Good afternoon and welcome to the Assertio Holdings, Inc. Third Quarter 2021 Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions]. I would now like to turn the conference over to Max Nemmers, Head, Investor Relations and Administration. Please go ahead, Max..

Thank you. Good afternoon and thank you all for joining us today to discuss Assertio’s third quarter 2021 financial results. 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’s important to today’s discussion. With me today are Dan Peisert, President and Chief Executive Officer; and Paul Schwichtenberg, Senior Vice President and Chief Financial Officer.

Dan will open the remarks and provide an overview of the business followed by Paul, who will review our financial results. 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 forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in this afternoon’s press release as well as 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 those forward-looking statements except as required by law. With that, I will now turn the call over to Dan.

Dan?.

Thanks, Max. Welcome to everyone joining us this afternoon. This September marked my fourth anniversary with Assertio.

As I reflected back on that time one thing struck me, change, tremendous change, it’s everywhere you look the people, the name of the company and its ticker symbol, the location of our headquarters, our portfolio of products, our investor base and our balance sheet.

In September of 2017, we had $720 million of debt and leverage measured by net debt to EBITDA of 5.5 times. This September of 2021, we had $75.5 million of debt and leverage of just 0.4 times. In that four year period, we’ve repaid over $900 million to debt holders for both principal and interest.

And we funded that largely from asset sales and legal settlements, as we’ve restructured the company in number of times to get us where we are today. Today, our restructuring is complete.

We reported two consecutive quarters of positive operating cash flow and this quarter’s cash flow and adjusted EBITDA is the highest it’s been since we divested NUCYNTA. We’re incredibly proud of what we’ve accomplished and especially in a condensed timeframe, we’ve been able to do it in.

Going forward, our debt service doesn’t need to come from these external sources of funding. We’re generating that cash from the operations of the business. We have enough runway into a maturity that debt to towards business development, investment and growth.

Our revenues so far this year have also been consistent on a quarterly basis, demonstrating the resilience of the portfolio.

As our non-personal promotional model continues to improve and mature the investments we’re making an INDOCIN bear fruit, we’re now seeing it show in our quarterly results and it’s being reflected in our forward-looking guidance as well. We now see our full-year revenues exceeding $103 million and our adjusted EBITDA exceeding $43 million.

We’ve come a long way in just a short time. This is considerably above our initial guidance for the year that we gave just six short months ago, and now expect to come in above the high end of our original adjusted EBITDA range despite the $11.3 million litigation charge we incurred last quarter.

Our operating cash flow results are even more impressive when you factor in that this quarter reflects the cash payments of $7 million to resolve our federal claims in the Glumetza antitrust matter. The class portion of the plaintiffs is still pending final court approval, but our belief is that it will become final early in the New Year.

The opt-out claims being brought by Humana and state court remain ongoing and are on a much slower track. We will continue to pursue all legal remedies available to us, including dismissal. And once those are exhausted, our desire with these claims will be the same as the others to resolve them on favorable terms when the opportunity arises.

In addition, we’re also disclosing that we’ve entered into a settlement agreement to resolve our securities class action litigation, and its related derivative suits. The total is $1.2 million, but will be net against $750,000 to be covered by our insurer. Having both of these cases behind us is a significant achievement for us.

And it also frees up management time to focus on operating the business and positioning for the future, as well as reducing the ongoing legal costs in the business. These matters – these were the matters for which we took the charge last quarter. So they were fully reserved for.

The only additional item being recorded this quarter is the benefit of the insurance proceeds. On the commercial side, I’m excited that our expanded alliance with Cove has gone live this quarter for both CAMBIA and SPRIX. Cove has been a customer of ours for about 18 months and it offered CAMBIA on their platform during that time.

What’s new now is that we’ve worked with them to build a broader set of DTC resources and engage with drivers for patients tailored to both CAMBIA and SPRIX. We think the telemedicine is going to be a very meaningful part of how patients interact with physicians and receive their prescriptions in the future versus just a niche yesterday.

As evidence, the most recent data from IQVIA showed that the rapid increase in prescription claims through telemedicine as a result of the pandemic has held. And the share of total claims has remained steady recently. The improvements being made by these platforms every day are only making them more convenient in the user-friendly.

Cove is just the first of what we hope is many such relationships, and in just the early days, we’re seeing great results. This quarter alone for CAMBIA 77% year-over-year growth in prescription volume at Cove. And despite getting SPRIX launched late in the quarter, we’ve already seen our first prescriptions through Cove for SPRIX as well.

In dollar terms, our sales to Cove were up 207%, it’s off a small base, and it’s still a small proportion of our overall revenue today, but reflective of the growth we can achieve with this platform.

Cove has tens of thousands of active patients today and is growing rapidly, which door some of the largest physician practices, but we had historically focused our detailing resources.

Another unique aspect is that 47% of Cove’s patients don’t have a single headache specialist in the country – in the county they live in and might otherwise consult a primary care physician who’s not overly familiar with innovative migraine or pain treatments for the CAMBIA and SPRIX.

But also likely physicians we wouldn’t have detailed on the past, and patients we wouldn’t have had access to your other promotional means. So this truly expands our market reach.

Today are offering in the Cove platform is for the cash pay market, Cove is currently contracting with health plans to offer insurance coverage for migraine care in 2022, for patients with commercial health insurance. As they’re able to add these capabilities, we’ll be able to add additional offerings for patients seeking insurance coverage.

Another exciting development, we have just recently finalized the terms of a contract with a large regional IDN for SPRIX. There’s still a lot of work to do to integrate SPRIX into this network, but this is a great first step in the right direction and affords us the opportunity to return the SPRIX franchise to growth.

Business development has always been a priority, it is more so now. In addition to having the financial resources to do BD, we’re making sure that we’re also bringing the right external resources to bear as well.

In combination with our own internal efforts, we’ve engaged Back Bay Life Science Advisors to aid us in the buy side and identifying and completing acquisitions. We’ve completed a comprehensive asset screening and evaluation process, which yielded many attractive opportunities. Our goals have not changed with respect to business development roadmap.

We still intend to acquire a product to products that fit within our platform and can generate at least $50 million in gross profit by 2024. Together with Back Bay, we have now turned our attention towards execution of a transaction. Now, I’ll turn the call over to Paul, who will walk through the quarterly results..

Thank you, Dan. This afternoon I will review the financial highlights from our third quarter of 2021. There are slides available on our website that I will reference as I discuss the results.

Starting with Slide 4, net product sales were $26 million for the three months ended September 30, 2021, compared to net product sales of $33.7 million in the prior year quarter and $25.2 million last quarter. The decline in sales versus the prior year quarter is driven by lower volume on SPRIX and are discontinued brands notably SoluMatrix.

As mentioned in previous quarters, SPRIX volume has been impacted by the prior year commercial coverage change. INDOCIN net sales in the third quarter increased by $1.5 million over the prior quarter.

As a reminder, the prior quarter reflected a one-time channel inventory adjustment related to a change in distribution strategy that will drive increased profitability in the future. Net sales for the remainder of the portfolio are down 5.8% versus the prior quarter, primarily due to unfavorable price mix during the quarter.

Overall portfolio net sales were up 3% versus the second quarter, please refer to our 10-Q for specific product level net sales information. Also on Slide 4 adjusted EBITDA for the third quarter was $15.8 million compared to a loss of $505,000 in the second quarter.

As a reminder, the second quarter was impacted by an $11.3 million legal reserve, excluding the impact of legal matters, EBITDA in the third quarter represents the second sequential quarter of growth and a 201% increase over the prior year quarter.

Adjusted EBITDA for the nine months ended September 30, 2021 was $31 million, which is $8.6 million higher than the full year EBITDA reported for 2020. As we have executed our restructuring plan and shifted our business model, we have focused on profitability across all of our products.

As a result, our portfolio gross profit margin excluding the impact of inventory step up amortization related to the Zyla acquisition. For the three months ended September 30, 2021 was 88.3% reflecting an increase of 600 basis points versus the same period in 2020.

A large driver of this improvement is due to an 84% year-over-year decline and SoluMatrix sales, which carried significantly lower margins in Q3 2020 versus the margins reflected in the Q3 2021 results. It was our intent to discontinue SoluMatrix because it was unprofitable.

However, we were able to identify alternate channels to sell the remaining inventory at a higher margin.

Summarized on Slide 5, our adjusted operating expenses, which reflect selling, general and administrative expenses in the third quarter were $7.9 million, which includes a $750,000 legal insurance benefit versus $22.8 million in the second quarter, which includes a legal reserve of $11.3 million.

This reflects a decrease of $2.8 million or 25% versus the second quarter adjusted operating expenses of $11.5 million excluding the legal adjustments. In 2021, we expected to achieve $40 million of cost savings and ultimately $45 million in annual savings beginning in 2022.

This represents a greater than 50% reduction in operating expenses based on an annualized run rate from the second half of 2020. Now that our restructuring is complete we’re once again, confirming that we expect to exceed the targeted cost savings. As a result of the higher cost savings and revenue, we are increasing our EBITDA guidance for 2021.

Net income for the third quarter was $3.7 million compared to the second quarter net loss of $14.2 million, as was stated on our prior quarter call, the second quarter was impacted by the legal reserve of $11.3 million and a loss of $2.2 million for the change in fair value of contingent consideration.

On September 30, 2021, our senior secured debt balance shown on Slide 6 was $75.5 million, which will not mature until Q1 of 2024. On November 1, the company paid scheduled interest in principal of $9.7 million. The remaining debt balance as of today is $70.8 million. Also on Slide 6 ending cash on September 30, 2021 was $58.7 million.

The net increase in cash of $4.3 million from the June 30, 2021 balance of $54.4 million is primarily attributable to the operating cash generated by the business, partially offset by $7 million of legal settlements paid during the quarter. Absent the legal settlements payments made during the quarter cash flow would have increased by $11.3 million.

Net cash provided by operating activities as reported in the company’s statement of cash flows for the quarter ended September 30, 2021 was $4.7 million reflecting the second consecutive quarter of positive operating cash flow and the highest amounts since Q4 of 2019.

Looking to Q4 2021, we have been anticipating and income tax refund of $8.3 million, which has been delayed due to IRS processing.

If this tax refund continues to be delayed into 2022, it will impact our operating cash flow in Q4 because there are other large outflows in Q4, such as the interest payment and the senior secured debt and timing of inventory purchases.

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 updated annual guidance for 2021 summarize on Slide 7 is as follows.

Product net sales greater than $103 million, reflecting a favorable response to our refined commercial platform and the actual results through the third quarter of 2021. Adjusted EBITDA, greater than $43 million reflecting a higher revenue and cost savings versus previous expectations. Overall we’re once again, very pleased with the quarter results.

We continue to see the positive impact of our product portfolio revenue and lower expenses on EBITDA and cash flow. Now that our restructuring is behind us and we expect to achieve our targeted expense savings in 2021 and beyond our focus now is to build on the platform we’ve created and position Assertio for long-term sustainable growth.

And now, I’ll turn the call back over to Max..

Thanks Paul.

Maxine, could we start the Q&A process, please?.

[Operator Instructions] Our first question comes from Scott Henry from Roth Capital Partners. Your line is now open..

Thank you. Good afternoon and congratulations, Dan, some really strong results here. I did have a couple questions.

I guess first, when should I expect to find the 10-Q and in the absence of that, could you maybe talk about, what products drove the upside? It sounds like CAMBIA was pretty strong, but any comments on the product profile and perhaps how the trends in SPRIX are doing as well?.

The 10-Q should be filed already if it hasn’t been, but it will be filed this afternoon. We saw it, I’ll start with commentary and Paul, if you have anything have specific.

You’ll see in the queue, what the individual products did, I don’t have them lined up relative to your expectations, but relative to ours, I think they all performed in line roughly with how we expected them to perform this quarter.

We do continue to see strength in CAMBIA throughout this year, it’s been continuing to be stronger than we had originally anticipated. And it’s been a big driver of the move upwards and guidance as well as INDOCIN and SPRIX has in the last couple of quarters.

Been a little bit better than expected, but Paul does anything else?.

Yes, I mean, I would say that first off, as I mentioned in my comments, the INDOCIN numbers were higher, obviously as we bounced back after that distribution model change in Q2. We also saw some higher volume in some of our non-promoted products.

And I would say that CAMBIA and SPRIX were in line with expectations, but quarter-over-quarter down just a little bit, just due to some price mix variances..

Okay.

And Dan, for those of us that look at prescription, audited prescription services, do you think they really provide any value given your different distribution channels or is that mostly noise?.

It would be hard for you to Scott. There’s been changes in that distribution channel in terms of who is included in it and whether or not they report to services like IQVIA and Symphony. And like as SPRIX historically never had anything. Then it started to show some things. One is just, it’s just noise.

So it’s hard to judge the underlying volume trends by looking at those audited services..

Okay. That’s what I would expect, but I wanted to confirm that.

And then on the legal front the Glumetza settlement, is there any chance of insurance for that or does that have to be paid out of pocket and as well, could you kind of speak to the magnitude of what litigation is left out there across product lines?.

Thanks for the question Scott, there isn’t any insurance coverage for Glumetza and that cash has been in one case paid, in the case of the class plaintiffs it’s put – has been put in escrow already, pending the finalization of that decision.

The other remaining litigation in general at this point is just the broad opioid litigation that we’ve been swept up in, that’s the last remaining large piece of litigation that we have outstanding..

Okay, great. And then I guess the final question you’ve got this great momentum, you seem to be on the front edge of a lot of this non-face-to-face marketing, which tends to be, or it seems like it’s an increasing trend out there. So, you have this first mover advantage. It’d probably be great to leverage it across some more products.

How confident are you that you can acquire some assets in the near term, obviously you’re looking for them, but I’m just trying to get a sense of how your progress has been. And what the urgency is to try to leverage a business model that seems to be working? Thank you..

Thanks, Scott. Appreciate the comments. And we do think that we are on the leading edge of this. We’re certainly one of the companies that has gone all in. On this, we do see a lot of other of our peers that are using this as a supplement to their in-person, especially now that access has been limited, but you’re right.

We see access to physician offices being something that’s permanently limited and why that this non-promotional model is going to be something that more and more companies will pivot more and more to as time goes on. And we do see it as a sustainable competitive advantage.

And you’re right, it’s also something that we would like to leverage and put more products behind and we’re getting more aggressive was we’ve done. I would say, gone beyond my prepared comments of just identifying opportunities and doing screening. We’ve already begun the outreach.

We’ve already started shaking that those trees and having those conversations and I’m encouraged by them that I would, I’m not at a very good odds maker, and I would probably not have a very good career in gambling on when deals will close.

So, I won’t make any predictions on when they’ll close, but we have a very favorable outlook on being able to get some transactions done in the near term..

Okay, great. Thank you for taking the questions..

Thank you, Scott..

[Operator Instructions] This concludes our question-and-answer session. I’d like to turn the conference back over to Dan Peisert, President and Chief Executive Officer for any closing remarks..

Thank you, Maxine. I hope you all share in the excitement. We here at Assertio have for our financial results. We made tremendous progress against their priorities this year, and they’ve executed flawlessly against our restructuring plans. And now it can be seen in the results of the business.

We remain committed to creating value for all of our stakeholders and have a positive outlook for the future given the trends we see in our current business. The pipeline of business development opportunities we’ve been creating, and there’s some of our historical BD investments mature such as NES Therapeutics.

Thank you for joining us this afternoon and have a good evening..

The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect your lines..