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Healthcare - Drug Manufacturers - Specialty & Generic - NASDAQ - US
$ 0.8114
-3.62 %
$ 77.5 M
Market Cap
-0.17
P/E
EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2020 - Q4
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Operator

Ladies and gentleman, thank you for standing by, and welcome to the Q4 2020 and Full-Year Assertio Holdings Incorporated Earnings Conference Call. At this time, all participants’ line are in a listen-only mode. After the speakers' presentation, there will be question-and-answer session. [Operator Instructions].

Please be advised that today’s conference is being recorded. [Operator Instructions] I would now like to hand the conference over to your speaker today, Mr. Max Nemmers. Thank you. Please go ahead, sir..

Max Nemmers

Thank you, Bueno,. Good afternoon and thank you all for joining us today to discuss Assertio's fourth quarter and full-year 2020 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 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 guaranteed of future performance and involves 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 these forward-looking statements except as required by law. With that I will now turn the call over to Dan.

Dan?.

Dan Peisert

patients, prescribers, payers and pharmacies. With our focus on profitability and growth, we've made this strategic decision quickly and decisively.

We believe this shift represents the best way to create value moving forward and we are confident that we can turn this platform into a substantial meaningful competitive advantage that can be applied to other assets as well.

COVID had a profound impact on our society or and has or will likely change all of our lives in some way but what has also done is taught us that we can interact digitally and virtually without detriment in many situations and we're finding that it is a preferred mode of communication.

I believe our industry could see a profound shift in how we commercialize products and we're just at the beginning.

We've already seen that some of our peers are already making small steps in this direction whether it is the success of virtual peer-to-peer educational meetings, on demand information, more targeted engagement or more personalized digital content our industry is beginning to make this shift.

Building upon our experience in the past year we've begun our own first steps in this direction by continuing with telesales, telesampling and email campaigns and we've seen that Assertio products are excellent candidates to be promoted in this manner. Now I will turn the call over to Paul who will walk through the quarterly results. .

Paul Schwichtenberg Senior Vice President & Chief Commercial Officer

Thank you Dan. This afternoon I will review the financial highlights from our fourth quarter and full-year 2020. As was the case in the last two quarters our year-over-year comparisons are challenging due to the many changes in our business.

For clarity any references to the pro forma results are reflective of our product investitures and the Zyla merger. Pro former net product sales were $30.1 million for the three months ended December 31, 2020 compared to pro forma net product sales of $31.1 million in the prior year quarter and $33.7 million last quarter.

Full-year pro forma net sales were $119.2 million in line with our guidance of a 5% decrease from the prior year pro forma net sales of $125.7 million. The Zipsor fourth quarter net sales showed growth over the third quarter and prior year quarter.

In addition, the fourth quarter net sales reflect better than expected sales from the value matrix brands as we prepared to exit commercialization of these products. Indecent sales were lower than the prior quarter which was our highest quarterly result in the past two years primarily due to lower volume and price mix.

The remainder of the portfolio continues to be impacted by lower volume due to COVID and the third quarter commercial coverage change for SPRIX. For cambia and Zipsor we are continuing to shift towards the hub model.

A portion of the prescriptions that go through the hub model are considered consignment sales and are specifically for non-covered patients. These consignment sales are not reported by the major prescription reporting services which will result in a decline of overall reported prescription volume.

However, our net sales will not reflect the same level of decline. In fact this model will generate overall cost savings for the company due to a reduction in overall distribution fees. Reported cost of sales was $6.8 million for the three months ended December 31, 2020 and $19.9 million for full-year 2020.

The increase over the prior year was influenced by the addition of the Zyla product portfolio and the inventory step-up expense associated with the fair value adjustments as part of the Zyla merger.

Additionally the fourth quarter cost of sales reflected a greater contribution from sales of lower margin products particularly the SOLUMATRIX brands and an inventory obsolescence write-off for sprigs.

Our non-GAAP adjusted operating expenses inclusive of R&D and SG&A in the fourth quarter for $16.1 million compared to $21.9 million in the fourth quarter of 2019 and $21.7 million in the prior quarter.

The results for the quarter reflect approximately 3 million of year-to-date payroll expenses that were previously accounted for and reported in SG&A but have been reclassified into restructuring costs in the fourth quarter. There are three chances of cost savings that the company has realized in 2020 and expects to realize in 2021 and beyond.

First, the Q4, 2019 restructuring resulted in $15 million of annual savings in 2020. Second, the merger with Zyla has resulted in the elimination of duplicative operating structures and we have achieved our goal of 40 million of SG&A synergies in 2020 relative to the pre-merger combined operating expenses of the two businesses.

Third, because of the recent restructuring we expect in 2021 to achieve additional SG&A savings off of the annualized second half 2020 operating expense run rate including opioid legal cost.

For clarity our pre-restructuring operating expense run rate including our opioid legal costs for the second half of 2020 is 43.7 million which translates into an annual operating expense run rate of approximately $87.4 million.

In 2021 we expect to achieve $40 million of savings off of this run rate and ultimately $45 million in annual savings beginning in 2022. Non-GAAP adjusted EBITDA for the fourth quarter was $9.4 million and EBITDA margin of 31% compared to 7 million in the third quarter this year.

The improvement is reflective of both the realization of the synergies and the impact of the payroll cost transfer to restructuring costs. Net loss for the three months ended December 31, 2020 was 24.4 million compared to the prior year's fourth quarter loss of $192.6 million.

This comparison is especially challenging given all the changes to the business. However, the largest change drivers are the loss on asset impairment from a divested product recorded in the prior year and the substantially higher interest and amortization expense the business previously incurred.

The fourth quarter 2020 results also reflect severance charges of $10.7 million and we expect to recognize in total $11 million to $12 million which accounts for additional non-cash charges relating to the write-off of certain office lease and furniture assets. The results also reflect a $17.4 million non-cash goodwill impairment in the quarter.

During the quarter, the company paid $10.3 million of our senior secured debt and accrued interest leaving us with $80.2 million of third-party debt which will not mature until Q1, 2024 and as Dan stated we've improved our ability to achieve better terms and costs if we were to refinance our remaining debt over the next 12 to 18 months.

Ending cash on December 31, 2020 was 20.8 million. The decline in cash of 13.9 million from our September 30 balance of $34.7 million is primarily attributable to the debt payment, cash royalties, restructuring payments, a final payment on 2020 inventory commitment purchases and a delay in the timing of expense reimbursements due from partners.

The company expects additional cash restructuring payments of approximately $8 million in the first half of 2021. With the $45.3 million in cash raised from the recent registered direct offerings we will be seeking to accelerate potential investments in 2021.

As the incoming CFO of Assertio my overarching goal is to help the organization achieve the priorities that Dan mentioned in his earlier comments. To that end my priorities are the following. One, cash flow maximization and management of working capital. Two, actively exploring opportunities to reduce cost of capital.

Three, execution of operating expense savings and four, supporting the development of a sustainable business model through effective commercial strategies and new investments. Lastly, like many other companies in our industry we believe it is prudent for us to hold in providing guidance at this time.

Instead our intent is to give guidance for 2021 on our first quarter earnings call in May and not today due to the volatility created by COVID and the possibility for accelerated investments. Now I'll turn the call back over to Max..

Max Nemmers

Thanks, Paul. Bueno, we can open up the call for Q&A. .

Operator

Absolutely, sir. [Operator Instructions] Your first question is from Scott Henry of ROTH Capital. Your line is open..

Scott Henry

Thank you, and good afternoon. A couple of questions.

First, could you give any color on the revenues for, I mean, I know you gave some directional comments, but could you give us sales for like INDOCIN and SPRIX, and maybe Zipsor and Cambia? And I'm just trying to get a sense of what those numbers were in the quarter?.

Dan Peisert

We'll report those or they'll be available in a 10-K that will be filed tomorrow..

Scott Henry

Okay. All right. Fair enough. And then I think you - I mean I know you gave some color around it, but could you talk about what real-time cash and debt are right now? I just want to make sure I have those - there's a lot – correct, there's a lot of moving levers..

Dan Peisert

So real-time cash right now is going to be north of high 50s?.

Paul Schwichtenberg Senior Vice President & Chief Commercial Officer

High 50s, yes..

Dan Peisert

Got it. And then the debt is $80.2 million of principal outstanding..

Scott Henry

Okay, perfect. And I'm going to go over the two limit on questions. My apologies. The SG&A, I mean, I thought I heard you say non-GAAP SG&A was around $16 million in the quarter and I just did it back in the envelope and got around $15 million.

When we but then when I look at your guidance for 2021, it sounds like it may even come down from those levels.

I just want to get your thoughts and how we should think about that SG&A line?.

Paul Schwichtenberg Senior Vice President & Chief Commercial Officer

Yes. I mean, what I would say is that if you – and what I was trying to explain in the script, this is Paul here, is that if you take our back half run rate for 2020 in the last two quarters, you add in our opioid legal expense and you look at what that annualized number will be, we'll save about $40 million off of that number in 2021.

So the short answer is yes, the SG&A will come down..

Scott Henry

Okay. Yes. I guess it all depends what you include and what you don't include. And then I promise this is the final question. I want to get a sense under the new business model, you've got some experience through COVID. You've got some experience through the last quarter.

When you do less face-to-face promotion for a product, what kind of script declines do you typically see? I mean, is it reasonable to think the scripts would decline 10%, which maybe you'll make some of that up on pricing or maybe you're doing better than that or worse than that? I just want to get kind of your thoughts based on your early experience?.

Dan Peisert

Well, I don't want to comment too much on the early experience that we've seen so far this year. What I can say is, unfortunately, there's not a great analog and we're also not just giving up. So yes, we are not going to be doing the same in person that we would have been doing in the past.

But I'd say that COVID last year could be very good case study. We had 80 reps in the field or 80 territories that we had. At best, we were seeing 40%, 50% of our calls made in person.

So we had a very strong virtual promotion last year just because of what COVID did and COVID was also in some ways worse than what you'd expect normally because patients weren't going to go visit their physicians. So I think we saw a resilience in the portfolio last year and that does bode well for what we expect going forward.

The biggest thing that I'd point out for and it might be obvious to you for our portfolio going forward is SPRIX did have that payer reimbursement change in early September of 2020. So the go forward run rate for 2021 will be more like what we saw here in the fourth quarter.

And then also notable is that the SOLUMATRIX products, of which Paul will comment in a second on what the total sales were that we recognized this year, that will not be happening or will not be continuing going forward as we exited the promotion of those brands and the distribution of those brands at the end of the year. So do you have the….

Paul Schwichtenberg Senior Vice President & Chief Commercial Officer

On a pro forma basis, the SOLUMATRIX sales were $8.2 million. .

Dan Peisert

So we will not be seeing that same level of sales for those products going forward. I know that doesn't help you, Scott, and I apologize that I can't give you a good solid answer there, but I hope the commentary –.

Scott Henry

Yes.

When you say on a pro forma basis, does that mean on a pro forma annualized basis?.

Dan Peisert

Those are the sales for SOLUMATRIX for both Zyla and Assertio. So the full calendar year of 2020 across both companies..

Scott Henry

Okay. Okay, perfect. Thank you, and thank you for taking the questions..

Operator

Your next question is from Kevin Kedra of G. Research. Your line is open..

Kevin Kedra

All right. Thanks for taking the questions. Dan, you mentioned the shift in the commercial model. I am wondering how's that impacted what you're looking at in the business development arena? I know you guys have been looking for a while.

But has that – has the shift in the model changed the sort of opportunities that you're looking for business development?.

Dan Peisert

So when it comes to business development, I think, the types of products that would work well for us if we looked at a product level acquisition are a lot like the products that we have in the portfolio today.

We think that what we've got now will benefits a lot from this digital virtual platform that we want to build in combination with the hub and pharmacy network that we have.

So I think what it does for us is it actually opens up more opportunities for us to possibly bid on assets that we might have not chased in the past because we had a fixed infrastructure calling on a certain set of physicians. That isn't the case today. We can send an e-mail across any therapeutic category.

We can display a banner ad or an ad in a electronic prescribing platform across any therapeutic category, and we can leverage our distribution model to effectively get that to patients.

So I think it creates more opportunities and combined with the liquidity on the balance sheet, will actually put us in a better position to be able to go after these assets..

Kevin Kedra

Great. Think more about business development opportunities about a year ago when you guys announced the Zyla merger, it seems fair to say things haven't gone quite the plan with that. Obviously, there's a lot that's been going on that’s out of your control with COVID.

But any learnings you can take from the combination with Zyla over the past year that you can apply to future business development opportunities, positives and negatives relative to your expectations going into that merger?.

Dan Peisert

It's a very good question, Kevin. And I reflect on some of the other BD - I made a mistake once in my career here to Assertio where I almost promised a BD deal and it didn't happen.

And now reflecting on what has happened since and seeing in hindsight what that company did with those assets, COVID was - has really ruined that acquisition for them and COVID did play a big hand in what we experienced last year. What I would still say though is our revenues were not down materially from what we did expect.

It wasn't as bad as it probably could have been, and I think that speaks to how resilient this portfolio is.

Going forward, one of the things that we will do is we're taking possibly a more conservative approach to underwriting these opportunities and making sure that we've got a conservative forecast and can build an infrastructure that if it needs to be built will be included in that evaluation..

Kevin Kedra

Great. If I can squeeze one more, you talked about some of the changes that that we can expect to see with CAMBIA and Zipsor where some of the scripts may not come through third-party. So that that's going to obviously make revenue look better than what the scripts would see.

But in terms of gross to net, should we expect improvement there in 2021 given the distribution model shift that you have?.

Dan Peisert

Yes. We will see a profound impact on gross to net actually. But what it does is it's also a lowering of gross revenue for any product that is dispensed via consignment we won't recognize the gross nor the gross to net. So it better aligns the two components where what goes in and what goes out are closer together.

So it does have an impact, a positive impact on gross to net but it also has a reduction in gross sales..

Kevin Kedra

Great. Thanks..

Operator

Thank you. That's it for Q&A today. I will turn the call to Dan Peisert for closing comments..

Dan Peisert

So in conclusion we have clear and ambitious priorities for the year ahead and I trust that you can see from our excellent start that we're truly focused on execution and results. Of course this cannot be possible without people.

I'm very proud of the team we have here at Assertio and I want to thank all of my colleagues who helped shape our company and positioned it for an exciting future and I thank you all for joining us this afternoon and hope you have a good evening..

Operator

Ladies and gentlemen, this concludes today's conference call and thank you for participating. You may not disconnect..

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