Good day, everyone, and welcome to First Quarter 2022 Call. At this time, all participants are in a listen-only mode. Later, you will have an opportunity to ask questions during question-and-answer session. [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..

Thank you, Emma. Welcome to ANI Pharmaceuticals' Q1 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; and Steve Carey, Chief Financial Officer; and Chris Mutz, Head of Rare Disease of ANI.

You can also access the webcast of this call through the Investors section of the ANI Web site at www.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 Web site, anipharmaceuticals.com.

For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on May 10, 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.

Nikhil?.

First, updating you on 2022 Q1 performance; second, sharing what we have accomplished and where we are headed on key growth initiatives; third, providing full-year 2022 guidance for the total company; and finally, discussing the organizational evolution to capture the opportunities that lie ahead for ANI.

First, on quarterly performance, we delivered net revenues of $64.5 million in the first quarter of 2022, an increase of 18% year-over-year. As Steve will detail later, excluding the Yescarta royalty from prior year result, total net revenues would have increased nearly 49% year-over-year.

This growth was driven by the acquisition of Novitium, and the new product launches both from the ANI legacy business and the Novitium acquisition. During this quarter, we launched purified Cortrophin Gel, the lead asset in our Rare Disease business, and began offering patients suffering from certain autoimmune conditions, a choice in ACTH therapy.

During the first quarter, after Cortrophin Gel launch, we achieved $1.3 million in net revenues. Our adjusted non-GAAP EBITDA for the quarter was $4.3 million. And the year-on-year reduction in non-GAAP EBITDA was driven primarily by the approximately $11 million of Cortrophin launch-related SG&A.

Now, let me share with you what we have accomplished and where we are headed on key growth initiatives. Our first initiative is to build a successful Cortrophin Gel franchise, the lead asset of our Rare Disease business unit. On January 24, 2022, we announced the U.S. commercial availability and launch of purified Cortrophin Gel.

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 nephritic syndrome. The further reintroduction of Cortrophin Gel and for over 20 years, patients had only one available ACTH treatment option.

We are pleased with our progress since launch approximately 15 weeks ago. And much credit must be given to our world-class cross-functional and commercial teams, including a dedicated and experienced Rare Disease sales force.

95% of our sales therapies are already sold, and our clinical account executives, i.e., sales force have already reached almost 50% of targeted prescribers and generated awareness of and interest in Cortrophin Gel.

Over 125 unique prescribers has initiated over 250 new patient cases for Cortrophin Gel therapy since launch with approximately 25% of the unique prescribers having enrolled more than one patient. Initially enrollments are distributed relatively evenly across our targeted specialties of rheumatology, neurology, and nephrology.

Our last trajectory has been strong with growth in the number of new patient cases per week and reduction in the average time from new case initiation to patient dispense.

Equally important, our market access efforts have resulted in formulary coverage for over a 100 million lives for one or more FDA approved indications and 16 million lives where we are advantaged. Our wholesale acquisition cost is approximately 23% lower than the wholesale acquisition cost of the only other ACTH therapy available.

In addition, our patient services organization remains focused on establishing expanded access to Cortrophin Gel for patients and their caregivers throughout the treatment journey. Finally, our sales performance in April and early in May reflects the strong launch trajectory. We have made very good progress in such a short time.

And we are pleased to issue 2022 revenue guidance for Cortrophin Gel in the range of $35 million to $40 million. The next key growth initiative I will speak about is driving growth of our generics business by enhancing our R&D capability through the Novitium acquisition.

The combined team has continued to execute well on ensuring continuity of business operations and capturing synergy from the combination.

During the first quarter of 2022, we successfully launched several products with total IQVIA market size of $240 million and with the majority of these launches such as Misoprostol, Rifabutin, and Bisoprolol having three or fewer competitors. Successful execution of these new launches helped counter the impact of business erosion.

We expect the pace and value of new launches to help drive growth for our generics business in the subsequent quarters. The R&D organization under the leadership of Samy Shanmugam continues to deliver with six new ANDA filings in Q1.

In addition, the company retained its leadership in competitive generic therapy, CGT approvals with securing the CGT approval of betaine anhydrous solution. Today, ANI has over 20 ANDA files pending with the FDA and over 20 applications and multiple 505(b)2 products under development.

The company remains focused on strengthening the product pipeline to further increase sustainability of our generics business. We have also made very good progress on driving efficiencies in our combined operations, procurement and distribution. We will increase efforts in the area to further drive cost competitiveness.

Next, I will turn to our established brands business. We are continuing to evaluate potential accretive asset acquisitions to capitalize on and augment our commercial and organizational capabilities. In parallel, we are maximizing the value of the current portfolio through innovative and fit for purpose commercialization strategies.

ANI is well past inflection point and has invested significantly in organizational capability and leadership bandwidth to support our evolution towards becoming a leading biopharmaceutical company. Our Rare Disease leadership team lead by Chris Multz, has experience over 20 rare disease product launches.

And nearly 75% of the sales team has won a President's Club or equivalent top 10 sales award in recent years. Our generic R&D team has a prolific track record of delivering limited competition new launches. With that, let me turn it over to Steve to share the financial results and the full-year total company guidance..

Net Revenue between $35 million and $40 million, and direct selling, general and administrative expenses between $42 million and $46 million. In addition, we currently anticipate between 16.9 million and 17.0 million shares outstanding and an effective tax rate of approximately 24% prior to any federal tax reform.

With that, we will now open up the call for questions. Operator, please go ahead with the instruction..

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

Thanks. Good morning. Just a couple of quick ones upfront for Steve, first, just looking to connect updated guidance versus the guidance provided back in early March, it doesn't look like there was any change with respect to anticipated EBITDA generation on the base business, but just wanted to confirm that.

And then, how should we think about your outlook for operating cash flow over the balance of the year, given the need to continue to support the initial Cortrophin launch? And then, I have got a couple for Nikhil as well..

Sure, Elliot. Good morning, and thanks for the question. So, yes, your observations regarding guidance this morning are spot on.

So, the base business guidance, which as you will recall, at our last earnings call we provided guidance ex-Cortrophin, so that portion of the guidance remains unchanged this morning, and we are overlaying the Cortrophin guidance on to that previous guidance.

And then, regarding the outlook, regarding operating cash, yes, we are very confident in terms of when we look for the quarterly projections, and the trajectory of the overall business as well as how we expect the Cortrophin standalone product P&L to develop over the next three quarters, we remain very confident in our cash position and the ability to support the business, and support all of our key initiatives for the business.

The quarterly cash flow that you are seeing in the first quarter is completely as expected, given the heavy lift in the early days of the Cortrophin launch, right, where the selling and marketing spend really occurs essentially on the divide-by-four basis, when you know, obviously the revenue and the associated gross profit streams, like you are starting from zero, and then building from there.

So, nothing unexpected in the first quarter, and we have a high degree of confidence in the following -- in the forthcoming quarters, two through four, to support the business. And I will turn it back to you to ask your questions for Nikhil there..

Yes, thanks. Not surprisingly a couple of the questions with respect to the initial Cortrophin launch. Nikhil, just wondering if you could provide maybe a little bit more detail in terms of some of the early success you are seeing with respect to just sort of the source of patients.

Are these patients new to therapy, are they switches from the competitive therapy that -- in the market, or are these patients that perhaps had been on ACTH therapy at some point during their -- the time they've been diagnosed with the respective ailment that have just been pushed out of the market due to access issues? So, just trying to get a sense maybe if you are seeing some early indications that maybe the launch of Cortrophin Gel is actually leading to market expansion as opposed to just [forges] [Ph] between Cortrophin and the other product on the marketplace?.

Yes, so, good morning, Elliot, and thank you for your questions. I'll start and then, we have our Head of Rare Disease, Chris Mutz on the call, so he can chime in with additional commentary.

I think that going back to your question, I think the first thing is to just clarify or -- we confirm that what we did right out of the gate, I think it's early days of the launch, is to focus on new target therapeutic areas and prescribers, right, so believers in the ACTH therapy, right? And so, our target is specialties of rheumatology, neurology, and nephrology, and looking at prescribers in there.

What we've seen, to answer your question, is that we are definitely seeing in the enrollments that we have that there are new patient starts.

But the other dynamic that is interesting, and answers your question is, you know, prescribers that had higher volumes of prescription in the prior periods, not the current, not the last 12 months, but the period prior to that, have started giving us additional prescriptions, which leads us to believe, and that was our intent with the launch of purified Cortrophin Gel, that we are expanding both through the access as well with the reach within the prescriber group, the number of patients that can benefit from this therapy.

Now, I [reframe] [Ph] something that I said at the last earnings call, which is when you look at a claims-based epidemiological analysis, right, that shows that less than 10% of patients who were steroid resistance and refractory across primary indications receive ACTH therapy. That's how we see the market and the patients who need this therapy.

Chris, would you like to add anything?.

Yes, sure. Thank you, Nikhil, and thanks for the question, Elliot. I think we are very focused as a dedicated Rare Disease sales team.

I am in clinical conversations with physicians who are more comfortable with ACTH-based therapy from the past experience who are focusing on new patients and focusing on the clinical discussion that will identify patients who really could benefit from Cortrophin Gel. And that really has been our primary focus.

And so, as Nikhil said, the vast majority of these conservations are leading to new patients starts currently and [indiscernible] launch..

Okay. And then just one follow-up question for you, Chris, can you just talk about -- your language in the release this morning talks about identifying new patient cases. And then ultimately turning those into Rx and then looking to shorten the period in which that occurs.

Could you just maybe give us a little bit of insight into sort of what some of the hurdles are and encumbrances in terms of just simply capturing mindshare at the physician level generating Rx and ultimately getting patient on [this] [Ph] therapy..

Yes, sure. Certainly, in the first few months of any new product launch and especially in the rare disease space where these therapies are often quite expensive, we turn into headwinds of initial denials from commercial insurance plan.

And so, that has really been kind of managing initial denial and using our internal team -- field reimbursement as well as the business trends experts that we have in our hub to kind of work with the office to prepare the package and the data that's needed to overcome those denials and ultimately get Cortrophin approved has been really I think key headwind early on.

So, that's what we are experiencing, for sure. But we are really confident in terms of the teams that we have in place to improve that [art for] [Ph] fulfillment pathway for patients, and we have seen that improvement..

Okay. And that's just you are seeing --.

So, Elliot --.

Sorry.

Is that just your standard payer, we don't cover products in the new -- new products in the first 12 months type of hurdles that you were referring to?.

Yes. I mean I would say that that in this first period of three-plus months, we're certainly [indiscernible] for sure..

So, Elliot, if I may just build what Chris said, I think couple of things. One is just to be clear, the 250 new case initiations over to 150 are patients that prescribers have written prescriptions for. So, I think that's just one thing to clarify.

Then the second thing is we have made good progress on the getting formally coverage for over 100 million lives where they are for at least one or more FDA approved indication. So, obviously, that's helping move the enrollment to fulfillment process.

And I think the last part to say is look, we are very encouraged by the progress we have made by improving the average time it takes from new case initiation to dispense vials during the first 3+ months of the launch. The time from new case initiation to fulfillment has varied and has been dependent on payoff coverages as Chris said.

But, in some cases we have seen Cortrophin Gel approved and shipped to patients in as fast as 36 hours when the coverage in place. So, this is -- as Chris said, this is classic. And as you were pointing out too, this is classic rare disease right out of the gate.

And we factored the acceleration of this time for enrollment to fulfillment as we read out our full-year guidance..

All right, thank you for the questions..

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

Hi, thanks for taking my questions.

Maybe just building on from the prior question, can you maybe talk about how many out of 250 patient cases are actually paid scripts at this stage versus they're not funding, any stocking in the first quarter, and any color on how many of 250 patient cases maybe initiated in the first quarter?.

Yes. Thank you, Brandon, and good morning to you. I think that, just to make sure I got all your three questions, I think your first question is how many of the 250 cases are paid cases; the second is, how many of the 250 -- the third one was how many of the 250 were initiated after quarter end.

And apologies, could you repeat your second question for me, please?.

Yes, the $1.3 million revenue recognized in the quarter, just any color on stocking?.

Got it. Yes. All right, so, yes, yes.

So, on the first one, is on the what portion of the cases are paid cases versus off the 250, as you would expect, right, we're processing the enrollment of fulfillment for the 250 cases, clearly the $1.3 million of revenue is in quarter one, is not reflective of majority of these patients moving to therapy, right? So, I can't give you a holistic answer on how many of these will be paid cases versus not, right? However, I will clarify that we obviously have a number of patients on therapy, and for those patients that are on therapy, what we're seeing in terms of paid versus non-revenue generating vials, I think that the mix is in line with what we had anticipated as we launch this product.

So, that's first. I think the second is how many of this, of the 250, have been initiated after the close of the quarter? I don't have an exact split, but the trend, the weekly number of new inpatient enrollments per week have increased week-on-week.

For us, there is a clear upward trajectory, clearly as you remember, we launched on January 24, and so they were about, let's call it, eight, nine weeks of the first quarter. So, there has been a significant improvement in the momentum, and new case generation.

And we are also seeing that in the revenue, like, we indicated revenues of $1.3 million for the first quarter, and I highlighted during my prepared comments that in April and May, we clearly have seen an increase in the sales, and that trajectory, and that's part of the data that we looked at as we give our full-year guidance.

And then, the third question is on the $1.3 million in first quarter, I think majority -- almost -- there was not a large stocking in that number. Remember, we are using a network of specialty pharmacies to our distribution, and then a distributor for the hospitals and IDMs.

And so, there is -- in the first quarter number there is limited stocking, to the best of our understanding..

Yes. I think it would also be safe to add to that, Nikhil, that based upon the reorders that we've seen in April and May, right, it suggests that the first quarter units have largely, if not entirely been consumed. So, I think that's another angle on that question as well..

Yes, thank you for that, Steve..

Okay, thank you very much..

There are no further questions at this time..

All right. Well, yes, it's back to me. Thank you everyone for joining us on the call, and being with us on this journey to deliver high quality medicines to unreserved patients, while creating shareholder value. We are pleased with how 2022 had begun. Thanks again, and stay well..

This does conclude today's program. Thank you for your participation. You may disconnect at any time..