Madrigal Q2 and updates

 

• Resmetirom new drug application (NDA) submitted to the U.S. Food and Drug Administration
• NASH disease education and market development activities expand to support potential first-to-market launch in the U.S.

• Madrigal announced submission of the NDA seeking accelerated approval of resmetirom for the treatment of NASH with liver fibrosis. The clinical development program for resmetirom is comprised of 18 clinical studies supporting the NDA: twelve Phase 1 studies, two Phase 2 studies, and four Phase 3 studies.
• Madrigal presented the Phase 3 MAESTRO-NASH primary results during the opening general session of the EASL Congress™. This first scientific presentation of detailed MAESTRO-NASH results confirmed achievement of the primary endpoints across multiple patient subgroups. Noninvasive imaging and biomarker data supported findings on liver biopsy and demonstrated broad treatment response to resmetirom. Further analyses of the results reinforced the resmetirom safety and tolerability profile.
• Madrigal highlighted its support for International NASH Day and announced expanded partnerships with patient advocacy groups focused on NASH disease education.
• Madrigal launched Taking on Fatty Liver and NASH, a new disease education campaign and website that is designed to educate, inform, and inspire people with NASH with liver fibrosis to find the right care team, understand their risk, and manage their liver health. It provides information about NASH disease progression, noninvasive testing options, and community resources from patient advocacy groups.
• The Institute for Clinical and Economic Review (ICER) published a Final Evidence Report for its value assessment of resmetirom and obeticholic acid. The Evidence Report indicates that resmetirom has the potential to be a cost-effective treatment for patients with at-risk NASH.

Financial Results for the Six Months Ended June 30, 2023

As of June 30, 2023, Madrigal had cash, cash equivalents and marketable securities of $298.4 million, compared to $358.8 million at December 31, 2022. The decrease in cash and marketable securities resulted primarily from cash used in operations of $159.4 million, partially offset by the capital raised under the Loan Facility (“Loan Facility”) with Hercules Capital, Inc. (“Hercules”) and our at-the-market sales agreement.

Operating expenses were $86.5 million and $164.8 million for the three month and six month periods ended June 30, 2023, compared to $70.3 million and $127.9 million in the comparable prior year periods.

Research and development expenses for the three and six month periods ended June 30, 2023 were $68.6 million and $130.8 million, compared to $58.5 million and $106.4 million in the comparable prior year periods. The increase is attributable primarily to additional activities related to the Phase 3 clinical trials, and an increase in head count.

General and administrative expenses for the three and six month periods ended June 30, 2023 were $17.8 million and $34.0 million, compared to $11.8 million and $21.4 million in the comparable prior year periods. The increase is due primarily to increases in commercial preparation activities, including an increase in headcount and an increase in non-cash stock compensation.

Interest income for the three and six month periods ended June 30, 2023 was $3.6 million and $7.3 million, compared to $0.3 million and $0.4 million in the comparable prior year periods. The increase in interest income was due primarily to a higher average interest rate in 2023.

Interest expense for the three and six month periods ended June 30, 2023 was $2.9 million and $5.2 million, compared to $0.8 million and $0.8 million in the comparable prior year periods. The increase in interest expense was as a result of the Loan Facility we entered with Hercules.

https://www.biospace.com/article/releases/madrigal-pharmaceuticals-provides-corporate-updates-and-reports-second-quarter-2023-financial-results/