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 first quarter 2023 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. May 9th, 2023. 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' first quarter 2023 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 Terrace, Chief Financial Officer Brian Cahill, and Vice President of Medical Affairs, Dr. Mike Greenberg. This morning, Eagle issued a press release detailing its financial results for the three months ended March 31st, 2023. 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 our findings 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. 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 30 days 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 May 9, 2023. 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. In addition, we will be discussing non-GAAP financial measures during this conference call in addition to financial information prepared in accordance with U.S. GAAP. These non-GAAP financial measures should be considered in addition to, but not as a substitute for, the information prepared in accordance with GAAP. A description of these non-gap financial measures and reconciliations of these non-gap financial measures to their most comparable gap measures are set forth in our earnings press release available on our website at EagleUS.com. And with that, I'll turn the call over to Eagle's President and CEO, Scott Tariff.

Well, thank you, Lisa. Good morning, everyone, and thank you for joining our call today. Following on from the outstanding year Eagle had in 2022, we remain well positioned for another strong year in 2023. Our products continue to do well, as you can see from the strong earnings we announced this morning. We expect this momentum to continue and our longer-term growth to come from our pipeline and potential acquisitions. For the first quarter of 2023, our net income was $5.8 million, or 44 cents per basic and diluted share, and adjusted non-GAAP earnings was 16.5 million, or $1.27 per basic and $1.26 per diluted share. Our adjusted non-GAAP EBITDA was 22.3 million for the first quarter. This positions us well to achieve our full year 23 guidance, which we reaffirmed. To be clear, the investments we are making for the future account for much of the expected difference of our earnings in 2023 versus 2022. We are investing to support our products and advance our pipeline, notably Cal O2, which bridges much of the year-over-year gap. With the commercial infrastructure already in place, we believe we will be able to capture synergies through a potential acquisition target. Let's look at the products. During the first quarter of 23, Pemfexi net product sales totaled $22.9 million, and we believe we are well on our way to surpassing the $67 million recorded for the full year of 2022. As you recall, we exited the fourth quarter of last year with a 6% share of commercial, non-340B, pemetrexid usage, and community oncology in the United States. Based on the internal data and customer feedback, we estimate that as of the second quarter to date that our share has now grown to 15%. We expect growth to continue throughout the year and believe that the market share at the end of Q2 could be greater than the current 15%. Pemfexi remains an important asset for us. As you recall, we eliminated the royalty on the first $85 million of profit on Pemfexi beginning October 1 of 22 and a reduced royalty thereafter in exchange for a one-time payment of $15 million. So far, that is looking like a great decision. Moving on to our Bendamustine franchise. As we have discussed in the past, our Bendamustine franchise faced new competition for the first time beginning on December 7, 2022. Since that time, we continue to be pleased with the strong performance of Bendecca and Belrapsa in the marketplace. It is our belief that Bendecca is a beneficial product for patients and healthcare providers. Together, Bendecca and Belrapsa maintained approximately 89% share of the Bendamustine U.S. market for the first quarter of 23 compared to approximately 90% historically. In the first quarter, we reached the settlement agreement with Dr. Reddy's. Eagles asserted its Orange Book listed patents against Dr. Reddy's related to its new drug application referencing Bendecca. The settlement follows our previously announced settlements with Hospirin Accord Healthcare related to their new drug applications, referencing Bendecca. Other than one recent challenger, which is for a proposed powder, not liquid formulation, all existing cases have now been settled. We remain confident in exclusivity into November of 27, which we believe positions Bendamusting to be a significant contributor for several more years. Turning now to the Acacia products, BarAmsys and Bifavo. Combined net sales of the two products total just shy of $1 million in the first quarter. BarAmsys and Bifavo product sales are up 32% sequentially versus Q4 of 22. Although this is a small base, it is a very solid showing, and we expect their shares to continue to grow nicely. Just last week, we announced That CMS established a unique product-specific billing code for Bifavo, which, as you may recall, is a short-acting sedative for procedures lasting 30 minutes or less. This new J code is effective on July 1 of 23. We believe the establishment of a unique J code for Bifavo is an important step in facilitating reimbursement and broadening access to this innovative sedation drug. our go-forward business development plans remain intact. As we've stated in the past, we intend to use our strong balance sheet and financial flexibility to potentially make an accretive acquisition with the aim to broaden our footprint within the acute care oncology space and solidify our foundation for future growth. We are also currently working with lenders to secure financing to support a potential accretive acquisition. Let me make a few comments on the pipeline. First, a global Phase II study is underway for CalO2, a novel first-in-class agent for the treatment of severe community-acquired bacterial pneumonia used in addition to standard of care, including antibiotic treatment. We expect to enroll 276 patients in 120 centers in 22 countries. Second, ENA001, an investigational one-of-a-kind new chemical entity, is an agnostic respiratory stimulant being developed by Analar for the potential treatment of postoperative respiratory depression, community drug overdose, and apnea of prematurity. As a reminder, we acquired approximately... 17% equity stake in ANILAR in exchange for two upfront investments paid in August of 22 and February of 23. And we have an option to purchase the rest of ANILAR in the event specified milestones are achieved. Third, Landia Law NDA is under review at FDA. The filing seeks approval for Landia Law for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter. To recap, as you can see, we had another impressive quarter. Our plan is to accelerate long-term growth through potential acquisitions and our pipelines. We believe that we are in a good position to execute on all three aspects of our business, namely strength from our existing product line, potential future creative acquisitions, and the development of our pipeline. With that, I'll turn the call over to Brian Cahill to discuss our first quarter financials. Brian?