ANI Pharmaceuticals, Inc.

Good day everyone and welcome to today's ANI Pharmaceuticals, Inc. Second Quarter 2022 Earnings Results Call. At this time, all participants are in a listen-only mode. Later, you will have an opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing the star and 1 on your touchtone phone. Please note this call may be recorded and I will be standing by should you need any assistance. It is now my pleasure to turn today's program over to Lisa Wilson, Investor Relations for ANI Pharmaceuticals, Inc.

Thank you, Brittany. Welcome to ANI Pharmaceuticals Q2 2022 Earnings Results Call. This is Lisa Wilson, Investor Relations for ANI. With me on today's call are Nikhil Lalwani, President and Chief Executive Officer, Steve Carey, Chief Financial Officer, and Christopher Mutz, head of rare disease of ANI. You can also access the webcast of this call through the investor section of the ANI website at anifarmaceuticals.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 A&I Pharmaceuticals Management as of today and involve risks and uncertainties, including those noted in our press release issued this morning 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. ANI specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. The archived webcast will be available for 30 days on our website, anifarmaceuticals.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on August 8, 2022. Since then, ANI may have made announcements related to the topics discussed so please reference the company's most recent press releases and SEC filing. And with that, I'll turn the call over to Nikhil Lalwani.

Nikhil Lalwani Thank you, Lisa. Good morning, everyone, and thank you for joining our call. Two years ago, we began a journey to transform A&I into a leading biopharmaceutical company serving patients in need. We continue to make strong progress in this journey and believe ANI remains well positioned to deliver sustainable long-term growth. I'm delighted to share that second quarter net revenues of $73.9 million represent a new quarterly record for ANI and an increase of 52% from a year earlier. This growth is driven both by the first full quarter sales of our lead rare disease asset, purified cortofan gel, and by growth in our genetics business unit. We continue to see acceleration in the number of patients treated with cortofan, reflecting the value seen by all stakeholders, patients, prescribers, payers, and PBMs. That cortofan is a new option in a category where patients for decades have only had one ACTH treatment available. These benefits and the hard work and dedication of our experienced rare disease team enabled us to deliver revenues of $10.2 million in the second quarter versus $1.3 million in the first quarter. In addition, our generic business unit continues to bring new products to patients and customers, and I am proud to share that ANI is now ranked sixth among all companies in terms of number of ANDA approvals received in the past 12 months. At this time, We are raising our 2022 net revenue guidance for Kerfrofen to a range of $40 million to $45 million and reiterating our total company net revenue guidance at $295 million to $315 million. Our adjusted non-GAAP EBITDA guidance remains at $54 million to $60 million. Let me now provide a few details on momentum we've built across key business lines before turning the call over to Steve to share our financial results. As most of you know, building a successful Cortofan gel franchise is our top priority. We are therefore very pleased to share that second quarter product sales came in at $10.2 million, up from $1.3 million in the first quarter. For those who may be new to the ANI story, Cortrophin gel has the potential to help patients with certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis and rheumatoid arthritis and excess urinary protein due to nephrotic syndrome. Our efforts to expand access and the number of patients benefiting from this therapeutic option are paying off. Now, I will share more about important elements of the Cortrophin launch which are launch trajectory, physician interest, and patient access. We are making good progress across each of these elements, and I'll tell you more about each. Since our last earnings report, new patient cases initiated have doubled. As of August 5th, approximately 500 new cases have been initiated since launch. We are also seeing meaningful improvement across conversion rates and time taken from enrollment to fulfillment. We have continued to strengthen our organizational infrastructure, including expansion of our hub, patient support services, and distribution network. Having said that, we retain our Corcoran SG&A guidance for the year in a range of $42 million to $46 million. Our commercial execution has increased prescriber awareness. In fact, the prescriber base has doubled to more than 250 unique prescribers as of August 5th. And what is really exciting about this number is that it includes both physicians who are experienced with ACTH therapy as well as many first-time prescribers. Another positive sign is that approximately one-third of the prescribers have written multiple prescriptions, which continue to be distributed across our targeted specialties. Our efforts to bring savings to the healthcare system have resulted in expanded market access, with over 134 million lives with at least one indication on formulary. Notably, on July 1, Cortrofen was added to the formulary for UnitedHealthcare's commercial plans. Today, patients across commercial, Medicare, and Medicaid payers have access to Cortrofen. The most heartening impact of our launch are the stories we hear of patients who have benefited from access to corticoprine therapy. Overall, we are confident of the launch momentum and are raising the guidance for 2022 corticoprine revenues to $40 million to $45 million. I'll turn next to our generics business. Sales of generic pharmaceutical products rose by 46% year over year in the second quarter. We remain focused on growing our new product pipeline and ensuring that we're driving cost competitiveness. During the first six months of 2022, ANI filed eight ANDAs and successfully launched multiple limited competition products. For example, we launched the second AB-rated generic for acebutylol, mesoprostol, and rifabutin. I am delighted to share that ANI is now ranked sixth in terms of ANDA approvals received in the past 12 months. That is quite an accomplishment. We will continue to invest R&D dollars in this critical organizational area of strength. During the second quarter, we also announced our intention to consolidate manufacturing operations and to seize operations at the OPWL Ontario Canada Manufacturing Plan. When we assess the manufacturing footprint, we determine that our manufacturing sites across Bodette and New Jersey were well-placed to support our future growth and continuing to serve patients and customers in need. The consolidation efforts are progressing well due to the thoughtful planning and relentless efforts of our teams across Oakville, Bodette, and New Jersey. Several products have already been transferred to our site in Baudette, and other product transfers are on track for transfer to Baudette in New Jersey. We're also making progress on finding a new buyer for the Oakville facility. Once fully executed, this operational efficiency is expected to improve bulk profitability and cash flow by $7 million to $8 million on an annualized basis. In parallel, we continue to invest to expand our capacity at our New Jersey manufacturing plant. Beyond manufacturing network consolidation, we are also driving and making progress on other operational efficiencies, including consolidation of our distribution operations. Business development has been a strength of our company, and we continue to be active on that front. In July, we acquired four limited competition ANDAs from Okram Pharma. This transaction complements efforts of our internal R&D team to expand our generics product portfolio, and we expect to launch these products and see the value unlock next year. In the established brands business unit, we are focused on increasingly, sorry, on efficiently increasing promotion to select high-value targets for key brands. For the dermatology products, we are partnering with an established dermatology company to grow these products. For other key brands, we are utilizing a focused telesales team to support promotional efforts as well as ongoing patient support through copay assistance and patient starter samples. In parallel, we continue to actively evaluate business development deals to expand the portfolio of established brands that we commercialize. Over the past two years, we have focused our efforts on strengthening our organization to transform ANI into a leading biopharmaceutical company serving patients in need. I am pleased to augment our leadership team and welcome Meredith Cook as Senior Vice President, General Counsel, and Corporate Secretary to ANI. Meredith brings over 20 years of legal and leadership experience in specialty and genetics pharmaceuticals, including in corporate governance, mergers and acquisitions, strategic transactions, and intellectual property. Welcome again, Meredith. Steve will now walk through our detailed second quarter results.