Molecular Partners AG Q4 FY2021 earnings call

R&D Accomplishments - Advanced ensovibep from preclinical to Phase 2 with Novartis, showing efficacy in inhibiting virus, reducing viral load, and protecting patients. - Advanced AMD 506 and MP0310, with a calculated delay but now back on track, testing weekly dosing. - Launched MP0317, a CD40 FAP molecule, with learnings from AMG 506 applicable. - Nominated 533, a tri-specific T-cell engager for AML, moving towards clinic. - Initiated radioligand therapy program with Novartis. - Introduced switch concept for DARPins, a unique technology feature. ### Milestones - Ensovibep in EUA review with Novartis, parallel discussions with governments on stockpiling. - AMD 506 expected to have weekly dosing data shared with Amgen by mid-2022. - MP0317 to have initial data by second half of 2022. - 533 to enter clinic by end of 2022. - Radioligand therapy program ongoing. - Abicipar package gathered for safety, engaging potential collaborators.

No detailed segment performance with revenue contribution percentages provided in the transcript. Total revenues and other income were CHF9.8 million in 2021 compared to CHF9.3 million in 2020. Total expenses were CHF73.2 million in 2021, an increase of CHF5.5 million from 2020.

Financial Guidance - Total revenues and other income in 2021 were CHF9.8 million. - Guiding for CHF75 million to CHF85 million in expenses for 2022, about 10% more than 2021. - Anticipating operational profit and positive cash flows in 2022 due to large collections early in the year. - Cash balance close to CHF300 million by end of February 2022, securing funding into 2025.

Risks - Forward-looking statements may differ materially from future events. - Challenges with targets in AML (CD33, 70, 123) being present on healthy cells, leading to potential on-target side effects like cytokine storm and killing of healthy hemopoietic stem cells.

Q: Please provide insight on timing or progress of EUA for ensovibep, update on EMPATHY trial Part B and subcutaneous versions, and virology candidates.

A: EUA is with Novartis, active process with no fixed timeline. EMPATHY trial Part B and subcutaneous versions under debate, considering different outcomes like viral load reduction. Virology Day in Q2 2022 to provide update on viruses worked on but no nominated candidates yet.

Q: What additional data might be required for EUA approval of ensovibep, plans for Omicron data, and learnings from 310 applicable to 317?

A: Additional data like safety after day 29 and efficacy data. Preclinical Omicron data strong enough for label expansion. Learnings from 310 on weekly dosing and bell-shaped activation curve applicable to 317, with weekly dosing and combination trials in mind.

Q: Clarification on EUA progress, timeline modeling, abicipar meeting with FDA, and finance related to ensovibep royalties.

A: EUA global, Novartis in discussions. Abicipar resubmission of BLA possible with controlled trial. No royalty to University of Zurich for ensovibep, CHF1.5 million paid to University of Utrecht. Ensovibep a pure royalty play with no manufacturing costs on Molecular Partners' side.

Q: Compare ensovibep data package to Lilly's bebtelovimab, and thoughts on endemic COVID and follow-on DARPins.

A: Similarity in neutralizing Omicron, difference in agency engagement history. Working on follow-on DARPins for potential new variants, including ensovibep 2.0.

Q: Surprise on guidance for operating expenses considering cash and future plans, and planning based on ensovibep sales.

A: Programs early, cash impact not high from doubling programs. Conservative spend reflects stages of molecules; if successful, would need to strategically invest more.