AC Immune
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AC Immune(ACIU) - 2022 Q2 - Quarterly Report
2022-07-27 16:00
Exhibit 99.1 The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited). Condensed Consolidated Balance Sheets (Unaudited) (in CHF thousands) Balance Sheets Notes As of June 30, 2022 | --- | --- | --- | --- | |----------------------------------------------------|-------|-----------|-----------| | | | | 2021 | | ASSETS | | | | | Non-current assets | | | | | Property, plant and equipment | 5 | 4,997 | 5,116 | | Right-of-use assets | 6 | 2,632 | 2,914 | ...
AC Immune(ACIU) - 2022 Q1 - Quarterly Report
2022-04-27 16:00
Interim Condensed Consolidated Financial Statements (Unaudited) [Condensed Consolidated Balance Sheets (Unaudited)](index=1&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(Unaudited)) As of March 31, 2022, the company's total assets were CHF 235.5 million, a decrease from CHF 261.4 million at the end of 2021, primarily driven by a reduction in cash and cash equivalents, while total shareholders' equity also decreased to CHF 214.1 million from CHF 232.0 million, mainly due to accumulated losses during the period Condensed Consolidated Balance Sheet Summary (in CHF thousands) | Balance Sheet Items | As of March 31, 2022 | As of December 31, 2021 | | :--- | :--- | :--- | | **Total Assets** | **235,519** | **261,443** | | Total non-current assets | 58,461 | 58,809 | | Total current assets | 177,058 | 202,634 | | *Cash and cash equivalents* | *57,835* | *82,216* | | **Total Shareholders' Equity and Liabilities** | **235,519** | **261,443** | | **Total Shareholders' Equity** | **214,131** | **231,979** | | *Accumulated losses* | *(218,793)* | *(200,942)* | | **Total Liabilities** | **21,388** | **29,464** | | Total non-current liabilities | 9,477 | 9,438 | | Total current liabilities | 11,911 | 20,026 | [Condensed Consolidated Statements of Income/(Loss) (Unaudited)](index=2&type=section&id=Condensed%20Consolidated%20Statements%20of%20Income%2F%28Loss%29%20(Unaudited)) For the three months ended March 31, 2022, the company reported zero contract revenue, consistent with the same period in 2021, with the operating loss increasing to CHF 18.8 million from CHF 17.3 million year-over-year due to higher research and development expenses, resulting in a net loss of CHF 18.8 million and a loss per share of CHF (0.23), unchanged from the prior year Statement of Income/(Loss) Summary (in CHF thousands) | Metric | For the Three Months Ended March 31, 2022 | For the Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Total Revenue | — | — | | Research & development expenses | (15,123) | (13,329) | | General & administrative expenses | (4,166) | (4,338) | | **Operating loss** | **(18,830)** | **(17,251)** | | **Loss for the period** | **(18,848)** | **(16,734)** | | **Basic and diluted loss per share** | **(0.23)** | **(0.23)** | [Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)](index=2&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income%2F%28Loss%29%20(Unaudited)) For the first quarter of 2022, the total comprehensive loss was CHF 18.8 million, composed of the net loss for the period of CHF 18.8 million, slightly offset by a CHF 10 thousand positive currency translation difference, while in the same period of 2021, the total comprehensive loss equaled the net loss of CHF 16.7 million Statement of Comprehensive Income/(Loss) (in CHF thousands) | Item | For the Three Months Ended March 31, 2022 | For the Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Loss for the period | (18,848) | (16,734) | | Other comprehensive income/(loss) | 10 | — | | **Total comprehensive loss, net of tax** | **(18,838)** | **(16,734)** | [Condensed Consolidated Statements of Changes in Equity (Unaudited)](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Equity%20(Unaudited)) Shareholders' equity decreased from CHF 232.0 million at the start of 2022 to CHF 214.1 million as of March 31, 2022, primarily driven by the total comprehensive loss of CHF 18.8 million for the period, which was slightly offset by share-based payments of CHF 1.0 million Changes in Equity for Q1 2022 (in CHF thousands) | Description | Amount | | :--- | :--- | | Balance as of January 1, 2022 | 231,979 | | Total comprehensive loss | (18,838) | | Share-based payments | 989 | | Issuance of shares, net | 1 | | **Balance as of March 31, 2022** | **214,131** | [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(Unaudited)) In the first quarter of 2022, the company used CHF 23.1 million in cash for operating activities, an increase from CHF 17.3 million in the prior-year period, while investing activities used CHF 0.5 million and financing activities used CHF 0.9 million, resulting in a net decrease in cash and cash equivalents of CHF 24.6 million, with the balance falling to CHF 57.8 million at the end of the period Cash Flow Summary (in CHF thousands) | Cash Flow Activity | For the Three Months Ended March 31, 2022 | For the Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash flows used in operating activities | (23,143) | (17,339) | | Net cash flows used in investing activities | (540) | (790) | | Net cash flows (used in)/provided by financing activities | (916) | 7,707 | | **Net decrease in cash and cash equivalents** | **(24,599)** | **(10,422)** | | Cash and cash equivalents at end of period | 57,835 | 151,092 | Notes to the Interim Condensed Consolidated Financial Statements (Unaudited) [Corporate Information](index=5&type=section&id=1.%20Corporate%20information) AC Immune SA is a clinical-stage biopharmaceutical company founded in 2003, focused on developing medicines and diagnostics for neurodegenerative diseases (NDD) like Alzheimer's and Parkinson's, with a strategy built on a three-pillar approach targeting AD, non-AD NDD, and diagnostics, utilizing its two proprietary technology platforms: SupraAntigen (biologics) and Morphomer (small molecules) - The company is a clinical-stage biopharmaceutical firm specializing in neurodegenerative diseases (NDD) associated with protein misfolding[11](index=11&type=chunk) - Corporate strategy is based on three pillars: (i) Alzheimer's Disease (AD), (ii) non-AD NDD (including Parkinson's, ALS, NeuroOrphan indications), and (iii) diagnostics[11](index=11&type=chunk) - Utilizes two proprietary technology platforms: SupraAntigen® for conformation-specific biologics and Morphomer® for conformation-specific small molecules[11](index=11&type=chunk) [Basis of Preparation and Accounting Policies](index=5&type=section&id=2.%20Basis%20of%20preparation%20and%20changes%20to%20the%20Company%27s%20accounting%20policies) The financial statements are prepared in accordance with IAS 34 and are presented in Swiss Francs (CHF), with the company asserting it has sufficient cash (**CHF 57.8 million**) and short-term financial assets (**CHF 116.0 million**) to operate as a going concern for at least 12 months from March 31, 2022, and key accounting estimates involve revenue recognition, clinical accruals, and valuation of its IPR&D asset - The financial statements have been prepared in accordance with International Accounting Standard 34 (IAS 34), Interim Financial Reporting[13](index=13&type=chunk) - The company has been prepared on a going-concern basis, with a cash position of **CHF 57.8 million** and short-term financial assets of **CHF 116.0 million** as of March 31, 2022[23](index=23&type=chunk) - Critical accounting judgments and estimates relate to revenue recognition, clinical development accruals, share-based compensation, and the IPR&D asset[19](index=19&type=chunk) [Contract Revenues](index=6&type=section&id=3.%20Contract%20revenues) The company generated **no contract revenues** for the three months ended March 31, 2022 and 2021, but recognized grant income of **CHF 0.4 million** from the Michael J. Fox Foundation and **less than CHF 0.1 million** from the Target ALS Foundation during the first quarter of 2022 - For the three months ended March 31, 2022 and 2021, AC Immune generated **no contract revenues**[26](index=26&type=chunk) - There were no significant events or transactions related to license and collaboration agreements in Q1 2022[28](index=28&type=chunk) - In Q1 2022, the company recognized **CHF 0.4 million** in grant income from the Michael J. Fox Foundation and **less than CHF 0.1 million** from the Target ALS Foundation[30](index=30&type=chunk)[31](index=31&type=chunk) [Loss Per Share](index=8&type=section&id=4.%20Loss%20per%20share) Basic and diluted loss per share for the first quarter of 2022 was CHF (0.23), identical to the same period in 2021, with the net loss attributable to shareholders being CHF 18.8 million, calculated on a higher weighted-average number of shares (83.5 million) compared to the prior year (72.3 million) Loss Per Share Calculation | Item | For the Three Months Ended March 31, 2022 | For the Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net loss attributable to equity holders (CHF thousands) | (18,848) | (16,734) | | Weighted-average shares outstanding | 83,486,354 | 72,305,949 | | **Basic and diluted loss per share (CHF)** | **(0.23)** | **(0.23)** | - Potentially dilutive securities, including **199,636 share options** and **521 restricted share awards**, were excluded from the calculation as they would be anti-dilutive[33](index=33&type=chunk)[34](index=34&type=chunk) [Property, Plant and Equipment](index=8&type=section&id=5.%20Property%2C%20plant%20and%20equipment) The carrying amount of property, plant, and equipment decreased slightly from CHF 5.1 million to CHF 4.9 million during the first quarter of 2022, with the company investing CHF 0.2 million in lab and IT equipment, while depreciation for the period was CHF 0.5 million Movement in Property, Plant and Equipment (in CHF thousands) | Item | December 31, 2021 | Additions | Depreciation | March 31, 2022 | | :--- | :--- | :--- | :--- | :--- | | **Carrying Amount** | **5,116** | **252** | **(460)** | **4,908** | [Right-of-Use Assets and Lease Liabilities](index=8&type=section&id=6.%20Right-of-use%20assets%20and%20lease%20liabilities) The net book value of right-of-use assets, primarily for buildings, decreased to CHF 2.8 million from CHF 2.9 million due to depreciation of CHF 0.14 million in Q1 2022, with total cash outflow for leases during the quarter being CHF 0.33 million, and the company having undiscounted lease obligations of CHF 2.9 million Lease Impact on Income Statement (in CHF thousands) | Expense Item | For the Three Months Ended March 31, 2022 | For the Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Depreciation of right-of-use assets | 140 | 107 | | Interest expense on lease liabilities | 18 | 14 | | Expense for short-term/low value leases | 174 | 187 | | **Total** | **332** | **308** | - Total undiscounted cash flows for lease obligations as of March 31, 2022, amount to **CHF 2.94 million**[40](index=40&type=chunk) [Accrued Expenses](index=9&type=section&id=7.%20Accrued%20expenses) Accrued expenses decreased significantly from CHF 16.7 million at year-end 2021 to CHF 10.6 million as of March 31, 2022, with the reduction primarily due to a **CHF 3.7 million** payment related to a cost-sharing arrangement with Janssen and a **CHF 2.3 million** payment for performance-related remuneration Accrued Expenses (in CHF thousands) | Date | Amount | | :--- | :--- | | As of December 31, 2021 | 16,736 | | As of March 31, 2022 | 10,571 | - The decrease is mainly due to payments of **CHF 3.7 million** for a cost sharing arrangement with Janssen and **CHF 2.3 million** for performance-related remuneration[41](index=41&type=chunk) [Intangible Assets](index=9&type=section&id=8.%20Intangible%20assets) The company holds a single intangible asset: an acquired In-Process Research and Development (IPR&D) asset for a Parkinson's disease vaccine candidate, with its carrying value remaining unchanged at **CHF 50.4 million** as of March 31, 2022, and the asset is not yet being amortized as it has not obtained market approval, and no impairment was identified during the period - The company's intangible asset is an acquired IPR&D asset, a clinically-validated active vaccine candidate for Parkinson's disease, with a carrying value of **CHF 50.4 million**[42](index=42&type=chunk) - The asset is not currently being amortized because it is not yet ready for use pending market approval[42](index=42&type=chunk) - The IPR&D asset was reviewed for impairment in accordance with IAS 36 and was not determined to be impaired as of March 31, 2022[42](index=42&type=chunk) [Prepaid Expenses](index=10&type=section&id=9.%20Prepaid%20expenses) Prepaid expenses, consisting of prepaid R&D, administrative, and insurance costs, totaled **CHF 2.8 million** as of March 31, 2022, representing a slight decrease from **CHF 3.0 million** at the end of 2021 - Prepaid expenses totaled **CHF 2.8 million** as of March 31, 2022, compared to **CHF 3.0 million** as of December 31, 2021[43](index=43&type=chunk) [Cash, Cash Equivalents, and Short-Term Financial Assets](index=10&type=section&id=10.%20Cash%20and%20cash%20equivalents%20and%20short-term%20financial%20assets) As of March 31, 2022, the company held CHF 57.8 million in cash and cash equivalents and CHF 116.0 million in short-term financial assets, with the cash balance decreasing from CHF 82.2 million at the end of 2021, while short-term financial assets remained unchanged Cash and Financial Assets (in CHF thousands) | Asset Type | As of March 31, 2022 | As of December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | 57,835 | 82,216 | | Short-term financial assets | 116,000 | 116,000 | [Treasury Shares](index=10&type=section&id=11.%20Treasury%20shares) As of March 31, 2022, AC Immune held **6,221,617 treasury shares** in relation to its at-the-market offering program - As of March 31, 2022, the Company has **6,221,617 treasury shares** remaining[45](index=45&type=chunk) [Finance Result, Net](index=10&type=section&id=12.%20Finance%20result%2C%20net) For the first quarter of 2022, the company recorded a net financial loss of **less than CHF 0.1 million**, a shift from a net financial gain of **CHF 0.5 million** in the same period of 2021, with the change primarily driven by lower foreign currency gains (**CHF 0.1 million** in Q1 2022 vs. **CHF 0.5 million** in Q1 2021) - In Q1 2022, the company recorded a net financial loss of **less than CHF 0.1 million**, compared to a net financial gain of **CHF 0.5 million** in Q1 2021[46](index=46&type=chunk) - The result was driven by foreign currency gains of **CHF 0.1 million** and interest expense of **CHF 0.2 million** in Q1 2022[46](index=46&type=chunk) [Subsequent Events](index=10&type=section&id=13.%20Subsequent%20events) Management evaluated events occurring after the balance sheet date through the issuance of the financial statements and determined there were **no events** that required recognition or disclosure - The company has determined that there were **no subsequent events** that warrant disclosure or recognition in these Interim Condensed Consolidated Financial Statements[48](index=48&type=chunk)
AC Immune(ACIU) - 2021 Q4 - Annual Report
2022-03-21 16:00
Product Development and Regulatory Approval - The company currently has no products approved for sale and has invested significantly in the development of ACI-35, ACI-24 for Alzheimer's disease (AD) and Down syndrome (DS), ACI-7104, semorinemab, crenezumab, Morphomer Tau, PI-2620, and its alpha-synuclein PET tracer, all of which are in clinical development[32]. - The company does not expect to generate product revenues for several years, relying heavily on successful clinical development and regulatory approval of its product candidates[32]. - The success of the company's product candidates is contingent upon completing preclinical and clinical studies that demonstrate efficacy, safety, and clinical utility, as well as obtaining marketing approvals from regulatory authorities[32]. - The company has no assurance that any of its product candidates will receive regulatory approval, which is necessary for commercialization[26]. - The company is subject to ongoing obligations and reviews that may result in significant additional expenses related to regulatory compliance[26]. - The successful commercialization of product candidates will depend on adequate coverage and reimbursement levels from governmental authorities and health insurers[46]. - The company faces risks related to regulatory approvals, which are necessary before any product candidates can be marketed[201]. - Clinical studies for product candidates have not yet been completed, which may impact approval timelines[209]. - Delays in clinical studies can arise from regulatory authorization issues, negotiation challenges with CROs, and patient enrollment difficulties[209]. - Compliance with regulatory requirements is critical, as noncompliance can lead to study suspensions[209]. Financial Condition and Funding - The company has a history of losses and anticipates incurring losses for the foreseeable future, which may necessitate delays or reductions in product development programs if additional funding is not secured[25]. - The company incurred a net loss of CHF 73.0 million for the year ended December 31, 2021, with accumulated losses totaling CHF 200.9 million[183]. - The company has never generated any revenue from product sales and relies on upfront and milestone payments from collaboration agreements[186]. - As of December 31, 2021, the company had cash and cash equivalents of CHF 82.2 million and short-term financial assets of CHF 116.0 million, resulting in a total liquidity position of CHF 198.2 million[192]. - The company expects to continue incurring significant operating losses as it advances its research and development efforts for current and future product candidates[184]. - The company anticipates requiring additional capital to develop and commercialize its product candidates, which may not be available on favorable terms[194]. - The company reported tax loss carry-forwards of CHF 197.2 million as of December 31, 2021, which could offset future taxable income[197]. Competition and Market Risks - The company faces intense competition from large biopharmaceutical and pharmaceutical companies, which may have greater financial and technical resources[19]. - The company operates in a highly competitive and rapidly changing industry, which may result in others discovering or commercializing competing products before it does[20]. - The company anticipates that additional competitors could enter the market with generic versions of its products, potentially leading to a material decline in sales[42]. - The company faces risks of product candidates becoming obsolete due to competitors developing safer, more effective, or less expensive alternatives[65]. - The potential market opportunity for the company's product candidates is difficult to estimate and may be smaller than expected[53]. - The company may not achieve market acceptance for its products, adversely affecting its ability to generate revenues[49]. Clinical Development Challenges - The company may experience delays in clinical studies due to patient enrollment challenges, which could increase costs and slow down product development[56]. - If serious adverse effects are identified during development, the company may need to abandon certain product candidates or limit their use[58]. - The company cannot assure that its clinical studies will demonstrate consistent efficacy and safety to obtain regulatory approval[37]. - Variability in patient retention rates during clinical studies may affect data completeness and study outcomes[209]. - The quality or stability of product candidates must meet acceptable standards to avoid delays in clinical trials[209]. - The company relies on CROs and clinical study sites to adhere to cGCP standards, and any failure could result in increased costs and program delays[208]. Strategic Partnerships and Collaborations - The company relies on collaboration partners for clinical development, and these partners may choose to discontinue the development process[32]. - The company may seek to form additional strategic alliances for its product candidates, and failure to realize benefits from such alliances could adversely affect its financial condition[21]. - The company has established partnerships with Genentech, Lilly, Janssen, and LMI for the development and commercialization of various therapeutic products, including anti-Tau antibodies and Morphomer Tau small molecules[111][112][113]. - The collaboration agreements grant partners control over clinical development processes, which may lead to delays or challenges in product commercialization if partners do not fulfill their obligations[113][118]. - The company may seek additional strategic alliances to enhance product development and commercialization prospects, which are critical for financial stability[114][115]. Intellectual Property Risks - Intellectual property risks include the limited lifespan of patents, which may expire before products are commercialized, exposing the company to competition from generics[130][131]. - The company relies on a combination of patents, trade secrets, and confidentiality agreements to protect its intellectual property[138]. - Patent applications may fail to issue or may not cover product candidates effectively, leading to increased competition[141]. - The company may face patent infringement claims from competitors, which could be costly and time-consuming[133]. - The company may struggle to protect its intellectual property rights globally due to varying enforcement laws in different jurisdictions[178]. - Legal proceedings to enforce patent rights in foreign jurisdictions could incur significant costs and divert resources from other business areas[179]. Operational and Compliance Risks - The company is subject to various international risks, including economic instability and differing regulatory requirements, which could adversely impact operations[71]. - The COVID-19 pandemic has caused disruptions in clinical trials and regulatory approvals, potentially affecting business operations[75]. - The company is increasingly dependent on technology systems, making it vulnerable to cyber-attacks that could disrupt operations and development programs[95]. - Data privacy and security breaches pose risks to sensitive information, and the company may incur significant costs related to compliance and remediation efforts[96]. - The evolving regulatory environment regarding data privacy, such as the GDPR, imposes strict obligations that could increase operational costs and affect business practices[102]. - Business disruptions from natural disasters or geopolitical tensions could adversely impact the company's supply chain and clinical trials[105]. Key Personnel and Resource Management - Key personnel retention is critical for the company's success, and competition for qualified personnel is intense[79]. - Limited resources and access to capital necessitate prioritization in the development of product candidates, which may lead to suboptimal decisions and missed opportunities[91]. - The company may face challenges in maintaining adequate liability insurance coverage, which could impair business operations if claims exceed coverage[84].
AC Immune(ACIU) - 2021 Q4 - Annual Report
2022-03-21 16:00
Exhibit 99.2 INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Audited consolidated financial statements — AC IMMUNE SA | --- | --- | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------| | | | | Report of independent registered public accounting firm | | | Consolidated Balance Sheets as of December 31, 2021 and 2020 | F-3 | | Consolidated Statements of Income/ ...
AC Immune(ACIU) - 2020 Q4 - Annual Report
2021-03-22 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...
AC Immune(ACIU) - 2019 Q4 - Annual Report
2020-03-30 13:04
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the fiscal year ended December 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...
AC Immune(ACIU) - 2018 Q4 - Annual Report
2019-03-21 11:51
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the fiscal year ended December 31, 2018 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...