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Molecular Partners AG(MOLN) - 2022 Q4 - Annual Report
2023-03-09 21:00
[Executive Summary](index=1&type=section&id=Executive%20Summary) Molecular Partners highlights 2022 achievements, including clinical advancements and a strong financial position with cash runway into 2026 [Overall Highlights and Outlook](index=1&type=section&id=Overall%20Highlights%20and%20Outlook) Molecular Partners highlights 2022 achievements, including MP0533 Phase 1, Radio DARPin Platform progress, and a strong financial position with cash into 2026 - Initiated Phase 1 study of MP0533, a novel tri-specific T-cell engager for the treatment of acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS)[5](index=5&type=chunk) - Established Radio DARPin Therapy (RDT) Platform, formally selecting tumor-associated protein Delta-like ligand 3 (DLL3) as a first target[5](index=5&type=chunk) - Signed a non-binding letter of intent with Novartis in early January 2023 to negotiate a Research Framework Agreement focused on emerging infectious global health threats[5](index=5&type=chunk) - **Net cash inflow from operating activities of CHF 118.6 million** in 2022[5](index=5&type=chunk) - Ongoing strong financial position with **CHF 249.1 million in cash and short-term deposits** as of December 31, 2022, anticipated to support operations into **2026**[5](index=5&type=chunk) - Full year 2023 operating expense guidance of **CHF 70-80 million**, reflecting ambition to further broaden the pipeline in oncology and virology[5](index=5&type=chunk) [Research & Development Highlights](index=1&type=section&id=Research%20%26%20Development%20Highlights) Molecular Partners advanced its oncology and Radio DARPin platforms, halted ensovibep, and regained abicipar rights, pursuing new infectious disease collaborations [Oncology](index=2&type=section&id=Oncology) Oncology pipeline advanced with MP0317 showing tumor-localized CD40 activation and MP0533 initiating Phase 1 for AML/MDS [MP0317](index=2&type=section&id=MP0317) MP0317 Phase 1 interim results showed tumor-localized CD40 activation, good tolerability, with dose escalation recruitment completing H1 2023 - Presented interim results from ongoing Phase 1 trial of MP0317 in November 2022, demonstrating first clinical observation of **tumor-localized CD40 activation**[7](index=7&type=chunk) - MP0317 was **safe and well tolerated** with no dose-limiting CD40-related systemic toxicities[7](index=7&type=chunk) - Patient recruitment in the dose escalation portion of the Phase 1 trial is expected to be completed in the **first half of 2023**[7](index=7&type=chunk) [MP0533](index=2&type=section&id=MP0533) MP0533 Phase 1 study for AML/MDS initiated in January 2023, with preclinical data showing preferential cancer cell killing - First patient dosed in Phase 1 study of MP0533 in January 2023; initial clinical results expected by **Q4 2023**[8](index=8&type=chunk) - Preclinical results showed MP0533 can induce **preferential killing of cells** expressing two or three tumor-associated antigens (TAAs) compared to cells expressing a single TAA, reducing damage to healthy cells[8](index=8&type=chunk) - MP0533 was demonstrated to activate T-cells and destroy AML cells, including leukemic stem cells (LSCs), while sparing hematopoietic stem cells[8](index=8&type=chunk) [Radio DARPin Therapy Platform](index=2&type=section&id=Radio%20DARPin%20Therapy%20Platform) Radio DARPin Therapy Platform advanced by reducing kidney uptake, with DLL3 selected as the first therapeutic target - Progressed Radio DARPin Therapy Platform by reducing kidney uptake of DARPin radio conjugates to overcome nephrotoxicity[9](index=9&type=chunk) - Selected tumor-associated protein Delta-like ligand 3 (DLL3) as the first target of a DARPin-based therapeutic candidate[9](index=9&type=chunk) [Virology](index=2&type=section&id=Virology) Ensovibep clinical development halted due to lack of efficacy, but a new research agreement with Novartis for infectious threats was signed - Clinical development of ensovibep was halted in 2022 due to a lack of neutralization activity against omicron subvariants[11](index=11&type=chunk) - Novartis submitted a request to withdraw ensovibep's EUA from the FDA, effective **January 25, 2023**[12](index=12&type=chunk) - Signed a non-binding letter of intent with Novartis in January 2023 to negotiate a Research Framework Agreement focused on pandemic preparedness and fighting emerging infectious global health threats[12](index=12&type=chunk) [Ophthalmology](index=3&type=section&id=Ophthalmology) Molecular Partners regained abicipar rights for nAMD and DME after positive Phase 3 studies and is evaluating business opportunities - Regained global development and commercial rights to abicipar for nAMD and DME in **November 2021**[13](index=13&type=chunk) - Abicipar completed two positive Phase 3 studies (CEDAR and SEQUOIA) supporting the non-inferior efficacy of its quarterly dosing regimen[13](index=13&type=chunk) [Corporate Governance and ESG](index=3&type=section&id=Corporate%20Governance%20and%20ESG) Molecular Partners implemented leadership changes and advanced ESG initiatives, establishing Board-level oversight and promoting diversity and inclusion [Leadership Changes](index=3&type=section&id=Leadership%20Changes) Molecular Partners announced leadership changes, including CEO's new board role, key promotions, a new General Counsel, and CFO's departure - CEO Patrick Amstutz was elected as President of the Swiss Biotech Association Board of Directors, effective **May 3, 2022**[15](index=15&type=chunk) - Alexander Zürcher was promoted to Chief Operating Officer, and Renate Gloggner to EVP People and Community, both effective **July 1, 2022**[16](index=16&type=chunk) - Michael Pitzner was appointed General Counsel and Senior Vice President of Legal, effective **November 1, 2022**[17](index=17&type=chunk) - CFO Andreas Emmenegger departed the company as of **December 31, 2022**, after more than 15 years[19](index=19&type=chunk) [ESG Initiatives](index=3&type=section&id=ESG%20Initiatives) Molecular Partners published 2022 ESG priorities, established Board-level oversight, and created an ESG Circle to integrate sustainability and DEI - Published environmental, social and governance (ESG) priorities and progress in **2022**[20](index=20&type=chunk) - Formally established corporate sustainability responsibility at a Board level, with the Finance and Audit Committee leading oversight of all ESG policies[21](index=21&type=chunk) - Created an ESG Circle of key internal stakeholders to ensure continued progress across key priorities, including human capital management and Diversity, Equity and Inclusion (DEI)[21](index=21&type=chunk)[22](index=22&type=chunk) [Financial Performance and Outlook](index=1&type=section&id=Financial%20Performance%20and%20Outlook) Molecular Partners reported a **CHF 117.8 million net profit** in 2022, projecting **CHF 70-80 million** operating expenses for 2023 with cash into 2026 [Full Year 2022 Financial Highlights](index=4&type=section&id=Full%20Year%202022%20Financial%20Highlights) Molecular Partners achieved a **CHF 117.8 million net profit** in 2022, driven by increased revenues, maintaining a strong cash position and debt-free balance sheet Key Financials (CHF million, except per share, FTE data) | Key Financials (CHF million, except per share, FTE data) | FY 2022 | FY 2021 | Change | | :--- | :--- | :--- | :--- | | Total revenues and other income | 189.6 | 9.8 | 179.8 | | R&D expenses | (50.7) | (55.7) | 5.0 | | SG&A expenses | (22.3) | (17.5) | (4.8) | | Operating result | 116.6 | (63.4) | 180.0 | | Net finance result | 1.2 | (0.4) | 1.6 | | Net result | 117.8 | (63.8) | 181.6 | | Basic net result per share (in CHF) | 3.63 | (2.06) | 5.69 | | Diluted net result per share (in CHF) | 3.54 | (2.06) | 5.60 | | Net cash from (used in) operating activities | 118.6 | (91.0) | 209.5 | | Cash & cash equivalents (incl. short-term time deposits) | 249.1 | 132.8 | 116.3 | | Total shareholders' equity | 235.2 | 107.3 | 127.9 | | Number of total FTE | 175.3 | 163.2 | 12.1 | - Total revenues and other income increased significantly to **CHF 189.6 million** in 2022 (from CHF 9.8 million in 2021), leading to an operating profit of **CHF 116.6 million** (vs. operating loss of CHF 63.4 million in 2021)[23](index=23&type=chunk) - Net profit for 2022 was **CHF 117.8 million** (vs. net loss of CHF 63.8 million in 2021)[23](index=23&type=chunk) - Net cash from operating activities was **CHF 118.6 million** in 2022 (vs. net cash used of CHF 91.0 million in 2021)[24](index=24&type=chunk) - Cash and short-term deposits stood at **CHF 249.1 million** as of December 31, 2022, an increase of **CHF 116.3 million** from year-end 2021[24](index=24&type=chunk) - The Company's balance sheet continued to be **debt-free** in 2022, and FTEs increased by **7%** year-on-year to **175.3**[25](index=25&type=chunk) [2023 Business and Financial Outlook](index=4&type=section&id=2023%20Business%20and%20Financial%20Outlook) Molecular Partners plans continued investment in clinical assets, with MP0533 results in Q4 2023, and projects **CHF 70-80 million** operating expenses with cash into 2026 - Anticipates initial clinical results of the Phase 1 trial for MP0533 in AML in **Q4 2023**[5](index=5&type=chunk)[28](index=28&type=chunk) - Expects completion of patient recruitment in the dose escalation of MP0317 Phase 1 trial in **H1 2023**[5](index=5&type=chunk)[28](index=28&type=chunk) - Full year 2023 operating expenses are expected to be **CHF 70-80 million** (at constant exchange rates)[5](index=5&type=chunk)[30](index=30&type=chunk) - Based on the cash position as of December 31, 2022, the cash runway is expected to reach into **2026**, excluding any potential receipts from R&D partners[5](index=5&type=chunk)[25](index=25&type=chunk)[30](index=30&type=chunk) [Company Information and Disclosures](index=5&type=section&id=Company%20Information%20and%20Disclosures) This section provides details on company reports, upcoming events, an overview of Molecular Partners AG, forward-looking statement disclaimers, and contact information [Documentation & Events](index=5&type=section&id=Documentation%20%26%20Events) Molecular Partners' 2022 annual reports will be available online, with a conference call on March 10, 2023, and a financial calendar for 2023 events - The Company's Annual Report on Form 20-F for the year ended December 31, 2022, and the annual report 2022 will be made available on www.molecularpartners.com after **March 9, 2023**[31](index=31&type=chunk) - A conference call and audio webcast for the full year 2022 results will be held on **March 10, 14.00 CET (8.00 am EST)**[32](index=32&type=chunk) Financial Calendar 2023 | Date | Event | | :--- | :--- | | April 4, 2023 | Annual General Meeting | | May 11, 2023 | Interim Management Statement Q1 2023 | | August 24, 2023 | Half-year results 2023 (unaudited) | | October 26, 2023 | Interim Management Statement Q3 2023 | [About Molecular Partners AG](index=5&type=section&id=About%20Molecular%20Partners%20AG) Molecular Partners AG is a clinical-stage biotech company developing DARPin therapeutics, partnering with pharmaceutical companies across multiple therapeutic areas - Molecular Partners AG is a clinical-stage biotech company developing DARPin therapeutics, a new class of custom-built protein drugs[35](index=35&type=chunk) - The Company has formed partnerships with leading pharmaceutical companies to advance DARPin therapeutics in ophthalmology, oncology, and infectious disease[35](index=35&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This section cautions that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially - Any statements in this press release that do not describe historical facts may constitute forward-looking statements[36](index=36&type=chunk) - These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected[37](index=37&type=chunk) - Key factors include plans to develop and commercialize product candidates, reliance on third-party partners, ongoing clinical trials, regulatory approvals, and the potential impact of the COVID-19 pandemic[37](index=37&type=chunk) [Contact Information](index=6&type=section&id=Contact%20Information) Contact details for investor relations and communications are provided for inquiries - Investor Relations contact: Seth Lewis, seth.lewis@molecularpartners.com, Tel: **+1 781 420 2361**[38](index=38&type=chunk) - Communications contact: Antonio Ligi, antonio.ligi@molecularpartners.com, Tel: **+41 79 723 36 81**[38](index=38&type=chunk)
Molecular Partners AG(MOLN) - 2022 Q2 - Earnings Call Transcript
2022-08-26 16:58
Financial Data and Key Metrics Changes - The company reported CHF 184.5 million in revenue for the first half of 2022, significantly higher than the previous year, primarily due to a CHF 150 million milestone payment from Novartis for the Ensovibep option [43][46] - Operating profit reached CHF 146.3 million, compared to an operating loss of CHF 34.8 million in the same period last year [47] - Net profit for the first half of 2022 was CHF 148.6 million, a substantial increase from a loss in the previous year [48] Business Line Data and Key Metrics Changes - The revenue from Novartis accounted for CHF 168 million of the total revenue, with the remainder coming from other collaborations [46] - Total operating expenses were CHF 38.3 million, slightly lower than the previous year, with personnel costs at CHF 20.5 million and external R&D at CHF 9.5 million [47] Market Data and Key Metrics Changes - The company has a strong cash position of CHF 285 million, providing a runway into 2026, which is a significant advantage in the current biotech environment [42][16] - The company is not currently paying taxes due to carried forward losses, which amounted to CHF 212 million last year [48] Company Strategy and Development Direction - The company aims to focus on early clinical readouts that provide true patient value, particularly in oncology and infectious diseases [17][18] - The strategy includes leveraging DARPins for unique solutions in drug development, avoiding me-too products [19] - The company is committed to partnerships and collaborations to advance its programs, which is a core aspect of its operational philosophy [20] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges posed by the global biotech crisis but emphasized the company's strong cash position and pipeline as key strengths [10][16] - The company is optimistic about its future, with several programs expected to reach candidate stage in the coming year [66] - Management highlighted the importance of maintaining flexibility in trial designs and partnerships to adapt to the evolving market conditions [92][94] Other Important Information - The company has issued 3.5 million treasury shares as part of a shelf filing, which is a customary practice for U.S. listed companies [45] - The company is exploring the potential for its drug candidates in various markets, including the possibility of addressing local surges in COVID-19 cases outside the U.S. [112] Q&A Session Summary Question: What should investors expect from the data disclosure for 317 later this year? - Management indicated that most data will be shared with potential partners rather than publicly, focusing on demonstrating drug activity and safety [72][74] Question: What is the expected percentage of AML blasts expressing at least two markers in the Phase 1 trial for 533? - Management stated that the co-expression percentage is above 90%, and they expect to see single-agent activity [76][78] Question: What is the timeline for Novartis to start the Phase 3 trial for Ensovibep? - Management noted that the timeline is uncertain due to changing endpoints and the need for agreement on trial design [90][92] Question: Can you elaborate on the causes of inflammation in Abicipar and the processes to remove it? - Management explained that the inflammation was caused by a contaminant in the syringe, which can be addressed by using non-silicon oil syringes [96][98]
Molecular Partners AG(MOLN) - 2022 Q2 - Earnings Call Presentation
2022-08-26 11:46
| --- | --- | --- | --- | |---------------------------------------------------------------|-------|-------|-------| | | | | | | | | | | | | | | | | H1 2022 Corporate Highlights and Financials | | | | | August 26 , 2022 | | | | | Molecular Partners AG, Switzerland (SIX: MOLN, NASDAQ: MOLN) | | | | 1 Disclaimer This presentation contains forward looking statements. Any statements contained in this presentation that do not describe historical facts may constitute forward-looking statements as that term is defi ...
Molecular Partners AG(MOLN) - 2021 Q4 - Earnings Call Transcript
2022-03-16 20:53
Molecular Partners AG (NASDAQ:MOLN) Q4 2021 Earnings Conference Call March 16, 2022 8:00 AM ET Company Participants Seth Lewis - Head, Investor Relations Patrick Amstutz - Chief Executive Officer Andreas Emmenegger - Chief Financial Officer Conference Call Participants Richard Vosser - JPMorgan Georgi Yordanov - Cowen & Company Jo Walton - Credit Suisse Daina Graybosch - SVB Leerink Operator Good morning and thank you for standing by. Welcome to the Publication of Full Year Results 2021. [Operator Instructi ...
Molecular Partners AG(MOLN) - 2021 Q4 - Annual Report
2022-03-15 20:30
EXHIBIT 99.1 Molecular Partners Reports Corporate Highlights From Q4 2021 and Key Financials for Full Year 2021 Research & Development Highlights: Leadership & Governance: Financial: ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., March 15, 2022 (GLOBE NEWSWIRE) -- Ad hoc announcement pursuant to Art. 53 LR: Molecular Partners AG (SIX: MOLN, NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built proteins known as DARPin therapeutics, today announced its corporate highlights ...
Molecular Partners AG(MOLN) - 2021 Q4 - Annual Report
2022-03-15 20:25
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, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...
Molecular Partners (MOLN) Presents at the Credit Suisse Healthcare Conference - Slideshow
2022-03-06 15:07
| --- | --- | --- | --- | |--------------------------------------------------------------------|-------|-------|-------| | | | | | | | | | | | | | | | | Custom Built Biology for Patients Credit Suisse Healthcare Conf. | | | | | March 2022 | | | | | Molecular Partners AG, Switzerland (SIX: MOLN, NASDAQ: MOLN) | | | | 1 Disclaimer This presentation contains forward looking statements. Any statements contained in this presentation that do not describe historical facts may constitute forward-looking statements ...
Molecular Partners (MOLN) presents at JP Morgan 40th Annual Virtual Healthcare Conference (Slideshow)
2022-01-12 20:56
| --- | --- | --- | --- | |-----------------------------------------------------------------------------------|-------|-------|-------| | | | | | | | | | | | Custom Built Biology for Patients 40th Annual JPM Healthcare Conf. January 2022 | | | | | Molecular Partners AG, Switzerland (SIX: MOLN, NASDAQ: MOLN) | | | | 1 Disclaimer This presentation contains forward looking statements. Any statements contained in this presentation that do not describe historical facts may constitute forward-looking statements a ...