Form 20-F
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☒
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Form 40-F
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☐
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Yes
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☐
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No
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☒
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Yes
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☐
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No
|
☒
|
AC IMMUNE SA
|
|||||
By:
|
/s/ Andrea Pfeifer
|
||||
Name:
|
Andrea Pfeifer
|
||||
Title:
|
Chief Executive Officer
|
||||
By:
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/s/ Joerg Hornstein
|
||||
Name:
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Joerg Hornstein
|
||||
Title:
|
Chief Financial Officer
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||||
Date:
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March 22, 2022
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Exhibit Number
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Description
|
|
Press Release dated March 22, 2022
|
||
2021 IFRS Consolidated Financial Statements
|
||
2021 Statutory Annual Report
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||
2021 Compensation Report
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![]() |
PRESS RELEASE
|
▪ |
Expanded the Phase 1b/2a trial evaluating the first-in-class anti-phosphorylated-Tau (pTau) vaccine candidate ACI-35.030 for the treatment of AD in collaboration with Janssen
Pharmaceuticals, Inc. The decision to expand the trial, which was made to support plans to advance ACI-35.030 into late-stage development, was based on encouraging interim safety, tolerability, and immunogenicity results. These showed that ACI-35.030 treatment was well tolerated and led to the strong induction of antibodies specific for pathological forms of Tau such as pTau and its aggregated form, enriched paired helical filaments
(ePHF).
|
▪ |
Top line data from the Phase 2 Lauriet trial of semorinemab in mild-to-moderate AD presented at CTAD 2021 showed a statistically significant (p=0.0008) 42.2% reduction in cognitive
decline vs. placebo as measured by ADAS-Cog11 at week 49, one of the trial’s co-primary endpoints. There were no statistically significant differences between semoribemab and placebo arms in the other co-primary endpoint, ADCS-ADL, or in the
secondary endpoints (MMSE and CDR-SB). AC Immune’s partner Genentech, a member of the Roche Group, is continuing with the trial’s open-label extension. Additional fluid biomarker data are expected in H2 2022.
|
▪ |
Presented full results from the landmark Phase 1b clinical trial evaluating the anti-Abeta vaccine ACI-24 in subjects living with Down syndrome (DS) at the Alzheimer’s Association
International Conference (AAIC) 2021. These results showed evidence of immunogenicity and pharmacodynamic response following ACI-24 treatment and demonstrated its favorable safety and tolerability profile.
|
▪ |
Presented at CTAD 2021 full results of the Phase 2 study evaluating ACI-24 in patients with mild AD. This assessment confirmed earlier results showing no safety concerns nor evidence of
inflammation or ARIA (amyloid-related imaging abnormalities) related to ACI-24 in any subject.
|
▪ |
New data on the optimized formulation of ACI-24 were published in a peer reviewed journal Brain Communications. The optimized formulation was
well tolerated in preclinical models and generated a broad polyclonal anti-Abeta response with high titers of antibodies against neurotoxic pyroglutamate Abeta (pyroGlu-Abeta), a major component of Abeta plaques. Additional preclinical data
on optimized ACI-24 were presented at AD/PD™ 2022 confirming its enhanced and sustained immunogenicity against another key pathological Abeta species, oligomeric Abeta.
|
▪ |
Clinical PET image analyses and preclinical studies were presented at AD/PD™ 2022 suggest that ACI-12589 was retained in brain areas affected by disease processes involving a-synuclein
(a-syn) aggregation, indicating the product-candidate has potential as the first non-invasive diagnostic for alpha-synucleinopathies (e.g. MSA).
|
▪ |
Completed all-stock acquisition of Affiris’ portfolio of therapeutics targeting a-syn, notably PD01, a clinically validated active vaccine candidate that places AC Immune at the
forefront of Parkinson’s disease (PD) drug development. ACI-7104, the optimized formulation of PD01, is on track to enter Phase 2 testing in early PD patients in H2 2022.
|
▪ |
Identified and characterized the first biologically active small molecule Morphomer® a-syn aggregation inhibitors, showing
that they significantly decreased a-syn aggregate formation in cellular assays by interfering with the fibrillation process.
|
▪ |
Reported key advancements for several therapeutic discovery programs targeting the (NOD)-like receptor protein 3 (NLRP3) inflammasome. Small molecule Morphomer® inhibitors of
NLRP3 showed the first evidence of in vivo activity in a model of peripheral inflammation, while high-affinity SupraAntigen® monoclonal antibodies were shown to bind extracellular
components (ASC) of the NLRP3 pathway and inhibit inflammasome-mediated immune responses in vitro.
|
▪ |
Strengthened cash position via an equity financing, adding the three lead investors in Covid-19 vaccine innovator BioNTech SE, Athos Service GmbH (Strüngmann family office), First
Capital Partner GmbH (Egger Family Office), and MIG Fonds, as part of the Affiris deal.
|
▪ |
Appointed Alan Colowick, M.D., Monica Shaw, M.D., and Prof. Monika Bütler, Dr. oec., to the Company’s Board of Directors. Dr. Colowick is a biotech and investment executive with more
than 20 years of experience in large and emerging biotech companies. Dr. Shaw is a pharmaceutical industry expert who has been involved in advancing more than 15 therapeutic products from first-in-human studies through commercialization.
Prof. Bütler is a leading Swiss economist and former Vice President of the independent Swiss COVID-19 Science Taskforce.
|
▪ |
Swiss Economic Forum (SEF) awarded AC Immune Co-Founder and CEO Prof. Andrea Pfeifer with the first SEF.WomenAward for CEO of the Year. This award recognizes women with an excellent
entrepreneurial track record, giving greater prominence to role models who can inspire the next generation of businesswomen.
|
▪ |
Expanded the Company’s research collaboration with leading scientists at the Center for Neurodegenerative Disease Research at the Perelman School of Medicine at the University of
Pennsylvania. This partnership aims to advance therapeutic strategies targeting TAR DNA-binding protein 43 (TDP-43), a major driver of neurodegenerative diseases.
|
▪ |
Received two Michael J. Fox Foundation grants to accelerate the development of first-in-class brain penetrant small molecules to inhibit alpha-synuclein aggregation and NLRP3
inflammasome activation in PD.
|
▪ |
ACI-7104 anti-a-syn vaccine candidate is on track to enter an adaptive, placebo-controlled, and biomarker-based Phase 1b/2 study in patients with early PD in H2 2022. The two part study
will evaluate safety, immunogenicity, and measure biomarkers of pathological alpha-synuclein in Part 1, with a seamless transition to Part 2, which will aim to establish clinical proof-of-concept by monitoring progression of PD symptoms and
biomarkers.
|
▪ |
Optimized ACI-24 Abeta vaccine is on track to enter a placebo-controlled Phase 1b/2 study evaluating different dosing regimens vs. placebo in up to four cohorts of patients with AD
before being expanded to a separate cohort of people living with DS to address DS-related AD. Key outcome measures for the study will include assessments of safety, immunogenicity, pharmacodynamics, target engagement, Abeta-PET and clinical
outcomes.
|
ACI-12589
a-syn-PET tracer
|
Reported results from first-in-human study at AD/PD™ 2022 conference
|
||
ACI-35.030
anti-pTau vaccine
|
Reported Phase 1b/2a interim analysis from highest dose group in Q1; disclose future late-stage development plans in H2
|
||
ACI-24 (optimized)
anti-Abeta vaccine
|
ACI-24 (optimized vaccine formulation) Phase 1b/2a First-Patient-In (AD) in H1
Phase 1b in AD readout and decision to move into DS in H2
|
||
Crenezumab
anti-Abeta antibody
|
Top line Phase 2 results from AD prevention trial in patients with autosomal dominant AD in H1
|
||
Semorinemab
anti-Tau antibody
|
Additional fluid biomarker data from the Phase 2 Lauriet study in mild-to-moderate AD in H2
|
||
PI-2620
Tau-PET tracer
|
Phase 2 and Phase 1 results in AD and progressive supranuclear palsy (PSP) respectively, in H2
|
||
ACI-7104
anti-a-syn vaccine
|
Initiate Phase 2 trial in early PD in H2
|
▪ |
Cash Position: The Company had a total cash balance of CHF 198.2 million, composed of CHF 82.2 million in cash
and cash equivalents and CHF 116.0 million in short-term financial assets. This compares to a total cash balance of CHF 225.9 million as of December 31, 2020. The Company’s cash balance provides enough capital resources to progress
through at least Q1 2024 without consideration of potential incoming milestone payments.
|
▪ |
Contract Revenues: The Company did not record contract revenues for the year ended December 31, 2021, a decrease of CHF 15.4 million from the
comparable period in 2020. The overall decrease is predominantly related to a CHF 10 million milestone payment as well as CHF 4.3 million associated with R&D activities in our agreement with Lilly that were recognized in 2020 and did
not repeat in the current period.
|
▪ |
R&D Expenditures: R&D expenses increased by CHF 2.8 million for the year ended December 31, 2021, to CHF 62.3 million.
|
o |
Discovery and preclinical expenses (- CHF 0.4 million): The Company decreased expenditures across a variety of its discovery and preclinical
programs. This was predominantly led by a decrease in investment for the research of alpha-synuclein antibodies and other discovery programs.
|
o |
Clinical expenses (- CHF 2.3 million): The Company decreased expenditures across multiple clinical programs, notably for Phase 1 activities
associated with our Morphomer Tau compound and expenses. These decreases were offset predominantly by ACI-35.030, which was driven by R&D cost sharing and increased patient enrollments into the Phase 1b/2a study.
|
o |
Salary- and benefit-related costs (+ CHF 2.3 million): The Company’s salary- and benefit-related costs increased primarily due to the internal
reallocation of certain employees’ salaries and the annualization of 2020 hires.
|
▪ |
G&A Expenditures: For the year December 31, 2021, G&A decreased by CHF 0.6 million to CHF 17.9 million. This decrease is predominantly
related to a reallocation of CHF 2.8 million of certain IT and facilities costs offset by transaction costs incurred to complete the asset acquisition for Affiris' alpha-synuclein portfolio.
|
▪ |
Other Operating Income: The Company recognized CHF 1.2 million in grant income for R&D activities performed under our Michael J. Fox
Foundation for Parkinson’s Research (MJFF) and Target ALS grants, a decrease of CHF 0.1 million compared to the prior period.
|
▪ |
IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 73.0 million for the year ended December 31, 2021, compared with a
net loss of CHF 61.9 million for the comparable period in 2020.
|
▪ |
For the full year 2022, the Company expects its total cash burn to be in the range, CHF 75 million to CHF 80 million. The Company defines cash burn as operating expenditures adjusted
to include capital expenditures and offset by significant non-cash items (including share-based compensation and depreciation expense).
|
Media Relations
Saoyuth Nidh
AC Immune
Phone: +41 21 345 91 34
Email: saoyuth.nidh@acimmune.com
|
Investor Relations
Gary Waanders, Ph.D., MBA
AC Immune
Phone: +41 21 345 91 91
Email: gary.waanders@acimmune.com
|
U.S. Media
Shani Lewis
LaVoieHealthScience
Phone: +1 609 516 5761
Email: slewis@lavoiehealthscience.com
|
U.S. Investors
Corey Davis, Ph.D.
LifeSci Advisors
Phone: +1 212 915 2577
Email: cdavis@lifesciadvisors.com
|
As of December 31,
2021
|
As of December 31,
2020
|
|||||||
ASSETS
|
||||||||
Non-current assets
|
||||||||
Property, plant and equipment
|
5,116
|
4,416
|
||||||
Right-of-use assets
|
2,914
|
2,223
|
||||||
Intangible asset
|
50,416
|
—
|
||||||
Long-term financial assets
|
363
|
334
|
||||||
Total non-current assets
|
58,809
|
6,973
|
||||||
Current assets
|
||||||||
Prepaid expenses
|
3,015
|
3,954
|
||||||
Accrued income
|
975
|
1,591
|
||||||
Other current receivables
|
428
|
329
|
||||||
Short-term financial assets
|
116,000
|
65,000
|
||||||
Cash and cash equivalents
|
82,216
|
160,893
|
||||||
Total current assets
|
202,634
|
231,767
|
||||||
Total assets
|
261,443
|
238,740
|
||||||
SHAREHOLDERS’ EQUITY AND LIABILITIES
|
||||||||
Shareholders’ equity
|
||||||||
Share capital
|
1,794
|
1,538
|
||||||
Share premium
|
431,251
|
346,890
|
||||||
Treasury shares
|
(124
|
)
|
(100
|
)
|
||||
Accumulated losses
|
(200,942
|
)
|
(132,850
|
)
|
||||
Total shareholders’ equity
|
231,979
|
215,478
|
||||||
Non-current liabilities
|
||||||||
Long-term lease liabilities
|
2,340
|
1,780
|
||||||
Net employee defined-benefit liabilities
|
7,098
|
7,464
|
||||||
Total non-current liabilities
|
9,438
|
9,244
|
||||||
Current liabilities
|
||||||||
Trade and other payables
|
2,003
|
2,184
|
||||||
Accrued expenses
|
16,736
|
11,085
|
||||||
Deferred income
|
717
|
306
|
||||||
Short-term lease liabilities
|
570
|
443
|
||||||
Total current liabilities
|
20,026
|
14,018
|
||||||
Total liabilities
|
29,464
|
23,262
|
||||||
Total shareholders’ equity and liabilities
|
261,443
|
238,740
|
For the Years Ended
December 31,
|
||||||||||||
2021
|
2020
|
2019
|
||||||||||
Revenues
|
||||||||||||
Contract revenue
|
—
|
15,431
|
110,456
|
|||||||||
Total revenue
|
—
|
15,431
|
110,456
|
|||||||||
Operating expenses
|
||||||||||||
Research & development expenses
|
(62,282
|
)
|
(59,487
|
)
|
(50,432
|
)
|
||||||
General & administrative expenses
|
(17,910
|
)
|
(18,557
|
)
|
(16,058
|
)
|
||||||
Other operating income/(expense)
|
1,182
|
1,353
|
570
|
|||||||||
Total operating expenses
|
(79,010
|
)
|
(76,691
|
)
|
(65,920
|
)
|
||||||
Operating income/(loss)
|
(79,010
|
)
|
(61,260
|
)
|
44,536
|
|||||||
Financial income
|
6,485
|
78
|
303
|
|||||||||
Financial expense
|
(581
|
)
|
(184
|
)
|
(1,926
|
)
|
||||||
Change in fair value of conversion feature
|
—
|
—
|
4,542
|
|||||||||
Exchange differences
|
113
|
(555
|
)
|
(2,013
|
)
|
|||||||
Finance result, net
|
6,017
|
(661
|
)
|
906
|
||||||||
Income/(loss) before tax
|
(72,993
|
)
|
(61,921
|
)
|
45,442
|
|||||||
Income tax expense
|
(3
|
)
|
—
|
—
|
||||||||
Income/(loss) for the period
|
(72,996
|
)
|
(61,921
|
)
|
45,442
|
|||||||
Earnings/(loss) per share:
|
||||||||||||
Basic income/(loss) for the period attributable to equity holders
|
(0.97
|
)
|
(0.86
|
)
|
0.64
|
|||||||
Diluted income/(loss) for the period attributable to equity holders
|
(0.97
|
)
|
(0.86
|
)
|
0.64
|
For the Years Ended
December 31,
|
||||||||||||
2021
|
2020
|
2019
|
||||||||||
Income/(loss) for the period
|
(72,996
|
)
|
(61,921
|
)
|
45,442
|
|||||||
Items that may be reclassified to income or loss in subsequent periods (net of tax):
|
||||||||||||
Currency translation differences
|
—
|
—
|
—
|
|||||||||
Items that will not be reclassified to income or loss in subsequent periods (net of tax):
|
||||||||||||
Re-measurement gains/(losses) on defined-benefit plans
|
956
|
726
|
(1,304
|
)
|
||||||||
Other comprehensive income/(loss)
|
956
|
726
|
(1,304
|
)
|
||||||||
Total comprehensive income/(loss), net of tax
|
(72,040
|
)
|
(61,195
|
)
|
44,138
|
For the Years Ended
December 31,
|
||||||||||||
(In CHF thousands, except for share and per share data)
|
2021
|
2020
|
2019
|
|||||||||
Income/(loss)
|
(72,996
|
)
|
(61,921
|
)
|
45,442
|
|||||||
Adjustments:
|
||||||||||||
Non-cash share-based payments1
|
4,126
|
4,088
|
2,834
|
|||||||||
Foreign currency (gains)/losses2
|
70
|
703
|
826
|
|||||||||
Change in fair value of derivative financial assets3
|
(6,459
|
)
|
—
|
—
|
||||||||
Transaction costs4
|
1,144
|
—
|
—
|
|||||||||
Effective interest expenses5
|
—
|
—
|
1,355
|
|||||||||
Change in fair value of conversion feature6
|
—
|
—
|
(4,542
|
)
|
||||||||
Adjusted income/(loss)
|
(74,115
|
)
|
(57,130
|
)
|
45,915
|
|||||||
Earnings/(loss) per share – basic
|
(0.97
|
)
|
(0.86
|
)
|
0.64
|
|||||||
Earnings/(loss) per share – diluted
|
(0.97
|
)
|
(0.86
|
)
|
0.64
|
|||||||
Adjustment to earnings/(loss) per share – basic
|
(0.02
|
)
|
0.07
|
0.01
|
||||||||
Adjustment to earnings/(loss) per share – diluted
|
(0.02
|
)
|
0.07
|
0.00
|
||||||||
Adjusted earnings/(loss) per share – basic
|
(0.99
|
)
|
(0.79
|
)
|
0.65
|
|||||||
Adjusted earnings/(loss) per share – diluted
|
(0.99
|
)
|
(0.79
|
)
|
0.64
|
|||||||
Weighted-average number of shares used to compute adjusted loss per share – basic
|
74,951,833
|
71,900,212
|
70,603,611
|
|||||||||
Weighted-average number of shares used to compute adjusted loss per share – diluted
|
74,951,833
|
71,900,212
|
71,103,341
|
Report of independent registered public accounting firm
|
|
Consolidated Balance Sheets as of December 31, 2021 and 2020
|
F-3
|
Consolidated Statements of Income/(Loss) and Consolidated Statements of Comprehensive Income/(Loss) for the fiscal years ended December 31, 2021, 2020 and 2019
|
F-4
|
Consolidated Statements of Changes in Equity for the fiscal years ended December 31, 2021, 2020 and 2019
|
F-5
|
Consolidated Statements of Cash Flows for the fiscal years ended December 31, 2021, 2020 and 2019
|
F-6
|
Notes to the Consolidated Financial Statements
|
F-7
|
![]() |
![]() |
We conducted full scope audit procedures on the Swiss entity. Our audit scope addressed over 99% of the Group’s total assets.
|
|
•
|
•
|
•
|
![]() |
5 AC Immune SA | Report of the statutory auditor to the General Meeting
|
![]() |
6 AC Immune SA | Report of the statutory auditor to the General Meeting
|
As of
December 31,
|
||||||||||||
Note
|
2021
|
2020
|
||||||||||
ASSETS
|
||||||||||||
Non-current assets
|
||||||||||||
Property, plant and equipment
|
4
|
5,116
|
4,416
|
|||||||||
Right-of-use assets
|
5
|
2,914
|
2,223
|
|||||||||
Intangible asset
|
6/7
|
50,416
|
—
|
|||||||||
Long-term financial assets
|
5
|
363
|
334
|
|||||||||
Total non-current assets
|
58,809
|
6,973
|
||||||||||
Current assets
|
||||||||||||
Prepaid expenses
|
9
|
3,015
|
3,954
|
|||||||||
Accrued income
|
9/13
|
975
|
1,591
|
|||||||||
Other current receivables
|
10
|
428
|
329
|
|||||||||
Short-term financial assets
|
8
|
116,000
|
65,000
|
|||||||||
Cash and cash equivalents
|
8
|
82,216
|
160,893
|
|||||||||
Total current assets
|
202,634
|
231,767
|
||||||||||
Total assets
|
261,443
|
238,740
|
||||||||||
SHAREHOLDERS’ EQUITY AND LIABILITIES
|
||||||||||||
Shareholders’ equity
|
||||||||||||
Share capital
|
11
|
1,794
|
1,538
|
|||||||||
Share premium
|
11
|
431,251
|
346,890
|
|||||||||
Treasury shares
|
11
|
(124
|
)
|
(100
|
)
|
|||||||
Accumulated losses
|
(200,942
|
)
|
(132,850
|
)
|
||||||||
Total shareholders’ equity
|
231,979
|
215,478
|
||||||||||
Non-current liabilities
|
||||||||||||
Long-term lease liabilities
|
5
|
2,340
|
1,780
|
|||||||||
Net employee defined benefit liabilities
|
17
|
7,098
|
7,464
|
|||||||||
Total non-current liabilities
|
9,438
|
9,244
|
||||||||||
Current liabilities
|
||||||||||||
Trade and other payables
|
12
|
2,003
|
2,184
|
|||||||||
Accrued expenses
|
12
|
16,736
|
11,085
|
|||||||||
Deferred income
|
13
|
717
|
306
|
|||||||||
Short-term lease liabilities
|
5
|
570
|
443
|
|||||||||
Total current liabilities
|
20,026
|
14,018
|
||||||||||
Total liabilities
|
29,464
|
23,262
|
||||||||||
Total shareholders’ equity and liabilities
|
261,443
|
238,740
|
For the Years Ended
December 31,
|
||||||||||||||||
Note
|
2021
|
2020
|
2019
|
|||||||||||||
Revenues
|
||||||||||||||||
Contract revenue
|
13
|
—
|
15,431
|
110,456
|
||||||||||||
Total revenue
|
—
|
15,431
|
110,456
|
|||||||||||||
Operating expenses
|
||||||||||||||||
Research & development expenses
|
14
|
(62,282
|
)
|
(59,487
|
)
|
(50,432
|
)
|
|||||||||
General & administrative expenses
|
14
|
(17,910
|
)
|
(18,557
|
)
|
(16,058
|
)
|
|||||||||
Other operating income/(expense)
|
13.2
|
1,182
|
1,353
|
570
|
||||||||||||
Total operating expenses
|
(79,010
|
)
|
(76,691
|
)
|
(65,920
|
)
|
||||||||||
Operating income/(loss)
|
(79,010
|
)
|
(61,260
|
)
|
44,536
|
|||||||||||
Financial income
|
14
|
6,485
|
78
|
303
|
||||||||||||
Financial expense
|
14
|
(581
|
)
|
(184
|
)
|
(1,926
|
)
|
|||||||||
Change in fair value of conversion feature
|
14
|
—
|
—
|
4,542
|
||||||||||||
Exchange differences
|
14
|
113
|
(555
|
)
|
(2,013
|
)
|
||||||||||
Finance result, net
|
6,017
|
(661
|
)
|
906
|
||||||||||||
Income/(loss) before tax
|
(72,993
|
)
|
(61,921
|
)
|
45,442
|
|||||||||||
Income tax expense
|
16
|
(3
|
)
|
—
|
—
|
|||||||||||
Income/(loss) for the period
|
(72,996
|
)
|
(61,921
|
)
|
45,442
|
|||||||||||
Earnings/(loss) per share:
|
||||||||||||||||
Basic income/(loss) for the period attributable to equity holders
|
20
|
(0.97
|
)
|
(0.86
|
)
|
0.64
|
||||||||||
Diluted income/(loss) for the period attributable to equity holders
|
20
|
(0.97
|
)
|
(0.86
|
)
|
0.64
|
For the Years Ended
December 31,
|
||||||||||||||||
Note
|
2021
|
2020
|
2019
|
|||||||||||||
Income/(loss) for the period
|
(72,996
|
)
|
(61,921
|
)
|
45,442
|
|||||||||||
Items that may be reclassified to income or loss in subsequent periods (net of tax):
|
||||||||||||||||
Currency translation differences
|
—
|
—
|
—
|
|||||||||||||
Items that will not be reclassified to income or loss in subsequent periods (net of tax):
|
||||||||||||||||
Re-measurement gains/(losses) on defined-benefit plans
|
17
|
956
|
726
|
(1,304
|
)
|
|||||||||||
Other comprehensive income/(loss)
|
956
|
726
|
(1,304
|
)
|
||||||||||||
Total comprehensive income/(loss), net of tax
|
(72,040
|
)
|
(61,195
|
)
|
44,138
|
Note |
Share
capital
|
Share
premium
|
Treasury
shares
|
Accumulated
losses
|
Total
|
||||||||||||||||||
Balance as of January 1, 2019
|
1,351
|
298,149
|
—
|
(121,877
|
)
|
177,623
|
|||||||||||||||||
Net income for the period
|
—
|
—
|
—
|
45,442
|
45,442
|
||||||||||||||||||
Other comprehensive loss
|
—
|
—
|
—
|
(1,304
|
)
|
(1,304
|
)
|
||||||||||||||||
Total comprehensive income
|
—
|
—
|
—
|
44,138
|
44,138
|
||||||||||||||||||
Share-based payments
|
18
|
—
|
—
|
—
|
2,834
|
2,834
|
|||||||||||||||||
Issuance of shares, net of transaction costs:
|
|||||||||||||||||||||||
Conversion note agreement
|
11
|
73
|
47,705
|
—
|
—
|
47,778
|
|||||||||||||||||
Restricted share awards
|
18
|
1
|
616
|
—
|
(616
|
)
|
1
|
||||||||||||||||
Exercise of options
|
18
|
12
|
56
|
—
|
—
|
68
|
|||||||||||||||||
Balance as of December 31, 2019
|
1,437
|
346,526
|
—
|
(75,521
|
)
|
272,442
|
Share
capital
|
Share
premium
|
Treasury
shares
|
Accumulated
losses
|
Total
|
|||||||||||||||||||
Balance as of January 1, 2020
|
1,437
|
346,526
|
—
|
(75,521
|
)
|
272,442
|
|||||||||||||||||
Net loss for the period
|
—
|
—
|
—
|
(61,921
|
)
|
(61,921
|
)
|
||||||||||||||||
Other comprehensive income
|
—
|
—
|
—
|
726
|
726
|
||||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
(61,195
|
)
|
(61,195
|
)
|
||||||||||||||||
|
|||||||||||||||||||||||
Share-based payments
|
18
|
—
|
—
|
—
|
4,088
|
4,088
|
|||||||||||||||||
Issuance of shares, net of transaction costs:
|
|||||||||||||||||||||||
Held as treasury shares
|
11
|
100
|
—
|
(100
|
)
|
—
|
—
|
||||||||||||||||
Restricted share awards
|
18
|
—
|
222
|
—
|
(222
|
)
|
—
|
||||||||||||||||
Exercise of options
|
18
|
1
|
142
|
—
|
—
|
143
|
|||||||||||||||||
Balance as of December 31, 2020
|
1,538
|
346,890
|
(100
|
)
|
(132,850
|
)
|
215,478
|
Share
capital
|
Share
premium
|
Treasury
shares
|
Accumulated
losses
|
Total
|
|||||||||||||||||||
Balance as of January 1, 2021
|
1,538
|
346,890
|
(100
|
)
|
(132,850
|
)
|
215,478
|
||||||||||||||||
Net loss for the period
|
—
|
—
|
—
|
(72,996
|
)
|
(72,996
|
)
|
||||||||||||||||
Other comprehensive income
|
—
|
—
|
—
|
956
|
956
|
||||||||||||||||||
Total comprehensive loss
|
—
|
—
|
—
|
(72,040
|
)
|
(72,040
|
)
|
||||||||||||||||
Share-based payments
|
18
|
—
|
—
|
—
|
4,126
|
4,126
|
|||||||||||||||||
Proceeds from sale of treasury shares in public offerings, net of underwriting fees and transaction costs
|
11
|
—
|
12,097
|
24
|
—
|
12,121
|
|||||||||||||||||
Issuance of shares, net of transaction costs:
|
|||||||||||||||||||||||
IPR&D asset purchase
|
6/11
|
130
|
49,741
|
—
|
—
|
49,871
|
|||||||||||||||||
Asset acquisition – common shares
|
6/11
|
12
|
4,587
|
—
|
—
|
4,599
|
|||||||||||||||||
Conversion note agreements
|
11
|
61
|
16,683
|
—
|
—
|
16,744
|
|||||||||||||||||
Held as treasury shares
|
11
|
48
|
—
|
(48
|
)
|
—
|
—
|
||||||||||||||||
Restricted share awards
|
18
|
1
|
171
|
—
|
(178
|
)
|
(6
|
)
|
|||||||||||||||
Exercise of options
|
18
|
4
|
1,082
|
—
|
—
|
1,086
|
|||||||||||||||||
Balance as of December 31, 2021
|
1,794
|
431,251
|
(124
|
)
|
(200,942
|
)
|
231,979
|
For the Years Ended
December 31,
|
||||||||||||||||
Note
|
2021
|
2020
|
2019
|
|||||||||||||
Operating activities
|
||||||||||||||||
Net income/(loss) for the period
|
(72,996
|
)
|
(61,921
|
)
|
45,442
|
|||||||||||
Adjustments to reconcile net income/(loss) for the period to net cash flows:
|
||||||||||||||||
Depreciation of property, plant and equipment
|
4
|
1,897
|
1,535
|
1,274
|
||||||||||||
Depreciation of right-of-use assets
|
5
|
509
|
432
|
420
|
||||||||||||
Finance result, net
|
14
|
(6,769
|
)
|
376
|
1,739
|
|||||||||||
Share-based compensation expense
|
18
|
4,126
|
4,088
|
2,834
|
||||||||||||
Changes in net employee defined benefit liability
|
17
|
590
|
705
|
516
|
||||||||||||
Change in fair value of conversion feature
|
11
|
—
|
—
|
(4,542
|
)
|
|||||||||||
Interest expense
|
5/14
|
573
|
175
|
1,894
|
||||||||||||
(Gain)/loss on sale of fixed assets
|
13
|
(64
|
)
|
—
|
||||||||||||
Changes in working capital:
|
||||||||||||||||
Decrease/(increase) in prepaid expenses
|
9
|
791
|
(1,304
|
)
|
(424
|
)
|
||||||||||
Decrease /(increase) in accrued income
|
9
|
594
|
(507
|
)
|
2,572
|
|||||||||||
(Increase)/decrease in other current receivables
|
10
|
(99
|
)
|
(25
|
)
|
(68
|
)
|
|||||||||
Increase /(decrease) in accrued expenses
|
12
|
5,214
|
(757
|
)
|
1,289
|
|||||||||||
Increase /(decrease) in deferred income
|
13
|
425
|
(4,157
|
)
|
4,126
|
|||||||||||
(Decrease)/increase in trade and other payables
|
12
|
(84
|
)
|
2,177
|
(1,845
|
)
|
||||||||||
Cash (used in)/provided by operating activities
|
(65,216
|
)
|
(59,247
|
)
|
55,227
|
|||||||||||
Interest income
|
14
|
—
|
78
|
304
|
||||||||||||
Interest paid
|
5/14
|
(465
|
)
|
(339
|
)
|
(296
|
)
|
|||||||||
Finance costs
|
14
|
(8
|
)
|
(9
|
)
|
(15
|
)
|
|||||||||
Net cash flows (used in)/provided by operating activities
|
(65,689
|
)
|
(59,517
|
)
|
55,220
|
|||||||||||
Investing activities
|
||||||||||||||||
Short-term financial assets
|
8
|
(51,000
|
)
|
30,000
|
(65,000
|
)
|
||||||||||
Purchases of property, plant and equipment
|
4
|
(2,635
|
)
|
(1,706
|
)
|
(1,885
|
)
|
|||||||||
Proceeds from sale of property, plant and equipment
|
4
|
—
|
64
|
—
|
||||||||||||
Rental deposits
|
5
|
(29
|
)
|
(29
|
)
|
—
|
||||||||||
Net cash flows (used in)/provided by investing activities
|
(53,664
|
)
|
28,329
|
(66,885
|
)
|
|||||||||||
Financing activities
|
||||||||||||||||
Proceeds from issuance of convertible loan
|
11
|
23,463
|
—
|
50,278
|
||||||||||||
Transaction costs on issuance of shares
|
11
|
(6
|
)
|
—
|
(510
|
)
|
||||||||||
Proceeds from issuance of treasury shares, net of underwriting fees and transaction costs
|
11
|
12,121
|
100
|
—
|
||||||||||||
Proceeds from issuance of common shares – asset acquisition, net of transaction costs
|
11
|
4,599
|
—
|
—
|
||||||||||||
Proceeds from issuance of common shares – option plan, net of transaction costs
|
11
|
1,082
|
143
|
69
|
||||||||||||
Principal payments of lease obligations
|
5
|
(513
|
)
|
(432
|
)
|
(420
|
)
|
|||||||||
Repayment of short-term financing obligation
|
—
|
(514
|
)
|
—
|
||||||||||||
Payment for the issuance of treasury shares
|
11
|
—
|
(100
|
)
|
—
|
|||||||||||
Proceeds from long-term financing obligation
|
—
|
—
|
199
|
|||||||||||||
Net cash flows provided by/(used in) financing activities
|
40,746
|
(803
|
)
|
49,616
|
||||||||||||
Net (decrease)/increase in cash and cash equivalents
|
(78,607
|
)
|
(31,991
|
)
|
37,951
|
|||||||||||
Cash and cash equivalents at January 1
|
160,893
|
193,587
|
156,462
|
|||||||||||||
Exchange losses on cash and cash equivalents
|
(70
|
)
|
(703
|
)
|
(826
|
)
|
||||||||||
Cash and cash equivalents at December 31
|
82,216
|
160,893
|
193,587
|
|||||||||||||
Net (decrease)/increase in cash and cash equivalents
|
(78,607
|
)
|
(31,991
|
)
|
37,951
|
|||||||||||
Supplemental non-cash activity
|
||||||||||||||||
Capital expenditures recorded in Accrued expenses
|
4
|
303
|
328
|
—
|
||||||||||||
Issuance of shares for purchase of IPR&D asset in asset acquisition
|
6/7
|
50,416
|
—
|
—
|
||||||||||||
Transaction costs associated with issuance of shares in relation to the asset acquisition recorded in Accrued expenses
|
6
|
776
|
—
|
—
|
||||||||||||
Settlement of convertible notes recorded within Shareholders’ equity
|
11
|
16,920
|
—
|
48,288
|
1. |
General information
|
2.
|
Basis of preparation
|
3.
|
Summary of significant accounting policies
|
For the Years Ended
December 31,
|
||||||||||||
2021
|
2020
|
2019
|
||||||||||
CHF/USD
|
||||||||||||
Closing rate, USD 1
|
0.923
|
N/A
|
N/A
|
|||||||||
Average exchange rate, USD 1
|
0.929
|
N/A
|
N/A
|
i. |
assets and liabilities for each balance sheet presented are translated at the closing rate at the date of that balance sheet;
|
ii. |
income and expenses for each statement of income/(loss) are translated at average exchange rates; and
|
iii. |
all resulting exchange differences are recognized in other comprehensive income/(loss), within cumulative translation differences.
|
• |
the cost of acquiring, developing and manufacturing active pharmaceutical ingredients for product candidates that have not received regulatory approval, clinical trial materials and other research and development materials;
|
• |
fees and expenses incurred under agreements with contract research organizations, investigative sites and other entities in connection with the conduct of clinical trials and preclinical studies and related services, such as
administrative, data-management and laboratory services;
|
• |
fees and costs related to regulatory filings and activities;
|
• |
costs associated with preclinical and clinical activities;
|
• |
employee-related expenses, including salaries and bonuses, benefits, travel and share-based compensation expenses; and
|
• |
all other allocated expenses such as facilities and information technology (IT) costs.
|
Buildings
|
5 years
|
Office equipment
|
5 years
|
IT equipment
|
5 years
|
IT equipment
|
3 years
|
Laboratory equipment
|
5 years
|
Leasehold improvements/furniture
|
5 years
|
4.
|
Property, plant and equipment
|
In CHF thousands
|
Furniture
|
IT
equipment
|
Laboratory
equipment
|
Leasehold
improvements
|
Total
|
|||||||||||||||
Acquisition cost:
|
||||||||||||||||||||
Balance at December 31, 2020
|
214
|
1,497
|
7,958
|
464
|
10,133
|
|||||||||||||||
Acquisitions
|
207
|
257
|
1,315
|
831
|
2,610
|
|||||||||||||||
Disposals
|
—
|
—
|
(77
|
)
|
—
|
(77
|
)
|
|||||||||||||
Balance at December 31, 2021
|
421
|
1,754
|
9,196
|
1,295
|
12,666
|
|||||||||||||||
Accumulated depreciation:
|
||||||||||||||||||||
Balance at December 31, 2020
|
(61
|
)
|
(970
|
)
|
(4,405
|
)
|
(281
|
)
|
(5,717
|
)
|
||||||||||
Depreciation expenses
|
(45
|
)
|
(346
|
)
|
(1,398
|
)
|
(108
|
)
|
(1,897
|
)
|
||||||||||
Disposals
|
—
|
—
|
64
|
—
|
64
|
|||||||||||||||
Balance at December 31, 2021
|
(106
|
)
|
(1,316
|
)
|
(5,739
|
)
|
(389
|
)
|
(7,550
|
)
|
||||||||||
Carrying amount:
|
||||||||||||||||||||
December 31, 2020
|
153
|
527
|
3,553
|
183
|
4,416
|
|||||||||||||||
December 31, 2021
|
315
|
438
|
3,457
|
906
|
5,116
|
In CHF thousands
|
Furniture
|
IT
equipment
|
Laboratory
equipment
|
Leasehold
improvements
|
Total
|
|||||||||||||||
Acquisition cost:
|
||||||||||||||||||||
Balance at December 31, 2019
|
158
|
1,187
|
6,698
|
402
|
8,445
|
|||||||||||||||
Acquisitions
|
96
|
310
|
1,566
|
62
|
2,034
|
|||||||||||||||
Disposals
|
(40
|
)
|
—
|
(306
|
)
|
—
|
(346
|
)
|
||||||||||||
Balance at December 31, 2020
|
214
|
1,497
|
7,958
|
464
|
10,133
|
|||||||||||||||
Accumulated depreciation:
|
||||||||||||||||||||
Balance at December 31, 2019
|
(68
|
)
|
(627
|
)
|
(3,619
|
)
|
(214
|
)
|
(4,528
|
)
|
||||||||||
Depreciation expenses
|
(33
|
)
|
(343
|
)
|
(1,092
|
)
|
(67
|
)
|
(1,535
|
)
|
||||||||||
Disposals
|
40
|
—
|
306
|
—
|
346
|
|||||||||||||||
Balance at December 31, 2020
|
(61
|
)
|
(970
|
)
|
(4,405
|
)
|
(281
|
)
|
(5,717
|
)
|
||||||||||
Carrying amount:
|
||||||||||||||||||||
December 31, 2019
|
90
|
560
|
3,079
|
188
|
3,917
|
|||||||||||||||
December 31, 2020
|
153
|
527
|
3,553
|
183
|
4,416
|
5.
|
Right-of-use assets and lease liabilities
|
In CHF thousands
|
Buildings
|
Office
equipment
|
IT
equipment
|
Total
|
||||||||||||
Balance as of December 31, 2020
|
2,106
|
63
|
54
|
2,223
|
||||||||||||
Additions and remeasurements
|
1,144
|
71
|
—
|
1,215
|
||||||||||||
Dispositions
|
—
|
(15
|
)
|
—
|
(15
|
)
|
||||||||||
Depreciation
|
(474
|
)
|
(21
|
)
|
(14
|
)
|
(509
|
)
|
||||||||
Balance as of December 31, 2021
|
2,776
|
98
|
40
|
2,914
|
In CHF thousands
|
Buildings
|
Office
equipment
|
IT
equipment
|
Total
|
||||||||||||
Balance as of December 31, 2019
|
2,106
|
81
|
68
|
2,255
|
||||||||||||
Additions and remeasurements
|
400
|
—
|
—
|
400
|
||||||||||||
Depreciation
|
(400
|
)
|
(18
|
)
|
(14
|
)
|
(432
|
)
|
||||||||
Balance as of December 31, 2020
|
2,106
|
63
|
54
|
2,223
|
For the Years Ended
December 31,
|
||||||||
In CHF thousands
|
2021
|
2020
|
||||||
Consolidated statements of income/(loss)
|
||||||||
Depreciation of right-of-use assets
|
509
|
432
|
||||||
Interest expense on lease liabilities
|
63
|
53
|
||||||
Expense for short-term leases and leases of low value
|
723
|
603
|
||||||
Total
|
1,295
|
1,088
|
||||||
Consolidated statements of cash flows
|
||||||||
Total cash outflow for leases
|
1,299
|
1,088
|
As of
December 31,
|
||||||||
In CHF thousands
|
2021
|
2020
|
||||||
Within 1 year
|
638
|
485
|
||||||
Between 1 and 3 years
|
1,260
|
970
|
||||||
Between 3 and 5 years
|
1,203
|
912
|
||||||
Total
|
3,101
|
2,367
|
6.
|
Asset acquisition
|
In CHF thousands
|
||||
Cash
|
4,634
|
|||
IPR&D Asset
|
50,416
|
|||
Total
|
55,050
|
7.
|
Intangible assets
|
As of December 31, 2021
|
As of December 31, 2020
|
|||||||||||||||||||||||
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
|
—
|
—
|
—
|
||||||||||||||||||
Total Intangible Assets
|
50,416
|
—
|
50,416
|
—
|
—
|
—
|
• |
Anticipated research and development costs;
|
• |
Anticipated costs of goods and sales and marketing expenditures;
|
• |
Probability of achieving clinical and regulatory development milestones in accordance with certain industry benchmarks;
|