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 FDA, as is expected for this type of sNDA filing. This refiling is a significant milestone for the organization and I’m 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 Cortrophin Gel launch preparation. We’ve made good progress on and remain focused on executing the holistic commercial approach that ensures this critical product reaches and serves the patients in need.

With only one competitor in the same class the Cortrophin 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 enhance R&D capabilities an increased focus on niche opportunities.

Our acquisition of Novitium 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. This deal signing in March, Novitium’s best-in-class R&D engine has continued to deliver.

Novitium has gained approval to launch nine new products, including limited competition products, such as the Famotidine powder for oral suspension, and fluphenazine tablets. In parallel, Novitium has filed four new ANDAs. Overall, Novitium 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 close an accretive deal to acquire the NDAs for Oxistat, Veregen 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 in our North America manufacturing footprint. In closing, we had a productive quarter. And we are pleased with our progress today.

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.

Steve?.

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 other revenues were $1.1 million during the second of 2021, a decrease from $1.5 million for the same period in 2020. This decrease primarily reflects declines in product development revenues earned by ANI Canada and the non-recurrence of royalty revenue related to Yescarta.

Our cost of sales, excluding depreciation and amortization, increased by $1.6 million or 7.8% to $22.3 million in the second quarter of 2021 mainly as a result of increased volumes in the current year period. The increase was tempered by a $1.2 million decrease related to the decline in sales of products subject to profit sharing arrangements.

In addition, during the three months ended June 30, 2021, and 2020, we recognize $1.5 million and $1.4 million respectively, in cost of sales representing the excess of fair value over cost for inventory acquired in acquisitions. Excluding these purchase accounting related charges and other non-GAAP items as detailed in our press release.

Our gross margin was 57.2% for the current year period, as compared to 60.9% in the prior year period. The compression in gross margin is mainly attributable to increased volumes at lower average selling prices.

Research and development expenses decreased from $3 million in the second quarter of 2021 to $2.8 million in the current year primarily due to the non-recurrence of $0.4 million of 2020 severance related expense associated with the restructuring of our internal Cortrophin development team.

Selling, general and administrative expenses decreased by an 11.3% from $21.2 million to $18.8 million primarily reflecting the non-recurrence of $6.5 million of termination benefit expenses related to the 2020 departure of our former President and CEO.

These decreases were offset by $1.7 million of transaction expenses related to the pending Novitium acquisition, and $2.5 million in sales and marketing expenses related to Cortrophin pre-launch activities, incurred during the three months ended June 30, 2021.

On August 3 2021, the company entered into a settlement agreement with Arbor Pharmaceuticals, LLC to resolve all claims related to our long standing commercial litigation, which was scheduled for an August 25 trial. Under the terms of the agreement ANI will pay Arbor $8.4 million and Arbor will dismiss the action with prejudice.

Neither party admitted wrongdoing in reaching the settlement. We recorded an $8.4 million charge in the second quarter as a Type 1 subsequent event and will pay the settlement from cash on the balance sheet this month.

Adjusted non-GAAP EBITDA was $13.1 million in the second quarter, down $2.3 million or 15% from the comparable period in 2020, driven by declines in gross profit. As detailed on Table 4 of this morning’s press release, our adjusted non-GAAP diluted earnings per share is $0.67 for the quarter, compared with $0.69 in the prior year period.

On a year-to-date basis, we have generated $20.9 million of cash flow from operations in the current year period. And as of the June 30 balance sheet date, we had $24.3 million of unrestricted cash and cash equivalents.

Total net debt as of June 30, 2021 increased $22 million to $181.5 million as compared to $159.5 million as of March 31, 2021 driven by borrowings to fund the April acquisition of the Sandoz products. This figure represents 2.7 times net leverage on a trailing 12 month basis.

Consistent with our comments on the first quarter earnings call, and in recognition of the ever evolving nationwide COVID-19 trend, we reiterate our full year guidance, albeit with a continued orientation towards the low end of the range.

Our 2021 guidance figures for ANI standalone prior to giving effect to the Novitium transaction are unchanged as follows. Net revenues of $207 million to $218 million, adjusted non-GAAP EBITDA of $60 million to $65 million and adjusted non-GAAP diluted earnings per share of between $3.30 and $3.59 per diluted share.

As with before any sustained COVID-19 suppression of script activity will adversely impact our ability to reach these goals.

Finally, on behalf of the entire ANI family, we thank our shareholders for the overwhelming show of support for the Novitium transaction at our Annual Meeting of shareholders, and in the vote to approve to finance a portion of the transaction with ANI equity.

We are energized by the potential of this acquisition, and look forward to locking arms with Novitium in our ongoing mission to bring high quality pharmaceutical solutions to patients, physicians and payers. We continue to expect to close the transaction in the second half. With that, I’ll now open up the call for questions.

Leo, please go ahead with the instructions..

[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..