![](/cdn/assets/images/search/clock.png)
We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
AC Immune SA | NASDAQ:ACIU | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.15 | -4.13% | 3.48 | 3.40 | 3.89 | 3.58 | 3.44 | 3.52 | 84,841 | 01:00:00 |
☐ |
REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☒ |
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☐ |
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Title of each class
|
Trading Symbol
|
Name of each exchange on which registered
|
Common Shares, nominal value CHF 0.02 per share
|
ACIU
|
The Nasdaq Global Market
|
Large accelerated filer ☐
|
Accelerated filer ☒
|
Non-accelerated filer ☐
|
Emerging growth company ☐
|
US GAAP ☐
|
International Financial Reporting Standards as issued by the International Accounting Standards
Board ☒
|
Other ☐
|
1
|
|||
2
|
|||
2
|
|||
A.
|
2
|
||
B.
|
2
|
||
C.
|
2
|
||
2
|
|||
A.
|
2
|
||
B.
|
2
|
||
2
|
|||
A.
|
3
|
||
B.
|
3
|
||
C.
|
3
|
||
D.
|
3
|
||
48
|
|||
A.
|
48
|
||
B.
|
48
|
||
C.
|
113
|
||
D.
|
114
|
||
114
|
|||
114
|
|||
A.
|
114
|
||
B.
|
130
|
||
C.
|
132
|
||
D.
|
133
|
||
E.
|
133
|
||
133
|
|||
A.
|
133
|
||
B.
|
137
|
||
C.
|
139
|
||
D.
|
142
|
||
E.
|
142
|
||
142
|
|||
A.
|
142
|
||
B.
|
144
|
||
C.
|
144
|
||
144
|
|||
A.
|
144
|
||
B.
|
145
|
||
145
|
|||
A.
|
145
|
||
B.
|
145
|
||
C.
|
145
|
||
D.
|
145
|
||
E.
|
145
|
||
F.
|
145
|
||
145
|
|||
A.
|
145
|
||
B.
|
145
|
||
C.
|
145
|
||
D.
|
145
|
||
E.
|
146
|
||
F.
|
152
|
G.
|
152
|
||
H.
|
153
|
||
I.
|
153
|
||
153
|
|||
154
|
|||
A.
|
154
|
||
B.
|
154
|
||
C.
|
154
|
||
D.
|
154
|
||
154
|
|||
154
|
|||
A.
|
154
|
||
B.
|
155
|
||
155
|
|||
155
|
|||
A.
|
155
|
||
B.
|
155
|
||
C.
|
155
|
||
D.
|
155
|
||
155
|
|||
155
|
|||
156
|
|||
156
|
|||
156
|
|||
156
|
|||
156
|
|||
156
|
|||
157
|
|||
157
|
|||
157
|
|||
157
|
|||
158
|
|||
158
|
• |
the success of our and our collaboration partners’ clinical studies, and our and their ability to obtain and maintain regulatory approval and to commercialize ACI-35, semorinemab, ACI-7104, Morphomer Tau, ACI-24 for Alzheimer’s disease
(AD) and for Down syndrome-related AD (ACI-24 for DS), crenezumab, PI-2620, our Tau-positron emission tomography (PET) imaging tracer, our alpha-synuclein (a-syn) PET tracer and to a lesser extent our preclinical candidates;
|
• |
the preclinical and clinical safety, efficacy and utility of our product candidates;
|
• |
the ability of our competitors to discover, develop or commercialize competing products before or more successfully than we do;
|
• |
our plans to research, develop and commercialize our product candidates;
|
• |
the identification of serious adverse, undesirable or unacceptable side effects related to our product candidates;
|
• |
our ability to maintain our current strategic relationships with our collaboration partners;
|
• |
our ability to protect and maintain our, and not infringe on third parties’, intellectual property rights throughout the world;
|
• |
our ability to raise capital when needed in order to continue our product development programs or commercialization efforts;
|
• |
our ability to attract and retain qualified employees and key personnel;
|
• |
the acceptance by the Food and Drug Administration (FDA) and applicable foreign regulatory authorities of data from studies that we and our collaboration partners conduct within and outside the US now and in the future;
|
• |
our foreign private issuer status, the loss of which would require us to comply with the Exchange Act’s domestic reporting regime, and cause us to incur significant legal, accounting and other expenses;
|
• |
our incorporation in Switzerland, the laws of which govern our corporate affairs and may differ from those applicable to companies incorporated in the US; and
|
• |
the other risk factors discussed under “Item 3. Key information—D. Risk factors.”
|
• |
We depend heavily on the success of our clinical and, to a lesser extent, preclinical products:
|
a. |
Our ability to generate product revenues, which we do not expect to occur for several years, will depend on clinical and regulatory success which have low probabilities of success in the central nervous
system (CNS) space in which we operate.
|
• |
Results of early preclinical and clinical studies may not be predictive of future results:
|
a. |
Products that show positive or timely preclinical or early clinical results may not show sufficient safety or efficacy in later-stage clinical studies and therefore may fail to obtain regulatory approvals.
|
• |
Our products may not gain market acceptance or may be preempted by competitors:
|
a. |
Even if our products obtain regulatory approval, they may not be accepted by healthcare providers, patients or the medical community.
|
b. |
Our success is dependent on the ability to discover, develop and obtain marketing approval for our products. We face and will continue to face intense competition from a variety of businesses, including
large fully integrated biopharmaceutical and pharmaceutical companies and others that may have greater financial, technical and human resources.
|
c. |
A competitor may enter with a generic of an approved innovator product.
|
• |
We may not be successful in using and expanding our Morphomer and SupraAntigen proprietary technology platforms.
|
• |
We operate in highly competitive and rapidly changing industries, which may result in others discovering, developing or commercializing competing products before or more successfully than we do.
|
• |
Our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel including members of our Executive Committee.
|
• |
If we fail to maintain, or realize the benefits from, our current strategic relationships with our current and potential future license and collaboration partners our financial condition may be
materially adversely affected.
|
• |
We may seek to form additional strategic alliances in the future with respect to our product candidates, and if we do not realize the benefits of such alliances, our business, financial condition,
commercialization prospects and results of operations may be materially adversely affected.
|
• |
Our collaboration agreements may make us an attractive acquisition target under certain circumstances.
|
• |
We or our licensing or collaboration partners may not have sufficient patent terms to protect our products and business effectively which may adversely affect our product sales and technology
development.
|
• |
If we fail to comply with the obligations to obtain and maintain patent protection such as compliance with intellectual property agreements, including those under which we license intellectual property
and other rights to or from third parties, or otherwise experience disruptions to our business relationships with our licensees, our licensors and partners, we could lose intellectual property rights that are important to our business.
|
• |
We may be subject to claims challenging the inventorship of our patents and other intellectual property.
|
• |
We are a clinical stage biopharmaceutical company with a history of losses. We anticipate incurring losses for the foreseeable future. As such, if we fail to obtain additional funding via product
revenues, license and collaboration agreements, equity offerings or other forms of financing, we may need to delay, reduce or eliminate certain of our product development programs.
|
• |
We cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized.
|
• |
Even if we obtain regulatory approvals in one jurisdiction, we may not be able to obtain approval in other jurisdictions. Additionally, we will be subject to ongoing obligations and review which may
result in significant additional expense.
|
• |
We have conducted and may in the future conduct clinical studies for our product candidates outside the US, and the FDA and applicable foreign regulatory authorities may not accept data from such
studies.
|
• |
Enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and may affect the prices we may set.
|
• |
We have limited free float in our common shares which may have a negative impact on the liquidity and market price of our common shares.
|
• |
Certain of our existing shareholders exercise significant control over us, and your or other shareholders’ interests may conflict with the interests of such shareholders.
|
• |
We are a Swiss corporation. The rights of our shareholders may be different from the rights of shareholders in companies governed by the laws of US jurisdictions.
|
• |
We are a foreign private issuer (FPI) and, as a result, we are not subject to US proxy rules and are subject to Exchange Act reporting obligations that, to some extent, are more lenient and less frequent
than those of a US domestic public company.
|
• |
As an FPI, and as permitted by the listing requirements of Nasdaq, we rely on certain home country governance practices rather than the corporate governance requirements of Nasdaq. Should we lose our FPI
status, we would be required to comply with the Exchange Act’s domestic reporting regime, which would cause us to incur significant legal, accounting and other expenses.
|
• |
It is likely that we were a PFIC for 2019 and 2020, and there can be no assurance that we were not, or will not be, a PFIC for any other taxable year. If a US investor held our common shares during any
taxable year in which we are or were a PFIC, the investor generally will be subject to adverse US federal income tax consequences.
|
• |
completing preclinical and clinical studies that demonstrate the efficacy, safety and clinical utility of our preclinical and clinical product candidates;
|
• |
receiving marketing approvals from applicable regulatory authorities;
|
• |
establishing commercial manufacturing capabilities;
|
• |
launching commercial sales, marketing and distribution operations;
|
• |
acceptance of our product candidates by patients, the medical community and third-party payors;
|
• |
a continued acceptable safety profile following approval;
|
• |
competing effectively with other therapies or diagnostic approaches; and
|
• |
obtaining, maintaining, enforcing and defending our intellectual property rights and claims and not infringing on third parties’ intellectual property rights.
|
• |
be delayed in obtaining marketing approval for our product candidates;
|
• |
not obtain marketing approval;
|
• |
obtain approval for indications or patient populations that are not as broad as intended or desired;
|
• |
obtain approval with labeling that includes significant use or distribution restrictions or significant safety warnings, including boxed warnings;
|
• |
be subject to conditional approval or otherwise to additional post-marketing studies or other requirements; or
|
• |
remove the product from the market after obtaining marketing approval.
|
• |
how clinicians and potential patients perceive our novel products;
|
• |
the timing of market introduction;
|
• |
the number and clinical profile of competing products;
|
• |
our ability to provide acceptable evidence of safety and efficacy or clinical utility;
|
• |
the prevalence and severity of any side effects;
|
• |
relative convenience and ease of administration;
|
• |
cost-effectiveness;
|
• |
patient diagnostics and screening infrastructure in each market;
|
• |
marketing and distribution support;
|
• |
availability of coverage, reimbursement and adequate payment from health maintenance organizations and other third-party payors, both public and private; and
|
• |
other potential advantages over alternative treatment methods.
|
• |
regulatory authorities may withdraw approvals of such product and require us or our collaboration partners to take any approved products off the market;
|
• |
regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication or field alerts to physicians and pharmacies;
|
• |
we may be required to create a medication guide outlining the risks of such side effects for distribution to patients;
|
• |
we may be required to change the way the product is administered, to conduct additional studies or to change the labeling of the product;
|
• |
we or our collaboration partners may be subject to limitations in how we promote the product;
|
• |
sales of the product may decrease significantly;
|
• |
we could be sued and held liable for harm caused to patients; and
|
• |
our reputation and physician or patient acceptance of our products may suffer.
|
• |
develop and commercialize products that are safer, more effective, less expensive, or more convenient or easier to administer;
|
• |
obtain quicker FDA or other regulatory approval for their products;
|
• |
establish superior intellectual property and proprietary positions;
|
• |
have access to more manufacturing capacity;
|
• |
implement more effective approaches to sales, marketing and distribution; or
|
• |
form more advantageous strategic alliances.
|
• |
economic weakness, including inflation, or political instability in particular non-US economies and markets;
|
• |
differing regulatory requirements for drug approvals in non-US countries;
|
• |
potentially reduced protection for intellectual property rights;
|
• |
difficulties in compliance with non-US laws and regulations;
|
• |
changes in non-US regulations and customs, tariffs and trade barriers;
|
• |
changes in non-US currency exchange rates and currency controls;
|
• |
changes in a specific country’s or region’s political or economic environment;
|
• |
trade protection measures, import or export licensing requirements or other restrictive actions such as sanctions by US or non-US governments;
|
• |
negative consequences from changes in tax laws;
|
• |
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
|
• |
workforce uncertainty in countries where labor unrest is more common than in the US;
|
• |
difficulties associated with staffing and managing international operations, including differing labor relations;
|
• |
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
|
• |
business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.
|
• |
delays or difficulties in conducting preclinical research and clinical trials;
|
• |
interruption in global manufacturing and shipping that may affect the manufacturing and/or transport of clinical trial materials and other materials, including testing equipment and personal protective equipment, used at our or our
contract research organizations’ (CROs’) and contract manufacturing organizations’ (CMOs’) facilities;
|
• |
changes in local regulations as part of a response to the Covid-19 coronavirus outbreak which may require us to change the way in which clinical trials are conducted and may result in unexpected costs; and
|
• |
impact our ability to secure additional financing.
|
• |
we may not be able to control the amount and timing of resources that the collaboration partner devotes to the product development program;
|
• |
the collaboration partner may experience financial difficulties;
|
• |
we may be required to grant or otherwise relinquish important rights such as marketing, distribution and intellectual property rights;
|
• |
a collaboration partner could move forward with a competing product developed either independently or in collaboration with third parties, including our competitors; or
|
• |
business combinations or significant changes in a collaboration partner’s business strategy may adversely affect our willingness to continue any arrangement.
|
• |
the scope of rights granted under the agreement, any restrictions in licensed fields and other interpretation-related issues;
|
• |
the extent to which our technology and processes infringe or otherwise violate the intellectual property of the licensor, the licensee or partner that is not subject to the agreement;
|
• |
the sublicensing of patent and other rights;
|
• |
the diligence, development and commercialization obligations under the agreement and what activities satisfy those obligations;
|
• |
the ownership of inventions and know-how resulting from the joint or mutual creation or use of intellectual property by our licensors or collaboration partners and us;
|
• |
the priority of invention in patented technology;
|
• |
non-compete commitments; and
|
• |
consequences for changes in control.
|
• |
successfully completing research and clinical development of our product candidates, by us or our collaboration partners, as the case may be;
|
• |
obtaining marketing approvals for our clinical product candidates, including ACI-35, ACI-24 for AD and DS, ACI-7104, semorinemab, crenezumab, Morphomer Tau, PI-2620 and our a-syn PET tracer, for which we or our collaboration partners
complete clinical studies;
|
• |
developing a sustainable and scalable manufacturing process for any approved product candidates, and maintaining supply and manufacturing relationships with third parties that can conduct the process and provide adequate (in amount,
quality and time) products to support clinical development and the market demand for our product candidates, if approved;
|
• |
launching and commercializing product candidates for which we obtain marketing approval, either directly or with a collaborator or distributor;
|
• |
obtaining market acceptance of our product candidates as viable treatment or diagnostic options;
|
• |
addressing any competing technological and market developments;
|
• |
identifying, assessing, acquiring and/or developing new product candidates;
|
• |
negotiating favorable terms in any collaboration, licensing, or other similar arrangements into which we may enter;
|
• |
maintaining, protecting, acquiring and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; and
|
• |
attracting, hiring and retaining qualified personnel.
|
• |
the FDA, EMA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical studies;
|
• |
the population studied in the clinical program may not be sufficiently broad or representative to assure safety in the full population for which we seek approval;
|
• |
the FDA, EMA or comparable foreign regulatory authorities may disagree with our interpretation of data from nonclinical or clinical studies;
|
• |
the data collected from clinical studies of our product candidates may not be sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the US or elsewhere;
|
• |
we may be unable to demonstrate to the FDA, EMA or comparable foreign regulatory authorities that a product candidate’s benefit-risk ratio for its proposed indication is acceptable;
|
• |
the FDA, EMA or other regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications, or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and
|
• |
the approval policies or regulations of the FDA, EMA or comparable foreign regulatory authorities may change significantly in a manner rendering our clinical data insufficient for approval.
|
• |
the delay or refusal of regulators or IRBs to authorize us to commence or amend a clinical study at a prospective study site or changes in regulatory requirements, policies and guidelines;
|
• |
delays or failure to reach agreement on acceptable terms with prospective CROs and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and study sites;
|
• |
delays in patient enrollment and variability in the number and types of patients available for clinical studies;
|
• |
the inability to enroll a sufficient number of patients in studies to ensure adequate statistical power to detect statistically significant treatment effects;
|
• |
negative or inconclusive results, which may require us to conduct additional preclinical or clinical studies or to abandon projects that we expected to be promising;
|
• |
safety or tolerability concerns, which could cause us to suspend or terminate a study if we find that the participants are being exposed to unacceptable health risks;
|
• |
regulators or IRBs requiring that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or safety concerns, among others;
|
• |
lower than anticipated retention rates of patients and volunteers in clinical studies;
|
• |
our CROs or clinical study sites failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, deviating from the protocol or dropping out of a study;
|
• |
delays relating to adding new clinical study sites;
|
• |
difficulty in maintaining contact with patients after treatment, resulting in incomplete data;
|
• |
delays in establishing the appropriate dosage levels;
|
• |
the quality or stability of the product candidate falling below acceptable standards;
|
• |
the inability to produce or obtain sufficient quantities of the product candidate to complete clinical studies; and
|
• |
exceeding budgeted costs due to difficulty in accurately predicting costs associated with clinical studies.
|
• |
restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls;
|
• |
fines, warning letters or holds on clinical studies;
|
• |
refusal by the FDA or an applicable foreign regulatory authority to approve pending applications or supplements to approved applications filed by us or our collaborations partners, or suspension or revocation of product license
approvals;
|
• |
regulatory constraints in promotion and distribution of drug products in various markets;
|
• |
product seizure or detention, or refusal to permit the import or export of products; and
|
• |
injunctions or the imposition of civil or criminal penalties.
|
• |
the US healthcare Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either
the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under US government healthcare programs such as Medicare and Medicaid;
|
• |
the US False Claims Act imposes criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for
knowingly presenting, or causing to be presented, to the US government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
|
• |
the US HIPAA imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
|
• |
the HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of
individually identifiable health information;
|
• |
the transparency requirements under the Health Care Reform Law require manufacturers of drugs, devices, biologics and medical supplies to report to the US Department of Health and Human Services information related to payments and other
transfers of value made by such manufacturers to physicians and teaching hospitals, and ownership and investment interests held by physicians or their immediate family members; and
|
• |
analogous laws and regulations, such as state anti-kickback and false claims laws, will apply to sales or marketing arrangements, consultancy and service agreements, and claims involving healthcare items or services reimbursed by
nongovernmental third-party payors, including private insurers, and some state laws require pharmaceutical and biopharmaceutical companies to comply with the pharmaceutical and biopharmaceutical industries’ voluntary compliance guidelines
and the relevant compliance guidance promulgated by the federal government, in addition to requiring manufacturers to report information related to payments to physicians and other healthcare providers or marketing expenditures.
|
• |
positive or negative results of testing and clinical studies by us, strategic partners, or competitors;
|
• |
delays in entering into strategic relationships with respect to development and/or commercialization of our product candidates or entry into strategic relationships on terms that are not deemed to be favorable to us;
|
• |
the sentiment of retail investors, including the perception of our clinical trial results by such retail investors, which investors may be subject to the influence of information provided by social media, third party investor websites
and independent authors distributing information on the internet;
|
• |
technological innovations or commercial product introductions by us or our collaboration partners or competitors;
|
• |
changes in government regulations;
|
• |
developments concerning proprietary rights, including patents and litigation matters;
|
• |
public concern relating to the commercial value or safety of any of our product candidates;
|
• |
financing or other corporate transactions;
|
• |
publication of research reports or comments by securities or industry analysts or key opinion leaders;
|
• |
general market conditions in the pharmaceutical or biopharmaceutical industry or in the economy as a whole; or
|
• |
other events and factors beyond our control.
|
• |
the non-Swiss court had jurisdiction pursuant to the Swiss Federal Act on Private International Law;
|
• |
the judgment of such non-Swiss court has become final and non-appealable;
|
• |
the judgment does not contravene Swiss public policy;
|
• |
the court procedures and the service of documents leading to the judgment were in accordance with the due process of law; and
|
• |
no proceeding involving the same parties and the same subject matter was first brought in Switzerland, or adjudicated in Switzerland, or was earlier adjudicated in a third state for which the decision is recognizable in Switzerland.
|
• |
The World Health Organization recognizes dementia as a global public health priority. Worldwide, there is a new case of dementia every 3 seconds, with an estimated global patient population of
greater than 50 million in 2020. This is predicted to increase to 139 million by 2050 (Alzheimer’s Disease International).
|
• |
The estimated total healthcare costs for the treatment of Alzheimer disease in the United States in 2021 is estimated to be USD 355 billion per the Alzheimer’s Association, with the worldwide cost for dementia expected to increase to
approximately USD 2.8 trillion annually by 2050 as the population ages. In fact, if the estimated global costs of dementia were a country, it would be the 14th
largest economy in the world.
|
• |
ACI-35.030. Janssen and AC Immune are evaluating the anti-phosphorylated-Tau (anti-pTau) vaccine candidate ACI-35.030 in a Phase 1b/2a
study in subjects with early AD. Interim results show that ACI-35.030 vaccination generated a strong antigen-specific antibody response against pTau in 100% of participants, achieving anti-pTau antibody levels of about two orders of
magnitude higher than pre-vaccination levels, whereas anti-ePHF (enriched paired helical filaments) antibody titers increased by one order of magnitude from baseline as early as two weeks after the second injection at week 8 of the mid-dose
of ACI-35.030. No clinically relevant safety concerns related to the vaccine candidate were observed. Based on these results, the second highest dose cohort was expanded in Q2 2021 to facilitate plans for further late-stage development.
ACI-35.030 specifically targets pathological pTau species and is eventually intended as a disease-modifying treatment for AD and other Tauopathies.
|
• |
ACI-24 for AD. A first Phase 1/2 study was completed and finalized in 2019. The subsequent Phase 2 study in AD assessed the safety, tolerability, immunogenicity and target
engagement of ACI-24 using intramuscular immunizations and analyzed the effects of ACI-24 on brain amyloid as assessed by PET imaging. This trial was completed and finalized in November 2021. ACI-24 was safe and well tolerated and triggered
a clear IgM response with lower Abeta-specific IgG titers. While no apparent effect in amyloid-PET was observed in this limited study population, there was evidence of a pharmacodynamic effect observed by an increase of CSF Aβ1-40 and
Aβ1-42 levels compared to the placebo, thus suggesting target engagement. These results support the clinical development of the optimized formulation of ACI-24 (i.e. ACI-24.060) with Abeta unrelated T-helper cell epitopes to increase the
magnitude and the boost-ability of the antibody response.
|
• |
ACI-24 for DS. Our Phase 1b clinical study of ACI-24 for individuals with DS, intended to assess safety, tolerability and immunogenicity at two doses, was completed and results
reported in Q1 2021. The results support a favorable safety and tolerability profile of ACI-24 and show a pharmacodynamic response in this vulnerable patient population and the advancement of this program with the optimized formulation of
ACI-24. The Clinical Trial Application (CTA) for the next study evaluating the optimized formulation of ACI-24 in AD and Down syndrome populations was submitted in Q4 2021. The trial initiation is planned in H1 2022.
|
• |
ACI-7104. ACI-7104, the optimized formulation of the clinically-validated PD vaccine candidate PD01, will advance into an adaptive, biomarker-based Phase 2 study. This trial will evaluate an
initial dose-response of the optimized formulation focusing on immunogenicity against a-syn and pathological a-syn species. Additionally, the identification or verification of disease-specific biomarkers and progression of motor and
non-motor symptoms of Parkinson’s disease will be monitored, together with digital, imaging and fluid biomarkers, in the second part of the study. The trial initiation is planned in H2 2022.
|
• |
Semorinemab. Our collaboration partner, Genentech, a member of the Roche Group, completed a
first Phase 2 study (Tauriel) conducted in patients with prodromal-to-mild AD in Q3 2020. This trial did not meet its primary efficacy endpoint of reducing decline on Clinical Dementia Rating-Sum of Boxes
(CDR-SB) compared to placebo; the primary safety endpoint was met. A second Phase 2 study (Lauriet) conducted in patients with mild-to-moderate AD was completed in Q3 2021 and top-line data from showed a statistically significant
reduction on one of two co-primary endpoints, ADAS-Cog11. The second co-primary endpoint, ADCS-ADL, and secondary endpoints were not met. Safety data showed that semorinemab is well tolerated with no unanticipated safety signals. Genentech
reported that the open label portion of the study will continue as planned and that further analyses are ongoing. Semorinemab is designed to slow the prion-like propagation of Tau pathology, which coincides with both clinical symptoms and
disease progression in AD.
|
• |
Crenezumab. Roche announced in 2019 the discontinuation of the Phase 3 clinical trials in AD but is continuing in a landmark prevention trial in Colombia, in a population of
genetically predisposed people at risk of developing familial AD. The overall beneficial safety profile was confirmed in the CREAD studies, supporting use of crenezumab in healthy individuals with risk of developing AD. Top-line results
from this Phase 2 Prevention trial are expected in H1 2022.
|
• |
Morphomer Tau aggregation inhibitors. In collaboration with our partner, Lilly, we are researching and developing small molecule Tau aggregation inhibitors with plans to
evaluate candidates in AD and NeuroOrphan indications. We completed a Phase 1 clinical study in healthy volunteers with ACI-3024, in Q2 2020, which showed a dose-dependent exposure and brain penetration, achieving the desired levels of
ACI-3024 in the CSF. In addition to AD, the program was expanded to NeuroOrphan indications and ACI-3024 will be further evaluated for efficacy in models of rare Tauopathies. Continued candidate characterization across the research program
has also identified new and highly differentiated candidates with excellent cerebrospinal fluid exposure and selectivity for pathological aggregated Tau. These will be broadly developed in Tau-dependent neurodegenerative diseases.
|
• |
Tau-PET tracer. PI-2620 is our Tau-PET imaging agent. We are working with our partner, LMI, to advance PI-2620 as a highly differentiated, best-in-class Tau diagnostic for AD
as well as non-AD Tauopathies such as progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD). Results have demonstrated PI-2620’s differentiated characteristics as a diagnostic tool for studying Tau-related diseases.
PI-2620 completed a Phase 2 clinical trial in AD in Q4 2021.
|
• |
A-syn-PET tracer. Our next-generation PET imaging tracer, derived from our Morphomer platform, has shown significant potential to reliably detect and map deposits of
pathological alpha-synuclein protein in the brain. Supported by the Michael J. Fox Foundation for Parkinson’s Research (MJFF), a first-in-human study and an investigator-initiated study of our latest diagnostic agent targeting a-syn were
initiated in Q1 and Q3 2021, respectively. The readouts of these trials in patients with PD, multiple system atrophy (MSA) and other synucleinopathies are anticipated by Q2 2022.
|
3. |
Accelerating the advancement of our diagnostic portfolio
|
4. |
Continuing to optimize our long-term growth by selectively partnering product candidates for global development and commercialization
|
• |
ACI-35 is composed of a human pTau synthetic peptide T3 as the antigen, derived from Tau sequence 393-408 and phosphorylated at serine residues S396 and S404. Lipidation of the peptide enables it to embed itself into the lipid bi-layer
of the liposome and confers a specific conformation to the peptide (Theunis et al., PLoS ONE 2013).
|
• |
In wild-type and transgenic mice, immunization with ACI-35 generated a specific antibody response to phosphorylated vs. non-phosphorylated Tau protein (Vukicevic et. al. AAT-AD/PD 2020).
|
• |
In transgenic mice, immunization with ACI-35 led to a significant decrease of soluble and insoluble total Tau protein and insoluble pTau species in brain (Figure 13).
|
• |
ACI-35.030 comprises a pTau peptide and a T-cell epitope capable of binding to human leukocyte antigen-major histocompatibility complex, class II (HLA-DR) molecules.
|
• |
In rhesus monkeys, ACI-35.030 induced a specific response to pTau over non-phosphorylated Tau, similar to that observed with ACI-35 (Vukicevic et. al. AAT-AD/PD 2020). This is meaningful as Tau
hyper-phosphorylation is considered an early event in the development of Tau pathology, occurring even several decades before the onset of Tau deposits.
|
• |
Sera from rhesus monkeys immunized with ACI-35.030 binds specifically to pathological Tau in brain sections with AD as compared to healthy human brain tissue (Kosco-Vilbois, KOL event ‘Untangling’ Tau Pathology to Treat Alzheimer’s and
Neurodegenerative Diseases NYC, Nov 2019)
|
• |
In preclinical studies, immunization of non-human primates (NHPs) with ACI-35.030 lead to enhanced and more uniform anti-pTau IgG -specific antibody titers with boosting effect compared to ACI-35 (Figure 14).
|
• |
JACI-35.054 is an alternative anti-pTau vaccine comprising a pTau peptide antigen conjugated to an immunogenic carrier protein CRM197, combined with adjuvants
|
• |
CRM197 is a well-defined recombinant protein that is a commercially available version of a non-toxic mutant of diphtheria toxin (DT) A chain and has been shown to be a safe carrier protein in commercial prophylactic vaccines and clinical
trials for a plethora of different vaccine candidates.
|
• |
Immunization of rhesus macaques with JACI-35.054 generates an antibody response that binds to pathological Tau structures in human AD brain.
|
• |
ACI-24 consists of an antigenic peptide (Pal1-15) containing the amino acid sequence 1-15 of the human Abeta1-42 protein, and an adjuvant, formulated as liposomal suspension. Pal1-15 is presented on the surface of the liposomes in a
conformational format mimicking the pathological form of the protein which is recognized by the immune system in order to induce antigen-specific antibody responses against the pathological forms of Abeta. Preclinical data demonstrated
significant activity in plaque reduction and memory restoration. ACI-24 formulations have a favorable safety profile, characterized by a lack of observed local and CNS inflammation and a mechanism of action independent of inflammatory T
cells. ACI-24 formulations are fully owned by AC Immune and have been developed in-house.
|
• |
ACI-24.060’s mechanism of action is similar to the one described with the original formulation of ACI-24. The incorporation of T-cell help epitopes in this optimized formulation is intended to prime, boost and maintain a strong antibody
response against key pathological Abeta species (including oligomeric and pyroglutamate Abeta). The antibodies elicited by the vaccine in NHPs showed clear target engagement by binding to human Abeta plaques on AD patient-derived brain
tissue.
|
• |
ACI-7104 is composed of a short engineered antigenic a-syn peptide. This peptide coupled to a carrier protein facilitates the induction of an a-syn-specific antibody response that binds to toxic aggregated a-syn species with high
selectivity (Mandler-M et al., Acta Neuropathol. 2014).
|
• |
Vaccination of wild-type and transgenic mice, resulted in high antibody titres in plasma, which crossed into the cerebrospinal fluid (CSF) (Mandler-M et al., Acta Neuropathol. 2014) and
recognized a-syn aggregates. Vaccination resulted in a decreased aggregation and accumulation of a-syn oligomers in brains of transgenic animals (Figure 16).
|
• |
Clearance of a-syn was accompanied by reduced neurodegeneration and by improvements in motor and memory deficits in both in vivo models (Mandler-M et al.,
Acta Neuropathol. 2014).
|
• |
In vivo target engagement of induced antibodies was demonstrated by lowering of oligomeric a-syn in CSF of vaccinated subjects (Figure 18B).
|
• |
A highly significant correlation between oligomeric a-syn concentration in CSF and MDS-UPDRS 3 score (motor-symptoms) in PD patients at baseline was shown for the first time.
|
• |
The reduction of oligomeric a-syn in CSF correlated significantly with clinical improvement, the changes in MDS-UPDRS 3 score over time (Figure 18C).
|
• |
Crenezumab binds to multiple forms of Abeta, particularly oligomeric forms, which it binds to with ten times higher affinity than to monomers. This is a desirable property since oligomeric forms of Abeta are believed to be principally
responsible for neurotoxicity in AD.
|
• |
Crenezumab localizes to brain regions rich in oligomers, including the halo around plaques and hippocampal mossy fibers, but not to vascular Abeta (Maloney et al., 2019).
|
• |
Crenezumab has been designed with an IgG4 backbone to reduce effector function on microglia compared with an IgG1 backbone, and to clear Abeta from the brain while limiting inflammation by minimizing FcγR-mediated inflammatory activation
of microglia (Adolfsson et al., J. Neurosci 2012).
|
• |
Due to its capacity to bind to multiple forms of Abeta, with 10-fold higher specificity to oligomers, which are thought to be the most toxic species, crenezumab also protects against oligomer-induced neurotoxicity.
|
• |
Linked to its unique epitope, crenezumab has been shown to promote disaggregation of existing Abeta aggregates and to disrupt their assembly, preventing amyloid plaque formation. The crystal structure reveals binding interactions that
are consistent with this flexible binding profile and provides further explanation for crenezumab’s ability to block aggregation and to promote disaggregation.
|
• |
In the proof-of-concept Phase 2 studies of crenezumab, a positive trend in cognition was observed, with a greater effect on cognition in patients with a milder stage of AD (MMSE 22–26).
|
• |
In the ABBY cognition study, there, was a statistically significant 35% reduction in the rate of cognitive decline in the non-pre-specified milder AD patient population (MMSE 22–26) for the high-dose arm.
|
• |
In the BLAZE biomarker study, the high-dose arm showed a consistent trend of reduced Abeta accumulation in the brain over time, as shown in two independent exploratory analyses of florbetapir-PET data. In addition, results have shown
that crenezumab has the ability to enhance the removal of these proteins from the brain as evidenced by a significant increase in CSF Abeta, confirming target engagement by crenezumab.
|
• |
Phase 2 data from ABBY and BLAZE studies suggested that there were no imbalances in overall rate of AEs, and these were not dose-related, with only one case of asymptomatic ARIA-E (0.4% in ABBY, 0.3% on active pooled) in patients treated
with crenezumab. AEs also included inflammation of the throat and nasal passages, urinary tract infections and upper respiratory infections. However, no patients in the studies experienced SAEs that were believed related to the
administration of crenezumab.
|
• |
A Phase 1 study with higher doses of crenezumab up to 120 mg/kg showed good tolerability with no investigator assessed drug-related SAEs and no events of ARIA-E, supporting the dose of 60 mg/kg in the Phase 3 CREAD clinical trials.
|
• |
The good safety profile and lack of induction of ARIA-E was confirmed in the Phase 3 CREAD and CREAD 2 studies, in which there was no increase in incidence of SAEs compared with placebo.
|
• |
Crenezumab is currently being evaluated in a Phase 2 clinical prevention trial in Colombia, which has enrolled 300 cognitively healthy individuals of whom 200 are genetically predisposed to develop early AD. As of January 2019, two Phase
3 clinical trials, CREAD and CREAD 2, in patients with prodromal-to-mild AD were discontinued after an interim analysis of the CREAD study conducted by our collaboration partner Genentech.
|
• |
a worldwide licensing agreement with Genentech signed in November 2006 (and amended in March 2009, January 2013, May 2014 and May 2015) for crenezumab for AD, under which we may become eligible to receive payments potentially greater
than USD 340 (CHF 314) million, excluding royalties;
|
• |
a worldwide licensing agreement with Genentech signed in June 2012 (and amended in December 2015) for anti-Tau antibodies to treat AD and potentially other indications, under which we may become eligible to receive payments potentially
greater than CHF 400 million, excluding royalties;
|
• |
a worldwide licensing agreement with Janssen signed in December 2014 (and amended in April 2016, July 2017, January 2019 and November 2019) for therapeutic anti-Tau vaccines for AD, and potentially other Tauopathies, under which we may
become eligible to receive payments totaling up to CHF 500 million, excluding royalties;
|
• |
a worldwide licensing and collaboration agreement (LCA) with LMI (formerly Piramal Imaging SA) signed in May 2014 for small-molecule Tau ligands for use as PET tracers under which we may become eligible to receive payments totaling up to
EUR 160 (CHF 167) million, excluding royalties; and
|
• |
a worldwide license agreement with Lilly to research and develop Morphomer Tau small molecules for the treatment of AD and other neurodegenerative diseases, which was entered into in December 2018 (and amended in September 2019 and March
2020). The agreement was deemed effective on January 23, 2019. Under this, we may become eligible to receive payments up to approximately CHF 1.9 billion, excluding royalties.
|
• |
provide constructive regulatory input for development products;
|
• |
ensure smooth regulatory approvals by anticipating hurdles; and
|
• |
build confidence with regulators by continuous communication.
|
• |
create and maintain a corporate quality management system; and
|
• |
ensure cGCP, cGMP, cGLP and current Good Distribution Practice (cGDP) compliance.
|
• |
the completion of preclinical laboratory tests and animal tests conducted under cGLP regulations;
|
• |
the submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical studies commence;
|
• |
obtaining a positive opinion from the ethics committee (Europe)/institutional review board (US) to commence study on human subjects;
|
• |
the performance of adequate and well-controlled human clinical studies to establish the safety and efficacy of the product candidate for each proposed indication and conducted in accordance with cGCP requirements;
|
• |
pre-NDA submission meeting with FDA (highly recommended);
|
• |
the submission to the FDA of an NDA;
|
• |
the FDA’s acceptance of the NDA;
|
• |
satisfactory completion of an FDA Pre-Approval Inspection (PAI) of the manufacturing facilities at which the product is made to assess compliance with cGMP requirements;
|
• |
the FDA’s review and approval of an NDA prior to any commercial marketing or sale of the drug in the US; and
|
• |
having parallel scientific advice from the EMA or Health Technology Assessment body whereby the payors are involved at the outset (Phase 2), which is intended to facilitate the design of clinical studies to target primarily populations
with a high chance of obtaining reimbursement and accelerate the process of time to reimbursement.
|
• |
restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;
|
• |
fines, warning letters or holds on post-approval clinical studies;
|
• |
refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product license approvals;
|
• |
product seizure or detention, or refusal to permit the import or export of products; or
|
• |
injunctions or the imposition of civil or criminal penalties.
|
• |
that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than 5 in 10,000 persons in the EU when the application is made, or that it is intended for the
diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the EU and that without incentives it is unlikely that the marketing of the drug in the EU would generate sufficient return
to justify the necessary investment; and
|
• |
that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorized in the EU or, if such method exists, that the drug will be of significant benefit to those affected by
that condition.
|
• |
the holder of the marketing authorization for the original orphan drug has given its consent to the second applicant;
|
• |
the holder of the marketing authorization for the original orphan drug is unable to supply sufficient quantities of the drug; or
|
• |
the second applicant can establish in the application that the second drug, although similar to the orphan drug already authorized, is safer, more effective or otherwise clinically superior.
|
• |
Manufacturing and batch release—MAHs should guarantee that all manufacturing operations comply with relevant laws and regulations, applicable GMPs, and the product specifications and manufacturing
conditions set out in the marketing authorization, and that each batch of product is subject to appropriate release formalities.
|
• |
Availability and continuous supply—Pursuant to Directive 2001/83/EC, as transposed into the national laws of the Member States, the MAH for a medicinal product and the distributors of the said
medicinal product actually placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medical product to pharmacies and persons authorized to supply medicinal
products so that the needs of patients in the Member State in question are covered.
|
• |
Pharmacovigilance—MAHs are obliged to establish and maintain a pharmacovigilance system, including a qualified person responsible for oversight, to submit safety reports to the regulators and to
comply with the good pharmacovigilance practice guidelines adopted by the EMA.
|
• |
Advertising and promotion—MAHs remain responsible for all advertising and promotion of their products, including promotional activities by other companies or individuals on their behalf, and in
some cases must conduct internal or regulatory pre-approval of promotional materials. Regulation in this area also covers interactions with healthcare practitioners and/or patient groups, and in some jurisdictions legal or self-regulatory
obligations to disclose such interactions exist.
|
• |
Medical affairs/scientific service—MAHs are required to disseminate scientific and medical information on their medicinal products to healthcare professionals, regulators and patients.
|
• |
Legal representation and distributor issues—MAHs are responsible for regulatory actions or inactions of their distributors and agents.
|
• |
Preparation, filing and maintenance of the application and subsequent marketing authorization— MAHs must maintain appropriate records, comply with the marketing authorization’s terms and
conditions, fulfill reporting obligations to regulators, submit renewal applications and pay all appropriate fees to the authorities. We may hold any future marketing authorizations granted for our product candidates in our own name, or
appoint an affiliate or a collaboration partner to hold marketing authorizations on our behalf. Any failure by an MAH to comply with these obligations may result in regulatory action against an MAH and ultimately threaten our ability to
commercialize our products.
|
Location
|
Primary Function
|
Approximate Size
|
||
École Polytechnique Fédérale Lausanne (EPFL)
Innovation Park Building B,
1015 Lausanne, Vaud, Switzerland
|
Headquarters
Research, discovery, preclinical and clinical development
Chemistry manufacturing and control
|
27,000 square feet
|
||
1230 Avenue of the Americas
Suite 1634
New York, New York 10020
|
US operations
|
1,600 square feet
|
• |
A right-of-use license;
|
• |
Clinical milestone payments: payable upon commencement of each of Phase 1 and Phase 2 of clinical developments, and upon the earlier of Genentech’s decision to authorize Phase 3 or the
commencement of Phase 3 of clinical developments. In addition, for a second indication, clinical milestone payments would be payable upon commencement of Phase 2 of clinical developments and upon the earlier of Genentech’s decision to
authorize Phase 3 or the commencement of Phase 3 of clinical developments;
|
• |
Regulatory milestone payments: payable upon making regulatory filings in the US and Europe, respectively, and milestone payments upon obtaining marketing approval in each of the US and Europe. In
addition, for a second indication, additional regulatory and approval milestones would be payable.
|
• |
Royalties: payable on sales, with different royalty rates applicable in the US and Europe. Royalty levels are tied to annual sales volumes. We may receive
royalties on sales of crenezumab with the percentage rates ranging from the mid-single digits to mid-teens.
|
• |
A right-of-use license.
|
• |
Preclinical and clinical milestone payments: payable upon selection of a lead candidate and commencement of each of Phase 1, 2 and 3 of clinical development. In addition, for a second indication,
clinical milestone payments would be payable upon commencement of each of Phase 2 and 3 of clinical development.
|
• |
Regulatory milestone payments: payable upon making regulatory filings for marketing approvals in each of the US, Europe and Japan. In addition, for a second indication, similar regulatory
milestones would be payable.
|
• |
Commercialization milestones: payable upon making a first commercial sale in each of the US, Europe and Japan. For a second indication, commercialization milestones exist for each of the US,
Europe and Japan, which are triggered by the first commercial sale for the second indication in each of those jurisdictions.
|
• |
Royalties: payable on sales with royalty rates differing based on the source of the intellectual property underlying the commercial product. We may receive royalties on sales at a percentage rate
ranging from the mid-single digits to low-double digits
|
• |
A right-of-use license.
|
• |
Clinical milestone payments: payable upon reaching certain milestones in the Phase 1b study, commencement of the first Phase 2b or 2b/3 of clinical development, upon reaching enrollment thresholds
in the first Phase 2b or Phase 2b part of the first Phase 2b/3, commencement of the first Phase 3 or Phase 3 part of a Phase 2b/3 study. In addition, for a second indication, clinical milestone payments would be payable upon commencement of
a Phase 3 clinical study, which would be payable concurrently with the first regulatory milestone, if Janssen were to file for regulatory approval based on Phase 2 clinical data.
|
• |
Regulatory milestone payments: payable upon making regulatory filings in the US, Europe, and Japan, respectively. In addition, for a second indication, similar regulatory milestones would be
payable. For a second indication, additional regulatory milestone payments are payable by Janssen to us upon receipt of each of the regulatory approvals in the US, Europe and Japan.
|
• |
Commercialization milestones: payable upon making a first commercial sale in each of the US, Europe and Japan, and upon achieving certain commercial milestones.
|
• |
Royalties: payable on sales, with royalty rates differing based on the level of annual sales. We may receive royalties on sales at a percentage rate ranging from the high-single digits to the
mid-teens for the phospho-tau vaccine program.
|
• |
A right-of-use license.
|
• |
Clinical milestone payments: payable upon the commencement of the Phase 1, 2 and 3 studies for generation of data intended to support a regulatory submission in the US or the EU. We would be
entitled to further clinical milestone payments for the commencement of a Phase 2 and 3 study for a second indication.
|
• |
Regulatory milestone payments: payable upon acceptance of Regulatory filing (NDA) and Regulatory approval for Commercialization in the US or the EU.
|
• |
Commercialization milestones: tied to specific annual net sales amounts.
|
• |
Royalties: payable on sales, with royalty rates differing based on the level of annual sales. We may receive royalties on sales at a percentage rate ranging from the mid-single digits to the
low-teens.
|
• |
An exclusive license: granted by us to Lilly under certain of our intellectual property to develop,
|
• |
Clinical milestone payments: payable upon completion of the Lilly preclinical activities period and following the first patient dosed in a Phase 2 and Phase 3 clinical study of a licensed product
in the US or the EU.
|
• |
Regulatory milestone payments: payable within 60 days after obtaining regulatory approval for any licensed product in the first indication and any licensed product in certain additional
indications in the US, Europe and Japan, respectively.
|
• |
Commercialization milestones: payable upon achieving certain commercial sales milestones.
|
• |
Royalties: payable on sales with royalty rates differing based on the level of annual sales of licensed products. We may receive royalties on sales at a percentage rate ranging from the low double-digits to the mid-teens.
|
• |
communicating with our applicable personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or
otherwise notified of actual costs;
|
• |
estimating and accruing expenses in our consolidated financial statements as of each balance sheet date based on facts and circumstances known to us at the time; and
|
• |
periodically confirming the accuracy of our estimates with selected providers and adjusting, if necessary.
|
• |
fees paid to CROs in connection with preclinical and toxicology studies and clinical studies;
|
• |
fees paid to investigative sites in connection with clinical studies;
|
• |
fees paid to CMOs in connection with the production of our product candidates prior to qualifying for capitalization as inventory; and
|
• |
professional service fees for consulting and related services.
|
Assumption
|
Method of estimation
|
||
●
|
Estimated expected term of options
|
●
|
Simplified method
|
●
|
Expected volatility
|
●
|
Estimate based on average historical volatilities of common shares of comparable publicly traded companies. We will continue to apply this process to grants made as a public company until a sufficient amount
of historical information regarding the volatility of our own stock price becomes available
|
●
|
Risk-free interest rate
|
●
|
Yields of long-dated Swiss government zero coupon bond issues
|
●
|
Expected dividends
|
●
|
Zero percent as dividends have not been paid
|
●
|
Forfeiture rates
|
●
|
Historical and expected forfeiture data
|
• |
AD;
|
• |
focused non-AD NDD including Parkinson’s disease, ALS and NeuroOrphan indications; and
|
• |
diagnostics.
|
For the Years Ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
Change
|
|||||||||
Contract revenue
|
—
|
15,431
|
(15,431
|
)
|
||||||||
Total revenues
|
—
|
15,431
|
(15,431
|
)
|
• |
a decrease of CHF 14.3 million in our agreement with Lilly. The Company recognized a CHF 10 million milestone as well as CHF 4.3 million for R&D activities in 2020; and
|
• |
a decrease of CHF 1.1 million in our collaboration with Janssen.
|
For the Years Ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
Change
|
|||||||||
Discovery and preclinical expenses
|
19,963
|
20,408
|
(445
|
)
|
||||||||
Clinical expenses
|
14,872
|
17,124
|
(2,252
|
)
|
||||||||
Group function expenses
|
929
|
904
|
25
|
|||||||||
Total Direct R&D
|
35,764
|
38,436
|
(2,672
|
)
|
||||||||
Payroll expenses
|
16,465
|
14,424
|
2,041
|
|||||||||
Share-based compensation
|
1,528
|
1,276
|
252
|
|||||||||
Other non-allocated
|
8,525
|
5,351
|
3,174
|
|||||||||
Total R&D
|
62,282
|
59,487
|
2,795
|
For the Years Ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
Change
|
|||||||||
Operating expenses1
|
44,289
|
43,787
|
502
|
|||||||||
Salaries and related costs2
|
17,993
|
15,700
|
2,293
|
|||||||||
Total research and development expenses
|
62,282
|
59,487
|
2,795
|
• |
a decrease of CHF 2.0 million for the research of alpha-synuclein antibodies.
|
• |
an increase of CHF 0.7 million for the expansion of our Morphomer Tau program into NeuroOrphan indications and the further characterization of our preclinical candidates, CHF 0.5 million for the optimization and development of our
anti-TDP-43 antibody, CHF 0.1 million for our diagnostic imaging agents and CHF 0.4 million in other discovery programs,
|
• |
a decrease of CHF 2.2 million for Phase 1 activities for our Morphomer Tau compound which completed in 2020, CHF 2.0 million for ACI-24 for DS as a result of prior period scaling up activities for a
Phase 2 clinical trial which were not repeated in the current period and CHF 1.8 million for ACI-24 for AD as the six-month safety period completed,
|
• |
an increase of CHF 3.5 million for ACI-35.030 driven by R&D cost sharing, increased patient enrollment into the Phase 1b/2a study and increased frequency of interim analysis testing and CHF 0.2 million for other clinical programs.
|
• |
an increase in salary and benefit related costs of CHF 2.0 million primarily related to the internal reallocation of certain employees’ personnel cost from general and administrative expenses to research and development personnel
expenses in 2021 and the annualization of 2020 hires; and
|
• |
higher share-based compensation expense of CHF 0.3 million related predominantly to an increase of stock options issued to employees.
|
• |
an increase of CHF 2.8 million associated with the reallocation of certain IT and facilities expenditures made in 2021 that were not reclassified in the prior period, CHF 0.3 million in depreciation expense and CHF 0.1 million in other
items.
|
For the Years Ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
Change
|
|||||||||
Operating expenses1
|
7,031
|
7,471
|
(440
|
)
|
||||||||
Salaries and related costs2
|
10,879
|
11,086
|
(207
|
)
|
||||||||
Total general and administrative expenses
|
17,910
|
18,557
|
(647
|
)
|
• |
CHF 2.8 million associated with the reallocation of certain IT and facilities expenditures made in 2021 that were not reclassified in the prior period,
|
• |
a CHF 1.1 million for transaction costs associated with our asset acquisition for a portfolio of therapeutics targeting alpha-synuclein from Affiris,
|
• |
a CHF 0.9 million increase in our directors’ and officers’ insurance for the period; and
|
• |
CHF 0.3 million increase in other administrative expenses.
|
For the Years Ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
Change
|
|||||||||
Other operating income/(expense)
|
1,182
|
1,353
|
(171
|
)
|
||||||||
Total other operating income/(expense)
|
1,182
|
1,353
|
(171
|
)
|
• |
a decrease of CHF 0.3 million in grant income related to activities completed prior to the start of the current period related to our MJFF awards in 2021,
|
• |
an increase of CHF 0.1 million in grant income for activities completed for our Target ALS Foundation award.
|
For the Years Ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
Change
|
|||||||||
Financial income
|
6,485
|
78
|
6,407
|
|||||||||
Financial expense
|
(581
|
)
|
(184
|
)
|
(397
|
)
|
||||||
Exchange differences
|
113
|
(555
|
)
|
668
|
||||||||
Finance result, net
|
6,017
|
(661
|
)
|
6,678
|
• |
an increase of CHF 6.4 million in financial income, predominantly related to a CHF 6.5 million gain on the change in fair value of derivative financial assets associated with two convertible notes sold to certain Affiris affiliated
entities as a result of fair value remeasurements; and
|
• |
a CHF 0.7 million increase in favorable foreign currency exchange differences related to movement in the CHF versus foreign currencies, predominantly the US Dollar and Euro,
|
• |
a CHF 0.4 million increase in financial expense, of which CHF 0.4 million relates to interest expense as many of our CHF-denominated deposit accounts bear negative interest as well as our lease liabilities in
accordance with IFRS 16.
|
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
|
For the Years Ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
Change
|
|||||||||
Net cash provided by (used in):
|
||||||||||||
Operating activities
|
(65,689
|
)
|
(59,517
|
)
|
(6,172
|
)
|
||||||
Investing activities
|
(53,664
|
)
|
28,329
|
(81,993
|
)
|
|||||||
Financing activities
|
40,746
|
(803
|
)
|
41,549
|
||||||||
Net change in cash and cash equivalents
|
(78,607
|
)
|
(31,991
|
)
|
(46,616
|
)
|
• |
The scope, rate of progress, results and cost of our preclinical and clinical studies and other related activities, according to our long-term strategic plan;
|
• |
The cost of manufacturing clinical supplies and establishing commercial supplies of our product candidates and any other products we may develop;
|
• |
The cost, timing and outcomes of regulatory approvals;
|
• |
The costs and timing of establishing sales, marketing and distribution capabilities;
|
• |
The terms and timing of any collaborative, licensing and other arrangements that we may establish, including any required milestone and royalty payments thereunder;
|
• |
The emergence of competing technologies or other adverse market developments; and
|
• |
The potential cost and timing of managing, protecting, defending and enforcing our portfolio of intellectual property.
|
Name
|
Position
|
Age
|
Initial year of
appointment
|
|||
Executive Officers
|
||||||
Andrea Pfeifer, Ph.D.
|
Chief Executive Officer and Director
|
64
|
2003
|
|||
Marie Kosco-Vilbois, Ph.D.
|
Chief Scientific Officer
|
64
|
2019
|
|||
Johannes Rolf Streffer, M.D.
|
Chief Medical Officer
|
53
|
2020
|
|||
Piergiorgio Donati
|
Chief Technical Operations Officer
|
51
|
2019
|
|||
Joerg Hornstein
|
Chief Financial Officer
|
44
|
2017
|
|||
Jean-Fabien Monin
|
Chief Administrative Officer
|
51
|
2009
|
|||
Other Key Employees
|
||||||
Julien Rongère, Ph.D.
|
VP Regulatory Affairs and Quality Assurance
|
44
|
2017
|
|||
Olivier Sol, M.D.
|
VP Head of Clinical Development
|
55
|
2016
|
|||
Alexandre Caratsch
|
General Counsel
|
56
|
2018
|
|||
Bojana Portmann, Ph.D.
|
AVP IP and Business Development
|
42
|
2011
|
|||
Julian Gray, M.D., Ph.D.
|
Clinical Advisor
|
64
|
2007
|
|||
Mark Danton
|
VP Information Systems, Security and Digital Technologies
|
58
|
2019
|
|||
Non-Executive Directors
|
||||||
Douglas Williams, Ph.D.
|
Chairman and Director
|
63
|
2018
|
|||
Thomas Graney
|
Director
|
57
|
2016
|
|||
Werner Lanthaler, Ph.D.
|
Director
|
53
|
2018
|
|||
Roy Twyman, M.D.
|
Director
|
65
|
2019
|
|||
Carl June, M.D.
|
Director
|
67
|
2020
|
|||
Alan Colowick, M.D.
|
Director
|
59
|
2021
|
|||
Monika Bütler, Ph.D.
|
Director
|
60
|
2021
|
|||
Monica Shaw, M.D.
|
Director
|
43
|
2021
|
• |
review and assess the qualifications, independence, performance and effectiveness of the independent auditor;
|
• |
review the scope of the prospective audit by the independent auditor, the estimated fees, and any other matters pertaining to the audit;
|
• |
approve any audit and non-audit services proposed to be provided by the independent auditor to ensure independent auditor independence;
|
• |
review and assess the independent auditor’s report and management letters and take notice of all comments of the independent auditor on accounting procedures and systems of control, and review the independent auditor’s reports with
management;
|
• |
be responsible for the resolution of disagreements between the management and the independent auditor;
|
• |
review and evaluate the lead audit partner of the independent audit team and confirm and evaluate their rotation;
|
• |
review and discuss all (i) consolidated financial statements, (ii) reports intended for publication and (iii) any other financial statements intended for publication to consider significant financial reporting issues and judgments
made in connection with the preparation of our consolidated financial statements, including any significant changes in our selection or application of accounting principles;
|
• |
approve the quarterly condensed consolidated financial statements;
|
• |
review with the management, personnel responsible for the design and implementation of the internal audit function, and the independent auditor in separate meetings any analysis or other written communication prepared by the
management and/or the independent auditor setting forth significant financial reporting issues and judgments made in connection with the preparation of the consolidated financial statements, including critical accounting policies, the
effect of regulatory and accounting initiatives, and off-balance sheet transactions and structures on our consolidated financial statements;
|
• |
review in cooperation with the independent auditor and the management whether the accounting principles applied are appropriate in view of our size and complexity;
|
• |
periodically review our policies and procedures for risk management and assess the effectiveness thereof, including discussing with management our major financial risk exposures and the steps that have been taken to monitor and
control such exposure;
|
• |
discuss with management and external advisors any legal matters that may have a material impact on our consolidated financial statements and any material reports or inquiries from regulatory or governmental agencies that could
materially impact our contingent liabilities and risks;
|
• |
review our disclosure controls and procedures and internal control over financial reporting, including significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting;
|
• |
establish procedures for the receipt, retention and treatment of complaints received regarding accounting, internal accounting controls or auditing matters, and the confidential, anonymous submission by employees of concerns
regarding questionable accounting or auditing matters; and
|
• |
review and approve or ratify any related-person transaction in accordance with our related-person transaction policy.
|
• |
recommend to the board the guidelines for the overall compensation and equity awards for the board of directors and executive officers along with the rationale for such recommendations;
|
• |
recommend to the board the compensation of executive officers;
|
• |
propose the maximum total compensation of the board of directors and executive officers for approval at the Annual General Meeting;
|
• |
periodically review policies and principles for the Company’s corporate governance;
|
• |
establish the process for assessment of the performance of members of the board, its committees and individual members;
|
• |
prepare and reviews the Company’s succession plan for members of the board and the executive committee;
|
• |
periodically review the Company’s code of conduct and recommends changes as needed;
|
• |
recommend for presentation to our shareholders the compensation report for shareholder vote; and
|
• |
define guidelines for the selection of candidates for election or re-election as members of the board and our executive officers.
|
• |
each person, or group of affiliated persons, known by us to own beneficially 5% or more of our outstanding common shares;
|
• |
each of our executive officers and directors; and
|
• |
all executive officers and directors as a group.
|
Shareholder
|
Number
|
Shares
beneficially
owned (%)
|
||||||
5% Shareholders
|
||||||||
dievini Hopp BioTech holding GmbH & Co KG1
|
18,041,000
|
21.6
|
%
|
|||||
Varuma AG2
|
11,999,999
|
14.4
|
%
|
|||||
Affiris AG3
|
10,133,474
|
12.1
|
%
|
|||||
Biotechnology Value Fund (BVF) Inc.4
|
7,062,379
|
8.5
|
%
|
|||||
Executive Officers and Directors
|
||||||||
Andrea Pfeifer5
|
2,684,105
|
3.2
|
%
|
|||||
Marie Kosco-Vilbois6
|
*
|
*
|
||||||
Johannes Rolf Streffer7
|
*
|
*
|
||||||
Piergiorgio Donati8
|
*
|
*
|
||||||
Joerg Hornstein9
|
*
|
*
|
||||||
Jean-Fabien Monin10
|
*
|
*
|
||||||
Douglas Williams11
|
*
|
*
|
||||||
Thomas Graney12
|
*
|
*
|
||||||
Werner Lanthaler13
|
*
|
*
|
||||||
Roy Twyman14
|
*
|
*
|
||||||
Carl June15
|
*
|
*
|
||||||
Alan Colowick16
|
*
|
*
|
||||||
Monika Bütler17
|
*
|
*
|
||||||
Monica Shaw18
|
*
|
*
|
||||||
All executive officers and directors as a group (14 persons)
|
3,878,722
|
4.6
|
%
|
• |
certain financial institutions;
|
• |
dealers or traders in securities that use a mark-to-market method of tax accounting;
|
• |
persons holding common shares as part of a hedging transaction, straddle, wash sale, conversion transaction or other integrated transaction or persons entering into a constructive sale with respect to the common shares;
|
• |
US Holders whose functional currency for US federal income tax purposes is not the US dollar;
|
• |
entities classified as partnerships for US federal income tax purposes;
|
• |
tax-exempt entities, “individual retirement accounts” or “Roth IRAs;”
|
• |
persons that received their common shares as compensation;
|
• |
persons that own or are deemed to own 10% or more of our shares, by vote or value; and
|
• |
persons holding common shares in connection with a trade or business conducted outside of the US.
|
• |
a citizen or individual resident of the US;
|
• |
a corporation, or other entity taxable as a corporation, created or organized in or under the laws of the US, any state therein or the District of Columbia; and
|
• |
an estate or trust the income of which is subject to US federal income taxation regardless of its source.
|
For the Years Ended
December 31,
|
||||||||
In CHF thousands
|
2021
|
2020
|
||||||
Audit fees
|
668
|
480
|
||||||
Audit-related fees
|
15
|
18
|
||||||
Total fees
|
683
|
498
|
Articles of Association of AC Immune SA
|
|
Research Collaboration and License Agreement between AC Immune SA Corporation and Genentech, Inc. dated November 6, 2006 (incorporated herein by reference to Exhibit 10.1 to the Company’s Registration Statement on Form F-1 (File No.
333-211714) filed with the SEC on May 31, 2016)
|
|
Amendment to the Research Collaboration and License Agreement between AC Immune SA Corporation and Genentech, Inc. dated May 7, 2015 (incorporated herein by reference to Exhibit 10.2 to the Company’s Registration Statement on Form
F-1 (File No. 333-211714) filed with the SEC on May 31, 2016)
|
|
Research Collaboration and License Agreement between AC Immune SA Corporation and Genentech, Inc. dated June 15, 2012 (incorporated herein by reference to Exhibit 10.3 to the Company’s Registration Statement on Form F-1 (File No.
333-211714) filed with the SEC on May 31, 2016)
|
|
License and Collaboration Agreement between Piramal Imaging Ltd., Piramal Imaging SA and AC Immune SA, dated May 9, 2014 (incorporated herein by reference to Exhibit 10.4 to the Company’s Registration Statement on Form F-1 (File No.
333-211714) filed with the SEC on May 31, 2016)
|
|
License, Development and Commercialization Agreement between Janssen Pharmaceuticals, Inc. and AC Immune SA, dated December 24, 2014 (incorporated herein by reference to Exhibit 10.5 to the Company’s Registration Statement on Form
F-1 (File No. 333-211714) filed with the SEC on May 31, 2016)
|
|
Form of Indemnity Agreement (incorporated herein by reference to Exhibit 10.6 to the Company’s Registration Statement on Form F-1 (File No. 333-211714) filed with the SEC on May 31, 2016)
|
|
AC Immune SA 2013 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.7 to the Company’s Registration Statement on Form F-1 (File No. 333-211714) filed with the SEC on May 31, 2016)
|
|
AC Immune SA 2013 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.7 to the Company’s Registration Statement on Form F-1, filed with the SEC on May 31, 2016)
|
|
AC Immune SA 2016 Stock Option and Incentive Plan (incorporated herein by reference to Exhibit 99.08 to the Company’s Report on Form 6-K, filed with the SEC on October 13, 2016)
|
|
License Agreement between AC Immune SA and Eli Lilly and Company, dated December 11, 2018 (incorporated herein by reference to Exhibit 4.14 to the Amendment No. 1 to the Company’s Annual Report on Form 20-F/A, filed with the SEC on
April 19, 2019)
|
|
Convertible Note Agreement between AC Immune SA and Eli Lilly and Company, dated December 11, 2018 (incorporated herein by reference to Exhibit 4.15 to the Company’s Annual Report on Form 20-F, filed with the SEC on March 21, 2019)
|
|
First Amendment to License Agreement between AC Immune SA and Eli Lilly and Company, dated September 19, 2019 (incorporated herein by reference to Exhibit 10.1 to the Company’s Report on Form 6-K, filed with the SEC on September 20,
2019)
|
|
Second Amendment to License Agreement between AC Immune SA and Eli Lilly and Company, dated March 20, 2020 (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 6-K (File No. 001-37891) filed with
the SEC on March 23, 2020)
|
|
Open Market Sale Agreement, dated as of May 5, 2021, between AC Immune SA and Jefferies LLC (incorporated herein by reference to Exhibit 1.1 to the Company’s Current Report on Form 6-K (File No. 001-37891) filed with the SEC on May
5, 2021)
|
|
Asset Purchase and Contribution in Kind Agreement, dated as of July 26, 2021, between AC Immune SA and Affiris AG (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 6-K (File No. 001-37891)
filed with the SEC on August 4, 2021)
|
|
Convertible Note Agreement, dated as of July 26, 2021, between AC Immune SA and Santo Venture GmbH (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 6-K (File No. 001-37891) filed with the SEC
on August 4, 2021)
|
* |
Filed herewith
|
AC IMMUNE SA
|
|||
Date: March 22, 2022
|
|||
By:
|
/s/ Andrea Pfeifer
|
||
Name:
|
Andrea Pfeifer
|
||
Title:
|
Chief Executive Officer
|
By:
|
/s/ Joerg Hornstein
|
||
Name:
|
Joerg Hornstein
|
||
Title:
|
Chief Financial Officer
|
Report of independent registered public accounting firm (PCAOB ID 1358)
|
F-2
|
F-4
|
|
F-5
|
|
F-6
|
|
F-7
|
|
F-8
|
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;
|
●
|
Target indication prevalence and incidence rates;
|
●
|
Anticipated market share;
|
●
|
General commercialization expectations such as anticipated pricing and uptake;
|
●
|
Expected patent life and market exclusivity periods; and
|
●
|
Other metrics such as the tax rate
|
8. |
Cash and cash equivalents and financial assets
|
As of
December 31,
|
||||||||
In CHF thousands
|
2021
|
2020
|
||||||
Cash and cash equivalents
|
82,216
|
160,893
|
||||||
Total
|
82,216
|
160,893
|
||||||
By currency
|
||||||||
CHF
|
64,941
|
152,537
|
||||||
EUR
|
2,253
|
4,215
|
||||||
USD
|
15,022
|
4,141
|
||||||
Total cash and cash equivalents
|
82,216
|
160,893
|
As of
December 31,
|
||||||||
In CHF thousands
|
2021
|
2020
|
||||||
Short-term financial assets due in 1 year or less
|
116,000
|
65,000
|
||||||
Total
|
116,000
|
65,000
|
9. |
Prepaid expenses and accrued income
|
As of
December 31,
|
||||||||
In CHF thousands
|
2021
|
2020
|
||||||
Prepaid expenses
|
3,015
|
3,954
|
||||||
Accrued income
|
975
|
1,591
|
||||||
Total
|
3,990
|
5,545
|
10. |
Other current receivables
|
As of
December 31,
|
||||||||
In CHF thousands
|
2021
|
2020
|
||||||
Other current receivable | 101 | — | ||||||
Swiss VAT
|
327
|
309
|
||||||
Withholding tax
|
—
|
20
|
||||||
Total
|
428
|
329
|
11. |
Share capital
|
In CHF thousands
|
||||||||||||||||||||
Common
shares
|
Treasury
shares
|
Share
capital
|
Share
premium
|
Treasury
shares
|
||||||||||||||||
December 31, 2019
|
71,859,431
|
—
|
1,437
|
346,526
|
—
|
|||||||||||||||
Issuance of shares – incentive plans, net of RSU expiration and forfeiture
|
77,307
|
—
|
1
|
364
|
—
|
|||||||||||||||
Issuance of shares to be held as treasury shares, net of transaction costs
|
5,000,000
|
(5,000,000
|
)
|
100
|
—
|
(100
|
)
|
|||||||||||||
December 31, 2020
|
76,936,738
|
(5,000,000
|
)
|
1,538
|
346,890
|
(100
|
)
|
|||||||||||||
Proceeds from sale of treasury shares in public offerings, net of underwriting fees and transaction costs
|
— | 1,171,543 | — | 12,097 | 24 | |||||||||||||||
Asset purchase agreement, net of transaction costs
|
7,106,840 | — | 142 | 54,328 | — | |||||||||||||||
Conversion of note agreements, net of transaction costs
|
3,026,634 | — | 61 | 16,683 | — | |||||||||||||||
Issuance of shares – incentive plans, net of transaction costs
|
237,258
|
—
|
5
|
1,253
|
—
|
|||||||||||||||
Issuance of shares to be held as treasury shares, net of transaction costs
|
2,393,160
|
(2,393,160
|
)
|
48
|
—
|
(48
|
)
|
|||||||||||||
December 31, 2021
|
89,700,630
|
(6,221,617
|
)
|
1,794
|
431,251
|
(124
|
)
|
12. |
Trade and other payables and accrued expenses
|
As of
December 31,
|
||||||||
In CHF thousands
|
2021
|
2020
|
||||||
Trade and other payables
|
2,003
|
2,184
|
||||||
Total trade and other payables
|
2,003
|
2,184
|
||||||
Accrued research and development costs
|
10,361
|
5,298
|
||||||
Accrued payroll expenses
|
3,562
|
3,494
|
||||||
Accrued stamp duty |
778 | — | ||||||
Accrued liabilities |
952 | 686 | ||||||
Other accrued expenses
|
1,083
|
1,607
|
||||||
Total accrued expenses
|
16,736
|
11,085
|
13. |
Contract revenues
|
For the years ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
2019
|
|||||||||
Lilly
|
—
|
14,348
|
105,662
|
|||||||||
Genentech
|
—
|
—
|
—
|
|||||||||
Janssen
|
—
|
1,083
|
1,173
|
|||||||||
Life Molecular Imaging
|
—
|
—
|
2,206
|
|||||||||
Biogen
|
—
|
—
|
1,063
|
|||||||||
Other
|
—
|
—
|
352
|
|||||||||
Total contract revenue
|
—
|
15,431
|
110,456
|
In CHF Thousands
|
Balance at
the beginning
of the
reporting
period
|
Additions
|
Deductions
|
Balance at
the end
of the
reporting
period
|
||||||||||||
Twelve months ended December 31, 2021:
|
||||||||||||||||
Accrued income
|
1,591
|
1,635
|
(2,251
|
)
|
975
|
|||||||||||
Deferred income
|
306
|
1,635
|
(1,224
|
)
|
717
|
|||||||||||
Twelve months ended December 31, 2020:
|
||||||||||||||||
Accrued income
|
1,095
|
2,354
|
(1,858
|
)
|
1,591
|
|||||||||||
Deferred income
|
4,477
|
1,467
|
(5,638
|
)
|
306
|
For the years ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
2019
|
|||||||||
Revenues recognized in the period from:
|
||||||||||||
Amounts included in the contract liability at the beginning of the period
|
—
|
4,477
|
351
|
|||||||||
Performance obligations satisfied in previous periods
|
—
|
10,000
|
2,206
|
13.1 |
Licensing and collaboration agreements
|
13.2 |
Grant income
|
14. |
Expenses by category
|
For the Years Ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
2019
|
|||||||||
Operating expenses
|
44,289
|
43,787
|
37,465
|
|||||||||
Payroll expenses
|
16,465
|
14,424
|
12,382
|
|||||||||
Share-based compensation
|
1,528
|
1,276
|
585
|
|||||||||
Total research and development expenses
|
62,282
|
59,487
|
50,432
|
For the Years Ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
2019
|
|||||||||
Operating expenses
|
7,031
|
7,471
|
6,637
|
|||||||||
Payroll expenses
|
8,281
|
8,274
|
7,172
|
|||||||||
Share-based compensation
|
2,598
|
2,812
|
2,249
|
|||||||||
Total general and administrative expenses
|
17,910
|
18,557
|
16,058
|
For the Years Ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
2019
|
|||||||||
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
|
15. |
Related-party transactions
|
For the years ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
2019
|
|||||||||
Short-term employee benefits
|
4,403
|
3,497
|
3,526
|
|||||||||
Post-employment benefits
|
266
|
214
|
215
|
|||||||||
Share-based compensation
|
2,997
|
2,578
|
2,155
|
|||||||||
Total
|
7,666
|
6,289
|
5,896
|
16. |
Income taxes
|
For the Years Ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
2019
|
|||||||||
Income/(loss) before income tax
|
(72,993
|
)
|
(61,921
|
)
|
45,442
|
|||||||
Tax (benefit)/expense calculated at the domestic rates applicable in the respective countries
|
(9,930
|
)
|
(8,441
|
)
|
6,194
|
|||||||
(Income not subject to tax)/expenses not deductible for tax purposes
|
(375
|
)
|
462
|
(62
|
)
|
|||||||
Effect of unused tax losses and tax offsets not recognized as deferred tax assets
|
10,308
|
7,979
|
(6,132
|
)
|
||||||||
Effective income tax rate (benefit)/expense
|
3
|
—
|
—
|
As of
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
2019
|
|||||||||
Unrecognized deductible temporary differences, unused tax losses and unused tax credits
|
||||||||||||
Deductible temporary differences, unused tax losses and unused tax credits for which no deferred tax assets have been recognized are attributable to the following:
|
||||||||||||
Tax losses
|
197,152
|
121,948
|
64,125
|
|||||||||
Deductible temporary differences related to:
|
||||||||||||
Right-of-use assets and lease liabilities, net
|
—
|
—
|
—
|
|||||||||
Retirement benefit plan
|
7,098
|
7,464
|
7,485
|
|||||||||
Total
|
204,250
|
129,412
|
71,610
|
As of
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
2019
|
|||||||||
Tax losses split by expiry date:
|
||||||||||||
December 31, 2024
|
15,231
|
15,231
|
15,231
|
|||||||||
December 31, 2025
|
48,894
|
48,894
|
48,894
|
|||||||||
December 31, 2026
|
—
|
—
|
—
|
|||||||||
December 31, 2027
|
57,824
|
57,824
|
—
|
|||||||||
December 31, 2028
|
75,204 | — | — | |||||||||
Total unrecorded tax loss carryforwards
|
197,153
|
121,949
|
64,125
|
17. |
Retirement benefit plan
|
As of
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
2019
|
|||||||||
Defined benefit obligation
|
(33,889
|
)
|
(30,213
|
)
|
(26,624
|
)
|
||||||
Fair value of plan assets
|
26,791
|
22,749
|
19,139
|
|||||||||
Total liability
|
(7,098
|
)
|
(7,464
|
)
|
(7,485
|
)
|
For the Years Ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
2019
|
|||||||||
Service cost
|
1,648
|
1,626
|
1,313
|
|||||||||
Interest cost
|
79
|
71
|
195
|
|||||||||
Interest income
|
(48
|
)
|
(42
|
)
|
(133
|
)
|
||||||
Net pension cost
|
1,679
|
1,655
|
1,375
|
A. |
Change in defined benefit obligation
|
For the Years Ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
2019
|
|||||||||
Defined benefit obligation as of January 1
|
(30,213
|
)
|
(26,624
|
)
|
(17,942
|
)
|
||||||
Service cost
|
(1,648
|
)
|
(1,626
|
)
|
(1,313
|
)
|
||||||
Interest cost
|
(79
|
)
|
(71
|
)
|
(195
|
)
|
||||||
Change in demographic assumptions
|
—
|
1,428
|
1,138
|
|||||||||
Change in financial assumptions
|
156
|
(71
|
)
|
(2,171
|
)
|
|||||||
Change in experience assumptions
|
(252
|
)
|
(931
|
)
|
(2,003
|
)
|
||||||
Benefits deposited
|
(894
|
)
|
(1,467
|
)
|
(3,382
|
)
|
||||||
Employees’ contributions
|
(959
|
)
|
(851
|
)
|
(756
|
)
|
||||||
Defined benefit obligation as of December 31
|
(33,889
|
)
|
(30,213
|
)
|
(26,624
|
)
|
B. |
Change in fair value of plan assets
|
For the Years Ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
2019
|
|||||||||
Fair value of plan assets as of January 1
|
22,749
|
19,139
|
12,277
|
|||||||||
Interest income
|
48
|
42
|
133
|
|||||||||
Employees’ contributions
|
959
|
851
|
756
|
|||||||||
Employer’s contributions
|
1,089
|
950
|
859
|
|||||||||
Benefits deposited
|
894
|
1,467
|
3,382
|
|||||||||
Return on plan assets excluding interest income
|
1,052
|
300
|
1,732
|
|
||||||||
Fair value of plan assets as of December 31
|
26,791
|
22,749
|
19,139
|
C. |
Change in net defined benefit liability
|
For the Years Ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
2019
|
|||||||||
Net defined benefit liabilities as of January 1
|
7,464
|
7,485
|
5,665
|
|||||||||
Net pension cost through statement of income/(loss)
|
1,679
|
1,655
|
1,375
|
|||||||||
Remeasurement through other comprehensive income/(loss)
|
(956
|
)
|
(726
|
)
|
1,304
|
|||||||
Employer’s contribution
|
(1,089
|
)
|
(950
|
)
|
(859
|
)
|
||||||
Net defined benefit liabilities as of December 31
|
7,098
|
7,464
|
7,485
|
D. |
Other comprehensive gains/(losses)
|
For the Years Ended
December 31,
|
||||||||||||
In CHF thousands
|
2021
|
2020
|
2019
|
|||||||||
Effect of changes in demographic assumptions
|
—
|
1,428
|
1,138
|
|||||||||
Effect of changes in financial assumptions
|
156
|
(71
|
)
|
(2,171
|
)
|
|||||||
Effect of changes in experience assumptions
|
(252
|
)
|
(931
|
)
|
(2,003
|
)
|
||||||
Return on plan assets excluding interest income
|
1,052
|
300
|
1,732
|
|||||||||
Total other comprehensive gain/(loss)
|
956
|
726
|
(1,304
|
)
|
Discount rate
|
Future salary increase
|
Future pension cost
|
Interest rate on
savings capital
|
|||||||||||||||||||||||||||||
Assumptions
|
0.5% increase
|
0.5% decrease
|
0.5% increase
|
0.5% decrease
|
0.5% increase
|
0.5% decrease
|
0.5% increase
|
0.5% decrease
|
||||||||||||||||||||||||
In CHF thousands
|
||||||||||||||||||||||||||||||||
Potential defined benefit obligation
|
31,190
|
37,006
|
34,578
|
33,176
|
35,497
|
32,435
|
34,822
|
33,007
|
||||||||||||||||||||||||
Decrease/(increase) from actual defined benefit obligation
|
2,699
|
(3,117
|
)
|
(689
|
)
|
713
|
(1,608
|
)
|
1,454
|
(933
|
)
|
882
|
Discount rate
|
Future salary increase
|
Future pension cost
|
Interest rate on
savings capital
|
|||||||||||||||||||||||||||||
Assumptions
|
0.5% increase
|
0.5% decrease
|
0.5% increase
|
0.5% decrease
|
0.5% increase
|
0.5% decrease
|
0.5% increase
|
0.5% decrease
|
||||||||||||||||||||||||
in CHF thousands
|
||||||||||||||||||||||||||||||||
Potential defined benefit obligation
|
27,740
|
33,080
|
30,912
|
29,519
|
31,652
|
28,916
|
31,070
|
29,405
|
||||||||||||||||||||||||
Decrease/(increase) from actual defined benefit obligation
|
2,473
|
(2,867
|
)
|
(699
|
)
|
694
|
(1,439
|
)
|
1,297
|
(857
|
)
|
808
|
18. |
Share-based compensation
|
PLAN
|
Number of
options awarded
(since inception)
|
Vesting conditions
|
Contractual
life of options
|
||||
Share option plan C1
|
6,775,250
|
4 years’ service from grant date
|
10 years
|
||||
2016 SOIP:
|
|||||||
Executives and directors
|
2,643,984
|
1 year, 3 year and 4 years’ service from the date of grant, quarterly and
annually
|
10 years
|
||||
Employees
|
1,354,431
|
4 years’ service from the date of grant, annually
|
10 years
|
Number of
options
|
Weighted-
average
exercise
price (CHF)
|
Weighted-
average
remaining
term (years)
|
||||||||||
Outstanding at January 1, 2019
|
1,618,856
|
4.25
|
6.3
|
|||||||||
Forfeited during the year
|
(73,699
|
)
|
6.71
|
—
|
||||||||
Exercised during the year
|
(616,833
|
)
|
0.15
|
—
|
||||||||
Granted during the year
|
1,053,305
|
5.24
|
—
|
|||||||||
Outstanding at December 31, 2019
|
1,981,629
|
5.93
|
8.3
|
|||||||||
Exercisable at December 31, 2019
|
602,218
|
4.94
|
6.5
|
|||||||||
Outstanding at January 1, 2020
|
1,981,629
|
5.93
|
8.3
|
|||||||||
Forfeited during the year
|
(53,591
|
)
|
6.03
|
—
|
||||||||
Expired during the year | (26,729 | ) | 4.38 |
— |
||||||||
Exercised during the year
|
(73,669
|
)
|
2.00
|
—
|
||||||||
Granted during the year
|
1,073,027
|
6.29
|
—
|
|||||||||
Outstanding at December 31, 2020
|
2,900,667
|
5.90
|
8.2
|
|||||||||
Exercisable at December 31, 2020
|
1,099,015
|
5.49
|
7.0
|
|||||||||
Outstanding at January 1, 2021
|
2,900,667
|
5.90
|
8.2
|
|||||||||
Forfeited during the year
|
(207,331
|
)
|
6.13
|
—
|
||||||||
Exercised during the year
|
(218,561
|
)
|
4.97
|
—
|
||||||||
Granted during the year
|
1,110,914
|
6.34
|
—
|
|||||||||
Outstanding at December 31, 2021
|
3,585,689
|
6.21
|
7.8
|
|||||||||
Exercisable at December 31, 2021
|
1,613,242
|
6.13
|
6.8
|
Total options
|
Range of
expiration
dates
|
|||||||
Range of exercise prices
|
||||||||
CHF 0.15
|
208,125
|
– |
||||||
CHF 9.53
|
223,646
|
|
||||||
USD 5.04 to USD 12.30
|
3,153,918
|
– |
||||||
Total outstanding options
|
3,585,689
|
For the Years Ended
December 31,
|
||||||||||||
2021
|
2020
|
2019
|
||||||||||
Exercise price (USD)
|
5.31-7.72
|
5.04-9.16
|
5.15-5.54
|
|||||||||
Share price (weighted average)
|
6.95
|
7.11
|
5.41
|
|||||||||
Risk-free interest rate
|
0
|
% |
0
|
% |
0
|
% | ||||||
Expected volatility
|
80
|
%
|
80
|
%
|
80
|
%
|
||||||
Expected term (in years)
|
5.1-6
|
5.5-6
|
5.5-6
|
|||||||||
Dividend yield
|
—
|
—
|
—
|
Grantee type
|
Number of
non-vested
share
awards
granted
|
Vesting conditions
|
Contractual
life of non-
vested
share
awards
|
||||
Restricted share units
|
|||||||
Directors
|
83,864
|
1 year service from date of grant, annually
|
10 years
|
||||
Executives
|
110,839
|
4 years’ service from the date of grant, quarterly
|
10 years
|
Number of
non-vested
shares
|
Weighted-
average
grant date fair
value (CHF)
|
|||||||
Non-vested at January 1, 2019
|
109,041
|
9.51
|
||||||
Forfeited during the year
|
—
|
—
|
||||||
Granted during the year
|
—
|
—
|
||||||
Vested during the year
|
(66,278
|
)
|
9.51
|
|||||
Non-vested at December 31, 2019
|
42,763
|
9.52
|
||||||
Vested and exercisable at December 31, 2019
|
130,290
|
9.58
|
||||||
Non-vested at December 31, 2019
|
42,763
|
9.52
|
||||||
Forfeited during the year
|
(11,828
|
)
|
9.47
|
|||||
Expired during the year
|
(7,804 | ) | 9.52 | |||||
Exercised during the year | (84,638 | ) | 9.51 |
|||||
Granted during the year
|
—
|
—
|
||||||
Vested during the year
|
(23,269
|
)
|
9.52
|
|||||
Non-vested at December 31, 2020
|
19,494
|
9.51
|
||||||
Vested and exercisable at December 31, 2020
|
49,289
|
9.47
|
||||||
Non-vested at December 31, 2020
|
19,494
|
9.51
|
||||||
Exercised during the year
|
(2,471
|
)
|
9.46
|
|||||
Vested during the year
|
(18,697
|
)
|
9.52
|
|||||
Non-vested at December 31, 2021
|
797
|
9.41
|
||||||
Vested and exercisable at December 31, 2021
|
65,515
|
9.48
|
19. |
Commitments and contingencies
|
As of
December 31,
|
||||||||
In CHF thousands
|
2021
|
2020
|
||||||
Within 1 year
|
19,785
|
25,072
|
||||||
Between 1 and 3 years
|
3,620
|
8,885
|
||||||
Between 3 and 5 years
|
243
|
341
|
||||||
More than 5 years
|
51
|
57
|
||||||
Total
|
23,699
|
34,355
|
20. |
Earnings per share
|
For the Years Ended
December 31,
|
||||||||||||
In CHF thousands, except for share and per share data
|
2021
|
2020
|
2019
|
|||||||||
Basic income/(loss) per share (EPS):
|
||||||||||||
Numerator:
|
||||||||||||
Net income/(loss) attributable to equity holders of the Company
|
(72,996
|
)
|
(61,921
|
)
|
45,442
|
|||||||
Denominator:
|
||||||||||||
Weighted-average number of shares outstanding to equity holders
|
74,951,833
|
71,900,212
|
70,603,611
|
|||||||||
Basic income/(loss) for the period attributable to equity holders
|
(0.97
|
)
|
(0.86
|
)
|
0.64
|
|||||||
Diluted income/(loss) per share (EPS):
|
||||||||||||
Numerator:
|
||||||||||||
Net income/(loss) attributable to equity holders of the Company
|
(72,996
|
)
|
(61,921
|
)
|
45,442
|
|||||||
Denominator:
|
||||||||||||
Weighted-average number of shares outstanding to equity holders
|
74,951,833
|
71,900,212
|
70,603,611
|
|||||||||
Effect of dilutive securities from equity incentive plans
|
—
|
—
|
499,730
|
|||||||||
Weighted-average number of shares outstanding – diluted to equity holders
|
74,951,833
|
71,900,212
|
71,103,341
|
|||||||||
Diluted income/(loss) for the period attributable to equity holders
|
(0.97
|
)
|
(0.86
|
)
|
0.64
|
As of
December 31,
|
||||||||||||
2021
|
2020
|
2019
|
||||||||||
Share options issued and outstanding (in-the-money)
|
1,140,388
|
412,191
|
1,081,836
|
|||||||||
Restricted share awards subject to future vesting
|
6,264
|
28,418
|
—
|
|||||||||
Convertible shares
|
41,461
|
—
|
911,261
|
|||||||||
Total
|
1,188,113
|
440,609
|
1,993,097
|
21. |
Financial instruments and risk management
|
As of
December 31,
|
||||||||
In CHF thousands
|
2021
|
2020
|
||||||
Financial assets
|
||||||||
Right-of-use assets |
2,914 |
2,223 |
||||||
Long-term financial assets
|
363
|
334
|
||||||
Other current receivables
|
428
|
329
|
||||||
Short-term financial assets
|
116,000
|
65,000
|
||||||
Cash and cash equivalents
|
82,216
|
160,893
|
||||||
Total financial assets
|
201,921
|
228,779
|
As of
December 31,
|
||||||||
In CHF thousands
|
2021
|
2020
|
||||||
Financial liabilities
|
||||||||
Long-term lease liabilities
|
2,340
|
1,780
|
||||||
Trade and other payables
|
2,003
|
2,184
|
||||||
Accrued expenses
|
16,736
|
11,085
|
||||||
Short-term lease liabilities
|
570
|
443
|
||||||
Total financial liabilities
|
21,649
|
15,492
|
22. |
Capital risk management
|
23. |
Subsequent events
|
1 Year AC Immune Chart |
1 Month AC Immune Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions