Marinus Pharmaceuticals, Inc.

Greetings, everyone, and welcome to the Marinus Pharmaceuticals fourth quarter and full year 2022 financial results and business update call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. If you have a question for us at that time, you may press star one. It is now my pleasure to introduce your host, Sasha Dumanielis, Senior Vice President of Corporate Affairs and Investor Relations. Please go ahead.

Thank you, and good afternoon. With me from Marinus are Dr. Scott Bronstein, Chairman and Chief Executive Officer, Christy Schaefer, Chief Commercial Officer, Dr. Joe Houlihan, Chief Medical Officer, and Steve Fanstil, Chief Financial Officer and Chief Operating Officer. Before we begin, I would like to remind everyone that some of the statements we are making today are forward-looking statements under the securities laws. These forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by such forward-looking statements. These risks and uncertainties and risks associated with our business are described in the company's reports filed with the Securities and Exchange Commission, including Form 10-K, 10-Q, and 8-K. I will now turn the call over to our Chief Executive Officer, Scott Bronstein.

Thank you, Sasha, and welcome to our call. In 2022, we continue to make important progress advancing our oral and IV Ganaxalone programs, driven by the cross-functional commitment of the Marinus team. At the forefront of our achievements was the landmark U.S. approval of the Ptolemy in March and the subsequent commercial launch in late July. Zytomi represents the cornerstone of our rare epilepsy franchise, and its U.S. approval validates our belief in the potential of Ganaxloan's differentiated mechanism of action and our ability to grow the commercial franchise. Importantly, we are pleased to report our first full quarter of sales, which are reflecting robust demand and give us confidence we are meeting the needs of this underserved patient population. Christy will provide further details on our commercial progress, including key launch metrics and an update on payer coverage. In parallel with our first product launch, we made significant progress advancing our broader clinical pipeline, including our second-generation formulation program and our two critically important pivotal trials for both the IV and oral franchise. We remain focused on expanding the value proposition of Ganaxalone for rare epilepsies and believe that a second generation formulation is an important piece of that puzzle. We are pleased with the early data we have seen in our phase one dosing studies, which Joe will discuss shortly, and look forward to seeing this program advance through the clinic. In a very short period of time and with a focused investment, we now see a new and expanded pathway for the oral Ganax Loan franchise. Although it is early, We are also on track to replicate this developmental success with a second generation IV formulation. Furthermore, we believe that the adjustments made to support recruitment and enrollment in the phase three RAISE trial in refractory status epilepticus are trending positively, and we've been met with enthusiasm by a growing number of participating sites. Just this month, I have met live with key investigators from Tampa, Baltimore, and Boston, and they are highly motivated to participate given the unmet medical need in this life-threatening condition. The protocol amendment has been fully implemented, and top-line results continue to be expected in the second half of 2023. I would like to also acknowledge that the other IB programs, RAISE II and RSE for European Registration, and RESET in Established Status continue to press forward. While all three trials progress, we will continue to focus our primary efforts on RAISE, the U.S. pivotal program, and have begun the commercial investments that we believe can help drive a successful U.S. launch. Let's move on to the current oral franchise. We are working closely with the TSC community and will continue to raise awareness around the Phase III Trust TSC clinical trial, which is now recruiting in the U.S. and Europe with additional site activations expected over the coming weeks and months in Canada, Israel, Italy, Belgium, Australia, and China. Last week, Marinus participated in a panel discussion hosted by the TSC Alliance, and we will use these types of forums to continue to educate the community about this clinical trial, one that we believe is first of its kind in a highly refractory TSC population. As we have learned with CDD, Efficacy and tolerability are key attributes to success in the refractory epilepsy population, and we are confident that changes to the titration schedule give us the maximal opportunity for a successful Phase III outcome. We remain on track to disclose top-line data in the first quarter of 2024. I would like to provide an update on the status of the Zetalmi marketing authorization application in Europe. We submitted our day 120 responses to the EMA in November. We received the day 180 report, including a list of outstanding issues in January. The list contained a number of major objections, including our choice of regulatory starting material, which is expected to be the biggest hurdle in bringing this medicine to patients in Europe. The formulation of Zytalmy recently approved in the U.S. contains the same starting material. The CHMP is expected to present its opinion on the EMA in the second quarter of 2023. We remain committed to working closely with the EMA, the advocacy community, and our partners at Orion Corporation to advance this important medicine. There remains a broad global opportunity for Ganaxalone. We announced a collaboration with Tenacia Biotechnology in November 2022 for the development and commercialization of Ganaxalone in China. Tenacia has moved quickly on the regulatory front, and as a result of our combined efforts, we plan to include Chinese sites within the trust TSC trial. Development plans are also underway to maximize the RSC opportunity. We continue to explore additional ex-US commercial alliances, including the MENA region and Japan, and expect to expand the commercial footprint of the Ptolemy in 2023. Before I hand it over to Christy, I want to share some exciting news. We received a notice of allowance from the US Patent and Trademark Office on March 1st for additional claims related to our clinical therapeutic regimen for the treatment of status epilepticus using IV Ganaxolone. This would be our second newly issued patent for the IV franchise. We believe the allowed claims will strengthen our IP portfolio and our status epilepticus program. Additionally, as many of you know, C. Phanfield, since joining the organization nearly two years ago, has played an integral role in the launches of Ptolemy, helped strengthen our balance sheet, and has been an important contributor to our strategic planning. He established himself as a leader within the organization, and has driven a number of important agreements since taking over as Chief Financial Officer. I am pleased to share that Steve will now be taking on the expanded role as Chief Operating Officer in addition to his responsibilities as CFO. Finally, we are pleased to announce the appointment of Christine Silverstein to our Board of Directors and Audit Committee in January. Christine brings a deep capital markets background and extensive expertise in corporate strategic planning, business development, compliance, and risk management. Her financial and strategic acumen, combined with her experience in neurology and rare diseases, make her an outstanding addition to the board. Now, I would like to turn the call over to our Chief Commercial Officer, Christy Schaefer, for updates on the commercial launch of Zitomis.