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6-K/Afalse2022-09-3012-31Immunocore Holdings 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INDEX TO UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
| Page | ||
| Unaudited Condensed Consolidated Statements of Profit / Loss and Other Comprehensive Loss for the Three and Nine Months Ended September 30, 2022 and 2021 | 2 | |
| Unaudited Condensed Consolidated Statements of Financial Position as at September 30, 2022 and December 31, 2021 | 3 | |
| Unaudited Condensed Consolidated Statements of Changes in Equity for the Nine Months Ended September 30, 2022 and 2021 | 4 | |
| Unaudited Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2022 and 2021 | 5 | |
| Unaudited Condensed Consolidated Notes to the Financial Statements | 6 |
Immunocore Holdings plc
Unaudited Condensed Consolidated Interim Financial Statements
Unaudited Condensed Consolidated Statements of Profit / (Loss) and Other Comprehensive Loss
| Three months ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||
| Notes | 2022 '000 | 2021 '000 | 2022 '000 | 2021 '000 | ||||||||||||||||
| Product revenue, net | 3 | 33,252 | - | 64,926 | - | |||||||||||||||
| Pre-product revenue, net | 3 | 3,051 | 474 | 9,588 | 474 | |||||||||||||||
| Total revenue from sale of therapies | 36,303 | 474 | 74,514 | 474 | ||||||||||||||||
| Collaboration revenue | 3 | 4,896 | 5,450 | 21,161 | 19,453 | |||||||||||||||
| Total revenue | 41,199 | 5,924 | 95,675 | 19,927 | ||||||||||||||||
| Cost of product revenue | 2 | ( 63 | ) | - | ( 345 | ) | - | |||||||||||||
| Research and development costs | ( 23,301 | ) | ( 16,798 | ) | ( 62,032 | ) | ( 53,154 | ) | ||||||||||||
| Selling and administrative expenses | 4 | ( 11,663 | ) | ( 20,048 | ) | ( 50,580 | ) | ( 64,033 | ) | |||||||||||
| Net other operating (expense) / income | - | ( 28 | ) | 1 | ( 70 | ) | ||||||||||||||
| Operating profit / (loss) | 6,172 | ( 30,950 | ) | ( 17,281 | ) | ( 97,330 | ) | |||||||||||||
| Finance income | 597 | 8 | 725 | 42 | ||||||||||||||||
| Finance costs | 5 | ( 1,785 | ) | ( 1,317 | ) | ( 4,515 | ) | ( 4,465 | ) | |||||||||||
| Non-operating expense | ( 1,188 | ) | ( 1,309 | ) | ( 3,790 | ) | ( 4,423 | ) | ||||||||||||
| Profit / (loss) before taxation | 4,984 | ( 32,259 | ) | ( 21,071 | ) | ( 101,753 | ) | |||||||||||||
| Income tax credit | 6 | 1,244 | 2,125 | 5,050 | 9,619 | |||||||||||||||
| Profit / (loss) for the period | 6,228 | ( 30,134 | ) | ( 16,021 | ) | ( 92,134 | ) | |||||||||||||
| Other comprehensive loss | ||||||||||||||||||||
| Other comprehensive loss that is or may be reclassified to profit or loss in subsequent periods: | ||||||||||||||||||||
| Exchange differences on translation of foreign operations | ( 1,730 | ) | ( 38 | ) | ( 1,848 | ) | ( 92 | ) | ||||||||||||
| Total Other comprehensive loss for the period | ( 1,730 | ) | ( 38 | ) | ( 1,848 | ) | ( 92 | ) | ||||||||||||
| Total comprehensive income / (loss) for the period | 4,498 | ( 30,172 | ) | ( 17,869 | ) | ( 92,226 | ) | |||||||||||||
| Basic earnings / (loss) per share - | 7 | 0.13 | ( 0.69 | ) | ( 0.36 | ) | ( 2.19 | ) | ||||||||||||
| Diluted earnings / (loss) per share - | 7 | 0.12 | ( 0.69 | ) | ( 0.36 | ) | ( 2.19 | ) |
The accompanying notes form part of these unaudited condensed consolidated interim financial statements.
Immunocore Holdings plc
Unaudited Condensed Consolidated Interim Financial Statements
Unaudited Condensed Consolidated Statements of Financial Position as at
| Notes | September 30, 2022 '000 | December 31, 2021 '000 | ||||||||||
| Non-current assets | ||||||||||||
| Property, plant and equipment | 6,580 | 8,944 | ||||||||||
| Right of use assets | 9 | 23,963 | 22,593 | |||||||||
| Other non-current assets | 6,749 | 4,935 | ||||||||||
| Deferred tax asset | 6 | 3,860 | 2,575 | |||||||||
| Total non-current assets | 41,152 | 39,047 | ||||||||||
| Current assets | ||||||||||||
| Inventory | 2 | 854 | - | |||||||||
| Trade and other receivables | 8 | 40,968 | 15,208 | |||||||||
| Tax receivable | 14,510 | 9,632 | ||||||||||
| Cash and cash equivalents | 347,189 | 237,886 | ||||||||||
| Total current assets | 403,521 | 262,726 | ||||||||||
| Total assets | 444,673 | 301,773 | ||||||||||
| Equity | ||||||||||||
| Share capital | 96 | 88 | ||||||||||
| Share premium | 120,147 | 212,238 | ||||||||||
| Foreign currency translation reserve | ( 1,759 | ) | 89 | |||||||||
| Other reserves | 337,847 | 386,167 | ||||||||||
| Share-based payment reserve | 74,538 | 54,357 | ||||||||||
| Accumulated deficit | ( 236,050 | ) | ( 481,392 | ) | ||||||||
| Total equity | 294,819 | 171,547 | ||||||||||
| Non-current liabilities | ||||||||||||
| Interest-bearing loans and borrowings | 45,563 | 37,226 | ||||||||||
| Deferred revenue | 3 | - | 6,408 | |||||||||
| Lease liabilities | 9 | 26,965 | 25,355 | |||||||||
| Provisions | 108 | 57 | ||||||||||
| Total non-current liabilities | 72,636 | 69,046 | ||||||||||
| Current liabilities | ||||||||||||
| Trade and other payables | 12 | 64,928 | 35,436 | |||||||||
| Deferred revenue | 3 | 10,681 | 24,450 | |||||||||
| Lease liabilities | 9 | 1,553 | 1,255 | |||||||||
| Provisions | 56 | 39 | ||||||||||
| Total current liabilities | 77,218 | 61,180 | ||||||||||
| Total liabilities | 149,854 | 130,226 | ||||||||||
| Total equity and liabilities | 444,673 | 301,773 |
The accompanying notes form part of these unaudited condensed consolidated interim financial statements.
Immunocore Holdings plc
Unaudited Condensed Consolidated Interim Financial Statements
Unaudited Condensed Consolidated Statements of Changes in Equity
| Notes | Share capital '000 | Share premium '000 | Foreign currency translation reserve '000 | Share- based payment reserve '000 | Other reserve '000 | Accumulated deficit '000 | Total equity '000 | |||||||||||||||||||||||||
| At January 1, 2022 | 88 | 212,238 | 89 | 54,357 | 386,167 | ( 481,392 | ) | 171,547 | ||||||||||||||||||||||||
| Loss for the period | - | - | - | - | - | ( 16,021 | ) | ( 16,021 | ) | |||||||||||||||||||||||
| Other comprehensive loss | - | - | ( 1,848 | ) | - | - | - | ( 1,848 | ) | |||||||||||||||||||||||
| Total comprehensive loss for the period | - | - | ( 1,848 | ) | - | - | ( 16,021 | ) | ( 17,869 | ) | ||||||||||||||||||||||
| Exercise of share options | 1 | 4,535 | - | - | - | - | 4,536 | |||||||||||||||||||||||||
| Capital reduction in Group's parent company | 10 | - | ( 213,043 | ) | - | - | ( 48,320 | ) | 261,363 | - | ||||||||||||||||||||||
| Issue of share capital | 10 | 7 | 116,417 | - | - | - | - | 116,424 | ||||||||||||||||||||||||
| Equity-settled share-based payment transactions | 11 | - | - | - | 20,181 | - | - | 20,181 | ||||||||||||||||||||||||
| At September 30 , 2022 | 96 | 120,147 | ( 1,759 | ) | 74,538 | 337,847 | ( 236,050 | ) | 294,819 |
| Notes | Share capital '000 | Share premium '000 | Foreign currency translation reserve '000 | Share- based payment reserve '000 | Other reserve '000 | Accumulated deficit '000 | Total equity '000 | |||||||||||||||||||||||||
| At January 1, 2021 | 64 | - | 163 | 18,821 | 386,167 | ( 349,869 | ) | 55,346 | ||||||||||||||||||||||||
| Loss for the period | - | - | - | - | - | ( 92,134 | ) | ( 92,134 | ) | |||||||||||||||||||||||
| Other comprehensive loss | - | - | ( 92 | ) | - | - | - | ( 92 | ) | |||||||||||||||||||||||
| Total comprehensive loss for the period | - | - | ( 92 | ) | - | - | ( 92,134 | ) | ( 92,226 | ) | ||||||||||||||||||||||
| Issue of share capital | 24 | 210,961 | - | - | - | - | 210,985 | |||||||||||||||||||||||||
| Exercise of share options | - | 644 | - | - | - | - | 644 | |||||||||||||||||||||||||
| Equity-settled share-based payment transactions | 11 | - | 325 | - | 26,813 | - | - | 27,138 | ||||||||||||||||||||||||
| At September 30 , 2021 | 88 | 211,930 | 71 | 45,634 | 386,167 | ( 442,003 | ) | 201,887 |
The accompanying notes form part of these unaudited condensed consolidated interim financial statements.
Immunocore Holdings plc
Unaudited Condensed Consolidated Interim Financial Statements
Unaudited Condensed Consolidated Statements of Cash Flows
| Nine Months Ended September 30, | ||||||||||||
| Notes | 2022 '000 | 2021 '000 | ||||||||||
| Cash flows from operating activities | ||||||||||||
| Loss for the period | ( 16,021 | ) | ( 92,134 | ) | ||||||||
| Adjustments for: | ||||||||||||
| Equity settled share-based payment expense | 11 | 20,181 | 27,138 | |||||||||
| Depreciation | 4,794 | 5,294 | ||||||||||
| Net finance costs (non-operating expense) | 3,790 | 4,423 | ||||||||||
| Foreign exchange differences | ( 20,498 | ) | 320 | |||||||||
| Other | ( 1 | ) | 273 | |||||||||
| Income tax credit | 6 | ( 5,050 | ) | ( 9,619 | ) | |||||||
| Working capital adjustments: | ||||||||||||
| Increase in receivables and other non-current assets | ( 25,021 | ) | ( 1,684 | ) | ||||||||
| Increase in trade and other payables | 27,501 | 3,085 | ||||||||||
| Decrease in deferred revenue | ( 20,177 | ) | ( 16,853 | ) | ||||||||
| Other working capital movements | ( 807 | ) | ( 21 | ) | ||||||||
| Cash used in operations | ( 31,309 | ) | ( 79,778 | ) | ||||||||
| Net taxation paid | ( 614 | ) | - | |||||||||
| Net cash used in operating activities | ( 31,923 | ) | ( 79,778 | ) | ||||||||
| Cash flows used in investing activities | ||||||||||||
| Proceeds from sale of property, plant and equipment | 5 | 64 | ||||||||||
| Purchase of property, plant and equipment | ( 869 | ) | ( 730 | ) | ||||||||
| Proceeds from investment in sub-leases | - | 549 | ||||||||||
| Other investing activities | 725 | 15 | ||||||||||
| Net cash flows used in investing activities | ( 139 | ) | ( 102 | ) | ||||||||
| Cash flows from financing activities | ||||||||||||
| Gross proceeds from issue of share capital | 10 | 116,812 | 226,528 | |||||||||
| Costs from issue of share capital | 10 | ( 388 | ) | ( 15,543 | ) | |||||||
| Exercise of share options | 4,536 | 644 | ||||||||||
| Interest paid on non-current interest-bearing loan | ( 3,050 | ) | ( 2,473 | ) | ||||||||
| Repayment of lease liabilities | ( 2,265 | ) | ( 2,465 | ) | ||||||||
| Net cash flows from financing activities | 115,645 | 206,691 | ||||||||||
| Increase in cash and cash equivalents | 83,583 | 126,811 | ||||||||||
| Net foreign exchange difference on cash | 25,720 | 24 | ||||||||||
| Cash and cash equivalents at beginning of the year | 237,886 | 129,716 | ||||||||||
| Cash and cash equivalents at end of the period | 347,189 | 256,551 |
The accompanying notes form part of these unaudited condensed consolidated interim financial statements.
Immunocore Holdings plc
Unaudited Condensed Consolidated Interim Financial Statements
Notes to the Financial Statements
1. Organization and nature of business
Immunocore Holdings plc (the "Company") is a public limited company incorporated in England and Wales and
has the following wholly owned subsidiaries: Immunocore Limited, Immunocore LLC, Immunocore Commercial LLC, Immunocore Ireland Limited, Immunocore GmbH, and Immunocore Nominees Limited (collectively referred to as the "Group").
The Company's American Depositary Shares ("ADSs") began trading on the Nasdaq Global Select Market under
the ticker symbol "IMCR" on February 5, 2021, following its initial public offering ("IPO"). The IPO and concurrent private placement generated net proceeds of 210,985,000 after underwriting discounts, commissions and directly attributable offering expenses. In July 2022, the Company issued and sold a total of 3,733,333 ordinary shares to certain institutional accredited investors as a private investment in public entity (the "PIPE") pursuant to a securities
purchase agreement, generating proceeds of 116,812,000 ($140,000,000) before deductions for offering expenses of 388,000.
The principal activity of the Group is pioneering the development and sale of a novel class of TCR
bispecific immunotherapies called ImmTAX - Immune mobilizing monoclonal TCRs
Against X disease - designed to treat a broad range of diseases, including cancer, infectious and autoimmune diseases. Leveraging its proprietary,
flexible, off-the-shelf ImmTAX platform, the Group is developing a deep pipeline in multiple therapeutic areas, including five clinical
stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs.
In January and April 2022, the Group received approval from the U.S. Food and Drug Administration ("FDA")
and European Commission ("EC"), respectively, for its lead product, KIMMTRAK, for the treatment of unresectable or metastatic uveal melanoma ("mUM"). In June 2022, the UK's MHRA, Health Canada, and the Australian Government Department of Health's TGA
have each approved KIMMTRAK for the treatment of HLA-A*02:01-positive adult patients with unresectable or mUM. KIMMTRAK is now approved in over 30 countries with commercial launches underway in the U.S., Germany, France and Canada. The Group expects
to obtain regulatory approval for KIMMTRAK in further territories in the next year.
2. Significant accounting policies
Basis of preparation
The unaudited condensed consolidated interim financial statements for the three and nine months ended September 30, 2022 and 2021 have been prepared
in accordance with International Accounting Standard 34, "Interim Financial Reporting" ("IAS 34"). Except as described in Significant Accounting Policies below, the accounting policies applied in these interim
financial statements are the same as those applied in the Group's consolidated financial statements as at and for the year ended December 31, 2021.
The unaudited condensed consolidated interim financial statements do not include all of the information required for the full annual financial
statements and should be read in conjunction with the annual consolidated financial statements of the Group for the year ended December 31, 2021 included in the Company's Annual Report on Form 20-F for the year ended December 31, 2021, filed with the
Securities and Exchange Commission on March 3, 2022 (the "Annual Report"). New accounting policies applicable to the three and nine months ended September 30, 2022, are outlined further below.
The unaudited condensed and consolidated interim financial statements have been prepared under the historical cost basis, as modified by the
recognition of certain financial instruments measured at fair value and are presented in pounds sterling which is the Company's functional currency. All values are rounded to the nearest thousand, except where otherwise indicated.
Date of authorization
These unaudited condensed consolidated interim financial statements were prepared at the request of the Company's Board of Directors (the "Board")
and were approved by the Board on November 9, 2022, and signed on its behalf by Dr. Bahija Jallal, Chief Executive Officer of the Group.
Adoption of new accounting standards
have been no new accounting standards adopted by the Group in 2022 which have had a material impact on these unaudited condensed consolidated interim financial statements. There are no standards issued but not yet effective that the Group expects
to have a material impact on its financial statements.
The Group reported cash and cash equivalents of 347,189,000
and net current assets of 326,303,000 as at September 30, 2022, with an operating profit / (loss) for the three and nine months ended
September 30, 2022 of 6,172,000 and ( 17,281,000),
respectively, and net cash used in operating activities for the nine months ended September 30, 2022 of 31,923,000. The negative
operational cash flow was largely due to the Group's continued focus on research, development, and clinical activities to advance preclinical and clinical programs within the Group's pipeline. The Group generated net product and net pre-product
revenue totalling 36,303,000 and 74,514,000
during the three and nine months ended September 30, 2022, respectively. In July 2022, the Group received 116,812,000 ($140,000,000) before deduction of attributable expenses of 388,000
In assessing the going concern assumptions, the Board has undertaken an assessment of the current business
and strategy forecasts covering a two-year period, which includes anticipated KIMMTRAK revenue. In assessing the downside risks, the Board has also considered scenarios incorporating a range of revenue arising from KIMMTRAK sales. As part of
considering the downside risks, the Board has considered the impact of the ongoing coronavirus 2019 ( COVID-19'') pandemic and other potential economic impacts including the war in Ukraine and related geopolitical tensions, as well as global
inflation, capital market instability, exchange rate fluctuations, and increases in commodity, energy and fuel prices. The Board has concluded that while these may have a future impact on the Group's business and implementation of its strategy and
plans, it anticipates that any such impact will be minimal on clinical trials or other business activities over the period assessed for going concern purposes. As of the date of these financial statements, the Group is not aware of any specific event
or circumstance that would require the Group to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. Actual results could differ from these estimates, and any such differences may be material to
the Group's financial statements.
Given the current cash position and the assessment performed, the Board believes that the Group will have sufficient funds to continue
to meet its liabilities as they fall due throughout the forecast period outlined above and therefore, the Group has prepared the financial statements on a going concern basis. This scenario is based on the Group's lower range of anticipated
revenue levels. As the Group continues to incur significant expenses in the pursuit of its business strategy, including further commercialization and marketing plans for KIMMTRAK, additional funding will be needed
before further existing clinical and preclinical programs may be expected to reach commercialization, which would potentially lead to additional operational cash inflows. Until the Group can generate
revenue from product sales sufficient to fund its ongoing operations and further develop its pipeline, if ever, it expects to finance its operations through a combination of public or private equity offerings and debt financings or other sources,
such as potential collaboration agreements, strategic alliances and licensing arrangements.
Estimates and judgements
The preparation of the unaudited condensed consolidated interim financial statements in conformity with IAS 34 requires management to make
judgments, estimates and assumptions. These judgments, estimates and assumptions affect the reported assets and liabilities as well as contingent liabilities and income and expenses in the financial period. The estimates and associated assumptions
are based on information available when the unaudited condensed consolidated interim financial statements are prepared, historical experience and various other factors which are believed to be reasonable under the circumstances. Existing
circumstances and assumptions about future developments may change due to market changes or circumstances arising that are beyond the Group's control. Therefore, estimates may vary from eventual outcomes and may be subject to updates in future
Judgements and estimates made, together with our significant accounting policies, are disclosed in the consolidated financial statements of the
Group for the year ended December 31, 2021, and are presented in the Group's Annual Report. Significant updates to the Group's estimates and accounting policies for the three and nine months ended September 30, 2022 are outlined below.
Critical Accounting Estimates
Estimated rebates, chargebacks and product returns
As outlined below in the "Product revenue, net" policy, the Group recognizes revenue net of estimated
deductions for rebates, chargebacks, other customer fees and product returns.
Due to its limited history of product sales in the United States having only recently received regulatory approval for its first product, the Group
has limited directly comparable information of actual rebate claims, chargebacks or levels of product returns, and the Group's early sales information may have limited predictive value. The Group uses the expected value method to estimate revenue
deductions, which considers the likelihood of a rebate, chargeback or product return being applicable to sales. The proportion of sales subject to a rebate or chargeback, and the level of product returns, is inherently uncertain and the Group's
estimates are based on internal assumptions, which may change as the Group develops more product experience, and third-party data, which the Group assesses for reliability and relevance.
Rebates and chargebacks
The Group is subject to state government Medicaid programs and other qualifying federal and state programs in the United States
requiring rebates to be paid to participating state and local government entities, depending on the eligibility and circumstances of patients treated with KIMMTRAK after the Group has sold vials to specialty distributors. The Group is also subject
to chargebacks from its specialty distributors under the 340B program in the United States, whereby qualifying hospitals are entitled to purchase KIMMTRAK at a lower price. For such sales, the Group's specialty distributors charge back the
difference between the wholesale acquisition cost and this lower price. Estimating rebate and chargeback deductions from revenue is judgmental due to the time delay between the date of the sale to specialty distributors and the subsequent dates on
which the Group is able to determine actual amounts of chargebacks and rebates. The Group forms estimates of 340B chargeback deductions by analyzing sell-through data relating to the hospital mix of onward
sales made by specialty distributors. For Medicaid and other rebates, the Group forms estimates based on internal forecasts of the patient mix and external health coverage statistics. Judgment is applied