RADNOR, PA - Marinus (NASDAQ:MRNS) Pharmaceuticals, Inc. (NASDAQ:MRNS), a biopharmaceutical company focused on the development of pharmaceutical preparations, announced today that the U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB) has upheld a key patent related to its product.
The patent in question, U.S. Patent No. 11,110,100, covers the use of the drug ganaxolone in treating status epilepticus, a severe form of epilepsy. On March 26, 2024, Ovid Therapeutics (NASDAQ:OVID), Inc. filed a petition seeking Inter Partes Review (IPR) of the patent, challenging its validity.
Marinus Pharmaceuticals filed a preliminary response to the petition on June 26, 2024. On September 20, 2024, the PTAB issued a decision denying the institution of the IPR, stating that Ovid did not demonstrate a reasonable likelihood of showing that the patent was unpatentable.
The PTAB's decision is a significant win for Marinus, as it protects the company's intellectual property rights surrounding ganaxolone. Ovid has the option to request a rehearing or seek director review at the PTAB within 30 days of the decision. However, they cannot appeal the PTAB's decision to the U.S. Court of Appeals for the Federal Circuit.
This development is critical for investors and stakeholders of Marinus Pharmaceuticals, as it ensures the company maintains exclusive rights to the use of ganaxolone for the specified treatment, potentially safeguarding future revenues and strengthening its market position.
The decision from the PTAB is accessible to the public on the official U.S. Patent Office website. The information is based on a press release statement filed with the Securities and Exchange Commission.
In other recent news, Marinus Pharmaceuticals reported significant growth in net product revenues, amounting to $8 million for the second quarter, primarily due to their flagship product, ZTALMY. The company is planning for the potential launch of ZTALMY for tuberous sclerosis complex (TSC) in the second half of 2025, aiming for profitability within 12 to 18 months post-launch.
Despite reporting a net loss before income taxes of $35.8 million for the quarter, Marinus remains on track to meet its revenue guidance for 2024, aiming for net product revenues between $33 million and $35 million.
TD Cowen maintained its Buy rating on Marinus, highlighting the company's $8 million revenue from Ztalmy and a cash reserve of $65 million. The firm is also looking forward to the upcoming Phase III trial results for the treatment of TSC. Moreover, Marinus successfully challenged a patent for IV ganaxolone, previously held by Ovid Therapeutics.
Oppenheimer upgraded its rating on Marinus to Outperform, expressing confidence in the trial design and potential efficacy of ganaxolone. The firm anticipates successful trial outcomes could bolster the case for the stock's upgrade. These are among the recent developments at Marinus Pharmaceuticals.
InvestingPro Insights
The recent patent victory for Marinus Pharmaceuticals (NASDAQ:MRNS) comes at a crucial time for the company, as reflected in its financial metrics. According to InvestingPro data, MRNS has a market capitalization of $91.99 million, with revenue growth of 16.56% over the last twelve months as of Q2 2024. This growth is even more pronounced on a quarterly basis, with a 32.48% increase in Q2 2024.
However, the company faces significant challenges. InvestingPro Tips highlight that MRNS is quickly burning through cash and suffers from weak gross profit margins. This is evident in the negative gross profit of -$67.16 million and an operating income of -$133.19 million over the last twelve months. The company's price has also fallen significantly over the last year, with a -77.85% one-year price total return.
Despite these challenges, there are some positive signals. The stock has shown a strong return over the last three months, with a 40.34% price total return. Additionally, MRNS's liquid assets exceed short-term obligations, providing some financial stability.
For investors considering MRNS, it's worth noting that analysts do not anticipate the company to be profitable this year, according to another InvestingPro Tip. This aligns with the current negative P/E ratio of -0.64.
InvestingPro offers 11 additional tips for MRNS, providing a more comprehensive analysis for those interested in deeper insights into the company's financial health and market position.
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