| Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the
related notes thereto appearing elsewhere in this Quarterly Report. The following discussion is based on our financial information prepared in accordance with accounting principles generally accepted in the U.S., or U.S. GAAP, as found in the
Accounting Standards Codification and Accounting Standards Update of the Financial Accounting Standards Board and the rules and regulations of the SEC. Some of the information contained in this discussion and analysis or set forth elsewhere in this
Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. We also recommend that you read our discussion and analysis of financial
condition and results of operations together with our audited financial statements and notes thereto, and the section entitled “Risk Factors”, each of which appear in our Annual Report on Form 10-K for the year ended December 31, 2023, as filed
with the SEC on February 28, 2024, or, our Annual Report as well as the section titled “Special Note Regarding Forward-Looking Statements.”
Overview
We are a commercial stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases, and
autoimmune diseases. Leveraging our proprietary, flexible, off-the-shelf ImmTAX (Immune mobilizing monoclonal TCRs Against X disease) platform, with a pipeline in multiple therapeutic areas, including nine active clinical and pre-clinical programs
in oncology, infectious disease, and autoimmune disease.
In 2022, we received approval for our lead product, KIMMTRAK, for the treatment of unresectable metastatic uveal melanoma from the FDA, the European Commission, and other health authorities.
KIMMTRAK is now approved in 38 countries for the treatment of unresectable or mUM. We have launched KIMMTRAK in 17 countries globally to date and we plan to launch KIMMTRAK in additional countries, if approved in those countries, in 2024.
KIMMTRAK is the lead product from our ImmTAX platform and was the first approved new therapy in mUM in four decades. To date, we have treated over 2,000 cancer patients with KIMMTRAK, tebentafusp,
and our other ImmTAX product candidates, which we believe is the largest clinical data set of any T cell engager bispecific in solid tumors and any TCR therapeutic. Our clinical programs are being conducted with patients with a broad range of
cancers including melanoma, ovarian, lung, endometrial, and colorectal, among others. We believe that these other tumor types have large addressable patient populations and significant unmet need. We are progressing two late-stage clinical programs
within our ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) portfolio, including KIMMTRAK and the PRAME-targeted brenetafusp (IMC-F106C).
Since our inception, we have focused on organizing and staffing our company, raising capital and performing research and development activities to advance our research, development and technology,
and commercializing KIMMTRAK. While we have successfully generated revenue from KIMMTRAK, which is our first marketed product, our ability to generate higher levels of product revenue from other marketed products, which may never be fully developed
or commercialized, depends on the successful development and regulatory approval of one or more of our product candidates and our ability to finance operations. Since inception, through to March 31, 2024, we have raised an aggregate of $1,677
million through our initial public offering, private placements of our ordinary and preferred shares, debt financings, and historical payments from our collaboration partners. These funds have been and are being used to fund operations and invest
in activities for technology creation, drug discovery and clinical development programs, infrastructure, creation of portfolio of intellectual property and commercial and administrative support.
We have incurred significant operating losses and expect to continue to incur significant expenses and operating losses for the near future. These net losses were $24.4 million and $19.4 million,
for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, our accumulated deficit was $769.1 million. We expect to continue to incur significant and increasing expenses and to incur operating losses for the foreseeable
future, as we advance our product candidates through preclinical and clinical development and seek regulatory approvals, manufacture drug product and drug supply, maintain and expand our intellectual property portfolio, as well as hire additional
personnel, pay for further accounting, audit, legal, regulatory and consulting services, and pay costs associated with maintaining compliance with Nasdaq listing rules and the requirements of the SEC, director and officer liability insurance,
investor and public relations activities and other expenses associated with operating as a public company.
We do not expect to generate revenue from the sale of our other product candidates unless and until we successfully complete clinical development of and obtain regulatory approval for such product
candidates. As a result, we may need additional funding to support our continued operations and pursue our clinical development and growth strategy. Until we can generate sufficient revenue from product sales, if ever, we expect to finance our
operations through a combination of public or private equity offerings, debt financings, government funding arrangements, collaborations and marketing, distribution and licensing arrangements. We may be unable to raise additional funds or enter
into such other arrangements on favorable terms, or at all, particularly in light of recently worsening macroeconomic conditions, such as supply chain disruptions, rising interest rates and volatility in the capital markets. If we fail to raise
capital or enter into such arrangements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our programs.
Because of the numerous risks and uncertainties associated with pharmaceutical development, we are unable to predict the timing or amount of future revenues, increased expenses or when or if we
will be able to achieve or maintain profitability. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to reduce our
operations.
Recent Developments
In April 2024, we announced that data from the Phase 1/2 study with brenetafusp in patients with late-line cutaneous melanoma was selected for oral presentation at the annual ASCO meeting on May
31, 2024. These patients were all previously treated with anti-PD1 and the vast majority having received ipilimumab. We will also present four posters, including one trial-in-progress poster of the Phase 3 PRISM-MEL301 trial with brenetafusp in
combination with nivolumab versus standard nivolumab regimens in HLA-A*02:01+ patients with first-line advanced melanoma, and three posters sharing clinical and translational data about KIMMTRAK in metastatic uveal melanoma.
In March 2024, we presented two preclinical posters at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI).
Components of Results of Operations
Revenue
Product revenue, net
Product revenue, net, relates to the sale of KIMMTRAK following marketing approval. We recognize product revenue at the point in time that control transfers to a customer, which is typically on
delivery to our distributors and healthcare providers. We also operate under consignment arrangements where control passes when our distributors take KIMMTRAK out of consignment inventory. The amount of revenue recognized reflects the consideration
to which we expect to be entitled, net of estimated deductions for rebates, chargebacks, other customer fees and product returns. These estimates consider contractual and statutory requirements, the expected payor and patient mix, sell-through
data, our customers’ inventory levels, anticipated demand and the volume of customer purchase orders, internal data, and other information provided by our customers and third-party logistics providers, and, in certain countries including France,
pricing negotiations. Further information on estimates is provided under the section below headed, “Critical Accounting Estimates”.
Collaboration revenue
Collaboration revenue arose under our collaboration agreement with Genentech. In February 2023, we and Genentech agreed to wind down the co-funding arrangements and clinical trial for IMC-C103C. We
could be eligible to receive development and commercial milestone payments and royalties from Genentech on any sales of MAGE-A4 HLA-A02 targeted products arising under the Genentech collaboration.
Collaboration revenue consisted of non-refundable upfront payments, development milestones as well as reimbursement of research and development expenses. As of December 31, 2023, we determined our
performance obligation under the collaboration with Genentech was complete.
Cost and Operating Expenses
Cost of product revenue
Cost of product revenue represents production costs including raw materials, external manufacturing costs, and other costs incurred in bringing inventories to their location and condition prior to
sale. Overheads and internal costs of product revenue are minimal under our manufacturing arrangements. Due to the low costs involved in manufacturing KIMMTRAK, cost of product revenue is currently not material, and while these costs are expected
to increase in future periods as inflationary pressures increase, we do not expect such costs to be material for the foreseeable future. Cost of product revenue may also include costs related to excess or obsolete inventory adjustment charges.
Research and development expense
Research and development, or R&D, expenses consist primarily of costs incurred for current or planned investigations undertaken with the prospect of gaining new scientific or technical
knowledge and understanding and consist primarily of personnel-related costs, including salaries and share-based compensation expense for the various R&D departments, costs associated with clinical trial activities undertaken by contract
research organizations, or CROs, and external manufacturing costs associated with R&D undertaken by contract manufacturing organizations, or CMOs, R&D laboratory consumables, internal clinical trial expenses, payments for purchased rights
and milestones in connection with third-party In-process R&D, or IPRD, agreements, costs associated with maintaining laboratory equipment, costs associated with our R&D facilities, including a reasonable allocation of overhead costs, and
reductions from expenses for R&D tax credits. R&D expenses are expensed as incurred, although the timing of expense recognition can vary with contractual and payment terms in order to determine when services are received.
R&D expenses incurred with external organizations to undertake R&D activities on our behalf typically relate to clinical programs and are assigned to the individual programs in tables
further below. However, for certain pre-clinical programs and other research spend incurred externally, such spend is not assigned to individual programs. Internal R&D expenses primarily relate to personnel-related costs, facilities, and
R&D laboratory consumables and due to the cross-functional expertise of our people, it is not possible to provide a breakdown of internal costs by program.
We expect our R&D expenses to increase in the future as we advance existing and future product candidates into and through clinical studies and pursue further regulatory approval. The process
of conducting the necessary clinical studies to obtain regulatory approval is costly and time-consuming. We maintain our headcount at a level required to support our continued research activities and development of our product candidates. Clinical
trials generally become larger and more costly to conduct as they advance into later stages. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical
trials of our product candidates due to the inherently unpredictable nature of preclinical and clinical development. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from
expectations. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of any product candidates that we develop from our programs. As a result, our
R&D expenses may vary substantially from period to period based on the timing of our R&D activities.
Research and development tax credits
As a company that carries out extensive R&D activities, we benefit from the U.K. R&D tax regime. For certain specific categories of expenditure, we have benefited from the Research and
Development Expenditure Credit, or RDEC, program for the three months ended March 31, 2024. R&D tax credits are presented as a reduction to R&D expenses. On April 1, 2023, the headline rate under the RDEC program increased from 13% to 20%
and can generate cash rebates of up to 15% (increased from 10.5%) on qualifying R&D expenditure incurred from this date.
Amendments to the U.K. R&D tax credit regime that are contained in the Finance Bill currently proceeding through the U.K. Parliament with effect from April 1, 2024 (i) (unless limited
exceptions apply) introduce restrictions on the tax relief that can be claimed for expenditure incurred on sub-contracted R&D activities or externally provided workers, where such sub-contracted activities are not carried out in the United
Kingdom or such workers are not subject to U.K. payroll taxes, and (ii) merge the Small and Medium-sized Enterprise Program and the RDEC program into a single scheme.
Selling, general and administrative expense
Selling, general and administrative, or SG&A, expenses consist primarily of personnel-related costs, including salaries and share-based compensation expense, for selling, corporate and other
administrative and operational functions including finance, legal, human resources, commercial-related expenses, information technology, as well as a proportion of facility-related costs.
Following our commercialization of KIMMTRAK and our substantial increase in planned R&D expenses, as explained above, we also expect that our SG&A expenses will increase. We expect that we
will incur increased selling, distribution, commercial, accounting, audit, legal, regulatory, compliance, director and officer insurance costs as well as investor and further public relations expenses associated with being a public company
operating in multiple territories. We anticipate that the additional costs for these services will substantially increase our SG&A expenses. Additionally, if and as we receive further regulatory approvals of product candidates, we anticipate an
increase in payroll and expenses in connection with our commercial operations. We have experienced, and may continue to experience, increased personnel costs attributable to offering and maintaining competitive salaries and other impacts due to
rising global inflation.
Interest income
Interest income arises on cash balances and short-term money market funds. Our interest income may fluctuate depending on the movement of interest rates and our total amount of cash and cash
equivalents.
Interest expense
Interest expense represents costs under our interest-bearing loans and borrowings under the effective interest method.
Foreign currency loss
These losses arise on a variety of items, including on U.S. dollar monetary assets and liabilities held by our main operating subsidiary in the United Kingdom, including our cash and cash
equivalent balances. Our foreign currency losses can vary significantly between periods as a result of volatility in foreign exchange rates.
Other expense, net
Other expense, net arises primarily on loan and borrowing costs and other items.
Income tax expense
We are subject to corporate taxation in the United Kingdom. Our wholly owned U.S. subsidiaries, Immunocore LLC and Immunocore Commercial LLC, are subject to corporate taxation in the United States.
Our wholly owned Irish subsidiary is subject to corporate taxation in Ireland. Our wholly owned Swiss subsidiary is subject to corporate taxation in Switzerland. Due to the nature of our business and on a consolidated basis, we have generated
losses since inception. Our income tax expense represents the sum of income taxes payable in the United States, Ireland and Switzerland, offset by deferred tax credits arising on deferred tax assets generated.
Un-surrendered tax losses are carried forward to be offset against future taxable profits. After accounting for tax credits receivable, there were accumulated tax losses available for carry forward
in the United Kingdom of $312 million as of March 31, 2024. A full valuation allowance is recognized in respect of accumulated tax losses and other temporary differences in the United Kingdom because future profits are not sufficiently certain. A
deferred tax asset is, however, recognized in respect of the subsidiary in the United States, relating to unused tax credits on share-based compensation expense and other temporary differences on the basis that we expect to continue generating U.S.
taxable income against which deductible temporary differences can unwind.
As we begin to generate significant net product revenue, we may benefit from the U.K.’s “patent box,” which allows profits attributable to revenues from patents or patented products to be taxed at
a lower rate than other revenue. The rate of tax for relevant streams of revenue for companies receiving this relief will be 10%.
Comparison of the Three Months Ended March 31, 2024 and 2023
Revenue
The following table summarizes our total revenue (in thousands):
| |
|
Three Months Ended March 31,
|
|
| |
|
2024
|
|
|
2023
|
|
|
Increase / (decrease)
|
|
|
% Increase / (decrease)
|
|
|
Product revenue, net
|
|
$
|
70,342
|
|
|
$
|
51,581
|
|
|
$
|
18,761
|
|
|
|
36.4
|
%
|
|
Collaboration revenue
|
|
|
160
|
|
|
|
3,078
|
|
|
|
(2,918
|
)
|
|
|
(94.8
|
)%
|
|
Total revenue
|
|
$
|
70,502
|
|
|
$
|
54,659
|
|
|
$
|
15,843
|
|
|
|
29.0
|
%
|
Product revenue, net
Product revenue, net from the sale of KIMMTRAK is presented by country / region based on location of the end customer below (in thousands).
| |
|
Three Months Ended March 31,
|
|
| |
|
2024
|
|
|
2023
|
|
|
Increase / (decrease)
|
|
|
% Increase / (decrease)
|
|
|
United States
|
|
$
|
50,026
|
|
|
$
|
36,224
|
|
|
$
|
13,802
|
|
|
|
38.1
|
%
|
|
Europe
|
|
|
18,952
|
|
|
|
15,124
|
|
|
|
3,828
|
|
|
|
25.3
|
%
|
|
International
|
|
|
1,364
|
|
|
|
233
|
|
|
|
1,131
|
|
|
|
485.4
|
%
|
|
Total product revenue, net
|
|
$
|
70,342
|
|
|
$
|
51,581
|
|
|
$
|
18,761
|
|
|
|
36.4
|
%
|
For the three months ended March 31, 2024, we generated product revenue, net of $70.3 million due to the sale of KIMMTRAK, of which $50.0 million was in the United States, $19.0 million in Europe
(including the impact of a net increase in estimated reserves related to prior periods of $5.4 million) and $1.4 million in International. Product revenue, net increased in the three months ended March 31, 2024 as compared to March 31, 2023, due
primarily to increased volume in the United States and global country expansion, as we continued our commercialization efforts.
Collaboration revenue
Revenue from collaboration agreements decreased by $2.9 million to $0.2 million in the three months ended March 31, 2024, compared to $3.1 million for the three months ended March 31, 2023. This
decrease was due to our February 2023 agreement with Genentech under the terms of our Genentech Collaboration, our only remaining revenue collaboration, to close the Phase 1 clinical trial and for the parties to fulfill the remaining obligations in
relation to the trial.
R&D Expenses
The following table summarizes our R&D expenses (in thousands):
| |
|
Three Months ended March 31,
|
|
| |
|
2024
|
|
|
2023
|
|
|
Increase / (decrease)
|
|
|
% Increase / (decrease)
|
|
|
External R&D expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tebentafusp programs
|
|
$
|
5,894
|
|
|
$
|
4,121
|
|
|
$
|
1,773
|
|
|
|
43.0
|
%
|
|
PRAME programs
|
|
|
26,700
|
|
|
|
8,795
|
|
|
|
17,905
|
|
|
|
203.6
|
%
|
|
Infectious disease programs
|
|
|
2,246
|
|
|
|
1,748
|
|
|
|
498
|
|
|
|
28.5
|
%
|
|
All other external clinical and pre-clinical costs
|
|
|
6,499
|
|
|
|
4,526
|
|
|
|
1,973
|
|
|
|
43.6
|
%
|
|
Total external R&D expenses
|
|
|
41,339
|
|
|
|
19,190
|
|
|
|
22,149
|
|
|
|
115.4
|
%
|
|
Internal R&D expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Salaries and other employee-related costs
|
|
|
9,754
|
|
|
|
9,180
|
|
|
|
574
|
|
|
|
6.3
|
%
|
|
Share-based compensation expense
|
|
|
1,980
|
|
|
|
1,696
|
|
|
|
284
|
|
|
|
16.7
|
%
|
|
All other internal R&D costs
|
|
|
6,209
|
|
|
|
7,237
|
|
|
|
(1,028
|
)
|
|
|
(14.2
|
)%
|
|
U.K. R&D tax credits
|
|
|
(1,823
|
)
|
|
|
(731
|
)
|
|
|
(1,092
|
)
|
|
|
149.4
|
%
|
|
Total internal R&D expenses
|
|
|
16,120
|
|
|
|
17,382
|
|
|
|
(1,262
|
)
|
|
|
(7.3
|
)%
|
|
Total R&D expenses
|
|
$
|
57,459
|
|
|
$
|
36,572
|
|
|
$
|
20,887
|
|
|
|
57.1
|
%
|
For the three months ended March 31, 2024, our R&D expenses were $57.5 million, as compared to $36.6 million for the three months ended March 31, 2023. For the three months ended March 31,
2024, our external R&D expenses increased by $22.1 million due to $17.9 million in expenses incurred for our PRAME programs due primarily to the initiation of our Phase 3 clinical trial.
SG&A Expenses
For the three months ended March 31, 2024, our SG&A expenses were $39.3 million, as compared to $32.6 million for the three months ended March 31, 2023, reflecting an increase of $6.7 million.
SG&A expenses for three months ended March 31, 2024 and 2023 comprised the following (in thousands):
| |
|
Three Months Ended March 31,
|
|
| |
|
2024
|
|
|
2023
|
|
|
Increase / (decrease)
|
|
|
% Increase / (decrease)
|
|
|
Share-based compensation expense
|
|
$
|
6,984
|
|
|
$
|
6,562
|
|
|
$
|
422
|
|
|
|
6.4
|
%
|
|
Salaries and other employee-related costs
|
|
|
14,840
|
|
|
|
9,244
|
|
|
|
5,596
|
|
|
|
60.5
|
%
|
|
Selling and commercial costs
|
|
|
10,649
|
|
|
|
10,244
|
|
|
|
405
|
|
|
|
4.0
|
%
|
|
Other administrative expenses
|
|
|
6,814
|
|
|
|
6,517
|
|
|
|
297
|
|
|
|
4.6
|
%
|
|
Total SG&A expenses
|
|
$
|
39,287
|
|
|
$
|
32,567
|
|
|
$
|
6,720
|
|
|
|
20.6
|
%
|
Salaries and other employee-related costs increased by $5.6 million during the three months ended March 31, 2024, primarily due to an
increase in the number of employees engaged in business support functions, including medical and regulatory activities to support our growing pipeline and commercial activities. In addition, the internalizing of our U.S. salesforce in the second
half of 2023 increased salaries and other employee-related costs for the three months ended March 31, 2024, as these costs were included within selling and commercial costs for the three months ended March 31, 2023.
Interest Income and Interest Expense
For the three months ended March 31, 2024, interest income was $8.2 million compared to $3.1 million for the three months ended March 31, 2023. This increase of $5.1 million reflects higher levels
of cash and cash equivalents held in 2024 relative to 2023 due to the net cash proceeds from the Notes issued in February 2024 and increases in interest rates earned on our cash and cash equivalents balances. For the three months ended March 31,
2024, interest expense was $3.2 million compared to $1.3 million for the three months ended March 31, 2023, and the increase was primarily related to our Notes issued in February 2024.
Foreign Currency Loss
For the three months ended March 31, 2024, foreign currency loss was $2.4 million compared to a loss of $6.0 million for the three months ended March 31, 2023. This change of $3.6 million reflects
smaller exchange rate movements in 2024.
Income Tax Expense
For the three months ended March 31, 2024, the income tax charge amounted to $0.4 million compared to a $0.3 million for the three months ended March 31, 2023.
Liquidity and Capital Resources
Sources of Liquidity
Although we have recorded product revenue for sales of KIMMTRAK in the three months ended March 31, 2024, we have continued to incur operating losses and negative cash flows from our operations
since our inception. We have an accumulated deficit of $769.1 million as of March 31, 2024.
Since our inception, we have funded our operations primarily with proceeds from sales of equity securities, debt financing, product and pre-product revenue and payments from collaboration partners.
Through March 31, 2024, we have raised an aggregate of $1,677 million. As of March 31, 2024 and December 31, 2023, we had cash and cash equivalents of $832.8 million and $442.6 million, respectively.
At our IPO in February 2021, we listed our ordinary shares in the form of ADSs on the Nasdaq Global Select Market and raised gross proceeds of approximately $297 million. In addition to the ADSs
sold in the IPO, we completed the concurrent sale of an additional 576,923 ADSs at the IPO price of $26.00 per ADS, for gross proceeds of approximately $15 million, in a private placement to the Gates Foundation, and in July 2022, we raised gross
proceeds of approximately $140.0 million through the sale of our ordinary shares in the form of ADSs and non-voting ordinary shares in a private placement.
On September 9, 2022, we entered into an Open Market Sale Agreement, or the Sales Agreement, with Jefferies LLC, or Jefferies, pursuant to which we may issue and sell ADSs, each representing one
ordinary share, having an aggregate offering price of up to $250 million, from time to time, in one or more at-the-market offerings, for which Jefferies will act as sales agent and/or principal. The at-the-market facility has been registered under
the Securities Act pursuant to our Registration Statement on Form F-3ASR (File No. 333-264105). As of March 31, 2024, no issuances or sales had been made pursuant to the Sales Agreement.
We entered into a loan with Pharmakon Advisors, LP, or the Pharmakon Loan Agreement, in November 2022, under which we have borrowed $50 million, which bears interest at a fixed rate of 9.75% and is
due to mature in November 2028.
On February 2, 2024, we completed a private offering of $402.5 million aggregate principal amount of the Notes. Our net proceeds from the offering of the Notes were $389.1 million, after
deducting the initial purchasers’ discounts and commissions and other offering expenses. The Notes are senior, unsecured obligations of the Company and will mature on February 1, 2030, unless earlier converted, redeemed or repurchased. The Notes
will accrue interest payable semi-annually in arrears on February 1 and August 1 of each year, beginning on August 1, 2024, at a rate of 2.50% per year. Our intention is to use part of the proceeds to repay in full, loans outstanding under the
Pharmakon Loan Agreement in the fourth quarter of 2024. As of the date of this Quarterly Report, we have not yet repaid those loans and our indebtedness includes both the Pharmakon Loan Agreement and the Notes.
Other than the abovementioned loan facilities we currently have no ongoing material financing commitments, such as lines of credit or guarantees, that are expected to affect our liquidity over the
next five years, other than our lease obligations and supplier purchase commitments.
Cash Flows
As of March 31, 2024, we had cash and cash equivalents of $832.8 million, as compared with $442.6 million as of December 31, 2023. Our working capital was $770.7 million as of March 31, 2024, as
compared with $389.8 million as of December 31, 2023.
The following table summarizes the primary sources and uses of cash for each period presented (in thousands):
| |
|
Three Months Ended March 31,
|
|
| |
|
2024
|
|
|
2023
|
|
|
Cash and cash equivalents at beginning of the period
|
|
$
|
442,626
|
|
|
$
|
402,472
|
|
|
Net cash (used in) / provided by operating activities
|
|
|
(4,587
|
)
|
|
|
10,539
|
|
|
Net cash used in investing activities
|
|
|
(430
|
)
|
|
|
(3,001
|
)
|
|
Net cash provided by financing activities
|
|
|
396,012
|
|
|
|
6,139
|
|
|
Net foreign exchange difference on cash held
|
|
|
(800
|
)
|
|
|
2,228
|
|
|
Cash and cash equivalents at end of the period
|
|
$
|
832,821
|
|
|
$
|
418,377
|
|
Net cash used in our operating activities was $4.6 million for the three months ended March 31, 2024, as compared to cash provided by operating activities of $10.5 million for the three months
ended March 31, 2023. The decrease of $15.1 million in the three months ended March 31, 2024 was primarily due to increases in clinical trial expenditures, partially offset by an increase in revenue and net interest income.
Net cash used in investing activities was $0.4 million and $3.0 million for the three months ended March 31, 2024 and 2023, respectively. The net cash used in investing activities during both
periods was primarily related to purchases of property and equipment.
Net cash provided by our financing activities during the three months ended March 31, 2024 was $396.0 million as compared to $6.2 million for the three months ended March 31, 2023. The increase of
$389.9 million was the result of the net cash proceeds from the Notes of $390.2 million with no similar proceeds in the three months ended March 31, 2023.
Future Capital Requirements
We expect to continue to incur significant operating losses in the foreseeable future and expect our expenses to increase in connection with our ongoing activities, particularly as
we continue to commercialize KIMMTRAK in additional territories, continue R&D and the advancement of our product candidates through preclinical and clinical development, and seek regulatory approval and pursue commercialization of any approved
product candidates. In addition, since our initial public offering in February 2021, we have incurred additional costs associated with operating as a public company, which could continue to increase further in future periods.
The amounts and timing of our actual expenditure may vary significantly depending on numerous factors. Our expenses will continue to increase if, and as, we:
|
• |
pursue further approval and commercialization of KIMMTRAK in additional indications and territories;
|
|
• |
continue to advance the development of our clinical trials and pre-clinical programs;
|
|
• |
continue to invest in our soluble TCR platforms to conduct research to identify novel technologies;
|
|
• |
change or add additional suppliers;
|
|
• |
add additional infrastructure to our quality control, quality assurance, legal, compliance and other groups to support our operations as we progress product candidates toward commercialization;
|
|
• |
seek to attract and retain skilled personnel;
|
|
• |
create additional infrastructure to further support our operations as a public company listed in the United States and our product development and planned future commercialization efforts;
|
|
• |
seek marketing approvals and reimbursement for our other product candidates;
|
|
• |
further develop a sales, marketing and distribution infrastructure to further commercialize any products for which we may obtain marketing approval;
|
|
• |
seek to identify and validate additional product candidates;
|
|
• |
acquire or in-license other product candidates and technologies;
|
|
• |
maintain, protect, defend, enforce and expand our intellectual property portfolio; and
|
|
• |
experience any delays, interruptions or encounter issues with any of the above, including any delays or other impacts as a result of the war in Ukraine, the state of war between Hamas and Israel, global geopolitical tension, worsening
macroeconomic conditions, including supply chain disruptions, rising interest rates and inflation, and health epidemics or pandemics.
|
In order to maintain such levels of expenditure and our anticipated expenditure, we expect to raise further funds by exploring debt or equity financing, or potentially further collaborations, in
the future. The amount we are able to raise from these options can vary with market conditions, including the impacts of recently worsening macroeconomic conditions such as supply chain disruptions, rising interest rates and volatility in the
capital markets, and our long-term strategy as a company is dependent on our ability to successfully raise such funding. Moreover, we have based our estimates on assumptions that may prove to be wrong, and we could use our available capital
resources sooner than we currently expect.
We held cash and cash equivalents of $832.8 million as of March 31, 2024. Based on our current operating plans, we expect that our existing cash and cash equivalents, along with anticipated revenue
from KIMMTRAK, will enable us to fund our operating expenses and capital expenditure requirements for at least twelve months from the date of filing of this Quarterly Report. Given our need for additional financing to support the long-term clinical
development of our programs, we intend to consider additional financing opportunities when market terms are favorable to us.
Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical product candidates, we are unable to estimate the exact amount of our
working capital requirements. Our future funding requirements will depend on and could increase significantly as a result of many factors, including:
|
• |
the progress, timing, scope and costs of our clinical trials, including the ability to timely initiate clinical sites, enroll subjects and manufacture soluble bispecific TCR product candidates for our ongoing, planned and potential
future clinical trials;
|
|
• |
the time and costs required to perform R&D to identify and characterize new product candidates from our research programs;
|
|
• |
the time and cost necessary to obtain regulatory authorizations and approvals that may be required by regulatory authorities to execute clinical trials or commercialize our products;
|
|
• |
the amount of sales and other revenues from KIMMTRAK in the United States, Europe, and other regions, if approved;
|
|
• |
our ability to successfully commercialize our other product candidates;
|
|
• |
our ability to have clinical and commercial products successfully manufactured consistent with FDA, regulations of the EU and other authorities’ regulations;
|
|
• |
the amount of sales and other revenues from product candidates that we may commercialize, if any, including the selling prices for such potential products and the availability of adequate third-party coverage and reimbursement for
patients;
|
|
• |
the sales and marketing costs associated with commercializing our products, if approved, including the cost and timing of building our marketing and sales capabilities;
|
|
• |
the cost of building, staffing and validating our manufacturing processes, which may include capital expenditure;
|
|
• |
the terms and timing of any revenue from our existing collaborations;
|
|
• |
the costs of operating as a public company;
|
|
• |
the time and cost necessary to respond to technological, regulatory, political and market developments;
|
|
• |
the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
|
|
• |
the costs, associated with, and terms and timing of, any future any potential acquisitions, strategic collaborations, licensing agreements or other arrangements that we may establish; and
|
|
• |
the inability of clinical sites to enroll patients as healthcare capacities are required to cope with natural disasters, epidemics or other health system emergencies.
|
A change in the outcome of any of these or other variables with respect to the development of any of our current and future product candidates could significantly change the costs and timing
associated with the development and commercialization of that product candidate. Furthermore, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such
operating plans.
Until we can generate sufficient revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity
offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements as well as grant funding. If we raise additional capital through marketing and distribution arrangements or
other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, technologies, future revenue streams or research programs or grant licenses on
terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, the terms of these securities may include liquidation or other preferences that adversely affect our shareholders’ rights. Further, to
the extent that we raise additional capital through the sale of ordinary shares or securities convertible or exchangeable into ordinary shares, our shareholders’ ownership interest will be diluted. If we raise additional capital through debt
financing, it would be subject to fixed payment obligations and may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we
are unable to obtain additional funding on favorable terms when needed, we may have to delay, reduce the scope of or terminate one or more of our R&D programs or clinical trials.
Our ability to raise additional capital may also be adversely impacted by potential worsening global economic conditions and disruptions to, and volatility in, financial markets in the United
States and worldwide. We are also mindful that conditions in the current macroeconomic environment could affect our ability to achieve our goals. We sell our products in countries that face economic volatility and weakness. Although we have
historically collected receivables from customers in such countries, sustained weakness or further deterioration of the local economies and currencies may cause customers in those countries to be unable to pay for our products. We will continue to
monitor these conditions and will attempt to adjust our business processes, as appropriate, to mitigate macroeconomic risks to our business.
Contractual Obligations
Leases and manufacturing
As part of our ongoing operations, we have material contractual lease obligations over expected lease terms of several years and expiry dates extending to 2043 primarily for our most significant
facilities in the United Kingdom. These obligations and potential obligations could result in payments of up to $60.1 million. The majority of such payments represent longer-term commitments as outlined in the notes to our condensed consolidated
financial statements. The lease agreements are cancellable assuming certain conditions are met prior to expiry. We expect to continue to incur expenses for such leases for the foreseeable future. As we continue to grow, launch further products or
expand our operations in other countries, we may determine that it is necessary to enter into further lease agreements, which would further increase our cash outflows. Further obligations or commitments in the near term relate to our capital
expenditure requirements for the purpose of improving our leased facilities. If we continue to grow, such commitments may become significant in value.
We have a number of existing manufacturing obligations, some of which relate to the manufacture of KIMMTRAK. We have similar obligations related to our earlier stage programs. These obligations and
potential obligations could result in payments of up to $11.7 million, and are expected to increase as we commit to advancing the development of our brenetafusp (IMC-F106C) program in 2024 and beyond. While we have already incurred costs for
commercial launches in the United States, Europe and other territories, additional manufacturing obligations may arise in future in relation to product sales in these territories. We have also entered into third-party agreements relating to
marketing and distribution. The majority of such obligations have standard payment terms, and our level of non-cancellable commitments with such parties is not considered material. To meet demand, we may amend or enter into further agreements with
CMOs or other parties which could cause our cash requirements to increase. While receipts from the sale of KIMMTRAK or other future products may fund our ongoing manufacturing and sales efforts, there can be no assurance that we will earn such
revenues. In the longer term, if we received regulatory approval for our other product candidates, we would expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on
where we choose to commercialize. We may also require additional capital to pursue in-licenses or acquisitions of other product candidates.
In addition to the above obligations, commitments and potential future cash outflows, we enter into a variety of agreements and financial commitments in the normal course of business. The terms
generally provide us the option to cancel, reschedule and adjust our requirements based on our business needs, prior to the delivery of goods or performance of services. However, it is not possible to predict the amount of future payments under
these agreements due to the conditional nature of our obligations and the unique facts and circumstances involved in each particular agreement.
Financing obligations
We are required to make interest payments for our Notes issued on February 2, 2024. As of March 31, 2024, we had $402.5 million aggregate principal amount of Notes outstanding, which will mature on
February 1, 2030, unless earlier converted, redeemed or repurchased. See Note 5. “Non-current interest-bearing loans and borrowings” of the notes to our condensed consolidated financial statements in Part I of this Quarterly Report for further
information.
We are also required to make interest payments, and, from 2026 onward, repayments of principal borrowings under our Pharmakon Loan Agreement, until at least 2028. The loan liability as of March 31,
2024 was $48.1 million and further details regarding this loan facility are provided in Note 5. “Non-current interest-bearing loans and borrowings” of the notes to our condensed consolidated financial statements in Part I of this Quarterly Report.
We have the option to draw down a further $50 million under our Pharmakon Loan Agreement.
Under the terms of our agreement with the Gates Foundation, we are required to develop, manufacture and commercialize soluble TCR bispecific therapeutic candidates targeted to mutually agreed
neglected diseases, currently HIV, with the potential to treat people at an affordable price in developing countries. In the event of certain defaults by us under the agreement, the Gates Foundation has the right to sell, or require us to buy-back,
any of the shareholdings of us held by the Gates Foundation. In such an event, if within 12 months after such redemption or sale, we experience a change in control at a valuation of more than 150% of the valuation used for the redemption or the
sale of the shares, we have agreed to pay the Gates Foundation compensation equal to the excess of what it would have received in such transaction if it still held its shares at the time of such change of control over what it received in the sale
or redemption of its shares.
Our Key Collaboration Agreements
Genentech Collaboration
In June 2013, we entered into a research collaboration and license agreement, or the 2013 Genentech Agreement, with Genentech, and F. Hoffmann-La Roche Ltd, or Roche, pursuant to which we, along
with Genentech and Roche, agreed to collaborate in the development, manufacture and ultimately, commercialization of soluble TCR bispecific therapeutic candidate compounds. Under the 2013 Genentech Agreement, Genentech paid us an initial upfront
payment of $20 million in exchange for exclusive licenses to two of our targets, MAGE-A4 and an undisclosed target. The first pre-clinical program nominated under the 2013 Genentech Agreement was target MAGE-A4, which we refer to as our IMC-C103C
program.
In February 2023, Genentech accepted our proposal to cease co-funding the development of MAGE-A4 HLA-A02 targeted programs, except for our equal share of the wind-down costs of the IMC-C103C Phase
1 clinical trial. Genentech will acquire an exclusive worldwide license to the MAGE-A4HLA-A02 soluble TCR bispecific therapeutic candidate compounds and will be fully responsible for all further development and commercialization of such candidate
compounds, at its expense. As of December 31, 2023, we determined our performance obligation under the collaboration with Genentech was complete. We are eligible to receive development and commercial milestone payments plus royalties from Genentech
on any sales of MAGE-A4 HLA-A02 targeted products arising under the Genentech Agreement. Any future milestones will be recorded when they become probable of being achieved.
BMS Collaboration
In February 2024, we entered into a clinical trial collaboration and supply agreement with BMS, or the BMS Agreement, to investigate our ImmTAC bispecific TCR candidate targeting PRAME HLA-A02,
brenetafusp (IMC-F106C), in combination with BMS’s nivolumab, in first-line advanced cutaneous melanoma. Under the terms of the BMS Agreement, we will sponsor and fund the registrational Phase 3 clinical trial of brenetafusp in combination with
nivolumab in first-line advanced cutaneous melanoma (PRISM-MEL-301), and BMS will provide nivolumab. No monetary consideration is transferred as a result of the BMS Agreement.
Gadeta Collaboration
In December 2022, we entered into a Collaboration, Option and License Agreement, or the Gadeta Collaboration, with Gadeta B.V., or Gadeta, which was acquired by Clade Therapeutics, or Clade, in
October 2023. Under the Gadeta Collaboration, we will collaborate on ‘201 γδ-TCR target discovery, and we will have the option to develop ImmTAC therapies derived from the ‘201 TCR as part of the research collaboration. Following the acquisition of
Gadeta by Clade, the rights under the Gadeta Collaboration were transferred to Ateda Therapeutics, or Ateda. Our rights and obligations have not altered through this transfer and we have an option for an exclusive license to further research,
develop and commercialize an ImmTAC candidate from the Gadeta Collaboration. If we exercised this option, Gadeta could be eligible to receive further payments from us. We have made payments totaling $2.0 million to Gadeta under the Gadeta
Collaboration as of March 31, 2024. Any further payments under the Gadeta Collaboration will be due to Ateda. In April 2024, it was announced that Clade has agreed to be acquired by Century Therapeutics, and we do not expect our rights or
obligations to be affected by the acquisition.
Critical Accounting Estimates
Our condensed consolidated financial statements as of March 31, 2024 and for the three months ended March 31, 2024 and 2023 have been prepared in accordance with U.S. GAAP. The preparation of the
condensed consolidated financial statements requires us to make judgments, estimates and assumptions that affect the value of assets and liabilities—as well as contingent assets and liabilities—as reported on the balance sheet date, and revenues
and expenses arising during the fiscal period.
The estimates and associated assumptions are based on information available when the condensed consolidated financial statements are prepared, historical experience and various other factors
which are believed to be reasonable under the circumstances, the results of which form the basis of making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Existing circumstances and
assumptions about future developments, however, may change due to market changes or circumstances arising that are beyond our control. Hence, estimates may vary from the actual values.
The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which they become known and are applied prospectively.
Those judgments and estimates made, together with our significant accounting policies, are set out in our Annual Report.
Expected rebate and chargeback percentage for revenue deductions
Since approval of KIMMTRAK in 2022, we have a short history of actual rebate claims or chargebacks, and such information may have limited predictive value. We use the expected value method to
estimate expected rebate and chargeback percentages for revenue deductions, which considers the likelihood of a rebate or chargeback being applicable to sales. The proportion of sales subject to a rebate or chargeback is inherently uncertain and
estimates are based on internal assumptions, which may change as we develop more product experience, and third-party data, which we assess for reliability and relevance.
We are 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 we have sold vials to specialty distributors. We are 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, our specialty distributors charge back the difference between the wholesale acquisition cost and this lower price. Estimating expected rebate
and chargeback percentages for revenue deductions is judgmental due to the time delay between the date of the sale to specialty distributors and the subsequent dates on which we are able to determine actual amounts of chargebacks and rebates. We
form 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, we form estimates based on information obtained from claims
received and other industry data, and external health coverage statistics. Judgment is applied to consider the relevance and reliability of information used to make these estimates.
Judgment is also required in determining expected rebate percentages for the amount of net product revenue in France. Rebates payable to the Economic Committee for Health Products, or CEPS, under
early access and commercial programs are subject to a high degree of estimation uncertainty. Our estimate of these rebates represents the difference between the expected agreed price for the commercial sale of KIMMTRAK in France, which is subject
to negotiation, and the initial price of tebentafusp and KIMMTRAK sold under early access and commercial programs until this price is agreed. Analysis of further legislative requirements, sales volumes and the expected benefit of KIMMTRAK to
patients in France is also required in the assessment of rebates payable. We apply judgement to assess internal targets, pricing information of other therapies approved for sale in France, information obtained from price negotiations of KIMMTRAK in
other countries, and information connected with KIMMTRAK’s safety profile when forming our estimated rebate deduction from revenue. A similar approach is taken across other European markets, with judgements made in line with expected pricing
outcomes.
Our total accrued revenue deductions as of March 31, 2024 were $85.9 million, including amounts of $77.3 million for the critical estimates subject to greater estimation uncertainty and judgments
described above. These are included within Accrued expenses and other current liabilities and Accrued expenses, non-current in the Condensed Consolidated Balance Sheet as of March 31, 2024.
A 20% increase or decrease in estimates of expected rebate and chargeback percentages for amounts payable to governments or government agencies for the critical estimates described above would have
resulted in a $15.5 million reduction or increase in Product revenue, net reported in the Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2024. We believe our expected values of accruals
reported in the Condensed Consolidated Balance Sheet are materially appropriate; however, due to the uncertainties and judgements outlined above, it is possible eventual amounts could significantly differ to these estimates. For critical estimates
reported as of December 31, 2023 where the uncertainty remains unresolved, additional information in the three months ended March 31, 2024, resulted in a change in estimate of $5.4 million net increase to our total accrued revenue deductions as of
March 31, 2024.
Recently Issued and Adopted Accounting Pronouncements
We discuss the effect of recently issued and adopted pronouncements in Note 2. “Summary of Significant Accounting Policies” to the condensed consolidated financial statements.
| Item 3. |
Quantitative and Qualitative Disclosures About Market Risk
|
We are exposed to interest rate, currency, credit and liquidity risks. Our executive board oversees the management of these risks supported by a financial risk committee that advises on financial
risks and the appropriate financial risk governance framework for us. The financial risk committee provides assurance to our executive board that our financial risk activities are governed by appropriate policies and procedures and that financial
risks are identified, measured and managed in accordance with our policies and risk objectives. The most significant financial risks to which we are exposed include the risks discussed below.
Interest Rate Risk
Our exposure to changes in interest rates relates to investments in deposits and to changes in the interest for overnight deposits. Changes in the general level of interest rates may lead to an
increase or decrease in the fair value of these investments. All of our interest-bearing loans and borrowings have a fixed rate of interest.
We are currently not subject to interest rate risks related to any other liabilities shown in the Condensed Consolidated Balance Sheets.
Currency Risk
Foreign currency risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in foreign exchange rates. Our exposure to the risk of changes
in foreign exchange rates relates primarily to fluctuations in value of foreign currency cash and cash equivalent balances held by our main operating subsidiary in the United Kingdom, our operating activities in the United States, and outsourced
supplier agreements denominated in currencies other than pound sterling. We minimize foreign currency risk by maintaining cash and cash equivalents of each currency at levels sufficient to meet foreseeable expenditure to the extent practical
Our cash and cash equivalents were $832.8 million and $442.6 million as of March 31, 2024 and December 31, 2023, respectively. As of March 31, 2024, 89.0% of our cash and cash equivalents were held
by our U.K. subsidiary, of which 13.9% were denominated in pounds sterling, 83.4% were denominated in U.S. dollars and 2.7% were denominated in euros. The significant remainder of our cash and cash equivalents are held in the United States and
denominated in U.S. dollars. Changes in exchange rates had a material impact on U.S. dollar balances held by our main operating subsidiary in the United Kingdom, which resulted in foreign exchange losses in the Condensed Consolidated Statements of
Operations and Comprehensive Loss due to the depreciation of the subsidiary’s U.S. dollars in pounds sterling terms. Further movements in exchange rates or returns to previous exchange rate levels have caused, and may continue to cause, material
fluctuations or equivalent losses in the Condensed Consolidated Statements of Operations and Comprehensive Loss.
A five percentage point increase in exchange rates would reduce the carrying value of net financial assets and liabilities held in foreign currencies as of March 31, 2024 by $10.5 million and as of
December 31, 2023 by $6.0 million. A five percentage point decrease in exchange rates would increase the carrying value of net financial assets and liabilities held in foreign currencies as of March 31, 2024 by $10.5 million and as of December 31,
2023 by $6.0 million.
Credit Risk
We are exposed to credit risk from our operating activities, primarily accounts receivable, and cash and cash equivalents held with banks and financial institutions. Cash and cash equivalents are
maintained with high-quality financial institutions in the United Kingdom and United States. We are also potentially subject to concentrations of credit risk in our accounts receivable. Concentrations of credit risk are with respect to accounts
receivable owed by a limited number of entities comprising our customer base. Our exposure to credit losses is low, however, owing largely to the credit quality of our distributors, collaboration partners, and other customers, the significant
majority of which are considerably larger than us.
We continually monitor our positions with, and the credit quality of, the financial institutions and corporations, which are counterparts to our financial instruments and do not anticipate
non-performance. The maximum default risk corresponds to the carrying amount of the financial assets shown in the Condensed Consolidated Balance Sheets. We monitor the risk of a liquidity shortage. The main factors we consider are the maturities of
financial assets as well as expected cash flows from equity measures.
| Item 4. |
Controls and Procedures
|
Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, that are designed to ensure
that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and is accumulated and
communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) as of March 31, 2024. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of March 31, 2024, our disclosure controls and procedures were effective.
Changes in Internal Control Over Financial Reporting
There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended March
31, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II – OTHER INFORMATION
| Item 1. |
Legal Proceedings
|
None.
Our business has significant risks. In addition to the other information set forth in this Quarterly Report on Form 10-Q, you should carefully consider the risks described in Part I, Item 1A.
“Risk Factors” in our Annual Report. These are not the only risks facing our business. Other risks and uncertainties that we are not currently aware of or that we currently consider immaterial also may materially adversely affect our business,
financial condition and future results. Risks we have identified but currently consider immaterial could still also materially adversely affect our business, financial condition and future results of operations if our assumptions about those
risks are incorrect or if circumstances change.
There were no material changes during the period covered in this Quarterly Report to the risk factors previously disclosed in Item 1A. Risk Factors in
our Annual Report.
| Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds and Issuer Purchases of Equity Securities.
|
| Item 3. |
Defaults Upon Senior Securities.
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| Item 4. |
Mine Safety Disclosures.
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| Item 5. |
Other Information.
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| |
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Incorporation by Reference
|
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Exhibit Number
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Description
|
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Schedule/
Form
|
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File Number
|
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Exhibit
|
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Filing Date
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Articles of Association of Immunocore Holdings plc
|
|
20-F
|
|
001-39992
|
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1.1
|
|
March 25, 2021
|
4.1
|
|
Indenture, dated as of February 2, 2024, by and between the Company and U.S. Bank Trust Company,
National Association, as Trustee. |
|
8-K
|
|
001-39992 |
|
4.1
|
|
February 2, 2024
|
4.2
|
|
Form of Global Note, representing the Company’s 2.50% Convertible Senior Notes due 2030 (included as Exhibit A to the Indenture filed as Exhibit
4.1). |
|
8-K
|
|
001-39992 |
|
4.2
|
|
February 2, 2024 |
|
|
|
Certification by the Principal Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
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Certification by the Principal Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
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Certification by the Principal Executive Officer and the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
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101.INS*
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Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document).
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101.SCH*
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Inline XBRL Taxonomy Extension Schema Document.
|
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101.CAL*
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Inline XBRL Taxonomy Extension Calculation Linkbase Document.
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101.DEF*
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Inline XBRL Taxonomy Extension Definition Linkbase Document.
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101.LAB*
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Inline XBRL Taxonomy Extension Labels Linkbase Document.
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101.PRE*
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Inline XBRL Taxonomy Extension Presentation Linkbase Document
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104*
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Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101).
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| ** |
This certification is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing
under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended.
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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IMMUNOCORE HOLDINGS PLC
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Date:
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May 8, 2024
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By:
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/s/ Bahija Jallal
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Name
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Bahija Jallal, Ph.D.
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Title:
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Chief Executive Officer
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(On Behalf of the Registrant and as Principal Executive Officer)
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Date:
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May 8, 2024
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By:
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/s/ Brian Di Donato
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Name
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Brian Di Donato
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Title:
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Chief Financial Officer
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(Principal Financial Officer)
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