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Condensed Consolidated Balance Sheets (Unaudited)
| As of | ||||||
| September 30, | December 31, | |||||
| Note | 2024 | 2023 | ||||
| Assets | ||||||
| Non-current assets | ||||||
| Property, plant and equipment | 5 | 2,736 | 3,376 | |||
| Right-of-use assets | 6 | 3,091 | 3,508 | |||
| Intangible asset | 8 | 50,416 | 50,416 | |||
| Long-term financial assets | 6 | 415 | 361 | |||
| Total non-current assets | 56,658 | 57,661 | ||||
| Current assets | ||||||
| Prepaid expenses | 9 | 3,446 | 6,437 | |||
| Accrued income | 780 | 246 | ||||
| Other current receivables | 869 | 622 | ||||
| Accounts receivable | 11 | 24,600 | 14,800 | |||
| Short-term financial assets | 10 | 125,478 | 24,554 | |||
| Cash and cash equivalents | 10 | 32,417 | 78,494 | |||
| Total current assets | 187,590 | 125,153 | ||||
| Total assets | 244,248 | 182,814 | ||||
| Shareholders' equity and liabilities | ||||||
| Shareholders' equity | ||||||
| Share capital | 12 | 2,218 | 2,089 | |||
| Share premium | 477,126 | 474,907 | ||||
| Treasury shares | 12 | (218) | (105) | |||
| Currency translation differences | (24) | (51) | ||||
| Accumulated losses | (348,937) | (316,197) | ||||
| Total shareholders' equity | 130,165 | 160,643 | ||||
| Non-current liabilities | ||||||
| Long-term deferred contract revenue | 3 | 4,790 | - | |||
| Long-term lease liabilities | 6 | 2,389 | 2,825 | |||
| Net employee defined benefit liabilities | 5,917 | 5,770 | ||||
| Total non-current liabilities | 13,096 | 8,595 | ||||
| Current liabilities | ||||||
| Trade and other payables | 1,416 | 1,679 | ||||
| Accrued expenses | 7 | 12,899 | 11,087 | |||
| Short-term deferred income | 16 | 138 | ||||
| Short-term deferred contract revenue | 3 | 85,962 | - | |||
| Short-term lease liabilities | 6 | 694 | 672 | |||
| Total current liabilities | 100,987 | 13,576 | ||||
| Total liabilities | 114,083 | 22,171 | ||||
| Total shareholders' equity and liabilities | 244,248 | 182,814 |
The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).
Condensed Consolidated Statements of Income/(Loss) (Unaudited)
(In CHF thousands except for per share data)
| For the Three Months | For the Nine Months | |||||||||
| Ended September 30, | Ended September 30, | |||||||||
| Note | 2024 | 2023 | 2024 | 2023 | ||||||
| Revenue | ||||||||||
| Contract revenues | 3 | 25,485 | - | 26,172 | - | |||||
| Total revenue | 25,485 | - | 26,172 | - | ||||||
| Operating expenses | ||||||||||
| Research & development expenses | (14,482) | (12,407) | (46,785) | (39,962) | ||||||
| General & administrative expenses | (3,753) | (3,465) | (13,275) | (11,252) | ||||||
| Other operating income/(expense), net | 19 | 406 | 128 | 1,131 | ||||||
| Total operating expenses | (18,216) | (15,466) | (59,932) | (50,083) | ||||||
| Operating income/(loss) | 7,269 | (15,466) | (33,760) | (50,083) | ||||||
| Financial income | 13 | 939 | 285 | 2,307 | 753 | |||||
| Financial expense | 13 | (33) | (26) | (103) | (150) | |||||
| Exchange differences, net | 13 | (2,672) | 67 | (3,563) | - | |||||
| Finance result, net | (1,766) | 326 | (1,359) | 603 | ||||||
| Income/(loss) before tax | 5,503 | (15,140) | (35,119) | (49,480) | ||||||
| Income tax expense | - | (3) | - | (9) | ||||||
| Income/(loss) for the period | 5,503 | (15,143) | (35,119) | (49,489) | ||||||
| Earnings/(loss) per share: | 4 | |||||||||
| Basic earnings/(loss) for the period attributable to equity holders | 0.06 | (0.18) | (0.35) | (0.59) | ||||||
| Diluted earnings/(loss) for the period attributable to equity holders | 0.05 | (0.18) | (0.35) | (0.59) |
Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)
| For the Three Months | For the Nine Months | |||||||||
| Ended September 30, | Ended September 30, | |||||||||
| Note | 2024 | 2023 | 2024 | 2023 | ||||||
| Income/(loss) for the period | 5,503 | (15,143) | (35,119) | (49,489) | ||||||
| Items that will be reclassified to income or loss in subsequent periods (net of tax): | ||||||||||
| Currency translation differences | 11 | 11 | 27 | (5) | ||||||
| Items that will not to be reclassified to income or loss in subsequent periods (net of tax): | ||||||||||
| Remeasurement gains on defined-benefit plans | - | - | - | - | ||||||
| Other comprehensive income/(loss) | 11 | 11 | 27 | (5) | ||||||
| Total comprehensive income/(loss) (net of tax) | 5,514 | (15,132) | (35,092) | (49,494) |
The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).
Condensed Consolidated Statements of Changes in Equity (Unaudited)
| Currency | ||||||||||||||
| Share | Share | Treasury | Accumulated | translation | ||||||||||
| Note | capital | premium | shares | losses | differences | Total | ||||||||
| Balance as of January 1, 2023 | 1,797 | 431,323 | (124) | (264,015) | 10 | 168,991 | ||||||||
| Net loss for the period | - | - | - | (49,489) | - | (49,489) | ||||||||
| Other comprehensive loss | - | - | - | - | (5) | (5) | ||||||||
| Total comprehensive loss | - | - | - | (49,489) | (5) | (49,494) | ||||||||
| - | - | |||||||||||||
| Share-based payments | - | - | - | 3,568 | - | 3,568 | ||||||||
| Proceeds from sale of treasury shares in public offerings, net of underwriting fees and transaction costs | 12 | - | 2,522 | 18 | - | - | 2,540 | |||||||
| Issuance of shares, net of transaction costs: | ||||||||||||||
| restricted share awards | 4 | 548 | - | (552) | - | - | ||||||||
| exercise of options | 1 | 58 | - | - | - | 59 | ||||||||
| Balance as of September 30, 2023 | 1,802 | 434,451 | (106) | (310,488) | 5 | 125,664 |
| Currency | ||||||||||||||
| Share | Share | Treasury | Accumulated | translation | ||||||||||
| Note | capital | premium | shares | losses | differences | Total | ||||||||
| Balance as of January 1, 2024 | 2,089 | 474,907 | (105) | (316,197) | (51) | 160,643 | ||||||||
| Net loss for the period | - | - | - | (35,119) | - | (35,119) | ||||||||
| Other comprehensive income | - | - | - | - | 27 | 27 | ||||||||
| Total comprehensive income/(loss) | - | - | - | (35,119) | 27 | (35,092) | ||||||||
| Share-based payments | - | - | - | 4,503 | - | 4,503 | ||||||||
| Proceeds from sale of treasury shares in public offerings, net of underwriting fees and transaction costs | 12 | - | 103 | 1 | - | - | 104 | |||||||
| Issuance of shares to be held as treasury shares | 12 | 114 | - | (114) | - | - | - | |||||||
| Issuance of shares, net of transaction costs: | ||||||||||||||
| restricted share awards | 15 | 2,109 | 0 | (2,124) | - | 0 | ||||||||
| exercise of options | 0 | 7 | - | - | - | 7 | ||||||||
| Balance as of September 30, 2024 | 2,218 | 477,126 | (218) | (348,937) | (24) | 130,165 |
The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).
Condensed Consolidated Statements of Cash Flows (Unaudited)
| For the Nine Months | ||||||
| Ended September 30, | ||||||
| Note | 2024 | 2023 | ||||
| Operating activities | ||||||
| Loss for the period | (35,119) | (49,489) | ||||
| Adjustments to reconcile net loss for the period to net cash flows: | ||||||
| Depreciation of property, plant and equipment | 5 | 1,126 | 1,255 | |||
| Depreciation of right-of-use assets | 6 | 507 | 405 | |||
| Finance expense/(income), net | 2,482 | (369) | ||||
| Share-based compensation expense | 4,503 | 3,568 | ||||
| Change in net employee defined benefit liability | 147 | 561 | ||||
| Interest expense | 98 | 151 | ||||
| Changes in working capital: | ||||||
| (Increase)/decrease in prepaid expenses | 9 | 2,992 | (841) | |||
| (Increase)/decrease in accrued income | (534) | 96 | ||||
| (Increase)/decrease in accounts receivable | 11 | (9,800) | - | |||
| (Increase)/decrease in other current receivables | (202) | (14) | ||||
| (Decrease)/increase in accrued expenses | 7 | 2,333 | (98) | |||
| (Decrease)/increase in deferred contract revenue, short-term | 3 | 85,962 | - | |||
| (Decrease)/increase in deferred income | (122) | (249) | ||||
| (Decrease)/increase in trade and other payables | (265) | 567 | ||||
| (Decrease)/increase in deferred contract revenue, long-term | 3 | 4,790 | - | |||
| Cash from/(used in) operating activities | 58,898 | (44,457) | ||||
| Interest received | 1,110 | 391 | ||||
| Interest paid | (88) | (142) | ||||
| Finance expenses paid | (12) | (9) | ||||
| Net cash flows from/(used in) operating activities | 59,908 | (44,217) | ||||
| Investing activities | ||||||
| Short-term financial assets, net | 10 | (100,924) | 43,000 | |||
| Purchases of property, plant and equipment | 5 | (486) | (635) | |||
| Rental deposits | 6 | (54) | - | |||
| Net cash flows (used in)/provided by investing activities | (101,464) | 42,365 | ||||
| Financing activities | ||||||
| Proceeds from sale of treasury shares in public offerings, net of underwriting fees and transaction costs | 12 | 129 | 2,571 | |||
| Proceeds from issuance of common shares - equity plan, net of transaction costs | 7 | 60 | ||||
| Transaction costs and stamp duty associated with the public offerings of common shares previously recorded in Accrued expenses | (521) | - | ||||
| Transaction costs associated with the sale of treasury shares in public offering previously recorded in Accrued expenses | (26) | - | ||||
| Principal payments of lease obligations | 6 | (512) | (409) | |||
| Net cash flows provided by/(used in) financing activities | (923) | 2,222 | ||||
| Net increase/(decrease) in cash and cash equivalents | (42,479) | 370 | ||||
| Cash and cash equivalents at January 1 | 78,494 | 31,586 | ||||
| Exchange (loss)/gain on cash and cash equivalents | (3,598) | (29) | ||||
| Cash and cash equivalents at September 30 | 32,417 | 31,927 | ||||
| Net increase/(decrease) in cash and cash equivalents | (42,479) | 370 | ||||
| Supplemental non-cash activity | ||||||
| Transaction costs associated with the sale of treasury shares in public offering recorded in Accrued expenses | 12 | 25 | 31 |
The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(in CHF thousands, except share and per share amounts)
AC Immune SA was founded in 2003. The Company controls a fully-owned subsidiary, AC Immune USA, Inc. ("AC Immune USA" or "Subsidiary" and, together with AC Immune SA, "AC Immune," "ACIU," "Company," "we," "our," "ours," "us"), which was organized under the laws of Delaware, USA in June 2021. The Company and its Subsidiary form the Group.
AC Immune SA is a clinical-stage biopharmaceutical company leveraging our two proprietary technology platforms to discover, design and develop novel proprietary medicines and diagnostics for prevention and treatment of neurodegenerative diseases (NDD) associated with protein misfolding. Misfolded proteins are generally recognized as the leading cause of NDD, such as Alzheimer's disease (AD) and Parkinson's disease (PD), with common mechanisms and drug targets, such as amyloid beta (Abeta), Tau, alpha-synuclein (a-syn) and TDP-43. Our corporate strategy is founded upon a three-pillar approach that targets (i) AD, (ii) focused non-AD NDD including Parkinson's disease, ALS and NeuroOrphan indications and (iii) diagnostics. We use our two unique proprietary platform technologies, SupraAntigen (conformation-specific biologics) and Morphomer (conformation-specific small molecules), to discover, design and develop novel medicines and diagnostics to target misfolded proteins.
The Interim Condensed Consolidated Financial Statements of AC Immune SA as of and for the three and nine months ended September 30, 2024 were authorized for issuance by the Company's Audit and Finance Committee on November 4, 2024.
Statement of compliance
These Interim Condensed Consolidated Financial Statements as of September 30, 2024 and for the three and nine months ended September 30, 2024 and 2023, have been prepared in accordance with International Accounting Standard 34 (IAS 34), Interim Financial Reporting, as issued by the International Accounting Standards Board (IASB), and such financial information should be read in conjunction with the audited consolidated financial statements in AC Immune's Annual Report on Form 20-F for the year ended December 31, 2023.
Basis of measurement
These Interim Condensed Consolidated Financial Statements have been prepared under the historical cost convention.
Functional and reporting currency
These Interim Condensed Consolidated Financial Statements and accompanying notes are presented in Swiss Francs (CHF), which is AC Immune SA's functional currency and the Group's reporting currency. The Company's subsidiary has a functional currency of the US Dollar (USD). The following exchange rates have been used for the translation of the financial statements of AC Immune USA:
| For the | ||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | Year Ended December 31, | ||||||||
| 2024 | 2023 | 2024 | 2023 | 2023 | ||||||
| CHF/USD | ||||||||||
| Closing rate, USD 1 | 0.850 | 0.924 | 0.850 | 0.924 | 0.851 | |||||
| Weighted average exchange rate, USD 1 | 0.877 | 0.892 | 0.891 | 0.911 | 0.908 |
Critical judgments and accounting estimates
The preparation of the Company's Interim Condensed Consolidated Financial Statements in conformity with IAS 34 requires management to make judgments, estimates and assumptions that affect the amounts reported in the Interim Condensed Consolidated Financial Statements and accompanying notes, and the related application of accounting policies as it relates to the reported amounts of assets, liabilities, income and expenses.
The areas where AC Immune has had to make judgments, estimates and assumptions relate to (i) revenue recognition on Licensing and Collaboration Agreements (LCAs), (ii) clinical development accruals, (iii) net employee defined benefit liability, (iv) share-based compensation, (v) right-of-use assets and lease liabilities and (vi) our IPR&D asset (intangible asset). Actual results may differ from these estimates. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.
Fair value of financial assets and liabilities
The Company's financial assets and liabilities are composed of receivables, short-term financial assets, cash and cash equivalents, trade payables, deferred contract revenue and lease liabilities. The fair value of these financial instruments approximates their respective carrying values due to the short-term maturity of these instruments, and are held at their amortized cost in accordance with IFRS 9, unless otherwise explicitly noted.
Accounting policies, new standards, interpretations and amendments adopted by the Company
The accounting policies adopted in the preparation of the Interim Condensed Consolidated Financial Statements are consistent with those followed in the preparation of the Company's annual consolidated financial statements for the year ended December 31, 2023.
As of January 1, 2024 the amendments to paragraphs 69 to 76 of IAS 1, Presentation of Financial Statements (IAS 1), as issued by the IASB became effective. The Company assessed the changes to the accounting standard and determined the amendments had an immaterial impact on the Company's financial statements. There are no other new IFRS standards, amendments or interpretations that are mandatory as of January 1, 2024 that are relevant to the Company. Additionally, in April 2024, the IASB issued IFRS 18 Presentation and Disclosure in Financial Statements (IFRS 18). The new standard on presentation and disclosure in the financial statements will change the structure of the statement of profit or loss, require disclosures for certain profit or loss performance measure that are reported outside of the financial statements, and will enhance principles on aggregation and disaggregation within the notes to the financial statements. This new standard will be effective for annual and interim reporting periods beginning on January 1, 2027 and will require retrospective application. The Company is currently evaluating the new standard to determine how it will impact the presentation and disclosure in its financial statements.
The Company believes that it will be able to meet all of its obligations as they fall due for at least 12 months from the filing date of this Form 6-K, after considering the Company's cash position of CHF 32.4 million and short-term financial assets of CHF 125.5 million as of September 30, 2024. Hence, these unaudited Interim Condensed Consolidated Financial Statements have been prepared on a going-concern basis.
To date, the Company has financed its cash requirements primarily from its public offerings, share issuances, contract revenues from its LCAs and grants. The Company is a clinical stage company and is exposed to all the risks inherent to establishing a business. Inherent to the Company's business are various risks and uncertainties, including the substantial uncertainty as to whether current projects will succeed and our ability to raise additional capital as needed. These risks may require us to take certain measures such as delaying, reducing or eliminating certain programs. The Company's success may depend in part upon its ability to (i) establish and maintain a strong patent position and protection, (ii) enter into collaborations with partners in the pharmaceutical and biopharmaceutical industries, (iii)
successfully move its product candidates through clinical development, (iv) attract and retain key personnel and (v) acquire capital to support its operations.
3.Contract revenues and other operating income
For the three and nine months ended September 30, 2024, AC Immune generated CHF 25.5 million and CHF 26.2 million in contract revenues compared with no contract revenue in the prior comparable periods, respectively.
| For the Three Months | ||||
| Ended September 30, | ||||
| In CHF thousands, unaudited | 2024 | 2023 | ||
| Janssen | 24,600 | - | ||
| Takeda | 885 | - | ||
| Total contract revenues | 25,485 | - |
| For the Nine Months | ||||
| Ended September 30, | ||||
| In CHF thousands, unaudited | 2024 | 2023 | ||
| Janssen | 24,600 | - | ||
| Takeda | 1,572 | - | ||
| Total contract revenues | 26,172 | - |
3.1Licensing and collaboration agreements
For a discussion of our licensing and collaboration agreements for the fiscal year ended December 31, 2023, please refer to Note 14.1 "Licensing and Collaboration agreements" of our Annual Report on Form 20-F for the year ended December 31, 2023 filed on March 14, 2024.
On January 22, 2024, the Company announced that the development of semorinemab and crenezumab in the collaboration agreements with Genentech, a member of the Roche Group, was terminated. These terminations became effective in April 2024.
Anti-Abeta Active Immunotherapy in AD - 2024 agreement with Takeda Pharmaceuticals, USA, Inc.
In May 2024, the Company entered into a worldwide option and license agreement with Takeda Pharmaceuticals, USA, Inc. (Takeda) for our active immunotherapies targeting Abeta, including ACI-24.060 for the treatment of AD. AC Immune will be responsible for completing the ABATE trial. Following option exercise, Takeda would conduct and fund all further clinical development and be responsible for all global regulatory activities as well as worldwide commercialization. Under the terms of the agreement, AC Immune received an upfront payment of USD 100.0 (CHF 92.3) million in May 2024 and is eligible to receive an option exercise fee in the low-to-mid nine-figure USD range and additional potential development, commercial and sales-based milestones of up to approximately USD 2.1 (CHF 1.8) billion if all related milestones are achieved over the course of the agreement. Upon commercialization, AC Immune will be entitled to receive tiered mid-to-high teens percentages royalties on worldwide net sales.
Under the terms of the agreement, Takeda may terminate the agreement at any time by providing 90 days' notice to the Company. If not otherwise terminated, the agreement shall continue until Takeda decides not to exercise its license option or until the expiration of all royalty obligations as outlined in the contract.
AC Immune assessed this arrangement in accordance with IFRS 15 and concluded that Takeda is a customer. The Company identified the following performance obligations under the contract: (i) a license option and (ii) development, chemistry, manufacturing, and controls ("CMC") and regulatory activities as outlined in the development and CMC plans, which are necessary to deliver the data package to Takeda. AC Immune concluded that the license option is considered a material right, as the value of the license exceeds the option exercise fee, thereby considering it a distinct performance obligation. The development, CMC, and regulatory activities are treated as one distinct performance
obligation because the underlying activities are not distinguishable in the context of the contract and are inputs to an integrated development program that will generate valuable data and information for Takeda in determining whether to exercise the option.
At the agreement's execution, the transaction price included only the upfront and non-refundable consideration of USD 100.0 (CHF 92.3) million. At inception, none of the development milestones, which may occur prior to the Takeda option exercise, were included in the transaction price, as all milestone amounts were fully constrained. The Takeda option exercise payment and any future development and commercial milestone payments, and royalties following the Takeda option exercise were excluded from the initial transaction price at contract inception. The option exercise fee is considered variable consideration as it depends on Takeda's decision to exercise. In assessing that future development or commercial milestones are fully constrained, the Company considered numerous factors, including that the receipt of these milestones is contingent upon success in future clinical trials and the licensee's efforts, and thus not highly probable to obtain. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur, as they predominantly relate to the license that will be granted to Takeda upon exercise and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period as uncertain events are resolved or other changes in circumstances occur.
The valuation of each performance obligation involves estimates and assumptions, with the timing of revenue recognition determined by either delivery or the provision of services. In line with the allocation objective under IFRS 15, the Company allocated the USD 100.0 (CHF 92.3) million upfront payment within the transaction price to the license option and development, CMC, and regulatory activities, using the relative stand-alone selling price method. For the standalone selling price of the license option, the Company utilized an income-based approach, which included key assumptions such as the post-option development timeline and costs, revenue forecasts, discount rates, and probabilities of development and regulatory success. The standalone selling price for the development, CMC and regulatory activities was calculated using a cost-plus margin approach based on the estimated development timeline. The Company allocated the transaction price based on the relative standalone selling prices, assigning USD 87.4 (CHF 80.7) million to the license option and USD 12.6 (CHF 11.6) million to development, CMC, and regulatory activities.
The Company has deferred revenue recognition for the license option and will recognize the entirety of the revenue either when the option is exercised and Takeda obtains the exclusive license, or when the option expires. The Company will recognize revenue related to the development, CMC and regulatory performance obligation over the estimated period of completion of these obligations, using an input method reflecting the costs incurred relative to the total costs expected to be incurred.
During the three and nine months ended September 30, 2024, the Company recorded contract revenue of CHF 0.9 million and CHF 1.6 million, respectively, reflecting its efforts under this agreement. As of September 30, 2024, the Company recorded CHF 90.7 million in deferred contract revenue related to the unsatisfied performance obligations under this agreement. The deferred contract revenue allocated to the license option is classified as short-term on the condensed consolidated balance sheets because, in accordance with IAS 1, the Company does not have the right to defer the settlement of that portion for at least twelve months after the reporting period. The deferred contract revenue allocated to development, CMC, and regulatory activities will be recognized over the remaining performance period and classified as either current or non-current on the condensed consolidated balance sheets, based on the expected timing of satisfaction of the performance obligations.
Tau active immunotherapy in AD - 2014 agreement with Janssen Pharmaceuticals, Inc.
In April 2016, July 2017, January 2019, November 2019, December 2022, November 2023 and September 2024, the companies entered into the first, second, third, fourth, fifth, sixth and seventh amendments, respectively, of the License, Development and Commercialization Agreement (the Janssen Agreement) between Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company, and the Company. These amendments allow for the alignment of certain payment and activity provisions with the Development Plan and Research Plan activities.
In September 2024, the Company announced that it will receive the second ReTain-related milestone payment of CHF 24.6 million under its agreement with Janssen. This milestone payment was triggered by the rapid rate of
prescreening in the potentially registrational Phase 2b ReTain trial investigating active-immunotherapy candidate ACI-35.030 (now called "JNJ-2056") to treat preclinical (pre-symptomatic) AD. The Company recognized this milestone of CHF 24.6 million as revenue because we deemed it highly probable that this milestone would be obtained and would not be subject to reversal in the future.
Grants from the Michael J. Fox Foundation
For a discussion of our Grants from the Michael J. Fox Foundation (MJFF) for the fiscal year ended December 31, 2023, please refer to Note 14.2 "Grant Income" of our Annual Report on Form 20-F for the year ended December 31, 2023 filed on March 14, 2024.
For the three months ended September 30, 2024 and 2023, the Company has recognized less than CHF 0.1 million and CHF 0.3 million in grant income under other operating income/(expense), net, respectively. For the nine months ended September 30, 2024 and 2023, the Company has recognized CHF 0.1 million and CHF 1.0 million in grant income, respectively.
4.Earnings and loss per share
| For the Three Months | ||||
| Ended September 30, | ||||
| In CHF thousands except for share and per share data | 2024 | 2023 | ||
| Basic earnings/(loss) per share (EPS): | ||||
| Numerator | ||||
| Net income/(loss) attributable to equity holders of the Company | 5,503 | (15,143) | ||
| Denominator | ||||
| Weighted-average number of shares outstanding used to compute EPS basic attributable to equity holders | 99,840,693 | 84,715,515 | ||
| Basic earnings/(loss) per share for the period attributable to equity holders | 0.06 | (0.18) | ||
| Diluted earnings/(loss) per share (EPS): | ||||
| Numerator | ||||
| Net income/(loss) attributable to equity holders of the Company | 5,503 | (15,143) | ||
| Denominator | ||||
| Weighted-average number of shares outstanding used to compute EPS basic attributable to equity holders | 99,840,693 | 84,715,515 | ||
| Effect of dilutive securities from equity incentive plans | 1,018,251 | - | ||
| Weighted-average number of shares outstanding - diluted attributable to equity holders | 100,858,944 | 84,715,515 | ||
| Diluted earnings/(loss) per share for the period attributable to equity holders | 0.05 | (0.18) |
| For the Nine Months | ||||
| Ended September 30, | ||||
| In CHF thousands except for share and per share data | 2024 | 2023 | ||
| Loss per share (EPS) | ||||
| Numerator | ||||
| Net loss attributable to equity holders of the Company | (35,119) | (49,489) | ||
| Denominator | ||||
| Weighted-average number of shares outstanding used to compute EPS basic and diluted attributable to equity holders | 99,592,932 | 84,012,166 | ||
| Basic and diluted loss per share for the period attributable to equity holders | (0.35) | (0.59) |
The outstanding number of potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows:
| For the Three Months | ||||
| Ended September 30, | ||||
| 2024 | 2023 | |||
| Share options issued and outstanding | 3,109,214 | 4,939,773 | ||
| Restricted share awards subject to future vesting | - | 1,045,648 |
| For the Nine Months | ||||
| Ended September 30, | ||||
| 2024 | 2023 | |||
| Share options issued and outstanding | 5,098,280 | 4,939,773 | ||
| Restricted share awards subject to future vesting | 1,265,458 | 1,045,648 |
5.Property, plant and equipment
The following table shows the movement in the net book values of property, plant and equipment for the nine months ended September 30, 2024:
| As of September 30, 2024 | ||||||||||||
| IT | Lab | Leasehold | Assets under | |||||||||
| In CHF thousands | Furniture | equipment | equipment | improvements | construction | Total | ||||||
| Acquisition cost: | ||||||||||||
| Balance at December 31, 2023 | 309 | 2,168 | 10,233 | 1,662 | - | 14,372 | ||||||
| Additions | 15 | 150 | 285 | 36 | - | 486 | ||||||
| Balance at September 30, 2024 | 324 | 2,318 | 10,518 | 1,698 | - | 14,858 | ||||||
| Accumulated depreciation: | ||||||||||||
| Balance at December 31, 2023 | (212) | (1,851) | (8,101) | (832) | - | (10,996) | ||||||
| Depreciation expense | (35) | (151) | (739) | (201) | - | (1,126) | ||||||
| Balance at September 30, 2024 | (247) | (2,002) | (8,840) | (1,033) | - | (12,122) | ||||||
| Carrying amount: | ||||||||||||
| December 31, 2023 | 97 | 317 | 2,132 | 830 | - | 3,376 | ||||||
| September 30, 2024 | 77 | 316 | 1,678 | 665 | - | 2,736 |
6.Right-of-use assets, long-term financial assets and lease liabilities
AC Immune recognized additions of CHF 0.1 million for its right-of-use leased assets for the nine months ended September 30, 2024.
Regarding lease liabilities, the amortization depends on the rate implicit in the contract or the incremental borrowing rate for the respective lease component. The weighted averages of the incremental borrowing rates are 3.5% for buildings, 3.3% for office equipment and 7.2% for IT equipment, respectively.
The following table shows the movements in the net book values of right-of-use of leased assets for the nine months ended September 30, 2024:
| Office | IT | |||||||
| In CHF thousands | Buildings | equipment | equipment | Total | ||||
| Balance as of December 31, 2023 | 3,446 | 50 | 12 | 3,508 | ||||
| Additions and remeasurements | - | 64 | 26 | 90 | ||||
| Depreciation | (479) | (17) | (11) | (507) | ||||
| Balance as of September 30, 2024 | 2,967 | 97 | 27 | 3,091 |
There are no variable lease payments that are not included in the measurement of lease obligations. All extension options have been included in the measurement of lease obligations.
For the three and nine months ended September 30, 2024, and 2023, the impact on the Company's condensed consolidated statements of income/(loss) and the condensed consolidated statements of cash flows is as follows:
| For the Three Months | ||||
| Ended September 30, | ||||
| In CHF thousands | 2024 | 2023 | ||
| Statements of income/(loss) | ||||
| Depreciation of right-of-use assets | 170 | 136 | ||
| Interest expense on lease liabilities | 28 | 22 | ||
| Expense for short-term leases and leases of low value | 177 | 109 | ||
| Total | 375 | 267 | ||
| Statements of cash flows | ||||
| Total cash outflow for leases | 377 | 268 |
| For the Nine Months | ||||
| Ended September 30, | ||||
| In CHF thousands | 2024 | 2023 | ||
| Statements of income/(loss) | ||||
| Depreciation of right-of-use assets | 507 | 405 | ||
| Interest expense on lease liabilities | 87 | 69 | ||
| Expense for short-term leases and leases of low value | 551 | 596 | ||
| Total | 1,145 | 1,070 | ||
| Statements of cash flows | ||||
| Total cash outflow for leases | 1,150 | 1,075 |
The following table presents the contractual undiscounted cash flows for lease obligations as of September 30, 2024:
| As of | ||
| In CHF thousands | September 30, 2024 | |
| Less than one year | 791 | |
| 1-3 years | 1,558 | |
| 3-5 years | 975 | |
| Total | 3,324 |
The Company also has deposits in escrow accounts totaling CHF 0.4 million for leases of the Company's premises as of both September 30, 2024 and December 31, 2023, respectively. These deposits are presented in Long-term financial assets on the Company's condensed consolidated balance sheets.
Accrued expenses consist of accrued R&D costs, accrued payroll expenses and other accrued expenses totaling CHF 12.9 million and CHF 11.1 million as of September 30, 2024 and December 31, 2023, respectively.
AC Immune's acquired IPR&D asset is a clinically-validated active immunotherapy candidate for the treatment of Parkinson's disease. The asset is not yet ready for use until the asset obtains market approval and is therefore not currently being amortized. The carrying amount and net book value are detailed below:
| As of September 30, 2024 | As of December 31, 2023 | |||||||||||
| Gross | Gross | |||||||||||
| Carrying | Accumulated | Net Book | Carrying | Accumulated | Net Book | |||||||
| In CHF thousands | Amount | Amortization | Value | Amount | Amortization | Value | ||||||
| Acquired IPR&D asset | 50,416 | - | 50,416 | 50,416 | - | 50,416 | ||||||
| Total intangible assets | 50,416 | - | 50,416 | 50,416 | - | 50,416 |
In accordance with IAS 36 Impairment of Assets, the IPR&D asset is reviewed at least annually for impairment by assessing the fair value less costs to sell (recoverable amount) and comparing this to the carrying value of the asset. The valuation is considered to be Level 3 in the fair value hierarchy in accordance with IFRS 13 Fair Value Measurement due to unobservable inputs used in the valuation. The Company has determined the IPR&D asset not to be impaired as of December 31, 2023. As of September 30, 2024, the Company did not identify any triggering events that could result in an impairment of the IPR&D asset.
Prepaid expenses include prepaid R&D costs and administrative costs totaling CHF 3.4 million and CHF 6.4 million as of September 30, 2024 and December 31, 2023, respectively.
10.Cash and cash equivalents and short-term financial assets
The following table summarizes AC Immune's cash and cash equivalents and short-term financial assets as of September 30, 2024 and December 31, 2023:
| As of | ||||
| In CHF thousands | September 30, 2024 | December 31, 2023 | ||
| Cash and cash equivalents | 32,417 | 78,494 | ||
| Total cash and cash equivalents | 32,417 | 78,494 |
| As of | ||||
| In CHF thousands | September 30, 2024 | December 31, 2023 | ||
| Short-term financial assets due in one year or less | 125,478 | 24,554 | ||
| Total short-term financial assets | 125,478 | 24,554 |
For the nine months ended September 30, 2024, the net investments associated with the short-term financial assets amounted to CHF 100.9 million, compared to net proceeds associated with the maturity of investments of CHF 43.0 million in the prior comparable period.
11.Accounts receivable
As of December 31, 2023, the balance of accounts receivable included the CHF 14.8 million milestone payment due under the Janssen Agreement for reaching the programmed launch of the Phase 2b ReTain trial study. This amount was received in Q1 2024.
As of September 30, 2024, the balance of accounts receivable included the CHF 24.6 million milestone payment due under the Janssen Agreement for triggering the rapid rate of prescreening in the potentially registrational Phase 2b ReTain trial investigating active-immunotherapy candidate ACI-35.030. This amount was received in October 2024.
12.Share capital and Treasury shares
For a discussion of our at the market (ATM) offering program with Jefferies LLC for the fiscal year ended December 31, 2023, please refer to Note 12 "Share capital" of our Annual Report on Form 20-F for the year ended December 31, 2023 filed on March 14, 2024.
In Q2 2024, the Company issued 5,700,000 registered shares to AC Immune USA, Inc. pursuant to a share agreement, which were subsequently repurchased to be held as treasury shares.
In Q2 2024, the Company sold 30,232 common shares previously held as treasury shares pursuant to the sales agreement under our prior ATM program with Jefferies LLC, raising USD 0.1 (CHF 0.1) million, net of underwriting fees.