Assertio Holdings, Inc. (NASDAQ:ASRT) Q4 2022 Earnings Call Transcript

Assertio Holdings, Inc. (NASDAQ:ASRT) Q4 2022 Earnings Call Transcript March 8, 2023

Operator: Good afternoon and welcome to the Assertio Holdings’ Fourth Quarter and Full Year 2022 Financial Results Conference Call. All participants are now in listen-only mode. 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 Matt Kreps from Darrow Associates Investor Relations for Assertio. Please go ahead.

Matt Kreps: Good afternoon and thank you all for joining us today to discuss Assertio’s fourth quarter and full year 2020 financials. The news release covering our earnings for this period is now available on the Investor page of our website at investor.soutiotx.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 Peisert, President and CEO; and Paul Schwichtenberg, Senior Vice President and CFO. Dan will open the remarks and provide an overview of the business followed by Paul who will review our financials. After that, we will open the call for your questions. During this call, management will make projections and other forward-looking statements regarding our future performance.

Such for forward-looking statements are not guarantees of future performance and involve risks and uncertainties including those noted in this morning’s press release as well as the Assertio’s filings with the SEC. These and other risks are more fully described in the Risk Factors 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 Assertio specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. With that I’ll now turn the call over to Dan.

Dan Peisert: Thank you, Matt. Welcome to everyone joining us this afternoon. Last quarter I had remarked that the actions we had taken in the third quarter marked to pivot from restructuring towards growth. Now, that we’ve reported our fourth quarter, that growth is self-evident. Net product sales increased 55% versus the prior year. Adjusted EBITDA increased 87%. Our adjusted EBITDA margins were 66% versus 53% last year. Adjusted EPS increased 52% and our cash flow from operations was up nearly 6.5-fold to $26.7 million. In fact we generated more operating cash flow this quarter than the business generated in net product sales in three of the four quarters of 2021. We’re extremely proud that the actions we’ve taken have led to these results including the acquisition of Sympazan early in the fourth quarter which contributed $1.8 million of net sales this quarter and to-date, in 2023, is outperforming our internal deal model expectations.

We’ve come a long way in a short period of time. What I’m most excited for is what’s yet to come. We’re in a far better position now to execute on our growth plans both financially and the current environment. As the song goes today is where our book begins the rest is still unwritten. I’ve developed a habit of laying out our corporate priorities and then discussing them on our first investor call of the year. This year will be no different. And our priority should not surprise — should not be a surprise to anyone who has followed our company. They are, first, to continue to build improve the value of our non-personal commercial platform; second, to maintain INDOCIN and execute on the INDOCIN life cycle management initiatives; third, business development to execute on our M&A plans to diversify our portfolio and create future growth opportunities for the business.

We’re going to be making some substantial investments and improvements in our commercial platform early this year. We’re doing this to continue to advance the internal platform and have more accurate and timely feedback so we can improve our ROI and our ability to grow demand. Let me break that down just a little bit across our key brands starting with SYMPAZAN and OTREXUP. As I mentioned earlier, the initial sales of SYMPAZAN are ahead of forecast. We’re seeing some very encouraging results with the digital campaigns we’ve been running. Open rates on our digital communications have been amazing and we see a significant education and awareness opportunity around the unique benefits of this drug’s dissolving film-based delivery to provide more accurate and consistent dosing.

Important attributes for the prescribers of this drug to LGS patients. Last year, we had some stumbles with OTREXUP that pushed growth opportunities into this year. Not only do we have an entrenched competitor, but we had some supply challenges with both finished product and samples. Our supply issues are now behind us. So we’re back and 100% focused on growth on that product and believe that the expanded reach through digital promotion, especially into the pediatric segment, can help create demand. With respect to INDOCIN, our goal as we entered the year was to maintain demand. We made some very impactful changes to the product by exiting from an unprofitable segment. To date, we’ve been able to retain the majority of those volumes and the team is incented to maintain the same level of volume as the prior year.

Recently, the American Society for Gastrointestinal Endoscopy or ASGE, which is nearly 15,000 members updated their guideline for post ERCP pancreatitis prevention strategies and now recommends the administration of pre-procedure rectal NSAIDs for all patients. Their previous guidelines recommended indomethacin only in patients considered at high risk for pancreatitis. Please remember that INDOCIN is the only FDA-approved rectolensit in the US. This change could be a tremendous opportunity for Assertio. Based upon our sales, who we see as the end customers and how the product is being used in the RCP, we believe that INDOCIN is used in approximately 160,000 procedures annually. We don’t have a reliable source for how many ERCPs are performed annually in the US, but from simple Internet searches, the most recent articles provide an estimate of 500,000 to 600,000.

This implies INDOCIN use is somewhere in the 25% to 31% neighborhood, which is consistent with what our market research indicated the high-risk segment represented or 22%. This guideline change has the potential to open up a new market that is three times larger than the current. The guidance we’re providing for net product sales and adjusted EBITDA does not assume any incremental benefit from this change. Assertio is acutely aware that currently, this is an off-label use for the product and Assertio remains deeply committed to remaining compliance with FDA promotional regulations. We’re currently evaluating how we can educate physicians and the institutions about these new guidelines within the constraints just mentioned. This change in ASGE guidelines makes it even more important that we execute on our plans to add this indication to the product’s label, so that we can provide physicians with the appropriate safe, dosing and usage of the product to prevent the serious complication of the ERCP and so that we can promote the product for this important use.

We received FDA feedback from our pre-IND submission and are now incorporating that feedback into the design of a clinical trial. We also have a new SVP of Medical on board as you saw earlier this week to lead this initiative for us and Howard has some very relevant experience in this area, which will be extremely beneficial in both the design and execution of the trial. Our next step will be to submit an IND with our proposed clinical design. Once approved, we will have additional clarity into how long the trial will take and how much it will cost and we’ll share with investors at that time. Our EBITDA guidance for 2023 does include an early estimate for the cost of the clinical of approximately $3 million to $4 million. In addition, there are changes that we are making to the product to make it more convenient and relevant in this setting.

The current product was designed years ago for a completely different use and for repeated use, as opposed to a single use. For the time being, we’re going to keep those changes to ourselves for competitive reasons, but we’ll share prior to starting the trials later this year. The rationale for adding this to our label and changing the product goes beyond promotion and growth. Upon successful execution, we will be eligible for three years of regulatory exclusivity for the product, which is a key driver for us. The enemy for this whole program is time. We want to do this as fast as possible. So we’re being deliberately designed to ensure we address all of the FDA’s input and have a trial that physicians will enroll. When the time comes, we will also do whatever we can to accelerate the enrollment.

With respect to business development, we’re extremely busy right now. I had a recent conversation with a healthcare banker who said, I have never seen so many assets available for sale at one point in the last six to seven years. I’ve been doing this since 2008 and I agree with that sentiment. It’s a tremendous time to be a buyer in this marketplace and have the balance sheet and cash flow that can support acquisitions. The opportunities that are available are diverse. Single products, both small and March, both early and late life cycle, to multiproduct portfolios and entire companies. Our mission remains the same. To acquire assets that diversify the business and provide future growth opportunities with a priority to those that have durable and long duration IP that are accretive.

I remain highly confident that we will be able to meet our goal to acquire an additional $32 million of gross profit by the end of this year. Now, I’ll turn the call over to Paul to discuss our quarterly results. Paul?

Paul Schwichtenberg: Thank you, Dan. This afternoon, I will review the financial highlights from our fourth quarter of 2022. As in previous quarters, there are slides available on our website that summarize these results. Net product sales were $49.9 million for the fourth quarter of 2022, compared to net product sales of $32.2 million in the prior year quarter and $34.3 million last quarter. The increase in net sales versus the prior year quarter is primarily driven by INDOCIN and the addition of OTREXUP and SYMPAZAN, which more than offset the expected declines in Zipsor and SoluMatrix. Full year 2022 net product sales were $155.1 million versus $109.4 million in 2021, representing a 42% year-over-year increase. INDOCIN family net sales in the fourth quarter increased by $15.9 million over the prior year quarter, primarily due to a volume mix shift to more profitable channels and a return to normal customer inventory levels after a reduction in the prior quarter.

Approximately $5 million of this increase was related to the inventory change. OTREXUP and SYMPAZAN combined net sales for the fourth quarter were $4.2 million. There were no sales for OTREXUP and SYMPAZAN in the prior year quarter, as these products were acquired in mid-December 2021 and October 2022, respectively. CAMBIA net sales of $7.3 million were flat to the prior year quarter, primarily due to lower volume partially offset by lower rebates due to a volume mix shift to more profitable channels. SPRIX net sales in the fourth quarter were $2.7 million reflecting an increase of $900,000 versus the prior year quarter due to higher volume partially offset by higher commercial rebates and discounts. Overall portfolio net sales were up 55% and versus the prior year quarter.

Consistent with the prior quarter products of goods sold in the fourth quarter reflect lower cost due to product mix and improved margins on INDOCIN resulting in a gross margin as a percentage of product net sales of 87.9%. The 2022 full year gross margin was also 87.9% versus 85.5% in 2021. Our continued focus on profitability across the portfolio throughout 2022 has led to improved net sales and gross profit margins and was achieved through lower co-pay and consignment costs and a reduction in the shipment of free goods, which resulted in lower gross to net expenses and cost of goods sold, respectively. Adjusted EBITDA for the fourth quarter was $33.4 million compared to $21.4 million last quarter and $17.8 million in the prior year quarter.

The year-over-year increase was driven by $17.7 million of additional product net sales and the resulting increase in gross profit, partially offset by higher selling general and administrative expenses due to increased sales and marketing expenses for Otrexup and Sympazan. Adjusted EBITDA margin reflected as a percentage of total revenue in the fourth quarter was 66.3% versus 53.5% in the prior year quarter. 2022 full year adjusted EBITDA was $101.6 million versus $48.8 million in 2021 reflecting an increase of 108%. The year-over-year increase was driven by higher net product sales primarily Indocinn and the addition of Otrexup and sympazan, improved gross margins and lower SG&A expenses. The fourth quarter non-GAAP adjusted earnings per share was $0.32 versus $0.22 in the prior quarter and $0.21 in the prior year quarter.

2022 full year non-GAAP adjusted earnings per share was $1.19. Please note that earnings per share is now calculated using diluted shares including the if-converted impact of the convertible notes as is required under GAAP. The full additional diluted share impact is 17.1 million shares in the fourth quarter. Adjusted selling, general and administrative expenses in the fourth quarter were $11.1 million compared to $9.3 million last quarter and $10.1 million in the prior year quarter. The increase versus the prior year quarter is primarily due to additional costs for both Sympazan and Otrexup along with personnel costs due to new headcount additions. 2022 full year adjusted SG&A expenses were $38.5 million versus $48.1 million in 2021. The year-over-year decrease is primarily due to a year-over-year change and onetime legal reserves and settlements and the cost savings from our non-personal — commercial platform.

Net income for the fourth quarter was $88.6 million compared to $4.2 million last quarter and $4.6 million in the prior year quarter. The fourth quarter net income was positively impacted by an $80.4 million tax benefit from the reversal of a valuation allowance against our deferred tax assets. This adjustment reflects the positive change in the company’s financial performance, which now has been consistently generating positive net income and operating cash flows. In addition to the higher sales, gross profit and change in SG&A expenses previously mentioned net income also included $9.8 million of higher fair value expense for contingent consideration as a result of an increase in the long-term Indocin sales forecast. Fourth quarter net income also reflected $1.1 million of lower interest expense, resulting from our convertible debt refinancing, which reduced our cash interest rate to 6.5% from 13%.

Net cash provided by operating activities as reported in the company’s statement of cash flows for the fourth quarter was $26.7 million. For the full year, we’ve generated $78.6 million in cash flow from operations, an increase of $73.1 million versus the prior year. In addition to the improvements in profitability, we’ve increased accounts receivable collections, collected an income tax refund, reduced debt service and effectively manage working capital throughout the year. Ending cash on December 31, 2022 was $64.9 million, reflecting a slight increase of $100,000 versus the prior quarter, despite making $25 million in final purchase price payments for Otrexup and Sympazan. The convertible debt refinancing in August resulted in the elimination of debt principal payments, resulting in $4.8 million of cash flow benefit in the fourth quarter versus the prior year quarter.

On December 31, 2022, our long-term debt balance was $66 million, reflecting the $70 million convertible debt balance, less unamortized debt issuance costs of $4 million. On February 23, 2023, Assertio entered into exchange agreements, pursuant to which Assertio exchanged $30 million aggregate principal amount of exchange notes for a combination of an aggregate of $10.5 million in cash and an aggregate of approximately seven million shares of its common stock in the transactions. This reduces the amount of convertible debt outstanding that can become senior indebtedness in the event the company seeks to finance any of its future business development transactions with secured debt. Assertio did not receive any cash proceeds from the issuance of the shares of its common stock.

The transactions reduced Assertio’s overall debt by 43% will save the company $2 million in annual interest payments, reduce the potential dilution from the exchange convertible notes by 4.6% and will be accretive to 2023 diluted EPS by $0.02. Lastly, our annual guidance for 2023 is as follows. Full year product net sales are expected to be $150 million to $160 million, and adjusted EBITDA is expected to be $85 million to $93 million. Since we are more than 60 days into the first quarter, we have good insight into the start of the year. Based on sales to-date, we anticipate product net sales in the first quarter to be $36 million to $38 million, reflecting typical seasonality due to patient co-pay and deductible resets on January 1 and the loss of Cambia exclusivity.

In addition, OXAYDO has been out of supply for most of the first quarter, but we do expect supply to resume by the second quarter. The guidance for our full year 2023 reflects the following factors. For net product sales, Cambia loss of exclusivity on January 1, 2023; the addition of SYMPAZAN, which partially offsets the Cambia loss of exclusivity; Indocin net sales growth driven by new commercial and channel strategies, including higher net pricing on Indocin driven by a volume shift to more profitable channels, less the one-time customer inventory benefit of approximately $5 million in Q4, 2022 that returned inventories to normal levels. EBITDA guidance reflects the step-up in operating expenses versus 2022 related to Indocin clinical expenses and additional costs for Sympazan, Otrexup samples and the annualization of employee costs.

This guidance does not include the effect of the potential acquisition of new portfolio assets as well as the potential benefit from the recently updated ASGE guidelines that Dan mentioned. It’s worth noting that as a result of our commercial execution and strategic actions in 2022, our 2023 guidance reflects the opportunity to increase net sales over 2022 despite the loss of exclusivity on Cambia, which was our second largest product. Additionally, we will be utilizing our operating cash flow to fund business development opportunities and continued investment in Indocin, Sympazan and Otrexup to maximize the revenue potential for these products. Overall, we are once again incredibly pleased with the quarter and full year results, most notably our commercial execution and operating cash flow generation.

Looking ahead, our 2023 strategies and goals are aimed at continuing Assertio’s path to long-term sustainable growth. And now, I’ll turn the call back over to Matt.

Matt Kreps: Thank you, Paul and Dan. At this time, we will take questions from our company research analysts and institutional investor community. Joel, can you please provide the instructions for Q&A from our listeners.

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Q&A Session

Operator: Absolutely. We will now begin the question-and-answer session. The first question is from the line of Thomas Flaten with Lake Street. You may proceed.

Thomas Flaten: Hey. Good afternoon, guys. Congrats. A couple of quick questions. Dan, if I heard you correct in your prepared remarks, you said that you’ve seen reordering or return of the majority of the 340B customers. If I heard that right, majority is anything greater than 51%. Is there any more color you can give us on that?

Dan Peisert: I think it — yes, majority does mean that but it’s north of 90%.

Thomas Flaten: Okay. And then I know you have it as a strategy to increase the proportion of your business that goes through direct distribution. Could you give us an update on that, and maybe where you hope to exit the year, and just some thoughts behind converting that business?

Dan Peisert: It is a strategy of ours. We’re keeping the metrics there close to the vest just for competitive reasons, but we’ve been having tremendous success there recently.

Thomas Flaten: Great. And then the final one kind of tagging on to the new guidelines. As you guys envisioned the protocol that you submitted and got feedback on, since it wasn’t a standard of care prior to these guidelines coming out, do you anticipate there being a wrinkle in the design of that protocol, because standard of care or at least according to the guidelines would be to use the product prophylactically, so you wouldn’t have a natural control arm. Any thoughts on that?

Dan Peisert: I don’t think this change is going to impact that. The FDA basically recognize that it was already standard of care for those that were considered high risk. So they were not pushing us to do, like for example, just a placebo-controlled trial. I think the biggest thing that we have to address, there’s a number of things that we have to address relative to our preliminary design that we had submitted to them. And the most notable is dose ranging so they would like to like us to try some additional doses. So we’re trying to accommodate that.

Thomas Flaten: Got it. Appreciate for taking the questions. Thanks.

Dan Peisert: Thank you.

Operator: Thank you. The next question is from the line of Scott Henry with ROTH Capital. You may proceed.

Scott Henry: Thank you. Good afternoon. Congratulations strong results. Again, a lot to unpack, so I just have a couple of questions that we’ll focus on. First, you gave some granularity about INDOCIN in fourth quarter. Could you just repeat that? I just want to make sure I had that correct in terms of the sales level for fourth quarter?

Paul Schwichtenberg: Well, so Scott, the fourth quarter reflected the continued buying of the 340B customers as Dan mentioned, so with some price benefit from that. But it also had what I mentioned was a $5 million inventory benefit, as we returned customer inventory levels to normal levels in Q4. If you recall we had mentioned that we had taken them down at the end of Q3. So there was a one-timer in Q4 of $5 million.

Scott Henry: Okay. Did you say overall, I thought I heard you say that it was sequentially $15 million higher is that €“ did I hear that correct?

Dan Peisert: $15.9 million €“ $15.9 million higher than the prior year quarter.

Scott Henry: Okay. And which would get to around $104 million, $105 million for the year. And when you were speaking of guidance of matching one year over the past, I assume that was referring to 2023. So you think you can match that annual number for 2023 again, which could be conservative depending on the new guidance?

Dan Peisert: Yes. Yes, Scott. That’s correct.

Scott Henry: Okay. Just such an important product. I just want to make sure I have that. And then on the new products, it sounded like Sympazan was a little higher than expected. But OTREXUP, if I did the math correct it was around $2.8 million in the quarter. How do you expect OTREXUP to grow sequentially? I think that’s a little lower but certainly within the ballpark of expectations?

Dan Peisert: Yes, you’ve got the number right there, Scott. And our expectation is that we will to be able to grow OTREXUP going into 2023. As Dan mentioned, the supply issues that we ran into in 2022 are behind us. And we’re also investing more in samples, which we believe will drive some additional volume.

Scott Henry: Okay. And then on the R&D side, obviously you’re just putting forth your trial, your IND. But when we think about a trial like this, it’s an acute indication, generally what kind of follow-up, are we looking at pretty short-term follow-up such that this could be the type of trial that you could typically do within a year from start to finish?

Dan Peisert: Yeah. It’s all going to depend on enrollment. You’re right that I think we’re measuring the primary endpoint there on day five with day seven, but we’ll have a total of 30 days like is what we’re going to propose a follow-up on a patient level basis. So this will — the timing will all hinge on how fast we can enroll the trial.