Mirum Pharmaceuticals shares target raised by JMP Securities on EU approval

On Tuesday, JMP Securities adjusted the price target for Mirum Pharmaceuticals (NASDAQ:MIRM) shares, increasing it to $69 from the previous $68, while retaining a Market Outperform rating.

The firm's decision follows the recent European Union (EU) approval of Mirum's drug, Livmarli, for progressive familial intrahepatic cholestasis (PFIC) patients aged three months and older. This approval is seen as a significant step following the positive Committee for Medicinal Products for Human Use (CHMP) recommendation received in May.

The EU's authorization is expected to aid in broadening the drug's current U.S. label, which, as of March, is approved for PFIC patients five years and older. Mirum Pharmaceuticals has also submitted a supplemental New Drug Application (sNDA) for a higher concentration formulation of Livmarli, aiming to extend its use to younger patients, specifically those one year and older. A further update on this development is anticipated later in the year.

Mirum estimates the combined population of PFIC patients in the U.S. and EU to be around 1,000, which enhances Livmarli's market potential beyond its current scope for approximately 4,000-5,500 Alagille syndrome patients in these regions.

JMP Securities expressed confidence in Livmarli's market position compared to its competitor, Bylvay, suggesting it could become the preferred treatment for newly diagnosed PFIC patients.

The financial performance of Mirum Pharmaceuticals has been robust, with the company reporting $69 million in total net product revenue in the first quarter of 2024, of which Livmarli contributed $43 million.

The company's revenue forecast for 2024 is between $310 million and $320 million, a target that JMP Securities believes is achievable, projecting a revenue estimate of $316 million, slightly above the consensus of $313 million. Achieving the midpoint of this guidance would signify a 67% year-over-year growth.

While management has not provided revenue breakdowns at the therapeutic level, a modest revenue contribution from PFIC is expected as the company continues to secure reimbursement coverage both domestically and internationally.

In other recent news, Mirum Pharmaceuticals received European Commission approval for Livmarli, a treatment for progressive familial intrahepatic cholestasis (PFIC).

This decision was underscored by the inclusion of patients aged 3 months and older, enhancing Livmarli's competitive edge. Stifel reaffirmed its Buy rating on Mirum Pharmaceuticals, expressing optimism for the drug's expansion and the potential for similar FDA approval in the United States.

Simultaneously, Mirum Pharmaceuticals reported promising results from its Phase 2b VANTAGE study of volixibat, a treatment for primary biliary cholangitis (PBC). This led to increased price targets by H.C. Wainwright, Evercore ISI, Morgan Stanley, and Baird.

Furthermore, the company reported a significant increase in its financial results for the first quarter of 2024, with net product sales reaching $68.9 million. It also provided a full-year revenue guidance of between $310 million and $320 million. These are recent developments that indicate the ongoing progress of Mirum Pharmaceuticals.

InvestingPro Insights

Following the positive outlook from JMP Securities on Mirum Pharmaceuticals, InvestingPro data and tips provide additional insights into the company's financial health and market performance. With a market capitalization of $1.69 billion and a significant revenue growth of 133.9% in the last twelve months as of Q1 2024, Mirum's financial trajectory appears strong. Despite the lack of profitability in the past year, as indicated by a negative P/E ratio of -9.81, the company's liquid assets outstripping short-term obligations suggest a stable financial position to support ongoing operations and investment in growth.

InvestingPro Tips highlight that analysts have recently lowered their earnings expectations, and do not foresee profitability for Mirum this year. Nonetheless, the company's stock has been performing well in the market, trading near its 52-week high and showing a robust return of over 43% in the last month. This could be reflective of investor confidence in the company's strategic moves, such as the EU approval of Livmarli and the potential market expansion. Mirum's strong market performance is also evidenced by its price maintaining 98.09% of its 52-week high.

For investors seeking a deeper dive into Mirum Pharmaceuticals' financials and future prospects, there are additional InvestingPro Tips available at https://www.investing.com/pro/MIRM. Use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, and unlock the full array of expert analysis and tips to inform your investment decisions.

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