Full Press Release Details
ASSERTIO HOLDINGS INC. (NASDAQ ASRT)
Q3 2024 EARNINGS CONFERENCE CALL
NOVEMBER 11, 2024 4 30 PM ET
Assertio Holdings Investor Relations
Assertio Holdings Chief Executive Officer
Assertio Holdings Chief Financial Officer
Lake Street Capital Markets Analyst
HC Wainwright Analyst
Thank you for standing by. My name is John and I'll be your conference operator today. At this time, I would like to welcome everyone to the Assertio Holdings third quarter Results Conference Call. Operator Instructions I would now like to turn the call over to Matt Kreps, Investor Relations. Please go ahead.
Thank you, John. Good afternoon. Thank you, all for joining us today to discuss Assertio's third quarter 2024 financials. The news release covering our results 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 tables in conjunction with today's discussion. With me today are Brendan O'Grady, our Chief Executive Officer and Ajay Patel, Chief Financial Officer.
In just a moment, Brendan will open the remarks and provide an overview of the business. Then Ajay will cover our financial results. After that, we will take questions from our covering research analysts.
Please note that 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 and in our Form 10-Q filings.
Our actual results may differ materially from those projected in the forward-looking statements.
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 Brendan.
Welcome, everyone, to today's call and thank you for joining.
I'd like to start by wishing you all a Happy Veterans Day, especially to our retired and active service members and their families.
In addition to our usual quarterly performance, there are two other relevant issues that I would like to begin my remarks by addressing. The first is the unwarranted attack on Assertio stakeholders by Mr.Alex Parker of Buxton Helmsley Group that was launched this past Friday November 8th.
I'm sure many, if not most of you have seen the letter I released this morning addressing Mr. Parker's rambling manifesto that he put out last Friday. Normally, I would not validate such conduct by speaking about it.
But because of the numerous falsehoods and baseless allegations that had such an impact on our share price, I want to use this opportunity to address this head on.
While we have taken Mr. Parker's allegations seriously and have looked into every single one of them, we found them all to be without merit.
We have communicated that to Mr. Parker on numerous occasions while at the same time refusing to bow to his demands of cash payments or a seat on Assertio's Board to which he would add zero, and I stress zero, value. And most importantly, neither of which would be in the best interest of shareholders.
If you happen to take the time to read through his less than cogent 24-page document, he is essentially making three baseless claims.
While I do not want to rehash my entire letter, I do want to take a minute to set the record straight specifically on those claims.
First and foremost, Rolvedon is a safe and effective product.
I am 100% confident in that.
Assertio was aware of the whistleblower claims around Rolvedon before the acquisition of Spectrum.
In fact, those claims were investigated by three different professional outside firms. The experts involved in those investigations determined that the FDA was supplied with all relevant and required data that led to Rolvedon's approval. Rolvedon has now been in the market in the U.S. and South Korea for two and a half years and has demonstrated its safety and efficacy in the clinic with patients in real-world settings.
It is well tolerated by patients and has been well received by providers.
Second, the impairment charges had nothing to do with any purported Rolvedon safety claims.
Assertio simply followed clearly established accounting principles, as we always do, in regards to any asset.
Our disclosures clearly explain the impairment and how any and why it was calculated the way that it was.
It is that simple. Third, no payment to the alleged whistleblower were ever made.
The proposed payments Mr. Parker is referring to related to -- is related to an employment claim that was raised by a disgruntled former employee. That employee brought claims forward about Rolvedon as leverage to boost the value of a settlement or reverse their pending termination. After a thorough investigation, it was determined those claims and allegations were false and without merit. The employee was subsequently terminated as part of a reduction in force and the case was later dismissed without any payment ever being made.
Finally, Mr. Parker's rambling rehash of connecting dots where none exist or misrepresenting long past settled issues, is ripe with false statements and mischaracterizations that we have pointed out to him numerous times including the circumstances and reasons for the departure of a former Board member.
While I don't expect his desperate attacks will stop, you should know that there is nothing here and we will vigorously defend our reputation using all legal and regulatory means at our
disposal. Today will be my last comments on this matter as I turn 100% of my focus to the business.
So now with that out of the way I'd like to focus my comments back to the business and the progress we are making in stabilizing the company and positioning it for transformational growth in the coming months.
As noted in our earnings release today I would like to announce that during the November 7th Board of Directors' Meeting, Chairman of the Board, Peter Staple, retired from the Board after twenty-one years of dedicated service and leadership. Peter was instrumental in bringing me to Assertio and although our time together was short, I appreciated his calm demeanor, deep expertise and presence on the Board.
I cannot thank him enough.
In addition, Dr. Jeff Vacirca has stepped back from the Board to focus on his many other business interests.
We thank Dr. Vacirca for his service and providing continuity through the acquisition and integration of Spectrum. His insight into the GCF -- G-CSF and oncology markets were invaluable, and we will miss his contributions to the Board. Both of these departures and continued transition of the Board have long been in the planning. With that, I'm also happy to announce that Heather Mason, Independent Director, has been appointed as Chairwoman of the Board.
Heather has been on the Assertio Board for over five years, serving as interim CEO prior to my joining and she has a wealth of industry experience.
I look forward to continuing to work with Heather in her newly expanded role.
I am also excited to announce that David Stark has joined the Assertio Board effective November 7th. David is an experienced litigator and senior pharmaceutical executive recently retiring from Teva as Chief Legal Officer. David brings a wealth of industry and relevant legal expertise from his 20-plus years at Teva.
David and I were colleagues at Teva, and I'm excited to be working with him again in this new capacity.
Now on to the business.
First and foremost, let me just say I'm very pleased with where we are today as a starting line for growth.
As I've said previously this year is about stabilizing the organization as we transition from Indocin as our lead product to Rolvedon and at the same time, positioning ourselves for more transformational growth in the coming months.
It is worth restating that we have a solid balance sheet, modest debt on favorable terms and a good stable of growth, core and legacy assets led by Rolvedon.
We also have an excellent team of dedicated professionals who know this industry extremely well, giving us the opportunity to add or enhance key capabilities as we grow.
Also important to note is that our capabilities and lean model will allow us to be relatively sector-agnostic, broadening the landscape for new assets and letting us focus on those that best fit our commercial parameters.
For all these reasons, we are well positioned to deliver value for patients and providers we serve, as well as shareholders and employees, as we build a significant branded specialty business through acquisition, integration and a focused go-to-market strategy.
As I said on my first call with you in August, our focus will remain on steady execution, driving cash flow and identifying new assets we can add to bring further scale to the Assertio's platform.
Now turning to performance, and I'll first address Rolvedon.
Rolvedon Q3 sales were essentially steady quarter-over-quarter, showing continued solid demand.
We continue to retain a stable share, around 33% in the oncology community -- community oncology clinic space where we have primarily focused.
We did see a dip in demand due to some typical seasonality that can occur in the third quarter as well as some shift in the community oncology clinic space, specifically Part B. This was offset by the addition of new customers, enabling further expansion into the hospital space and community oncology clinics where we did not have a presence. There are segments -- these are segments that will be important for further future growth.
We remain focused on using our position, a safe and effective non-biosimilar G-CSF, to offer stability to providers and patients, positioning ourselves as a predictable, reliable solution at a more stable price and of course this is a market dynamic, but our message continues to resonate.
Additionally, Rolvedon same-day dosing trial wrapped up in early Q2 and I'm excited to announce that the data will be presented as a poster exhibit at the San Antonio Breast Cancer Symposium in December.
I'm excited about Rolvedon as it's going to play a key role for us over the next several years, both in our current clinic-focused market as well as hospital -- as well as the hospital market, as we prepare to expand into those additional opportunities.
As the only available G-CSF approved under a BLA without biosimilar copies, there may also be opportunities for label expansion.
We're in the very early phases of making that assessment.
Now a couple of words about Indocin.
On Indocin, we continue to manage the life cycle process and drive cash flow generating from the asset. Although there is some compounding activity, to date, we have only one generic competitor.
Our share of the market is holding steady at our internal target levels, which is around 50% of the ex-compounding market.
We will compete to hold our rightful share of the market and at the same time, we will work to maintain our share and optimize price.
Having worked at Teva for more than 20 years, this is something I am very familiar with and know how to do.
Looking at Sympazan, while this is a smaller asset, we believe that it has underpenetrated the market and there is room for growth.
We also understand that Sympazan is especially responsive to key opinion leader awareness and support.
I think I mentioned on the last call that we're piloting and executing sales and marketing tactics designed to drive prescriber awareness and prescription growth in key markets. Although early, we have seen record demand levels in Sympazan prescriptions in July and August as a result of these activities.
This is a product I liked from the beginning of my time at Assertio.
It serves a specific unmet medical need, we have a broad coalition of growing support among patients, caregivers and providers and look to expand both awareness and use of Sympazan going forward.
And then lastly, just a quick word about some of our remaining assets.
I'd like to just talk a little bit about how to characterize the business.
I see it really in three main buckets.
I see a growth asset bucket, this is clearly Rolvedon, and I've spoken about it.
I see a core asset bucket, this is Sympazan and SPRIX.
While I discussed Sympazan in our plan there, I've not said much about SPRIX.
What I will say about SPRIX is that it serves a significant unmet medical need by providing opioid-level pain relief.
In fact, our indication states that SPRIX is indicated in moderate to moderately severe pain that requires analgesia at the opioid level.
There continues to be a focus on non-opioid pain relief and the NOPAIN Act, which expands reimbursement for non-opioid post surgical options starting January 1, 2025, could be an opportunity that we are looking at very seriously for SPRIX.
If nothing else, it brings the need for non-opioid pain relief back to the forefront and reason to believe that SPRIX could be a bigger asset for us than it currently is. The last bucket is our legacy assets. These are our tail products that have lost exclusivity or face very difficult market dynamics.
In this bucket, it's all about asset optimization and includes Indocin and Cambia, among others.
I understand how to extract maximum value out of assets like this, and we'll continue to focus on cash generation in this bucket. With that, I'll conclude my remarks, and I'll hand it over to Ajay Patel, our Chief Financial Officer.
Thanks, Brendan. Today I would like to cover our financial results for the third quarter of 2024. Before I begin, I want to note that my commentary will focus on sequential comparisons to the prior quarter. Comparisons to the prior year are less relevant given the acquisition of Spectrum and generic competition of Indocin that occurred in the prior year third quarter.
Also I want to remind everyone that Rolvedon is now our lead asset and brings with it the associated changes in margin, operating cost structure and cash flows that you are seeing in our results throughout this year.
For the third quarter of 2024, our total product sales were $28.7 million, down slightly from $30.7 million in the second quarter, primarily due to Rolvedon sales being offset by the expected decline in Indocin. Rolvedon sales were $15 million in the third quarter compared to $15.1 million in the second quarter. The change was driven by continued volume growth, offset by lower net pricing.
We continue to hold about a one third share in our served markets. Indocin sales were $5.7 million in the third quarter, down from $6.9 million in the second quarter, driven by lower net pricing as a result of generic competition.
In terms of volume, we continue to target and hold an approximate market share split. Reported gross margin in the third quarter improved to 74% compared to 71% in the second quarter primarily due to level of inventory step-up amortization and write-downs from prior quarter not repeating. Turning to operating expenses, SG A expense was $16.7 million in the third quarter, decreased from $18.4 million in the second quarter. R D expense in the third quarter was relatively flat at approximately $1 million.
On an adjusted basis, excluding stock compensation, D A and change in fair value, adjusted operating expense was $16.4 million in the third quarter, down from $17.7 million in the second quarter. The decrease was primarily due to lower sales and marketing and other G A costs, partially offset by net higher legal-related charges. GAAP net income for the third quarter was a loss of $2.9 million, down from a loss of $3.7 million in the second quarter.
Because GAAP net income includes a number of noncash expenses, we also use adjusted EBITDA as a good indicator of the operating performance of core business. Q3 adjusted EBITDA was a positive $5.3 million, increased from $5 million in the second quarter due to lower operating expenses, partially offset by lower product sales.
Please refer to our press release for a detailed reconciliation of our adjusted EBITDA results. Crossing over to cash flow and our balance sheet.
As a reminder, we invest cash into short-term investments. Therefore, our reference to total cash position includes both cash and cash equivalents and short-term investments. Total cash at the end of the quarter was $88.6 million, effectively flat to the $88.4 million in the second quarter and debt remained unchanged at $40 million.
As we previously noted, quarterly operating cash flows will fluctuate due to timing of working capital in terms of cash receipts and payments due to shift in product mix from Indocin to Rolvedon. Third quarter operating cash flows were negligible and were impacted by timing of working capital from cash collection and lower product sales. Year-to-date, we have generated $15 million in cash flows from operations. With that, we will open the floor to questions from our covering research analysts.
Operator, please go ahead with the instructions.
Our first question comes from the line of Thomas Flaten with Lake Street Capital Markets. Please go ahead.