ANI Pharmaceuticals, Inc.
Q1 2022 Earnings Call Transcript

Published: 10 May 2022

[Operator:]

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.

[Lisa Wilson:]

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?

[Nikhil Lalwani:]

Thank you, Lisa. Good morning, everyone, and it's great to have you all join the ANI Pharmaceutical's call today, and for your interest in our company. We are looking forward to covering four key topics with you today

[Steve Carey:]

Thank you, Nikhil, and good morning to everyone on the call. As I review our first quarter financial results, please keep in mind that this was the first full quarter of Novitium operations in our consolidated results. In addition, it is the first quarter in which we are reflecting Cortrophin sales and marketing cost sales and marketing cost in our non-GAAP profitability measures now that we are in the post launch period. For the three months ended March 31, 2022, we posted total net revenues of $64.5 million. Up nearly $10 million or 18.3% as compared to the prior year period driven by revenues from the Novitium acquisition and new product launches tempered by the non-recurrence of the material royalty item that occurred in the first quarter of 2021. In total, the Novitium acquisition benefited net revenue comparisons by approximately $19.2 million across our generic pharmaceuticals, contract manufacturing, royalties, and product development services categories of revenue. This significant gain was somewhat offset by the non-recurrence of $11.2 million of royalty income recognized in the first quarter of 2021, resulting from the final Yescarta-related royalties from Kite Pharma. Excluding the Yescarta royalty from prior year result, total net revenues would have increased nearly 49% year-over-year. Net revenues for the generic pharmaceutical products were $49.1 million during the three months ended March 31, 2022, an increase of $16.1 million or 49% from $33 million in the prior year period. The net increase was principally driven by $15.7 million in revenues associated with the Novitium acquisition as well as sales of Nebivolol which ANI launched in September of 2022 -- I am sorry, September of 2021. We also saw an increase in overall volumes in the generic segment as the market continued to recover from the COVID-related suppression experienced in 2020 and 2021. Net revenues for branded pharmaceutical products were $8.5 million during the three months ended March 31, 2022. An increase of 12% compared to the $7.5 million for the same period in 2021. The net increase was driven by modest increases in sales across several portfolio products, including those acquired from Sandoz and launched in April of 2021, and a shift in mix towards products with higher average selling prices. Contract manufacturing revenues were $2.9 million during the three months ended March 31, 2022, an increase of 13% compared to the $2.6 million for the prior year period, due to an increase in the volume of orders, including $1.1 million of Novitium contract manufacturing revenues. Royalty and other revenues were $2.7 million during the three months ended March 31, 2022, a decrease of $8.7 million from $11.4 million for the prior year period, due to the aforementioned final royalty payment under the Kite Pharma license agreement for Yescarta that was recognized during the three months ended March 31, 2021. Royalty and other revenues in the first quarter of 2022 consisted primarily of $1.9 million in royalty revenues related to Novitium arrangements, and $0.6 million in product development service revenues. Net revenues of rare disease pharmaceutical products consist entirely of sales of Cortrophin Gel, and totaled $1.3 million during the three months ended March 31, 2022. These recognized sales figures reflect a natural lag between new case initiation and the dispensing of a product that is inherent in the early days of a rare disease new product launch. Looking forward, we anticipate very strong quarter-over-quarter sequential growth during the remainder of the year. There were no sales of rare disease pharmaceutical products during the comparable prior year period. Operating expenses increased by 63% to $83.7 million for the three months ended March 31, 2022, up from $51.5 million in the prior year period. Cost of sales, excluding depreciation and amortization, increased by $14.3 million to $34.3 million in the first quarter of 2022, compared to $20.0 million in the prior year period, primarily as a result of increased volumes, including $9.5 million of costs related to sales of Novitium products. The Novitium cost included $3.2 million charge representing the excess of fair value over cost for inventory acquired in the business combination, partially offset by a decline in sales tied to profit-sharing arrangements. Excluding the impact of acquisition, accounting, and stock compensation, cost of sales on a non-GAAP basis as a percentage of total net revenues increased 10.4 points from 36.6% in the prior year to 47% in the current year period. This increase was driven by the non-recurrence of Yescarta royalties, which had no corresponding cost of goods sold, and a higher mix of generic sales. Excluding Yescarta from the prior year calculation, cost of good on a non-GAAP basis would have been approximately 46.1%, essentially flat with the current year. Research and development expenses increased to $5.3 million in the first quarter of 2022, from $3 million, an increase of 78% primarily due to the addition of Novitium cost tempered by a decrease in expenses associated with the completion of our Cortrophin development efforts. During the quarter, we filed six new ANDAs with the FDA on the strength of our R&D efforts. Selling, general, and administrative expenses increased by $11.2 million in the first quarter of 2022, to $28.8 million compared to $17.6 million in the comparable quarter in 2021. The increase primarily reflects $11.0 million increase in sales and marketing expense related to the Cortrophin launch, and $2.7 million of expenses primarily related to the addition of Novitium headcount and activities, partially offset by a decrease in transaction expenses related to the Novitium acquisition. Depreciation and amortization expense was $14.6 million for the three months ended March 31, 2022, an increase of $3.7 million compared to $10.9 million for the same period in 2021. This increase is primarily a result of amortization of intangible assets acquired in the Novitium transaction. Our $1.27 GAAP net loss per share reflects significant amortization and inventory step up charge, resulting from the Novitium acquisition, coupled with the sales and marketing expense behind our initial commercial launch of Cortrophin. As it relates to our non-GAAP profitability measures, the current period in the first quarter that we are reflecting Cortrophin sales and marketing costs, prior to this period, 100% of such cost were added back as pre-launch related expenditures. Adjusted non-GAAP EBITDA for the first quarter was $4.3 million as compared to $18.9 million for the first quarter of 2021. And our adjusted non-GAAP diluted loss per share was $0.12 for the quarter, compared to diluted earnings per share of $1.04 for the first quarter of 2021. As of the March 31 balance sheet, we had 76.9 million of unrestricted cash, and cash equivalents, and total net debt utilizing the face value of debt net of unrestricted cash on hand as of March 31, was $222.4 million, compared to $199.7 million as of December 31, 2021, reflective of lower cash on hand as we utilize cash in the quarter to support our Cortrophin launch efforts. Now, turning our attention to forward-looking guidance, due to increased Cortrophin launch visibility and momentum, we are providing total company guidance with today's release. On a total company basis, for the projected 12 months ended December 31, 2022, we currently anticipate net revenue between $295 million and $315 million, representing approximately 36% to 46% growth as compared to the $216.1 million recognized in 2021. Research and development expenses between $16 million and $18 million, adjusted non-GAAP EBITDA between $54 million and $60 million, adjusted non-GAAP diluted earnings per share between $1.34 and $1.62. In addition, we are providing the following purified Cortrophin Gel specific measures

[Operator:]

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

[Elliot Wilbur:]

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.

[Steve Carey:]

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.

[Elliot Wilbur:]

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?

[Nikhil Lalwani:]

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?

[Chris Mutz:]

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.

[Elliot Wilbur:]

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.

[Chris Mutz:]

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.

[Elliot Wilbur:]

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

[Nikhil Lalwani:]

So, Elliot --

[Elliot Wilbur:]

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?

[Chris Mutz:]

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

[Nikhil Lalwani:]

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.

[Chris Mutz:]

All right, thank you for the questions.

[Operator:]

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

[Brandon Folkes:]

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?

[Nikhil Lalwani:]

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?

[Brandon Folkes:]

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

[Nikhil Lalwani:]

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.

[Steve Carey:]

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.

[Brandon Folkes:]

Yes, thank you for that, Steve.

[Steve Carey:]

Okay, thank you very much.

[Operator:]

There are no further questions at this time.

[Nikhil Lalwani:]

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.

[Operator:]

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