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Name | Symbol | Market | Type |
---|---|---|---|
Immunocore Holdings PLC | NASDAQ:IMCR | NASDAQ | Depository Receipt |
Price Change | % Change | Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.39 | -1.09% | 35.44 | 35.00 | 36.29 | 35.83 | 34.90 | 35.70 | 401,387 | 21:00:05 |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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(Address of principal executive offices)
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(Zip Code)
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+
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(Registrant’s telephone number, including area code)
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(Former name, former address and former fiscal year, if changed since last report)
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Accelerated filer ☐
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Non-accelerated filer ☐
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Smaller reporting company
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Emerging growth company ☐
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Class
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Name of each exchange on which registered
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Ordinary shares, nominal value £0.002 per share (including ordinary shares represented by American Depositary Shares)
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Non-voting ordinary shares, nominal value £0.002 per share
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|
• |
the therapeutic potential and expected clinical benefits of KIMMTRAK;
|
• |
the safety, efficacy and clinical progress of our various ongoing clinical programs and any planned clinical programs, including those for tebentafusp, brenetafusp (previously IMC-F106C), IMC-R117C,
IMC-M113V and IMC-I109V;
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• |
our ability to continue to generate revenues, which is dependent upon maintaining significant market acceptance among physicians, patients and healthcare payors;
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• |
our ability to maintain regulatory approval of KIMMTRAK for metastatic uveal melanoma, or mUM, in the United States, European Union and other territories, as well as our ability to obtain and maintain
regulatory approval in additional indications, jurisdictions, and the timing thereof;
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• |
our expectations regarding the continued commercialization and marketing of KIMMTRAK for mUM, including expanding into and the related timing of reaching patients in additional indications and territories;
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• |
our ability to build a sustainable pipeline of new medicine candidates, including but not limited to future generations of KIMMTRAK and additional product candidates identified and developed using our
ImmTAX platform;
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• |
our ability to continue successfully executing our sales and marketing strategy of KIMMTRAK in the United States, Europe and elsewhere, including continuing to successfully recruit and retain sales and
marketing personnel and to successfully build the market for our medicines;
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• |
the rate and degree of market acceptance of our product candidates among physicians, patients, patient advocacy groups, third-party payors and the medical community and our ability and our distribution and
marketing partners’ ability to obtain coverage and adequate reimbursement and pricing for our medicines from government and third-party payors and risks relating to the success of our patient assistance programs;
|
• |
the initiation, timing, progress and results of our ongoing clinical trials and any planned clinical trials, including the expansion arms of such trials, for tebentafusp in advanced melanoma and adjuvant
uveal (or ocular) melanoma, brenetafusp, IMC-P115C, IMC-T119C, IMC-R117C, IMC-M113V, and IMC-I109V, and our research and development programs, including delays or disruptions in clinical trials, non-clinical experiments and
investigational new drug application-enabling studies;
|
• |
our estimates regarding the period of time for which our current capital resources will be sufficient to fund our continued operations, our future expenses, including the impact thereon of rising inflation,
fluctuating exchange rates and other macroeconomic factors, and our future revenues and our needs for and ability to obtain additional financing;
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• |
our expectations regarding timing of regulatory filings for, or our ability to obtain regulatory approval of, our product candidates other than KIMMTRAK;
|
• |
our ability to obtain accelerated approval for current and future product candidates from the U.S. Food and Drug Administration, or FDA, the European Commission, or other comparable regulatory authorities
in other jurisdictions;
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• |
our expectations regarding business disruptions affecting the initiation, patient enrollment, clinical trial site monitoring, development and operation of our current and proposed clinical trials, including
as a result of a public health emergency or other global and macroeconomic factors, such as the war in Ukraine, the state of war between Hamas and Israel and the potential for a broader regional conflict in the Middle East, global
geopolitical tensions, supply chain disruptions, rising interest rates and rising inflation;
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• |
our business strategies and goals;
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• |
our plans to collaborate, or statements regarding our current collaborations, and our ability to find future partners and collaborators;
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• |
the performance of our third-party suppliers and manufacturers,
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• |
our expectations regarding our ability to obtain, maintain and enforce intellectual property protection for our product candidates and our ability to operate our business without infringing,
misappropriating or otherwise violating the intellectual property rights of others;
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• |
our expectations regarding competition with respect to KIMMTRAK or any of our other current or future product candidates, as well as innovations by current and future competitors in our industry;
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• |
our expectations regarding regulatory developments in the United States and other countries, including potential changes in healthcare laws and regulations;
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• |
our financial performance and our ability to effectively manage our anticipated growth;
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• |
our ability to identify, recruit and retain qualified employees, including key commercial or management personnel; and
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• |
whether we are classified as a Passive Foreign Investment Company, or PFIC, for current and future periods.
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PART I – FINANCIAL INFORMATION
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Page
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ITEM 1.
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2
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2
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||
3 | ||
4 | ||
5 | ||
6 | ||
ITEM 2.
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13 | |
ITEM 3.
|
23 | |
ITEM 4.
|
24 | |
PART II – OTHER INFORMATION
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||
ITEM 1.
|
25 | |
ITEM 1A.
|
25 | |
ITEM 2.
|
25
|
|
ITEM 3.
|
25 | |
ITEM 4.
|
25 | |
ITEM 5.
|
25 | |
ITEM 6.
|
25 | |
27 |
Item 1. |
Financial Statements
|
March 31,
2024
|
December 31,
2023
|
|||||||
Assets
|
||||||||
Current assets
|
||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Accounts receivable, net
|
|
|
||||||
Prepaid expenses and other current assets
|
|
|
||||||
Inventory, net
|
|
|
||||||
Total current assets
|
|
|
||||||
Property and equipment, net
|
|
|
||||||
Operating lease right of use assets, net
|
|
|
||||||
Deferred tax assets, net
|
|
|
||||||
Other non-current assets
|
|
|
||||||
Total assets
|
$
|
|
$
|
|
||||
Liabilities and shareholders’ equity
|
||||||||
Current liabilities
|
||||||||
Accounts payable
|
$
|
|
$
|
|
||||
Accrued expenses and other current liabilities
|
|
|
||||||
Operating lease liabilities, current
|
|
|
||||||
Total current liabilities
|
|
|
||||||
Accrued expenses, non-current
|
|
|
||||||
Deferred revenue, non-current
|
|
|
||||||
Operating lease liabilities, non-current
|
|
|
||||||
Interest-bearing loans and borrowings
|
|
|
||||||
Total liabilities
|
|
|
||||||
Shareholders’ equity
|
||||||||
Ordinary shares (voting and non-voting), £
|
|
|
||||||
Deferred shares, £
|
|
|
||||||
Additional paid-in capital
|
|
|
||||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||
Accumulated other comprehensive loss
|
(
|
)
|
(
|
)
|
||||
Total shareholders’ equity
|
|
|
||||||
Total liabilities and shareholders’ equity
|
$
|
|
$
|
|
Three Months Ended March 31,
|
||||||||
2024
|
2023
|
|||||||
Revenue:
|
||||||||
Product revenue, net
|
$
|
|
$
|
|
||||
Collaboration revenue
|
|
|
||||||
Total revenue
|
|
|
||||||
Cost and operating expenses:
|
||||||||
Cost of product revenue
|
(
|
)
|
(
|
)
|
||||
Research and development expense
|
(
|
)
|
(
|
)
|
||||
Selling, general and administrative expense
|
(
|
)
|
(
|
)
|
||||
Loss from operations
|
(
|
)
|
(
|
)
|
||||
Other income (expense):
|
||||||||
Interest income
|
|
|
||||||
Interest expense
|
(
|
)
|
(
|
)
|
||||
Foreign currency loss
|
(
|
)
|
(
|
)
|
||||
Other expense, net
|
(
|
)
|
(
|
)
|
||||
Net loss before income taxes
|
(
|
)
|
(
|
)
|
||||
Income tax expense
|
(
|
)
|
(
|
)
|
||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Other comprehensive income:
|
||||||||
Exchange differences on translation of foreign operations
|
|
|
||||||
Total comprehensive loss
|
(
|
)
|
(
|
)
|
||||
Basic and diluted net loss per share
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Basic and diluted weighted-average number of shares outstanding
|
|
|
Ordinary Shares
|
Deferred Shares
|
Additional
Paid-in
|
Accumulated
|
Accumulated
other
comprehensive
|
Total
Shareholders’
|
|||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
deficit
|
loss
|
Equity
|
|||||||||||||||||||||||||
As of December 31, 2023
|
|
$
|
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
||||||||||||||||
Net loss
|
—
|
|
—
|
|
|
(
|
)
|
|
(
|
)
|
||||||||||||||||||||||
Other comprehensive income
|
—
|
|
—
|
|
|
|
|
|
||||||||||||||||||||||||
Exercise of share options
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||
Share-based compensation expense
|
—
|
|
—
|
|
|
|
|
|
||||||||||||||||||||||||
As of March 31, 2024
|
|
$ |
|
|
$ |
|
$ |
|
$ |
(
|
)
|
$ |
(
|
)
|
$ |
|
Ordinary Shares
|
Deferred Shares
|
Additional
Paid-in
|
Accumulated
|
Accumulated
other
comprehensive
|
Total
Shareholders’
|
|||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
deficit
|
loss
|
Equity
|
|||||||||||||||||||||||||
As of December 31, 2022
|
|
$
|
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
||||||||||||||||
Net loss
|
—
|
|
—
|
|
|
(
|
)
|
|
(
|
)
|
||||||||||||||||||||||
Other comprehensive income
|
—
|
|
—
|
|
|
|
|
|
||||||||||||||||||||||||
Exercise of share options
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||
Share-based compensation expense
|
—
|
|
—
|
|
|
|
|
|
||||||||||||||||||||||||
As of March 31, 2023
|
|
$ |
|
|
$ |
|
$ |
|
$ |
(
|
)
|
$ |
(
|
)
|
$ |
|
Three Months Ended March 31,
|
||||||||
2024
|
2023
|
|||||||
Cash flows from operating activities
|
||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Adjustments for:
|
||||||||
Share-based compensation expense
|
|
|
||||||
Depreciation
|
|
|
||||||
Unrealized foreign exchange losses
|
|
|
||||||
Non-cash lease expense
|
|
|
||||||
Other
|
(
|
)
|
|
|||||
Changes in assets and liabilities:
|
||||||||
Increase in accounts receivable
|
(
|
)
|
(
|
)
|
||||
(Increase) decrease in prepayments and other current assets
|
(
|
)
|
|
|||||
Decrease in accounts payable
|
(
|
)
|
(
|
)
|
||||
Increase in accrued expenses
|
|
|
||||||
Decrease in deferred revenue
|
|
(
|
)
|
|||||
Decrease in operating lease liabilities
|
(
|
)
|
(
|
)
|
||||
Increase in other operating assets
|
(
|
)
|
(
|
)
|
||||
Increase (decrease) in other operating liabilities
|
|
(
|
)
|
|||||
Net cash (used in) provided by operating activities
|
(
|
)
|
|
|||||
Cash flows from investing activities
|
||||||||
Purchase of property and equipment
|
(
|
)
|
(
|
)
|
||||
Net cash used in investing activities
|
(
|
)
|
(
|
)
|
||||
Cash flows from financing activities
|
||||||||
Proceeds from issue of convertible loan notes
|
|
|
||||||
Payments for debt issuance costs
|
(
|
)
|
|
|||||
Proceeds from exercise of share options
|
|
|
||||||
Net cash provided by financing activities
|
|
|
||||||
Increase in net cash and cash equivalents
|
|
|
||||||
Net foreign exchange difference on cash held
|
(
|
)
|
|
|||||
Cash and cash equivalents at beginning of period
|
|
|
||||||
Cash and cash equivalents at end of period
|
$
|
|
$
|
|
||||
Supplemental disclosure of cash flow and non-cash information
|
||||||||
Cash received for interest, net
|
$
|
|
$
|
|
||||
Cash paid for income taxes, net
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Debt issuance costs in accrued expenses and other current liabilities
|
$
|
(
|
)
|
$
|
|
|||
Purchases of property and equipment in accrued expenses and other current liabilities
|
$
|
|
$
|
|
Three Months Ended March 31,
|
||||||||
2024
|
2023
|
|||||||
United States
|
$
|
|
$
|
|
||||
Europe
|
|
|
||||||
International
|
|
|
||||||
Total product revenue, net
|
$
|
|
$
|
|
Rebates
|
Chargebacks
|
Returns
|
Total
|
|||||||||||||
As of December 31, 2023
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Provisions related to sales in the period
|
|
|
|
|
||||||||||||
Adjustments related to sales in prior periods
|
|
|
|
|
||||||||||||
Credits and payments made
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
As of March 31, 2024
|
$
|
|
$
|
|
$
|
|
$
|
|
March 31,
2024
|
December 31,
2023
|
|||||||
Rebates, chargebacks, other customer fees and returns
|
$
|
|
$
|
|
||||
Clinical accruals
|
|
|
||||||
Contract manufacturing
|
|
|
||||||
Commercial services
|
|
|
||||||
Employee related expenses
|
|
|
||||||
Other taxation and social security
|
|
|
||||||
Other accruals
|
|
|
||||||
$
|
|
$
|
|
Fair Value
|
|||||||||||||||||
Principal Amount
|
Unamortized Debt Issuance Costs
|
Net Carrying Amount
|
Amount
|
Levelling
|
|||||||||||||
Convertible Senior Notes
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
|
Level 2
|
|||||||
Pharmakon loan
|
|
(
|
)
|
|
|
Level 2
|
Fair Value
|
|||||||||||||||||
Principal Amount
|
Unamortized Debt Discount and Issuance Costs
|
Net Carrying Amount
|
Amount
|
Levelling
|
|||||||||||||
Convertible Senior Notes
|
$
|
|
$
|
|
$
|
|
$
|
|
Not applicable
|
||||||||
Pharmakon loan
|
|
(
|
)
|
|
|
Level 2
|
Three Months Ended March 31,
|
||||||||
2024
|
2023
|
|||||||
Convertible Senior Notes
|
||||||||
Coupon interest
|
$
|
|
$
|
|
||||
Amortization of debt issuance costs
|
|
|
||||||
Pharmakon loan
|
|
|
||||||
Interest expense
|
$
|
|
$
|
|
2024
|
$
|
|
||
2025
|
|
|||
2026
|
|
|||
2027
|
|
|||
2028
|
|
|||
2029 and thereafter
|
|
|||
Total principal payments
|
$
|
|
||
Less: debt issuance costs
|
(
|
)
|
||
Total interest-bearing loans and borrowings
|
$
|
|
Three Months Ended March 31,
|
||||||||
2024
|
2023
|
|||||||
Research and development
|
$
|
|
$
|
|
||||
Selling, general and administrative
|
$
|
|
$
|
|
Number of
Share Options (#)
|
Weighted
Average
Exercise Price ($)
|
Average
Remaining
Contractual Term
|
Aggregate
Intrinsic Value
(in thousands)
|
||||||||||
Outstanding as of December 31, 2023
|
|
$
|
|
|
$
|
|
|||||||
Awards granted
|
|
|
|||||||||||
Awards exercised
|
(
|
)
|
|
||||||||||
Awards forfeited
|
(
|
)
|
|
||||||||||
Outstanding as of March 31, 2024
|
|
$
|
|
|
$
|
|
|||||||
Exercisable as of March 31, 2024
|
|
$
|
|
|
$
|
|
Three Months Ended March 31,
|
||||||||
2024
|
2023
|
|||||||
Share price at grant date
|
$
|
|
$
|
|
||||
Exercise price
|
$
|
|
$
|
|
||||
Expected volatility
|
|
%
|
|
%
|
||||
Expected life (years)
|
|
|
||||||
Risk free rate
|
|
%
|
|
%
|
||||
Fair value
|
$
|
|
$
|
|
Three Months Ended March 31,
|
||||||||
2024
|
2023
|
|||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Basic and diluted weighted-average number of shares outstanding
|
|
|
||||||
Basic and diluted net loss per share
|
$
|
(
|
)
|
$
|
(
|
)
|
2024
|
||||
2024
|
$
|
|
||
2025
|
|
|||
2026
|
|
|||
2027
|
|
|||
2028
|
|
|||
2029 and thereafter
|
|
|||
Total lease payments
|
|
|||
Less imputed interest
|
(
|
)
|
||
Present value of operating lease liabilities
|
$
|
|
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
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
|
%
|
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
|
%
|
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
|
%
|
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
|
%
|
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
|
• |
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.
|
• |
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.
|
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk
|
Item 4. |
Controls and Procedures
|
Item 1. |
Legal Proceedings
|
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds and Issuer Purchases of Equity Securities.
|
Incorporation by Reference
|
||||||||||
Exhibit Number
|
Description
|
Schedule/
Form
|
File Number
|
Exhibit
|
Filing Date
|
|||||
Articles of Association of Immunocore Holdings plc
|
20-F
|
001-39992
|
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
|
||||||||||
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
|
||||||||||
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
|
||||||||||
101.INS*
|
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).
|
101.SCH*
|
Inline XBRL Taxonomy Extension Schema Document.
|
|||||||||
101.CAL*
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
|
|||||||||
101.DEF*
|
Inline XBRL Taxonomy Extension Definition Linkbase Document.
|
|||||||||
101.LAB*
|
Inline XBRL Taxonomy Extension Labels Linkbase Document.
|
|||||||||
101.PRE*
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document
|
|||||||||
104*
|
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101).
|
* |
Filed herewith.
|
** |
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.
|
IMMUNOCORE HOLDINGS PLC
|
||||
Date:
|
May 8, 2024
|
By:
|
/s/ Bahija Jallal
|
|
Name
|
Bahija Jallal, Ph.D.
|
|||
Title:
|
Chief Executive Officer
|
|||
(On Behalf of the Registrant and as Principal Executive Officer)
|
||||
Date:
|
May 8, 2024
|
By:
|
/s/ Brian Di Donato
|
|
Name
|
Brian Di Donato
|
|||
Title:
|
Chief Financial Officer
|
|||
(Principal Financial Officer)
|
1. |
I have reviewed this quarterly report on Form 10-Q of Immunocore Holdings plc;
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not
misleading with respect to the period covered by this report;
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and
for, the periods presented in this report;
|
4. |
The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting
(as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and
the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c) |
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by
this report based on such evaluation; and
|
(d) |
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report)
that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
|
5. |
The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors
(or persons performing the equivalent functions):
|
(a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and
report financial information; and
|
(b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
|
Date: May 8, 2024
|
||
By:
|
/s/ Bahija Jallal
|
|
Bahija Jallal, Ph.D.
|
||
Chief Executive Officer
|
||
(Principal Executive Officer)
|
1. |
I have reviewed this quarterly report on Form 10-Q of Immunocore Holdings plc;
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not
misleading with respect to the period covered by this report;
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and
for, the periods presented in this report;
|
4. |
The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting
(as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and
the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c) |
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by
this report based on such evaluation; and
|
(d) |
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report)
that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
|
5. |
The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors
(or persons performing the equivalent functions):
|
(a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and
report financial information; and
|
(b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
|
Date: May 8, 2024
|
||
By:
|
/s/ Brian Di Donato
|
|
Brian Di Donato
|
||
Chief Financial Officer
|
||
(Principal Financial Officer)
|
1. |
The Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, to which this Certification is attached as Exhibit 32.1 (the “Quarterly Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of
the Exchange Act; and
|
2. |
The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Dated: May 8, 2024
|
||
/s/ Bahija Jallal
|
||
Chief Executive Officer
|
||
(Principal Executive Officer)
|
||
/s/ Brian Di Donato
|
||
Chief Financial Officer
|
||
(Principal Financial Officer)
|
Condensed Consolidated Balance Sheets (Parenthetical) - GBP (£) |
Mar. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Shareholders' equity | ||
Common stock, par value (in pounds per share) | £ 0.002 | £ 0.002 |
Common stock, shares issued (in shares) | 50,006,085 | 49,725,649 |
Common stock, shares outstanding (in shares) | 50,006,085 | 49,725,649 |
Deferred shares, par value (in pounds per share) | £ 0.0001 | £ 0.0001 |
Deferred stock, shares authorized (in shares) | 5,793,501 | 5,793,501 |
Deferred stock, shares issued (in shares) | 5,793,501 | 5,793,501 |
Deferred stock, shares outstanding (in shares) | 5,793,501 | 5,793,501 |
Maximum [Member] | ||
Shareholders' equity | ||
Authority to allot nominal value | £ 97,454 | £ 109,335 |
Condensed Consolidated Statements of Shareholders' Equity - USD ($) $ in Thousands |
Ordinary Shares [Member] |
Deferred Shares [Member] |
Additional Paid-in Capital [Member] |
Accumulated Deficit [Member] |
Accumulated Other Comprehensive Loss [Member] |
Total |
---|---|---|---|---|---|---|
Balance at Dec. 31, 2022 | $ 129 | $ 1 | $ 1,082,833 | $ (689,387) | $ (54,673) | $ 338,903 |
Balance (in shares) at Dec. 31, 2022 | 48,088,346 | 5,793,501 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Net loss | $ 0 | $ 0 | 0 | (19,449) | 0 | (19,449) |
Other comprehensive income | 0 | 0 | 0 | 0 | 7,434 | 7,434 |
Exercise of share options | $ 1 | $ 0 | 6,157 | 0 | 0 | 6,158 |
Exercise of share options (in shares) | 291,063 | 0 | ||||
Share-based compensation expense | $ 0 | $ 0 | 8,258 | 0 | 0 | 8,258 |
Balance at Mar. 31, 2023 | $ 130 | $ 1 | 1,097,248 | (708,836) | (47,239) | 341,304 |
Balance (in shares) at Mar. 31, 2023 | 48,379,409 | 5,793,501 | ||||
Balance at Dec. 31, 2023 | $ 134 | $ 1 | 1,149,643 | (744,674) | (36,261) | $ 368,843 |
Balance (in shares) at Dec. 31, 2023 | 49,725,649 | 5,793,501 | 49,725,649 | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Net loss | $ 0 | $ 0 | 0 | (24,436) | 0 | $ (24,436) |
Other comprehensive income | 0 | 0 | 0 | 0 | 897 | 897 |
Exercise of share options | $ 1 | $ 0 | 5,212 | 0 | 0 | $ 5,213 |
Exercise of share options (in shares) | 280,436 | 0 | 280,436 | |||
Share-based compensation expense | $ 0 | $ 0 | 9,017 | 0 | 0 | $ 9,017 |
Balance at Mar. 31, 2024 | $ 135 | $ 1 | $ 1,163,872 | $ (769,110) | $ (35,364) | $ 359,534 |
Balance (in shares) at Mar. 31, 2024 | 50,006,085 | 5,793,501 | 50,006,085 |
Description of Business |
3 Months Ended |
---|---|
Mar. 31, 2024 | |
Description of Business [Abstract] | |
Description of Business |
1. Description of Business
Immunocore Holdings plc (collectively with its subsidiaries, 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 with operations based primarily in the United
Kingdom and United States. The Company is pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases, and autoimmune diseases. Leveraging its proprietary, flexible, off-the-shelf ImmTAX (Immune mobilizing monoclonal TCRs Against X disease) platform, the Company’s pipeline includes nine active clinical and pre-clinical programs in oncology, infectious diseases, and autoimmune diseases.
In January and April 2022, the Company received approval from the U.S. Food and Drug Administration, or FDA, and European Commission, or EC,
respectively, for its lead product, KIMMTRAK, for the treatment of unresectable or metastatic uveal melanoma and has subsequently received approvals in further territories, and the Company continues to launch and seek approvals in additional
territories. KIMMTRAK is now approved in 38 countries and the Company has commercially launched the product in the United States,
Germany and France, among other territories.
|
Summary of Significant Accounting Policies |
3 Months Ended |
---|---|
Mar. 31, 2024 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies |
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the U.S., or U.S. GAAP, for interim financial reporting and pursuant to the requirements for reporting on Form 10-Q and Article 10 of Regulation S-X. Accordingly, they 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 Company for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K filed with the Securities
and Exchange Commission, or the SEC, on February 28, 2024, or the Annual Report. The accompanying condensed consolidated financial statements contain all normal recurring adjustments necessary to present fairly the financial position, results
of operations, and cash flows for the interim periods reported. In the opinion of management, all adjustments considered necessary to present fairly the results of the interim periods have been included and consist only of normal and recurring
adjustments. Certain information and footnote disclosures have been condensed or omitted as permitted under U.S. GAAP. The results for the three months ended March 31, 2024 are not necessarily indicative of the results to be expected for the
year ending December 31, 2024, any other interim periods, or any future year or period.
Use of Estimates
The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and
assumptions. These judgments, estimates and assumptions affect the reported assets and liabilities as well as income and expenses in the financial 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
the Company’s control. Actual results could differ from those estimates. Estimates are primarily made in relation to revenue recognition, estimation of operating lease incremental borrowing rates, share-based compensation expense, clinical
accruals, and deferred tax asset valuation allowances.
Significant Accounting Policies
With the exception of the below polices, the significant accounting policies used in the preparation of these condensed consolidated financial
statements as of and for the three months ended March 31, 2024 are consistent with those described in Note 2. “Summary of Significant Accounting Policies” in the Company’s
Annual Report.
Collaboration and Supply Agreements
In February 2024, the Company entered into a clinical trial collaboration and supply agreement with Bristol Myers Squibb, or BMS, to investigate the
Company’s ImmTAC bispecific TCR candidate targeting PRAME HLA-A02, brenetafusp (IMC-F106C), in combination with BMS’s nivolumab, in first-line advanced cutaneous melanoma, or the BMS Agreement. Under the terms of the collaboration, the Company
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. Both parties will own the study data produced
in the clinical trial, other than study data related solely to nivolumab, which will belong solely to BMS, or study data related solely to IMC-F106C, which will belong solely to the Company. Given the terms of the BMS Agreement, the Company
concluded that it is not within the scope of ASC 808 or ASC 606. Any relevant costs arising from the clinical trial will be expensed as incurred and recorded in research and development expenses. The Company will initiate the clinical trial for
the combination therapy of nivolumab and IMC-F106C in the second quarter of 2024. There has been no impact to the condensed consolidated financial statements as of March 31, 2024 relating to the Company’s collaboration with BMS.
Convertible Senior Notes
The Company issued 2.5% Convertible Senior Notes due
in 2030 in February 2024, or the Notes, and evaluated to determine whether they contain features that qualify as embedded derivatives in accordance with ASC 815. Embedded derivatives must be separately measured from the host contract if all the
requirements for bifurcation are met. The assessment of the conditions surrounding the bifurcation of embedded derivatives depends on the nature of the host contract and the features of the derivatives. In accounting for the issuance of the
Notes, the Company treats the instrument wholly as a liability, in accordance with ASC 470, as the conversion features do not require bifurcation as a derivative in accordance with ASC 815 and the Notes were not issued at a substantial premium.
Costs directly associated with the borrowing have been capitalized and are netted against the corresponding debt liabilities in the Company’s Condensed Consolidated Balance Sheets at issuance and amortized over the contractual term of the
convertible debt instrument using the effective interest rate method.
See Note 5. “Non-current interest-bearing loans and borrowings” for additional information.
Foreign currencies
The reporting currency of the Company is the U.S. dollar. Effective January 1, 2024, the Company’s ultimate parent adopted the U.S. dollar as
its functional currency. Prior to January 1, 2024, the functional currency of the Company’s ultimate parent was the British pound sterling. The functional currency of the Company’s ultimate parent and each subsidiary is based on the currency of
the economic environment in which they operate. The change in functional currency of the Company’s ultimate parent is due to a change in the economic facts and circumstances of the entity due to the increased exposure to the U.S. dollar primarily
as a result of the increased cash flows related to financing and investing activities that are now expected to occur going forward in this entity. The effect of the change in functional currency for the Company’s ultimate parent was applied
prospectively in the condensed consolidated financial statements effective January 1, 2024.
Upon consolidation, assets and liabilities of each subsidiary with a functional currency that differs to the Company’s ultimate parent are
translated into U.S. dollars at period-end exchange rates, and revenues and expenses are translated into U.S. dollars using average exchange rates for each reporting period. Translation adjustments are reflected as other comprehensive (loss)
income.
Fair value measurements
Where financial and non-financial assets and liabilities are measured at fair value, the Company uses appropriate valuation techniques for which
sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs.
As of March 31, 2024 and December 31, 2023, the Company held $726.0 million and $331.0 million, respectively, of money market funds required to be measured at fair
value on a recurring basis. The fair value of these cash equivalents is based on quoted prices from active markets (Level 1 inputs). Other financial instruments, although not recorded at fair value on a recurring basis, include cash, accounts
receivable, accounts payable and debt obligations.
The fair value of borrowings under the Notes and Pharmakon Loan Agreement (disclosed in
Note 5. “Non-current interest-bearing loans and borrowings”) were based on Level 2 inputs, which include observable inputs estimated using discounted cash flows and market-based expectations for interest rates, credit risk, and the contractual
terms of debt instruments. After initial recognition, borrowings are measured at amortized cost using the effective interest method.
Recently issued and recently adopted accounting pronouncements
In March 2024, the SEC issued Release No. 33-11275, The Enhancement and Standardization of Climate-Related Disclosures for Investors. The final rule requires registrants to provide climate-related disclosures in their annual reports and registration
statements, beginning with annual reports for the year ending December 31, 2025, for calendar-year-end large accelerated filers. The Company is currently assessing the impact of this guidance on its disclosures.
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Revenue |
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Revenue [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue |
3. Revenue
During the three months ended March 31, 2024, the Company recognized $70.3 million (2023: $51.6 million) of net product revenue relating to the sale of KIMMTRAK primarily
in the United States and Europe after estimated deductions for rebates, chargebacks, other customer fees and returns, which are recognized in Accrued expenses and other current liabilities as set out in the Company’s accounting policies included
in the Annual Report.
Product revenue, net from the sale of KIMMTRAK is presented by country / region based on the location of the end customer below (in thousands).
Product revenue, net for the three months ended March 31, 2024 and the three months ended March 31, 2023 includes $2.2 million and $0.9 million,
respectively, of partnered revenue under the Company’s agreement with Medison Pharma Ltd, or Medison, and such revenue is split between its European and international markets.
Collaboration revenue for the three months ended March 31, 2024 and March 31, 2023 was $0.2 million and $3.1 million, respectively, and arose under the Company’s
collaboration agreement with Genentech who is based in the United States.
Accounts receivable from contracts with customers
Accounts receivable as of March 31, 2024 and December 31, 2023 was $57.8 million and $52.1 million, respectively. An allowance for lifetime expected credit losses on
accounts receivable is measured using historical credit loss experience, conditions at the end of each reporting period, and reasonable and supportable forecasts that affect collectability. Expected credit losses as of March 31, 2024 and December
31, 2023 were immaterial.
Accruals for rebates, chargebacks and returns
Current and non-current accruals for rebates, chargebacks and returns as of March 31, 2024 were as follows (in thousands):
Included in the above are non-current accruals for rebates, chargebacks and returns of $1.1 million and $0 as of March 31, 2024, and December 31, 2023, respectively, which are not expected
to be paid in the twelve months from the balance sheet date.
For accruals for rebates, chargebacks and returns 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 the Company’s
total accrued revenue deductions as of March 31, 2024.
Deferred revenue
Non-current deferred revenue as of March 31, 2024 and December 31, 2023 relates to $5.0 million received from Medison in the year ended December 31, 2023. The Company expects to recognize revenue for this combined performance obligation of supplying
KIMMTRAK and granting Medison the exclusive right to distribute KIMMTRAK in South America with the sale of products following regulatory approval in South America. The Company estimates that product revenue recognition of this non-current
deferred revenue will commence later than March 31, 2025.
|
Accrued expenses and other current liabilities |
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Accrued expenses and other current liabilities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued expenses and other current liabilities |
4. Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consists of the following (in thousands):
See Note 3. “Revenue” for a detailed breakdown of rebates, chargebacks, other customer fees and returns.
Clinical accruals primarily represent unbilled work undertaken by contract research organizations, or CROs, as part of the advancement of the
Company’s clinical programs.
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Non-current interest-bearing loans and borrowings |
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Non-current interest-bearing loans and borrowings [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Non-current interest-bearing loans and borrowings |
5. Non-current interest-bearing loans and borrowings
Non-current interest-bearing loans and borrowings consists of the following (in thousands) as of March 31, 2024:
Non-current interest-bearing loans and borrowings consists of the following (in thousands) as of December 31, 2023:
Interest expense consists of the following (in thousands):
On February 2, 2024, the Company completed a private offering, or the Offering, of $402.5 million aggregate principal amount of Notes, including the exercise in full of the initial purchasers’ option to purchase up to an additional $52.5 million principal amount of Notes. The Notes were issued pursuant to an indenture, dated February 2, 2024, or the Indenture, between the Company
and U.S. Bank Trust Company, National Association, as trustee. The Company’s net proceeds from the Offering of the Notes were $389.1
million, after deducting issuance costs of $13.4 million.
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.
As of March 31, 2024, lender fees and issuance costs incurred with the Notes were $13.4 million and are being amortized as interest expense on an effective interest rate method over the expected life of the Notes, through February 2030, at an effective interest rate of 3.06%.
Holders may convert all or any portion of their Notes at their option at any time prior to the close of business on the business day immediately preceding the
maturity date. The Notes have an initial conversion rate of 10.5601 American Depository Shares or ADSs per $1,000 principal amount of the Notes, which will be subject to anti-dilution adjustments in certain circumstances. This represented an initial
conversion price of $94.70 per ADS. As of March 31, 2024, the number of shares that would be issuable assuming conversion of all of the
Notes is 5,950,600 (assuming the maximum increase to the conversion rate in connection with a “make-whole fundamental change” (as
defined in the Indenture)). Upon conversion, the Notes may be settled in shares of the Company’s ordinary shares, cash or a combination of cash and shares of the Company’s ordinary shares, at the Company’s
election. Upon the occurrence of a make-whole fundamental change (as defined in the Indenture), the Company may, in certain circumstances, be required to increase the conversion rate by a number of additional shares for a holder that elects to
convert its Notes in connection with such make-whole fundamental change.
The Company may not redeem the Notes prior to February 5, 2027, except in the event of certain tax law changes as described below and in the Indenture. The Company
may redeem for cash all or any portion of the Notes (subject to the partial redemption limitation described in the Indenture), at its option, on or after February 5, 2027 if the last reported sale price of the ADSs has been at least 130% of the conversion price for the Notes then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive
trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides notice of optional redemption, at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the optional redemption date.
If, as a result of certain changes in the law of any relevant tax jurisdiction the Company would be required to pay additional amounts (as defined in the Indenture)
on the Notes, the Company may redeem the Notes in whole, but not in part, at a tax redemption price of 100% of the aggregate principal
amount thereof, plus accrued and unpaid interest to, but excluding, the tax redemption date and all additional amounts, if any, which otherwise would be payable to the date of tax redemption. Upon the Company giving notice of a tax redemption, a
holder may elect not to have its Notes redeemed, in which case the holder would not be entitled to receive any additional amounts with respect to its Notes after the tax redemption date.
If the Company undergoes a fundamental change, holders may require the Company to repurchase for cash all or any portion of their
Notes at a repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date.
On November 8, 2022, the Company entered into the Pharmakon loan agreement, or the Pharmakon Loan Agreement, providing for term loans to the Company
in an aggregate principal amount of up to $100 million to be funded in two tranches. The first tranche of $50 million bears interest at a fixed rate
of 9.75%, which is payable quarterly in arrears, with payments commencing in 2023. The Company is also required to pay a further fee
of $1.25 million at the latest by June 2024, regardless of whether it elects to draw down on the second $50 million tranche under the Pharmakon Loan Agreement. The second tranche, consisting of one or two term loan(s) of up to $50 million is available until June 30, 2024, and may be advanced at the Company’s election. The Pharmakon Loan Agreement has a maturity of November 8, 2028.
The Company has pledged its total assets of $994.0
million, presented in the Condensed Consolidated Balance Sheet as of March 31, 2024, as collateral for the $50 million loan drawn down
under the Pharmakon Loan Agreement. In the event the Company was unable to repay the loan, the pledged assets may instead be used to repay the outstanding amount of loan and interest.
The Company’s borrowings under the Pharmakon Loan Agreement, contain customary representations and warranties and customary affirmative and negative
covenants, including limitations on the Company’s ability to dispose of assets, enter into merger, consolidation or acquisition transactions, and incur additional debt. The Company monitors these covenants and is in compliance as of the date of
this Quarterly Report.
As of March 31, 2024, future principal payments are due as follows (in thousands):
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Share-based compensation |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Share-based compensation [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation |
6. Share-based compensation
Under the Company’s Equity Incentive Plan, or EIP, the Company may grant market value options, share appreciation rights or restricted shares,
restricted share units, performance share units and other share-based awards to the Company’s employees. The Company’s board members and consultants are eligible to receive awards under the Company’s non-employee sub-plan to the EIP. Awards may
be granted at such times as the Company may determine, but will generally be granted annually following the end of the financial year. Awards vest at such times and as specified in the award agreement, typically being over a four-year period, although the Company retains the discretion to provide for other vesting schedules. If the participant violates the non-competition,
non-solicitation, confidentiality or other similar restrictive covenant provisions of any employment contract, the right of the participant to receive these shares on vesting shall terminate immediately. The Company maintains discretion over the
type and terms of equity awards granted. All awards lapse on the tenth anniversary from the date of grant, and they are not subject to performance conditions or entitled to dividends. The Company has reserved 5,722,132 authorized shares for future issuance under the EIP.
The following table shows the total share-based compensation expense recorded in the Condensed Consolidated Statements of Operations and
Comprehensive Loss (in thousands):
Share option activity
The number and weighted average exercise prices of share options are as follows:
As of March 31, 2024, total unrecognized compensation expense related to share options granted but not vested was $56.7 million, which the Company expects to recognize over a remaining weighted-average period of 1.2 years.
Awards granted in the three months ended March 31, 2024 and 2023 have been valued using the Black-Scholes option pricing model. The assumptions used
in the models for share options granted during the three months ended March 31, 2024 and 2023, are as follows:
Share options are not entitled to receive dividends.
|
Basic and diluted net loss per share |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||
Basic and diluted net loss per share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
Basic and diluted net loss per share |
7. Basic and diluted net loss per share
Basic and diluted net loss per share is calculated as follows (in thousands, except share and per share amounts):
The potential shares through share options of 9,537,918
and 10,290,982 for the three months ended March 31, 2024 and 2023, respectively, have been excluded from the calculation of diluted
net loss per share due to their anti-dilutive effect.
For the three months ended March 31, 2024, shares issuable upon the potential conversion of all of the Notes (as defined in Note 5. “Non-current interest-bearing
loans and borrowings”) were excluded from the calculation of diluted loss per share because they were anti-dilutive. Diluted earnings per share for the Notes is calculated under the if-converted method in accordance with ASC 260, Earnings Per Share.
|
Income taxes |
3 Months Ended |
---|---|
Mar. 31, 2024 | |
Income taxes [Abstract] | |
Income taxes |
8. Income taxes
Income tax expense is recognized at an amount determined by multiplying the net loss before income taxes for the interim reporting period by
the Company’s estimated annual effective tax rate, adjusted for the tax effect of certain items recognized in full in the interim period. As such, the effective tax rate in the condensed consolidated financial statements may differ from the
Company’s estimate of the effective tax rate for the Company’s audited financial statements for the year ending December 31, 2024.
The Company’s consolidated estimated effective tax rate for the three months ended March 31, 2024 was 1.5%. During the three months ended March 31, 2024, the Company recorded a tax charge of $0.4 million, compared to a tax charge for the three months ended March 31, 2023 of $0.3 million. The Company continues to benefit from the U.K. large company, Research & Development Expenditure Credit, or RDEC, regime which can generate a cash rebate of up to 15% of qualifying research and development expenditures incurred after April 1, 2023. Tax credits receivable under the RDEC regime are recorded
“above the line” as a reduction from research and development expenses. For the three months ended March 31, 2024, the Company excluded the United Kingdom from the calculation of the Annual Estimated Tax Rate, or AETR, as the Company
anticipates an ordinary loss in this jurisdiction for which no tax benefit can be recognized.
A net deferred tax asset of $10.8
million has been recognized as of March 31, 2024 (December 31, 2023: $11.0 million) primarily representing research and development
credits and share-based compensation for one of the Company’s U.S. subsidiaries, Immunocore LLC, following an annual assessment, or periodically as required, of all available and applicable information, including its forecasts of costs and
future profitability and the resulting ability to reverse the recognized deferred tax assets over a short period of time.
During the three months ended March 31, 2024, the Company received U.K. tax credits of $0 relating to research and development expenditure in the year ended December 31, 2023. During the three months ended March 31, 2024, the Company made tax payments of $0.1 million in relation to estimated U.S. corporate income taxes for 2023.
|
Commitments and contingencies |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and contingencies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and contingencies |
9. Commitments and contingencies
Lease Commitments
The maturities of operating lease liabilities as of March 31, 2024 are as follows (in thousands):
Manufacturing Commitments
The Company enters into a number of manufacturing commitments for the future purchase of materials and contract manufacturing services. While the
majority of such contracts can be cancelled on reasonable notice, due to the significant ongoing expenditure associated with the Company’s programs, including brenetafusp (IMC-F106C), the Company estimates it has noncancellable commitments in
relation to the development and supply of product candidates totaling, $11.7 million, which are expected to be paid during the
remainder of 2024.
Legal proceedings
The Company is not currently a party to any material legal proceedings.
|
Insider Trading Arrangements |
3 Months Ended |
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Mar. 31, 2024 | |
Insider Trading Arrangements [Line Items] | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of Significant Accounting Policies (Policies) |
3 Months Ended |
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Mar. 31, 2024 | |
Summary of Significant Accounting Policies [Abstract] | |
Basis of Presentation |
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the U.S., or U.S. GAAP, for interim financial reporting and pursuant to the requirements for reporting on Form 10-Q and Article 10 of Regulation S-X. Accordingly, they 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 Company for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K filed with the Securities
and Exchange Commission, or the SEC, on February 28, 2024, or the Annual Report. The accompanying condensed consolidated financial statements contain all normal recurring adjustments necessary to present fairly the financial position, results
of operations, and cash flows for the interim periods reported. In the opinion of management, all adjustments considered necessary to present fairly the results of the interim periods have been included and consist only of normal and recurring
adjustments. Certain information and footnote disclosures have been condensed or omitted as permitted under U.S. GAAP. The results for the three months ended March 31, 2024 are not necessarily indicative of the results to be expected for the
year ending December 31, 2024, any other interim periods, or any future year or period.
|
Use of Estimates |
Use of Estimates
The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and
assumptions. These judgments, estimates and assumptions affect the reported assets and liabilities as well as income and expenses in the financial 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
the Company’s control. Actual results could differ from those estimates. Estimates are primarily made in relation to revenue recognition, estimation of operating lease incremental borrowing rates, share-based compensation expense, clinical
accruals, and deferred tax asset valuation allowances.
|
Collaboration and Supply Agreements |
Collaboration and Supply Agreements
In February 2024, the Company entered into a clinical trial collaboration and supply agreement with Bristol Myers Squibb, or BMS, to investigate the
Company’s ImmTAC bispecific TCR candidate targeting PRAME HLA-A02, brenetafusp (IMC-F106C), in combination with BMS’s nivolumab, in first-line advanced cutaneous melanoma, or the BMS Agreement. Under the terms of the collaboration, the Company
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. Both parties will own the study data produced
in the clinical trial, other than study data related solely to nivolumab, which will belong solely to BMS, or study data related solely to IMC-F106C, which will belong solely to the Company. Given the terms of the BMS Agreement, the Company
concluded that it is not within the scope of ASC 808 or ASC 606. Any relevant costs arising from the clinical trial will be expensed as incurred and recorded in research and development expenses. The Company will initiate the clinical trial for
the combination therapy of nivolumab and IMC-F106C in the second quarter of 2024. There has been no impact to the condensed consolidated financial statements as of March 31, 2024 relating to the Company’s collaboration with BMS.
|
Convertible Senior Notes |
Convertible Senior Notes
The Company issued 2.5% Convertible Senior Notes due
in 2030 in February 2024, or the Notes, and evaluated to determine whether they contain features that qualify as embedded derivatives in accordance with ASC 815. Embedded derivatives must be separately measured from the host contract if all the
requirements for bifurcation are met. The assessment of the conditions surrounding the bifurcation of embedded derivatives depends on the nature of the host contract and the features of the derivatives. In accounting for the issuance of the
Notes, the Company treats the instrument wholly as a liability, in accordance with ASC 470, as the conversion features do not require bifurcation as a derivative in accordance with ASC 815 and the Notes were not issued at a substantial premium.
Costs directly associated with the borrowing have been capitalized and are netted against the corresponding debt liabilities in the Company’s Condensed Consolidated Balance Sheets at issuance and amortized over the contractual term of the
convertible debt instrument using the effective interest rate method.
See Note 5. “Non-current interest-bearing loans and borrowings” for additional information.
|
Foreign currencies |
Foreign currencies
The reporting currency of the Company is the U.S. dollar. Effective January 1, 2024, the Company’s ultimate parent adopted the U.S. dollar as
its functional currency. Prior to January 1, 2024, the functional currency of the Company’s ultimate parent was the British pound sterling. The functional currency of the Company’s ultimate parent and each subsidiary is based on the currency of
the economic environment in which they operate. The change in functional currency of the Company’s ultimate parent is due to a change in the economic facts and circumstances of the entity due to the increased exposure to the U.S. dollar primarily
as a result of the increased cash flows related to financing and investing activities that are now expected to occur going forward in this entity. The effect of the change in functional currency for the Company’s ultimate parent was applied
prospectively in the condensed consolidated financial statements effective January 1, 2024.
Upon consolidation, assets and liabilities of each subsidiary with a functional currency that differs to the Company’s ultimate parent are
translated into U.S. dollars at period-end exchange rates, and revenues and expenses are translated into U.S. dollars using average exchange rates for each reporting period. Translation adjustments are reflected as other comprehensive (loss)
income.
|
Fair value measurements |
Fair value measurements
Where financial and non-financial assets and liabilities are measured at fair value, the Company uses appropriate valuation techniques for which
sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs.
As of March 31, 2024 and December 31, 2023, the Company held $726.0 million and $331.0 million, respectively, of money market funds required to be measured at fair
value on a recurring basis. The fair value of these cash equivalents is based on quoted prices from active markets (Level 1 inputs). Other financial instruments, although not recorded at fair value on a recurring basis, include cash, accounts
receivable, accounts payable and debt obligations.
The fair value of borrowings under the Notes and Pharmakon Loan Agreement (disclosed in
Note 5. “Non-current interest-bearing loans and borrowings”) were based on Level 2 inputs, which include observable inputs estimated using discounted cash flows and market-based expectations for interest rates, credit risk, and the contractual
terms of debt instruments. After initial recognition, borrowings are measured at amortized cost using the effective interest method.
|
Recently issued and recently adopted accounting pronouncements |
Recently issued and recently adopted accounting pronouncements
In March 2024, the SEC issued Release No. 33-11275, The Enhancement and Standardization of Climate-Related Disclosures for Investors. The final rule requires registrants to provide climate-related disclosures in their annual reports and registration
statements, beginning with annual reports for the year ending December 31, 2025, for calendar-year-end large accelerated filers. The Company is currently assessing the impact of this guidance on its disclosures.
|
Revenue (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue by Country/Region Based on Location of Customer |
Product revenue, net from the sale of KIMMTRAK is presented by country / region based on the location of the end customer below (in thousands).
|
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Current and Non-current Accruals for Rebates, Chargebacks and Returns |
Current and non-current accruals for rebates, chargebacks and returns as of March 31, 2024 were as follows (in thousands):
|
Accrued expenses and other current liabilities (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued expenses and other current liabilities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Expenses and Other Current Liabilities |
Accrued expenses and other current liabilities consists of the following (in thousands):
|
Non-current interest-bearing loans and borrowings (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Non-current interest-bearing loans and borrowings [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Non-Current Interest-Bearing Loans and Borrowings |
Non-current interest-bearing loans and borrowings consists of the following (in thousands) as of March 31, 2024:
Non-current interest-bearing loans and borrowings consists of the following (in thousands) as of December 31, 2023:
|
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Interest Expense |
Interest expense consists of the following (in thousands):
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Future Principal Payments Due |
As of March 31, 2024, future principal payments are due as follows (in thousands):
|
Share-based compensation (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based Compensation Expense Recorded in Consolidated Statements of Operations and Comprehensive Loss |
The following table shows the total share-based compensation expense recorded in the Condensed Consolidated Statements of Operations and
Comprehensive Loss (in thousands):
|
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Number and Weighted Average Exercise Prices of Share Options Activity |
The number and weighted average exercise prices of share options are as follows:
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Assumptions used in Determining Fair Value of Stock Options |
Awards granted in the three months ended March 31, 2024 and 2023 have been valued using the Black-Scholes option pricing model. The assumptions used
in the models for share options granted during the three months ended March 31, 2024 and 2023, are as follows:
|
Basic and diluted net loss per share (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||
Basic and diluted net loss per share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
Basic and Diluted Net Loss Per Share |
Basic and diluted net loss per share is calculated as follows (in thousands, except share and per share amounts):
|
Commitments and contingencies (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and contingencies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||
Maturities of Operating Lease Liabilities |
The maturities of operating lease liabilities as of March 31, 2024 are as follows (in thousands):
|
Description of Business (Details) |
3 Months Ended |
---|---|
Mar. 31, 2024
Country
program
| |
Description of Business [Abstract] | |
Number of active clinical and pre-clinical program developed by organization | program | 9 |
Number of countries KIMMTRAK is approved | Country | 38 |
Summary of Significant Accounting Policies, Convertible Senior Notes (Details) |
Feb. 02, 2024 |
---|---|
2.50% Convertible Senior Notes Due 2030 [Member] | |
Convertible Senior Notes [Abstract] | |
Interest rate on notes | 2.50% |
Summary of Significant Accounting Policies, Fair Value Measurements (Details) - USD ($) $ in Millions |
Mar. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Recurring [Member] | Money Market Funds [Member] | ||
Fair Value Measurements [Abstract] | ||
Assets at fair value | $ 726.0 | $ 331.0 |
Revenue, Revenue by Region Based on Location of Customer (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
|
Revenue Recognition [Abstract] | ||
Total revenue | $ 70,502 | $ 54,659 |
Medison [Member] | ||
Revenue Recognition [Abstract] | ||
Total revenue | 2,200 | 900 |
Genentech [Member] | ||
Revenue Recognition [Abstract] | ||
Collaboration revenue | 200 | 3,100 |
Product Revenue [Member] | ||
Revenue Recognition [Abstract] | ||
Total revenue | 70,342 | 51,581 |
Product Revenue [Member] | United States [Member] | ||
Revenue Recognition [Abstract] | ||
Total revenue | 50,026 | 36,224 |
Product Revenue [Member] | Europe [Member] | ||
Revenue Recognition [Abstract] | ||
Total revenue | 18,952 | 15,124 |
Product Revenue [Member] | International [Member] | ||
Revenue Recognition [Abstract] | ||
Total revenue | $ 1,364 | $ 233 |
Revenue, Accounts Receivable, Net (Details) - USD ($) $ in Millions |
Mar. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Accounts Receivable [Member] | ||
Accounts Receivable from Contracts with Customers [Abstract] | ||
Accounts receivable | $ 57.8 | $ 52.1 |
Revenue, Deferred Revenue (Details) - USD ($) $ in Millions |
Mar. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Deferred Revenue [Abstract] | ||
Deferred revenue, non-current | $ 5.0 | $ 5.0 |
Accrued expenses and other current liabilities (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Accrued expenses and other current liabilities [Abstract] | ||
Rebates, chargebacks, other customer fees and returns | $ 84,803 | $ 66,726 |
Clinical accruals | 26,536 | 22,459 |
Contract manufacturing | 3,140 | 4,356 |
Commercial services | 5,309 | 6,900 |
Employee related expenses | 5,531 | 11,598 |
Other taxation and social security | 5,774 | 1,807 |
Other accruals | 7,456 | 5,989 |
Total accrued expenses and other current liabilities | $ 138,549 | $ 119,835 |
Share-based compensation, Summary (Details) - Equity Incentive Plan [Member] |
3 Months Ended |
---|---|
Mar. 31, 2024
shares
| |
Equity Incentive Plan and Pre-IPO Grants [Abstract] | |
Vesting period | 4 years |
Reserved authorized shares for future issuance (in shares) | 5,722,132 |
Share-based compensation, Share-based Compensation Expense Recorded in Statement of Operations and Comprehensive Loss (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
|
Research and Development [Member] | ||
Stock-based Compensation Expense [Abstract] | ||
Share-based compensation expense | $ 1,980 | $ 1,696 |
Selling, General and Administrative [Member] | ||
Stock-based Compensation Expense [Abstract] | ||
Share-based compensation expense | $ 6,984 | $ 6,562 |
Share-based compensation, Assumptions used in Determining Fair Value of Stock Options (Details) - $ / shares |
3 Months Ended | |
---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
|
Assumptions for Stock Awards Granted [Abstract] | ||
Expected volatility, minimum | 59.94% | 71.57% |
Expected volatility, maximum | 66.17% | 72.05% |
Risk free rate, minimum | 3.93% | 3.57% |
Risk free rate, maximum | 4.30% | 4.06% |
Minimum [Member] | ||
Assumptions for Stock Awards Granted [Abstract] | ||
Share price at grant date (in dollars per share) | $ 67.51 | $ 57 |
Exercise price (in dollars per share) | $ 67.51 | $ 57 |
Expected life (years) | 5 years | 5 years |
Fair value (in dollars per share) | $ 39.5 | $ 35.14 |
Maximum [Member] | ||
Assumptions for Stock Awards Granted [Abstract] | ||
Share price at grant date (in dollars per share) | 70.5 | 64.53 |
Exercise price (in dollars per share) | $ 70.5 | 64.53 |
Expected life (years) | 5 years 6 months | |
Fair value (in dollars per share) | $ 40.47 | $ 39.92 |
Basic and diluted net loss per share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
|
Basic and diluted net loss per share [Abstract] | ||
Net loss | $ (24,436) | $ (19,449) |
Basic weighted-average number of shares outstanding (in shares) | 49,877,218 | 48,183,771 |
Diluted weighted-average number of shares outstanding (in shares) | 49,877,218 | 48,183,771 |
Basic net loss per share (in dollars per share) | $ (0.49) | $ (0.4) |
Diluted net loss per share (in dollars per share) | $ (0.49) | $ (0.4) |
Stock Options [Member] | ||
Basic and Diluted Net Loss per Share [Abstract] | ||
Antidilutive securities excluded from earnings per share (in shares) | 9,537,918 | 10,290,982 |
Income taxes (Details) - USD ($) $ in Thousands |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
|
Income taxes [Abstract] | |||
Effective tax rate | 1.50% | ||
Net Loss Before Income Taxes [Abstract] | |||
Income tax charge (expense) | $ (357) | $ (293) | |
Net deferred tax assets | 10,800 | $ 11,000 | |
R&D credits | 0 | ||
United Kingdom [Member] | |||
Net Loss Before Income Taxes [Abstract] | |||
Income tax charge (expense) | $ 100 | ||
United Kingdom [Member] | Maximum [Member] | |||
Net Loss Before Income Taxes [Abstract] | |||
R&D expenditure credits | 15.00% |
Commitments and contingencies (Details) $ in Thousands |
Mar. 31, 2024
USD ($)
|
---|---|
Maturities of operating lease liabilities [Abstract] | |
2024 | $ 2,700 |
2025 | 3,852 |
2026 | 3,838 |
2027 | 3,661 |
2028 | 3,844 |
2029 and thereafter | 42,211 |
Total lease payments | 60,106 |
Less imputed interest | (24,874) |
Present value of operating lease liabilities | 35,232 |
Non cancellable commitments in relation to development and supply of product | $ 11,700 |
1 Year Immunocore Chart |
1 Month Immunocore Chart |
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