EX-99.1 2 dp171567_ex9901.htm EXHIBIT 99.1

Exhibit 99.1

 

Condensed Consolidated Balance Sheets (Unaudited)

(in CHF thousands)

 

 

Balance Sheets  Notes 

As of March 31,

2022

 

As of December 31,

2021

ASSETS         
Non-current assets         
Property, plant and equipment    5    4,908    5,116 
Right-of-use assets    6    2,774    2,914 
Intangible asset   8    50,416    50,416 
Long-term financial assets   6    363    363 
Total non-current assets         58,461    58,809 
                
Current assets               
Prepaid expenses    9    2,805    3,015 
Accrued income    3    152    975 
Other current receivables         266    428 
Short-term financial assets    10    116,000    116,000 
Cash and cash equivalents    10    57,835    82,216 
Total current assets         177,058    202,634 
Total assets        235,519    261,443 
                
SHAREHOLDERS’ EQUITY AND LIABILITIES               
                
Shareholders’ equity               
Share capital         1,795    1,794 
Share premium         431,253    431,251 
Treasury shares   11    (124)   (124)
Accumulated losses         (218,793)   (200,942)
Total shareholders’ equity        214,131    231,979 
                
Non-current liabilities               
Long-term lease liabilities   6    2,196    2,340 
Net employee defined benefit liabilities        7,281    7,098 
Total non-current liabilities         9,477    9,438 
                
Current liabilities               
Trade and other payables         501    2,003 
Accrued expenses    7    10,571    16,736 
Deferred income    3    266    717 
Short-term lease liabilities   6    573    570 
Total current liabilities        11,911    20,026 
Total liabilities         21,388    29,464 
Total shareholders’ equity and liabilities         235,519    261,443 

 

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

 

1 

 

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

(in CHF thousands except for share and per share data)

 

      For the Three Months
Ended March 31,
   Notes  2022  2021
Revenue         
Contract revenue   3        
Total revenue            
              
Operating expenses             
Research & development expenses       (15,123)   (13,329)
General & administrative expenses       (4,166)   (4,338)
Other operating income/(expense)   3   459    416 
Total operating expenses       (18,830)   (17,251)
Operating loss      (18,830)   (17,251)
              
Financial income  12        
Financial expense  12   (154)   (26)
Exchange differences  12   140    543 
Finance result, net   12   (14)   517 
              
Loss before tax       (18,844)   (16,734)
Income tax expense      (4)    
Loss for the period       (18,848)   (16,734)
              
Loss per share:  4          
Basic and diluted loss per share for the period attributable to equity holders       (0.23)   (0.23)
              

 

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

 

 

      For the Three Months
ended March 31,
(in CHF thousands)  Note  2022  2021
         
Loss for the period         (18,848)   (16,734)
Items that may be reclassified to income or loss in subsequent periods (net of tax):               
Currency translation differences       10     
Items that will not be reclassified to income or loss in subsequent periods (net of tax):               
Re-measurement losses on defined-benefit plans              
Other comprehensive income/(loss)       10     
Total comprehensive loss, net of tax        (18,838)   (16,734)

 

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

 

2 

 

Condensed Consolidated Statements of Changes in Equity (Unaudited)

(in CHF thousands)

 

 

   Notes  Share
capital
  Share
premium
  Treasury shares  Accumulated losses  Total
Balance as of January 1, 2021       1,538    346,890    (100)   (132,850)   215,478 
Loss for the period                   (16,734)   (16,734)
Other comprehensive income/(loss)                       
Total comprehensive loss                   (16,734)   (16,734)
                            
Share-based payments                   857    857 
Proceeds from sale of treasury shares in public offerings, net of underwriting fees  11       7,937    15        7,952 
Transaction offering costs           (125)             (125)
Issuance of shares, net of transaction costs:                            
restricted share awards       1    39        (47)   (7)
exercise of options           (5)           (5)
Balance as of March 31, 2021       1,539    354,736    (85)   (148,774)   207,416 

 

   Notes  Share
capital
  Share
premium
  Treasury shares  Accumulated losses  Total
Balance as of January 1, 2022       1,794    431,251    (124)   (200,942)   231,979 
Loss for the period                   (18,848)   (18,848)
Other comprehensive income/(loss)                  10    10 
Total comprehensive loss                  (18,838)   (18,838)
                             
Share-based payments                   989    989 
Transaction offering costs                            
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)   (218,793)   214,131 

 

The accompanying notes form 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,
   Notes  2022  2021
Operating activities         
Loss for the period       (18,848)   (16,734)
Adjustments to reconcile net loss for the period to net cash flows:             
Depreciation of property, plant and equipment   5   460    441 
Depreciation of right-of-use assets   6   140    107 
Finance (income)/expense, net   12   (179)   (638)
Share-based compensation expense       989    857 
Change in net employee defined benefit liability       183    155 
Interest expense   12   151    23 
Changes in working capital:             
Decrease in prepaid expenses   9   186    586 
Decrease in accrued income   3   828    810 
Decrease/(increase) in other current receivables       162    (50)
(Decrease) in accrued expenses       (5,128)   (1,449)
(Decrease)/increase in deferred income   3   (459)   368 
(Decrease) in trade and other payables      (1,493)   (1,798)
Cash used in operating activities      (23,008)   (17,322)
Interest income           
Interest paid       (132)   (15)
Finance costs      (3)   (2)
Net cash flows used in operating activities       (23,143)   (17,339)
              
Investing activities             
Purchases of property, plant and equipment   5   (540)   (790)
Net cash flows used in investing activities       (540)   (790)
              
Financing activities             
Principal payments of lease obligations   6   (141)   (108)
Proceeds from sale of treasury shares in public offerings, net of underwriting fees  11       7,952 
Transaction costs on public offerings  11       (125)
Transaction costs associated with issuance of shares      (776)    
Proceeds from issuance of common shares       1    (12)
Net cash flows (used in)/provided by financing activities       (916)   7,707 
              
Net decrease in cash and cash equivalents       (24,599)   (10,422)
              
Cash and cash equivalents at January 1       82,216    160,893 
Exchange gain/(loss) on cash and cash equivalents       218    621 
Cash and cash equivalents at March 31       57,835    151,092 
Net decrease in cash and cash equivalents       (24,599)   (10,422)

  

  Supplemental non-cash activity         
Capital expenditures in Trade and other payables or Accrued expenses   5    15    131 

 

The accompanying notes form 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 registered and organized under the laws of Delaware, USA in June 2021. The Company and its Subsidiary form the Group (See “Note 2. Basis of Preparation”).

 

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, 2022 were authorized for issuance by the Company’s Audit and Finance Committee on April 26, 2022.

 

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, 2022 and for the three months ended March 31, 2022 and 2021, 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, 2021.

 

Basis of measurement

 

These Interim Condensed Consolidated Financial Statements have been prepared under the historical cost convention except for items that are required to be accounted for at fair value.

 

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 March 31
   2022  2021
CHF/USD      
Closing rate, USD 1    0.932     
Weighted average exchange rate, USD 1   0.933     

 

Basis of consolidation

 

The Company wholly owns its Subsidiary and fully consolidates its financial statements into these Interim Condensed Consolidated Financial Statements.

 

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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, (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, 2021.

 

The Company has not adopted any other 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 March 31, 2022, after considering the Company’s cash position of CHF 57.8 million and short-term financial assets of CHF 116.0 million as of March 31, 2022. Hence, the 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 license and collaboration agreements 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. 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.

 

In addition to the foregoing, based on the Company’s current assessment, the Company does not expect any material impact on its long-term development timeline, its liquidity or ability to remain a going concern due to the worldwide spread of the Covid-19 virus. The Company continues to assess the effect on its operations by carefully monitoring the spread of Covid-19 and taking appropriate steps intended to offset any negative impacts from the Covid-19 virus.

 

3.Contract revenues

 

For the three months ended March 31, 2022 and 2021, AC Immune generated no contract revenues. This represents no change.

 

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The following table presents changes in the Company’s contract assets and liabilities during the three months ended March 31, 2022 and 2021:

 

in CHF thousands  Balance at the beginning of the reporting period  Additions  Deductions  Balance at the end of the reporting period
Three months ended March 31, 2022:            
Accrued income    975    164    (987)   152 
Deferred income    717        (451)   266 

 

Three months ended March 31, 2021:            
Accrued income    1,591    781    (1,591)   781 
Deferred income    306    781    (414)   673 

 

During the three months ended March 31, 2022 and 2021, the Company did not recognize contract revenues as a result of changes in the contract asset and the contract liability balances in the respective periods nor from performance obligations satisfied in previous periods.

 

  3.1 Licensing and collaboration agreements

 

For a discussion of our licensing and collaboration agreements for the fiscal year ended December 31, 2021, please refer to Note 13.1 “Licensing and Collaboration agreements” of our Annual Report on Form 20-F for the year ended December 31, 2021 filed on March 22, 2022.

 

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, 2022.

 

  3.2 Grant 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, 2021, please refer to Note 13.2 “Grant Income” of our Annual Report on Form 20-F for the year ended December 31, 2021 filed on March 22, 2022.

 

For the three months ended March 31, 2022 and 2021, the Company has recognized CHF 0.4 million and CHF 0.4 million in grant income, respectively. As of March 31, 2022, the Company has recorded CHF 0.2 million as deferred income.

 

Grant from the Target ALS Foundation

 

In Q1 2021, AC Immune was awarded a USD 0.3 (CHF 0.2) million grant from the Target ALS Foundation (“Target ALS”). This grant funds a collaboration between the Company and the Investigators at the Healey Center for ALS at Massachusetts General Hospital (“MGH”) to accelerate the development of the Company’s proprietary immunoassays to detect disease-associated forms of TDP-43 in CSF and blood samples.

 

For the three months ended March 31, 2022 and 2021, the Company recognized less than CHF 0.1 million, respectively. As of March 31, 2022, the Company recorded CHF 0.1 million in accrued income and CHF 0.1 million in deferred income, respectively.

 

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4. Loss per share

 

   For the Three Months
March 31,
in CHF thousands except for share and per share data  2022  2021
Loss per share (EPS)      
Numerator      
Net loss attributable to equity holders of the Company    (18,848)   (16,734)
Denominator          
Weighted-average number of shares outstanding used to compute EPS basic and diluted attributable to equity holders   83,486,354    72,305,949 
Basic and diluted loss per share for the period attributable to equity holders   (0.23)   (0.23)

 

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,
   2022  2021
Share options issued and outstanding    199,636    1,180,778 
Restricted share awards subject to future vesting    521    14,711 

 

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, 2022:

 

   As of March 31, 2022
in CHF thousands  Furniture  IT Equipment  Lab Equipment  Leasehold Improvements  Assets Under Construction  Total
Acquisition Cost                              
Balance at December 31, 2021   263    1,756    9,142    810    695    12,666 
Additions   3    38    173    2    36    252 
Transfers        4    17    8    (29)    
Balance at March 31, 2022   266    1,798    9,332    820    702    12,918 
                               
Accumulated depreciation                              
Balance at December 31, 2021   (106)   (1,316)   (5,739)   (389)       (7,550)
Depreciation expense   (13)   (72)   (339)   (36)       (460)
Balance at March 31, 2022   (119)   (1,388)   (6,078)   (425)       (8,010)
                               
Carrying Amount                              
December 31, 2021    157    440    3,403    421    695    5,116 
March 31, 2022    147    410    3,254    395    702    4,908 

 

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, 2021, with CHF 0.2 million invested in lab equipment, including the expansion of our leased lab space, and IT equipment, representing an increase of 1.9% from the beginning of the year in these categories.

 

6.Right-of-use assets and lease liabilities

 

AC Immune recognized no additions for its right-of-use of leased assets for the three months ended March 31, 2022.

 

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 2.5% 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, 2022:

 

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in CHF thousands  Buildings  Office Equipment  IT
Equipment
  Total
Balance as of December 31, 2021   2,776    98    40    2,914 
Depreciation   (131)   (6)   (3)   (140)
Balance as of March 31, 2022   2,645    92    37    2,774 

 

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 months ended March 31, 2022, and 2021, the impact on the Company’s consolidated statements of income/(loss) and consolidated statements of cash flows is as follows:

 

  

For the Three Months

Ended March 31,

in CHF thousands  2022  2021
Consolidated statements of income/(loss)      
Depreciation of right-of-use assets   140    107 
Interest expense on lease liabilities   18    14 
Expense for short-term leases and leases of low value   174    187 
Total   332    308 
           
Consolidated statements of cash flows          
Total cash outflow for leases   333    308 

 

The following table presents the contractual undiscounted cash flows for lease obligations as of March 31, 2022:

 

in CHF thousands 

As of

March 31, 2022

Less than one year    638 
1-3 years    1,253 
3-5 years    1,052 
Total    2,943 

 

The Company also has deposits in escrow accounts totaling CHF 0.4 million for leases of the Company’s premises as of March 31, 2022 and December 31, 2021, 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, 2022   December 31, 2021
Accrued Expenses 10,571   16,736
Total 10,571   16,736

 

The Company paid CHF 3.7 million in the period for a previous accrual associated with our cost sharing arrangement with Janssen and CHF 2.3 million related to performance-related remuneration for the three months ended March 31, 2022.

 

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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, 2022  As of December 31, 2021
In CHF thousands  Gross Carrying Amount  Accumulated Amortization  Net Book Value  Gross Carrying Amount  Accumulated Amortization  Net Book 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 not determined the IPR&D asset to be impaired as of March 31, 2022.

 

9.Prepaid expenses

 

Prepaid expenses include prepaid R&D costs, administrative and insurance costs totaled CHF 2.8 million and CHF 3.0 million as of March 31, 2022 and December 31, 2021, 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, 2022 and December 31, 2021:

 

   As of
in CHF thousands  March 31, 2022  December 31, 2021
Cash and cash equivalents   57,835    82,216 
Total    57,835    82,216 

 

 

   As of
in CHF thousands  March 31, 2022  December 31, 2021
Short-term financial assets due in one year or less    116,000    116,000 
Total    116,000    116,000 

 

11. Treasury shares

 

For a discussion of our at the market offering program with Jefferies LLC for the fiscal year ended December 31, 2021, please refer to Note 11 “Share capital” of our Annual Report on Form 20-F for the year ended December 31, 2021 filed on March 22, 2022.

 

As of March 31, 2022, the Company has 6,221,617 treasury shares remaining.

 

12.Finance result, net

 

For the three months ended March 31, 2022 and 2021, AC Immune recorded less than CHF 0.1 million in net financial losses and CHF 0.5 million in net financial gains, respectively. The Company recorded CHF 0.1 million and CHF 0.5 million in foreign currency gains in the respective periods. Finally, the Company recorded CHF 0.2 million and less than CHF 0.1 million in interest expense in the respective periods.

 

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

 

10 

 

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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