Core Insights - Immunocore reported a strong revenue performance in Q1 2025, with net revenues of $93.9 million, reflecting a 33% year-over-year growth, primarily driven by the sales of KIMMTRAK [1][2][3] Financial Results - Total net product revenue from KIMMTRAK was $93.9 million in Q1 2025, an increase from $70.3 million in Q1 2024, with $56.6 million generated in the United States, $32.8 million in Europe, and $4.5 million in international regions [3][24] - Research and development expenses for Q1 2025 were $56.5 million, slightly down from $57.5 million in Q1 2024, while selling, general, and administrative expenses increased to $40.2 million from $39.3 million [4][25] - The company achieved a net income of $5.0 million in Q1 2025, compared to a net loss of $24.4 million in the same period in 2024, with basic and diluted income per share at $0.10, up from a loss of $(0.49) [5][20] Product and Market Updates - KIMMTRAK is approved in 39 countries and launched in 26 countries for HLA-A*02:01 positive patients with metastatic uveal melanoma, continuing to be the standard of care in most markets [6][36] - The company is focusing on three key growth areas for KIMMTRAK: global expansion in metastatic uveal melanoma, potential expansion into second-line advanced cutaneous melanoma, and adjuvant uveal melanoma [7] - KIMMTRAK net product sales in the U.S. grew by 13% year-over-year, with increased demand driven by community outreach and new country launches in Europe and international regions [8] Research and Development Progress - Immunocore is on track for the Phase 3 TEBE-AM trial to complete enrollment in the first half of 2026 and for dose selection in the Phase 3 PRISM-MEL-301 trial in the second half of 2025 [1][14] - Initial multiple ascending dose data for the HIV functional cure candidate was presented at CROI 2025, with ongoing dose escalation [1][22] - The company is advancing its PRAME portfolio, with brenetafusp being evaluated in combination with nivolumab in a Phase 3 trial for first-line advanced cutaneous melanoma [10][15]

Core Viewpoint - Immunocore Holdings PLC (IMCR) has seen a 6.4% increase in share price over the past four weeks, closing at $30.47, with analysts suggesting a potential upside of 107.5% based on a mean price target of $63.21 [1] Price Targets - The average of 14 short-term price targets ranges from a low of $24 to a high of $100, with a standard deviation of $23.20, indicating variability among analysts [2] - The lowest estimate suggests a decline of 21.2% from the current price, while the highest estimate indicates a potential upside of 228.2% [2] Analyst Consensus and Earnings Estimates - Analysts are increasingly optimistic about IMCR's earnings prospects, as evidenced by a strong agreement in revising EPS estimates higher, which correlates with potential stock price increases [4][11] - The Zacks Consensus Estimate for the current year has risen by 3.9% over the past month, with one estimate increasing and no negative revisions [12] Zacks Rank - IMCR holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside [13]

Company Overview - Immunocore Holdings PLC shares ended the last trading session 6% higher at $30.43, following a period of 3.6% loss over the past four weeks, indicating a significant price movement driven by higher-than-average trading volume [1] - The company presented encouraging initial data from the phase I/II STRIVE study for its functional cure candidate, IMC-M113V, for treating HIV, showing well-tolerated treatment and dose-dependent viral control after interruption of antiretroviral treatment [2] Financial Expectations - The company is expected to report a quarterly loss of $0.35 per share, reflecting a year-over-year change of +28.6%, with revenues projected at $86.81 million, up 23.1% from the previous year [3] - The consensus EPS estimate for the quarter has been revised 30.6% lower over the last 30 days, indicating a negative trend in earnings estimate revisions, which typically does not correlate with price appreciation [4] Industry Context - Immunocore is part of the Zacks Medical - Biomedical and Genetics industry, where another company, Adherex Technologies Inc., has a consensus EPS estimate change of +32.4% to -$0.12, representing a year-over-year change of -129.3% [4][5]

Core Insights - Immunocore presented initial data from the multiple ascending dose (MAD) portion of its Phase 1/2 STRIVE trial for IMC-M113V, a functional cure candidate for HIV, at CROI 2025, indicating the treatment is well tolerated and shows potential for viral control after antiretroviral treatment interruption [1][2][3] Group 1: Trial Data and Results - The MAD trial included 16 participants living with HIV who were stable on antiretroviral therapy (ART), with doses evaluated at 60 mcg, 120 mcg, and 300 mcg over 12 weeks, followed by a treatment interruption for up to 12 weeks [4][10] - No serious adverse events or dose-limiting toxicities were reported, with mild cytokine release syndrome observed in five participants at the highest dose [5][6] - Among 15 evaluable participants, delayed viral rebound was noted in 0 of 5 at 60 mcg, 1 of 5 at 120 mcg, and 2 of 5 at 300 mcg, with the historical rate for such observations being 5% [7][8] Group 2: Mechanism and Objectives - IMC-M113V employs a T cell receptor that targets HIV-infected immune cells, aiming to eliminate CD4+ cells containing integrated HIV DNA [10] - The STRIVE trial's objectives include establishing safe dosing regimens alongside ART and quantifying antiviral activity, specifically post-treatment viral control [11][13] Group 3: Future Directions - The company is advancing its clinical candidates to achieve a functional cure for HIV and aims for sustained control of the virus after ART cessation without virological relapse [13][14] - Further data from the trial at higher doses is anticipated, contributing to broader efforts to enable individuals with HIV to maintain health without lifelong ART [3][12]

Core Insights - Immunocore Holdings is a biotech company focused on immunotherapy in oncology, gaining attention for its novel treatment approach to rare skin cancers approved in 2022 [1] Company Overview - Immunocore Holdings operates in the oncology space, specifically targeting immunotherapy solutions [1] Recent Developments - The company made a significant impact with the approval of a new treatment for rare skin cancers, marking a pivotal moment in its development [1]

Financial Data and Key Metrics Changes - For the full year 2024, Immunocore reported total revenues of $310 million, representing a 30% year-on-year growth [8][51] - In Q4 2024, net revenues reached $84.1 million, a 5% increase from Q3 2024 [16][51] - The United States accounted for $206 million of the total revenue, growing at an impressive 34% year-on-year [17] Business Line Data and Key Metrics Changes - KymTrak achieved 30% year-on-year revenue growth, with $310 million in net revenues for 2024 [8][16] - KymTrak's Q4 revenues were $84.1 million, reflecting a 5% increase from the previous quarter [16][51] - The company launched KymTrak in 14 new countries in 2024, bringing the total to 39 countries [15] Market Data and Key Metrics Changes - The US market penetration for KymTrak is estimated at around 65%, with nearly half of new patients starting treatment in community settings [17][104] - The reimbursement environment in Europe remains challenging, impacting revenue recognition [52][67] Company Strategy and Development Direction - The company is focused on expanding KymTrak's market presence and exploring new therapeutic areas, including autoimmune diseases and infectious diseases [11][12] - Immunocore is advancing its clinical pipeline with three ongoing phase three trials and two phase one trials [9][26] - The company aims to leverage its modular technology to tackle autoimmune diseases and expand its therapeutic offerings [11][38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in KymTrak's potential for incremental growth in 2025, driven by community expansion and new launches [18][54] - The company anticipates increased R&D expenses as it advances its clinical pipeline [52][55] - Management highlighted a strong financial position with $820 million in cash and marketable securities at the end of 2024 [56] Other Important Information - The company initiated two phase one trials in 2024 and completed a single ascending dose trial for HBV [11][26] - Management emphasized the importance of data-driven investments and disciplined spending to support growth [56] Q&A Session Summary Question: Upcoming HIV results and patient follow-up - All patients will be off therapy for twelve weeks to assess antiviral activity and viral reservoir reduction [63] - A good rate of success would be suppression of viral copies to less than 200 copies per ml for 20-30% of patients [65] Question: European sales adjustments - The reimbursement environment in Europe is challenging, with ongoing price negotiations affecting sales [67] Question: Factors for determining go-forward dose in HIV - Factors include tolerability, evidence of antiviral activity, and potential need for dose optimization [71] Question: Duration of patient follow-up in HIV trials - Patients will be followed for twelve weeks to assess antiviral control, with potential for longer follow-up [78] Question: Updates on branetafus and patient follow-up - Patients in the dose selection analysis will be followed for eight to twelve weeks to assess safety and initial response [84] Question: Safety and tolerability profile in non-oncology settings - Mild cytokine release syndrome is expected in infectious disease settings, while autoimmune treatments should avoid systemic immune suppression [90] Question: Business development opportunities for 2025 - The company is continuously looking for strategic partnerships to enhance portfolio value [100] Question: KymTrak market penetration and treatment duration - KymTrak has achieved 65% market penetration in the US, with ongoing efforts to expand community prescriptions [104] Question: HIV data and potential for combination strategies - The platform is combinable with other therapies, and the goal is to achieve a finite dosing regimen [127] Question: Atopic dermatitis program benchmarks - Initial entry will focus on patients refractory to all therapy to find a signal for efficacy [132] Question: Preclinical data supporting HIV program - Preclinical studies show the ability to redirect T cells to kill HIV-infected cells, providing confidence for the trial [141]

Product Development and Approval - KIMMTRAK has been approved in 39 countries for the treatment of unresectable or metastatic uveal melanoma, with launches in 24 countries as of December 31, 2024[610]. - The company has treated over 2,000 cancer patients with KIMMTRAK and other ImmTAX product candidates, representing a significant clinical data set in solid tumors[611]. - The company received regulatory approval for KIMMTRAK in Brazil in February 2025[618]. - The company plans to submit a CTA or IND for its second autoimmune candidate, IMC-U120AI, in 2026 for a Phase 1 trial in atopic dermatitis[616]. Financial Performance - Total revenue for the year ended December 31, 2024, was $310.2 million, a 24% increase from $249.4 million in 2023[638]. - Revenue from the sale of therapies, net, was $310.0 million, with $226.7 million from the United States, $73.2 million from Europe, and $10.1 million from International, reflecting a 30% increase year-over-year[639]. - Collaboration revenue decreased by 98% to $0.2 million in 2024, down from $10.7 million in 2023, due to the closure of a Phase 1 clinical trial[640]. Expenses and Losses - Net losses for the years ended December 31 were $51.1 million in 2024, $55.3 million in 2023, and $52.5 million in 2022, with an accumulated deficit of $795.8 million as of December 31, 2024[613]. - The company expects to continue incurring significant operating losses and expenses as it advances product candidates through clinical development and seeks regulatory approvals[614]. - Research and development expenses are anticipated to increase as the company advances existing and future product candidates into clinical studies[624]. - R&D expenses for the year ended December 31, 2024, totaled $222.2 million, a 36% increase from $163.5 million in 2023, driven by increased spending on PRAME and tebentafusp programs[642]. - SG&A expenses increased to $155.8 million in 2024, up 8% from $144.5 million in 2023, primarily due to the internalization of the U.S. sales force[646]. Cash Flow and Funding - Cash and cash equivalents increased to $455.7 million as of December 31, 2024, compared to $442.6 million in 2023, with marketable securities of $364.6 million[652]. - Net cash provided by operating activities was $26.1 million for the year ended December 31, 2024, significantly up from $2.9 million in 2023[658]. - Net cash used in investing activities increased to $355.1 million for the year ended December 31, 2024, from $5.4 million in 2023, primarily due to purchases of marketable securities of $350.0 million[659]. - Net cash provided by financing activities rose to $343.9 million in 2024, compared to $34.3 million in 2023, driven by net cash proceeds of $389.1 million from the offering of Notes after deducting issuance costs of $13.4 million[660]. - The company has raised funds through various means, including an initial public offering and private placements, to support operations and R&D activities[612]. - The company may need additional funding to support continued operations and pursue its clinical development and growth strategy[614]. - Future funding requirements may increase significantly due to various factors, including the progress and costs of clinical trials and the ability to commercialize product candidates[664]. - The company intends to explore additional financing opportunities to support long-term clinical development, depending on favorable market conditions[663]. Tax and Credit - The U.K. R&D tax credit regime allows the company to claim credits under the R&D Expenditure Credit program, with potential cash rebates increasing from 10.5% to 15% for qualifying R&D expenses incurred after April 1, 2023[627]. - Total accrued revenue deductions as of December 31, 2024, were $110.9 million, with $103.9 million subject to greater estimation uncertainty[681]. - A 20% increase or decrease in expected rebate and chargeback percentages could result in a $20.8 million reduction or increase in revenue from therapy sales for the year ended December 31, 2024[682]. Financial Position and Risks - The company reported an accumulated deficit of $795.8 million as of December 31, 2024[651]. - Cash and cash equivalents totaled $455.7 million, with marketable securities of $364.6 million as of December 31, 2024, expected to fund operating expenses for at least twelve months[663]. - The company has material contractual lease obligations potentially resulting in payments of up to $65.6 million, with lease terms extending to 2043[667]. - Existing manufacturing obligations could result in payments of up to $27.7 million, expected to increase as the company advances the development of its brenetafusp program in 2024 and beyond[668]. - Credit risk exposure is primarily from accounts receivable, cash and cash equivalents, and marketable securities held with high-quality financial institutions[692]. - The company continually monitors credit quality and does not anticipate non-performance from financial institutions and corporations[693].

Core Insights - Immunocore Holdings plc reported Q4 net sales of $84.1 million and full-year sales of $310.0 million for 2024, with continued growth expected in 2025 [1][9][28] - The company has achieved 11 consecutive quarters of revenue growth for KIMMTRAK (tebentafusp), with significant expansion in the U.S. and launches in 14 new territories outside the U.S. [4][7] - Immunocore is advancing its clinical pipeline with multiple Phase 3 trials and new candidates targeting various cancers and autoimmune diseases [5][6][12] Financial Performance - Q4 2024 net sales of KIMMTRAK were $84.1 million, with $63.8 million from the U.S., $17.8 million from Europe, and $2.5 million from international regions [9][28] - Full-year 2024 net sales totaled $310.0 million, an increase from $238.7 million in 2023, reflecting a 30% year-on-year growth [9][28] - R&D expenses for 2024 were $222.2 million, up from $163.5 million in 2023, driven by the advancement of clinical trials [10][30] - SG&A expenses increased to $155.8 million in 2024 from $144.5 million in 2023, primarily due to growth in business support functions [31] Clinical Development - The company is executing on KIMMTRAK lifecycle management with two Phase 3 trials (TEBE-AM and ATOM) for additional melanoma indications [1][4] - The first patient was randomized in the Phase 3 PRISM-MEL-301 trial for brenetafusp in advanced cutaneous melanoma, with ongoing enrollment in other trials for ovarian cancer and NSCLC [5][15] - Immunocore plans to file clinical trial applications for new candidates targeting type 1 diabetes and atopic dermatitis in the coming years [29] Cash Position - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $820.4 million [11][32] - The company repaid its existing Pharmakon loan of $50.0 million in November 2024, strengthening its financial position [11][32]

Core Viewpoint - Immunocore Holdings plc, a biotechnology company focused on immunomodulating medicines, will report its financial results for Q4 and the year ended December 31, 2024, on February 26, 2025 [1]. Company Overview - Immunocore is pioneering a novel class of TCR bispecific immunotherapies known as ImmTAX, aimed at treating various diseases including cancer, autoimmune diseases, and infectious diseases [4]. - The company has developed a deep pipeline across multiple therapeutic areas, with its leading oncology TCR therapeutic, KIMMTRAK, already approved for treating HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in several regions including the US, EU, Canada, Australia, and the UK [4]. Upcoming Events - Following the financial results announcement, the company will host a live teleconference and webcast on February 26, 2025, at 8:00 a.m. EST to discuss the results and provide a business update [2]. - The webcast will be accessible through the company's website, and a replay will be available for a limited time after the event [3]. Contact Information - For inquiries, Immunocore's Head 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].

Core Viewpoint - Investors are expected to focus on the sales performance of Immunocore Holdings plc's sole marketed drug, Kimmtrak, during the upcoming fourth-quarter 2024 results, with a consensus estimate of $83.5 million in revenue and a loss of 40 cents per share [1]. Group 1: Sales Performance and Market Presence - Kimmtrak is approved in 38 countries and has been launched in 21 countries, serving as the standard of care for metastatic uveal melanoma (mUM) in most markets where it is available [3]. - Revenue for the upcoming quarter is anticipated to be driven by increased sales of Kimmtrak in the U.S. and other markets due to strong demand [4]. - The company aims to expand its reach to more mUM patients globally by 2025 through additional launches and increased community penetration [5]. Group 2: Pipeline and Development - Immunocore is developing brenetafusp in combination with Bristol Myers' Opdivo for treating first-line advanced cutaneous melanoma, with studies also targeting other cancer indications [5]. - The company has a robust pipeline with nine active clinical and pre-clinical programs across oncology, infectious diseases, and autoimmune diseases, with updates expected in the upcoming earnings call [8]. Group 3: Earnings Performance and Predictions - Immunocore has a mixed history of earnings surprises, having beaten earnings estimates in two of the last four quarters, with an average surprise of 25.57% [9]. - The company's Earnings ESP is +20.57%, indicating a potential earnings beat, with the most accurate estimate at a loss of 32 cents compared to the consensus estimate of a loss of 40 cents [11].