ANI Pharmaceuticals, Inc.

Good day, everyone, and welcome to today's ANI Pharmaceuticals Incorporated second quarter 2021 earnings call. At this time, all participants are in a listen-only mode. Later, you'll have the opportunity to ask questions during the question and answer session. You may register to ask a question by pressing star and one on your phone. You may withdraw yourself from the queue by pressing the pound key. Please note, this call may be recorded. I'll be standing by should you need any assistance. It is my pleasure to turn the program over to Lisa Wilson.

Thank you, Leo. Welcome to ANI Pharmaceuticals Q2 2021 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, and Steve Carey, Chief Financial Officer 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 6, 2021. Since then, ANI may have made announcements related to the topics discussed So please reference the company's most recent press releases in SEC violence. And with that, I'll turn the call over to Nikhil Lalwani. Thank you, Lisa.

Good morning, everyone, and thank you for joining our call. Before I begin, I'd like to acknowledge the challenging times we're facing as the pandemic lingers on and continues to impact lives around our country and the world over. We very much appreciate the continued efforts of our employees, our partners, suppliers, and customers as we focus on ensuring patients in need get access to our medications. I am pleased to share that on June 29th, we accomplished one of our key goals. We refiled our Supplemental New Drug Application, or SNDA, to the U.S. Food and Drug Administration for cortofan gel. Building a successful cortofan business is the first of our four pillars of our overall growth strategy. But before I discuss the details of the Cortofin program and other progress we have made during the quarter, let me share some high-level performance metrics for the quarter. Second quarter revenues totaled $48.6 million compared to $48.5 million in the comparable quarter in 2020. Adjusted non-GAAP EBITDA was $13.1 million. Key drivers of our performance versus last quarter were successful new product launches Share capture in existing molecules and improvement in overall market volumes in our generics business. And for our brand business, integration of the Sandoz dermatology portfolio and improvement in overall market volumes were key. Steve will cover the financials in more detail shortly. As many of you know, we have put a great deal of effort diligently engaging with industry experts and the FDA along the way into preparing what we believe is a robust and comprehensive filing package to the FDA for corticofin gel. We filed the SNDA on June 29, 2021. Our goal date is October 29, 2021. Since our submission, we have been engaged in regular productive communications with the FDA as is expected for this type of SNDA filing. This refiling is a significant milestone for the organization, and I am proud of what we have accomplished to date. In parallel, we are continuing to strengthen our rare disease business leadership team and overall organization to drive the Quartrofen gel launch preparation. We have made good progress on and remain focused on executing a holistic commercial approach that ensures this critical product reaches and serves the patients in need. With only one competitor in the same class, the cortofan gel market opportunity remains significant and capable of transforming the size and scale of our company. Turning now to the second pillar of our growth strategy, which is to strengthen our generics business with enhanced R&D capabilities and increased focus on niche opportunities. Our acquisition of NVIDIA was an important step in this direction. The acquisition remains on track to close in the second half of this year, pending FTC clearance and customary closing conditions. In the interim, we are actively planning for integration and ensuring that we combine the complementary strengths of the two companies to bring more new products to market, serve more patients and customers, and maximize the value of our combined assets. Since the deal signing in March, NVIDIA's best-in-class R&D engine has continued to deliver. NVIDIA has gained approval to launch nine new products, including limited competition products such as famotidine powder for oral suspension and flufenazine tablets. In parallel, NVIDIA has filed four new ANDAs. Overall, NVIDIA performs well in line with our investment pieces, and we look forward to closing the deal. As you may recall, our third pillar for sustained growth is maximizing the value of our established brands portfolio. In early April, we signed and closed an accretive deal to acquire the NDAs for OxyStat, Verigen, and Pandel Cream, and the ANDA for Apexicon Cream from Sandoz. I'm pleased to share that these high-quality dermatology products are now integrated into the ANI portfolio. This acquisition exemplifies our stated strategy to expand this part of our business by identifying opportunities with the potential to leverage our innovative brand commercialization infrastructure and our North America manufacturing strength. In closing, we had a productive quarter, and we are pleased with our progress to date. Our goal remains to execute on critical initiatives aligned with the four pillars of our growth strategy to build a sustainable biopharmaceutical company serving patients in need. With that, I'll turn the call over to Steve to discuss our Q2 2021 financials.