Core Insights - Er-Kim has been appointed by Immunocore as the distribution and commercialization partner for KIMMTRAK in Turkey and the MENA, Caucasus, and CIS regions [1][3] - KIMMTRAK is a treatment for HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma, a rare and aggressive form of melanoma [1][2][4] - The partnership aims to improve access to innovative cancer treatments in regions with high unmet medical needs [3] Company Overview - Er-Kim, established in 1981, specializes in biopharmaceutical innovation and has partnered with over 40 global leaders [3] - The company has a reach of over 600 million patients and generates revenues exceeding EUR 305 million [3] - Er-Kim employs over 300 professionals worldwide and focuses on sustainable and flexible business models [3] Product Information - KIMMTRAK (tebentafusp) is approved in certain countries as a monotherapy for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma [4] - The availability and prescribing conditions for KIMMTRAK may vary by country [4]

KIMMTRAK® - KIMMTRAK® is the global standard of care for HLA-A*02:01-positive patients with 1L mUM, expecting continued moderate growth in 2025[19, 23] - Q1 2025 net sales for KIMMTRAK® reached $94 million, including $6 million of one-time favorable adjustments[20, 23] - A Phase 3 trial (TEBE-AM) is underway for 2L+ advanced cutaneous melanoma, targeting an enrollment completion in 1H 2026, addressing a market opportunity of up to 4,000 patients[16, 27, 29] - The ATOM Phase 3 trial is designed for adjuvant uveal melanoma, targeting ~1,200 patients, with the first patient randomized in Q4 2024[16, 34, 35] - KIMMTRAK® has the potential to help up to 6,000 patients per year across various melanoma indications[36] PRAME Portfolio - Brenetafusp, targeting PRAME-A02, is in Phase 1/2 development for NSCLC and additional solid tumors[16] - Phase 3 PRISM-MEL-301 trial is randomizing for Cutaneous Melanoma[44] - In a Phase 1 ovarian cancer trial, 94% of monotherapy patients and 81% of chemo combination patients were PRAME positive[70, 72] Infectious Diseases - IMC-M113V3, targeting Gag-A02, is in Phase 1/2 development for Human Immunodeficiency Virus (HIV)[16] - There are 40 million people living with HIV (PLWH)[103] - Initial cohorts (n=16) of dose escalation presented at CROI 2025 showed IMC-M113V is well tolerated, with only low grade cytokine release syndrome[113, 114] Autoimmune Diseases - IMC-S118AI (PPI-A02 x PD1) for Type 1 Diabetes is expected to submit CTA/IND in 2H 2025[16, 133] - IMC-U120AI (CD1a x PD1) for Atopic Dermatitis is expected to submit CTA/IND in 2026[16] Financial Position - The company's Q1 2025 cash position is $837 million[150]

Summary of Immunocore Holdings (IMCR) 2025 Conference Call Company Overview - **Company**: Immunocore Holdings (IMCR) - **Focus**: Development and commercialization of innovative therapies for cancer and infectious diseases, particularly in uveal melanoma and cutaneous melanoma Key Points Financial Performance - **ChemTrak Revenue**: Achieved net revenues of $94 million in Q1, representing a 33% year-over-year increase, marking the twelfth consecutive quarter of growth [6][7] - **One-time Revenue Adjustment**: Recognized a one-time revenue adjustment of $6 million due to finalized pricing agreements in France and Germany [7] Product Pipeline and Growth Strategy - **ChemTrak**: - Expected to exceed $300 million in revenue [2] - Focus on increasing penetration in the U.S. market, currently at 65% for HLA-O2-01 positive metastatic uveal melanoma patients [9] - Plans for new launches in 26 countries, with recent launches in the UK, Poland, and the Netherlands [14] - Duration of therapy is around 12 months, which is an improvement from the clinical trial data of 10 months [16][18] - **Competition**: - Acknowledgment of potential competition from another company, Idea, which is developing an oral therapy for melanoma [29] - Emphasis on ChemTrak being the first approved medicine for HLA-2-01 patients in over 40 years, with a median overall survival of 22 months [32][34] Clinical Trials - **Cutaneous Melanoma Trials**: - Ongoing pivotal Phase 2/3 trial for ChemTrak in combination with pembrolizumab, targeting overall survival as the primary endpoint [43] - Historical one-year survival rate in late-line cutaneous melanoma was 75%, compared to 55% historically [44] - **PRAME Study**: - Phase 3 randomized controlled study of PRAME plus PD-1 in first-line melanoma, with a focus on progression-free survival (PFS) as the primary endpoint [68][90] - Confidence in the study's design based on previous data showing disease stabilization and T-cell fitness improvement [73][81] New Developments - **PWIL Target**: - New TCR bispecific targeting PWIL, expressed in colorectal cancer, gastric, and pancreatic cancers, currently in dose escalation [115] - **HIV Program**: - Ongoing dose escalation studies with promising initial data indicating biological activity [124][126] Additional Insights - **Market Position**: ChemTrak is positioned as the standard of care and the most prescribed medicine across major markets, making it challenging for competitors to displace it [40] - **Long-term Survival Data**: The company has established long-term survival data, with 27% of patients alive at three years, which is unprecedented in this field [36][38] - **Focus on Early Detection**: Efforts are being made to find patients earlier to improve outcomes and duration of therapy [15][24] This summary encapsulates the key discussions and insights from the Immunocore Holdings conference call, highlighting the company's financial performance, product pipeline, clinical trials, and competitive landscape.

Group 1 - Immunocore Holdings PLC (IMCR) shares have increased by 20.2% over the past four weeks, closing at $36.60, with a mean price target of $60.47 indicating a potential upside of 65.2% [1] - The average of 15 short-term price targets ranges from a low of $24 to a high of $100, with a standard deviation of $21.18, suggesting variability in analyst estimates [2] - Analysts show strong agreement on the company's ability to report better earnings than previously predicted, which supports the expectation of an upside [4][11] Group 2 - The Zacks Consensus Estimate for the current year has increased by 42.9% over the past month, with seven estimates revised higher and 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] - While consensus price targets may not be reliable for predicting the extent of gains, they can indicate the direction of price movement, which appears to be a good guide [13]

Core Insights - Immunocore Holdings plc is a commercial-stage biotechnology company focused on developing immunomodulating medicines for cancer, infectious diseases, and autoimmune diseases [1][3] - The company will participate in the 2025 Jefferies Global Healthcare Conference, indicating its ongoing engagement with investors and the healthcare community [1][2] Company Overview - Immunocore is pioneering a novel class of TCR bispecific immunotherapies known as ImmTAX, aimed at treating a wide range of diseases [3] - The company has a robust pipeline with multiple active clinical and pre-clinical programs across oncology, infectious diseases, and autoimmune diseases [3] - KIMMTRAK, Immunocore's leading oncology TCR therapeutic, is 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 [3]

Core Insights - Immunocore's Kimmtrak is experiencing significant sales growth, generating $310 million in 2024, a nearly 30% increase year-over-year, with Q1 2025 sales rising 33.6% to $93.9 million [2][5][8] Company Performance - Immunocore's stock has increased by 5.8% year-to-date, contrasting with a 5.5% decline in the industry [3] - The company has a Zacks Rank 1 (Strong Buy), with narrowed loss per share estimates for 2025 from $1.50 to $0.86 and for 2026 from $1.68 to $1.34 [9] Product Development - Kimmtrak is approved in 39 countries and launched in 26, serving as the standard of care for metastatic uveal melanoma in most markets [1][5] - Ongoing label expansion studies for Kimmtrak aim to target earlier-line settings for melanoma indications [5] - Immunocore is developing brenetafusp in combination with Bristol Myers' Opdivo for first-line advanced cutaneous melanoma, with additional studies across various tumor types [6] Market Context - Bristol Myers' Opdivo recorded $2.26 billion in sales in Q1 2025, highlighting its significance as a growth driver in oncology [7]

Group 1 - Immunocore Holdings PLC (IMCR) closed at $29.06, with a 2.3% gain over the past four weeks, and has a mean price target of $62.29, indicating an upside potential of 114.4% [1] - The average of 14 short-term price targets ranges from a low of $24 to a high of $100, with a standard deviation of $23.44, suggesting variability in analyst estimates [2] - Analysts show strong agreement on the company's ability to report better earnings than previously predicted, which supports the view of potential upside [4][11] Group 2 - The Zacks Consensus Estimate for the current year has increased by 42.9% over the last 30 days, with seven estimates moving higher and 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] - While consensus price targets may not be reliable for predicting the extent of gains, they can indicate the direction of price movement [13]

Core Insights - Immunocore Holdings PLC reported a revenue of $93.88 million for the quarter ended March 2025, reflecting a year-over-year increase of 33.2% [1] - The earnings per share (EPS) for the quarter was $0.10, a significant improvement from -$0.49 in the same quarter last year [1] - The reported revenue exceeded the Zacks Consensus Estimate of $87.06 million by 7.84%, while the EPS surpassed the consensus estimate of -$0.35 by 128.57% [1] Revenue Breakdown - Geographic revenue from the United States was $56.61 million, which fell short of the two-analyst average estimate of $65.33 million [4] - International revenue reached $4.47 million, exceeding the two-analyst average estimate of $2.67 million [4] - Revenue from Europe was $32.80 million, significantly higher than the average estimate of $18.53 million based on two analysts [4] - Overall product revenue netted $93.88 million, surpassing the average estimate of $85.61 million from four analysts [4] Stock Performance - Immunocore's shares have returned +14.4% over the past month, outperforming the Zacks S&P 500 composite's +10.6% change [3] - The stock currently holds a Zacks Rank 2 (Buy), indicating potential for outperformance in the near term [3]

[Q1 2025 Report Overview](index=1&type=section&id=Immunocore%20reports%20first%20quarter%20financial%20results%20and%20provides%20a%20business%20update) The company reports strong Q1 2025 results driven by KIMMTRAK revenue growth and pipeline advancements - Immunocore reported strong Q1 2025 results, highlighted by significant year-over-year revenue growth for its lead product, KIMMTRAK, and progress across its oncology, infectious disease, and autoimmune pipelines[1](index=1&type=chunk)[2](index=2&type=chunk) **Q1 2025 Key Highlights** | Metric | Value | Note | | :--- | :--- | :--- | | KIMMTRAK Net Revenues | $93.9 million | +33% Year-over-Year | | Cash & Marketable Securities | $837 million | As of March 31, 2025 | | Net Income | $5.0 million | Compared to a net loss of $24.4 million in Q1 2024 | | Diluted EPS | $0.10 | Compared to $(0.49) in Q1 2024 | - Key clinical trial milestones are on track, including completing enrollment for the Phase 3 TEBE-AM trial in 1H 2026 and dose selection for the Phase 3 PRISM-MEL-301 trial in 2H 2025[1](index=1&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Results) The company achieved profitability with a $5.0 million net income, driven by a 33% rise in KIMMTRAK sales [Q1 2025 Financial Results](index=2&type=section&id=Q1%202025%20Financial%20Results) The company achieved profitability with a $5.0 million net income, reversing a prior-year loss of $24.4 million **Q1 2025 vs Q1 2024 Financial Summary (in millions)** | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Total Net Revenue | $93.9 | $70.5 | +33.2% | | R&D Expenses | $56.5 | $57.5 | -1.7% | | SG&A Expenses | $40.2 | $39.3 | +2.3% | | Net Income / (Loss) | $5.0 | $(24.4) | N/A | | Diluted EPS | $0.10 | $(0.49) | N/A | | Cash & Marketable Securities | $837.0 | - | - | **KIMMTRAK Q1 2025 Net Sales by Region (in millions)** | Region | Net Sales | | :--- | :--- | | United States | $56.6 | | Europe | $32.8 | | International | $4.5 | | **Total** | **$93.9** | - Growth in Europe was driven by increased demand, new country launches, and a **one-time favorable revenue adjustment of $6.0 million** from price negotiations in France and Germany[10](index=10&type=chunk)[26](index=26&type=chunk) [Business and Pipeline Update](index=2&type=section&id=Business%20and%20Pipeline%20Update) Updates highlight KIMMTRAK's commercial success and progress across the oncology, infectious disease, and autoimmune pipelines [KIMMTRAK® (tebentafusp)](index=2&type=section&id=KIMMTRAK) KIMMTRAK maintains its standard-of-care status for mUM with strong sales and ongoing label expansion trials - KIMMTRAK is now **approved in 39 countries** and launched in 26 for HLA-A*02:01 positive people with metastatic uveal melanoma (mUM)[7](index=7&type=chunk)[10](index=10&type=chunk) - Key growth areas include continued global expansion in mUM, and potential expansions into **2L+ advanced cutaneous melanoma (CM)** and adjuvant uveal melanoma[8](index=8&type=chunk) - The registrational Phase 3 TEBE-AM trial for 2L+ advanced CM is enrolling and expects to **complete enrollment in the first half of 2026**[9](index=9&type=chunk)[14](index=14&type=chunk) - The EORTC is enrolling patients in the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM), targeting a high-risk patient population of up to 1,200[14](index=14&type=chunk)[37](index=37&type=chunk) [Oncology Pipeline](index=3&type=section&id=PRAME%20portfolio) The PRAME franchise leads the oncology pipeline, with brenetafusp advancing in a Phase 3 trial for melanoma - The Phase 3 PRISM-MEL-301 trial is evaluating brenetafusp + nivolumab in 1L advanced cutaneous melanoma, with the company on track to **select the go-forward dose in 2H 2025**[11](index=11&type=chunk)[15](index=15&type=chunk)[33](index=33&type=chunk) - Brenetafusp is also being evaluated in a Phase 1/2 trial in multiple solid tumors, including ovarian and non-small cell lung cancer (NSCLC), in combination with various standard-of-care therapies[11](index=11&type=chunk)[13](index=13&type=chunk) - IMC-P115C, a half-life extended version of brenetafusp designed for less frequent dosing, is enrolling in a Phase 1 dose escalation trial[17](index=17&type=chunk)[18](index=18&type=chunk) - A Phase 1/2 trial is enrolling for IMC-R117C, which targets PIWIL1, for patients with advanced solid tumors including colorectal cancer[18](index=18&type=chunk) [Infectious Disease Pipeline (ImmTAV)](index=4&type=section&id=ImmTAV%20candidates%20for%20a%20functional%20cure%20in%20infectious%20diseases) The ImmTAV platform shows promise for functional cures in HIV and HBV, with positive initial data for its HIV candidate - At CROI 2025, initial data for HIV candidate IMC-M113V showed it was **well-tolerated with no serious adverse events**, and dose escalation is ongoing[1](index=1&type=chunk)[19](index=19&type=chunk) - In the HIV trial, **3 out of 10 evaluable patients at higher doses showed delayed viral rebound** or viremia control during treatment interruption[19](index=19&type=chunk)[24](index=24&type=chunk) - For the HBV candidate, IMC-I109V, the company plans to report data from the single ascending dose portion of its Phase 1 trial in the **second half of 2025**[20](index=20&type=chunk) [Autoimmune Disease Pipeline (ImmTAAI)](index=5&type=section&id=Tissue-specific%20down%20modulation%20of%20the%20immune%20system%20for%20autoimmune%20diseases) The ImmTAAI platform is advancing candidates for type 1 diabetes and atopic dermatitis using tissue-specific immune suppression - The company is on track to file a CTA or IND for **IMC-S118AI (for type 1 diabetes) in the second half of 2025**[25](index=25&type=chunk) - A CTA/IND filing is planned for **2026 for IMC-U120AI**, a universal (non-HLA-restricted) candidate for atopic dermatitis[25](index=25&type=chunk) - The ImmTAAI platform's key differentiator is its ability to suppress pathogenic T cells via PD1 agonism only when tethered to the target tissue, aiming for **localized immune modulation**[21](index=21&type=chunk) [About Immunocore & Technology Platforms](index=6&type=section&id=About%20Immunocore%20%26%20Technology%20Platforms) The company leverages three proprietary TCR technology platforms for cancer, infectious diseases, and autoimmune disorders [Technology Platforms](index=6&type=section&id=Technology%20Platforms) The company's core technologies include ImmTAC®, ImmTAV, and ImmTAAI for distinct therapeutic areas - **ImmTAC® (for Cancer):** Soluble TCRs designed to recognize intracellular cancer antigens and kill cancer cells via an anti-CD3 effector function[28](index=28&type=chunk) - **ImmTAV (for Infectious Diseases):** Novel bispecifics designed to enable the immune system to recognize and eliminate virally infected cells, aiming for functional cures in diseases like HIV and HBV[30](index=30&type=chunk)[31](index=31&type=chunk) - **ImmTAAI (for Autoimmune Diseases):** Novel bispecifics designed for tissue-specific down-modulation of the immune system by suppressing pathogenic T cells via PD1 receptor agonism[32](index=32&type=chunk) [KIMMTRAK® Safety Information](index=9&type=section&id=IMPORTANT%20SAFETY%20INFORMATION) KIMMTRAK carries a boxed warning for Cytokine Release Syndrome and other significant risks like skin reactions - **Boxed Warning - Cytokine Release Syndrome (CRS):** CRS occurred in **89% of patients** (0.8% grade 3/4) and requires monitoring for at least 16 hours after the first three infusions[42](index=42&type=chunk) - **Skin Reactions:** Occurred in **91% of patients**, including rash, pruritus, and cutaneous edema, which may require management with antihistamines or steroids[43](index=43&type=chunk) - **Elevated Liver Enzymes:** Occurred in **65% of patients**, requiring liver function monitoring before and during treatment[44](index=44&type=chunk) - **Embryo-Fetal Toxicity:** KIMMTRAK may cause fetal harm, and patients of reproductive potential should use effective contraception[46](index=46&type=chunk) [Financial Statements](index=13&type=section&id=Financial%20Statements) This section presents the condensed consolidated statements of operations, balance sheets, and cash flows for Q1 2025 [Condensed Consolidated Statement of Operations](index=13&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations) The company reported total revenues of $93.9 million and a net income of $5.0 million for the quarter **Condensed Consolidated Statement of Operations (In thousands, except per share data)** | | Quarter Ended March 31, 2025 | Quarter Ended March 31, 2024 | | :--- | :--- | :--- | | **Total revenue** | **$93,881** | **$70,502** | | Loss from operations | $(3,616) | $(26,490) | | **Net income (loss)** | **$5,023** | **$(24,436)** | | Basic net income (loss) per share | $0.10 | $(0.49) | | Diluted net income (loss) per share | $0.10 | $(0.49) | [Condensed Consolidated Balance Sheets](index=14&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The company maintained a strong financial position with $837.0 million in cash and marketable securities **Condensed Consolidated Balance Sheets (In thousands)** | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $476,845 | $455,731 | | Marketable securities | $360,185 | $364,645 | | **Total current assets** | **$948,625** | **$929,864** | | **Total assets** | **$1,028,008** | **$1,009,506** | | Total current liabilities | $149,163 | $212,181 | | **Total liabilities** | **$649,529** | **$648,790** | | **Total shareholders' equity** | **$378,479** | **$360,716** | [Summary Condensed Consolidated Statements of Cash Flows](index=15&type=section&id=Summary%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash from operating activities was positive at $0.4 million, a significant improvement from the prior year **Summary Condensed Consolidated Statements of Cash Flows (In thousands)** | | Quarter Ended March 31, 2025 | Quarter Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $435 | $(4,587) | | Net cash provided by (used in) investing activities | $9,702 | $(430) | | Net cash provided by financing activities | $2,551 | $396,012 | | **Cash and cash equivalents at end of period** | **$476,845** | **$832,821** | [Forward-Looking Statements](index=11&type=section&id=Forward%20Looking%20Statements) This section outlines the risks and uncertainties associated with the company's forward-looking statements [Forward-Looking Statements Disclaimer](index=11&type=section&id=Forward%20Looking%20Statements%20Disclaimer) The report's forward-looking statements are subject to numerous risks and uncertainties that could affect actual results - The report contains forward-looking statements concerning the company's clinical pipeline, commercial performance of KIMMTRAK, trial enrollment and results, and potential regulatory approvals[52](index=52&type=chunk) - These statements are subject to significant risks and uncertainties, including macroeconomic impacts, supply chain issues, regulatory hurdles, clinical trial delays or failures, and competition, as detailed in the company's SEC filings[52](index=52&type=chunk)

[PART I – FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This section presents the company's unaudited condensed consolidated financial statements and related disclosures for the quarter ended March 31, 2025 [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for Q1 2025 show total assets of **$1.028 billion**, a net income of **$5.0 million**, and a **33.5%** revenue increase from KIMMTRAK [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets increased to **$1.028 billion**, driven by a rise in cash and cash equivalents to **$476.8 million**, while total liabilities remained stable Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $476,845 | $455,731 | | Marketable securities | $360,185 | $364,645 | | Total current assets | $948,625 | $929,864 | | Total assets | $1,028,008 | $1,009,506 | | **Liabilities & Equity** | | | | Total current liabilities | $149,163 | $212,181 | | Interest-bearing loans and borrowings | $391,530 | $391,013 | | Total liabilities | $649,529 | $648,790 | | Total shareholders' equity | $378,479 | $360,716 | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20%28Loss%29) For Q1 2025, the company reported a net income of **$5.0 million**, a significant improvement from a **$24.4 million** net loss in Q1 2024, primarily due to a **33.5%** increase in net revenue Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Revenue from sale of therapies, net | $93,881 | $70,342 | | Total revenue | $93,881 | $70,502 | | Research and development expense | ($56,468) | ($57,459) | | Selling, general and administrative expense | ($40,198) | ($39,287) | | Loss from operations | ($3,616) | ($26,490) | | Net income (loss) | $5,023 | ($24,436) | | Diluted net income (loss) per share | $0.10 | ($0.49) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash provided by operating activities was **$0.4 million** in Q1 2025, a positive shift from the prior year, with total cash and cash equivalents ending at **$476.8 million** Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $435 | ($4,587) | | Net cash provided by (used in) investing activities | $9,702 | ($430) | | Net cash provided by financing activities | $2,551 | $396,012 | | **Increase in net cash and cash equivalents** | **$12,688** | **$390,995** | | **Cash and cash equivalents at end of period** | **$476,845** | **$832,821** | [Notes to the Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies, a **33.5%** year-over-year increase in KIMMTRAK revenue driven by Europe and International markets, and the issuance of **$402.5 million** in convertible senior notes - The company's lead product, KIMMTRAK, is now approved in **39 countries** and commercially launched in **26 countries** for the treatment of unresectable or metastatic uveal melanoma[23](index=23&type=chunk) Revenue from Sale of Therapies by Region (in thousands) | Region | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | United States | $56,607 | $50,026 | | Europe | $32,804 | $18,952 | | International | $4,470 | $1,364 | | **Total** | **$93,881** | **$70,342** | - In February 2024, the company issued **$402.5 million** in 2.50% convertible senior notes due 2030, with net proceeds of **$389.1 million** after issuance costs[50](index=50&type=chunk)[51](index=51&type=chunk) - The company has noncancellable manufacturing commitments totaling **$27.5 million**, primarily for the development and supply of product candidates like brenetafusp[71](index=71&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses a **33.5%** increase in KIMMTRAK net revenue to **$93.9 million** for Q1 2025, stable R&D expenses, and a net income of **$5.0 million**, affirming sufficient capital for the next twelve months [Overview and Recent Developments](index=20&type=section&id=Overview%20and%20Recent%20Developments) The company, a commercial-stage biotechnology firm, highlights KIMMTRAK's approval in **39 countries** and recent positive Phase 1/2 data for its HIV candidate IMC-M113V - KIMMTRAK is now approved in **39 countries** and commercially launched in **26** for the treatment of unresectable or metastatic uveal melanoma[76](index=76&type=chunk) - Initial data from the Phase 1/2 STRIVE trial of HIV candidate IMC-M113V was presented, showing the drug was well-tolerated and demonstrated delayed viral rebound or viremia control in **3 out of 10** evaluable patients at the two highest doses[82](index=82&type=chunk)[84](index=84&type=chunk) - The company has successfully completed pricing negotiations for KIMMTRAK in France and Germany[83](index=83&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Total revenue increased by **33.2%** to **$93.9 million** in Q1 2025, driven by strong KIMMTRAK sales, particularly in Europe and International markets, while R&D expenses slightly decreased Revenue from Sale of Therapies, Net (in thousands) | Region | Q1 2025 | Q1 2024 | % Change | | :--- | :--- | :--- | :--- | | United States | $56,607 | $50,026 | 13.2% | | Europe | $32,804 | $18,952 | 73.1% | | International | $4,470 | $1,364 | 227.7% | | **Total** | **$93,881** | **$70,342** | **33.5%** | Research & Development Expenses (in thousands) | Category | Q1 2025 | Q1 2024 | % Change | | :--- | :--- | :--- | :--- | | PRAME programs | $17,305 | $26,700 | (35.2)% | | Tebentafusp programs | $7,990 | $5,894 | 35.6% | | Infectious disease programs | $1,405 | $2,246 | (37.4)% | | All other external clinical and preclinical costs | $11,231 | $6,499 | 72.8% | | Total internal R&D expenses | $18,537 | $16,120 | 15.0% | | **Total R&D expenses** | **$56,468** | **$57,459** | **(1.7)%** | - The decrease in external R&D expenses was primarily due to a **$9.4 million** reduction in PRAME program costs related to the timing of manufacturing batches and drug consumable purchases in the prior year[108](index=108&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held **$476.8 million** in cash and cash equivalents and **$360.2 million** in marketable securities, with management confident in funding operations for at least the next twelve months - As of March 31, 2025, the company held **$476.8 million** in cash and cash equivalents and **$360.2 million** in marketable securities[116](index=116&type=chunk) - In February 2024, the company completed a private offering of **$402.5 million** in convertible notes, receiving net proceeds of **$389.1 million**[118](index=118&type=chunk) - Based on current plans, the company expects existing cash, marketable securities, and anticipated revenue will fund operating expenses and capital requirements for at least twelve months from the filing date of this report[127](index=127&type=chunk) [Critical Accounting Estimates](index=31&type=section&id=Critical%20Accounting%20Estimates) The most critical accounting estimate involves revenue deductions for rebates and chargebacks, with a **$6.0 million** net decrease in accrued deductions due to completed price negotiations in Q1 2025 - Estimating expected rebate and chargeback percentages for revenue deductions is a critical accounting estimate due to the time delay and uncertainty in determining actual amounts[142](index=142&type=chunk)[143](index=143&type=chunk) - The completion of price negotiations in France and Germany in Q1 2025 resulted in a change in estimate, causing a **$6.0 million** net decrease to total accrued revenue deductions as of March 31, 2025[146](index=146&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company faces currency risk from its UK subsidiary's multi-currency holdings, while interest rate risk is mitigated by fixed-rate convertible notes, and credit risk is low - The company's **$402.5 million** in convertible notes carry a fixed interest rate of **2.50%**, mitigating exposure to interest rate fluctuations on its debt[150](index=150&type=chunk) - As of March 31, 2025, **75%** of cash and cash equivalents were held by the U.K. subsidiary, with balances denominated in U.S. dollars (**45%**), pounds sterling (**40%**), and euros (**15%**), creating exposure to foreign currency fluctuations[153](index=153&type=chunk) - A hypothetical **5%** adverse change in foreign exchange rates would reduce the carrying value of net financial assets by **$5.7 million** as of March 31, 2025[154](index=154&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of March 31, 2025, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[158](index=158&type=chunk) - No changes occurred during the quarter ended March 31, 2025, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[159](index=159&type=chunk) [PART II – OTHER INFORMATION](index=35&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, and other standard disclosures, confirming no material changes or significant new events [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material legal proceedings that would significantly adversely affect its business, operating results, or financial condition - As of the reporting date, the company is not involved in any material legal proceedings[160](index=160&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) The company states that there have been no material changes to the risk factors previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2024 - There were no material changes during the quarter to the risk factors previously disclosed in the company's Annual Report[162](index=162&type=chunk) [Items 2-6. Other Information](index=35&type=section&id=Items%202-6.%20Other%20Information) This section confirms no unregistered sales of equity securities, no defaults on senior securities, and no new insider trading plans for directors or officers during the quarter - The company reports no unregistered sales of equity securities, defaults upon senior securities, or new insider trading plans for directors and officers during the quarter[163](index=163&type=chunk)[164](index=164&type=chunk)[165](index=165&type=chunk)