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INDEX TO UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
| Page | ||
| Unaudited Condensed Consolidated Statements of Loss and Other Comprehensive Income for the Three Months Ended March 31, 2022 and 2021 | 2 | |
| Unaudited Condensed Consolidated Statements of Financial Position as at March 31, 2022 and December 31, 2021 | 3 | |
| Unaudited Condensed Consolidated Statements of Changes in Equity for the Three Months Ended March 31, 2022 and 2021 | 4 | |
| Unaudited Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 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 Loss and Other Comprehensive Income
| Three months ended March 31, | ||||||||||||
| Notes | 2022 '000 | 2021 '000 | ||||||||||
| Product revenue, net | 3 | 7,682 | - | |||||||||
| Pre-product revenue, net | 3 | 2,829 | - | |||||||||
| Collaboration revenue | 3 | 11,963 | 8,270 | |||||||||
| Total revenue | 22,474 | 8,270 | ||||||||||
| Cost of product revenue | (248 | ) | - | |||||||||
| Research and development costs | (18,581 | ) | (19,885 | ) | ||||||||
| Selling and administrative expenses | (20,106 | ) | (20,184 | ) | ||||||||
| Net other operating income / (expense) | 1 | (82 | ) | |||||||||
| Operating loss | (16,460 | ) | (31,881 | ) | ||||||||
| Finance income | 10 | 22 | ||||||||||
| Finance costs | 4 | (1,333 | ) | (1,860 | ) | |||||||
| Non-operating expense | (1,323 | ) | (1,838 | ) | ||||||||
| Loss before taxation | (17,783 | ) | (33,719 | ) | ||||||||
| Income tax credit | 5 | 1,655 | 4,681 | |||||||||
| Loss for the period | (16,128 | ) | (29,038 | ) | ||||||||
| Other comprehensive income / (loss) | ||||||||||||
| Other comprehensive income / (loss) that is or may be reclassified to profit or loss in subsequent periods: | ||||||||||||
| Exchange differences on translation of foreign operations | 205 | (92 | ) | |||||||||
| Total other comprehensive income / (loss) for the period | 205 | (92 | ) | |||||||||
| Total comprehensive loss for the period | (15,923 | ) | (29,130 | ) | ||||||||
| Basic and diluted loss per share - | 6 | (0.37 | ) | (0.76 | ) |
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 as at March 31, 2022 and December 31, 2021
| Notes | March 31, 2022 '000 | December 31, 2021 '000 | ||||||||||
| Non-current assets | ||||||||||||
| Property, plant and equipment | 7,849 | 8,944 | ||||||||||
| Right of use assets | 22,199 | 22,593 | ||||||||||
| Other non-current assets | 5,955 | 4,935 | ||||||||||
| Deferred tax asset | 2,650 | 2,575 | ||||||||||
| Total non-current assets | 38,653 | 39,047 | ||||||||||
| Current assets | ||||||||||||
| Inventory | 496 | - | ||||||||||
| Trade and other receivables | 7 | 25,746 | 15,208 | |||||||||
| Tax receivable | 11,289 | 9,632 | ||||||||||
| Cash and cash equivalents | 205,853 | 237,886 | ||||||||||
| Total current assets | 243,384 | 262,726 | ||||||||||
| Total assets | 282,037 | 301,773 | ||||||||||
| Equity | ||||||||||||
| Share capital | 88 | 88 | ||||||||||
| Share premium | 212,499 | 212,238 | ||||||||||
| Foreign currency translation reserve | 294 | 89 | ||||||||||
| Other reserves | 386,167 | 386,167 | ||||||||||
| Share-based payment reserve | 61,770 | 54,357 | ||||||||||
| Accumulated deficit | (497,520 | ) | (481,392 | ) | ||||||||
| Total equity | 163,298 | 171,547 | ||||||||||
| Non-current liabilities | ||||||||||||
| Interest-bearing loans and borrowings | 38,370 | 37,226 | ||||||||||
| Deferred revenue | 3 | 2,136 | 6,408 | |||||||||
| Lease liabilities | 25,043 | 25,355 | ||||||||||
| Provisions | 70 | 57 | ||||||||||
| Total non-current liabilities | 65,619 | 69,046 | ||||||||||
| Current liabilities | ||||||||||||
| Trade and other payables | 9 | 34,695 | 35,436 | |||||||||
| Deferred revenue | 3 | 17,089 | 24,450 | |||||||||
| Lease liabilities | 1,294 | 1,255 | ||||||||||
| Provisions | 42 | 39 | ||||||||||
| Total current liabilities | 53,120 | 61,180 | ||||||||||
| Total liabilities | 118,739 | 130,226 | ||||||||||
| Total equity and liabilities | 282,037 | 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 | - | - | - | - | - | (16,128 | ) | (16,128 | ) | |||||||||||||||||||||||
| Other comprehensive income | - | - | 205 | - | - | - | 205 | |||||||||||||||||||||||||
| Total comprehensive income/ (loss) for the period | - | - | 205 | - | - | (16,128 | ) | (15,923 | ) | |||||||||||||||||||||||
| Exercise of share options | - | 261 | - | - | - | - | 261 | |||||||||||||||||||||||||
| Equity-settled share-based payment transactions | 8 | - | - | - | 7,413 | - | - | 7,413 | ||||||||||||||||||||||||
| At March 31, 2022 | 88 | 212,499 | 294 | 61,770 | 386,167 | (497,520 | ) | 163,298 |
| 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 | - | - | - | - | (29,038 | ) | (29,038 | ) | ||||||||||||||||||||||||
| Other comprehensive loss | - | - | (92 | ) | - | - | - | (92 | ) | |||||||||||||||||||||||
| Total comprehensive loss for the period | - | - | (92 | ) | - | - | (29,038 | ) | (29,130 | ) | ||||||||||||||||||||||
| Issue of share capital | 24 | 210,961 | - | - | - | - | 210,985 | |||||||||||||||||||||||||
| Equity-settled share-based payment transactions | 8 | - | 325 | - | 8,271 | - | - | 8,596 | ||||||||||||||||||||||||
| At March 31, 2021 | 88 | 211,286 | 71 | 27,092 | 386,167 | (378,907 | ) | 245,797 |
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
| Three months ended March 31, | ||||||||
| 2022 '000 | 2021 '000 | |||||||
| Cash flows from operating activities | ||||||||
| Loss for the period | (16,128 | ) | (29,038 | ) | ||||
| Adjustments for: | ||||||||
| Equity settled share-based payment expense | 7,413 | 8,596 | ||||||
| Depreciation | 1,679 | 1,807 | ||||||
| Net finance costs | 1,323 | 1,838 | ||||||
| Foreign exchange differences | 945 | (368 | ) | |||||
| Other | (1 | ) | 219 | |||||
| Income tax credit | (1,655 | ) | (4,681 | ) | ||||
| Working capital adjustments: | ||||||||
| (Increase) / decrease in receivables and other non-current assets | (11,489 | ) | 2,068 | |||||
| (Decrease) / increase in trade and other payables | (807 | ) | 631 | |||||
| Decrease in deferred revenue | (11,633 | ) | (7,051 | ) | ||||
| Other working capital movements | (480 | ) | - | |||||
| Net cash used in operating activities | (30,833 | ) | (25,979 | ) | ||||
| Cash flows from investing activities | ||||||||
| Proceeds from sale of property, plant and equipment | 5 | - | ||||||
| Purchase of property, plant and equipment | (138 | ) | (220 | ) | ||||
| Proceeds from investment in sub-leases | - | 245 | ||||||
| Net cash flows (used in) / generated by investing activities | (133 | ) | 25 | |||||
| Cash flows from financing activities | ||||||||
| Gross proceeds from issue of share capital | - | 226,528 | ||||||
| Costs from issue of share capital | - | (15,543 | ) | |||||
| Exercise of share options | 261 | - | ||||||
| Interest paid on non-current interest-bearing loan | (838 | ) | (810 | ) | ||||
| Repayment of lease liabilities | (755 | ) | (802 | ) | ||||
| Net cash flows (used in) / generated by financing activities | (1,332 | ) | 209,373 | |||||
| (Decrease) / increase in cash and cash equivalents | (32,298 | ) | 183,419 | |||||
| Net foreign exchange difference on cash held | 265 | (52 | ) | |||||
| Cash and cash equivalents at beginning of the year | 237,886 | 129,716 | ||||||
| Cash and cash equivalents at end of the period | 205,853 | 313,083 |
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 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 to the Bill & Melinda Gates Foundation generated net proceeds of 210,985,000 after underwriting discounts, commissions and directly attributable offering expenses.
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.
The Group is currently selling KIMMTRAK in the United States and Europe. The Group plans to sell KIMMTRAK in additional territories later in 2022, subject to further regulatory approval.
2. Significant accounting policies
Basis of preparation
The unaudited condensed consolidated interim financial statements for the three months ended March 31, 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 31 December 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 months ended March 31, 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 May 11, 2022,
and signed on its behalf by Dr. Bahija Jallal, Chief Executive Officer of the Group.
Adoption of new accounting standards
There have been no 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 205,853,000 and net current assets of 190,730,000 as at
March 31, 2022, with an operating loss for the three months ended March 31, 2022 of 16,460,000 and net cash used in operating activities of 30,833,000. 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. While the Group generated a negative operational cash flow overall, net product and pre-product revenue totalling 10,511,000 was
recorded during the three months ended March 31, 2022. During the three months ended March 31, 2022, the Group received approval from the FDA for its lead product, KIMMTRAK, for the treatment of
metastatic uveal melanoma and has commenced selling the product in the United States during the period. The Group subsequently received marketing approval from the European Commission ("EC") for KIMMTRAK on April 1, 2022.
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 KIMMTRAK revenue. In
assessing the downside risks, the Board has also considered scenarios incorporating a range of revenue arising from KIMMTRAK. As part of considering the downside risks, the Board has considered the impact of the ongoing coronavirus 2019
( COVID-19'') pandemic and have concluded that the pandemic may have a future impact on the Group's business and implementation of its strategy and plans, but 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 Company is not aware of any specific event or circumstance that would require the Company 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 Company's financial statements.
Given the current cash position and the assessment performed, the Board is confident that the Group will
have sufficient funds to continue to meet its liabilities as they fall due until at least the third quarter of 2024 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 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 reported periods.
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 on Form 20-F filed on March 3, 2022. Significant updates to the Group's estimates and accounting policies for the three months ended March 31, 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 net product revenue on delivery to its specialty distributors and forms estimates of deductions related to these sales
for rebates, chargebacks and returns based on statutory and contractual requirements.
Due to its limited history of product sales having only recently received regulatory approval for its
first product, the Group has no previous 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 the Medicaid program in the United States, which requires rebates to be paid to
states in accordance with federal requirements, depending on the eligibility and circumstances of patients treated with KIMMTRAK after the Group has sold vials to specialty distributors. In addition, the Group is 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. The Group is also subject to chargebacks from participation under a program with the Department of Veteran Affairs in the United States. 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 rebates and chargebacks. The Group forms estimates of chargeback deductions by analyzing sell-through data relating to the hospital mix of onward sales made by specialty distributors. For rebates, the Group forms estimates based on internal
forecasts of the patient mix and external health coverage statistics. Judgment is applied to consider the relevance and reliability of information used to make these estimates.
The Group considers several inputs when estimating potential levels of product returns. Due to the nature of KIMMTRAK as a therapy, the Group expects no product returns following patient
administration by trained healthcare professionals. The Group applies judgement in assessing the level of returns for sales made to specialty distributors which have yet to be administered to patients. The Group considers industry average return
levels, specialty distributor sell-through rates, the levels of inventory in the distribution channel, the period of time for which inventory has been held by its specialty distributors, the level of orders placed, the expiry date of products sold,
and its distributors' right to return products in the case of vials of KIMMTRAK with a shorter period to expiry. As orders are typically placed based on scheduled administration by hospitals and healthcare facilities, the Group does not expect a
significant level of product returns.
Significant Accounting Policies
Product revenue, net
Product revenue, net relates to the sale of KIMMTRAK following marketing approval. The Group recognizes revenue at the point in time that control transfers to a customer, which is typically on
delivery. The amount of revenue recognized reflects the consideration to which the Group expects to be entitled to, net of estimated deductions for rebates, chargebacks, other customer fees and product returns. Estimated revenue deductions are
updated at the end of each reporting period using the latest available data. The Group considers whether any part of amounts expected to be received should be constrained to ensure that it is highly probable that a significant reversal in the
cumulative revenue recognized will not occur. Estimating such deductions involves judgments which are detailed further above under "Critical accounting estimates".