Eagle Pharmaceuticals, Inc.

Please continue to stand by. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Please stand by. Your program is about to begin. Good morning, everyone. My name is Keith, and I'll be your conference operator today. At this time, I'd like to welcome everyone to Eagle Pharmaceutical's second 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 answers period. At that time, if you have a question, please press star 1 on your telephone keypad. As a reminder, this conference call is being recorded today, August 5th, 2021. And it's now my pleasure to turn the floor over to Ms. Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. Please go ahead.

Thank you, Keith. Welcome to Eagle Pharmaceuticals' second quarter earnings call. This is Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. With me on today's call are Eagle's Chief Executive Officer, Scott Tariff, Chief Medical Officer, Dr. Judith Noonkashen, and Chief Financial Officer, Brian Cahill. This morning, the company issued a press release detailing financial results for the three-month end of June 30th, 2021. This press release and a webcast of this call can be accessed through the investor section of the Eagle website at eagleus.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 are filing through the SEC. Such forward-looking statements are not guaranteed the 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 August 9, 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 filings. And with that, I'll turn the call over to EGLE CEO, Scott Karrasch.

Thank you, Lisa. Good morning, everyone, and thank you for joining our call today. We had a strong and productive quarter. Before I get into those details, I wanted to share some overarching thoughts. We are proud of the strategy deployed here at Eagle over the past few years. If we assume for a moment that we bring vasopressin to the market relatively soon, then we are entering a new phase where vasopressin, pemfexi, bendamustine in Japan, and now landilol, are shaping our growth. Some may argue that this progress has been slow, but we have managed EGLE with a low-risk, effective, and efficient approach. Importantly, every day we add to our footprint in hospitals and oncology, and every day our EGLE employees interact with physicians, pharmacists, and nurses in these settings. Combine this with our clinical regulatory quality and manufacturing experience. and we believe that we will continue to drive growth. What we have quietly done is build a very robust hospital and oncology company with broad multifunctional capabilities. We've accomplished this while still buying back $211 million, or 22% of our company, maintaining a clean, strong balance sheet and continue to post strong earnings as evidenced by today's announced 93 cents. which represents a 63% increase from $0.57 a year ago. We also have net cash and working capital of around $100 million on hand. Obviously, our goal is to accelerate the growth of the company. Bendamustine in both U.S. and Japan and Rianidex, Basopressin, and Pemfexi have all been largely organic. We now add in Philandialol. Let me point out that by being disciplined, meaning not using significant amounts of our cash to pay up for assets or diluting our shareholders, we have done this in a way that, in essence, we get paid for our commercial and functional infrastructure. With Landia Law, we will use our much-needed and clearly much-desired commercial and functional capability that we have been building. Landialol will enter the organization with very little additional infrastructure requirements or cash requirements. We are also hopeful that other companies see the value and need for the Eagle platform and that we announce a further expansion of the pipeline. At the same time, we are targeting products like Landialol, which are more mainstream pharma products with longer exclusivity and and transitioning away from reformulations in spec pharma. We remain very proactive about building out a strong foundation for sustained future growth and believe additional pipeline products will be announced soon. Between our internal research and development and our ongoing business development efforts, we believe we'll be able to generate consistent growth for the company. Turning now to our second quarter, we outperformed consensus earnings forecast, and we had what we believe was an excellent few days in court on vasopressin. We expanded the Mustang franchise in Japan, and we're getting very close to our Penthexy launch and a period of exclusivity beginning February 1st already. Taken together, these factors will contribute to a potentially doubling of revenues and impressive revenue growth next year in 2022. In terms of our products, let me start with days of Preston, the trial, which had been delayed more than a year due to COVID began on July 7th. We believe the trial went well in some respects, the delay turned into a positive as it allowed us to gather significantly more proof and assurance that our product is manufactured and maintained within the appropriate non-infringing pH range. We expect to have the courts ruling around mid September. In mid-June, we responded to the CRL with full study results and were assigned a GDUFA date of December 15th. Our belief is that we had a very robust response and believe we satisfied all questions raised by FDA. We were pleased that FDA maintained priority review of our ANDA for vasopressin, which is a very important program for us. And remember, EGLE is first to file with an ANDA referencing vasostrict, which had total U.S. sales of $786 million in 2020. In light of the priority review, as well as being flagged as a COVID priority, we continue to believe that we can bring vasopress into the market this year. We look forward to updating you about the trial outcome and the decision from FDA in the weeks and months to come. In addition to the VASA present opportunity, we are excited now to be getting close to our four-month exclusivity period for Pemfexi, which begins on February 1st. This is another significant market for us. A U.S. sales of Olympia in 2020 totaled nearly $1.3 billion. As you recall, we also have approval for a multi-dose file, and we have a unique J-code, which provides coding clarity to outpatient facilities and physicians and also facilitates access for patients and reimbursement from Medicare, Medicaid, and commercial insurance. We've been looking forward to this launch since we first received FDA approval in February of last year, and believe it will be an important revenue stream in 2022 and beyond. Now, moving to our Bend and Mustang products in Japan, which are progressing nicely. In the second quarter, we announced that Symbio, our partner in Japan, received approval from the Pharmaceuticals and Medical Devices Agency, or PMDA, for trachosin, ready to dilute liquid formulation. That approval meaningfully increases the market opportunity for Triacosem in Japan. Also in the second quarter, and notably ahead of schedule, Symbio filed an application with the PMDA for the Triacosem rapid infusion 50 ml liquid formulation. That application was based on the results of clinical studies investigating the safety and pharmacokinetics of Triacosem RTD administered by 10-minute intravenous infusion. With these important extensions of the Bend the Mustang franchise, Eagle's Japan royalty and milestone income next year is expected to be in the $20 to $25 million range, representing another solid source of revenue. Taken together, the launch of Days of Press and Late This Year, an exclusive launch of Pemfexi, and the royalty income from Japan, we have a solid foundation for revenue growth next year. In 2022, we will have ample cash, and we will be very well positioned for another strong year. So now let's turn to 23, 24, and beyond, and how we plan to ensure long-term sustainable growth for Eagle, and in the face of declining revenue due to trend and generics in late 22. Our licensing agreement with AOP Orphan Pharmaceuticals for the U.S. commercial rights to land the all is a very exciting near-term opportunity. Judy will discuss the scientific merits of the product as well as the regulatory path forward in a few moments. But first, I'd like to share how it helps in our transformation to a company that is less reliant on spec form and reformulations. First, for the initial indication, upon approval, as I mentioned earlier, EGLE will need very little additional infrastructure to support the launch, as we already call on most of these providers. And second, Landialol is a new chemical entity, or NCE, and will therefore receive five years of exclusivity. This is Eagle's first NCE and is a true catalyst in reshaping our company as we evolve into a mainstream pharmaceutical company with a vibrant pipeline of products less reliant on reformulations. And third, it allows for a very efficient flow-through to the in place in our existing footprint to handle marketing and commercial efforts. We're excited to bring this important therapeutic to the United States and believe that we have a clear regulatory path forward. In addition to the upfront $5 million milestone payment, and we will split profits equally, which we believe benefits our shareholders, we can look forward to a significant revenue stream in 2023. We're very proud that we were able to find a way to bring such an important product to the company. And in light of all of these factors, vasopressin, panfexis, and bio now landia law, we anticipate significant growth going forward, even in the face of diminishing revenue eventually for Benamustine in 2023. With that, I'll now call, turn the call over to Judy, our medical officer, our chief medical officer, to discuss landia law in more detail. Judy?