Good day everyone and welcome to today’s ANI Pharmaceuticals, Inc. Second Quarter 2022 Earnings Results Call. [Operator Instructions] Please note, this call may be recorded. 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 Investors section of the ANI website at anipharmaceuticals.com.

Before we get started, I'd 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 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 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. Two years ago, we began a journey to transform ANI 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 Cortrophin Gel and by growth in our generics business unit.

We continue to see acceleration in the number of patients treated with Cortrophin, reflecting the value seen by all stakeholders -- patients, prescribers, payers and PBMs -- that Cortrophin is a new option in a category where patients for decades have only had 1 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 generics business unit continues to bring new products to patients and customers.

And I am proud to share that ANI is now ranked 6th among all companies in terms of number of ANDA approvals received in the past 12 months. At this time, we're raising our 2022 net revenue guidance for Cortrophin 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 Cortrophin Gel franchise is our 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're 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 5, 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 retained our Cortrophin 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 1. 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 1/3 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 1 indication on formulary.

Notably, on July 1, Cortrophin was added to the formulary for UnitedHealthcare's commercial plans. Today, patients across commercial, Medicare and Medicaid payers have access to Cortrophin. The most heartening impact of our launch are the stories we hear of patients who have benefited from access to Cortrophin therapy.

Overall, we are confident of the launch momentum and are raising the guidance for 2022 Cortrophin 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 6 months of 2022, ANI filed 8 ANDAs and successfully launched multiple limited competition products. For example, we launched the second AB-rated generic for acebutolol, misoprostol and rifabutin.

I am delighted to share that ANI is now ranked 6th 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 Oakville, Ontario, Canada manufacturing plant.

When we assessed the manufacturing footprint, we determined that our manufacturing sites across Baudette 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, Baudette 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 and 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 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 the strength of our company and we continue to be active on that front. In July, we acquired 4 limited competition ANDAs from Oakrum 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 co-pay 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 2 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 generics 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.

Steve?.

net revenue between $295 million and $315 million, representing approximately 36% to 46% growth as compared to $216.1 million recognized in 2021; total company research and development expense of between $16 million and $18 million; adjusted non-GAAP EBITDA of between $54 million and $60 million; and adjusted non-GAAP diluted earnings per share of between $1.34 and $1.62.

In addition, we currently anticipate between 16.9 million and 17 million shares outstanding and an effective tax rate of approximately 24% prior to any federal tax reform. We will now open up the call for questions. Operator, please go ahead with instructions..

[Operator Instructions] And we will take our first question from Elliot Wilbur with Raymond James..

Just wanted to ask a couple of questions on the base business and then I had a few on Cortrophin.

So first, with respect to the base business, obviously the company’s had a lot of top line momentum in terms of approvals but still a relatively mixed narrative from the industry overall -- and I’m speaking specifically with respect to generics -- as to the general health of that market, direction, trends in terms of price volume.

So just maybe some high-level commentary in terms of what you’re seeing with respect to erosion in the base and your ability to offset that the new product launches? And then as a follow-up question on the base, just want to get a little bit more insight into what is happening with respect to the branded business.

It’s been a little bit light relative to external expectations last couple of quarters. Just sort of wondering if the run rate for the first 6 months kind of represents sort of a new normalized baseline for that business going forward..

All right. Thank you, Elliot, for your questions. I think the first question on the overall generics business, look, we've seen growth in our genetics business quarter-on-quarter and expect this trend to continue.

As you mentioned, our approach here is very straightforward that we have launches that are coming from our R&D engine that we acquired last year and that will outpace the erosion that we're seeing on our base or in-line products, if you will. And that is playing out, whether you look at it year-on-year or even quarter-on-quarter.

Having said that, your other question around pricing erosion that's still there on the in-line products and it is in line with what we have seen historically and being seen by our peers. We, at this point, don't see that accelerating or any trigger for accelerating that. It's in line with what's been going on. So that's the first question.

And then on the established brands, yes, we have seen a decline in a couple of our larger products on the established brands business. Having said that, as I mentioned, we're doing a number of things to address that, right? We have partnered with a dermatology company to drive promotion of our dermatology products.

And we're doing targeted reach outs to prescribers on the established brands to complement our -- the other elements of our commercialization strategy. To your specific question around established brands and whether the run rate now is a new normal, I think we've not given guidance at that level. So let us come back on that question..

Okay. Then just a couple of quick follow-ups on Cortrophin. Can you just talk about some or success rates that you've seen in terms of enabling patients to continue on therapy once they've received an initial prescription. Just sort of the persistence rates you've seen, kind of given maybe from some of the early initial patient starts.

I know if you look back at the history of ACTH products, I think for variety of different ailments but you've seen something like 7 to 9 vials kind of on average per patient. And I'm just wondering if there's anything you could say at this point with respect to overall persistence.

Then the last question here is just talk about where you guys are in terms of your ultimate physician detailing strategy, whether or not all physician targets have been reached with at least an initial detail.

And sort of how you're thinking about how many details may be necessary before you can convert targeted physicians over to actual prescribers..

Got it. Thank you again, Elliot, for your questions. I think the first question on success rates and persistence, because as you know well, that the number of vials or the course of therapy varies from indication to indication. And also the coverage varies from patient to patient, like what insurance plan they're on.

With these 2 factors in mind, as a broad trend, we are absolutely seeing that patients that start on therapy are getting the follow-on therapy that they need and that the -- both the coverage that is -- that they have and the prescriptions that are written are ones that are just beyond just the first vial, if you will.

So we are seeing the persistence and in line with what we believe is being used -- what is the appropriate course of therapy. So I'd say that on the success rate and persistence. And then on the physician detailing, as you would imagine, at this point, we have had an initial reach out to all of our -- a majority of our physician detailing targets.

And on the how much time does it take to convert them? Look, the facts are straightforward, right? Since the last earnings, we’ve doubled the number of prescribers that have written -- that have initiated new patient cases and 1/3 of them are writing multiple cases.

And there are prescribers that have never -- Cortrophin -- the ACTH therapy before the ever [ph]. So, I think the physician response has been very strong..

We will take our next question from Greg Fraser with Truist Securities..

A couple on Cortrophin. Can you provide some specifics on patient numbers? Maybe the average number of patients on therapy during the quarter or how many patients are on therapy at the end of the quarter? And then if you could just comment on the percentage of scripts that are being written that are being filled.

And for those that are not filled, what are the primary reasons?.

Got it. So, look -- and thank you for your question, Greg. On the question on patients on therapy, look, we're very encouraged by our early physician demand that has resulted in doubling of manual case initiations to more than 500 new case initiations for Cortrophin Gel.

We've also made good progress so far by gaining formulary coverage for 134 million lives. Our ambition to significantly expand access for patients that need Cortrophin Gel is obviously still something that we're working on.

And in terms of specific numbers of patients on therapy, we're currently at north of 225 patients on therapy, as it currently stands..

Got it. Just a couple follow-ups.

What portion of that 134 million-plus covered lives have advantaged access? And do you have a target for number of covered lives for which you’re looking to contract for favorable access? And then if you could just comment on any sort of reactionary behavior that you’ve seen so far from Mallinckrodt, that would be helpful..

Yes. Thanks, Greg. As you will expect, that commenting on this while we're in the middle of contracting, I think we've shared a great degree of information.

But in terms of targeted coverage specifics and specifics on how many we want to be advantaged is something that we'd like to steer clear from, as I said, that our ambition is to significantly expand access for patients that need for Cortrophin Gel. And we've made very good progress getting to 134 million lives.

And I highlighted some of our recent wins, or one of our recent wins, in the press release.

And then, Greg, would you mind repeating the second question?.

Yes. Just curious if you’ve seen some reactionary behavior from Mallinckrodt..

Yes. Look, we're tracking what Mallinckrodt is doing and the changes that have happened at the company and any resulting changes. But more than that, we're importantly focused on what we need to do to achieve our purpose of providing another choice in ACTH therapy to our patients.

As mentioned before, a claims-based epidemiology analysis suggests less than 10% of patients who are steroid resistant and refractory across primary indications actually receive ACTH therapy. So this is the unmet need that we're focused on..

[Operator Instructions] We will take our next question from Brandon Folkes with Cantor Fitzgerald..

Congratulations on the results. Maybe just 2 on Cortrophin.

Any color -- additional color on the split of ATCH-experienced prescribers versus first-time prescribers? And then the guidance raise, can you just help us think about how we should sort of think about the moving parts there? Do you expect to increase the pace of new patient starts in the back half of the year with the guidance raise driven by the better coverage that you have coming online there? And then, I’ll just ask my other one.

Just in terms of business development going forward, do you look to bring in additional rare disease assets or continue to bring in generic assets? Just longer term, should we think of ANI sort of growing its generics business as the primary driver or maybe bringing in additional specialty assets?.

Yes. And thank you, Brandon, for your question. In terms of the split between experienced prescribers versus new prescribers, we're not sharing those details at this time. As you can imagine, there's a competitive context here that drives what we can share or not share on these calls and I appreciate your understanding there.

Regarding your second question on the guidance and the raise on the Cortrophin guidance, look, we absolutely see an increase in the number of patients that will get on therapy and acceleration there. And that does inform the guidance range of -- and the momentum that we believe drives our guidance increase.

Yes, so it's both -- it's not -- it is the increase in the number of patients that will get on therapy as we go forward and that is driven by both factors, right? Increase in the number of new enrollments, new patient cases initiated. As I just said, we've doubled the number of new patient cases initiated since the last earnings.

We expect that momentum to continue, as well as getting those patients on therapy. And then, your third question on business development, look, the rare disease business unit is one that we have invested in heavily and one that we will absolutely bring additional assets in to expand and use the rare disease platform that we have.

Of course, at this time, we're focused on executing on the Purified Cortrophin Gel launch. There are many other elements of the Cortrophin Gel launch that will unravel as we move forward.

But in terms of how you think about business development and where ANI will be focused, I think that rare disease is an areas that will absolutely get allocation of capital and bringing additional assets in to drive that platform and drive it forward. And as far as the generics business goes, look, we have a rock solid, high-performing R&D engine.

And that will be the source of organic growth as we look at – potentially look at other dosage forms, that’s where the business development will be targeted there. Of course, the Oakrum Pharma-type acquisitions are opportunistic where we achieve better chance to expand our portfolio..

We do have a follow-up question from Elliot Wilbur with Raymond James..

Just real quickly on pipeline, specifically thinking about generic business. Nikhil, I don’t know if you have the numbers in front of you or not but just wondering where things stand in terms of number of ANDAs currently pending at FDA. And also, I think there’s been a settlement reached in your Paragraph IV filing on reprostinil [ph].

Just wondering if there’s anything you can say about that in terms of when you may be able to monetize that opportunity. And I think as part of the Novitium acquisition, you also picked up a couple of 505(b)(2) assets. Just wondering what developments have occurred since the acquisition.

If there’s anything more you could say about the time line associated with those..

Yes. Thank you, Elliot, for your question. So on the 2 505(b)(2) assets, they're progressing well. Or I'm sorry, on the multiple 505(b)(2) assets that we had. It's not just 2. They're progressing well. We have made significant progress on the launch of one of them and we'll share more details in future calls.

But I think the idea of looking at 505(b)(2)s and using the Novitium R&D engine to drive that forward is something that we are committed to and we'll take forward. So that's on the 505(b)(2)s. The reprostinil settlement is not one that we can share more on than what’s in the public domain. So I think I’ll have to steer clear of that.

And then your third question which is the number of ANDAs pending at the FDA. I have the number of the total ANDAs, so allow me to come back to you in terms of the total number of ANDAs. But it’s – that are pending, it’s I think close to 30 that are pending at the FDA.

But obviously, as you know well, Elliot, this is something that we keep adding to the pipeline. We have a high-performing R&D engine, ranked number 6 in terms of the number of ANDA approvals received in the past 12 months. So it’s something that we keep adding to the pipeline, as you will imagine..

It appears we have no further questions on the line at this time. I will turn the program back over to our presenters for any additional or closing remarks..

Yes. Thank you very much for turning the call back. Thank you, everyone, for joining our call this morning.

We’ve made excellent progress to date and remain committed to capturing the full potential of our lead rare disease product, Cortrophin Gel, all while advancing our active R&D engine to continue delivering high-quality medicines to patients in need.

As always, we appreciate the support of our shareholders and look forward to sharing our future progress. Thanks again and stay well..

This does conclude today's program. Thank you for your participation. You may disconnect at any time and have a wonderful day..