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Immunocore(IMCR) - 2023 Q2 - Earnings Call Transcript
2023-08-10 17:26
Financial Data and Key Metrics Changes - Net KIMMTRAK revenue increased to $57.8 million in Q2 from $52 million in Q1, representing an 11% quarter-over-quarter growth and a year-to-date revenue of $111 million [7][22][46] - The net loss for the period was approximately $18 million, with SG&A expenses year-to-date around $60 million [8][49] - The cash position of the company increased to $435 million, driven by KIMMTRAK revenue and disciplined expense management [49] Business Line Data and Key Metrics Changes - KIMMTRAK sales in the U.S. saw a 14% demand growth, increasing first-line market share from approximately 50% in Q1 to 60% in Q2 [10][22] - The company launched KIMMTRAK in four additional countries, including Italy, Austria, Finland, and Israel, expanding its market presence [22] Market Data and Key Metrics Changes - KIMMTRAK is now approved in over 35 countries, with reimbursement agreements reached in Germany, expected to be published in September [20][22] - The company anticipates further growth in the U.S. and Italy, with plans to launch in additional European countries by the end of the year [23][64] Company Strategy and Development Direction - The company is committed to expanding its oncology pipeline, with plans to submit three INDs or CTAs over the next 18 months, starting with PIWIL-targeted candidates in Q4 [18][64] - The first Phase 3 trial for the PRAME-targeted therapy is set to begin by Q1 2024, focusing on advanced cutaneous melanoma patients [37][61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing educational efforts to support KIMMTRAK therapy, which is expected to drive further growth [23] - The company remains focused on making KIMMTRAK available to over 1,000 patients per year by 2025 [25] Other Important Information - The company is exploring a less frequent dosing regimen for KIMMTRAK based on insights from clinical data, which may enhance patient compliance [80][102] - The company is also investigating the potential for a functional cure for HIV and HBV through ongoing clinical trials [18][65] Q&A Session Summary Question: Plans for Phase 3 in melanoma - Management confirmed that the decision to start the Phase 3 study was based on positive data from ESMO and ongoing expansion cohort data [40][41] Question: Market size comparison for gp100 versus PRAME - Management highlighted that the accessible market for PRAME in first-line treatment is greater than 10,000 patients per year, compared to 2,000 to 4,000 for KIMMTRAK in second-line treatment [73] Question: Efficacy changes based on Phase 2 data - Management indicated that the Phase 2 data could inform changes to the Phase 3 design, including potential discontinuation of less effective arms [79] Question: Less frequent dosing rationale - The decision for less frequent dosing was influenced by KIMMTRAK's experience and the observation that most progression occurs within the first 12 weeks of treatment [80][102] Question: Initial data expectations for HIV program - Management outlined that initial data will include safety and biomarkers during the first 12-week treatment period, followed by a virus rebound assessment after ART withdrawal [96]
Immunocore(IMCR) - 2023 Q2 - Quarterly Report
2023-05-10 11:27
Exhibit 99.1 Immunocore Holdings plc Unaudited Condensed Consolidated Interim Financial Statements | | Notes | £'000 | £'000 | £'000 | £'000 | £'000 | £'000 | £'000 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | At January 1, 2022 | | 88 | 212,238 | 89 | 54,357 | 386,167 | (481,392) | 171,547 | | Loss for the period | | — | — | — | — | — | (16,128) | (16,128) | | Other comprehensive | | | | | | | | | | income | | — | — | 205 | — | — | — | 205 | | Total comprehensive | | | | | | | | | | loss for ...
Immunocore (IMCR) Investor Presentation - Slideshow
2023-03-10 12:33
▸ CM: all received prior anti-PD1 and anti-CTLA4 IMC-F106C was well tolerated Most frequent related AE was Grade 1/2 CRS, consistent with proposed mechanism | --- | --- | --- | --- | |----------------------------------------------|--------------------------------|-----------------------|------------| | Preferred Term (MedDRA v23.1) | 0.3 – 10 mcg † N=18 | 20 – 320 mcg † N=37 | Total N=55 | | All grades events in ≥ 25% of patients , n % | | | | | At least one event | 18 (100) | 34 (92) | 52 (95) | | Pyrexia* ...
Immunocore(IMCR) - 2022 Q4 - Earnings Call Transcript
2023-03-01 18:33
Immunocore Holdings plc (NASDAQ:IMCR) Q4 2022 Earnings Conference Call March 1, 2023 8:00 AM ET Company Participants Clayton Robertson - Head of Investor Relations Bahija Jallal - Chief Executive Officer & Director Ralph Torbay - Head of Commercial Brian Di Donato - Chief Financial Officer & Head of Strategy David Berman - Head of Research & Development Conference Call Participants Michael Yee - Jefferies Patrick Trucchio - H.C. Wainwright Justin Kim - Oppenheimer Justin Zelin - BTIG Peter Lawson - Barclays ...
Immunocore(IMCR) - 2022 Q4 - Annual Report
2023-03-01 14:13
Financial Performance - The company incurred net losses of £41.2 million, £131.5 million, and £74.1 million for the years ended December 31, 2022, 2021, and 2020, respectively, with an accumulated deficit of £261.3 million as of December 31, 2022[36]. - The company expects to continue incurring significant expenses and operating losses over the next several years, impacting shareholder equity and net assets[38]. - As of December 31, 2022, the company reported working capital of £308.8 million and cash and cash equivalents of £332.5 million, expected to meet liabilities until 2026[50]. - The company anticipates substantial additional funding will be required to support research, clinical trials, and commercialization efforts, with inflation impacting costs more noticeably in 2023 and beyond[49][54]. - The company may need to seek additional capital sooner than planned due to potential revenue shortfalls or changes in its operating plan[50][54]. Product Development and Commercialization - The company is heavily dependent on the success of KIMMTRAK and future product candidates, with revenues potentially reduced by drug pricing reforms requiring rebates[33]. - The commercialization strategy for KIMMTRAK is critical, with the company focusing substantial resources on its marketing and sales efforts in the United States and Europe[43]. - The company anticipates that its expenses will increase substantially as it seeks to develop and commercialize additional products[41]. - The ability to generate revenues from KIMMTRAK is contingent on market acceptance among physicians, patients, and healthcare payers[44]. - The company must continue to develop its commercial organization to effectively market KIMMTRAK, which requires significant resources and time[56]. Regulatory and Competitive Landscape - The company has received regulatory approval for KIMMTRAK for mUM in the United States and the European Union, but lacks approvals for other indications or product candidates[37]. - The company faces substantial competition, which may hinder its ability to successfully develop and commercialize its product candidates[35]. - The company is subject to various risks, including regulatory challenges and the need to protect its intellectual property, which could adversely affect its business[35]. - The company faces risks from drug pricing reforms and potential rebates that could reduce revenues from KIMMTRAK, particularly in the US starting Q4 2023[47][48]. - The company is aware of competitors developing similar therapies, which could affect the market position of its product candidates[149]. Clinical Trials and Research - The company is evaluating the safety of IMC-F106C in patients with advanced solid tumors, estimating up to 150,000 patients worldwide may benefit from this program[60]. - The company is also assessing IMC-M113V for chronic HIV patients, with over one million globally testing positive for HLA-A*02:01[61]. - Health epidemics, including COVID-19, have materially impacted the company's business operations, clinical trials, and supply chain[70]. - The company may experience delays in clinical trials due to health crises, affecting patient enrollment and site initiation[75]. - The company acknowledges the high attrition rate in clinical trials, with many product candidates failing to receive regulatory approval despite initial successes[111]. Manufacturing and Supply Chain - The company relies on third-party vendors for clinical trials and manufacturing, which may lead to less control over timelines and potential delays[91][92]. - The manufacturing facility in the United States has been approved by the FDA and other international regulatory authorities for the production of KIMMTRAK[135]. - The company relies on third-party manufacturers for portions of its commercial products, which poses risks if those manufacturers fail to meet contractual obligations[144]. - The active pharmaceutical ingredients (API) used in product candidates are supplied from single-source suppliers, posing a risk if any supplier ceases operations, which could significantly harm the business[185]. - The complexity of manufacturing processes may lead to difficulties in producing sufficient quantities of KIMMTRAK at acceptable costs[140]. Intellectual Property and Legal Risks - The company seeks to protect its proprietary technology through patent applications, but the patent landscape is uncertain and may not provide adequate protection against competitors[196]. - The patent protection for product candidates may be limited, and the lifespan of patents could expire before commercialization, affecting competitive advantage[197]. - The company may face claims from former employees asserting ownership rights in patents or applications, which could jeopardize its intellectual property[203]. - Legal proceedings regarding intellectual property rights could materially affect the company's ability to commercialize its product candidates[212]. - The company may face difficulties in enforcing intellectual property rights globally due to varying patent laws and potential compulsory licensing in foreign jurisdictions[223].
Immunocore(IMCR) - 2023 Q1 - Quarterly Report
2023-03-01 13:06
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 program 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 half-life extension IND planned for first- ...
Immunocore (IMCR) Investor Presentation - Slideshow
2023-01-12 16:19
| --- | --- | --- | --- | --- | --- | --- | --- | |-------|-------|-------|-------|-------|--------------|-------------------------------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Patients | Transformative Medicines for | | | | | | | | | | | | | | | | | JANUARY 2023 | | | Forward-looking statement This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "can," "will," "believe," "ex ...
Immunocore Holdings (IMCR) Investor Presentation - Slideshow
2022-11-15 19:20
KIMMTRAK (Tebentafusp) Achievements and Commercial Launch - KIMMTRAK received FDA approval as the first TCR therapeutic for metastatic uveal melanoma (mUM)[10, 61] - KIMMTRAK is the first T-cell engager to demonstrate an Overall Survival (OS) benefit in solid tumors[61] - KIMMTRAK has been approved in over 30 countries, including the US, UK, EU, Australia, and Canada[10, 62, 70] - Immunocore reported $465 million in KIMMTRAK net revenue for the first half of 2022[62] - In the US, over 60% of patients are now receiving KIMMTRAK as a first-line treatment[64] Clinical Trial Updates and Pipeline - A Phase 2/3 study of Tebentafusp for previously treated advanced melanoma patients is expected to begin in Q4 2022[10, 23, 24] - Phase 1 data for IMC-F106C (targeting PRAME) was presented at ESMO, with expansion arms initiated for cutaneous melanoma, ovarian, NSCLC, and endometrial cancers[10] - Initial Phase 1 data for IMC-I109V (targeting Hepatitis B Virus) was presented at EASL[10] - Phase 1 trial of IMC-M113V (targeting HIV) has been initiated in 2022[10, 60] PRAME and MAGE-A4 Programs - IMC-F106C demonstrated strong and consistent pharmacodynamic activity at doses ≥20 mcg[31] - Responses were observed in multiple tumor types in the IMC-F106C PRAME Phase 1 study, including cutaneous melanoma, uveal melanoma, ovarian cancer, endometrial cancer and NSCLC[36] - Reduction in circulating tumor DNA (ctDNA) was observed across tumor types in the IMC-F106C study, with 90% showing any reduction[40]
Immunocore (IMCR) Presents at ESMO Congress 2022
2022-09-09 19:46
#728O Phase 1 dose escalation of IMC-F106C, the first PRAME × CD3 ImmTAC bispecific protein in solid tumors Omid Hamid, 1 Takami Sato,2 Diwakar Davar,3 Margaret Callahan,4 Fiona Thistlethwaite,5 Raid Aljumaily,6 Melissa Johnson,7 Hendrik-Tobias Arkenau,8 Ecaterina Dumbrava,9 Benjamin Izar,10 Hui Amy Chen,11 Shannon Marshall,12 Yuan Yuan,12 Mugdha Deo,12 Sarah Stanhope,12 Laura Collins,12 Renee Mundy,12 Shaad Abdullah,12 Juanita Lopez13 1The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate, Lo ...
Immunocore(IMCR) - 2022 Q2 - Earnings Call Presentation
2022-08-11 05:35
KIMMTRAK (Tebentafusp-tebn) - KIMMTRAK is the first T-cell engager to show Overall Survival (OS) in solid tumors and the first and only FDA-approved treatment for metastatic uveal melanoma (mUM)[6] - The Phase 3 IMCgp100-202 study showed that KIMMTRAK significantly improved overall survival (OS) with a hazard ratio (HR) of 0.51 (95% CI, 0.37-0.71; P ≤ 0.0001) compared to investigator's choice in first-line treatment of mUM[19] - In the IMCgp100-202 study, 99.6% of patients treated with KIMMTRAK experienced adverse reactions of any grade, while 45% experienced grade 3 or 4 adverse reactions[20] - KIMMTRAK has regulatory approvals in 30 countries, including the US, UK, EU, Australia, and Canada[79] - Immunocore estimates ~1,000 patients per year in the US and initial priority European markets[73] Pipeline and Technology - Immunocore is pioneering soluble, off-the-shelf, bispecific therapeutics (ImmTAX) that can target >90% of the human proteome, applicable to oncology, infectious disease, and autoimmune diseases[15, 16] - IMC-C103C, targeting MAGE-A4, has shown clinical activity in MAGE-A4 positive ovarian and HNSCC, with potential for >75,000 patients/year (G7)[48, 39, 51] - IMC-F106C targets PRAME, with potential for >150,000 patients/year (G7)[56] - Initial Phase 1 data for IMC-F106C (PRAME) is expected in Q3 2022, and an update on IMC-C103C (MAGE A4) Phase 1 data is expected in Q4 2022[76] Financials - Immunocore had approximately $393 million in adjusted cash and cash equivalents[76]