Eagle Pharmaceuticals, Inc.

Good morning, everyone. My name is Ashley, and I will be your conference operator today. At this time, I'd like to welcome everyone to Eagle Pharmaceutical's third 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 telephone keypad. If your question has been answered, you may remove yourself from the key by pressing the pound key. As a reminder, this conference call is being recorded today, November 9th, 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, Ashley. Welcome to Eagle Pharmaceuticals' third quarter earnings call. This is Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. With me on today's call are Eagle's President and 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 months ended September 30th, 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. 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 archived webcast, this call was held and recorded on November 9th, 2021. Since then, EGLE may have made announcements related to the topics discussed, so please reference the company's most recent press releases and SEC filings. With that, I'll turn the call over to EGLE's President and CEO, Scott Tarab.

Thank you, Lisa. Good morning, everyone, and thank you for joining our call today. This is truly a very exciting time for EGLE. In the third quarter, we brought on two great assets, Cal O2 and LandiaLaw. We had a court victory on vasopressin, which we expect to gain approval for and launch shortly. And we are getting very close to bringing Pemfexi to the market within 90 days from now. In fact, we just held our national sales meeting to prepare for two launches. It's a truly exciting time. With this momentum, we believe that we will be on the path to double our revenues and more than double our earnings in 2022 over 21. Over time, we will evolve Eagle into a mainstream pharmaceutical company and continue to be a significant commercial organization in the hospital oncology space. With the launch of two products in the upcoming months, the company is at an important inflection point. Because we've effectively managed our balance sheet, building cash while building our pipeline, Eagle is in a strong position to take advantage of future opportunities and deploy the necessary resources to keep our company growing. The best way to articulate our next 18 months are as follows. Assume for a moment Bayes & Preston is launched and we meet our profit targets. We would leave 2022 with a very significant cash position and no debt. Thereafter, we will be waiting for the Elandi Law approval and we will be close to interim Cal O2 results. And we would be leaving next year with a new base of revenue and profitability. Our intention is to maintain the new level of profitability, and to do so, we will need to add to the portfolio and pipeline. Fortunately, we will be rewarded for managing our debt and cash so well over the years. Our plan is to make a meaningful acquisition for currently marketed products first, Our infrastructure and sales team can handle a significant increase in assets with little infrastructure investment. With this first acquisition in hand, we will then continue to in-license or acquire clinical assets. Our hope is that by the end of next year, this new level of profitability will again be in growth mode and also provide an enhanced pipeline. The really exciting aspect of all this is that we should be able to accomplish this with little dilution or debt relative to our new planned growth. We have invested about 21% of our money back into R&D and still have about $123 million in net working capital. Our strategy to grow the company remains highly focused. During the quarter, we had diluted non-GAAP earnings per share of $0.56. Our reveso press and spend was 5.3 million, which is non-reoccurring and significantly brought down Q3. We expect a strong Q4 for the existing portfolio heading into a strong 2022 as we launch vasopressin and pemfexi. With that backdrop, let me start with vasopressin, an important opportunity for us and what we expect will be a key contributor to our near-term growth once approved. As those who have followed the story know, we had two hurdles to clear, one in court and one in terms of getting approval from the FDA. We cleared the first hurdle in late August when the U.S. District Court for the District of Delaware ruled that our proposed vasopressin product does not infringe any of the patents PAR asserted against us. In terms of the second hurdle, on August 26, we received a 30-day information request from FDA, which is very positive. and we believe an information request at this point of the review process may be indicative that the ANDA is advancing towards an approval. The request asked four questions, three pertain to clarifications, and one question required additional analytical work. On September 20th, we responded in full to the request, and there are currently no other review requests. Based on this recent engagement and our prior FDA communications, as well as that we have priority review and are also flagged as a COVID priority, we maintain our view of an anticipated approval on or before the December 15, 2021, GDUFA date. With that goal in mind, we've been building inventory and intend to launch into this lucrative market soon. Remember, in 2020, U.S. sales of Azastric were $785 million. We expect to have 180-day market exclusivity. We are really excited about this and hope to get good news very shortly. Now, let me turn to Pemfexi. On February 1st, exclusive launch date will be here before you know it. The Olympia market totaled nearly $1.3 billion last year, and this is clearly another great opportunity for us that will contribute to the significant revenue growth that we expect in 22. We are going into our exclusive launch on February 1, 2022. We are gearing up, building inventory, and we will be ready to go. Remember, too, that we have a unique J code for Pemfexi. It's also worth noting that Pemfexi is a ready-to-use liquid in contrast to Olympta, which requires dilution. If we look at basopressin and Pemfexi in the context of our company today, Eagle is a fully commercial clinical regulatory hospital oncology company. We have a team of about 40 direct reps who call on oncologists, surgeons, anesthesiologists, and hospital pharmacists on a regular basis. We have strong relationships. For vasopressin, the purchasing decision is made by the hospital pharmacist, and they are already our customers. Importantly, we can launch both products with little to no expansion of our existing infrastructure. And when you add in the Bendamustine business, which I'll review next, that is how we plan to double our revenue next year. So now turning to Bendamustine, we strengthened our patent protection for Bendamustine in late August when we were granted a new patent, which was listed in the Orange Book. Our partner Symbio launched in Japan. The Symbio relationship is going well, and we expect a full or nearly full conversion to our product in the near term. We also expect royalty and milestone revenues of about $20 million next year. And now, when we look at Cal O2 and Landy Law, we're also very excited about these two new assets we brought in during the third quarter, Cal O2 and Landy Law. As a team, when we think about the pharmaceutical industry and how to deploy our cash to bring value to shareholders, we look for opportunities that address unmet medical needs and have promising clinical potential. CalO2 is a novel approach to the treatment of severe bacterial pneumonia. As you may recall from our investor day, we in-licensed the global rights to CalO2 from Compioxone. We are preparing to continue the clinical development of CalO2 by mid-22 If it continues to perform well in larger clinical trials, we think this has the potential to be a groundbreaking advancement in the treatment of severe bacterial pneumonia. We anticipate investing $25 million to achieve interim results, which are expected around the middle of 23. Turning now to Landilol, while Landilol is a novel therapeutic in the United States, is a leading commercial product and has been used in the care of critically ill patients in Japan and Europe for years. It is covered by several patents, and we anticipate five years of NCE exclusivity. The good news here is that we don't believe we will have to run additional clinical trials. We anticipate filing an NDA in the first half of 22, seeking the approval of Landy Law for the short-term reduction of ventricular rate in patients with supraventricle tachycardia, including atrial fibrillation and atrial flutter. We will facilitate the U.S. regulatory pathway for approval and will be responsible for the U.S. commercialization upon approval. As you can see, we have a lot to look forward to. And with that, I'll turn the call over to Brian Cahill to discuss our third quarter financials. Brian?