Madrigal Pharmaceuticals Provides Clinical and Business Updates and Reports 2022 Second Quarter Financial Results

Madrigal Pharmaceuticals

CONSHOHOCKEN, PA — Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) recently provided a summary of recent corporate accomplishments and reports its second quarter 2022 financial results.

Paul Friedman, M.D., Chief Executive Officer of Madrigal, stated, “We believe resmetirom, a once-daily oral medication that targets the steatohepatitis and resulting fibrosis in the liver, has the potential to transform the treatment of NASH. As we enter an important period for the company, I’m confident in our strategic plan and operational readiness: we’ve continued to advance our Phase 3 MAESTRO program, expanded our market development activities in the U.S., and improved our financial position with the term loan agreement announced last quarter. Madrigal is well-positioned for the road ahead.”

Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, “The MAESTRO-NAFLD-1 results we recently presented at EASL reinforce our understanding of the favorable safety and tolerability profile of resmetirom, and we remain on track for topline data from the pivotal MAESTRO-NASH biopsy study in the fourth quarter. These studies are intended to serve as the foundation for a new drug application filing for resmetirom in the noncirrhotic NASH population in the first half of next year.”

Remy Sukhija, Chief Commercial Officer of Madrigal, added, “As we continue to lay the foundation for a potential first-to-market launch in the U.S., our engagement with key stakeholders has accelerated in recent months. In June we launched the ‘NASH Explored’ disease education campaign for healthcare providers and announced expanded partnerships with key patient advocacy groups. Additionally, our Market Access and Medical Affairs teams have conducted NASH disease education sessions with payers that together account for more than 80% of all branded prescriptions in the U.S. All stakeholder groups recognize the serious unmet need for approved therapies to treat NASH with liver fibrosis and extensive market research has reinforced our confidence in the commercial potential of resmetirom.”

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Financial Results for the Six Months Ended June 30, 2022

As of June 30, 2022, Madrigal had cash, cash equivalents and marketable securities of $211.8 million, compared to $270.3 million at December 31, 2021. The decrease in cash and marketable securities resulted primarily from cash used in operations of $107.3 million, partially offset by the capital raised under the Loan Facility (“Loan Facility”) with Hercules Capital, Inc. (“Hercules”).

Operating expenses were $70.3 million and $127.9 million for the three month and six month periods ended June 30, 2022, compared to $61.7 million and $114.7 million in the comparable prior year periods.

Research and development expenses for the three and six month periods ended June 30, 2022 were $58.5 million and $106.4 million, compared to $51.6 million and $97.4 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, 2022 were $11.8 million and $21.4 million, compared to $10.1 million and $17.3 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, 2022 was $0.3 million and $0.4 million, compared to $0.1 million and $0.3 million in the comparable prior year periods. The increase in interest income was due primarily to a higher average interest rates in 2022.

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Interest expense for the three and six month periods ended June 30, 2022 was $0.8 million and $0.8 million, compared to $0 million and $0 million in the comparable prior year periods. The increase in interest expense was as a result of the Loan Facility the Company entered with Hercules.

For more information, visit www.madrigalpharma.com.

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