Evoke Pharma, Inc.

Good afternoon, and welcome to the Evoque Pharma fourth quarter and full year 2022 earnings conference call. Currently, all callers have been placed in listen-only mode, and following management's prepared remarks, the call will be opened for questions. If you would like to ask a question at that time, please press star 1 on your telephone keypad. If you need to remove yourself from the queue, press star 2. If at any time you should need operator assistance, press star 0. Please be advised that today's call is being recorded. I will now turn the call over to Daniel Kuntabwate. Thank you, and you may begin.

Daniel Kuntabwate Good afternoon, and thank you for participating in EVOPE Commerce conference call today. With me today are David Garnier, EVOPE's Chief Executive Officer, Chris Questenberry, Jamodi's Chief Commercial Officer from Eversana, and Matthew D'Onofrio, EVOPE's Chief Business Officer. By now, you should have a copy of the press release we issued earlier. If not, it is available on the investor relations page of our website at evokepharma.com. We encourage everyone to read today's press release as well as Evoque's annual report on Form 10-K, which is now filed with the SEC. The company's Form 10-K and earnings release are also available on Evoque's website. Please note that certain information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigations Reform Act. We caution listeners that during this call, management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in EVOKE's press releases and SEC filings, including its annual report on Form 10-K and subsequent filings. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast. EVOKE undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With that, I would now like to turn the call over to David Gagner. Dave?

Thank you, Daniel. Thanks, everyone, for joining us today. I'll start by outlining the important progress Evoque made in 2022 in meeting key strategic goals. I'll also review key events and metrics in the fourth quarter of 2022 and thus far in 2023. I'll then turn the call over to Chris and Matt, who will discuss commercial operations and financials. As I mentioned in today's release, EVOTE's fiscal year 2022 was a period of significant growth and progress on several key fronts. Year-over-year revenues, new Gemoti prescribers, prescription fills, and patient enrollments all showed substantial improvements in 2022 compared to 2021. Looking back in 2021, we focused our attention to Gemoti's value proposition in the marketplace. There was and is a clear unmet need in the market for a non-oral treatment for symptoms associated for diabetic gastroparesis, which for those who are new to the story, is a stomach paralysis caused by the nerve damage that can result from uncontrolled high blood sugars. In such cases, the stomach doesn't empty properly and food and medications may take a long time to leave the stomach and move into the intestines where they need to be to be absorbed. Far too many of the approximately two to three million patients being treated with traditional oral therapeutics for this debilitating disease end up in the ER or take more invasive steps to address their symptoms, of which oral medications simply don't help improve or could have even made symptoms worse. These symptoms can include nausea, vomiting, bloating, abdominal pain, and are often accompanied by dehydration, malnutrition, and erratic blood sugars. Gemoti is our nasal spray formulation of metoclopramide, proven to be an effective medication for treating diabetic gastroparesis. Gemoti is the only FDA-approved nonoral outpatient therapy for gastroparesis, and received FDA approval in June of 2020, and then entered the market in the fourth quarter of 2020. After establishing GEMOTI's viability in the marketplace in 2021 by addressing unmet needs, in 2022 we focused on the following. First, increasing the awareness of and access to GEMOTI as a groundbreaking new treatment for diabetic gastroparesis among patients and their healthcare providers, or HCPs. And those are primarily gastroenterologists. And we did this through face-to-face educational interactions with HCPs by our commercial partner, Eversana, and the sales team, building channel partnerships in conjunction with Eversana to improve access to Gemoti. These include VitaCare, our pharmacy partner, wholly owned by GoodRx, and also Upscript Health, a consumer telehealth platform, and increasing state Medicaid coverage for Gemoti. Second, we succeeded in making progress toward our ultimate objective of having Gemoti become the standard of care for treating diabetic gastroparesis by presenting compelling real-world data at leading medical and scientific forums. And finally, in 2022, we focused on fortifying and enhancing our intellectual property estate to deter potential generic competitors and ensure that Gemoti is the only such product available in the market for as long as possible. And Chris will provide more detail on these areas by expanding on some specific milestones. At Tilgemodi, there has been nothing new to treat gastroparesis in over 40 years since the approval of oral medical opramide and no pharmaceutical company voice in the marketplace. The immense challenge that we have undertaken in upending medical consensus that has been in place for more than four decades simply does not happen overnight. Happily, though, we're making impressive progress in convincing the diabetic gastroparesis treatment community that Jamodi's nasal spray medical mite formulation is an important and needed treatment for patients instead of current oral tablet options. To that point, Jamodi was added to the new gastroparesis guidelines by the American College of Gastroenterology as recommended first-line therapy. This is a very important milestone for Jamodi and Evoke. In September of last year, we announced that Gemoti was nominated for Helio's annual Disruptive Innovators Award under their industry breakthrough category. Gemoti was selected among other novel gastroenterology products from major pharmaceutical companies. Helio is an online source for in-depth specialty clinical information and offers a wide industry accepted news. The Disruptive Innovators Award hosted by Helio is an annual event to honor the trailblazers, movers, and industry personnel that are creating a difference in the field of gastroenterology. And as a nominee for the award, Jamodi was recognized for its role in changing the face of gastroenterology and shifting the status quo towards a betterment of the field. In May 2022, you both participated at DDW at Digestive Disease Week, which is the largest global conference for gastroenterology, and we were pleased to present a poster of distinction to the scientific and clinical experts and key opinion leaders from around the world. The study provided real-world statistics using the largest claims database available, which covers over 80 million lives in the U.S., to assess the incidence of tardive dyskinesia, or TD, for patients taking metoclopramide over a 10-year period. Results for patients that had received metoclopramide demonstrated a lower risk of developing TB than stated in previously reported studies. The data revealed an incidence of TB among gastroparesis patients treated with metoclopramide of just 0.1%. The poster data supports the safety profile of metoclopramide. And the aim of the study was to update the medical literature with current information about the incidence of TD in patients with and without gastroparesis and those taking metoclopramide. By supporting the largest ever real-world study on this important issue, we hope to help HCPs and organizations understand the incidence of TD, recognize patients who might be at higher risk, and revisit the benefit versus the risk of this important compound in patients with gastroparesis. In addition to the new ACG guidelines and Jamodi's first line recommendations, two recent announcements also reveal how we're chipping away at the medical consensus I mentioned earlier. In January of this year, we announced that another of our studies will be presented as an abstract at the Academy of Managed Care Pharmacy, or AMCP, annual meeting taking place this week in San Antonio. The abstract, entitled Real-World Healthcare Resource Utilization of Patients Treated with Metoclopramide Nasal for Diabetic Gastroparesis, is a study of nearly 300 patients using Gemoti that revealed a reduced need to visit the ER or take more invasive steps to treat their condition. These results have been extremely well received with key opinion leaders. Last month, together with Eversana, we reported that yet another abstract was not only accepted but selected for the plenary lecture presentation at the upcoming Digestive Disease Week in Chicago from May 6th to May 9th. This abstract, entitled Reducing Real-World Healthcare Resource Utilization for Patients with Diabetic Gastroparesis Treated with Metaclopramide Nasal Spray versus Oral Metaclopramide, provides compelling healthcare resource utilization data on the effectiveness of Gemoti as a potentially needle-moving solution in the treatment of gastroparesis. For the remainder of 2023 and beyond, we'll continue our strategy of highlighting the benefits of GMODI at important medical meetings and continue to generate new data. Next, as I referred to earlier, fortifying and enhancing EVO's intellectual property estate is a vital component of our strategy to make GMODI brand synonymous with the new treatment paradigm for diabetic gastroparesis. A prime example is the recent successful litigation against generic pharma giant Teva Pharmaceuticals. Last year, we received a Paragraph 4 certification notice letter from Teva. This notice indicated that Teva had submitted an abbreviated new drug application, or ANDA, to FDA, seeking approval to manufacture and sell a generic version of Gemoti prior to the expiration of certain Orange Book-listed patents protecting Gemoti. We initiated a patent infringement lawsuit against Teva and vigorously defended our intellectual property rights protecting the product. And as a result, Teva withdrew its paragraph four for its generic ANDA and will not pursue approval until Gemote's last orange book listed patent expires. And this is currently 2030, but may be extended pending other filed patents. In addition, no further ANDA filer will be eligible to receive 180-day generic exclusivity for an ANDA that references GMODI. This first-to-file regulatory path is typically a highly sought after by generic firms. Consequently, this matter has ended, and we believe the successful outcome reflects the strength of our intellectual property. Furthermore, it strengthens our resolve to defend our rights, particularly against larger, well-resourced companies. During 2022, we also bolstered Gemote's intellectual property estate with key milestones I'll briefly summarize. In December, USPTO issued Evoque a patent under the title Treatment of Moderate and Severe Gastroparesis. This patent expires in 2038 and covers the methods for treating moderate to severe gastroparesis with metoclopramide via the intranasal route of administration. The grant of this patent confirms what we observed in our Phase III trial results from utilizing nasal metoclopramide to treat patients suffering from moderate to severe gastroparesis. In November, the USPTO issued a notice of allowance for a patent application entitled Nasal Formulations of Metoclopramide, which would expire in December 2029. This patent application is a continuation of several other U.S. patents filed by the company over the last decade. And in July, the Canadian Intellectual Property Office granted Evoque a key patent for a previously submitted application entitled Nasal Formulations of Metachloroquine. This patent corresponds to the two other FDA Orange Book listed patents under the same title that expire in 2029 and 2030. The patent covers the methods of use of nasal deliberate metoclopramide for treating diabetic gastroparesis. This Canadian patent expires in 2029 and provides patent protection in another potential market for our novel gastroparesis treatment. We're pleased with the progress we made in 2022 and thus far in 2023 to further establish our proprietary concept of delivering effective medication through the nasal pathway to treat symptoms associated with diabetic gastroparesis. We're eager to further our goal to capitalize on this large and growing market opportunity in the U.S. and abroad. Our intellectual property portfolio now includes FDA Orange Book listed patents and other patents in the EU, Japan, Canada, and Mexico. Before turning the call over to Chris, I want to provide a little color on the fourth quarter of 2022 financial operating results. And Matt will take us through key components of our financials for the quarter and the year as well. As mentioned in today's press release, the fourth quarter saw a slight $36,000 decrease in our net product sales in the third quarter, even though we had an 8% increase in GMODI prescription fills. The reason for this decline after three-quarters of sequential revenue growth in 2022 is straightforward. First, Q4 has more holidays and fewer working days than Q3. Those holidays coincide with the end of the month, which tend to be our stronger weeks, and there were also pharmacy closures due to weather events during that time. And lastly, we experienced a slightly higher number of prescriptions provided to uninsured or underinsured patients. In such circumstances, it devotes practice to offer Gemoti at a discount to those patients in urgent need of gastroparesis symptom relief. We expect to return to positive sequential revenue growth in 2023 as the sales mix returns to levels we saw in the first three quarters of 2022. Finally, the number of cumulative Gemoti prescribers increased by approximately 25% to 1,017 HCPs at December 31st, 2022, from 812 to December 31st, 2021. This metric continues to increase, reaching 205 prescribers at the end of January this year, the highest month on record. And finally, as I've mentioned, prescription fills in the fourth quarter of 2022 increased by 8% compared to the previous quarter. Prescription fills for all of 2022 increased by 178% compared to 2021. With that, I'll turn the call over to Chris.