Eagle Pharmaceuticals, Inc.

Good morning, everyone. My name is Todd, and I'll be your conference operator. At this time, I'd like to welcome everyone to Eagle Pharmaceutical's third quarter 2022 financial results. 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 and one on your telephone keypad. As a reminder, this conference call is being recorded today, November 7, 2022. It is now my pleasure to turn the floor over to Ms. Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. Please go ahead.

Thank you, Todd. Welcome to Eagle Pharmaceuticals' third quarter 2022 earnings call. This is Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. With me on today's call are EGLE's President and Chief Executive Officer Scott Tariff, Chief Financial Officer Brian Cagle, and Vice President of Medical Affairs, Dr. Michael Greenberg. This morning, EGLE issued a press release detailing the financial results for the three-month sentence, September 30, 2022. 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 Ego 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 guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. EGLE 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 EGLEUS.com. For the benefit of those who may be listening to the replay or archived webcast, this call will be recorded on November 7, 2022. 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's President and CEO, Scott Harris.

Well, thank you, Lisa. Good morning, everyone, and thank you for joining our call today. It was another strong quarter for EGLE. The earnings growth trajectory that we had expected continued in the third quarter, with non-GAAP earnings per diluted share coming in at $1.12. For the year to date, we have sold $114.9 million of vasopressin and Pemfexi combined. We are posting record earnings this year, as evidenced by the fact that in the first nine months of the year, we have already earned $6.69 per share. To put it into context, that number already tops our previous best full year ever of $4.34 in 2017. So we really are on a solid path of earnings growth. And while there may be a disconnect with our current valuation, we believe 2023 has the potential to be another strong year for Eagle in terms of both revenue and profit. The story is fairly simple. We have a company which is generating a lot of cash with a very strong balance sheet. We have taken that money and used it to fund the acquisition of Acacia, the equity stake in Analar, licensing of Landia Law, and the clinical development of Cal O2. Additionally, we repurchased $10 million of our shares this quarter, bringing our total repurchases to $246 million. We remain very excited about the Acacia products by Emsys and by Fevo, and hopeful for the potential of Analar's portfolio of novel MCEs, Landia Law, and Cal O2. We had a strong first nine months of 22, and we expect 2023 and 24 to be strong in terms of revenue and profit as well. To reiterate, we believe we will sell more Pemfexi in 2023 than we did in 22, and the Bendamustine situation is very manageable. We anticipate increased revenue as we build out and realize the full value of the Acacia products. and from the potential approval of Landy Law. Additionally, we anticipate deploying the cash from our earnings and strong balance sheet, not only to fund our key clinical initiatives, but also to make an accretive acquisition to round out the portfolio. We believe we have put ourselves in a strong position to achieve all of this through our disciplined approach to managing our cash and balance sheet. Between potential acquisitions and our pipeline, We believe Eagle can grow significantly in both the short and the long term. We are well on our way to achieving our stated objective of transitioning to a branded pharmaceutical company with a diversified portfolio of assets. Now turning to the third quarter. The third quarter was an active and productive time for Eagle. We are relaunching Baramsys and Byfava, the two products we acquired in the Acacia transactions. We submitted an investigational new drug application to the FDA for Cal O2, a novel first-in-class broad-spectrum antivirulence agent for the treatment of severe community-acquired bacterial pneumonia. And in August, as you may recall, we took an equity stake in Analar. We are thrilled to share that ENA-001, a new chemical entity being developed as an agnostic respiratory stimulant, had two big wins in the quarter. First, ENA001 received orphan drug designation for the treatment of apnea of prematurity from FDA. And second, NLR received an additional award worth up to $50 million based on achievement of milestones from BARDA to advance an intramuscular formulation of ENA001. BARDA is the Biomedical Advanced Research and Development Authority. which is part of the Administration for Strategic Preparedness and Response in the United States Department of Health and Human Services. This is incredibly exciting news for the program. When we look at our business in its entirety, we have built a formidable stream of earnings from our legacy products, specifically Vendeca, ORAPSA, Triakizan in Japan, Ryanodex, and most recently, Vasopressin and Pempexi. This space has provided us with a record year supported by record sales, profits, and earnings. Eagle finds itself in a particularly strong position. As mentioned, we have a company whose revenue, earnings, and cash flow are strong, and at the same time, we're able to invest heavily in our pipeline, a pipeline that has so much potential to contribute meaningfully to the options available to acute care and other physicians treating critically ill patients and or perioperative patients, as well as to diversify EGLE's revenue stream. While I will touch briefly on Cali2, LandiaLong, and ENA001 this morning, I strongly urge you to attend our Investor Day on December 6th, when you will hear from a group of internationally renowned KOLs and physicians who will provide in-depth explanations of the scientific and clinical rationale behind these programs. as well as the substantial unmet medical needs that each address. Let's start with ENA001, an agnostic respiratory stimulant under the development for three indications, postoperative respiratory depression, community drug overdose, and apnea of prematurity. ENA001 is designed to work prolifically by inhibiting big potassium ion channels in the carotid bodies, which are located in the neck. By inhibiting these channels, EMA001 is designed to utilize the body's own ventilatory control system to stimulate breathing, and it does so across multiple causes of respiratory depression. It's helpful to think of EMA001 as a pharmacologic ventilator, and as such, you can imagine the myriad of applications. ENA001 is expected to enter a Phase II study with the first patient dosed early next year. The trial is expected to recruit about 200 subjects over one year. Turning to CALO2, a novel agent with a unique mechanism of action for the treatment of severe community-acquired bacterial pneumonia. It's being developed as an adjunct to the clinically indicated antibiotic treatment and it potentially offers unique therapeutic benefits to critically ill patients. Some of those benefits could include shorter duration of critical care management, such as mechanical ventilation, and ultimately a reduced mortality risk, as well as an immediate decrease in inflammatory biomarkers. Severe community-acquired bacterial pneumonia is a challenging disease to treat, and remains among the leading causes of death in infectious diseases worldwide. So there's an incredible opportunity to shift the treatment paradigm for patients with severe community-acquired pneumonia. The IMD for CAL-2 has been submitted, and we aim to be dosing the first patients in this adequately powered Phase II study, enrolling approximately 276 patients at 120 sites worldwide as early as the beginning of 2023. And remember, too, that the NBA submission to FDA for Landy Law is under review, and the action date is May 31st of 2023. The filing seeks approval for Landy Law for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter. Our Ben Mustin franchise revenues continue with There continues to be a shift in the United States market away from lyophilized Trianda toward the liquid RTD products, Bendecca and Belrazzo, which offer numerous advantages for patients and healthcare providers. According to IQVIA data, Trianda's share of the Bendamustine market is now down from 15% to 9% since January. In Q3 of 2022, the gross profit generated by our Bend and Mustine franchise grew by 9% compared to Q3 of 2021. These products have provided us with consistent high margin contribution throughout their lifecycle. Of note, we have historically paid a 10% royalty on all Bend and Mustine products to our development partners. These royalties have a lifetime cap that we will soon reach, helping the contribution of Bendecca, Belrazzo, and Triacosem beginning in 2023. Even as we continue to diversify our commercial portfolio with the additions of Pemfexi, Baremsis, Bytheva, and potentially Landilife, we expect the Bend and Mustine franchise to remain a meaningful part of our earnings. Similarly, we are confident that we will sell more Pemfexi next year than we will have this year. Our Q3 run rate is significantly higher than reported sales as the trade works off inventory. And as Barampsis and Byfavor make gains in the marketplace, we believe they will begin to approach the value levels that we anticipate. We remain quite enthusiastic, and you'll hear more on our Investor Day, which I will discuss before turning the call over to Brian. I encourage you all to attend our December 6th Investor Day, preferably in person at the Palace Hotel in New York or via webcast. You'll be hearing from some of the best and brightest internationally recognized key opinion leaders who have firsthand experience treating these devastating conditions. They will speak to the urgent treatment gaps in hospital-based medicine today and how our pipeline and commercial products can play a significant role in addressing those gaps. With that, I'll turn the call over to Brian Cahill to discuss our third quarter of financials.