H.C. Wainwright has maintained its Buy rating and $13.00 price target for Genfit (NASDAQ: GNFT).
The firm's stance follows the recent approval by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for Genfit's partner Ipsen's drug Iqirvo (elafibranor) 80 mg tablets.
The drug has been authorized for the treatment of Primary Biliary Cholangitis (PBC) in adults, to be used in combination with the standard care ursodeoxycholic acid (UDCA) for patients not adequately responding to UDCA, or as a single treatment for those who cannot tolerate UDCA.
The MHRA's approval of Iqirvo as a new treatment option came shortly after the European Commission granted conditional approval for the same medication on September 20, 2024. This marks a significant regulatory milestone for Iqirvo, expanding its potential reach within the European market.
The drug is currently under review by the National Institute for Health and Care Excellence (NICE) in the U.K. to assess reimbursement eligibility for PBC patients, with a decision anticipated later in 2024.
Genfit's collaboration with Ipsen on Iqirvo underscores the company's commitment to addressing unmet needs in the treatment of liver diseases. With the MHRA approval and the ongoing NICE review, Genfit and Ipsen are poised to potentially offer new therapeutic options to PBC patients in the U.K. who have been inadequately served by existing treatments.
In other recent news, Genfit, a biopharmaceutical company, has been highlighted by H.C. Wainwright, which maintained a Buy rating for the company's shares. The focus was on the initiation of royalty payments by Genfit to its partner Ipsen for the drug Iqirvo, used to treat Primary Biliary Cholangitis.
Genfit has initiated the billing process for the first U.S. royalty payments to Ipsen, following the latter's acquisition of global rights to develop and market Iqirvo, barring certain Asian regions.
Since June 2024, Ipsen has been marketing Iqirvo in the U.S, leading to a milestone payment of €48.7 million to Genfit after the first U.S. commercial sale. The company is also entitled to tiered double-digit net sales royalties of up to 20%. These are recent developments that could impact the company's revenue stream.
Genfit is awaiting a decision from the European Commission on market authorization for Iqirvo in Europe, expected in the latter half of 2024. A positive opinion from the EMA's Committee for Medicinal Products for Human Use supports the likelihood of approval. Additionally, pricing and reimbursement approval in three European countries would result in a milestone payment of €26.5 million to Genfit.
Beyond Iqirvo, Genfit is focusing on potential milestones from its programs targeting acute on chronic liver failure and its cholangiocarcinoma candidate, GNS561. With U.S. commercialization in progress and a European decision pending, Genfit's partnership with Ipsen is set to provide ongoing revenue through royalties and potential milestone payments.
InvestingPro Insights
Genfit's recent regulatory successes with Iqirvo are reflected in its strong financial performance and market position. According to InvestingPro data, the company has shown impressive revenue growth, with a 175.45% increase in the last twelve months as of Q2 2024. This growth aligns with the positive developments in the approval and potential commercialization of Iqirvo.
InvestingPro Tips highlight that Genfit's net income is expected to grow this year, and analysts anticipate sales growth in the current year. These projections are consistent with the expanding market opportunities for Iqirvo following its approvals in the UK and EU. Additionally, the company's strong return over the last month (32.88%) and three months (25.82%) suggests that investors are responding positively to these regulatory milestones.
It's worth noting that Genfit operates with a moderate level of debt and its liquid assets exceed short-term obligations, indicating a stable financial position as it moves forward with the commercialization of Iqirvo. For investors seeking more comprehensive analysis, InvestingPro offers 12 additional tips for Genfit, providing a deeper understanding of the company's financial health and market potential.
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