AC Immune Reports Q1 2019 Financial Results and Business Update

15.May 2019 13:00 CET

English

Lausanne, Switzerland, May 15, 2019 - AC Immune SA (NASDAQ: ACIU), a Swiss-based, biopharmaceutical company with a broad clinical-stage pipeline focused on pioneering Precision Medicine in neurodegenerative diseases, today announced financial results for the first quarter ended March 31, 2019.

Prof. Andrea Pfeifer, Ph.D., CEO of AC Immune, commented: "Our CHF 300 million cash position, funds operations through Q3 2023, allowing us to achieve multiple potentially transformative goals. This is thanks to SupraAntigenTM and MorphomerTM, our proprietary discovery platforms, which already have generated multiple clinical and preclinical product-candidates and about CHF 300 million in partnering revenues for rights to our industry-leading therapeutic candidates to treat neurodegenerative diseases. We expect multiple developments in 2019, including initiation of a Phase 1 trial of small molecule Tau MorphomerTM, as we advance our new partnership with Eli Lilly, and the interim Phase 1b data on ACI-24 to treat Alzheimer's disease (AD) in Down syndrome."

"Our key near- to medium-term focus is on developing our Tau therapies to treat early and moderate AD based on the growing body of clinical evidence that Tau pathology drives disease progression," added Dr Pfeifer. "As the key opinion leaders have advised, we also are continuing testing of Abeta therapeutics, like ACI-24 and crenezumab, in carefully selected more homogeneous populations for early treatment and prevention, such as AD in Down syndrome patients and familial AD, respectively. The Roadmap to successful therapies for neurodegenerative diseases like Alzheimer's requires that we treat earlier in the course of disease and select more homogenous populations using Precision Medicine and, as soon as practical, combination therapies."

Financial Highlights Q1 2019

Research & Development Highlights Q1 2019

Analysis of Financial Statements for the Three Months Ended March 31, 2019

Revenues

Research & Development (R&D) Expenses

General & Administrative (G&A) Expenses

IFRS Income/(Loss) for the period

Balance Sheet

About AC Immune

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 is utilizing two proprietary discovery 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 five currently in clinical trials. It has collaborations with major pharmaceutical companies including Roche/Genentech, Lilly and Janssen.

For further information, please contact:

U.S. Investors
Lisa Sher
AC Immune Investor Relations
Phone: +1 970 987 26 54
E-mail: lisa.sher@acimmune.com
U.S. Media
Katie Gallagher
LaVoieHealthScience
Phone: +1 617 792 3937
E-mail: kgallagher@lavoiehealthscience.com

 
European Investors & Media
Chris Maggos
LifeSci Advisors
Phone: +41 79 367 6254 
E-mail: chris@lifesciadvisors.com

 
 

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

 

As of
March 31,
2019

As of December 31,
2018

in CHF thousands    
ASSETS    
     
Non-current assets    
Property, plant and equipment............................................................ 3,570 3,324
Right-of-use assets............................................................................ 2,082 -
Long-term financial assets..................................................................

304

304

Total non-current assets....................................................................

5,956

3,628

     
Current assets    
Prepaid expenses............................................................................... 3,000 2,364
Accrued income................................................................................. 813 3,667
Finance receivable ............................................................................. 201 199
Other current receivables..................................................................... 784 236
Short-term financial assets.................................................................. 80,000 30,000
Cash and cash equivalents..................................................................

222,138

156,462

Total current assets...........................................................................

306,936

192,928

Total assets.......................................................................................

312,892

196,556

     
SHAREHOLDERS' EQUITY AND LIABILITIES    
     
Shareholders' equity    
Share capital...................................................................................... 1,361 1,351
Share premium................................................................................... 298,259 298,149
Accumulated losses...........................................................................

(57,766)

(121,877)

Total shareholders' equity.................................................................

241,854

177,623

     
Non-current liabilities    
Long-term financing obligation............................................................ 225 186
Long-term lease liabilities.................................................................... 1,666 -
Long-term deferred income................................................................. 2,628 -
Net employee defined benefit liabilities................................................ 5,809 5,665
Total non-current liabilities............................................................... 10,328 5,851
     
Current liabilities    
Trade and other payables.................................................................... 829 1,979
Accrued expenses.............................................................................. 8,800 10,420
Short-term deferred income................................................................. 3,546 351
Convertible loan................................................................................. 46,740 -
Liability related to conversion feature................................................... 43 -
Short-term debt obligation.................................................................. 336 332
Short-term lease liabilities...................................................................

416

-

Total current liabilities......................................................................

60,710

13,082

Total liabilities..................................................................................

71,038

18,933

Total shareholders' equity and liabilities...........................................

312,892

196,556

Statement of Income/(Loss)

 

For the Three Months
Ended March 31,

 

2019

2018

in CHF thousands except for share and per share data  
Revenue    
Contract revenue.........................................................................

75,042

1,458

Total revenue.............................................................................

75,042

1,458

     
Operating expenses    
Research & development expenses.............................................. (11,592) (10,069)
General & administrative expenses...............................................

(3,294)

(2,711)

Total operating expenses...........................................................

(14,886)

(12,780)

Operating income/(loss).............................................................

60,156

(11,322)

     
Finance expense, net................................................................... (80) (281)
Change in fair value of conversion feature.................................... 4,505 -
Interest income............................................................................ 89 1
Interest expense..........................................................................

(1,096)

(12)

Finance result, net.....................................................................

3,418

(292)

     
Income/(loss) before tax.............................................................

63,574

(11,614)

Income tax expense...................................................................

-

-

Income/(loss) for the period.......................................................

63,574

(11,614)

     
Income/(loss) per share (EPS):    
Basic income/(loss) for the period attributable to equity holders.... 0.94 (0.20)
Diluted income/(loss) for the period attributable to equity holders.. 0.91 (0.20)

Statements of Comprehensive Income/(Loss)

 

For the Three Months
ended March 31,

 

2019

2018

in CHF thousands  
Income/(loss) for the period ............................................................................ 63,574 (11,614)
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...................................................

63,574

(11,614)

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,

 

2019

2018

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

63,574

(11,614)

Adjustments:    
Non-cash share-based payments (a) ............................................ 584 602
Foreign currency losses (b) ......................................................... 45 202
Effective interest expense (c) ...................................................... 991 -
Change in fair value of conversion feature (d)...............................

(4,505)

-

Adjusted Income/(Loss) ............................................................

60,689

(10,810)

 

 

 

Earnings/(Loss) per share - basic..............................................

0.94

(0.20)

Earnings/(Loss) per share - diluted............................................

0.91

(0.20)

Adjustment to earnings/(loss) per share - basic.........................

(0.05)

0.01

Adjustment to earnings/(loss) per share - diluted......................

(0.06)

0.01

Adjusted earnings/(loss) per share - basic.................................

0.89

(0.19)

Adjusted earnings/(loss) per share - diluted..............................

0.85

(0.19)

Weighted-average number of shares used to compute Adjusted earnings/(loss) per share - basic.................................................. 67,922,939 57,368,015
Weighted-average number of shares used to compute Adjusted earnings/(loss) per share - diluted................................................ 71,276,000 57,368,015

(a)        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.

(b)        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.

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

(d)        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, 2019 and March 31, 2018 were CHF 2.9 million in net gains compared to CHF 0.8 million in net losses. The Company recorded CHF 0.6 million for the three months, respectively, for share-based compensation expenses. There were foreign currency remeasurement losses of CHF 45 thousand and CHF 0.2 million, respectively, predominantly related to the reduced foreign currency cash balance of the Company and reduced exposure to foreign currency fluctuations. The Company recorded CHF 1.0 million for amortization of effective interest for the three months ended March 31, 2019. Finally, the Company recognized a CHF 4.5 million gain for the change in fair value of the liability related to the conversion feature.