Benzinga | Jan 6, 2021 04:02PM EST

Chiasma Offers Expected 2021 Milestones

Anticipated 2021 Milestones and Related Guidance:

* Grow MYCAPSSA revenues in the U.S. by building on the progress made with the initial, focused selling effort in the first four months since launch: Chiasma plans to drive adoption for MYCAPSSA with a broader group of physicians by expanding from a 36-person customer-facing team today to an approximately 45-person customer-facing team as market challenges associated with COVID-19 recede and payer coverage continues to expand.

* MYCAPSSA EMA Submission. In mid-2021, Chiasma plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking regulatory approval to market MYCAPSSA to patients with acromegaly in the EU.

* CHIASMA OPTIMAL Open Label Extension Data Oral Presentation at Virtual ENDO 2021. Chiasma plans to present data on longer-term efficacy and safety of MYCAPSSA from the CHIASMA OPTIMAL trial's open-label extension at the virtual 2021 Endocrine Society Annual Meeting (ENDO), which is being held March 20-23.

* Presentation of MPOWERED Phase 3 Data at Medical Conferences and Publication in a Peer Reviewed Medical Journal. Chiasma expects to present MPOWERED Phase 3 data analyses at upcoming endocrinology scientific meetings in spring and in fall 2021 and submit the results of the MPOWERED trial to a peer-reviewed journal for expected publication in 2021.

* 2021 Financial Guidance. Operating expense for the full year 2021 is expected to be in a range of $80 million to $90 million, including estimated stock-based compensation expense in a range of $5 million to $6 million. This guidance is based on the company's current U.S. commercial plans and excludes expenditure for potential EU launch preparations of MYCAPSSA and potential additional new product development programs.