Eagle Pharmaceuticals, Inc.

Stand by, your program is about to begin. If you need assistance on today's program, 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 fourth quarter and full year 2020 financial results and pipeline review 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 one on your touchtone phone. As a reminder, this conference call is being recorded today, March 2nd, 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, Operator. Welcome to Eagle Pharmaceuticals' fourth quarter 2020 earnings and pipeline review call. This is Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. With me on today's call are Eagle's Chief Executive Officer, Scott Terrace, Chief Financial Officer Brian Cahill, President and Chief Operating Officer David Purnock, and Chief Medical Officer Dr. Judith Nung Tashin. This morning, the company issued a press release detailing financial results for the three months ended December 31, 2020. 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 is held and recorded on March 2, 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. And with that, I'll turn the call over to EGLE CEO, Scott Tariff.

Scott Tariff Thank you, Lisa. Good morning, everyone, and welcome to our conference call today. In addition to discussing our fourth quarter and full year 2020 earnings, we will also give updates on our products, including a review of vasopressin, fulvastram, pemfexine, and ryanodex as a nerve agent medical countermeasure. David Pernock, Eagle's President and Chief Operating Officer, will provide an overview of the Symbio opportunity in Japan and discuss our agreement with Time Technologies. For vasopressin, fulvastram, pemfexine, and ryanodex, You'll hear from EGLE's Chief Medical Officer, Dr. Judith Nung-Kashen, who will walk you through our approach here. Our goal is that this expanded presentation will provide clarity on the status and path forward for each of these products. Before we get to all that, let me begin by saying that 2020 was a great earnings year for EGLE and one of our strongest. $2.96 per share in the fourth quarter and $3.54 per share for the year, which is a significant 36% increase over 2019 levels. We outperformed expectations, and this performance is especially impressive given the headwinds presented by COVID-19. As we reflect, our commercial products are hospital-related and to our chemotherapy products. For most of the year, our sales reps had no direct access to their customers within the hospitals, and chemotherapy visits fell substantially due to the various constraints imposed. Many customers were destocking during the year, using their inventory capabilities to stock up on COVID-related products. Our earnings were driven by strong sales, which would have been even stronger without these challenges. We did, however, have some lower R&D expense that was deferred into 21. And we did have some pandemic-related reductions in travel expense. But all in all, we believe that we would have had an even better earnings year had it not been for COVID. As we continue to discuss the impact of COVID on the company, days of precedent is a clear example of the negative impact. The patent trial against Endo was scheduled for last May. And had that occurred, we believe we would have had a favorable decision by now, which in turn could have generated more investor confidence. The trial is now set to begin on July 7th, 2021, about a 14-month delay from the original date. Extremely important to note, as we stated previously, ENDO's asserted patents claim a formulation with a pH range of 3.7 to 3.9. Our proposed ANDA product specifies a pH outside of that range. We are confident that our ANDA, which has been prioritized by FDA and also flagged as a COVID priority, will be approved in a reasonable timeframe, and we still anticipate being on the market this year. We would obviously have loved the legal decision to have been delivered by now, but unfortunately we just have to wait. But July 7th will be here quickly. Yet this delay has affected people's perceptions about our stock and about our company. Considering all the challenges brought on by the pandemic, Eagle has done remarkably well. Our focus now is ensuring that the growth we experienced in 20 over 19 continues this year, next year, and beyond. A key component to our planning for the future is to proactively positioning ourselves to withstand the impact of losing some revenue due to trend of generics starting in December of 2022. We plan to accomplish this through a combination of organic loads, including vasopressin, confexy, and the mustine in Japan, as we advance our pipeline, including fulvastrant, nerve agent, medical countermeasures, and by looking for product opportunities to in-license or acquire, such as our co-promotion agreement with Time for its SM88 product. We are in the middle of our growth curve. We just had a big earnings year. it's very likely that we will continue this growth in 2021 as we expect to have the approval of vasopressin in time to do so. And the Penthexy launch to that, add the Penthexy launch to that, and 2022 will follow on as a strong growth year as well. So what can we expect in 23 and beyond? It is clear that this is what's on the minds of our investors that we speak to. I want to make it very clear that our board and management teams have every expectation that EGLE will continue to grow in 23, in 24, and 25. Not only do we have a pipeline with the potential to deliver long, sustainable growth, but we also have managed our P&L and our cash extremely well in the last several years. Our company is in excellent financial shape. We have been diligent in managing expenses. Our balance sheet is strong with more than $103 million of cash and cash equivalents at year-end. We now have bought back approximately $207 million of stock as of December 31, 2020, at a price a bit more than where we are today, but we think that will take care of itself once we launch vasopressin, pemfexi, and other products. The cash we expect to generate is combined with our clean balance sheet and our ability to use equity as we have never done before, provides us with the capability to augment our pipeline or replace it, if it should not pan out, through in-licensing or acquisitions. Whether through organic or inorganic needs, we will still grow this company beyond 23. We have built a strong foundation for growth that starts with vasopressin continues with our February 2022 exclusive Pemfexi launch, supported by royalties from Symbio, and beyond that to opportunities such as Fulvestrant, NerveAgent for countermeasures, and our stake in Time's SM88 candidate for pancreatic cancer. What this all means is that we have the commitment and the financial flexibility to capitalize on strategic opportunities as they arise. We feel confident that we have the visibility on our earnings capability and that we will be successful in extending the growth pattern of 2020 well into the future. Let me talk about these programs in general now, and then in a few minutes you'll get a more detailed type of review. I mentioned the delay of ASA press and trial earlier, but there's another piece here. We had our post-CRL meeting with FDA just late last week, It was a very productive meeting, and we have clear agreement on how to proceed. We've already done quite a bit of work since the CRL, and we have some more to do here. We hope to have all the data we need to submit by mid-year. Gazopressin is a large and important program for us, and one that we believe will drive growth. We are first to file for this polypeptide, where brand sales of the product total more than $785 million annually. This is a difficult product to get approval for, but our goal remains to do so before the end of the year and then bring this lower-price, high-quality product to the market as soon as possible. Looking to 2022, in just 11 months from now, we will be launching Pemfexi with its unique J-code and four months of exclusivity. As a reference for the size of this opportunity, U.S. sales of Olympia in 2020 were nearly $1.3 billion today. And since we are also approved for the multi-use bio, we have an even larger opportunity here. If you look at vasopressin and Pempexi together, Eagle should be launching into about $2 billion in exclusivity. Add to that the ramping up of endomustine sales in Japan through our partner Symbio, which we anticipate will eventually bring royalties and milestones of $10 to $25 million per year. Together, vasopressin, pemfexi, and symbio will represent a consistent revenue stream, all of which should contribute to meaningful growth and a stockpiling of our already strong cash provision. Turning now to Fulvestrant, we have now followed 750 subjects for 140 to 280 days. Our intention is to commence a clinical trial in cancer patients that could lead to improved outcomes in specific breast cancer patients. We have continued productive engagement with FDA and now have agreement for the clinical design and study endpoints. Our goal is to develop a differentiated product with meaningful benefits to patients and physicians. In consultation with FDA, we have agreed to continue the formulation work, and on completion of that work, we'll commence the study. We believe the new formulation work will provide a more efficient path to approval. Together, these assets make for a strong lineup of programs to support growth and to fill the gap as the Bend a Mustang franchise diminishes. We truly believe our best years are ahead of us. I think our speakers today are going to offer a lot of important context that will shed light on the complexities and the opportunities ahead. With that, I'll turn the call over to Brian Cahill to discuss our fourth quarter and full-year financials. Brian?