Good day everyone, and welcome to today’s ANI Pharmaceuticals Inc. Second Quarter 2021 Earnings Call. At this time all participants are in listen-only mode. [Operator Instructions] It’s now 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 Investors section of the ANI website at anipharmaceuticals.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 ANI 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 anipharmaceuticals.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 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 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 continues to impact wise ground 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’m pleased to share that on June 29, 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 Cortrophin Gel. Building a successful Cortrophin and business is the first of our four pillars of our overall growth strategy. But before I discuss the details of the Cortrophin 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 [ph]. 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 Cortrophin 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…

Thank you, Nikhil, and good morning to everyone on the line. Well, we are acutely aware that many communities across the country are dealing with the resurgence of COVID-19 cases. We were pleased to see the initial signs of a return to growth for the U.S. generic prescription market in the second quarter. Well total U.S. generic market prescriptions for the second quarter of 2021 continue to trail pre-COVID levels they were up versus prior year and versus prior quarter. We hope for the renewed health of our communities and continued return to normalcy as the second half of the year progresses. Turning to ANI results. Net revenues for the second quarter of 2021 were $48.6 million, as compared to $48.5 million posted in the second quarter of 2020. Sales of our generic products were $34.2 million during the second quarter of 2021, an increase of 2.4% compared to $33.4 million for the same period in 2020. The net gain was due to the increased sales of fenofibrate, Potassium Citrate ER, vancomycin oral solution and the second quarter 2021 launch of Nicardipine. However, these increases were tempered by declines in sales of Methazolamide, Miglustat, Penicillamine, and Mixed Amphetamine Salts. Net revenues for our branded products were $11 million during the second quarter of 2021, an increase of 3.8% compared to $10.6 million for the same period in 2020. The primary reason for the increase was the launch of four products acquired from Sandoz in April, and increased sales of InnoPran XL. These gains were tempered by decreased revenues of Atacand and Arimidex. Contract manufacturing revenues were $2.3 million during the second quarter of 2021 compared to $2.9 million for the same period in 2020, due to decreased volume of orders from contract manufacturing customers in the current period. Royalty and…

[Operator Instructions] We’ll take a question from Elliot Wilbur of Raymond James. Your line is open.

Thanks. Good morning. Not surprisingly, I guess first question will be with respect to the refiling and acceptance of the sNDA for Cortrophin and actually a three part question for yourself Nikhil. Specifically, I guess based on initial interaction and dialogue with the agency on the filing obviously, you have a relatively short timeline here in terms of the established action date, just wondering if you have any sense yet as to the agency’s view of the requirement for inspection or inspections at any or all of the key points in the supply chain. Second, part of the question is specifically has there been any dialogue with the agency around the infantile spasms, indication on the label? Where’s that just not part of the discussion at this point in time? And then last part of the question, I just want to get your thoughts on recent trends in competitive product Acthar and sales there have declined rather substantially over the last couple of quarters, there may be a lot of unique factors there in terms of I guess, just Mallinckrodt status and maybe the removal from some government programs. But you have signaled more of a true specialty approach in terms of re-launching this asset. And I just wanted to get maybe your initial observations on, whether you think this decline in units in Acthar maybe creates an easier setup for you in terms of launch, or whether you think that there may be more heavy lifting involved in terms of you’re trying to reactivate unit demand in that market.

Thank you, Elliot. I will take these questions one at a time. So, your first question on the agency view inspection requirement. Look as you know, well, we can’t give specifics on the dialogue. What I can say is, we put a great deal of effort in diligently engaging with multiple experts and the FDA, along the way into preparing what we believe is a robust and comprehensive filing package to the FDA for Cortrophin, since our submission on June 29, the FDA has engaged in productive communication, as it would be expected for this type of sNDA filing. We’ve responded to their requests and are pleased with the continued engagement with the FDA. So that’s on your first question. On the labeling, and specific on infantile spasms, again, this is a competitive situation. So, I cannot feel that question at this time. And then your third one, which is – what’s going on with our competing product? Look, we’re monitoring the market dynamics closely here, right, as you would imagine and we continue to believe that the commercial opportunity is going to be significant for ANI and most importantly to bring a much needed therapy to patients in need. And while I cannot go into specifics for competitive reasons, we do believe that our holistic commercial strategy addresses the headwinds that our competitor is facing.

Okay. Maybe just one quick follow-up question on the pending Novitium acquisition, I guess, has the interaction with the FTC sort of gone according to plan in terms of review of any potential overlap or divestiture requirements is that business at this point still tracking in line with some of the initial numbers you provided in terms of the expected, immediate revenue and EBITDA contribution from that deal? Thanks.

Yes. Thank you for that, Elliot. Look the acquisition remains on practicals in the second half of the year. That’s obviously, as I’m saying that we’re factoring in the – where the discussions are with the FTC. And look we’re actively planning for integration and ensuring that we combine the complementary strengths with companies to bring more new products to the market, serve more patients and customers and maximize value for combined assets. And look, as I said in the prepared remarks that Novitium’s performance, since the deal closed has been, well in line with our investment pieces, and in most, in a number of cases ahead. As you would have noted in terms of the approvals that they have gotten, one thing I forgot to mention in my prepared remarks, which I would like to add is that over the last couple of months, Novitium has also at a successful GMP inspection. It was a prior approval inspection, but they also did the GMP inspection with the FDA. And, just continues to maintain no surprise to us, but they continue to maintain their very strong track record with the FDA, in terms of GMP and that’s another sort of strength that we will carry forward, so yes.

And this does conclude our question-and answer-session for today. I’d be happy to return the calls to our host for any concluding remarks.

Yes. Thank you. Thank you, Leo. This is Nikhil Lalwani again. Look, I’m very pleased to that we were able to accomplish our goal of refiling our sNDA for Cortrophin in Q1 and with the strides that we continue to make in building our business based on our four core pillars for growth. With an eye towards the future, we are excited about the prospects of ramping our internal research and development capabilities, and capturing all of the – synergistic opportunities we see with Novitium. As always, we remain committed to delivering value to shareholders and bringing important medicines to the patients in need. We want to thank all of you for your time today. And hope that you and your families and friends stay safe during this lingering pandemic. Thank you.

This does conclude today’s call. You may now disconnect your lines. And everyone have a great day.