ACIU AC Immune SA

7.06
+0.21  (+3%)
Previous Close 6.85
Open 6.8
52 Week Low 4.07
52 Week High 10.14
Market Cap $507,327,583
Shares 71,859,431
Float 27,016,816
Enterprise Value $202,692,393
Volume 41,859
Av. Daily Volume 84,987
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Upcoming Catalysts

Drug Stage Catalyst Date
ACI-35.030
Alzheimer’s Disease
Phase 1/2
Phase 1/2
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Semorinemab (Anti-Tau RO7105705)
Alzheimer’s disease
Phase 2
Phase 2
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ACI-3024
Alzheimer’s disease
Phase 1
Phase 1
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ACI-24
Alzheimer’s disease (AD)
Phase 2
Phase 2
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ACI-24 (anti-Abeta vaccine)
Alzheimer's disease-like characteristics in individuals with Down syndrome
Phase 1b
Phase 1b
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Drug Pipeline

Drug Stage Notes
MTAU9937A
Alzheimer’s disease
Phase 2
Phase 2
Phase 2 trial initiation announced February 20, 2019.
Crenezumab - CREAD 2
Alzheimer’s disease
Phase 3
Phase 3
Phase 3 trial terminated following interim analysis indicating primary endpoint would not be met.
Crenezumab - CREAD 1
Alzheimer’s disease
Phase 3
Phase 3
Phase 3 trial terminated following interim analysis indicating primary endpoint would not be met.

Latest News

  1. LAUSANNE, Switzerland, June 26, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, announced AC Immune shareholders approved all of the resolutions as proposed by the Board of Directors at today's Annual General Meeting (AGM) in Lausanne.

    At the AGM, shareholders re-elected Douglas Williams, Martin Velasco, Peter Bollmann, Andrea Pfeifer, Thomas Graney, Werner Lanthaler and Roy Twyman to their positions on the Board of Directors. Douglas Williams and Martin Velasco will continue to serve as Chairman and Vice-Chairman of the Board, respectively.

    Douglas Williams, Chairman of the Board, said: "The Company is gathering momentum…

    LAUSANNE, Switzerland, June 26, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, announced AC Immune shareholders approved all of the resolutions as proposed by the Board of Directors at today's Annual General Meeting (AGM) in Lausanne.



    At the AGM, shareholders re-elected Douglas Williams, Martin Velasco, Peter Bollmann, Andrea Pfeifer, Thomas Graney, Werner Lanthaler and Roy Twyman to their positions on the Board of Directors. Douglas Williams and Martin Velasco will continue to serve as Chairman and Vice-Chairman of the Board, respectively.



    Douglas Williams, Chairman of the Board, said: "The Company is gathering momentum on the back of strong progress, and we remain on track to meet multiple value-creating milestones this year with five clinical readouts expected in 2020. We are especially excited about the Phase 2 trial evaluating our anti-Tau antibody semorinemab in Alzheimer's disease. The primary completion of the trial is expected soon and we expect top line data in the second half of 2020.



    We are also extremely pleased to report AC Immune's solid financial position, with operations fully funded through at least Q1 2024."



    AC Immune has always maintained a robust business continuity plan. During the Covid-19 outbreak, every provision has been made to protect the health of patients, staff and investigators, as well as the productivity and integrity of our clinical development. Importantly, we currently remain on track to deliver all clinical and preclinical readouts expected in 2020. The Swiss Government's management of Covid-19 means that businesses have been able to return to near normal working practices with all AC Immune staff now back on site in Lausanne.



    As part of its efforts to ensure stakeholder safety during the Covid-19 outbreak, AC Immune held only the mandatory part of the AGM as stipulated by Swiss law and by the Company's Articles of Association. Voting took place via the independent proxy.



    About AC Immune SA

    AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in precision medicine for neurodegenerative diseases. The Company utilizes two proprietary platforms, SupraAntigenTM and MorphomerTM, to design, discover and develop small molecule and biological therapeutics as well as diagnostic products intended to diagnose, prevent and modify neurodegenerative diseases caused by misfolding proteins. The Company's pipeline features nine therapeutic and three diagnostic product candidates, with six currently in clinical trials. It has collaborations with major pharmaceutical companies including Roche/Genentech, Eli Lilly and Company and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations

    Joshua Drumm, Ph.D.

    AC Immune

    Phone: +1 917 809 0814

    Email:



     
    US Media

    Katie Gallagher

    LaVoieHealthScience

    Phone: +1 617 792 3937

    Email:



     
    Global Head of Communications

    Judith Moore

    AC Immune

    Phone: +41 79 826 63 82

    Email:



     
    European Investors & Media

    Chris Maggos

    LifeSci Advisors

    Phone: +41 79 367 6254

    Email:



     

    Forward looking statements

    This press release contains statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions "Item 3. Key Information – Risk Factors" and "Item 5. Operating and Financial Review and Prospects" in AC Immune's Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

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  2. LAUSANNE, Switzerland, May 15, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that it will showcase key programs focused on novel targets in neurodegenerative diseases at next week's UBS Virtual Global Healthcare Conference (May 18–20, 2020).

    Speaking on May 20th, Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune SA, will outline the cutting-edge science behind AC Immune's therapeutic and diagnostic programs in TDP-43 and alpha-synuclein – which are amongst the most comprehensive in the field. Both targets are considered to be major pathologies in neurodegenerative diseases, and increasingly thought to be important…

    LAUSANNE, Switzerland, May 15, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced that it will showcase key programs focused on novel targets in neurodegenerative diseases at next week's UBS Virtual Global Healthcare Conference (May 18–20, 2020).

    Speaking on May 20th, Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune SA, will outline the cutting-edge science behind AC Immune's therapeutic and diagnostic programs in TDP-43 and alpha-synuclein – which are amongst the most comprehensive in the field. Both targets are considered to be major pathologies in neurodegenerative diseases, and increasingly thought to be important co-pathologies in Alzheimer's disease and Parkinson's disease.  This highlights the need for the precision medicine approach pioneered by AC Immune to achieve earlier and more accurate diagnosis. 

    In addition to the Company's TDP-43 and alpha-synuclein targeting programs, the presentation will also detail advances for the clinical stage assets addressing the well-established pathophysiology mediated by Tau and Abeta. The critical role of the Company's two proprietary platforms, SupraAntigen™ and Morphomer™, in fueling advances for antibodies and small molecules, respectively, will also be highlighted.

    UBS Virtual Global Healthcare Conference
    Date: May 20, 2020 | 9:10–10:00 am ET/ 3:10–4:00 pm CET
    Format: Virtual presentation
    Presenter: Prof. Andrea Pfeifer, CEO, AC Immune SA

    A webcast of the presentation will be available on the Events Page of AC Immune's website.

    About AC Immune SA
    AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in precision medicine for neurodegenerative diseases. The Company utilizes two proprietary platforms, SupraAntigen™ and Morphomer™, to design, discover and develop small molecule and biological therapeutics as well as diagnostic products intended to diagnose, prevent and modify neurodegenerative diseases caused by misfolding proteins. The Company's pipeline features nine therapeutic and three diagnostic product candidates, with six currently in clinical trials. It has collaborations with major pharmaceutical companies including Roche/Genentech, Eli Lilly and Company and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations
    Joshua Drumm, Ph.D.
    AC Immune
    Phone: +1 917 809 0814
    Email:
    US Media
    Katie Gallagher
    LaVoieHealthScience
    Phone: +1 617 792 3937
    Email:
       
    Global Head of Communications
    Judith Moore
    AC Immune
    Phone: +41 79 826 63 82
    Email:
    European Investors & Media
    Chris Maggos
    LifeSci Advisors
    Phone: +41 79 367 6254
    Email:

    Forward looking statements

    This press release contains statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions "Item 3. Key Information – Risk Factors" and "Item 5. Operating and Financial Review and Prospects" in AC Immune's Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

     

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    • On track to meet the five clinical milestones expected in 2020 with no modifying guidance as a result of Covid-19

    • Ongoing strong financial position with CHF 277.9 million in cash, ensuring the Company is fully financed through Q1 2024, excluding potential incoming milestones

    • Added new potential CHF 60 million Phase 2 initiation milestone for the small molecule Morphomer™ Tau aggregation inhibitor program and received CHF 10 million milestone in Q1 2020 in Lilly partnership

    • Advanced a lead anti-alpha-synuclein therapeutic antibody candidate into preclinical development based on new proof-of-concept data presented at AAT-AD/PDTM

    LAUSANNE, Switzerland, May 04, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage…

    • On track to meet the five clinical milestones expected in 2020 with no modifying guidance as a result of Covid-19

    • Ongoing strong financial position with CHF 277.9 million in cash, ensuring the Company is fully financed through Q1 2024, excluding potential incoming milestones

    • Added new potential CHF 60 million Phase 2 initiation milestone for the small molecule Morphomer™ Tau aggregation inhibitor program and received CHF 10 million milestone in Q1 2020 in Lilly partnership

    • Advanced a lead anti-alpha-synuclein therapeutic antibody candidate into preclinical development based on new proof-of-concept data presented at AAT-AD/PDTM

    LAUSANNE, Switzerland, May 04, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced financial results for the first quarter ended March 31, 2020 and provided a business and 2020 research and development update.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "AC Immune has had a strong start to 2020. We received a second milestone payment and expanded our transformative agreement with Eli Lilly and Company, further reinforcing our position as one of the most influential biotechnology companies targeting neurodegenerative diseases.

    "With increasing recognition that precision medicine is likely to be the best way to address the complexity of neurodegenerative disease (NDD) pathology, one of AC Immune's key strengths is our diversified approach. New proof-of-concept data presented at this year's AAT-AD/PDTM reflects that alongside programs advancing on well-established targets like Tau and Abeta, we are also focused on novel targets and mechanisms. Our TDP-43 and alpha-synuclein therapeutic and diagnostic programs are amongst the most advanced in the field, as it becomes clear that co-pathologies in AD and NDD are an important element in the route to a cure.

    "We continue to believe that 2020 will be an important and eventful year for AC Immune and for the entire field of neurodegenerative diseases, despite the challenges posed by the Covid-19 pandemic. Our continued strong cash position of CHF 277.9 million provides a solid foundation with the Company being fully financed through at least Q1 2024. And we remain on track to meet multiple value-creating milestones this year, with five clinical readouts, including the first Phase 2 proof-of-concept data for semorinemab, an anti-Tau antibody, through our partnership with Genentech, a member of the Roche group."

    Q1 2020 Research & Development Highlights:

    • Presented new preclinical data at the first ever online AAT-AD/PD™ Focus, describing proof-of-concept data for lead candidates in AC Immune's therapeutic and diagnostic programs targeting TDP-43 and alpha-synuclein. These pathological proteins represent targets of increasing interest for the treatment of neurodegenerative diseases, and AC Immune's programs are amongst the most advanced in the field
    • Dr. Juan Fortea, an internationally renowned neurologist with a specific focus in the emerging field of Down syndrome-related Alzheimer's disease, joined AC Immune's Clinical Advisory Board (CAB)
    • Received a second milestone payment of CHF 10 million from Lilly related to development progress in the small molecule Morphomer™ Tau aggregation inhibitor program. Under updated collaboration terms, AC Immune is now eligible for a new additional milestone payment of CHF 60 million within 60 days after dosing of the first patient in the first Phase 2 clinical trial of a Morphomer™ Tau in the United States or European Union. The amendment to the financial terms increases the total deal value by CHF 40 million to CHF 1.86 billion, up from CHF 1.82 billion

    2020 Research & Development Outlook
    The coming years will be transformational for the field of neuroscience and AC Immune is poised to make significant clinical contributions, capturing substantial interest and value in 2020 and beyond. The Company expects to deliver multiple near-term catalysts, including results from five clinical trials in 2020. The Company's sustained growth is being fueled by its proprietary discovery platforms, SupraAntigen™ and Morphomer™, and driven by its industry-leading strategy, summarized in AC Immune's Roadmap to Successful Therapies for Neurodegenerative Diseases.

    2020 Clinical Readouts

    • Semorinemab, anti-Tau antibody: Phase 2 trial primary completion (estimated last patient, last visit) in prodromal/mild in Q2
    • ACI-24 anti-Abeta vaccine in Down syndrome (DS): Phase 1b full study reporting in H2
    • ACI-35.030 anti-pTau vaccine: Phase 1b/2a in AD interim analysis in Q2
    • ACI-3024 small molecule Morphomer™ Tau aggregation inhibitor: Phase 1 results in healthy volunteers in Q2; data disclosed by Lilly in H2 (expected)
    • ACI-24 in AD: Phase 2, 12-month interim analysis in H2

    2020 Preclinical Milestones

    • Alpha-synuclein antibody: started investigational new drug (IND)-enabling studies for lead candidate in Q1 (achieved)
    • Anti-TDP-43 antibody: declare clinical lead and start IND-enabling studies in Q2
    • Alpha-synuclein small molecule: identify first biologically active small molecule in Q2
    • Alpha-synuclein imaging agent: advance third generation candidate to clinical stage in Q4
    • Neuroinflammation: declare lead candidates for small molecule and antibody programs in Q4

    Update on Covid-19
    AC Immune has always maintained a robust business continuity plan. During the Covid-19 outbreak, every provision is being made to protect the health of patients, staff and investigators, as well as the productivity and integrity of our clinical development. Importantly, the Company currently remains on track to deliver the five clinical readouts expected in 2020, owing largely to the fact that many of the Company's key trials are already fully enrolled, and patient follow up is continuing virtually. AC Immune notes the following additional considerations related to Covid-19:

    • The 12-month interim data analysis for ACI-24 in AD will proceed as planned on a reduced patient data-set

    • Plans to initiate a Phase 2 study of ACI-24 in DS in the second half of 2020 are progressing and will be initiated in line with public health guidance at that time 

    • Dosing of participants in the Phase 2 Colombian Alzheimer's disease prevention initiative (API) study has been temporarily interrupted by the countrywide stay at home order. While the ultimate duration of the dosing interruption is not yet known, participants are receiving crenezumab or placebo for at least five years as part of the long-term prevention study, and we continue to expect data from the study in 2022

    There are positive signs that countries, including Switzerland, are beginning to ease restrictions. AC Immune remains in continuous contact with its partners and other important stakeholders, including the Swiss government, trial investigators and contractors. At this stage the Company is not modifying guidance with respect to the multiple clinical and preclinical data readouts anticipated this year. AC Immune will keep the market apprised of any new developments or information that may impact clinical timelines.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, concluded: "With the support of our highly respected investors and partners as well as our strong balance sheet, AC Immune is in an excellent position to deliver on these exciting plans and make a significant difference for patients with neurodegenerative diseases."

    Analysis of Financial Statements for the Three Months Ended March 31, 2020

    • Revenues: Revenues for the three months ended March 31, 2020 totaled CHF 12.4 million. This represents a CHF 62.6 million decrease compared to the three months ended March 31, 2019. The decrease predominantly relates to CHF 73.9 million recognized in the prior period associated with our license agreement with Lilly offset by a recognition of the CHF 10 million milestone payment and CHF 2.1 million for research and development activities performed in the current period
    • R&D Expenditures: R&D expenses increased by CHF 3.6 million to CHF 15.2 million for the three months ended March 31, 2020 compared to the prior period. Of this increase, CHF 2.4 million relates to increases in R&D expenses directly allocated to R&D programs such as a CHF 1.3 million increase related to scaling up activities for the Phase 2 clinical trial for ACI-24 in DS and a CHF 1.0 million increase for certain Phase 1 clinical activities completed for our lead MorphomerTM Tau compound. Additionally, personnel costs increased by CHF 0.6 million through the addition of 15 FTEs with remaining increases of CHF 0.6 million in regulatory and quality assurance and other unallocated research and development costs
    • G&A Expenses: For the three months ended March 31, 2020, G&A increased CHF 1.2 million to CHF 4.5 million. Increases were driven by the addition of seven FTEs as well as an increase in administrative and depreciation expenses
    • IFRS (Loss)/Income for the period: The Company recorded a net loss after taxes of CHF 7.7 million for the three months ended March 31, 2020, compared with net income after taxes of CHF 63.6 million for the prior period
    • Cash Position: The Company had a total cash balance of CHF 277.9 million, comprised of CHF 182.9 million in cash and cash equivalents and CHF 95 million in short-term financial assets. This compares to a total cash balance of CHF 288.6 million as of December 31, 2019. This decrease of CHF 10.7 million is principally due to the factors noted above in the income statement which resulted in a CHF 7.7 million net loss for the period and changes in our working capital. Further details are available in our Statements of Cash Flows on the accompanying Form 6-K

    About AC Immune SA
    AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in precision medicine for neurodegenerative diseases. The Company utilizes two proprietary platforms, SupraAntigenTM and MorphomerTM, to design, discover and develop small molecule and biological therapeutics as well as diagnostic products intended to diagnose, prevent and modify neurodegenerative diseases caused by misfolding proteins. The Company's pipeline features nine therapeutic and three diagnostic product candidates, with six currently in clinical trials. It has collaborations with major pharmaceutical companies including Roche/Genentech, Lilly and Janssen Pharmaceuticals.

    For further information, please contact:

    Head of Investor Relations
    Joshua Drumm
    AC Immune
    Phone: +1 917 809 0814
    Email:
    US Media
    Katie Gallagher
    LaVoieHealthScience
    Phone: +1 617 792 3937
    Email:  
       
    Global Head of Communications
    Judith Moore
    AC Immune
    Phone: +41 79 826 63 82
    Email:
    European Investors & Media
    Chris Maggos
    LifeSci Advisors
    Phone: +41 79 367 6254
    Email:

    Forward looking statements

    This press release contains statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions "Item 3. Key Information – Risk Factors" and "Item 5. Operating and Financial Review and Prospects" in AC Immune's Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

    Balance Sheets
    (in CHF thousands)

           
      As of March 31,
    2020
      As of March 31,
    2019
    ASSETS      
    Non-current assets      
    Property, plant and equipment  3,761     3,917  
    Right-of-use assets  2,147     2,255  
    Long-term financial assets 304     304  
    Total non-current assets  6,212     6,476  
           
    Current assets      
    Prepaid expenses  3,419     2,788  
    Accrued income  190     1,095  
    Other current receivables  551     304  
    Short-term financial assets  95,000     95,000  
    Cash and cash equivalents  182,860     193,587  
    Total current assets  282,020     292,774  
    Total assets 288,232     299,250  
           
    SHAREHOLDERS' EQUITY AND LIABILITIES      
           
    Shareholders' equity      
    Share capital  1,437     1,437  
    Share premium  346,568     346,526  
    Accumulated losses  (82,404 )   (75,521 )
    Total shareholders' equity 265,601     272,442  
           
    Non-current liabilities      
    Long-term lease liabilities  1,713     1,813  
    Net employee defined benefit liabilities  7,666     7,485  
    Total non-current liabilities  9,379     9,298  
           
    Current liabilities      
    Trade and other payables  760     142  
    Accrued expenses  9,155     11,797  
    Short-term deferred income  2,452     4,477  
    Short-term financing obligation  324     652  
    Short-term lease liabilities 435     442  
    Other short-term liabilities  126      
    Total current liabilities 13,252     17,510  
    Total liabilities  22,631     26,808  
    Total shareholders' equity and liabilities  288,232     299,250  
               

    Statements of Income/(Loss)
    (in CHF thousands except for share and per share data)

       
      For the Three Months
    Ended March 31,
      2020   2019 
    Revenue      
    Contract revenue  12,411     75,042  
    Total revenue  12,411     75,042  
             
    Operating expenses        
    Research & development expenses  (15,209 )   (11,592 )
    General & administrative expenses  (4,504 )   (3,294 )
    Total operating expenses  (19,713 )   (14,886 )
    Operating income/(loss)  (7,302 )   60,156  
             
    Finance expense, net  (393 )   (80 )
    Change in fair value of conversion feature      4,505  
    Interest income  60     89  
    Interest expense  (54 )   (1,096 )
    Finance result, net  (387 )   3,418  
             
    Income/(loss) before tax  (7,689 )   63,574  
    Income tax expense      
    Income/(loss) for the period  (7,689 )   63,574  
             
    Earnings/(loss) per share (EPS):        
               
    Basic income/(loss) for the period attributable to equity holders  (0.11 )   0.94  
               
    Diluted income/(loss) for the period attributable to equity holders  (0.11 )   0.91  
               


    Statements of Comprehensive Income/(Loss) For the Three Months
    Ended March 31,
    (in CHF thousands)  2020     2019  
             
    Income/(loss) for the period  (7,689 )   63,574  
    Other comprehensive income/(loss) not to be reclassified to income or loss in subsequent periods (net of tax):        
    Re-measurement losses on defined benefit plans       
    Total comprehensive income/(loss), net of tax  (7,689 )   63,574  
               

    Reconciliation of Income/(Loss) to Adjusted Income/(Loss) and
    Earnings/(Loss) Per Share to Adjusted Earnings/(Loss) Per Share

       
      For the Three Months
    Ended March 31,
      2020   2019
    (in CHF thousands except for share and per share data)  
    Income/(Loss)  (7,689 )   63,574  
    Adjustments:          
    Non-cash share-based payments (a)  852     584  
    Foreign currency losses (b)  454     45  
    Effective interest expense (c)  54     991  
    Change in fair value of conversion feature (d)      (4,505 )
    Adjusted Income/(Loss)  (6,329 )   60,689  
               
    Earnings/(Loss) per share – basic  (0.11 )   0.94  
    Earnings/(Loss) per share – diluted  (0.11 )   0.91  
    Adjustment to earnings/(loss) per share – basic  0.02     (0.05 )
    Adjustment to earnings/(loss) per share – diluted  0.02     (0.06 )
    Adjusted earnings/(loss) per share – basic  (0.09 )   0.89  
    Adjusted earnings/(loss) per share – diluted  (0.09 )   0.85  
    Weighted-average number of shares outstanding Adjusted earnings/(loss)–basic 71,864,213     67,922,939  
    Weighted-average number of shares outstanding Adjusted earnings/(loss)–diluted  71,882,607     71,276,000  
    1. Reflects non-cash expenses associated with share-based compensation for equity awards issued to Directors, Management and employees of the Company. This expense reflects the awards' fair value recognized for the portion of the equity award which is vesting over the period.

    2. Reflects foreign currency remeasurement gains and losses for the period, predominantly impacted by the change in the exchange rate between the US Dollar and the Swiss Franc.

    3. Effective interest expense for the period relates to the accretion of the Company's convertible loan in accordance with the effective interest method.

    4. Change in fair value of conversion feature that is bifurcated from the convertible loan host debt with Lilly.

    Adjustments for the three months ended March 31, 2020 and March 31, 2019 were CHF 1.3 million in net losses and CHF 2.9 million in net gains, respectively. The Company recorded CHF 0.9 million for the three months, respectively, for share-based compensation expenses. There were foreign currency remeasurement losses of CHF 0.5 million and less than CHF 0.1 million, respectively, predominantly related to the increased foreign currency cash balance of the Company and movement in our forward contract. In Q1 2019, the Company recorded CHF 1.0 million for amortization of effective interest and recognized a CHF 4.5 million gain for the change in fair value of the liability related to the conversion feature. These were not repeated in the current period.

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  3. Seven presentations by AC Immune and its partners at AAT-AD/PD™

    New data on early-stage TDP-43 and alpha-synuclein therapeutic and diagnostic candidates

     A lead anti-alpha-synuclein therapeutic antibody candidate has advanced into preclinical development to treat Parkinson's disease and other synucleinopathies

    LAUSANNE, Switzerland, April 02, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company today outlined new preclinical data that will be presented at this year's first ever online AAT-AD/PD™ Focus Meeting from April 2–5, 2020. The presentations describe proof-of-concept preclinical data for lead candidates in AC Immune's therapeutic and diagnostic programs targeting TDP-43 and alpha-synuclein…

    Seven presentations by AC Immune and its partners at AAT-AD/PD™

    New data on early-stage TDP-43 and alpha-synuclein therapeutic and diagnostic candidates

     A lead anti-alpha-synuclein therapeutic antibody candidate has advanced into preclinical development to treat Parkinson's disease and other synucleinopathies

    LAUSANNE, Switzerland, April 02, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company today outlined new preclinical data that will be presented at this year's first ever online AAT-AD/PD™ Focus Meeting from April 2–5, 2020. The presentations describe proof-of-concept preclinical data for lead candidates in AC Immune's therapeutic and diagnostic programs targeting TDP-43 and alpha-synuclein. These pathological proteins represent targets of increasing interest for the treatment of neurodegenerative diseases, and AC Immune's programs are amongst the most advanced in the field.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "Our heritage as a leader in delivering cutting-edge science and our strong cash position provides the foundation to continue advancing data on novel targets for neurodegenerative diseases. The aggregation of pathological forms of TDP-43 and alpha-synuclein proteins are hallmarks of numerous neurodegenerative diseases, including neuroOrphan indications such as frontotemporal lobar degeneration, amyotrophic lateral sclerosis and multiple system atrophy. As novel therapeutic targets in Alzheimer's disease (AD), it has been shown that patients with a high degree of Abeta and Tau pathologies also show a high level of alpha-synuclein and/or TDP-43 co-pathology."

    Prof. Pfeifer continued: "The prevalence of co-pathologies in AD and other neurodegenerative diseases highlights the need for the precision medicine pioneered by AC Immune and the opportunity for earlier and more accurate diagnosis.  As one of the most advanced programs targeting TDP-43, with in vivo proof-of-concept data, we intend to develop our antibody candidate in a neuroOrphan indication. Leading the way in developing the first TDP-43 positron emission tomography (PET) imaging agent, we hope to improve the timing and accuracy of diagnoses in neurodegenerative disease, representing our complementary diagnostics portfolio."

    TDP-43 and alpha-synuclein pathologies have been shown to start from a focal point in the brain and progressively spread to other brain regions with disease progression. Antibody-mediated clearance of pathological TDP-43 and alpha-synuclein represent attractive strategies for therapeutic intervention. Availability of non-invasive tools like PET imaging agents would allow accurate diagnosis and monitoring of disease progression, and would potentially enable longitudinal drug efficacy measurements in patients.

    The three preclinical studies that will be presented at AAT-AD/PD™ illustrate how AC Immune continues to leverage its proprietary technology platforms, SupraAntigen™ and Morphomer™ to develop product candidates against pathologies associated with TDP-43 and alpha-synuclein.

    Anti-TDP-43 antibody

    Data to be presented for the first time, shows that the Company's lead TDP-43 antibody candidate mitigated TDP-43 neuropathology in a mouse model of TDP-43 proteinopathies. The unique pool of TDP-43 antibodies generated by AC Immune's proprietary SupraAntigen™ platform also allowed development of highly sensitive assays for detection and quantification of total and disease-specific TDP-43 isoforms in biofluids with the potential for clinical biomarker evaluation.

    Morphomer™ TDP-43 imaging

    Data for a first in class TDP-43 PET tracer will illustrate how the lead candidate was identified and optimized. The lead candidate, generated using the proprietary Morphomer™ platform, demonstrates binding to brain-derived pathological TDP-43 aggregates with high affinity and, importantly, direct target engagement on patient brain tissue.

    Anti-alpha-synuclein antibody

    Using the SupraAntigen™ platform, antibodies with high-affinity for aggregated alpha-synuclein have been developed which prevent the intercellular spreading of toxic alpha-synuclein species. Data, presented for the first time, demonstrate that lead candidate antibodies reduce the de novo formation of alpha-synuclein aggregates in vitro and significantly decrease spreading of alpha-synuclein pathology in a mouse model of human disease. A lead therapeutic candidate has been advanced into preclinical development to treat Parkinson's disease and other synucleinopathies.

    Prof. Pfeifer added: "AC Immune continues to deliver on its Roadmap to Successful Therapies for Neurodegenerative Diseases, enabling precision medicine by selecting clinical study populations based on the presence of the underlying proteinopathies."

    AAT-AD/PD™ features seven presentations by AC Immune and its partners:

    • Exploratory analysis of biomarker data from Phase 2/3 crenezumab studies using the neurotoolkit assay panel
      Date: April 2, 2020 | 11:40 – 12:00 am CET
      Presenter: Oral presentation Christina Rabe (Roche program)

    • 18F-PI2620 Tau-PET for assessment of heterogeneous neuropathology in corticobasal syndrome
      Date: April 2, 2020 | 12:40 – 1:00 pm CET
      Presenter: Oral presentation by Carla Palleis (Life Molecular Imaging program)

    • Development of ACI-35.030, a second generation anti-phospho tau vaccine, in clinical evaluation for the treatment of Alzheimer's disease
      Date: April 2, 2020 | 6:15 – 6:35 pm CET
      Presenter: Oral presentation by Marija Vukicevic
    • Monoclonal antibody targeting TDP-43 mitigates associated neuropathology in mouse model of TDP-43 proteinopathy
      Date: April 3, 2020 | 3:10 – 3:30 pm CET
      Presenter: Oral presentation Tariq Afroz

    • Discovery and optimization of candidates for molecular imaging of TDP-43 proteinopathies
      Date: April 3, 2020 | 9:29 – 9:35 am CET
      Presenter: Short oral poster presentation by Tariq Afroz

    • 18F-PI-2620 Tau PET is associated with beta-amyloid in MCI or mild-AD dementia subjects from the elenbecestat Mission AD program
      Date: April 3, 2020 | 5:50 – 6:10 pm CET
      Presenter: Oral presentation Andrew Stephens (Life Molecular Imaging program)

    • Targeting spreading of pathological alpha-synuclein to treat Parkinson's disease
      Date: April 5, 2020 | 8:55 – 9:15 am CET
      Presenter: Oral presentation Elpida Tsika

    AC Immune's presentations are available to download from the AAT-AD/PD™ website for those registered to attend the congress.

    About AC Immune SA

    AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in precision medicine for neurodegenerative diseases. The Company utilizes two proprietary platforms, SupraAntigen™ and Morphomer™, to design, discover and develop small molecule and biological therapeutics as well as diagnostic products intended to diagnose, prevent and modify neurodegenerative diseases caused by misfolding proteins. The Company's pipeline features nine therapeutic and three diagnostic product candidates, with six currently in clinical trials. It has collaborations with major pharmaceutical companies including Roche/Genentech, Lilly and Janssen.

    For further information, please contact:

    Head of Investor Relations
    Joshua Drumm
    AC Immune
    Phone: +1 917 809 0814
    Email:

     
    US Media
    Katie Gallagher
    LaVoieHealthScience
    Phone: +1 617 792 3937
    Email:

     
    Global Head of Communications
    Judith Moore
    AC Immune
    Phone: +41 79 826 63 82
    Email:

    European Investors & Media
    Chris Maggos
    LifeSci Advisors
    Phone: +41 79 367 6254
    Email:

    Forward looking statements

    This press release contains statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions "Item 3. Key Information – Risk Factors" and "Item 5. Operating and Financial Review and Prospects" in AC Immune's Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

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    • Ongoing strong financial position with CHF 288.6 million in cash, ensuring the Company is fully financed through Q1 2024, excluding potential incoming milestones

    • Received CHF 110 million in upfront and development milestone payments and a USD 50 million equity note in 2019 as a result of the Morphomer™ Tau Lilly partnership

    • Added new potential CHF 60 million Phase 2 initiation milestone and achieved CHF 10 million milestone in Q1 2020 in Lilly partnership

    • Five clinical milestones expected in 2020 including the first Phase 2 readout of an anti-Tau antibody in Alzheimer's disease (AD)

    • Initiated three clinical trials targeting Tau and a substudy within the ongoing Phase 2 Alzheimer's Prevention Initiative trial

    LAUSANNE, Switzerland, March 30…

    • Ongoing strong financial position with CHF 288.6 million in cash, ensuring the Company is fully financed through Q1 2024, excluding potential incoming milestones

    • Received CHF 110 million in upfront and development milestone payments and a USD 50 million equity note in 2019 as a result of the Morphomer™ Tau Lilly partnership

    • Added new potential CHF 60 million Phase 2 initiation milestone and achieved CHF 10 million milestone in Q1 2020 in Lilly partnership

    • Five clinical milestones expected in 2020 including the first Phase 2 readout of an anti-Tau antibody in Alzheimer's disease (AD)

    • Initiated three clinical trials targeting Tau and a substudy within the ongoing Phase 2 Alzheimer's Prevention Initiative trial

    LAUSANNE, Switzerland, March 30, 2020 (GLOBE NEWSWIRE) -- AC Immune SA (NASDAQ:ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced financial results for the year ended December 31, 2019, and provided a business and 2020 research and development outlook.

    Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "AC Immune is building on clinical and business accomplishments in 2019, and anticipates multiple clinical, value-creating milestones in 2020. We anticipate reporting data from two studies of our proprietary anti-Abeta vaccine program, ACI-24 as well as Phase 1 results for the small molecule Morphomer™ Tau aggregation inhibitor, ACI-3024, in partnership with Eli Lilly and Company.

    Prof. Pfeifer continued: "In parallel, our heritage as a leader in delivering cutting-edge science enables our Company to advance novel preclinical therapeutic and diagnostic candidates focused on emerging targets and neuroinflammation towards the clinic, setting the stage for additional value creation and partnership opportunities. AC Immune's leading position in the field is built upon our proprietary discovery technology platforms, SupraAntigen™ and Morphomer™, as well as our personalized medicine approach and exceptional development execution."

    2019 and Q1 2020 Research & Development Highlights
    Successful execution in preclinical and clinical development during 2019 resulted in a stronger pipeline.

    • A Phase 1 study is ongoing for ACI-3024, a first-in-class investigational oral small molecule Morphomer™ Tau specific aggregation inhibitor that will be studied in neurodegenerative diseases characterized by the presence of pathological Tau aggregates. The initial CHF 60 million milestone payment has been modified such that Lilly has paid AC Immune CHF 30 million during Q3 2019 and CHF 10 million in Q1 2020; and, AC Immune now is eligible for a new additional milestone payment of CHF 60 million within 60 days after dosing of the first patient in the first Phase 2 clinical trial of a Morphomer™ Tau in the United States or European Union. The amendment to the financial terms increases the total deal value by CHF 40 million to CHF 1.86 billion, up from CHF 1.82 billion.
    • Initiation of a second Phase 2 trial of semorinemab in patients with moderate AD, by our collaboration partner Genentech, a member of the Roche Group. This antibody is also being studied in a separate Phase 2 trial in prodromal to mild AD
    • Received a milestone payment from our collaboration partner, Life Molecular Imaging, in connection with the initiation of a Phase 2 study in AD of the Tau positron emission tomography (PET) tracer PI-2620
    • Initiation of a Phase 1b/2a clinical trial in early AD to evaluate the anti-phospho-Tau vaccine, ACI-35.030, which targets pathological Tau and is intended as a disease-modifying treatment for AD and other Tauopathies in collaboration with Janssen Pharmaceuticals, Inc
    • Initiation of a substudy by our partner Genentech, a member of the Roche Group, within the ongoing Phase 2 Alzheimer's Prevention Initiative (API) trial of AC Immune's investigational candidate, crenezumab. This substudy aims to measure Tau burden using PET in order to increase the understanding of disease progression in the preclinical stage of autosomal dominantly inherited AD
    • Presented initial interim data from an on-going Phase 1b trial of the ACI-24 anti-Abeta vaccine to treat Down syndrome (DS)-related AD 
    • Discontinuation by our collaboration partner Roche of the CREAD and CREAD 2 Phase 3 studies of the anti-beta-amyloid antibody, crenezumab, in people with prodromal to mild sporadic AD
    • Established a research collaboration with leading scientists at the Perelman School of Medicine, University of Pennsylvania focused on studying the pathological mechanisms of TDP-43 misfolding and aggregation
    • Awarded a new grant from The Michael J. Fox Foundation (MJFF) for development of AC Immune's pioneering alpha-synuclein PET tracers
    • Hosted two Key Opinion Leader (KOL) events focused on "untangling" Tau pathology as an important therapeutic and diagnostic target for AD and other neurodegenerative diseases, and on treating DS-related AD

    2020 Research & Development Outlook
    The coming years will be transformational for the field of neuroscience and AC Immune is poised to make significant clinical contributions, capturing substantial interest and value in 2020 and beyond.  The Company will deliver multiple near-term catalysts, including results from five clinical trials. The Company's sustained growth is driven by its industry-leading Roadmap to Successful Therapies for Neurodegenerative Diseases, and is fueled by its proprietary technology platforms, SupraAntigen™ and Morphomer™, which continue to generate therapeutic antibody, small molecule and vaccine candidates.

    2020 Clinical Readouts

    • Semorinemab, anti-Tau antibody: Phase 2 trial primary completion (estimated last patient, last visit) in prodromal/mild in Q2
    • ACI-24 anti-Abeta vaccine in DS: Phase 1b full study reporting in H2
    • ACI-35.030 anti-pTau vaccine: Phase 1b/2a in AD interim analysis in Q2
    • ACI-3024 small molecule Morphomer™ Tau aggregation inhibitor: Phase 1 results in healthy volunteers in Q2; data disclosed by partner in H2 (expected)
    • ACI-24 in AD: Phase 2, 12-month interim analysis in H2

    2020 Preclinical Milestones

    • Alpha-synuclein antibody: started investigational new drug (IND)-enabling studies for lead candidate in Q1
    • Anti-TDP-43 antibody: declare clinical lead and start IND-enabling studies in Q2
    • Alpha-synuclein small molecule: identify first biologically active small molecule in Q2
    • Alpha-synuclein imaging agent: advance third generation candidate to clinical stage in Q4
    • Neuroinflammation: declare lead candidates for small molecule and antibody programs in Q4

    Prof. Pfeifer concluded: "In summary, 2020 begins a decade with the potential for major neuroscience advances. With AC Immune's remarkably broad development pipeline focused on neurodegenerative diseases we have multiple opportunities to contribute to the advancement of this field from a business, clinical and human perspective."

    Analysis of Financial Statements for the year ended December 31, 2019

    • Cash Position: The Company had a total cash balance of CHF 288.6 million, comprised of CHF 193.6 million in cash and cash equivalents and CHF 95 million in short-term financial assets. This compares to a total cash balance of CHF 186.5 million as of December 31, 2018. The increase of CHF 102.1 million is principally due to the CHF 80 million upfront payment, USD 50 million convertible equity note and CHF 30 million milestone payment related to the agreement with Lilly. The total shareholders' equity position increased to CHF 272.4 million from CHF 177.6 million as of the prior year. The Company's cash balance provides enough capital resources to progress through at least Q1 2024
    • Revenues: Revenues for the year ended December 31, 2019 totaled CHF 111.0 million. This represents an increase of CHF 103.8 million compared to 2018. The increase for the year end relates to the recognition of CHF 75.7 million from the right-of-use license and research and development activities linked to the 2018 Lilly agreement and a CHF 30 million payment for the first milestone achieved with Lilly. Additionally, the Company recorded a EUR 2 million (CHF 2.2 million) in connection with the initiation of a Phase 2 trial in AD of Tau PET Tracer with Life Molecular Imaging
    • R&D Expenditures: R&D expenses increased by CHF 6.2 million to CHF 50.4 million for the year ended December 31, 2019. Of this increase, CHF 1.7 million relates to increases in R&D expenses directly allocated to R&D programs such as a CHF 0.9 million increase related to higher research, preclinical and manufacturing costs for the lead alpha-synuclein antibody and a CHF 0.7 million increase for manufacturing and preparation of the Phase 2 study for ACI-24 for DS. Additionally, the personnel costs increased by CHF 1.6 million through the addition of 16 FTEs with remaining increases of CHF 2.8 million in the area of consumables, depreciation of R&D equipment and regulatory and quality assurance
    • G&A Expenses: For the year ended December 31, 2019, G&A increased CHF 3.6 million to CHF 16.1 million. Increases were driven by personnel and IT expenses
    • IFRS Income/(Loss) for the period: The Company recorded net income after taxes of CHF 45.4 million for the year ended December 31, 2019, compared with net losses of CHF 50.9 million for 2018

    2020 Financial Guidance
    For the full year 2020, the Company expects its total cash burn to range between CHF 65‒80 million at constant exchange rates.

    About AC Immune SA
    AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in precision medicine for neurodegenerative diseases. The Company utilizes two proprietary platforms, SupraAntigen™ and Morphomer™, to design, discover and develop small molecule and biological therapeutics as well as diagnostic products intended to diagnose, prevent and modify neurodegenerative diseases caused by misfolding proteins. The Company's pipeline features nine therapeutic and three diagnostic product candidates, with six currently in clinical trials. It has collaborations with major pharmaceutical companies including Roche/Genentech, Lilly and Janssen.

    For further information, please contact:

    Head of Investor Relations
    Joshua Drumm
    AC Immune
    Phone: +1 917 809 0814
    Email:

     
    US Media
    Katie Gallagher
    LaVoieHealthScience
    Phone: +1 617 792 3937
    Email:

     
    Global Head of Communications
    Judith Moore
    AC Immune
    Phone: +41 79 826 63 82
    Email:

    European Investors & Media
    Chris Maggos
    LifeSci Advisors
    Phone: +41 79 367 6254
    Email:
     

    Forward looking statements

    This press release contains statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions "Item 3. Key Information – Risk Factors" and "Item 5. Operating and Financial Review and Prospects" in AC Immune's Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.


    Balance Sheets
    (in CHF thousands)

      As of
    December 31,
    2019
      As of
    December 31,

    2018
         
         
    ASSETS    
         
    Non-current assets    
    Property, plant and equipment 3,917     3,324  
    Right-of-use assets 2,255      
    Long-term financial assets 304     304  
    Total non-current assets 6,476     3,628  
         
         
    Current assets    
    Prepaid expenses 2,788     2,364  
    Accrued income 1,095     3,667  
    Finance receivable     199  
    Other current receivables 304     236  
    Short-term financial assets 95,000     30,000  
    Cash and cash equivalents 193,587     156,462  
    Total current assets 292,774     192,928  
    Total assets 299,250     196,556  
         
         
    SHAREHOLDERS' EQUITY AND LIABILITIES    
         
    Shareholders' equity    
    Share capital 1,437     1,351  
    Share premium 346,526     298,149  
    Accumulated losses (75,521 )   (121,877 )
    Total shareholders' equity 272,442     177,623  
         
         
    Non-current liabilities    
    Long-term financing obligation     186  
    Long-term lease liabilities 1,813      
    Net employee defined benefit liabilities 7,485     5,665  
    Total non-current liabilities 9,298     5,851  
         
         
    Current liabilities    
    Trade and other payables 142     1,979  
    Accrued expenses 11,797     10,420  
    Short-term deferred income 4,477     351  
    Short-term financing obligation 652     332  
    Short-term lease liabilities 442      
    Total current liabilities 17,510     13,082  
    Total liabilities 26,808     18,933  
    Total shareholders' equity and liabilities 299,250     196,556  
               

    Statements of Income/(Loss)
    (in CHF thousands except for per share data)

      For the years ended
    December 31,
      2019    2018    2017 
       
       
    Revenue      
    Contract revenue 111,026     7,194     20,255  
    Total revenue 111,026     7,194     20,255  
           
           
    Operating expenses      
    Research & development expenses (50,432 )   (44,277 )   (32,663 )
    General & administrative expenses (16,058 )   (12,467 )   (10,131 )
    Total operating expenses (66,490 )   (56,774 )   (42,794 )
    Operating income/(loss) 44,536     (49,550 )   (22,539 )
           
    Finance income / (expense), net (2,046 )   (1,132 )   (4,055 )
    Change in fair value of conversion feature 4,542          
    Interest income 304     29     330  
    Interest expense (1,894 )   (298 )   (147 )
    Finance result, net 906     (1,401 )   (3,872 )
    Income/(loss) before tax 45,442     (50,951 )   (26,411 )
    Income tax expense          
    Income/(loss) for the period 45,442     (50,951 )   (26,411 )
           
           
    Income/(loss) per share (EPS):      
    Basic income/(loss) for the period attributable to equity holders 0.64     (0.82 )   (0.46 )
    Diluted income/(loss) for the period attributable to equity holders 0.64     (0.82 )   (0.46 )
                     

    Statements of Comprehensive Income/(Loss)
    (in CHF thousands)

      For the years ended
    December 31,
      2019    2018    2017 
       
       
    Income/(loss) for the period 45,442     (50,951 )   (26,411 )
    Other comprehensive income/(loss) not to be reclassified to income or loss in subsequent periods (net of tax):      
    Re-measurement losses on defined benefit plans (net of tax) (1,304 )   (302 )   (780 )
    Total comprehensive income/(loss), net of tax 44,138     (51,253 )   (27,191 )
                     


    Reconciliation of Income/(Loss) to Adjusted Income/(Loss) and
    Earnings/(Loss) Per Share to Adjusted Earnings/(Loss) Per Share

      For the Years Ended
    December 31,
    (in CHF thousands except for share and per share data) 2019    2018    2017 
    Income/(Loss) 45,442     (50,951 )   (26,411 )
           
    Adjustments:      
    Non-cash share-based payments (a) 2,834     2,518     1,579  
    Foreign currency (gains)/losses (b) 826     1,179     4,168  
    Effective interest expense (c) 1,355          
    Change in fair value of conversion feature (d) (4,542 )        
    Adjusted Income/(Loss) 45,915     (47,254 )   (20,664 )
                     
    Earnings/(Loss) per share – basic 0.64     (0.82 )   (0.46 )
    Earnings/(Loss) per share – diluted 0.64     (0.82 )   (0.46 )
    Adjustment to earnings/(loss) per share – basic 0.01     0.06     0.10  
    Adjustment to earnings/(loss) per share – diluted 0.00     0.06     0.10  
    Adjusted earnings/(loss) per share – basic 0.65     (0.76 )   (0.36 )
    Adjusted earnings/(loss) per share – diluted 0.64     (0.76 )   (0.36 )
    Weighted-average number of shares used to compute Adjusted Loss per share – basic 70,603,611     61,838,228     57,084,295  
    Weighted-average number of shares used to compute Adjusted Loss per share – diluted 71,103,341     61,838,228     57,084,295  
    1. Reflects non-cash expenses associated with share-based compensation for equity awards issued to Directors, Management and employees of the Company. This expense reflects the awards' fair value recognized for the portion of the equity award which is vesting over the period.
    2. Reflects foreign currency remeasurement gains and losses for the period, predominantly impacted by the change in the exchange rate between the US Dollar and the Swiss Franc.
    3. Effective interest expense for the period relates to the accretion of the Company's convertible loan in accordance with the effective interest method.
    4. Change in fair value of conversion feature that is bifurcated from the convertible loan host debt with Lilly.

    Adjustments for the years ended December 31, 2019, 2018 and 2017, were CHF 0.4 million in net gains, CHF 3.7 million in net losses and CHF 5.7 million in net losses, respectively. The Company recorded CHF 2.8 million, CHF 2.5 million and CHF 1.6 million for the years ended December 31, 2019, 2018 and 2017, respectively, for share-based compensation expenses. There were foreign currency remeasurement losses of CHF 0.8 million, CHF 1.2 million, CHF 4.2 million for the years ended December 31, 2019, 2018 and 2017, respectively, predominantly related to the cash balance of the Company as a result of fluctuations of the US Dollar against the Swiss Franc. Related to the Company's convertible note settled with Lilly in 2019, we recorded CHF 1.4 million for amortization of effective interest for the year ended December 31, 2019 and recognized a CHF 4.5 million gain for the change in fair value of the liability related to the conversion feature in 2019. There were no comparable expenses and gains in 2018 nor 2017, respectively.

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