Assertio Holdings, Inc.

Good morning and welcome to the Assertio Holdings Incorporated fourth quarter and full year 2021 financial results conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Max Nemes, Head, Investor Relations and Administration. Please go ahead.

Good morning, and thank you all for joining us today to discuss Assertio's fourth quarter and full year 2021 financial. The news release covering our earnings for this period is now available on the investor page of our website at investor.assertiotx.com. I would encourage you to review the release and the accompanying presentation as it is important to today's discussion. With me today are Dan Pizer, President and Chief Executive and Paul Schwichtenberg, Senior Vice President and Chief Financial Officer. Dan will open the arcs and provide an overview of the business, followed by Paul, who will review our financial results. After that, we'll open the call for your questions. During this call, management will make projections and other forward-looking statements regarding our future performance. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in this afternoon's press conference. as well as ASSERDIO's filings with the SEC. These and other risks are more fully described in the risk factor section and other sections of our annual report on Form 10-K. Our actual results may differ materially from those projected in the forward-looking statements, and ASSERDIO specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. With that, I will now turn the call over to Dan. Dan?

Thank you, Max. Welcome to everyone joining us here this morning. Last quarter, I made some remarks about everything that had happened in the prior year and how much change had taken place here at Asserdio. In addition to what I made mention of at that time, we've also closed the acquisition of Atrexa from Antares and have now integrated it into our business. This was the first acquisition of a product by Asserdio since 2015 and the first by our new management team. And to date, all has gone extremely well. As you can see from the results we released this morning and that Paul will expand upon in a few minutes, we had a very strong fourth quarter. We delivered top line growth of 7% versus the prior year despite discontinuing our product line and 23.8% versus the prior quarter. Our adjusted EBITDA results reflect an increase of 118% versus the prior year and 12.7% versus the prior quarter demonstrating the success of our restructuring. In a short period of time, we were able to transform this company such that we generated more in the fourth quarter of this year versus the entire year of 2020. And I'm looking forward to the next 12 months and see a lot to get excited about. To build on our momentum, I've created our corporate priorities for 2022 to ensure continued success. These are as follows. First, retention of our employees, attraction to new talent, and to continue to build upon our culture of teamwork, inclusion, and results. Second, prove the efficacy of our new commercial model as we transition or tracks up from traditional in-person to non-personal promotion in what looks like it could be an environment where COVID-19 is moving to endemic. Third, reduce our concentration in industry. Fourth, executing on a comprehensive lifecycle management program for Indusim, and finally, improving our balance sheet and reducing the cost of capital. We're keenly focused on integrating Atrexa, expanding upon the reach and frequency of promotion, improving upon its market access, finding new avenues of growth, and doing so in a capital-efficient manner. This should allow us to build confidence and interest in the business model, not only from investors, but also potential new business partners. We're also aggressively targeting new business development opportunities and have added both internal and external resources aimed at accelerating our efforts here. It is largely through acquisitions that we expect to reduce our reliance on Induson. We have not wandered from our goal of adding $50 million in incremental gross profit to the business by 2024. or trex up accounted only for one-fifth of this goal we believe there is a favorable acquisition environment right now we're seeing a lot of new product acquisition opportunities increasing activity from those looking to sell as conditions ease up post the pandemic and many of our peers who have been and would like to be buyers are far more levered than we are there is no doubt that indusin is currently an important part of the business and we intend for that that to continue into the future. We're actively working on our plans to grow and expand the label for the product. And once we have clarity on the timing and cost of these development programs, we'll communicate those to investors. Paul and I are both extremely focused on our balance sheet and are looking for the right balance of reducing our cost of capital, leaving flexibility for future acquisitions, extending our maturities, and balancing our debt to market cap. We're currently evaluating multiple proposals for refinancing and weighing the appropriate options and timing. Execution against our business plan and these priorities over the next 12 to 18 months will be key to our success. Fortunately, management time looks like it won't be distracted by the legacy legal liabilities that have chewed up a lot of our time historically, thanks to first, the resolution of the antitrust and shareholder litigation that we drove to settlements recently, and second, As was the case in 2021, we expect no movement in the opioid lawsuits for what is likely the next 12 months and possibly longer. Recently, we were dismissed from two additional cases, bringing the total to 82 dismissals. These two cases were on track to go to trial sometime in early 2023. But now we can focus our time on managing the business and executing on these priorities. In addition, we're optimistic that our investment in NES will mature inside of this timeframe. This represents a nice source of upside optionality for Assyria, as we have the potential to be approximately 12% equity owners of a life-saving drug for an ultra-orphan condition for which there is no available treatment and a priority review voucher. Our strategic interest in this investment is not simply to be an equity participant, but to be either the marketing partner or owner. Before I turn the call over to Paul to discuss our quarterly results, I'll spend a minute on our guidance for 2022. We expect to generate net product sales of 126 to 136 million and adjusted EBITDA of 64 to 72 million in 2022. This represents growth of 15 to 24% in the top line and 31 to 47% in EBITDA. Our revenue forecast reflects a net pricing benefit for Innocent, offset by the loss of exclusivity for ZipSor, which we expect later this month, as well as the inclusion of Atrexa. For your awareness, after completing the acquisition, we did not sell any Atrexa in December, nor through most of January this year, as we normalized the level of inventory in the distribution channel. For Anderson, we have seen an increased mix of heavily discounted product sales through 340B in the last few months of 2021 and early 2022. This mix is unpredictable and ebbs and flows through the year. Our full year forecast, however, assumes that we continue to see an elevated mix from this channel. Our EBITDA forecast reflects the full year benefit of the restructuring we completed in the third quarter last year, as well as the elimination of nearly 6 million in one-time costs in 2021, for the legal settlement's net of insurance proceeds. Now I'll turn the call over to Paul, who will walk through our quarterly results and guidance in more detail.

Thank you, Dan. This morning I will review the financial highlights from our fourth quarter and full year 2021. There are slides available on our website that I will reference as I discuss these results. Starting with slide three, net product sales were $32.2 million for the fourth quarter 2021 compared to net product sales of 30.1 million in the prior year quarter and 26 million last quarter. The increase in net sales versus the prior quarter is driven by Induson, Cambia, and ZipSor. Full year 2021 net sales were 109.4 million versus 92.1 million in 2020, representing a 19% year-over-year increase. Cambia and Zipsor net sales in the fourth quarter reflect one-time price favorability driven by a shift toward more profitable sales channels in the fourth quarter, while maintaining consistent overall volume relative to the prior three quarters. Index in net sales in the fourth quarter increased by 3.8 million over the third quarter, and $5.9 million over the prior year quarter on comparable volume due to an improvement in net realized price that is expected to continue into 2022. Overall, portfolio net sales were up 24% versus the third quarter. Please refer to our 10-K for specific product level net sales information. Cost of goods sold in the fourth quarter included a one-time inventory reserve for Sprex due to a single manufacturing batch that didn't meet the required specifications, resulting in a decline in the gross margin versus the third quarter. Absent discharge, gross margin in the fourth quarter increased 730 basis points over the prior year quarter. Also on slide three, Adjusted EBITDA for the fourth quarter was $17.8 million compared to $15.8 million in the third quarter, reflecting 13% quarter-over-quarter growth. EBITDA in the fourth quarter represents the third sequential quarter of growth after adjusting for one-time legal matters and 118% increase over the prior year quarter. Adjusted EBITDA for the 12 months ended December 31st, 2021 was $48.8 million, reflecting $32.5 million or 200% growth over the prior year adjusted EBITDA of $16.3 million. It is worth noting that the fourth quarter 2021 EBITDA has exceeded the full year EBITDA for 2020. Summarized on slide four, Adjusted selling general administrative expenses in the fourth quarter were $10.1 million versus $7.9 million in the third quarter. Full year 2021 adjusted SG&A expenses were $48.1 million versus $73.1 million in 2020, reflecting a decrease of $24.9 million or 34%. Excluding the net impact of one-time legal matters of $5.6 million recorded earlier in 2021, Adjusted SG&A expenses were $42.6 million, reflecting approximately $45 million of savings versus the annual second half operating expense run rate in 2020, representing a greater than 50% reduction. Net income for the fourth quarter was $4.6 million compared to the third quarter net income of $3.7 million. The full year 2021 net loss was $1.3 million compared to a net loss of $28.1 million in 2020. As was stated previously, 2021 net income was impacted by one-time legal matters expense of $5.6 million and also a loss of $3.9 million for the change in fair value of contingent considerations. On December 31st, 2021, our senior secured debt balance shown on slide five was 70.8 million. On November 1st, 2021, the company paid scheduled interest and principal of 9.7 million. Also on slide five, ending cash on December 31st, 2021 was 36.8 million. The net decrease in cash of 21.9 million from the September 30th, 2021 balance of $58.7 million is primarily attributable to the initial payment of $18 million on December 15th, 2021 for the acquisition of Otrexa and other working capital changes in the fourth quarter. As of December 31st, 2021, the company's net debt defined as senior secured debt less cash to trailing 12-month adjusted EBITDA ratio was 0.7. reflecting a substantial reduction from a ratio of 3.65 at the end of 2020. Net cash provided by operating activities, as reported in the company's statement of cash flows for the fourth quarter, was 4.1 million, reflecting the third quarter of positive operating cash flows. For full year 2021, the company generated $5.5 million of operating cash flow, with $8.8 million generated after the completion of our restructuring in the second half of 2021. This amount includes nearly $10 million for one-time legal settlements and the extension of the Innocence Supply Agreement. Absent these payments, the operating cash flow generated in the second half of 2021 was approximately $18.8 million. As was stated on the prior earnings call, we had been expecting an income tax refund of $8.3 million in the fourth quarter of 2021, which has continued to be delayed due to IRS processing. If this tax refund is further delayed, it will impact our operating cash flow in the first half of 2022 because there are other large outflows, such as interest payment on the senior secured debt and timing of inventory purchases that are expected in this time frame. On an annual basis, we expect cash flows to be positive, but due to the timing of working capital and interest payments, the quarterly operating cash flows will fluctuate. Lastly, our annual guidance for 2022, summarized on slide six, is as follows. Product net sales of 126 to 136 million and adjusted EBITDA of 64 to 72 million. The guidance for 2022 reflects the following factors. Indicative net sales growth driven by favorable pricing, partially offset by higher mix and discounted channels. The addition of Otrexip sales and expenses. Initial sales of Otrexip were delayed to late January 2022 due to the high level of channel inventory that existed at the time of the product acquisition on December 15, 2021. Also reflected in the guidance are the loss of exclusivity for Zip Store in March of 2022, increased rebates and discounts to maintain managed care access for Cambia, and finally, the discontinuation of Solumatrix sales. Overall, we are very pleased with how the business has performed in 2021 through the efforts of our dedicated and committed team. We are very optimistic about the outlook for 2022, and we continue to focus on positioning Assertio for long-term sustainable growth. And now I'll turn the call back over to Max.

Thank you, Paul. At this time, can we open the call for Q&A, please?

We will now begin the question and answer session. To ask a question, you may press star, then one on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. Our first question comes from Scott Henry from Roth Capital. Your line is open.

Thank you, and good morning. A couple questions. First, on Indosyn, how should we think about the duration of the pricing power for that product? Obviously, price has went up. Would you expect that to be – what sort of duration do you think is reasonable to think about there?

Yeah.

In terms of our ability to continue, I would say it's... Well, do you think it will bring new competition? How long do you expect before you start to see competitive factors there?

Okay. So we don't think that the net pricing benefit that we experienced here in the fourth quarter is something that attracts competition. potential new competition or attracts it more. If the product has been attractive in the past, I think it continues to be. And the fact that it's been branded as long as it has speaks to the difficulties in manufacturing and other things that prevent people from competing with this product.

Okay. I guess shifting gears, Dan, you spoke a little bit about this orphan drug investment that the company has. I caught a lot of that, but I missed a little. Could you just talk about that asset and how we should think about it and what kind of value that asset could have?

Yeah, it's for an ultra-rare condition called neonatal entoviral sepsis. And it affects, it's a seasonal disease, typically June to October, affects about 7,000 newborns a year. And these are children who, in most cases, contract an enterovirus during birth. And because of weakened immune systems, the disease can be fatal. And these babies, when they present to the hospital, are severely ill with many of them having to go right away on ECMO. And this product would be the only available product for this disease. And the data shows that it's life-saving. So it's a very important medicine that we want to be a part of bringing to market, not only financially, but also strategically for this company. We think this would be an ideal asset for us to be promoting, which is why we got into this investment in the first place. And at a minimum, it will come with seven years of Hatch Waxman exclusivity. And if approved, it would also come with a priority review voucher.

And what would the timeline be in terms of approval?

So we think they've had some delays. The CDC is an important ally for them in testing a lot of their samples. And as you can imagine, with COVID, the CDC has been a little backed up. They're a little delayed in when they had expected to file this with the FDA, but they're still indicating that they're on time to be able to file with the FDA in the second quarter of this year. So typical review times for these types of assets in the six to 10 months, depending on if FDA has any questions. So there is a chance that we could see approval by the end of this year, and certainly it's on the path to be ahead of the next season in 2023.

Okay, great. And how do you think about kind of peak revenues for a product like this? I don't know if you can think of just, you know, general terms, but just trying to get a sense.

Yeah, so... I think that's a very relevant question. The question really comes down to what do you think the pricing could be? We haven't completed our pricing work for this yet, but we think that if you just look at other similar products, it's not a stretch to assume that you could get a pricing on an annual basis north of $200,000 a year. That is not an uncommon thing in this type of environment. Whether or not that's true for this product is yet to be seen. The net pricing can be very attractive.

And how many patients are there typically treated in a year?

We think the annual occurrence is about, or incidence is about 7,000 patients a year.

Okay. And as far as Assertio's economic participation, how should we think about it? I thought you said you own 12% of this asset. Is that correct? And is there any other component with regards to your participation?

So today it's currently, it's on our balance sheet in the form of a convertible note. And carried at right now half of our original investment. So the way this investment works is upon FDA acceptance of their NDA, that note will convert into equity. So right now on the current timeline, we were expected to convert into what looks like 12% equity ownership, like you had mentioned. If their timelines are delayed, there's interest that accrues on that note, and there's a chance for our economic interest to go up above 12%. But we'd rather see this come to market sooner than later.

Okay. And are there any royalties involved or just that 12% is how we should think about it?

Just that 12% right now.

Okay. Great. Very interesting. Okay. I guess just a couple more quick questions. Otrexip, now that you've got a couple months under your belt, any surprises there, or is that asset meeting your expectations?

As I said in my prepared remarks, everything's going well. The asset's meeting expectations, and I'm really excited about getting it into our commercial engine further. so that we can start to see what we can do with it.

Okay, great. And then I guess the final question, which is sort of a big-picture question relative to the virtual model, I felt like when you started out with this strategical initiative, the thought that would be without the face-to-face promotion, you'd have a – you know, an erosion at whatever rate, perhaps 10% a year or whatever. But then as it's turned out, you've actually grown the prescriptions for a lot of these products. How should we think about organic growth under this virtual model based on, you know, the data points you have so far?

I think that it's a very fair question and a lot of people have answered it. One of the reasons why we switched to this model wasn't necessarily just because we thought we could grow it faster. It was more the economic side of things. So we don't think that promotion nor how you promote for assets like these is the single greatest barrier for that growth or accelerator pedal for that growth. The one that is more important that you need to spend more time and resources on is market access. And not only contracting with PBMs and working your deals with the wholesalers, but also just in terms of building the infrastructure to deliver to patients like we do with our hub and network pharmacy design where we can offer attractive copay benefits. So it's getting those things right that could be the biggest governor of your growth. So we don't think that necessarily moving from in-person to digital is what does that. We think we just drive a better ROI on those investments.

Okay, great. Well, Dan, thank you for taking all the questions. I appreciate it.

All right. Thank you very much, Scott.

Again, if you have a question, please press star then one. Our next question comes from Scott Wise from Simcoe Capital. Your line is open.

Thank you, guys. Congratulations on the turnaround in 2021. Really great job. I've got a couple of questions. One on Indicent. Is there an alternative to this drug in the marketplace? And secondly, how can we think about the TAM and the size of the market as we look forward over the next couple of years?

So in terms of an alternative right now, no, there isn't. There's other things that people have tried. But the only thing that's available on the U.S. market is Indicin. The question about TAM and also I think about an alternative is really at the new possible indication for Indicin that we're exploring right now, which is the prevention of pancreatitis in ERCP surgeries. There's about 400,000 of those procedures done annually in the United States. And at the current pricing of roughly $700 per procedure, there's a very attractive TAM in front of us. So it's something that we're looking to see how fast we can penetrate into that market as well as how deeply. Today, Indicent is recommended in its guidelines largely just for the high-risk segment of that 400,000 procedure market, which is about 20% of that total patient pool. The other two segments, which are moderate and mild, account for about 40% of that market each. So we think that the bigger opportunity here is to receive a broad label for this indication and then start promoting to physicians the benefit of the product, not only in high risk, but also in moderate and low risk patients as well.

Okay. So this drug has grown quite a bit since 2020, and there's no reason, assuming you can continue to penetrate, that this couldn't be a $80 million to $100 million drug over the next couple of years? It's certainly on that path, Scott. Okay. Regarding the refinance, your comment was you're weighing proposals. Can you give us some perspective on the timing? Do you think it's a first-half-21 type of an event? And then what would the refinance look like? Would it be a straight refi of the debt with a lower interest rate? Would it include some cash? Any color around that would be appreciated.

Michael Heaney Yeah. So we are, as I said, weighing some alternatives right now. The key thing in the timing and the execution has always been, have we diversified the business enough on the top line? And the fact of the matter is that Induson on a quarterly basis still earns as much revenue as we expect their trucks up to do inside of a full year. So we need to keep that in perspective as we go out right now. So like I said, we're trying to do the thing that is best for the business and for shareholders. The goal is to extend maturities, reduce the cost of capital, and ideally, leave flexibility for business development. That is above all the number one thing, is making sure that we have the flexibility and additional financial capacity. The ideal situation is a straight refi of the existing term with a lender that has the ability to expand and continue funding. So we can be able to benefit from future deals down the road. And we certainly think that with now our guidance of $64 to $72 million of EBITDA, the fact that we've reported two consecutive quarters of stable business and now growing business here in the fourth quarter, that that will increase the confidence that these lenders will have in our business and their ability to allow for leverage.

Okay. All right. Thank you very much, guys. Thank you, Scott.

This concludes our question and answer session. I would like to turn the conference back to Dan Persett, President and Chief Executive Officer, for any closing remarks.

Thank you. In conclusion, 2021 was an important and transformative year for Sergio that has laid the foundation for growth in 2022. I trust you all now see why we're excited about the opportunities that lie ahead for Assertio. We're scheduled to present next week at the Roth Conference on March 14th, where we hope to see and speak to some of you in person. None of this could have been possible without the talented, committed team and board we have here at Assertio. We're all aligned in creating value for all of our stakeholders under the clear responsibility we have to patients and community. Thank you for joining us this morning, and have a good day.

The conference has now concluded. Thank you for attending. You may now disconnect.