Eton Pharmaceuticals, Inc.

Good afternoon and welcome to the Eaton Pharmaceuticals first quarter 2021 financial and operating results conference call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up for your questions. Please be advised that this call is being recorded at the company's request. At this time, I'd like to turn it over to David Krempa, Senior Vice President of Business Development and Investor Relations at Eaton Pharmaceuticals. Please proceed.

Good afternoon, everyone, and welcome to Eaton's first quarter 2021 conference call. This afternoon, we issued a press release that outlines the topics that we plan to discuss on today's call. The release is available on our website, eatonpharma.com. Joining me on our call today, we have Sean Brinch-Elson, our CEO, Wilson Troutman, our CFO, and Paul Stickler, our Senior Vice President of Sales and Marketing. Before we begin, I would like to remind everyone that statements made during this call may contain forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those contained in these forward-looking statements. Please see the company's forward-looking statements disclaimer in our earnings release and the risk factors in the company's filings with the SEC. Now, I will turn the call over to our CEO, Shawn Brinjelson.

Shawn Brinjelson Thank you, David, and thank you, everyone, for joining us today as we discuss our first quarter earnings results. I am pleased to share that we reported record revenue and, more importantly, profitability in the first quarter of 2021. The strong earnings were a result of the years of hard work we have put in since starting the company a few years ago. With the recent launches of Alkindi Sprinkle and Aloe Preservative Free, we now have three commercial products generating revenue for us. In addition, this quarter, we were able to monetize the work we put into our Neurology Oral Liquids franchise with Azurity Pharmaceuticals or with the Azzurri Pharmaceuticals transaction. This transaction brought in 9.5 million in the quarter and should provide us with payments of up to 45 million in the coming quarters and years, in addition to a single-digit royalty on future sales of the products. I will start my remarks today with our lead product, Alkindi Sprinkle. Alkindi is an orphan drug product for the treatment of adrenocortical insufficiency. It became commercially available in late Q4 and fully promoted in January after the holidays. Our sales reps have already engaged with more than 90% of their initial targets in the pediatric endocrinology community. These engagements have been largely virtual through video conference calls and such, but we have recently seen a growing group of physicians and hospitals allowing for in-person meetings. Furthermore, we expect in-person meetings to lead to drastically higher conversion rates and are therefore shifting our sales focus strategy to allocate more resources to states that are allowing in-person meetings. We will be focusing nearly all of our sales rep efforts on accounts in states that are open so that we can conduct as many in-person meetings as possible and as quickly as possible. For example, if the Northeast Territory is not accepting in-person meetings, that sales rep would be helping out in Texas, Florida, or whichever states we have scheduled in-person meetings in. We've got all hands on deck targeting the open states, and as additional states open up, the team's focus will rotate to the newly open states. Just to be clear, there are some states which aren't fully open that do accept visits, and obviously we would continue to visit those hospitals as well. So the key point here is really that in-person visits will take precedence over Zoom calls. We find them far more effective than Zoom calls, and we find them far more informative for the physicians. As a lean and nimble company, we have the advantage of being able to quickly make these types of changes and rapidly adapt to the evolving landscape across the United States. We believe this strategy will produce stronger results than continuing to have sales rep pursue strictly Zoom calls in closed states, for example. And I am very proud of how quickly our team was able to implement this strategy. As we discussed on our last call, we have implemented a quick start program that allows new prescriptions to be immediately filled for patients even while the administrative paperwork and reimbursement process is worked through behind the scenes, which may take a few weeks. We think this is an important program to get patients in need treatment as quickly as possible, but it does mean that the revenue for those scripts can often lag the start of treatment by a month or two. We will continue to focus on generating as many new scripts as possible, and we know that the revenue will follow. I'm pleased to report that we've already received more than 100 new patient scripts, and we continue to work towards our goal of having more than 400 new patient scripts by the end of 2021. Now a few words regarding EM-100. During the quarter, our partner, Bausch Health, launched Aloe preservative-free in major retailers across the country. We've been pleased with the commercial launch efforts by Bausch so far, and given the initial sales data, it looks like the product will be a success. Patients and doctors are excited to finally have a preservative-free allergy treatment available over the counter. Our third commercial product is Biorphin, our ready-to-use phenylephrine injection. Biorphin sales continue to grow as more hospitals adopt the product, and we believe that major market adoption will coincide with availability of both our vial and pre-filled syringe presentations. Sales month over month continue to grow with phenylephrine. We would expect that to increase dramatically once we offer these additional presentations. However, our vial manufacturer ran into delays due to government-mandated capacity reservation for the COVID vaccine production, but we went ahead and executed a backup plan and expect to have the vial product available in 2022. In addition, we've made progress on the pre-filled syringe line extension, and we expect to have that product also in 2022. Now turning to our pipeline products. We are approaching a very exciting period for our company and our pipeline. We have a total of six products under review at the FDA, with four of those PDUFA dates coming up in the next three months. We or our partners are engaged in regular communications with the FDA, and we hope to have these products approved and launched very shortly. We expect to continue to replenish our pipeline with additional business development transactions in the near future. We remain active in our pursuit of high value, additional late-stage orphan drug products, and look forward to transacting in the coming quarters. With that, I would like to turn the call over to Wilson Trautman, who will briefly walk through some of the financials before we open up the call. Wilson?