Eagle Pharmaceuticals, Inc.

Again, if you need assistance on today's call, please press star zero. Good morning, everyone. My name is Leo, and I'll be your conference operator. At this time, I'd like to welcome everyone to Eagle Pharmaceutical's first quarter 2021 financial results call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer period. At that time, if you have a question, please press star 1 on your touchtone phone. As a reminder, this conference is being recorded today, May 10, 2021. It is now my pleasure to turn the floor over to Ms. Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. Please go ahead.

Thank you, Leo. Welcome to Eagle Pharmaceuticals' first quarter earnings call. This is Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. With me on today's call are EGLE's Chief Executive Officer, Scott Tariff, and Chief Financial Officer, Brian Cahill. This morning, the company issued a press release detailing financial results for the three-month ended March 31st, 2021. This press release and a webcast of this call can be accessed through the investor section of the EGLE website at EGLEUS.com. Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation, or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to Eagle Pharmaceuticals Management as of today and involve risks and uncertainties, including those noted in this morning's press release and our filings with the SEC. Such forward-looking statements are not guarantees of future performance. Any actual results may differ materially from those projected in the forward-looking statements. Eagle Pharmaceuticals specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. A telephone replay will be available shortly after completion of this call. You'll find the dial-in information in today's press release. The archived webcast will be available for one year on our website at EagleUS.com. For the benefit of those who may be listening to the replay or archive webcast, this call was held and recorded on May 10th, 2021. Since then, EGLE may have made announcements related to the topics discussed. So please refer to the company's most recent press releases and SEC filing. And with that, I'll turn the call over to EGLE CEO, Scott Cara.

Well, thank you, Lisa. Good morning, everyone, and welcome to our conference call today. The lingering effects of COVID-19 continue to impact our industry. And although the country is beginning to open up, it may take some time to return to pre-pandemic levels of access to providers and patient visits. EGLE has done a tremendous job in the face of these challenges, but like our peers, especially those in the oncology space, we have all felt the effects of fewer oncology visits. Oncology treatments across the industry were down this quarter, mostly for patients holding off their chemotherapy visits waiting for the washout period for their vaccinations. However, we expect chemotherapy visits to return to normal this year. At the same time, our expenses are up a little bit more than in previous four quarters, mainly because of the way the R&D fell into the quarters for the year. We expect both sales to bounce back and expenses to come down over the next three quarters, and Brian will walk you through the numbers in a few moments. In 2020, we had a great year from an earnings standpoint. The focus, of course, is and has been on the pipeline and how we ultimately grow the company. I acknowledge the approach we have taken has been a slow process, but we believe that we and our shareholders will be rewarded. The stock buyback of 23% of the company should ultimately lead to significant value creation for our shareholders. We anticipate our revenue next year will be significantly higher than in the past years. The Pemfexi launch in February of 2022, with four months of exclusivity and a $1.3 billion market alone, is significant. As we go through today's presentation, you will also hear that we expect a vasopressin launch. These two events, combined with the two good pieces of news reported this past week out of Japan, should all lead to this large growth. We will also touch base on the substantial progress we are making in our pipeline, both organically and projected in licensing. We have adapted to these unprecedented times and continue to focus on growing our business and positioning ourselves for sustainable growth. Let's look at the progress since our last call just two months ago. Starting with vasopressin, obviously a critical short-term program for us. Vasopressin is tracking exactly as outlined previously. Based on discussions with the FDA at the post-CRL meeting, we designed and completed a pilot study to provide clarity on the appropriate experimental conditions for the final study. The pilot study results were as hoped, and the data provided the clarity for the conditions. About two weeks ago now, we completed the final study that we need to respond to FDA, and that study also ran as expected. We will be receiving unaudited results shortly and will update our shareholders accordingly. The final audited report takes a few weeks, and then we require some time to prepare and send the full response to the CRL to FDA. Based on all of this, our expectation is these final study results will be available here soon, and then in a relatively short amount of time after this, we will fully respond to the CRL in the previous timeframe articulated, which is by mid-year. I will remind everyone that we are first to file for this ANDA referencing phasor stress. which had a total US sales of $786 million in 2020. Our AMDA is currently prioritized by the FDA and also flagged as a COVID priority. Our expectation remains that we will receive final approval in plenty of time to bring the product to market this year. Furthermore, We want to note that the majority of questions asked by FDA are molecule questions, not necessarily specific to the EGLE formulation. We believe those questions will be asked of all ANDA holders. Our formulation is robust and has held up well to all questions FDA has asked of us thus far. As we turn our attention now to the patent trial, if you recall from our prior statements, the non-infringement case when you break it down is relatively easy to understand. The patents involved in the trial require a vasopressin product within a specific pH range of 3.7 to 3.9, while the specifications for our vasopressin product require a pH below that range. So if we can manufacture our product and maintain it within these specifications, which are outside of the pH range of 37 to 39, we should prevail in this litigation. Although the delay has been extremely difficult for all of us, we feel that we are close to a conclusion. There is somewhat of a silver lining to the delay. Since the time that the trial was initially scheduled back in May of 2020, we have been collecting a tremendous amount of additional pH data, all of which has been positive. Therefore, the delay has allowed us to gather significantly more proof and assurance to the court that our product is manufactured and maintained within the appropriate non-infringing pH range. We recognize that our launch is later than we had anticipated, But we again, we are now coming to the end of that process with the CRL being responded to soon and the court case within 60 days from now. We reiterate our expectation of bringing the product to market by year end. The trial will be taking place in person, not virtually. We believe that the strength of our position will become clear during the trial and we look forward to that week. We also have had two excellent pieces of news coming out of Japan. Our Bendamustine product licensed to Symbio from Eagle and marketed under the trade name Triacosim was approved by the Pharmaceuticals and Medical Devices Agency for a new indication for the ready-to-dilute liquid formulation for the treatment for relapsed or refractory diffuse large B-cell lymphoma used in combination with rituximab. This latest approval is another meaningful extension of our Bendamustine franchise, and we believe it will significantly increase the market opportunity for Triacosem in Japan. And just last week, Symbio announced that they have filed their application for the 10-minute rapid infusion liquid formulation ahead of schedule. Over the past 12 months, Triacosem has been selling $85 million per year. Based on the recent approval as well as the filing and anticipated approval of the 10-minute formulation, we believe that the milestones and royalties coming from these products will contribute $25 million at peak, and we believe we can get close to that peak income level as early as next year. Moving on to Pemfexi, the Pemfexi launch is only nine months away from now. As you recall, we settled with Lilly in December of 2019 and received final FDA approval in February of 2020. It's a significant market, as U.S. sales of Olympta in 2020 totaled nearly $1.3 billion, and where we will have four months of exclusivity. We are also approved for the multi-dose vial, making Pemfexi an even larger opportunity for us. As you know, we were granted a unique J-code, which provides coding clarity to outpatient facilities and physicians and facilities access for patients and reimbursement for Medicare, Medicaid, and commercial insurance. This is an exciting time leading up to our launch. We are now within nine months of launching into $2 billion of branded sales between Vasopressin and Pemfexi and our Vendor Mustang Japanese Label Expansion should get us close to our previously disclosed peak milestone in royalty revenue of $25 million as early as next year. I realize that everyone is waiting to hear more news on vasopressin. The good news is that we will be refiling by mid-year, and the trial is happening shortly. We will finally get this behind us, and we just have to be a little bit more patient. Now, let me touch briefly on our Fulvastrand program. We expect to have the results from our formulation work shortly. Depending upon those results, we plan to run a small pilot study and then consult with FDA prior to starting a clinical trial. Regarding Lyanodex, our work on nerve agent continues. The study is ongoing. We expect to report the data as it becomes available. We also have some important new directional comments to make. As we have discussed, we have been searching for acquisitions and in-licensing to augment organic development. One such example is our co-promotion agreement with Time Technologies for their SM88 product to treat pancreatic cancer. We look forward to updating you on further progress here. Although it is premature to provide additional details, we are now in late-stage diligence for several in-licensing opportunities that would leverage our capabilities, meet our criteria, and broaden our portfolio and pipeline. We aim to finalize a few transactions which would considerably bolster our EPS in the short and long term. Lastly, I'd like to extend a warm welcome to Dr. Luciana Borio, who recently joined our Board of Directors. Dr. Borio is a former FDA official and renowned public healthcare expert. who has spent her career at the forefront of U.S. healthcare policy, addressing some of the world's most complex challenges. Taken together, we are very excited about vasopressin, pemfexi, and triacosam as we look forward to 22, 23, and 24, all of which have the potential to provide a consistent future revenue stream for EGLE. We expect the vasopressin and pemfexi launches will generate significant cash along with our current net cash position. At the same time, we believe we have some exciting and promising strategic transactions that will broaden our portfolio of important therapeutics. With that, I'll turn the call over to Brian Cahill to discuss our first quarter results.