Amphastar Pharmaceuticals, Inc.

Greetings and welcome to the Amphistar Pharmaceuticals second quarter earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note that certain statements made on this regarding matters that are not historical facts, including but not limited to management's outlook or predictions for future periods, are forward-looking statements. These statements are based solely on information that is available to us. We encourage you to review the section entitled Forward-Looking Statements in the press release issued today and the presentation on the company's website. Also, please refer to our SEC can be found on our website and the SEC's website for a discussion of numerous factors that may impact our future performance. We will also discuss certain non-GAAP measures, important information on our use of these measures, and reconciliations to U.S. GAAP may be found in our earnings release. Please note that this conference call is... Our speakers today are Mr. Bill Peters, CFO, Mr. Dan Dishner, VP of Corporate Communications, and Mr. Tony Mars, SVP of Regulatory Affairs and Clinical Operations. I will now turn the conference over to your host, Mr. Dan Dishner, Vice President of Corporate Communications. Dan, you may begin.

Thank you, Paul. I'd like to thank everyone for joining us for our second quarter earnings call for 2022. We believe we made great strides in the first half of 2022 towards portfolio diversification with approvals while driving our existing portfolio revenue growth. We look forward to discussing the specifics behind the quarter's commercial success and our regulatory developments. On the call with me today is Bill Peters, CFO and Executive Vice President of Finance and Senior Vice President of Regulatory Affairs and Clinical Operations, Tony Mars. Following the prepared remarks from management, we'll open up for Q&A. I will first discuss our financial and commercial strengths, supported by our portfolio that remains strong amid a changing volatile market landscape. The second quarter saw net revenues of $123.5 million, representing a solid 21% increase compared to Q2 2021, with a significant increase in net income. Our existing products have again provided a solid baseline the strength. Primatine missed sales recorded solid revenues representing a 14% increase over the same period in 2021. Our existing IMS product sales recorded strong revenues validating our planned increased capacity designed to meet the increased market demands our competitors remain troubled in supporting. We remain confident that our current capacity will meet the increased demand for our products even if competitor shortages remain for an extended period. We believe that demand for our IMS products will remain robust into the second half of 2022. Glucagon remains a valued asset in our portfolio as the only FDA-approved generic as the product continues to have strong sales. Looking to Q3, we look forward to our Ganarelix product, which will see a full quarter of sales as the product was launched late in June, and we are excited about the imminent launch of our vasopressor product this month. Regarding our regulatory efforts, I would like to bring our discussion towards our AMP-002 and a filing, to which we received a CRL last month. We believe the issues raised are addressable and will be fully responded to this quarter. Therefore, we anticipate the GDUFA action date for this filing in the first quarter of 2023. While this news is certainly not one we would have liked to receive, we remain confident with AMP-002's future commercial prospects as it remains without any generic. We aim to work closely with the FDA to make this first generic available to the market and patients as quickly as possible. To our AMP015 ANDA filing, teriparatide, and the CRL received in June, we anticipate filing our response in the fourth quarter of this year. Likewise, we remain confident that the inquiries made for this filing are entirely achievable. I think it's important to remember that these products are highly complex, remain without any generics, and are in line with Amphistar's business model in pursuit of challenging-to-develop products in hopes of increasing patient access to these high-in-demand products while benefiting from its difficulty as it creates market sustainability, insulating our portfolio from substantial price erosion and product sales life cycles that occur with traditional generic products. We remain committed to the pursuit of approvals for these two ANDAs. On our AMP008 ANDA, our first ANDA inhalation filing, it's important to point out that this filing received early review by the FDA. AMP008's development remains positive with a positive mid-cycle review received and conducted last quarter. All of the clinical site inspections that have been performed were completed without observation. This maintains our confidence in the filing and AMP008 remains on track for a fourth quarter GDUFA date. While I'm on the topic of our inhalation pipeline, I'm excited to announce that another inhalation pipeline candidate has progressed and is anticipated to be filed by Q1 2023, which is our AMP007 product. This represents two of our five announced yet undisclosed inhalation ANDAs as seen in our updated corporate presentation. representing over an $8 billion market opportunity in combined Equivia sales. As for our proprietary products in development, we continue to make progress on our intranasal naloxone response, which we expect to be filed this month. Speaking briefly on this product, we continue to believe that there is a community need for intranasal naloxone, and our supply continues to be part of our nation's strategy, combined with several state and local strategies, for combating the opioid abuse epidemic. As for intranasal epinephrine, another proprietary product representing a potential plus $1 billion market opportunity, the pipeline candidate continues to progress well within several studies and discussions with the agency. We anticipate intranasal epinephrine to be on track to be filed in 2023 as planned. And finally, turning to our biosimilar pipeline as part of our three-pronged strategy, Our diabetes portfolio with our insulin candidates aiming to all achieve interchangeable designation, we continue to see positive development on the front and an increasingly constructive and encouraging regulatory landscape that supports biosimilar interchangeable . We are seeing more biologic products achieve interchangeable status, which is generally encouraging. It supports our strategy and shows the FDA's willingness to provide approval to different scientifically logical approved pathways. We remain confident that the insulin market remains robust. At the same time, our extensive, complex molecular development experience, most notably our proven sophisticated characterization technology and achievements in highly purified peptides, along with an in-house developed API platform, supports a full-scale launch and an affordable as we continue to invest in R&D. We are excited to announce that we plan to file our first BLA for an interchangeable insulin product, AMP004, in 2023. Again, I'd like to reiterate that while our pipeline remains challenging in pursuing difficult-to-develop products, it is made with a deliberate purpose, supported by extensive thought and research investments and self-funding. As proven with our current product portfolio, we continue to be supported by complex products that serve as a solid support base for the further development of complex, proprietary, and biosimilar candidates. We foresee this three-pronged strategy as an enduring stronghold for the company, backed by our commitment towards quality and high purified products as all of our finished products continue and will remain produced in the United States. Likewise, with current volatile market landscapes that seemingly will persist for some time, we see this U.S.-focused strategy as increasingly beneficial and advantageous to the company as a long-term driver for further sustainability within our business model and the commercialization of our portfolio. As we have seen with previous approvals and launches, such as the impressive execution on primatine mist, epinephrine, and glucagon, all of which were exampled in recent quarters in driving growth while being supplemented with our high-in-demand IMS products, we are confident that challenges met to approval remain within the company's reach to overcome. I would like to turn the call to our CFO and Executive Vice President of Finance, Bill Peters, to discuss the second quarter's financial results and give further details behind this quarter's commercial success.

Thanks, Dan. We're just going to pause here a second because I think there's some beeping around. Let's see if we can solve this.