EX-99.1 2 aciu-20241105xex99d1.htm EX-99.1

Exhibit 99.1

Condensed Consolidated Balance Sheets (Unaudited)

(In CHF thousands)

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)

(In CHF thousands)

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).

2


Condensed Consolidated Statements of Changes in Equity (Unaudited)

(In CHF thousands)

    

    

    

    

    

    

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).

3


Condensed Consolidated Statements of Cash Flows (Unaudited)

(In CHF thousands)

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).

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 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.

2.Basis of preparation and changes to the Company’s accounting policies

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

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) 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.

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 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)

6


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

7


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

8


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.

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, 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)

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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

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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.

7.Accrued expenses

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.

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8.Intangible assets

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.

9.Prepaid expenses

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.

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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.

We have entered into a new Open Market Sale Agreement (“the Sales Agreement”), with Jefferies LLC dated August 6, 2024, relating to our common shares offered by a prospectus supplement and the accompanying prospectus. In accordance with the terms of the Sales Agreement, we may offer and sell our common shares having an aggregate offering price of up to USD 80.0 (CHF 68.0) million from time to time through Jefferies LLC, acting as our sales agent.

As of September 30, 2024 and December 31, 2023, the Company had 10,899,773 and 5,243,958 treasury shares remaining, respectively.

13.Finance result, net

For the three months ended September 30, 2024 and 2023, the net finance result amounted to a loss of CHF 1.8 million and a gain of CHF 0.3 million, respectively. For the nine months ended September 30, 2024 and 2023, AC Immune recorded a net financial loss of CHF 1.4 million and a net financial gain of CHF 0.6 million, respectively. The losses in 2024 are primarily due to foreign currency exchange differences on cash balances, particularly with the CHF strengthening against the US Dollar. These losses are partially offset by an increase in financial income, attributed to higher interest received on net investments in short-term financial assets, with more deposits made in 2024 compared to the previous period.

14.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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