EX-99.1 2 aciu-20230428xex99d1.htm EX-99.1

Exhibit 99.1

Condensed Consolidated Balance Sheets (Unaudited)

(In CHF thousands)

As of

March 31, 

December 31, 

    

Note

    

2023

    

2022

Assets

 

  

 

  

 

  

Non-current assets

 

  

 

  

 

  

Property, plant and equipment

 

5

 

4,011

 

4,259

Right-of-use assets

 

6

 

2,674

 

2,808

Intangible asset

 

8

 

50,416

 

50,416

Long-term financial assets

 

6

 

361

 

361

Total non-current assets

 

57,462

 

57,844

Current assets

 

 

Prepaid expenses

 

9

 

5,438

 

4,708

Accrued income

 

3

 

218

 

408

Other current receivables

 

 

598

 

392

Short-term financial assets

 

10

 

48,000

 

91,000

Cash and cash equivalents

 

10

 

57,434

 

31,586

Total current assets

 

111,688

 

128,094

Total assets

 

169,150

 

185,938

Shareholders' equity and liabilities

 

 

Shareholders’ equity

 

 

Share capital

 

 

1,797

 

1,797

Share premium

 

 

431,365

 

431,323

Treasury shares

 

11

 

(124)

 

(124)

Currency translation differences

2

10

Accumulated losses

 

(280,105)

 

(264,015)

Total shareholders’ equity

 

152,935

 

168,991

Non-current liabilities

 

 

Long-term lease liabilities

 

6

 

2,115

 

2,253

Net employee defined benefit liabilities

 

 

3,345

 

3,213

Total non-current liabilities

 

5,460

 

5,466

Current liabilities

 

 

Trade and other payables

 

 

1,136

 

929

Accrued expenses

 

7

 

8,653

 

9,417

Deferred income

 

3

 

415

 

587

Short-term lease liabilities

 

6

 

551

 

548

Total current liabilities

 

10,755

 

11,481

Total liabilities

 

16,215

 

16,947

Total shareholders’ equity and liabilities

 

169,150

 

185,938

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

Ended March 31, 

Note

2023

2022

Revenue

    

  

    

  

    

  

Contract revenue

 

3

 

 

Total revenue

 

 

 

 

Operating expenses

 

 

Research & development expenses

 

 

(13,873)

 

(15,123)

General & administrative expenses

 

 

(4,106)

 

(4,166)

Other operating income/(expense), net

 

3

 

408

 

459

Total operating expenses

 

(17,571)

 

(18,830)

Operating loss

 

(17,571)

 

(18,830)

Financial income

 

 

209

 

Financial expense

 

 

(97)

 

(154)

Exchange differences

 

 

(51)

 

140

Finance result, net

12

 

61

 

(14)

Loss before tax

 

(17,510)

 

(18,844)

Income tax expense

 

 

(3)

 

(4)

Loss for the period

 

(17,513)

 

(18,848)

Loss per share:

4

 

 

Basic and diluted loss per share for the period attributable to equity holders

 

 

(0.21)

 

(0.23)

Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)

(In CHF thousands)

For the Three Months

ended March 31, 

    

Note

    

2023

    

2022

Loss for the period

 

(17,513)

 

(18,848)

Items that will be reclassified to income or loss in subsequent periods (net of tax):

 

 

Currency translation differences

 

(8)

 

10

Items that will not to be reclassified to income or loss in subsequent periods (net of tax):

 

 

Remeasurement gains on defined-benefit plans (net of tax)

 

 

 

Other comprehensive income/(loss)

 

(8)

 

10

Total comprehensive loss, net of tax

 

(17,521)

 

(18,838)

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, 2022

1,794

431,251

(124)

(200,942)

231,979

Net loss for the period

(18,848)

(18,848)

Other comprehensive income

 

 

 

 

 

 

10

 

10

Total comprehensive loss

 

 

 

 

 

(18,848)

 

10

 

(18,838)

 

 

Share-based payments

 

 

 

 

989

 

 

989

Issuance of shares, net of transaction costs:

 

 

  

 

  

 

  

 

  

 

  

 

  

restricted share awards

 

 

 

2

 

 

(2)

 

 

exercise of options

 

 

1

 

 

 

 

 

1

Balance as of March 31, 2022

 

 

1,795

 

431,253

 

(124)

 

(218,803)

 

10

 

214,131

    

    

    

    

    

    

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

 

 

 

 

(17,513)

 

 

(17,513)

Other comprehensive loss

 

 

 

 

 

 

(8)

 

(8)

Total comprehensive loss

 

 

 

 

(17,513)

 

(8)

 

(17,521)

 

 

Share-based payments

 

 

 

 

1,472

 

 

1,472

Issuance of shares, net of transaction costs:

 

 

 

  

 

 

 

restricted share awards

 

0

 

49

 

 

(49)

 

 

0

exercise of options

 

 

(7)

 

 

 

 

(7)

Balance as of March 31, 2023

 

1,797

 

431,365

 

(124)

 

(280,105)

 

2

 

152,935

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 Three Months

Ended March 31, 

Note

2023

2022

Operating activities

    

  

    

  

    

  

    

Loss for the period

 

(17,513)

 

(18,848)

Adjustments to reconcile net loss for the period to net cash flows:

 

 

Depreciation of property, plant and equipment

 

5

 

436

 

460

 

Depreciation of right-of-use assets

 

6

 

134

 

140

 

Finance (income), net

 

12

 

(59)

 

(179)

 

Share-based compensation expense

 

 

1,472

 

989

 

Change in net employee defined benefit liability

 

 

132

 

183

 

Interest expense

 

12

 

97

 

151

 

Changes in working capital:

 

  

 

  

(Increase)/decrease in prepaid expenses

 

9

 

(737)

 

186

 

Decrease in accrued income

 

3

 

190

 

828

 

(Increase)/decrease in other current receivables

 

 

(206)

 

162

 

(Decrease) in accrued expenses

 

7

 

(751)

 

(5,128)

 

(Decrease) in deferred income

 

3

 

(172)

 

(459)

 

Increase/(decrease) in trade and other payables

 

 

208

 

(1,493)

 

Cash used in operating activities

 

(16,769)

 

(23,008)

Interest received

 

 

67

 

 

Interest paid

 

 

(97)

 

(132)

 

Finance expenses paid

 

 

(2)

 

(3)

 

Net cash flows used in operating activities

 

(16,801)

 

(23,143)

 

  

 

  

Investing activities

 

  

 

  

Short-term financial assets, net

 

10

 

43,000

 

 

Purchases of property, plant and equipment

 

5

 

(200)

 

(540)

 

Net cash flows provided by/(used in) investing activities

 

42,800

 

(540)

 

  

 

  

Financing activities

 

  

 

  

Principal payments of lease obligations

 

6

 

(135)

 

(141)

 

Transaction costs associated with issuance of shares

(776)

Proceeds from issuance of common shares

(6)

1

Net cash flows (used in) financing activities

 

(141)

 

(916)

 

  

 

  

Net increase/(decrease) in cash and cash equivalents

 

25,858

 

(24,599)

Cash and cash equivalents at January 1

 

31,586

 

82,216

Exchange gain on cash and cash equivalents

 

(10)

 

218

Cash and cash equivalents at March 31

 

57,434

 

57,835

Net increase/(decrease) in cash and cash equivalents

 

25,858

 

(24,599)

Supplemental non-cash activity

 

  

 

  

Capital expenditures in Trade and other payables or Accrued expenses

 

5

 

 

15

 

The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).

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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 months ended March 31, 2023 were authorized for issuance by the Company’s Audit and Finance Committee on April 26, 2023.

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

Statement of compliance

These Interim Condensed Consolidated Financial Statements as of March 31, 2023 and for the three months ended March 31, 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 U.S. 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 March 31, 

Year Ended December 31,

2023

    

2022

2022

CHF/USD

 

  

 

  

 

  

Closing rate, USD 1

 

0.923

 

0.932

 

0.933

Weighted-average exchange rate, USD 1

 

0.935

 

0.933

 

0.965

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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) income taxes, (v) share-based compensation, (vi) right-of-use assets and lease liabilities and (vii) 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 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, 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 57.4 million and short-term financial assets of CHF 48.0 million as of March 31, 2023. Hence, these 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 revenue and other operating income

For the three months ended March 31, 2023 and 2022, AC Immune generated no contract revenues.

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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 months ended March 31, 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 0.5 (CHF 0.5) million for the continued development of its alpha-synuclein PET imaging diagnostic agent. As part of this grant, AC Immune received USD 0.4 (CHF 0.4) million directly from the MJFF. Skåne will receive USD 0.1 (CHF 0.1) million of the total grant directly from the MJFF duration of the grant period.

In February 2023, the Company was awarded a new grant from the MJFF totaling USD 0.5 (CHF 0.5) million to support the development of its TDP-43 PET tracer program.

For the three months ended March 31, 2023 and 2022, the Company has recognized CHF 0.4 million in grant income, respectively. As of March 31, 2023, the Company has recorded CHF 0.3 million in deferred income.

4.Loss per share

    

For the Three Months

Ended March 31, 

In CHF thousands except for share and per share data

    

2023

    

2022

Loss per share (EPS)

 

  

 

  

Numerator

 

  

 

  

Net loss attributable to equity holders of the Company

 

(17,513)

 

(18,848)

Denominator

 

  

 

  

Weighted-average number of shares outstanding used to compute EPS basic and diluted attributable to equity holders

 

83,625,826

 

83,486,354

Basic and diluted loss per share for the period attributable to equity holders

 

(0.21)

 

(0.23)

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 March 31, 

    

2023

    

2022

Share options issued and outstanding

 

97,875

 

199,636

Restricted share awards subject to future vesting

 

1,236,774

 

521

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5.Property, plant and equipment

The following table shows the movement in the net book values of property, plant and equipment for the three months ended March 31, 2023:

    

As of March 31, 2023

    

IT

    

Lab

    

Leasehold

    

Assets under

    

In CHF thousands

Furniture

equipment

equipment

improvements

construction

Total

Acquisition cost:

 

  

 

  

 

  

 

  

 

  

 

  

Balance at December 31, 2022

 

285

 

1,909

 

9,765

 

1,640

 

3

 

13,602

Additions

 

 

154

 

46

 

 

 

200

Disposals

(12)

(12)

Transfers

 

 

 

 

3

 

(3)

 

Balance at March 31, 2023

 

285

 

2,063

 

9,811

 

1,631

 

 

13,790

Accumulated depreciation:

 

 

 

 

 

 

Balance at December 31, 2022

 

(159)

 

(1,599)

 

(7,017)

 

(568)

 

 

(9,343)

Depreciation expense

 

(14)

 

(68)

 

(288)

 

(66)

 

 

(436)

Balance at March 31, 2023

 

(173)

 

(1,667)

 

(7,305)

 

(634)

 

 

(9,779)

Carrying amount:

 

 

  

 

  

 

  

 

  

 

  

December 31, 2022

 

126

 

310

 

2,748

 

1,072

 

3

 

4,259

March 31, 2023

 

112

 

396

 

2,506

 

997

 

 

4,011

AC Immune continues to enhance its laboratory equipment to support its R&D functions and IT equipment. This effort has continued since the year ended December 31, 2022, with CHF 0.2 million invested in lab equipment, including the expansion of our leased lab space, and IT equipment, representing an increase of 1.7% from the beginning of the year in these categories.

6.Right-of-use assets, long-term financial assets and lease liabilities

AC Immune recognized no additions for its right-of-use of leased assets for the three months ended March 31, 2023.

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, 5.3% for office equipment and 2.6% for IT equipment, respectively.

The following table shows the movements in the net book values of right-of-use of leased assets for the three months ended March 31, 2023:

    

    

Office

    

IT

    

In CHF thousands

Buildings

equipment

equipment

Total

Balance as of December 31, 2022

 

2,708

 

74

 

26

 

2,808

Depreciation

 

(124)

 

(6)

 

(4)

 

(134)

Balance as of March 31, 2023

 

2,584

 

68

 

22

 

2,674

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.

8


For the three months ended March 31, 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 March 31, 

In CHF thousands

    

2023

    

2022

Statements of income/(loss)

 

  

 

  

Depreciation of right-of-use assets

 

134

 

140

Interest expense on lease liabilities

 

24

 

18

Expense for short-term leases and leases of low value

 

298

 

174

Total

 

456

 

332

Statements of cash flows

 

 

  

Total cash outflow for leases

 

458

 

333

The following table presents the contractual undiscounted cash flows for lease obligations as of March 31, 2023:

As of

In CHF thousands

    

March 31, 2023

Less than one year

 

636

1-3 years

 

1,222

3-5 years

 

1,038

Total

 

2,896

The Company also has deposits in escrow accounts totaling CHF 0.4 million for leases of the Company’s premises as of both March 31, 2023 and December 31, 2022, respectively. These deposits are presented in Long-term financial assets on the Company’s condensed consolidated balance sheets.

7.Accrued expenses

    

As of

In CHF thousands

March 31, 2023

December 31, 2022

Accrued expenses

 

8,653

 

9,417

Total accrued expenses

 

8,653

 

9,417

Accrued expenses consists of accrued R&D costs, accrued payroll expenses and other accrued expenses totaling CHF 8.7 million and CHF 9.4 million as of March 31, 2023 and December 31, 2022, respectively.

8.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 March 31, 2023

As of December 31, 2022

    

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

9


December 31, 2022. As of March 31, 2023, 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, administrative costs and employee social obligations totaling CHF 5.4 million and CHF 4.7 million as of March 31, 2023 and December 31, 2022, 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 March 31, 2023 and December 31, 2022:

    

As of

In CHF thousands

March 31, 2023

    

December 31, 2022

Cash and cash equivalents

 

57,434

 

31,586

Total cash and cash equivalents

 

57,434

 

31,586

    

As of

In CHF thousands

March 31, 2023

    

December 31, 2022

Short-term financial assets due in one year or less

 

48,000

 

91,000

Total short-term financial assets

 

48,000

 

91,000

For the three months ended March 31, 2023, a net amount of CHF 43.0 million in short-term financial assets matured compared to no net maturation in the comparable prior period.

11.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.

As of March 31, 2023 and December 31, 2022, the Company had 6,214,021 treasury shares remaining, respectively.

12.Finance result, net

For the three months ended March 31, 2023 and 2022, AC Immune recorded CHF 0.1 million in net financial gains and less than CHF 0.1 million in net financial losses, respectively.

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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