Mirum Pharmaceuticals Inc (MIRM) Reports Robust Revenue Growth and Expanding Commercial ...
Net Product Sales: $178.9 million in 2023, a significant increase from $75.1 million in 2022.
Total Revenue: Grew to $186.4 million in 2023, up 142% from the previous year.
Operating Expenses: Increased to $293.0 million in 2023 from $208.3 million in 2022.
Net Loss: Reported a net loss of $160.9 million in 2023, compared to a net loss of $135.7 million in 2022.
Cash Position: Strong liquidity with cash and cash equivalents of $286.3 million as of December 31, 2023.
2024 Sales Forecast: Expected global net product sales of $310 million to $320 million.
Mirum Pharmaceuticals Inc (NASDAQ:MIRM) released its 8-K filing on February 28, 2024, detailing its financial results for the fourth quarter and year-end 2023. The company, known for its focus on rare and orphan diseases, reported a substantial increase in net product sales, primarily driven by its flagship product, Livmarli, an IBAT inhibitor approved for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS).
Financial Highlights and Business Update
Mirum Pharmaceuticals Inc (NASDAQ:MIRM) achieved a remarkable year-over-year growth in net product sales, totaling $178.9 million for the year 2023, which represents an 89% increase in Livmarli sales alone. The company's total revenue for the year reached $186.4 million, marking a 142% surge compared to the previous year. This growth is attributed to the expansion of Livmarli's commercial reach to 18 countries with reimbursed access and the successful integration of CHOLBAM and CHENODAL into Mirum's portfolio.
Despite the revenue growth, the company's operating expenses also rose to $293.0 million in 2023, up from $208.3 million in 2022. This increase was primarily due to a $32.2 million rise in the cost of goods sold and a $56.8 million increase in sales, general, and administrative expenses. Research and development expenses saw a slight decrease of $4.2 million. As a result, Mirum reported a net loss of $160.9 million for the year, compared to a net loss of $135.7 million in 2022.
Looking ahead, Mirum anticipates continued revenue growth across all approved medicines, with expected global net product sales between $310 million and $320 million for 2024. The company remains well-capitalized with $286.3 million in cash and cash equivalents as of December 31, 2023.
Operational and Regulatory Developments
On the regulatory front, Mirum is poised for several key milestones in 2024. The FDA has set a PDUFA date of March 13, 2024, for Livmarli in progressive familial intrahepatic cholestasis (PFIC). Additionally, the company plans to submit a New Drug Application (NDA) for CHENODAL in cerebrotendinous xanthomatosis (CTX) in the first half of 2024. Interim analyses for the volixibat adult indications in the VISTAS and VANTAGE studies are expected in the first half of 2024.
Chris Peetz, CEO of Mirum, expressed confidence in the company's trajectory, stating, "2023 was a landmark year for Mirum as we significantly expanded our commercial footprint, realizing $179 million in net product sales, and achieved another year of strong global LIVMARLI growth." He further emphasized the company's commitment to delivering life-changing medicines to patients in need.
"In 2024, we look forward to further expanding the reach of our approved medicines, potential LIVMARLI and CHENODAL label expansions and interim analyses for our volixibat adult indications. Operationally and financially, we are well positioned for this next phase of growth," said Chris Peetz.
Mirum's continued focus on its pipeline and the potential for label expansions for its approved products underscore the company's commitment to addressing unmet needs in rare diseases. The financial results and upcoming regulatory milestones position Mirum Pharmaceuticals Inc (NASDAQ:MIRM) for sustained growth and innovation in the biotechnology industry.
For more detailed information, investors and interested parties are encouraged to join Mirum's conference call today, February 28, 2024, at 1:30 p.m. PT/4:30 p.m. ET.
The full financial tables and additional details can be found in the company's 8-K filing.
Explore the complete 8-K earnings release (here) from Mirum Pharmaceuticals Inc for further details.
This article first appeared on GuruFocus.
