking up to three years for accrual [54][59] Question: How is the duration of therapy trending in Europe compared to the U.S.? - The duration of therapy in Europe is expected to be consistent with the U.S., with mature markets showing excellent duration similar to the U.S. [79][80] Question: What is the company's confidence regarding U.S. trial centers and patient demographics? - The company is confident that the site footprint will meet FDA requirements, with sufficient U.S. sites for both trials [108] Question: What are the expectations around the HIV program's dose escalation and expansion? - The company aims to see viral control beyond twelve weeks to trigger expansion, with ongoing dose escalation to find the right dose [88][90]
Immunocore(IMCR) - 2025 Q2 - Earnings Call Presentation
2025-08-07 12:00
Financial Performance - 1H 2025 KIMMTRAK net sales reached $192 million, a 32% year-over-year increase[10] - Q2 2025 KIMMTRAK net revenue was $98 million, including $641 million from the US and $33 million from Europe[19] - The company's cash position as of June 30, 2025, was $883 million[11] KIMMTRAK Market Expansion - KIMMTRAK is approved in 39 countries and launched in 28 countries[17] - US revenue for KIMMTRAK showed a 15% year-on-year quarterly growth[21] - European revenue for KIMMTRAK showed a 115% year-on-year quarterly growth[25] Pipeline Development - The company is advancing autoimmune candidates towards CTA/IND[10] - Phase 3 trials are ongoing for TEBE-AM, ATOM, and PRISM-MEL[10] - Phase 1/2 trials are ongoing for HIV and HBV infectious diseases trials[10] Clinical Trials - TEBE-AM Phase 3 trial in 2L+ cutaneous melanoma is expected to complete randomization in 1H 2026[35] - PRISM-MEL-301 Phase 3 trial for 1L advanced cutaneous melanoma is ongoing, with dose selection expected in 2H 2025[32] - ATOM Phase 3 trial is ongoing in adjuvant uveal melanoma[32]
Immunocore(IMCR) - 2025 Q2 - Quarterly Results
2025-08-07 11:40
[Executive Summary & Business Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Highlights) [Q2 2025 Key Achievements](index=1&type=section&id=Q2%202025%20Key%20Achievements) Immunocore achieved KIMMTRAK net revenue of $98 million in Q2 2025, a 30% year-over-year increase, and reported robust cash reserves, making progress in several key clinical trials, including Phase 3 trials for TEBE-AM and PRISM-MEL-301, and planning to release Phase 1 HBV data Q2 2025 Key Financial and Business Highlights | Metric | Amount/Status | | :--- | :--- | | KIMMTRAK Net Revenue (Q2 2025) | $98.0 million | | KIMMTRAK Net Revenue YoY Growth (Q2 2025) | 30% | | Cash, Cash Equivalents, and Marketable Securities (as of June 30, 2025) | $883 million | | Phase 3 TEBE-AM Trial | Enrollment on track for H1 2026 | | PRISM-MEL-301 Phase 3 Trial | Dose selection expected H2 2025 | | Phase 1 HBV Data | To be presented at AASLD Liver Meeting 2025 | [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CEO Bahija Jallal highlighted strong revenue growth (32% YoY) in H1 2025, attributed to KIMMTRAK's global market expansion, and noted good progress in multiple Phase 3 and Phase 1/2 clinical trials, preparing for autoimmune CTA submissions, demonstrating platform depth and diversity - Revenue grew **32% year-over-year** in the first half of 2025, primarily driven by the continued rollout of KIMMTRAK in the US and global markets[3](index=3&type=chunk) - The Phase 3 TEBE-AM trial is on track for enrollment completion in the first half of 2026, with other Phase 3 trials like PRISM-MEL-301 and ATOM also progressing well[3](index=3&type=chunk) - The company is advancing Phase 1/2 trials in oncology and infectious diseases and preparing to submit clinical trial applications for autoimmune candidates, showcasing platform depth and diversity[3](index=3&type=chunk) [Product & Pipeline Update](index=1&type=section&id=Product%20%26%20Pipeline%20Update) [KIMMTRAK® (tebentafusp)](index=1&type=section&id=KIMMTRAK%C2%AE%20(tebentafusp)) KIMMTRAK is approved in 39 countries and launched in 28, establishing itself as the standard of care for HLA-A*02:01-positive metastatic uveal melanoma (mUM) patients, with plans for continued global mUM expansion and potential extension to 2L+ advanced cutaneous melanoma (CM) and adjuvant uveal melanoma - KIMMTRAK is approved in **39 countries** globally and launched in **28 countries** for HLA-A*02:01-positive metastatic uveal melanoma patients[4](index=4&type=chunk) - The company plans to achieve three key growth areas for KIMMTRAK through global mUM expansion, potential extension to 2L+ advanced CM, and adjuvant uveal melanoma[6](index=6&type=chunk) [Commercial Performance & Expansion](index=2&type=section&id=Commercial%20Performance%20%26%20Expansion) KIMMTRAK achieved net sales of $98 million in Q2 2025 and $191.8 million in H1 2025, representing 30% and 32% YoY growth respectively, driven by increased demand, new country launches, and completed price negotiations in France and Germany, with new distribution agreements signed for the Middle East and North Africa KIMMTRAK Net Product Sales (million USD) | Period | 2025 | 2024 | YoY Growth | | :--- | :--- | :--- | :--- | | Three Months Ended June 30 | $98.0 | $75.3 | 30% | | Six Months Ended June 30 | $191.8 | $145.7 | 32% | Regional Quarterly Growth (YoY) | Region | Growth Rate | | :--- | :--- | | US | 15% | | Europe & International | 71% | - Growth in Europe and international markets was primarily driven by increased demand, new country launches, and completed price negotiations in France and Germany[10](index=10&type=chunk) - The company signed a distribution and commercialization agreement with Er-Kim Pharmaceuticals for KIMMTRAK in Turkey, the Middle East, North Africa, the Caucasus, and CIS regions[10](index=10&type=chunk) [KIMMTRAK Clinical Development](index=2&type=section&id=KIMMTRAK%20Clinical%20Development) The Phase 3 TEBE-AM trial for KIMMTRAK is recruiting patients, with enrollment expected to complete in H1 2026, addressing unmet needs in 2L+ advanced cutaneous melanoma, while the EORTC is expanding site coverage for the Phase 3 ATOM adjuvant uveal melanoma trial, targeting 1,200 high-risk patients in the US and Europe - The TEBE-AM registrational Phase 3 trial is recruiting patients, with enrollment expected to complete in the first half of 2026, addressing a significant unmet need in 2L+ advanced cutaneous melanoma[10](index=10&type=chunk) - The European Organisation for Research and Treatment of Cancer (EORTC) is expanding site coverage for the Phase 3 ATOM adjuvant uveal melanoma trial[10](index=10&type=chunk) - The company estimates the HLA-A*02:01 high-risk adjuvant uveal melanoma patient population could be as many as **1,200 individuals** in the US and Europe[10](index=10&type=chunk) [PRAME Portfolio (Brenetafusp)](index=2&type=section&id=PRAME%20Portfolio%20(Brenetafusp)) Brenetafusp, the company's leading PRAME-A02 ImmTAC bispecific candidate, is being evaluated in multiple clinical trials, including the Phase 3 registrational trial PRISM-MEL-301 for first-line advanced cutaneous melanoma, and Phase 1/2 trials as monotherapy and in combination across various tumor types like ovarian cancer and non-small cell lung cancer - Brenetafusp, the company's leading PRAME-A02 ImmTAC bispecific candidate, is undergoing a Phase 3 registrational trial (PRISM-MEL-301) in combination with nivolumab for first-line advanced cutaneous melanoma patients[9](index=9&type=chunk) - Brenetafusp is also being evaluated in Phase 1/2 clinical trials as monotherapy and in combination across various tumor types, including ovarian cancer and non-small cell lung cancer[9](index=9&type=chunk) [PRISM-MEL-301 Phase 3 Trial](index=3&type=section&id=PRISM-MEL-301%20Phase%203%20Trial) PRISM-MEL-301, a Phase 3 registrational trial for brenetafusp combined with nivolumab in first-line advanced cutaneous melanoma, has activated over 150 global sites, with the IDMC recommending continuation after reviewing safety data from the first 30 patients, and final dose selection expected in H2 2025, addressing an unmet need for approximately 10,000 HLA-A*02:01-positive patients - The PRISM-MEL-301 trial has activated over **150 clinical sites** globally and is recruiting HLA-A*02:01-positive, first-line, advanced or metastatic cutaneous melanoma patients[15](index=15&type=chunk) - The IDMC reviewed safety data from the first **30 patients** and recommended continuation of the study, with final brenetafusp dose selection expected in the second half of 2025[15](index=15&type=chunk) - The company estimates approximately **10,000 HLA-A*02:01-positive patients** in the US and Europe have an unmet need for improved progression-free and overall survival[15](index=15&type=chunk) [Brenetafusp Phase 1/2 in Multiple Solid Tumors](index=3&type=section&id=Brenetafusp%20Phase%201%2F2%20in%20Multiple%20Solid%20Tumors) Brenetafusp is being evaluated in Phase 1/2 trials in combination with non-platinum chemotherapy for platinum-resistant ovarian cancer, and with bevacizumab or platinum chemotherapy for early platinum-sensitive ovarian cancer, while also undergoing signal detection in non-small cell lung cancer cohorts, including combinations with docetaxel and osimertinib, with an estimated 150,000 eligible HLA-A*02:01-positive solid tumor patients globally annually - The company continues to evaluate brenetafusp in Phase 1/2 trials in combination with non-platinum chemotherapy for platinum-resistant ovarian cancer, and with bevacizumab or platinum chemotherapy for early platinum-sensitive ovarian cancer[15](index=15&type=chunk) - In the same trial, the company continues signal detection in metastatic non-small cell lung cancer cohorts, including brenetafusp in combination with docetaxel and osimertinib[15](index=15&type=chunk) - The company estimates that as many as **150,000 HLA-A*02:01-positive patients** are eligible for testing across all solid tumors globally each year[15](index=15&type=chunk) [Other PRAME Candidates](index=3&type=section&id=Other%20PRAME%20Candidates) The company is conducting a Phase 1 dose-escalation trial for IMC-P115C (PRAME-A02 half-life extended) in multiple solid tumors - The company is recruiting patients for a Phase 1 dose-escalation trial of IMC-P115C (PRAME-A02 half-life extended) in multiple solid tumors[12](index=12&type=chunk) [Other Oncology Programs (IMC-R117C)](index=3&type=section&id=Other%20Oncology%20Programs%20(IMC-R117C)) The company is conducting a Phase 1/2 dose-escalation trial for IMC-R117C (PIWIL1) in HLA-A*02:01-positive advanced solid tumors, including colorectal cancer, as monotherapy and in combination with standard of care - The company is recruiting patients for a Phase 1/2 dose-escalation trial of IMC-R117C (PIWIL1) in HLA-A*02:01-positive advanced solid tumors, including colorectal cancer, as monotherapy and in combination with standard of care[13](index=13&type=chunk) [Infectious Disease Programs (ImmTAV)](index=3&type=section&id=Infectious%20Disease%20Programs%20(ImmTAV)) The ImmTAV platform aims for a 'functional cure' of chronic infections through bispecific TCR technology, with two candidates in Phase 1 or Phase 1/2 trials targeting HIV and chronic Hepatitis B virus (HBV) infection - The ImmTAV platform aims to provide a new approach for certain chronic infections, targeting a 'functional cure' where patients eliminate evidence of the virus from their bodies after stopping treatment[14](index=14&type=chunk) [HIV Program (IMC-M113V)](index=4&type=section&id=HIV%20Program%20(IMC-M113V)) The Phase 1/2 multi-dose escalation trial for IMC-M113V (Gag-A02) continues to recruit patients to determine a safe and tolerable dose - The Phase 1/2 multi-dose escalation clinical trial for IMC-M113V (Gag-A02) continues to recruit patients at higher doses to determine a safe and tolerable dose[16](index=16&type=chunk) [HBV Program (IMC-I109V)](index=4&type=section&id=HBV%20Program%20(IMC-I109V)) Phase 1 single-dose escalation trial data for IMC-I109V (Envelope-A02) will be presented at the AASLD Liver Meeting in November 2025 - The company will present single-dose escalation data from the Phase 1 trial of IMC-I109V (Envelope-A02) at the AASLD Liver Meeting in November 2025[17](index=17&type=chunk) [Autoimmune Disease Programs (ImmTAAI)](index=4&type=section&id=Autoimmune%20Disease%20Programs%20(ImmTAAI)) The ImmTAAI platform aims to tissue-specifically downregulate the immune system by inhibiting pathogenic T cells via PD1 receptor agonism, with two candidates in development: IMC-S118AI (PPI-A02) for Type 1 Diabetes, with CTA/IND submission expected in H2 2025, and IMC-U120AI (CD1a) for Atopic Dermatitis, with CTA/IND submission expected in 2026 - The ImmTAAI platform achieves tissue-specific downregulation of the immune system by inhibiting pathogenic T cells via PD1 receptor agonism when binding to target tissues[18](index=18&type=chunk) [Type 1 Diabetes (IMC-S118AI)](index=4&type=section&id=Type%201%20Diabetes%20(IMC-S118AI)) IMC-S118AI (PPI-A02) for Type 1 Diabetes is expected to have its Clinical Trial Application (CTA) or Investigational New Drug (IND) application submitted in the second half of 2025 - The company is on track to submit a CTA or IND application for IMC-S118AI (PPI x PD1) for Type 1 Diabetes in the second half of 2025[19](index=19&type=chunk) [Atopic Dermatitis (IMC-U120AI)](index=4&type=section&id=Atopic%20Dermatitis%20(IMC-U120AI)) IMC-U120AI (CD1a) for Atopic Dermatitis is expected to have its CTA/IND submission in 2026 - The company plans to submit a CTA/IND application for IMC-U120AI (CD1a x PD1) for Atopic Dermatitis in 2026[20](index=20&type=chunk) [Corporate Update](index=4&type=section&id=Corporate%20Update) [Director Resignation](index=4&type=section&id=Director%20Resignation) Rob Perez resigned from the company's Board of Directors on August 5, 2025, effective September 16, 2025, with the company expressing gratitude for his six years of contributions to Immunocore - Rob Perez resigned from the company's Board of Directors on August 5, 2025, effective September 16, 2025[21](index=21&type=chunk) [Financial Results](index=4&type=section&id=Financial%20Results) [Q2 2025 Financial Performance Overview](index=4&type=section&id=Q2%202025%20Financial%20Performance%20Overview) Immunocore achieved net product sales of $98 million in Q2 2025, a 30% YoY increase, with R&D expenses rising to $69 million due to autoimmune programs and Phase 3 trials, and SG&A expenses increasing to $42.8 million to support pipeline and global commercial expansion, resulting in a narrowed net loss of $10.3 million, or $0.20 per share Q2 2025 Key Financial Data (million USD) | Metric | Q2 2025 | Q2 2024 | YoY Change | | :--- | :--- | :--- | :--- | | Net Product Sales | $98.0 | $75.3 | 30% increase | | R&D Expenses | $69.0 | $51.1 | increase of $17.9 | | SG&A Expenses | $42.8 | $38.6 | increase of $4.2 | | Net Loss | ($10.3) | ($11.6) | loss narrowed by $1.3 | | Basic and Diluted Loss Per Share | ($0.20) | ($0.23) | loss narrowed by $0.03 | - R&D expenses increased primarily due to the advancement of autoimmune programs and Phase 3 trials (TEBE-AM and PRISM-MEL-301)[23](index=23&type=chunk) - SG&A expenses increased mainly due to business support function costs for the company's growing pipeline and global commercial expansion[24](index=24&type=chunk) [Balance Sheet & Cash Position](index=5&type=section&id=Balance%20Sheet%20%26%20Cash%20Position) As of June 30, 2025, the company's cash, cash equivalents, and marketable securities totaled $882.8 million, an increase from $820.4 million at the end of 2024, with an estimated $65 million in sales-related rebate accruals expected to be paid in H2 2025 Cash, Cash Equivalents, and Marketable Securities (million USD) | Date | Amount | | :--- | :--- | | June 30, 2025 | $882.8 | | December 31, 2024 | $820.4 | | Change | increase of $62.4 | - The company expects to pay approximately **$65 million** in sales-related rebate accruals in the second half of 2025[27](index=27&type=chunk) [About Immunocore & Technologies](index=5&type=section&id=About%20Immunocore%20%26%20Technologies) [About ImmTAC® molecules for cancer](index=5&type=section&id=About%20ImmTAC%C2%AE%20molecules%20for%20cancer) ImmTAC molecules are novel bispecific biologics generated by Immunocore's proprietary T-cell receptor (TCR) technology, designed to redirect the immune system to recognize and kill cancer cells, functioning as soluble TCRs with ultra-high affinity for intracellular cancer antigens and selective killing via anti-CD3 immune activating effector function, holding promise for various hematological and solid tumors - ImmTAC molecules are novel bispecific biologics generated by Immunocore's proprietary T-cell receptor (TCR) technology, designed to redirect the immune system to recognize and kill cancer cells[28](index=28&type=chunk) - ImmTAC molecules selectively kill cancer cells by recognizing intracellular cancer antigens with ultra-high affinity and employing anti-CD3 immune activating effector function, holding promise for both hematological and solid tumors[28](index=28&type=chunk) [About ImmTAV infectious disease molecules](index=5&type=section&id=About%20ImmTAV%20molecules%20and%20infectious%20diseases) ImmTAV molecules are novel bispecific drugs designed to enable the immune system to recognize and eliminate virally infected cells, with Immunocore advancing clinical candidates to achieve a 'functional cure' for HIV and HBV patients, meaning sustained viral control after stopping medication - ImmTAV molecules are novel bispecific drugs designed to enable the immune system to recognize and eliminate virally infected cells[29](index=29&type=chunk) - Immunocore is advancing clinical candidates to achieve a 'functional cure' for HIV and HBV patients, meaning sustained control of HIV after stopping antiretroviral therapy (ART), and sustained clearance of circulating viral antigens and replication markers for HBV after stopping medication[29](index=29&type=chunk) [About ImmTAAI autoimmune disease molecules](index=5&type=section&id=About%20ImmTAAI%20molecules%20and%20autoimmune%20diseases) ImmTAAI molecules are novel bispecific drugs designed for tissue-specific downregulation of the immune system, inhibiting pathogenic T cells via PD1 receptor agonism when binding to target tissues, currently in development for Type 1 Diabetes and inflammatory skin diseases - ImmTAAI molecules are novel bispecific drugs designed to achieve tissue-specific downregulation of the immune system[30](index=30&type=chunk) - When binding to target tissues, ImmTAAI candidates inhibit pathogenic T cells via PD1 receptor agonism[30](index=30&type=chunk) - The company is currently advancing two autoimmune disease candidates, including for Type 1 Diabetes and inflammatory skin diseases[30](index=30&type=chunk) [Detailed Clinical Trial Information](index=6&type=section&id=Detailed%20Clinical%20Trial%20Information) This section provides detailed information on Immunocore's key clinical trials, including the design, patient populations, randomization, and primary endpoints for PRISM-MEL301, IMC-F106C-101, TEBE-AM, and ATOM trials [PRISM-MEL301 (NCT06112314)](index=6&type=section&id=PRISM-MEL301%20(NCT06112314)) PRISM-MEL301 is a Phase 3 registrational trial for untreated HLA-A*02:01-positive advanced melanoma patients, randomized to brenetafusp + nivolumab or control, with an initial three-arm randomization and a primary endpoint of blinded independent central review of progression-free survival (PFS) - PRISM-MEL301 is a Phase 3 registrational trial for HLA-A*02:01-positive, untreated advanced melanoma patients[32](index=32&type=chunk) - Patients are randomized to brenetafusp + nivolumab or a control arm (nivolumab or nivolumab + relatlimab)[32](index=32&type=chunk) - The primary endpoint is blinded independent central review of progression-free survival (PFS), with secondary endpoints including overall survival (OS) and overall response rate (ORR)[32](index=32&type=chunk) [IMC-F106C-101 Phase 1/2 trial](index=6&type=section&id=IMC-F106C-101%20Phase%201%2F2%20trial) IMC-F106C-101 is a first-in-human Phase 1/2 dose-escalation trial for various solid tumor patients, aiming to determine the maximum tolerated dose and evaluate the safety, preliminary anti-tumor activity, and pharmacokinetics of IMC-F106C (brenetafusp), with a current focus on recruiting patients for combination with standard of care - IMC-F106C-101 is a first-in-human Phase 1/2 dose-escalation trial for various solid tumor patients, including non-small cell lung cancer and ovarian cancer[33](index=33&type=chunk) - The trial aims to determine the maximum tolerated dose (MTD) and evaluate the safety, preliminary anti-tumor activity, and pharmacokinetics of IMC-F106C (brenetafusp)[33](index=33&type=chunk) - The company's current focus is on recruiting patients for combination with standard of care[33](index=33&type=chunk) [TEBE-AM Phase 2/3 trial](index=6&type=section&id=TEBE-AM%20Phase%202%2F3%20trial) The TEBE-AM trial targets 2L+ advanced cutaneous melanoma patients who progressed after anti-PD1 therapy and received ipilimumab, randomizing them to tebentafusp monotherapy, tebentafusp plus anti-PD1, or a control arm, with overall survival as the primary endpoint - The TEBE-AM trial targets 2L+ advanced cutaneous melanoma patients who progressed after anti-PD1 therapy and received ipilimumab[34](index=34&type=chunk) - Patients are randomized to tebentafusp monotherapy, tebentafusp plus anti-PD1, or a control arm[34](index=34&type=chunk) - The primary endpoint is overall survival (OS)[34](index=34&type=chunk) [ATOM Phase 3 trial](index=6&type=section&id=ATOM%20Phase%203%20trial) The EORTC-sponsored Phase 3 ATOM clinical trial will establish sites in 10 EU countries and the US, recruiting HLA-A*02:01-positive, high-risk primary uveal melanoma patients randomized 1:1 to tebentafusp monotherapy or observation, with recurrence-free survival (RFS) as the primary endpoint - The EORTC-sponsored Phase 3 ATOM clinical trial will establish sites in **10 EU countries** and the US[35](index=35&type=chunk) - The trial will recruit HLA-A*02:01-positive, high-risk primary uveal melanoma patients, randomized to tebentafusp monotherapy or observation[35](index=35&type=chunk) - The primary endpoint is recurrence-free survival (RFS), with secondary objectives including overall survival and the safety and tolerability of tebentafusp[35](index=35&type=chunk) [Disease Background](index=7&type=section&id=Disease%20Background) This section describes the characteristics, prognosis, and unmet treatment needs of uveal melanoma and cutaneous melanoma, highlighting KIMMTRAK's significance in uveal melanoma treatment [Uveal Melanoma](index=7&type=section&id=Uveal%20Melanoma) Uveal melanoma is a rare, aggressive ocular melanoma and the most common primary intraocular malignancy in adults, with up to 50% of patients developing metastatic disease, often leading to poor prognosis, and no approved treatments existed before KIMMTRAK - Uveal melanoma is a rare and aggressive ocular melanoma, representing the most common primary intraocular malignancy in adults[37](index=37&type=chunk) - Up to **50%** of uveal melanoma patients eventually develop metastatic disease, often with a poor prognosis, and no approved treatment options existed prior to KIMMTRAK's approval[37](index=37&type=chunk) [Cutaneous Melanoma](index=7&type=section&id=Cutaneous%20Melanoma) Cutaneous melanoma is the most common and aggressive form of melanoma, responsible for the vast majority of skin cancer-related deaths, and despite advances in advanced melanoma treatment, unmet needs persist in improving first-line response rates, extending response duration, and treating patients resistant to first-line therapies - Cutaneous melanoma is the most common form of melanoma and the most aggressive skin cancer, associated with the vast majority of skin cancer-related deaths[38](index=38&type=chunk) - Despite advances in advanced melanoma treatment, unmet needs persist in improving first-line response rates, extending response duration, and treating patients resistant to first-line therapies[38](index=38&type=chunk) [About KIMMTRAK®](index=7&type=section&id=About%20KIMMTRAK%C2%AE) KIMMTRAK is a novel bispecific protein, a soluble T-cell receptor fused to an anti-CD3 immune-effector function, specifically targeting the gp100 antigen, and is the first molecule developed from Immunocore's ImmTAC technology platform, designed to redirect and activate T cells to recognize and kill tumor cells, approved for HLA-A*02:01-positive, unresectable or metastatic uveal melanoma in adults - KIMMTRAK is a novel bispecific protein, a soluble T-cell receptor fused to an anti-CD3 immune-effector function, specifically targeting the gp100 antigen[39](index=39&type=chunk) - KIMMTRAK is the first molecule developed from Immunocore's ImmTAC technology platform, designed to redirect and activate T cells to recognize and kill tumor cells[39](index=39&type=chunk) - KIMMTRAK is approved for the treatment of HLA-A*02:01-positive, unresectable or metastatic uveal melanoma in adults, with approvals in the US, EU, Canada, Australia, and the UK[39](index=39&type=chunk) [Important Safety Information](index=7&type=section&id=Important%20Safety%20Information) KIMMTRAK treatment may cause serious cytokine release syndrome (CRS), skin reactions, elevated liver enzymes, and embryo-fetal toxicity, requiring close monitoring for CRS symptoms and treatment or discontinuation based on severity, with common side effects including CRS, rash, fever, pruritus, fatigue, and laboratory abnormalities like decreased lymphocyte count, elevated creatinine, and liver enzymes - KIMMTRAK treatment may cause serious cytokine release syndrome (CRS), occurring in **89%** of patients, with **0.8%** being Grade 3 or 4[40](index=40&type=chunk) - Skin reactions (including rash, pruritus, skin edema) occurred in **91%** of patients, and elevated liver enzymes in **65%**[41](index=41&type=chunk)[43](index=43&type=chunk) - KIMMTRAK may cause fetal harm, and patients of reproductive potential are advised to use effective contraception during treatment and for **1 week** after the last dose[44](index=44&type=chunk) - The most common adverse reactions (≥**30%**) include cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting[45](index=45&type=chunk) [KIMMTRAKConnect](index=8&type=section&id=KIMMTRAKConnect) The KIMMTRAKConnect program provides personalized support services, including educational resources, financial assistance, and care site coordination, delivered by dedicated nurse case managers, to help patients access KIMMTRAK - The KIMMTRAKConnect program offers personalized support, including educational resources, financial assistance, and care site coordination, to help patients access KIMMTRAK[47](index=47&type=chunk) [About Immunocore](index=8&type=section&id=About%20Immunocore) Immunocore is a commercial-stage biotechnology company developing novel TCR bispecific immunotherapies, ImmTAX, for cancer, autoimmune diseases, and infectious diseases, leveraging its proprietary ImmTAX platform to build a deep pipeline across multiple therapeutic areas, including KIMMTRAK, approved for HLA-A*02:01-positive, unresectable or metastatic uveal melanoma in adults - Immunocore is a commercial-stage biotechnology company dedicated to developing novel TCR bispecific immunotherapies, ImmTAX, for cancer, autoimmune diseases, and infectious diseases[48](index=48&type=chunk) - The company leverages its proprietary, flexible, and off-the-shelf ImmTAX platform to develop a deep pipeline across oncology, infectious diseases, and autoimmune diseases[48](index=48&type=chunk) - The company's most advanced oncology TCR therapeutic, KIMMTRAK, is approved for the treatment of HLA-A*02:01-positive, unresectable or metastatic uveal melanoma in adults[48](index=48&type=chunk) [Forward-Looking Statements](index=9&type=section&id=Forward-Looking%20Statements) [Nature and Risks of Forward-Looking Statements](index=9&type=section&id=Nature%20and%20Risks%20of%20Forward-Looking%20Statements) This press release contains forward-looking statements regarding the company's clinical pipeline progress, KIMMTRAK's commercial performance and potential expansion, TCR technology platform potential, patient population size, clinical trial design and results, regulatory approvals, funding needs, and intellectual property protection, which are based on management's current expectations and subject to various risks and uncertainties that could cause actual results to differ materially from expectations - Forward-looking statements cover the company's clinical pipeline progress, KIMMTRAK's commercial performance and expansion, TCR technology platform potential, patient population size, clinical trial design and results, regulatory approvals, funding needs, and intellectual property protection[50](index=50&type=chunk) - These statements are based on management's current expectations but are subject to various risks and uncertainties, including macroeconomic conditions, clinical trial delays, regulatory actions, ability to obtain funding, and intellectual property protection, which could cause actual results to differ materially from expectations[50](index=50&type=chunk) [Contact Information](index=10&type=section&id=Contact%20Information) [Company Contacts](index=10&type=section&id=Company%20Contacts) Provides contact information for Immunocore's corporate communications and investor relations, including names, phone numbers, and email addresses, for media and investor inquiries - Immunocore's corporate communications contact is Sébastien Desprez, and investor relations contacts are Clayton Robertson / Morgan Warenius[52](index=52&type=chunk) [Financial Statements](index=11&type=section&id=Financial%20Statements) [Condensed Consolidated Statement of Operations](index=11&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations) In Q2 2025, the company reported total revenue of $97.964 million, a net loss of $10.3 million, and basic and diluted loss per share of $0.20, showing increased revenue and narrowed loss compared to Q2 2024, with H1 total revenue of $191.8 million and a net loss of $5.277 million, or $0.11 per share Immunocore Holdings plc Condensed Consolidated Statement of Operations (Unaudited, in thousands of USD, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net product sales | $97,964 | $75,347 | $191,845 | $145,689 | | Collaboration revenue | — | $53 | — | $213 | | **Total revenue** | **$97,964** | **$75,400** | **$191,845** | **$145,902** | | Cost of product sales | ($1,040) | ($1,707) | ($1,871) | ($1,953) | | Research and development expenses | ($69,008) | ($51,072) | ($125,476) | ($108,531) | | Selling, general and administrative expenses | ($42,791) | ($38,638) | ($82,989) | ($77,925) | | **Operating loss** | **($14,875)** | **($16,017)** | **($18,491)** | **($42,507)** | | Interest income | $4,271 | $6,239 | $8,447 | $14,485 | | Interest expense | ($3,045) | ($4,277) | ($6,070) | ($7,516) | | Foreign currency (loss) gain | ($738) | ($508) | $2,342 | ($2,914) | | Other income, net | $4,693 | $4,433 | $10,162 | $4,243 | | Net income (loss) before income taxes | ($9,694) | ($10,130) | ($3,610) | ($34,209) | | Income tax expense | ($606) | ($1,486) | ($1,667) | ($1,843) | | **Net income (loss)** | **($10,300)** | **($11,616)** | **($5,277)** | **($36,052)** | | Net loss per share, basic and diluted | ($0.20) | ($0.23) | ($0.11) | ($0.72) | | Weighted-average shares outstanding, basic and diluted | 50,294,205 | 50,014,086 | 50,191,018 | 49,944,767 | [Condensed Consolidated Balance Sheets](index=12&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, the company reported total assets of $1.0824 billion, total liabilities of $693.9 million, and total shareholders' equity of $388.5 million, with cash and cash equivalents at $487.9 million and marketable securities at $394.9 million, totaling $882.8 million Immunocore Holdings plc Condensed Consolidated Balance Sheets (Unaudited, in thousands of USD) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $487,933 | $455,731 | | Marketable securities | $394,878 | $364,645 | | Accounts receivable, net | $69,761 | $63,009 | | Prepaid expenses and other current assets | $44,270 | $41,033 | | Inventories, net | $5,456 | $5,446 | | **Total current assets** | **$1,002,298** | **$929,864** | | Property and equipment, net | $9,548 | $10,092 | | Operating lease right-of-use assets, net | $39,428 | $37,643 | | Deferred tax assets, net | $14,077 | $14,790 | | Other non-current assets | $17,036 | $17,117 | | **Total assets** | **$1,082,387** | **$1,009,506** | | **Liabilities and Shareholders’ Equity** | | | | Accounts payable | $23,856 | $25,100 | | Accrued expenses and other current liabilities | $143,785 | $185,534 | | Deferred revenue, current | $0 | $0 | | Operating lease liabilities, current | $1,843 | $1,547 | | **Total current liabilities** | **$170,078** | **$212,181** | | Accrued expenses, non-current | $83,960 | $0 | | Deferred revenue, non-current | $5,247 | $5,434 | | Operating lease liabilities, non-current | $42,561 | $40,162 | | Interest-bearing loans and borrowings | $392,060 | $391,013 | | **Total liabilities** | **$693,906** | **$648,790** | | Ordinary shares | $135 | $135 | | Deferred shares | $1 | $1 | | Additional paid-in capital | $1,215,997 | $1,190,104 | | Accumulated deficit | ($801,038) | ($795,761) | | Accumulated other comprehensive loss | ($26,614) | ($33,763) | | **Total shareholders’ equity** | **$388,481** | **$360,716** | | **Total liabilities and shareholders’ equity** | **$1,082,387** | **$1,009,506** | [Summary Condensed Consolidated Statements of Cash Flows](index=13&type=section&id=Summary%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash provided by operating activities was $26.4 million, net cash used in investing activities was $20.712 million, and net cash provided by financing activities was $6.221 million, with cash and cash equivalents totaling $487.9 million at period end Immunocore Holdings plc Summary Condensed Consolidated Statements of Cash Flows (Unaudited, in thousands of USD) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents at beginning of period | $455,731 | $442,626 | | Net cash provided by operating activities | $26,399 | $18,885 | | Net cash used in investing activities | ($20,712) | ($350,761) | | Net cash provided by financing activities | $6,221 | $395,194 | | Net effect of exchange rate changes on cash | $20,294 | ($959) | | **Cash and cash equivalents at end of period** | **$487,933** | **$504,985** |
Immunocore(IMCR) - 2025 Q2 - Quarterly Report
2025-08-07 11:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number: 001-39992 Immunocore Holdings plc (Exact name of registrant as specified in its charter) | England and Wales | Not Ap ...
Immunocore to report second quarter 2025 financial results and host call on August 7, 2025
Globenewswire· 2025-07-31 06:00
Core Viewpoint - Immunocore Holdings plc is set to report its second quarter financial results on August 7, 2025, and will host a teleconference to discuss these results and provide a business update [1][2]. Company Overview - Immunocore is a commercial-stage biotechnology company focused on developing TCR bispecific immunotherapies, known as ImmTAX, aimed at treating various diseases including cancer, autoimmune diseases, and infectious diseases [4]. - The company's leading oncology product, KIMMTRAK, is approved for treating HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in multiple regions including the US, EU, Canada, Australia, and the UK [4]. Upcoming Events - A live teleconference and webcast will occur on August 7, 2025, at 8:00 a.m. EDT to discuss the financial results and provide updates on the business and portfolio [2][3]. Contact Information - For inquiries, Immunocore's VP of Communications is Sébastien Desprez, reachable at +44 (0) 7458030732 or via email at sebastien.desprez@immunocore.com [7]. - Investor relations can be contacted through Clayton Robertson or Morgan Warenius at +1 (215) 384-4781 or ir@immunocore.com [7].
Wall Street Analysts See a 72.34% Upside in Immunocore (IMCR): Can the Stock Really Move This High?
ZACKS· 2025-07-24 14:56
Core Viewpoint - Immunocore Holdings PLC (IMCR) has shown a significant price increase of 12.6% over the past four weeks, with a mean price target of $62.13 indicating a potential upside of 72.3% from the current price of $36.05 [1] Price Targets and Analyst Consensus - The average price target for IMCR is based on 15 short-term estimates, ranging from a low of $24.00 to a high of $100.00, with a standard deviation of $22.46, indicating variability in analyst predictions [2] - The lowest estimate suggests a decline of 33.4%, while the highest indicates a potential upside of 177.4% [2] - Analysts' price targets should be approached with caution, as their reliability has been questioned in empirical research [3][7] Earnings Estimates and Analyst Agreement - There is strong agreement among analysts regarding IMCR's ability to report better earnings than previously predicted, which supports the view of potential upside [4] - The Zacks Consensus Estimate for the current year has increased by 20.4% over the past month, with no negative revisions [12] - IMCR holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimates [13] Implications of Price Movement - While the consensus price target may not be a reliable indicator of the extent of potential gains, it does provide a directional guide for price movement [14]