Immunocore(IMCR)

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Immunocore(IMCR) - 2025 Q1 - Quarterly Results
2025-05-07 11:33
[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)
Immunocore(IMCR) - 2025 Q1 - Quarterly Report
2025-05-07 11:00
[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)
Immunocore reports first quarter financial results and provides a business update
Globenewswire· 2025-05-07 11:00
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]
Wall Street Analysts Think Immunocore (IMCR) Could Surge 107.45%: Read This Before Placing a Bet
ZACKS· 2025-04-30 15:00
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]
Immunocore (IMCR) Moves 6.0% Higher: Will This Strength Last?
ZACKS· 2025-03-21 15:25
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]
Immunocore presents initial multiple ascending dose data for HIV functional cure candidate in an oral presentation at CROI 2025
Newsfilter· 2025-03-10 19:00
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]
Immunocore: A Commercial Biotech Nearing Its Pivotal Break-Even Point
Seeking Alpha· 2025-02-27 13:11
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]
Immunocore(IMCR) - 2024 Q4 - Earnings Call Transcript
2025-02-26 18:24
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]
Immunocore(IMCR) - 2024 Q4 - Annual Report
2025-02-26 12:00
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].
Immunocore reports fourth quarter and full year 2024 financial results and provides a business update
Globenewswire· 2025-02-26 12:00
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]