Exhibit 99.1
Condensed Consolidated Balance Sheets (Unaudited)
(In CHF thousands)
As of | ||||||
June 30, | December 31, | |||||
| Note |
| 2023 |
| 2022 | |
Assets |
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Non-current assets |
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Property, plant and equipment |
| 5 |
| |
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Right-of-use assets |
| 6 |
| |
| |
Intangible asset |
| 9 |
| |
| |
Long-term financial assets |
| 6 |
| |
| |
Total non-current assets |
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| | ||
Current assets |
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Prepaid expenses |
| 10 |
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Accrued income |
| 3 |
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Other current receivables |
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| |
| | |
Short-term financial assets |
| 11 |
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Cash and cash equivalents |
| 11 |
| |
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Total current assets |
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Total assets |
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Shareholders' equity and liabilities |
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Shareholders’ equity |
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Share capital |
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Share premium |
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| |
| | |
Treasury shares |
| 12 |
| ( |
| ( |
Currency translation differences | ( | | ||||
Accumulated losses |
| ( |
| ( | ||
Total shareholders’ equity |
| |
| | ||
Non-current liabilities |
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Long-term lease liabilities |
| 6 |
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Net employee defined benefit liabilities |
| 7 |
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Total non-current liabilities |
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Current liabilities |
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Trade and other payables |
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| |
| | |
Accrued expenses |
| 8 |
| |
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Deferred income |
| 3 |
| |
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Short-term lease liabilities |
| 6 |
| |
| |
Total current liabilities |
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| | ||
Total liabilities |
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Total shareholders’ equity and liabilities |
| |
| |
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 Six Months | |||||||||
Ended June 30, | Ended June 30, | |||||||||
Note | 2023 | 2022 | 2023 | 2022 | ||||||
Revenue |
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Contract revenue |
| 3 |
| — |
| — |
| — |
| — |
Total revenue |
| — |
| — |
| — |
| — | ||
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Operating expenses |
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Research & development expenses |
|
| ( |
| ( |
| ( |
| ( | |
General & administrative expenses |
|
| ( |
| ( |
| ( |
| ( | |
Other operating income/(expense), net |
| 3 |
| |
| |
| |
| |
Total operating expenses |
| ( |
| ( |
| ( |
| ( | ||
Operating loss |
| ( |
| ( |
| ( |
| ( | ||
Financial income |
|
| |
| — |
| |
| — | |
Financial expense |
|
| ( |
| ( |
| ( |
| ( | |
Exchange differences |
|
| ( |
| |
| ( |
| | |
Finance result, net |
| |
| |
| |
| | ||
Loss before tax |
| ( |
| ( |
| ( |
| ( | ||
Income tax expense |
|
| ( |
| ( |
| ( |
| ( | |
Loss for the period |
| ( |
| ( |
| ( |
| ( | ||
Loss per share: | 4 |
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| |||||
Basic and diluted loss per share for the period attributable to equity holders |
|
| ( |
| ( |
| ( |
| ( |
Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)
(In CHF thousands)
For the Three Months | For the Six Months | |||||||||
Ended June 30, | Ended June 30, | |||||||||
| Note |
| 2023 |
| 2022 |
| 2023 |
| 2022 | |
Loss for the period |
| ( |
| ( |
| ( |
| ( | ||
Items that will be reclassified to income or loss in subsequent periods (net of tax): |
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Currency translation differences |
| ( |
| |
| ( |
| | ||
Items that will not to be reclassified to income or loss in subsequent periods (net of tax): |
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Remeasurement gains on defined-benefit plans |
|
| — |
| |
| — |
| | |
Total comprehensive loss (net of tax) |
| ( |
| ( |
| ( |
| ( |
The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).
2
Condensed Consolidated Statements of Changes in Equity (Unaudited)
(In CHF thousands)
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| Currency |
| |||||||
Share | Share | Treasury | Accumulated | translation | ||||||||||
| Note |
| capital |
| premium |
| shares |
| losses |
| differences |
| Total | |
Balance as of January 1, 2022 | | | ( | ( | — | | ||||||||
Net loss for the period | — | — | — | ( | — | ( | ||||||||
Other comprehensive income |
|
| — |
| — |
| — |
| |
| |
| | |
Total comprehensive income/(loss) |
|
| — |
| — |
| — |
| ( |
| |
| ( | |
|
| — |
| — | ||||||||||
Share-based payments |
| — |
| — |
| — |
| |
| — |
| | ||
Transaction offering costs |
| — |
| — |
| — |
| — |
| — |
| — | ||
Issuance of shares, net of transaction costs: |
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restricted share awards |
|
| — |
| |
| — |
| ( |
| — |
| — | |
exercise of options |
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| |
| |
| — |
| — |
| — |
| | |
Balance as of June 30, 2022 |
|
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| |
| ( |
| ( |
| |
| |
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| Currency |
| |||||||
Share | Share | Treasury | Accumulated | translation | ||||||||||
| Note |
| capital |
| premium |
| shares |
| losses |
| differences |
| Total | |
Balance as of January 1, 2023 |
| |
| |
| ( |
| ( |
| |
| | ||
Net loss for the period |
| — |
| — |
| — |
| ( |
| — |
| ( | ||
Other comprehensive loss |
|
| — |
| — |
| — |
| — |
| ( |
| ( | |
Total comprehensive loss |
| — |
| — |
| — |
| ( |
| ( |
| ( | ||
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Share-based payments |
| — |
| — |
| — |
| |
| — |
| | ||
Proceeds from sale of treasury shares in public offerings, net of underwriting fees and transaction costs | 12 | — | | | — | — | | |||||||
Issuance of shares, net of transaction costs: |
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restricted share awards |
| |
| |
| — |
| ( |
| — |
| ( | ||
exercise of options |
| — |
| ( |
| — |
| — |
| — |
| ( | ||
Balance as of June 30, 2023 |
| |
| |
| ( |
| ( |
| ( |
| |
The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).
3
Condensed Consolidated Statements of Cash Flows (Unaudited)
(In CHF thousands)
For the Six Months | |||||||
Ended June 30, | |||||||
Note | 2023 | 2022 | |||||
Operating activities |
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Loss for the period |
| ( |
| ( | |||
Adjustments to reconcile net loss for the period to net cash flows: |
|
| |||||
Depreciation of property, plant and equipment |
| 5 |
| |
| |
|
Depreciation of right-of-use assets |
| 6 |
| |
| |
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Finance (income), net |
|
| ( |
| ( |
| |
Share-based compensation expense |
|
| |
| |
| |
Change in net employee defined benefit liability |
| 7 |
| |
| |
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Interest expense |
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| |
| |
| |
Changes in working capital: |
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| |||
(Increase) in prepaid expenses |
| 10 |
| ( |
| ( |
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(Increase) / decrease in accrued income |
| 3 |
| ( |
| |
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Decrease in other current receivables |
|
| |
| |
| |
(Decrease) in accrued expenses |
| 8 |
| ( |
| ( |
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(Decrease) in deferred income |
| 3 |
| ( |
| ( |
|
Increase / (decrease) in trade and other payables |
|
| |
| ( |
| |
Cash used in operating activities |
| ( |
| ( | |||
Interest received |
|
| |
| — |
| |
Interest paid |
|
| ( |
| ( |
| |
Finance expenses paid |
|
| ( |
| ( |
| |
Net cash flows used in operating activities |
| ( |
| ( | |||
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Investing activities |
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Short-term financial assets, net |
| 11 |
| |
| |
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Purchases of property, plant and equipment |
| 5 |
| ( |
| ( |
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Rental deposits |
| 6 |
| — |
| |
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Net cash flows provided by investing activities |
| |
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Financing activities |
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Principal payments of lease obligations |
| 6 |
| ( |
| ( |
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Proceeds from sale of treasury shares in public offerings, net of underwriting fees and transaction costs | 12 | | — | ||||
Transaction costs associated with issuance of shares in relation to asset acquisition previously recorded in Accrued expenses | — | ( | |||||
Proceeds from issuance of common shares, net of transaction costs | ( | | |||||
Net cash flows provided by/(used in) financing activities |
| |
| ( | |||
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Net increase/(decrease) in cash and cash equivalents |
| |
| ( | |||
Cash and cash equivalents at January 1 |
| |
| | |||
Exchange (loss)/gain on cash and cash equivalents |
| ( |
| | |||
Cash and cash equivalents at June 30 |
| |
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Net increase/(decrease) in cash and cash equivalents |
| |
| ( | |||
Supplemental non-cash activity |
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Capital expenditures in Trade and other payables or Accrued expenses |
| 5 |
| — |
| |
|
Transaction costs associated with the sale of treasury shares in public offering recorded in Accrued expenses |
| 12 |
| |
| — |
|
The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).
4
Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(in CHF thousands, except share and per share amounts)
1. | Corporate information |
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
The Interim Condensed Consolidated Financial Statements of AC Immune SA as of and for the three and six months ended June 30, 2023 were authorized for issuance by the Company’s Audit and Finance Committee on August 3, 2023.
2. | Basis of preparation and changes to the Company’s accounting policies |
Statement of compliance
These Interim Condensed Consolidated Financial Statements as of June 30, 2023 and for the three and six months ended June 30, 2023 and 2022, 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, 2022.
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 June 30, | Six Months Ended June 30, | Year Ended December 31, | ||||||||
2023 |
| 2022 | 2023 |
| 2022 | 2022 | ||||
CHF/USD |
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Closing rate, USD 1 |
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Weighted average exchange rate, USD 1 |
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5
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) clinical development accruals, (ii) net employee defined benefit liability, (iii) share-based compensation, (iv) right-of-use assets, short-term lease liabilities and long-term lease liabilities and (v) our IPR&D 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 and long-term financial assets, cash and cash equivalents, trade and other payables, accrued expenses, short-term lease liabilities and long-term 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, 2022.
There are no new IFRS standards, amendments or interpretations that are mandatory as of January 1, 2023 that are relevant to the Company. Additionally, the Company has not adopted any standard, interpretation or amendment that has been issued but is not yet effective. Such standards are not currently expected to have a material impact on the entity in the current or future reporting periods and on foreseeable future transactions.
Going concern
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
To date, the Company has financed its cash requirements primarily from its public offerings, share issuances, contract revenues from its Licensing and Collaboration Agreements (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.
For the three and six months ended June 30, 2023 and 2022 AC Immune generated
6
3.1Licensing and collaboration agreements
For a discussion of our licensing and collaboration agreements for the fiscal year ended December 31, 2022, please refer to Note 13.1 “Licensing and Collaboration agreements” of our Annual Report on Form 20-F for the year ended December 31, 2022 filed on March 16, 2023.
As it relates to revenue recognition, there have been no significant events or transactions associated with our license and collaboration agreements that have occurred for the three and six months ended June 30, 2023.
3.2Grant income
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, 2022, please refer to Note 13.2 “Grant Income” of our Annual Report on Form 20-F for the year ended December 31, 2022 filed on March 16, 2023.
In August 2022, the Company received follow-on grant funding as part of its joint arrangement with Skåne University Hospital (Skåne) in Sweden totaling USD
In February 2023, the Company was awarded a new grant from the MJFF totaling USD
For the three months ended June 30, 2023 and 2022, the Company has recognized CHF
7
4.Loss per share
| For the Three Months | |||
Ended June 30, | ||||
In CHF thousands except for share and per share data |
| 2023 |
| 2022 |
Loss per share (EPS) |
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Numerator |
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Net loss attributable to equity holders of the Company |
| ( |
| ( |
Denominator |
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Weighted-average number of shares outstanding used to compute EPS basic and diluted attributable to equity holders |
| |
| |
Basic and diluted loss per share for the period attributable to equity holders |
| ( |
| ( |
For the Six Months | ||||
Ended June 30, | ||||
In CHF thousands except for share and per share data |
| 2023 | 2022 | |
Loss per share (EPS) |
|
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| |
Numerator |
|
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| |
Net loss attributable to equity holders of the Company | ( |
| ( | |
Denominator |
| |||
Weighted-average number of shares outstanding used to compute EPS basic and diluted attributable to equity holders | |
| | |
Basic and diluted loss per share for the period attributable to equity holders | ( |
| ( |
The weighted-average 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 June 30, | ||||
| 2023 |
| 2022 | |
Share options issued and outstanding |
| |
| |
Restricted share awards subject to future vesting |
| |
| |
For the Six Months | ||||
Ended June 30, | ||||
2023 | 2022 | |||
Share options issued and outstanding |
| |
| |
Restricted share awards subject to future vesting |
| |
| |
8
5.Property, plant and equipment
The following table shows the movement in the net book values of property, plant and equipment for the six months ended June 30, 2023:
| As of June 30, 2023 | |||||||||||
| IT |
| Lab |
| Leasehold |
| Assets under |
| ||||
In CHF thousands | Furniture | equipment | equipment | improvements | construction | Total | ||||||
Acquisition cost: |
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Balance at December 31, 2022 |
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Additions |
| |
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| |
| — |
| — |
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Disposals | — | ( | — | ( | — | ( | ||||||
Transfers |
| — |
| — |
| — |
| |
| ( |
| — |
Balance at June 30, 2023 |
| |
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| |
| |
| — |
| |
Accumulated depreciation: |
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Balance at December 31, 2022 |
| ( |
| ( |
| ( |
| ( |
| — |
| ( |
Depreciation expense |
| ( |
| ( |
| ( |
| ( |
| — |
| ( |
Disposals |
| — | | — | — | — | | |||||
Balance at June 30, 2023 |
| ( |
| ( |
| ( |
| ( |
| — |
| ( |
Carrying amount: |
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December 31, 2022 |
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June 30, 2023 |
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| — |
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AC Immune continues to enhance its laboratory equipment to support its R&D functions and continues to invest in its IT infrastructure. This effort has continued since the year ended December 31, 2022, with CHF
6.Right-of-use assets, long-term financial assets and lease liabilities
AC Immune recognized
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
The following table shows the movements in the net book values of right-of-use of leased assets for the six months ended June 30, 2023:
|
| Office |
| IT |
| |||
In CHF thousands | Buildings | equipment | equipment | Total | ||||
Balance as of December 31, 2022 |
| |
| |
| |
| |
Depreciation |
| ( |
| ( |
| ( |
| ( |
Balance as of June 30, 2023 |
| |
| |
| |
| |
There are
9
For the three and six months ended June 30, 2023, and 2022, 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 June 30, | ||||
In CHF thousands |
| 2023 |
| 2022 |
Statements of income/(loss) |
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Depreciation of right-of-use assets |
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Interest expense on lease liabilities |
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Expense for short-term leases and leases of low value |
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Total |
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Statements of cash flows |
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Total cash outflow for leases |
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For the Six Months | ||||
Ended June 30, | ||||
In CHF thousands |
| 2023 |
| 2022 |
Statements of income/(loss) |
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Depreciation of right-of-use assets |
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Interest expense on lease liabilities |
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Expense for short-term leases and leases of low value |
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Total |
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Statements of cash flows |
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Total cash outflow for leases |
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The following table presents the contractual undiscounted cash flows for lease obligations as of June 30, 2023:
As of | ||
In CHF thousands |
| June 30, 2023 |
Less than one year |
| |
1-3 years |
| |
3-5 years |
| |
Total |
| |
The Company also has deposits in escrow accounts totaling CHF
7.Net employee defined benefit liabilities
For the six months ended June 30, 2023, the Company recorded CHF
10
8.Accrued expenses
| As of | |||
In CHF thousands | June 30, 2023 | December 31, 2022 | ||
Accrued expenses |
| |
| |
Total accrued expenses |
| |
| |
Accrued expenses consists of accrued R&D costs, accrued payroll expenses and other accrued expenses totaling CHF
9.Intangible assets
AC Immune’s acquired IPR&D asset is a clinically-validated active vaccine 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 June 30, 2023 | As of December 31, 2022 | ||||||||||
| Gross |
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| Gross |
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Carrying | Accumulated | Net Book | Carrying | Accumulated | Net Book | |||||||
In CHF thousands | Amount | Amortization | Value | Amount | Amortization | Value | ||||||
Acquired IPR&D asset | |
| — |
| |
| |
| — |
| | |
Total intangible assets | |
| — |
| |
| |
| — |
| |
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, 2022. As of June 30, 2023, the Company did not identify any triggering events that could result in an impairment of the IPR&D asset.
10.Prepaid expenses
Prepaid expenses include prepaid R&D costs, administrative costs and employee social obligations totaling CHF
11.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 June 30, 2023 and December 31, 2022:
| As of | |||
In CHF thousands | June 30, 2023 |
| December 31, 2022 | |
Cash and cash equivalents |
|
| ||
Total cash and cash equivalents |
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| As of | |||
In CHF thousands | June 30, 2023 |
| December 31, 2022 | |
Short-term financial assets due in one year or less |
| |
| |
Total short-term financial assets |
| |
|
For the six months ended June 30, 2023, a net amount of CHF
11
12.Treasury shares
For a discussion of our at the market offering program with Jefferies LLC for the fiscal year ended December 31, 2022, please refer to Note 11 “Share capital” of our Annual Report on Form 20-F for the year ended December 31, 2022 filed on March 16, 2023.
In Q2 2023, the Company sold
As of June 30, 2023 and December 31, 2022, the Company had
13.Subsequent events
Management has evaluated subsequent events after the balance sheet date, through the issuance of these Interim Condensed Consolidated Financial Statements, for appropriate accounting and disclosures. The Company has determined that there were no other such events that warrant disclosure or recognition in these Interim Condensed Consolidated Financial Statements.
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