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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]
Immunocore(IMCR) - 2022 Q2 - Earnings Call Transcript
2022-08-10 18:55
Immunocore Holdings (NASDAQ:IMCR) Q2 2022 Earnings Conference Call August 9, 2022 8:00 AM ET Company Participants Clayton Robertson - Head, IR Bahija Jallal - CEO & Director Brian Di Donato - CFO & Head, Strategy Ralph Torbay - Head, Commercial David Berman - Head, Research & Development Conference Call Participants Michael Yee - Jefferies Jessica Fye - JPMorgan Chase & Co. Tyler Van Buren - Cowen and Company Justin Kim - Oppenheimer Justin Zelin - BTIG Matthew Phipps - William Blair & Company Gil Blum - Ne ...
Immunocore(IMCR) - 2022 Q2 - Quarterly Report
2022-08-10 12:00
Revenue Performance - Product revenue for the three months ended June 30, 2022, was £23,992,000, compared to £0 in the same period of 2021[4] - Total revenue from the sale of therapies for the six months ended June 30, 2022, was £38,211,000, significantly up from £0 in 2021[4] - Total revenue for the six months ended June 30, 2022, was £54,476,000, a significant increase from £14,003,000 in the same period of 2021[44] - Revenue recognized during the three and six months ended June 30, 2022, included product revenue from KIMMTRAK and pre-product revenue from tebentafusp[43] - Collaboration revenue for the six months ended June 30, 2022, was £16,265,000, up from £14,003,000 in 2021, representing a 16% increase[4] - Collaboration revenue from Genentech for the three months ended June 30, 2022, was £4,302,000, slightly down from £4,447,000 in the same period of 2021[48] Financial Losses - Operating loss for the three months ended June 30, 2022, was £6,993,000, an improvement from a loss of £34,499,000 in the same period of 2021[4] - Loss for the period for the six months ended June 30, 2022, was £22,249,000, compared to £62,000,000 in 2021, indicating a reduction of 64%[4] - The operating loss for the six months ended June 30, 2022, was £23,453,000, with net cash used in operating activities of £40,017,000[24] - The company reported a basic and diluted loss per share of £0.14 for the three months ended June 30, 2022, compared to £0.75 for the same period in 2021[56] Cash and Assets - Cash and cash equivalents at the end of the period were £208,064,000, down from £278,870,000 at the end of June 30, 2021[12] - The Group reported cash and cash equivalents of £208,064,000 and net current assets of £192,548,000 as of June 30, 2022[24] - Total assets as of June 30, 2022, were £295,568,000, a decrease from £301,773,000 as of December 31, 2021[7] - As of June 30, 2022, trade receivables increased to £24,424,000 from £6,047,000 at the end of 2021[58] Research and Development - Research and development costs for the six months ended June 30, 2022, were £38,731,000, compared to £36,356,000 in 2021, reflecting a 6% increase[4] - The company is developing a pipeline of five clinical stage programs in oncology and infectious disease, leveraging its ImmTAX platform[17] Regulatory Approvals - KIMMTRAK received regulatory approval from the FDA and EC in January and April 2022, respectively, and is now approved in over 30 countries[18] - The Group expects to obtain further regulatory approvals for KIMMTRAK in additional territories in the second half of 2022[18] Funding and Future Outlook - The Group anticipates needing additional funding to support ongoing operations and further development of its pipeline[26] - The Group's estimated rebates and chargebacks are subject to significant judgment due to limited sales history in the U.S.[30] - The Board assessed downside risks, including the impact of COVID-19 and geopolitical tensions, concluding minimal future impact on clinical trials[25] Capital and Lease Activities - The company issued 2,000,000 American Depositary Shares (ADSs) generating proceeds of £116,700,000 in July 2022[16] - The company completed a capital reduction on April 28, 2022, creating distributable reserves of £261.4 million[59] - The company entered into a new lease for additional laboratory space in the UK, with potential total payments of up to £5,317,000[66]
Immunocore Holdings (IMCR) Investor Presentation - Slideshow
2022-06-09 19:38
IMMUNOCORE Corporate Presentation June 2022 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "believe," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. All statements, other than statements of historical facts, included in this pres ...
Immunocore(IMCR) - 2021 Q4 - Annual Report
2022-03-03 12:09
[PART I](index=9&type=section&id=PART%20I) [Item 3. Key Information](index=9&type=section&id=Item%203.%20Key%20Information.) This section details key investment risks, including financial losses, operational challenges, and dependence on KIMMTRAK's commercial success [Risk Factors](index=9&type=section&id=D.%20Risk%20factors.) This section details financial, clinical, commercial, and operational risks, emphasizing historical losses and reliance on the ImmTAX platform - The company has incurred significant net losses each year since inception, with a loss of **£131.5 million** in 2021 and an accumulated deficit of **£481.4 million** as of December 31, 2021, with losses expected to continue for the foreseeable future[34](index=34&type=chunk) - Future prospects are highly dependent on the successful commercialization of **KIMMTRAK**, approved by the FDA in January 2022 for metastatic uveal melanoma (mUM), with revenue generation subject to achieving significant market acceptance[32](index=32&type=chunk)[41](index=41&type=chunk) - The business is heavily reliant on the success of its **ImmTAX platform** to develop new product candidates, where any significant delays or failures could harm the business[35](index=35&type=chunk)[60](index=60&type=chunk) - The COVID-19 pandemic has adversely impacted and may continue to impact business operations, including the commercialization of KIMMTRAK, clinical trials, and the supply chain[32](index=32&type=chunk)[66](index=66&type=chunk) - The company will require substantial additional funding, with existing cash and cash equivalents expected to fund operations until at least Q3 2023, and with expected KIMMTRAK revenue, into the second half of 2024[32](index=32&type=chunk)[47](index=47&type=chunk) [Item 4. Information on the Company](index=88&type=section&id=Item%204.%20Information%20on%20the%20Company.) This section provides a comprehensive overview of Immunocore's history, structure, and business, highlighting its ImmTAX platform and KIMMTRAK product [History and Development of the Company](index=88&type=section&id=A.%20History%20and%20development%20of%20the%20company.) Immunocore Holdings plc was incorporated in January 2021, completed its IPO in February 2021, and focuses capital expenditures on UK assets - The company was incorporated as **Immunocore Holdings plc** on January 7, 2021, and completed its **IPO** on February 9, 2021, listing its ADSs on the Nasdaq under the symbol **IMCR**[398](index=398&type=chunk)[400](index=400&type=chunk) Capital Expenditures (£M) | Year | 2021 | 2020 | 2019 | | :--- | :--- | :--- | :--- | | Capital Expenditures | £1.0M | £3.1M | £4.3M | [Business Overview](index=89&type=section&id=B.%20Business%20overview.) Immunocore is a commercial-stage biotech company focused on ImmTAX immunotherapies, with FDA-approved KIMMTRAK and a pipeline in oncology and infectious diseases - On January 26, 2022, the FDA approved **KIMMTRAK** (tebentafusp-tebn) for unresectable or metastatic uveal melanoma (mUM), marking the first TCR therapeutic and first bispecific T cell engager for a solid tumor to receive FDA approval[404](index=404&type=chunk) - The company's proprietary **ImmTAX platform** engineers soluble, off-the-shelf, bispecific TCRs designed to target a wide range of intracellular proteins, expanding the therapeutic landscape beyond what is accessible to antibody-based therapies[403](index=403&type=chunk)[409](index=409&type=chunk) Clinical Pipeline Overview (as of Dec 31, 2021) | Candidate | Target | Indication | Phase 1 / 2 | Phase 3 | Approved | | :--- | :--- | :--- | :--- | :--- | :--- | | **Oncology** | | | | | | | KIMMTRAK® | gp100 | Uveal melanoma | | ✓ | ✓ | | | | Cutaneous melanoma | ✓ | | | | IMC-C103C | MAGE-A4 | NSCLC, gastric, head & neck, ovarian, etc. | ✓ | | | | IMC-F106C | PRAME | NSCLC, breast, endometrial, ovarian, etc. | ✓ | | | | **Infectious Diseases** | | | | | | | IMC-1109V | Envelope | Hepatitis B Virus (HBV) | ✓ | | | | IMC-M113V | Gag | Human Immunodeficiency Virus (HIV) | Pre-clinical | | | - The company has active strategic collaborations with **Genentech** for its MAGE-A4 program (IMC-C103C), and with **Eli Lilly** for other targets, while the collaboration with **GSK** was terminated in January 2022[462](index=462&type=chunk)[472](index=472&type=chunk)[473](index=473&type=chunk) [Organizational Structure](index=123&type=section&id=C.%20Organizational%20structure.) Immunocore Holdings plc, a UK-incorporated parent, oversees wholly-owned subsidiaries in the UK, US, and Ireland - The parent company is **Immunocore Holdings Plc**, incorporated in the UK, with subsidiaries in the UK, US, and Ireland[576](index=576&type=chunk) [Property, Plant and Equipment](index=123&type=section&id=D.%20Property%2C%20plant%20and%20equipment.) The company leases corporate headquarters and R&D facilities in Oxfordshire, UK, and additional office space in the US and Ireland - The main corporate headquarters and R&D facilities are leased in **Oxfordshire, UK**, with leases expiring between 2037 and 2040[577](index=577&type=chunk) - The company maintains **U.S. headquarters** in Pennsylvania and Maryland through leased office space[577](index=577&type=chunk) [Item 5. Operating and Financial Review and Prospects](index=123&type=section&id=Item%205.%20Operating%20and%20Financial%20Review%20and%20Prospects.) This section analyzes financial performance, reporting a **£131.5 million** net loss in 2021, and discusses liquidity and critical accounting estimates [Operating Results](index=124&type=section&id=A.%20Operating%20Results) In 2021, Immunocore reported a **£131.5 million** net loss, with decreased revenue and significantly increased administrative expenses Consolidated Statement of Loss Summary (£'000) | | 2021 | 2020 | | :--- | :--- | :--- | | **Revenue** | **26,520** | **30,114** | | Research and development expenses | (73,226) | (74,809) | | Administrative expenses | (88,399) | (45,740) | | **Operating loss** | **(135,162)** | **(86,193)** | | Loss before taxes | (140,928) | (87,360) | | Income tax credit | 9,405 | 13,267 | | **Loss for the period** | **(131,523)** | **(74,093)** | - Collaboration revenue decreased from **£30.1 million** in 2020 to **£23.5 million** in 2021, mainly due to a pause in revenue recognition from the Lilly collaboration and reduced reimbursable costs from Genentech[630](index=630&type=chunk) - Administrative expenses increased by **£42.7 million**, primarily due to a **£23.8 million** increase in non-cash share-based payment charges related to the IPO and a **£17.4 million** increase in pre-commercial expenditure for tebentafusp[638](index=638&type=chunk) [Liquidity and Capital Resources](index=136&type=section&id=B.%20Liquidity%20and%20Capital%20Resources) As of December 2021, the company held **£237.9 million** in cash, funded by IPO proceeds, and expects to fund operations into 2024 - The company completed its IPO in February 2021, raising gross proceeds of **$297.1 million**, plus an additional **$15.0 million** from a concurrent private placement[648](index=648&type=chunk) Cash and Cash Flow Summary (£'000) | | 2021 | 2020 | | :--- | :--- | :--- | | Cash and cash equivalents at end of year | 237,886 | 129,716 | | Net cash used in operating activities | (96,110) | (61,250) | | Net cash from / (used in) investing activities | (367) | 1,143 | | Net cash from financing activities | 204,631 | 115,941 | - Management projects that existing cash and expected revenues will fund operations into 2024, however, future funding requirements are significant and depend on the progress of clinical trials and commercialization efforts[666](index=666&type=chunk) [Critical Accounting Estimates](index=142&type=section&id=E.%20Critical%20Accounting%20Estimates) Critical accounting estimates include revenue recognition for collaboration agreements and the valuation of share options, both requiring significant judgment - Revenue from collaboration agreements is recognized over time using a percentage of completion method, which requires management to estimate project timelines, where a six-month underestimation of project life would have increased deferred revenue by **£5.3 million** as of year-end 2021[678](index=678&type=chunk)[679](index=679&type=chunk) - The valuation of share options requires subjective assumptions, including expected life and share price volatility, with the fair value of ordinary shares prior to the IPO determined using third-party valuations and other factors, introducing significant judgment[680](index=680&type=chunk)[681](index=681&type=chunk)[682](index=682&type=chunk) [Item 6. Directors, Senior Management and Employees](index=143&type=section&id=Item%206.%20Directors%2C%20Senior%20Management%20and%20Employees.) This section details the company's leadership, including executive officers, directors, their compensation, board practices, and employee headcount [Directors and Senior Management](index=143&type=section&id=A.%20Directors%20and%20senior%20management.) The company's executive team is led by CEO Bahija Jallal, Ph.D., supported by a seven-member Board of Directors - The executive team is led by **CEO Bahija Jallal, Ph.D.**, formerly President of MedImmune at AstraZeneca[687](index=687&type=chunk) - The Board of Directors is composed of **seven members**, including distinguished scientists and industry veterans such as Chairman Professor Sir John Bell and Nobel laureate Professor Sir Peter Ratcliffe[686](index=686&type=chunk)[691](index=691&type=chunk)[696](index=696&type=chunk) [Compensation](index=146&type=section&id=B.%20Compensation.) In 2021, aggregate compensation for directors and executive officers totaled **£2.0 million**, including salaries, bonuses, and equity awards - Aggregate compensation for directors and executive officers in 2021 was **£2.0 million**, including salaries, benefits, and bonuses[701](index=701&type=chunk) 2021 Director and Executive Officer Compensation Summary | Name | Total Fixed Remuneration ($) | Annual Bonus ($) | Share-Based Awards ( options) | | :--- | :--- | :--- | :--- | | **Bahija Jallal, Ph.D. (CEO)** | 745,414 | 525,000 | 2,076,080 | | **Other Executive Officers (Group)** | 989,309 | 518,100 | 875,507 | | **Non-Executive Directors (Group)** | 222,477 | — | 58,383 | [Board Practices](index=149&type=section&id=C.%20Board%20Practices.) The Board of Directors comprises seven members, with six independent, and operates through three standing committees - The board is composed of **seven directors**, with **six** determined to be independent under Nasdaq rules[715](index=715&type=chunk) - The board has **three standing committees**: Audit, Remuneration, and Nominating and Corporate Governance[719](index=719&type=chunk) [Employees](index=153&type=section&id=D.%20Employees.) As of December 2021, Immunocore had **324** full-time employees, with **247** in R&D, primarily based in the UK Employee Headcount by Function and Geography | | 2021 | 2020 | 2019 | | :--- | :--- | :--- | :--- | | **Function** | | | | | Administrative | 77 | 55 | 67 | | Research and development | 247 | 236 | 392 | | **Total** | **324** | **291** | **459** | | **Geography** | | | | | United Kingdom | 264 | 242 | 409 | | United States | 58 | 47 | 47 | | European Union | 2 | 2 | 3 | [Item 7. Major Shareholders and Related Party Transactions](index=153&type=section&id=Item%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions.) This section details major shareholders as of December 2021 and outlines the company's policy for related party transactions [Major Shareholders](index=153&type=section&id=A.%20Major%20Shareholders.) As of December 2021, General Atlantic was the largest shareholder at **11.2%**, with other significant holders including Baker Brothers and Eli Lilly Principal Shareholders (as of December 31, 2021) | Name of Beneficial Owner | Percent of Ordinary Shares Beneficially Owned (%) | | :--- | :--- | | Entities affiliated with General Atlantic | 11.2% | | Entities affiliated with Baker Brothers | 7.6% | | Eli Lilly S.A. | 5.8% | | Entities affiliated with Rock Springs Capital | 5.6% | | Malin Life Sciences Holdings Limited | 5.4% | | Ian Laing | 5.4% | | All current directors and executive officers as a group | 5.7% | [Item 8. Financial Information](index=156&type=section&id=Item%208.%20Financial%20Information.) This section presents consolidated financial statements, dividend policy, and legal proceedings, including a concluded internal investigation - The company has not declared or paid any dividends since its incorporation and does not plan to in the foreseeable future, intending to retain earnings for business use[746](index=746&type=chunk) - The company is involved in a patent opposition proceeding at the European Patent Office and a trademark opposition for IMMTAX, but does not believe the outcomes will materially harm the business[748](index=748&type=chunk) - An internal investigation into a kickback scheme involving an employee and vendors between 2018-2020 was concluded, and the company recovered its estimated losses of **£1.8 million** in December 2020[749](index=749&type=chunk) [Item 9. The Offer and Listing](index=157&type=section&id=Item%209.%20The%20Offer%20and%20Listing.) The company's ADSs have been listed and traded on the Nasdaq Global Select Market under "IMCR" since February 5, 2021 - The company's ADSs are listed on the **Nasdaq Global Select Market** under the ticker symbol "**IMCR**" since February 5, 2021[752](index=752&type=chunk)[754](index=754&type=chunk) [Item 10. Additional Information](index=159&type=section&id=Item%2010.%20Additional%20Information.) This section provides supplementary information on material contracts, exchange controls, and U.K. and U.S. tax considerations for ADS holders [Taxation](index=159&type=section&id=E.%20Taxation) This subsection details U.S. and U.K. tax implications for ADS holders, including PFIC risk for U.S. holders and U.K. dividend tax - For U.S. tax purposes, there is a risk the company could be classified as a **Passive Foreign Investment Company (PFIC)**, and while the company believes it was not a PFIC for the 2021 taxable year, this is an annual determination and its status could change[377](index=377&type=chunk)[771](index=771&type=chunk) - Because the company has U.S. subsidiaries, its non-U.S. subsidiaries are treated as **controlled foreign corporations (CFCs)**, and U.S. holders owning 10% or more of the company's shares may be subject to specific anti-deferral tax rules[373](index=373&type=chunk) - For U.K. tax purposes, dividends paid by the company are not expected to be subject to **U.K. withholding tax**[799](index=799&type=chunk) - Transfers of ADSs are generally not subject to **U.K. stamp duty** or **Stamp Duty Reserve Tax (SDRT)**, however, the issuance or transfer of ordinary shares to a depositary may be subject to a 1.5% SDRT charge[811](index=811&type=chunk)[814](index=814&type=chunk) [Item 11. Quantitative and Qualitative Disclosures About Market Risk](index=168&type=section&id=Item%2011.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) The company faces market risks including interest rate, currency, and credit risk, with currency risk being significant due to global operations - The company is exposed to **interest rate risk** through its variable-rate loan from Oxford Finance, which has an interest rate of LIBOR plus 8.85% within a defined cap and collar[824](index=824&type=chunk) - **Currency risk** is significant due to global operations, where as of December 31, 2021, 54% of cash held in the UK was denominated in U.S. dollars and 2% in euros, and a 5 percentage point change in exchange rates would impact the carrying value of net financial assets by **£2.6 million**[827](index=827&type=chunk)[828](index=828&type=chunk) - **Credit risk** is considered low, as cash is held with high-quality financial institutions and trade receivables are primarily from large, reputable pharmaceutical collaboration partners[829](index=829&type=chunk) [PART II](index=170&type=section&id=PART%20II) [Item 15. Controls and Procedures](index=170&type=section&id=Item%2015.%20Controls%20and%20Procedures.) This section confirms the effectiveness of the company's disclosure controls and internal control over financial reporting as of December 31, 2021 - Management concluded that as of December 31, 2021, the company's disclosure controls and procedures were **effective**[845](index=845&type=chunk) - Based on an assessment using the COSO 2013 framework, management concluded that the company's internal control over financial reporting was **effective** as of December 31, 2021[848](index=848&type=chunk) - A material weakness related to procurement processes, identified in 2020, was **remediated** as of December 31, 2020[670](index=670&type=chunk) [Item 16. Corporate Governance and Other Matters](index=171&type=section&id=Item%2016.%20Corporate%20Governance%20and%20Other%20Matters) This section covers corporate governance, including the audit committee expert, code of conduct, accountant fees, and foreign private issuer exemptions - The Board has identified Mr. Coy as an "**audit committee financial expert**"[852](index=852&type=chunk) Principal Accountant Fees (£'000) | | 2021 | 2020 | | :--- | :--- | :--- | | Audit fees | 650 | 470 | | Audit-related fees | 125 | 237 | | **Total** | **775** | **707** | - As a **foreign private issuer**, the company follows **U.K. corporate governance practices** and is exempt from certain Nasdaq rules, including those related to shareholder approval for certain security issuances and the composition of the compensation committee[861](index=861&type=chunk)[863](index=863&type=chunk) [PART III](index=175&type=section&id=PART%20III) [Item 17. Financial Statements](index=175&type=section&id=Item%2017.%20Financial%20Statements.) This section presents the audited consolidated financial statements for 2019-2021, prepared under IFRS, including statements of loss, position, equity, and cash flows Key Financial Metrics (£'000) | Metric | 2021 | 2020 | 2019 | | :--- | :--- | :--- | :--- | | **Revenue** | 26,520 | 30,114 | 25,669 | | **Operating Loss** | (135,162) | (86,193) | (118,320) | | **Loss for the year** | (131,523) | (74,093) | (103,931) | | **Total Assets** | 301,773 | 197,194 | N/A | | **Total Equity** | 171,547 | 55,346 | 14,771 | | **Cash at Year End** | 237,886 | 129,716 | 73,966 |