Q3 2025 Assertio Holdings Inc Earnings Call

Hi, My name is Abby and I'll be your conference operator today.

125 results conference call.

Operator: Ladies and gentlemen, thank you for standing by. My name is Abby, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Assertio Holdings Q3 2025 Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. If you would like to ask a question during that time, simply press star followed by number 1 on your telephone keypad. If you would like to withdraw your question, press star 1 a second time. Thank you. I would now like to turn the conference over to Dan Santos with Longacre Square Partners. You may begin.

All lines have been placed on mute to prevent any background noise.

At this time I would like to welcome everyone to the studio Holdings third quarter 2025 results conference call.

After the Speakers' remarks, there will be a question and answer session.

All lines have been placed on mute to prevent any background noise.

He would like to ask a question during that time simply press star followed by the number one on your telephone keypad.

After the Speakers' remarks, there will be a question and answer session. If he would like to ask a question during that time simply press star followed by the number one on your telephone keypad. If he would like to withdraw your question Press Star one a second time.

If you would like to withdraw your question Press Star one a second time.

Thank you and I would now like to turn the conference over to Daniel Santos with long acre Square partners you may begin.

Thank you good afternoon, and thank you all for joining us today to discuss <unk> third quarter 2025 financial results and business update.

Thank you and I would now like to turn the conference over to Daniel Santos with long acre Square partners you may begin.

Thank you good afternoon, and thank you all for joining us today to discuss <unk> third quarter 2025 financial results and business update.

The news release covering our results for this period is now available on the Investor page of our website at Investor Dot <unk> Dot Com I would encourage you to review the release and tables in conjunction with today's discussion.

Dan Santos: Thank you. Good afternoon, thank you all for joining us today to discuss Assertio's Q3 2025 financial results and business update. 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. 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.

A news release covering our results for this period is now available on the Investor page of our website at Investor Dot <unk> Dot Com I would encourage you to review the release and tables in conjunction with today's discussion.

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 the <unk> filings with the SEC. These.

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 the <unk> filings with the SEC. These.

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 these from those projected in the forward looking statements <unk>, specifically disclaims any intent or obligation to update these.

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 these from those projected in the forward looking statements <unk>, 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 Mark Watson, Our Chief Executive Officer.

Forward looking statements, except as required by law with that I will now turn the call over to Mark <unk>, Our Chief Executive Officer.

Dan Santos: Our actual results may differ materially from those projected in the forward-looking statements. Assertio specifically disclaims any intents or obligation to update these forward-looking statements except as required by law. With that, I will now turn the call over to Mark Reisenauer, Chief Executive Officer.

Thank you Daniel and thank you to everyone for taking the time to join today.

This is my first earnings call as CEO of <unk> and I'm excited to be here today I'm joined by Paul Schwichtenberg, Our President and Chief operating Officer, and Ajay Patel, Our Chief Financial Officer.

Thank you Daniel and thank you to everyone for taking the time to join today.

Mark Reisenauer: Thank you, Dan, and thank you to everyone for taking the time to join today. This is my first earnings call as CEO of Assertio, and I'm excited to be here today. I'm joined by Paul Schwichtenberg, our President and Chief Operating Officer, and AJ Patel, our Chief Financial Officer. I'd like to give you some background on myself and touch on some high-level financial results from the quarter. Paul will talk about the ROLVEDON pull forward, and AJ will go over the financial results in more detail. As you may know, I've served on the board for the past several months, bringing 30-plus years' experience commercializing and launching innovative products. Most recently at Astellas Pharma Inc., I led the commercializing of blockbuster therapies XTANDI and PADCEV. I also built and successfully scaled the Astellas Oncology franchise from scratch.

This is my first earnings call as CEO of <unk> and I'm excited to be here today.

I'd like to give you some background on myself and touch on some high level financial results from the quarter.

I'm joined by Paul Schwichtenberg, our President and Chief operating Officer, and AJ Patel, our Chief Financial Officer.

Then Paul will talk about the <unk> pull forward and AJ will go over the financial results in more detail.

I'd like to give you some background on myself and touch on some high level financial results from the quarter.

As you May know I've served on the board for the past several months, bringing 30 plus years experience commercializing and launching innovative products.

Then Paul will talk about the <unk> pull forward and AJ will go over the financial results in more detail.

As you May know I've served on the board for the past several months, bringing 30 plus years experience commercializing and launching innovative products.

Most recently at Astellas Pharmaceuticals.

Ed the commercializing a blockbuster therapies extending and pads.

Most recently at Astellas Pharmaceuticals, I led the commercializing a blockbuster therapies extending and pads.

I also built and successfully scaled the astellas oncology franchise from scratch.

That included enhancing market access and distribution capabilities.

I also built and successfully scaled the astellas oncology franchise from scratch.

Tracking and growing talent.

And implementing successful product launches as well as growth in lifecycle management strategies.

That included enhancing market access and distribution capabilities.

Mark Reisenauer: That included enhancing market access and distribution capabilities, attracting and growing talent, and implementing successful product launches as well as growth and lifecycle management strategies. I'm thrilled to step into the CEO role and apply my experience here because I truly believe Assertio has the potential to generate significant value for patients and shareholders. The team has made a lot of progress and set the company up for a promising future with core growth assets like ROLVEDON and SYMPAZAN and a solid balance sheet. Before I turn to our Q3 results, I want to take a moment to acknowledge the promotion of Paul Schwichtenberg to President and COO. Many of you know Paul from the numerous roles he's held during his time at Assertio, most recently as Chief Transformation Officer. Paul is a strategic and practical leader who has guided the company through several transformative initiatives.

Attracting and growing talent.

I'm thrilled to step into the CEO role and apply my experience here because I truly believe <unk> has the potential to generate significant value for patients and shareholders.

And implementing successful product launches as well as growth in lifecycle management strategies.

I'm thrilled to step into the CEO role and apply my experience here because I truly believe as Sergio has the potential to generate significant value for patients and shareholders.

The team has made a lot of progress.

Set the company up for a promising future with core growth assets like <unk> done in sympathy them.

Team has made a lot of progress and set the company up for a promising future with core growth assets like <unk> done in symposium and a solid balance sheet.

And a solid balance sheet.

Before I turn to our third quarter results I want to take a moment to acknowledge the promotion of pulse Wittenberg to president and COO.

Before I turn to our third quarter results I want to take a moment to acknowledge the promotion of pulse lichtenberg to president and COO.

Many of you know Paul from the numerous roles. He has held during this time of the <unk> most recently as Chief transformation Officer.

Many of you know Paul from the numerous roles. He has held during his time at <unk>.

Paul is of strategic and practical leader, who has guided the company through several transformative initiatives.

Most recently as Chief transformation Officer.

I look forward to working closely with him as we continue driving <unk> forward.

<unk> is of strategic and practical leader, who has guided the company through several transformative initiatives.

Now onto this quarter's results.

I look forward to working closely with him as we continue driving <unk> forward.

In the third quarter, we achieved financial results that position us to narrow our full year 2025 guidance.

Mark Reisenauer: I look forward to working closely with him as we continue driving Assertio forward. Now onto this quarter's results. In Q3, we achieved financial results that position us to narrow our full year 2025 guidance, and we continued to support high quarterly unit demand for ROLVEDON and maintained a leading market share position. As outlined in the release, ROLVEDON net product sales were $38.6 million for Q3 2025, up from $15 million in the prior year quarter due to the pull forward of two quarters of ROLVEDON sales through the wholesale distribution channel. ROLVEDON net product sales also drove adjusted EBITDA of $20.9 million for Q3 2025, up from $4.4 million in the prior year quarter.

Now onto this quarter's results.

In the third quarter, we achieved financial results that position us to narrow our full year 2025 guidance.

And we continued to support high quarterly unit demand for roll, the Don and maintained our leading market share position.

And we continued to support high quarterly unit demand for roll Verdun and maintained our leading market share position.

As outlined in the release drove an on net product sales were $38 6 million for the third quarter of 2025.

As outlined in the release rather than net product sales were $38 6 million for the third quarter of 2025.

Up from $15 million in the prior year quarter due to the pull forward of two quarters of robot on sales through the wholesale distribution channel.

From $15 million in the prior year quarter due to the pull forward of two quarters of <unk> sales through the wholesale distribution channel.

<unk> net product sales also drove adjusted EBITDA of $20 9 million for the third quarter of 2025 up from $4 4 million in the prior year quarter.

<unk> net product sales also drove adjusted EBITDA of $20 9 million for the third quarter of 2025 up from $4 4 million in the prior year quarter.

The pull forward was done to ensure seamless availability to patients as we transition rolled on to our consolidated commercial label or and we realign our corporate subsidiaries under a single operating entity.

The pull forward was done to ensure seamless availability to patients as we transition roles it onto a consolidated commercial label or and we realign our corporate subsidiaries under a single operating entity.

Mark Reisenauer: The pull forward was done to ensure seamless availability to patients as we transition ROLVEDON to our consolidated commercial labeler and we realign our corporate subsidiaries under a single operating entity. While this transaction will result in a temporary decrease in operating cash flow in Q4 of this year and Q1 of next year, we expect to maintain a leading market share and uninterrupted patient supply. Regular sales of the newly labeled ROLVEDON will resume in Q2 2026. SYMPAZAN net product sales grew to $2.8 million for Q3 2025, up from $2.6 million in the prior year quarter, driven by higher volume. We continued to strengthen our SYMPAZAN oral film franchise with new data the team presented at the American Neurological Association meeting, which underscored the value the drug offers patients with difficulty swallowing.

This transaction will result in a temporary decrease in operating cash flow in the fourth quarter of this year and the first quarter of next year, we expect to maintain our leading market share and uninterrupted patient supply.

While this transaction will result in a temporary decrease in operating cash flow in the fourth quarter of this year and the first quarter of next year.

Regular sales of the newly labeled roll down will resume in the second quarter of 2026.

We expect to maintain our leading market share and uninterrupted patient supply.

Regular sales of the newly labeled rolled the dawn will resume in the second quarter of 2026.

<unk> net product sales grew to $2 8 million for the third quarter of 2025 up from $2 6 million in the prior year quarter driven by higher volume.

<unk> net product sales grew to $2 8 million for the third quarter of 2025 up from $2 6 million in the prior year quarter driven by higher volume.

We continued to strengthen our sympathy and oral film franchise with new data. The team presented at the American Neurological Association meeting, which underscored the value of the drug offers patients with difficulty swallowing.

We continued to strengthen our sympathy and oral film franchise with new data. The team presented at the American Neurological Association meeting, which underscored the value of the drug offers patients with difficulty swallowing.

This quarter's results allow us to narrow our full year 2025 guidance.

Our updated 2025 guidance reflects the impact of the roll down pull forward and our greater visibility into the expected performance for the remainder of the year.

This quarter's results allow us to narrow our full year 2025 guidance.

Mark Reisenauer: This quarter's results allow us to narrow our full year 2025 guidance. Our updated 2025 guidance reflects the impact of the ROLVEDON pull forward and our greater visibility into the expected performance for the remainder of the year. This narrowing also reflects negative impacts from INDOCIN generic competition and decommercialization of Otrexup. I'll now pass the call over to Paul to introduce himself and provide more detail about the ROLVEDON pull forward. Paul?

Our updated 2025 guidance reflects the impact of the roll down pull forward.

This narrowing also reflects negative impacts from <unk> generic competition and the commercialization of Otrexup.

And our greater visibility into the expected performance for the remainder of the year.

This narrowing also reflects negative impacts from <unk> generic competition and the commercialization of Otrexup.

I'll now pass the call over to Paul to introduce himself and provide more detail about the <unk> pull forward Paul.

Thanks, Mark over the last several years I've had many roles at <unk>.

I'll now pass the call over to Paul to introduce himself and provide more detail about the role of the dawn pull forward Paul.

Including Chief Commercial Officer, Chief Financial Officer, and most recently achieved transformation officer. So I had a front row seat to many of our recent initiatives.

Thanks, Mark over the last several years I've had many roles at <unk>.

Paul Schwichtenberg: Thanks, Mark. Over the last several years, I've had many roles at Assertio, including chief commercial officer, chief financial officer, and most recently, chief transformation officer. I've had a front-row seat to many of our recent initiatives, including the consolidation of our operations and driving continued growth for ROLVEDON. First off, reflecting on ROLVEDON's performance to date in 2025, we have seen 42% Q3 year-to-date demand growth versus the same period in 2024. We have been able to provide continued price stability and predictability for our customers over the last several quarters and achieved a 43% market share in the clinic Medicare Part B segment of the market in Q3.

Including Chief Commercial Officer, Chief Financial Officer, and most recently Chief transformation Officer.

Including the consolidation of our operations and driving continued growth for <unk>.

Had a front row seat to many of our recent initiatives.

First off reflecting on <unk> performance to date in 2025.

Including the consolidation of our operations and driving continued growth for <unk>.

We have seen 42% third quarter year to date demand growth versus the same period in 2024.

First off reflecting on <unk> performance to date in 2025.

We have been able to provide continued price stability and predictability for our customers over the last several quarters and achieved a 43% market share in the clinic Medicare part D segment of the market in the third quarter.

We have seen 42% third quarter year to date demand growth versus the same period in 2024.

We have been able to provide continued price stability and predictability for our customers over the last several quarters and achieved a 43% market share in the clinic Medicare part D segment of the market in the third quarter.

Third quarter <unk> sales reflect both normal demand and large purchases by several national distributors to help ensure consistent supply of <unk> over the next two quarters.

Third quarter <unk> sales reflect both normal demand and large purchases by several national distributors to help ensure consistent supply of <unk> over the next two quarters.

Paul Schwichtenberg: Q3 ROLVEDON sales reflect both normal demand and large purchases by several national distributors to help ensure consistent supply of ROLVEDON over the next two quarters as we complete the integration of ROLVEDON into Assertio. This was done to ensure uninterrupted product availability to patients during the integration and allow sufficient time to manufacture the newly labeled products, establish ROLVEDON with a new 3PL distributor, and execute on many other integration-related activities. Specifically, the volume sold in Q3 2025 includes expected channel inventory sufficient to supply end customer demands for Q4 2025 and Q1 2026. No further sales of the Spectrum labeled ROLVEDON will occur, and Assertio Specialty does not expect to record material product sales of ROLVEDON until Q2 2026. From a customer and patient perspective, this will be a seamless transition.

As we complete the integration of roll on into <unk>.

This was done to ensure uninterrupted product availability to patients during the integration and allow sufficient time to manufacture the newly label products.

As we complete the integration of roll on into <unk>.

This was done to ensure uninterrupted product availability to patients during the integration and allow sufficient time to manufacture the newly label products.

Established for all of it on with a new <unk> distributor and execute on many other integration related activities.

Specifically the volume sold in the third quarter of 2025 includes expected channel inventory is sufficient to supply and customer demand.

Establish rolling on with the new <unk> distributor and execute on many other integration related activities.

Specifically the volume sold in the third quarter of 2025 includes expected channel inventory is sufficient to supply and customer demand.

For the fourth quarter of 2025, and the first quarter of 2026.

No further sales of the spectrum label enrollment will occur and the <unk> specialty does not expect to record material product sales of <unk> until the second quarter of 2026.

For the fourth quarter of 2025, and the first quarter of 2026.

No further sales of the spectrum label enrollment will occur and the <unk> specialty does not expect to record material product sales of Ramadan until the second quarter of 2026.

From a customer and patient perspective, this will be a seamless transition.

Also related to roll the Don we executed a long term supply agreement with Hanmi, our API manufacturer in the third quarter, which positions us for continued stable supply and pricing going forward.

From a customer and patient perspective, this will be a seamless transition.

Also related to roll it on we executed a long term supply agreement with Hanmi, our API manufacturer in the third quarter, which positions us for continued stable supply and pricing going forward.

Paul Schwichtenberg: Related to ROLVEDON, we executed a long-term supply agreement with Hanmi, our API manufacturer, in Q3, which positions us for continued stable supply and pricing going forward. Additionally, our same-day dosing data was presented at four oncology conferences since December 2024 and most recently at the Network for Collaborative Oncology Development and Advancement Conference in October of this year, and we anticipate publication in a major journal in the near future. Looking ahead to 2026 and beyond, our goal is to maintain our strategy of price stability and predictability for our customers as we continue to pursue further demand and market share growth for ROLVEDON. With that, I'll now pass the call over to AJ, who will cover the financial results. AJ?

Additionally, our same day dosing data was presented at for oncology conferences since December of 2024, and most recently at the network for collaborative oncology development and Advancement conference in October of this year.

Additionally, our same day dosing data was presented at for oncology conferences since December of 2024, and most recently at the network for collaborative oncology development and Advancement conference in October of this year.

And we anticipate publication in a major journal in the near future.

Looking ahead to 2026 and beyond our goal is to maintain our strategy of price stability and predictability for our customers as we continue to pursue further demand.

And we anticipate publication in a major journal in the near future.

Looking ahead to 2026 and beyond our goal is to maintain our strategy of price stability and predictability for our customers as we continue to pursue further demands.

Market share growth for rolled it up.

With that I'll now pass the call over to Jay who will cover the financial results.

Okay.

Market share growth for rolled it up.

Thanks, Paul today, I'll walk through our financial results for the third quarter of 2025 as a reminder, starting this year, we have resumed to the use of a year over year comparisons.

With that I'll now pass the call over to Jay who will cover the financial results.

Okay.

Thanks, Paul today, I'll walk through our financial results for the third quarter of 2025 as a reminder, starting this year, we have resumed to the use of a year over year comparisons.

Ajay Patel: Thanks, Paul. Today, I'll walk through our financial results for Q3 2025. As a reminder, starting this year, we have resumed the use of year-over-year comparisons. Total product sales in Q3 were $49.5 million compared to $28.7 million in the prior year, primarily driven by the ROLVEDON two-quarter pull forward, as previously mentioned. As a result of this, we do not anticipate material ROLVEDON sales to wholesalers in Q4 2025 and Q1 2026 and expect sales of the newly labeled ROLVEDON to begin in Q2 2026. SYMPAZAN sales were $2.8 million in Q3, up from $2.6 million in the prior year, driven by higher volume and partially offset by the impact of payer mix.

Total product sales in the third quarter were $49 5 million compared.

Compared to $28 7 million in the prior year.

Total product sales in the third quarter were $49 5 million compared.

Primarily driven by the role of <unk> two quarter pull forward as previously mentioned.

Compared to $28 $7 million in the prior year.

As a result of this we do not anticipate material <unk> sales to wholesalers in the fourth quarter of 2025, and first quarter of 2026 and expect sales of the newly labeled rollover down to began in the second quarter of 2026.

Primarily driven by the role of <unk> two quarter pull forward as previously mentioned.

As a result of this we do not anticipate material <unk> sales to wholesalers in the fourth quarter of 2025, and first quarter of 2026 and expect sales of the newly labeled were overdone to began in the second quarter of 2026.

<unk> sales were $2 8 million in the third quarter up from $2 6 million in the prior year, driven by higher volume and partially offset by the impact of payer mix.

<unk> sales were $2 8 million in the third quarter up from $2 $6 million in the prior year, driven by higher volume and partially offset by the impact of payer mix.

<unk> sales were $4 $8 million in the third quarter down from $5 7 million in the prior year, reflecting expected impacts from previously announced generic competition.

<unk> sales were $4 $8 million in the third quarter down from $5 7 million in the prior year, reflecting expected impacts from previously announced generic competition.

Ajay Patel: INDOCIN sales were $4.8 million in Q3, down from $5.7 million in the prior year, reflecting expected impacts from previously announced generic competition. The higher proportion of ROLVEDON sales relative to our other products drove a modest decrease in overall gross margin to 72%, compared to 74% in the prior year. Turning to operating expenses, reported SG&A expenses were $16.9 million, up slightly from $16.7 million in the prior year quarter, reflecting non-recurring costs related to the decommercialization of Otrexup, partially offset by lower legal expense following the completion of related initiatives this year. Adjusted operating expenses, which exclude stock compensation, D&A, and other specified items, were $14.9 million compared to $17.3 million in the prior year, reflecting our efforts to streamline the business and drive cost efficiencies.

The higher proportion of Ramadan sales relative to our other products drove a modest decrease in overall gross margin to 72% compared to 74% in the prior year.

The higher proportion of Ramadan sales relative to our other products drove a modest decrease in overall gross margin to 72% compared to 74% in the prior year.

Turning to operating expenses.

<unk> SG&A expenses were $16 9 million.

Turning to operating expenses.

Up slightly from $16 7 million in the prior year quarter, reflecting non recurring costs related to the commercialization of old trucks up partially offset by lower legal expense. Following the completion of related initiatives for this year.

<unk> SG&A expenses were $16 $9 million up.

Up slightly from $16 $7 million in the prior year quarter.

Reflecting non recurring costs related to the commercialization of old trucks, partially offset by lower legal expense. Following the completion of related initiatives for this year.

Adjusted operating expenses, which excludes stock compensation DNA and other specified items were $14 9 million.

Adjusted operating expenses, which exclude stock compensation DNA and other specified items were $14 9 million.

Compared to $17 3 million in the prior year, reflecting our efforts to streamline the business and drive cost efficiencies.

Compared to $17 3 million in the prior year, reflecting our efforts to streamline the business and drive cost efficiencies.

GAAP net income for the third quarter was 11 $4 million.

<unk> to a loss of $3 million in the prior year.

GAAP net income for the third quarter was $11 $4 million.

And adjusted EBITDA for the third quarter was $29 million.

Ajay Patel: GAAP net income for Q3 was $11.4 million compared to a loss of $3 million in the prior year. Adjusted EBITDA for Q3 was $20.9 million, up from $4.4 million in the prior year, both driven primarily by higher ROLVEDON sales. Turning to our balance sheet, as of 30 September 2025, cash equivalents, and short-term investments totaled $93.4 million compared to $98.2 million at 30 June 2025. The timing of cash collections and payments associated with the ROLVEDON sell-in is expected to result in a temporary decline in cash over the next 2 quarters before increasing in Q2 2026.

<unk> to a loss of $3 million in the prior year.

From $4 4 million in the prior year.

And adjusted EBITDA for the third quarter was $29 million.

Both are driven primarily by higher <unk> sales.

From $4 4 million in the prior year.

Turning to our balance sheet as of September 32025, cash cash equivalents and short term investments totaled $93 4 million compared to $98 2 million at June 32025.

Both are driven primarily by higher <unk> sales.

Turning to our balance sheet as of September 32025, cash cash equivalents and short term investments totaled $93 4 million.

The timing of cash collections and payments associated with the role of a down sell and is expected to result in a temporary decline in cash over the next two quarters.

Compared to $98 2 million at June 32025.

The timing of cash collections and payments associated with the role of the down sell and is expected to resolve in a temporary decline in cash over the next two quarters.

<unk>, increasing in the second quarter of 2026.

Total debt outstanding as of September 32025 remains unchanged at $40 million comprised of the company's six 5% convertible notes with no maturities until September 2027.

<unk>, increasing in the second quarter of 2026.

Total debt outstanding as of September 32025 remains unchanged at $40 million comprised of the company's six 5% convertible notes with no maturities until September 2027.

Ajay Patel: Total debt outstanding as of 30 September 2025 remains unchanged at $40 million, comprised of the company's 6.5% convertible notes with no maturities until September 2027. Lastly, as Mark mentioned, we are tightening our 2025 guidance within the range previously provided. We anticipate full year product sales on the current operating portfolio to be between $110 million and $112 million and adjusted EBITDA to be between $14 million and $16 million. Both the product sales and adjusted EBITDA guidance reflects the impacts of the pull forward of the ROLVEDON sales into the Q3. With that, I will turn the call back to Mark.

Lastly, as Mark mentioned, we are tightening our 2025 guidance within the range previously provided we anticipate full year product sales on the current operating portfolio to be between 110, and $112 million and adjusted EBITDA to be between 14% and <unk>.

Lastly, as Mark mentioned, we are tightening our 2025 guidance within the range previously provided.

We anticipate full year product sales on the current operating portfolio to be between 110 and $112 million.

$16 million.

Both the product sales and adjusted EBITDA guidance reflects the impacts of the pull forward of the <unk> sales into the third quarter.

Adjusted EBITDA to be between 14 and $16 million.

Both the product sales and adjusted EBITDA guidance reflects the impact of the pull forward of the robot on sales into the third quarter.

With that I will turn the call back to Mark.

Thank you AJ.

I am pleased with the strong financial position we are currently in.

With that I will turn the call back to Mark.

As I continue in my new role my focus is on advancing strategic initiatives that will drive growth.

Thank you a J.

I am pleased with the strong financial position we are currently in.

Mark Reisenauer: Thank you, AJ. I'm pleased with the strong financial position we are currently in. As I continue in my new role, my focus is on advancing strategic initiatives that will drive growth. I will provide updates on those initiatives as they materialize. Abby, we're ready to take questions now.

I will provide updates on those initiatives as they materialize.

As I continue in my new role my focus is on advancing strategic initiatives that will drive growth.

Debby, we're ready to take questions now.

I will provide updates on those initiatives as they materialize.

Thank you and we will now begin the question and answer session.

Abby, we're ready to take questions now.

You have dialed in and we'd like to ask a question. Please press star one on your telephone keypad to raise your hand and join the queue if.

Thank you and we will now begin the question and answer session.

Operator: Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one a second time. If you are called upon to ask your question and are listening via speakerphone on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. To be able to take as many questions as possible, we ask that you please limit yourself to one question and one follow-up. Again, it is star one if you would like to join the queue. Our first question comes from the line of Thomas Flaten with Lake Street. Your line is open.

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To be able to take as many questions as possible. We ask that you. Please limit yourself to one question and one follow up.

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To be able to take as many questions as possible. We ask that you. Please limit yourself to one question and one follow up.

And our first question.

Comes from the line of Thomas Flaten with Lake Street. Your line is open.

Again, it is star one if you would like to join the queue.

And our first question.

Hey, good afternoon, thanks for taking the questions Paul Congrats on the promotion of nice to have you back on the calls.

Comes from the line of Thomas Flaten with Lake Street. Your line is open.

Let me, let me start with you could you explain to us what if any linkage there is between labor code and Asps, but you inherit.

Hey, good afternoon, thanks for taking the questions Paul Congrats on the promotion of nice to have you back on the calls.

Thomas Flaten: Hey, good afternoon. Thanks for taking the questions. Paul, congrats on the promotion. Nice to have you back on the calls. let me start with you. Could you explain to us what, if any, linkage there is between labeler code and ASP? Like, do you inherit the Spectrum labeled ASP, or can you just walk us through the mechanics of that?

Let me, let me start with you could you explain to us what if any linkage there is between labor code and Asps, what you inherit the spectrum labels Asps can you just walk us through the mechanics of that.

<unk> spectrum labeled ASP.

This is the mechanics of that.

We don't really comment on forward looking.

Reimbursement for Robert on.

So.

What I can tell you is that we expect to continue our strategy that I mentioned in my comments, our price stability and predictability.

We don't really comment on forward looking.

Paul Schwichtenberg: Thomas, we don't really comment on forward-looking reimbursement for ROLVEDON. Basically what I can tell you is that we expect to continue our strategy that I mentioned in my comments of price stability and predictability. The labeler code change is not tied to ASP. It's really about the integration of ROLVEDON into Assertio.

Reimbursement for <unk>.

So basically what I can tell you is that we expect to continue.

So the labor code changes not tied to <unk>.

Continue our strategy that I mentioned in my comments, our price stability and predictability.

Asps is really about the integration of <unk>.

I'm, sorry to roll it out into <unk>.

So that's the labor code changes not tied to.

Got it.

ASP is really about the integration of the <unk> I'm, sorry to roll it out into <unk>.

And then there was a there was a sequential uptick in interest in sales, which was a bit surprising any comments on whats kind of going on out there in the market trends.

Got it.

Thomas Flaten: Got it. Then there was a sequential uptick in INDOCIN sales, which was a bit surprising. Any comments on what's kind of going out, on out there in the market for INDOCIN?

Then there was there was a sequential uptick in sales, which was a bit surprising any comments on whats kind of going on out there in the market trends.

Yes, two things related to Edison, we've continued to maintain a good market share and volume and discipline. Despite the competition and we've seen a little bit of price favorability as well.

Yes, two things related to Edison, we've continued to maintain a good market share and volume and discipline. Despite the competition and we've seen a little bit of price favorability as well.

Paul Schwichtenberg: Yeah, two things related to INDOCIN. We've continued to maintain some good market share and volume in INDOCIN despite the competition, and we've seen a little bit of price favorability as well, quarter-over-quarter. We're continuing to compete as best we can in the generic space.

Quarter over quarter.

So we're continuing to compete as best we can in the generic space.

Awesome I appreciate you taking the questions. Thank you.

Quarter over quarter.

Sure.

We're continuing to compete as best we can in the generic space.

And our next question comes from the line of Mars Raman with Maxim Group. Your line is open.

Awesome I appreciate you taking the questions. Thank you.

Thomas Flaten: Awesome. Appreciate you taking the question. Thank you.

Yes.

Hi, Thanks for taking my questions first of all as soon as now.

And our next question comes from the line of Mars Raman with Maxim Group. Your line is open.

The mutual Paul we spoke before.

Operator: Our next question comes from the line of Naz Rahman with Maxim Group. Your line is open.

But my question is geared multi towards mark.

Hi, Thanks for taking my questions first of all I, just want to say nicely.

So mark you.

Naz Rahman: Hi, thanks for taking my questions. First of all, I just wanna say, nice to meet you, Paul. I don't believe we spoke before. My question is geared mostly towards Mark. Mark, you obviously have a background in oncology, and ROLVEDON obviously competes in that space. I understand you've only been at the co for a few weeks now, but sort of based on everything you've seen and everything you know, do you have any thoughts on potentially optimizing ROLVEDON's either promotional strategy or commercial strategy, and also potentially adjusting the reimbursement strategy?

Nice to meet you Paul.

I'll just have a background oncology enrollment obviously compete in that space I understand you've only been on the CRC.

Hope before.

So my question is geared multi towards mark.

For a few weeks now, but based on everything you've seen and everything you know do you have any thoughts on potentially optimizing robot arms, either promotional strategy of commercial strategy and also potentially.

Mark.

I'll just have a background oncology enrollment obviously compete in that space I understand you've only been on the CRC.

A few weeks now.

Based on everything you're seeing in everything we know.

Do you have any thoughts.

Adjusting the reimbursement strategy.

And potentially optimizing Robert on the either promotional strategy of commercial strategy and also potentially.

Okay.

Yes. Thank you for the question.

And what I would say, yes, it's a couple of weeks in.

Adjusting the reimbursement strategy.

We're currently reviewing with the team all of the current strategies.

Okay.

Yes. Thank you for the question.

And what I would say, yes, it's a couple of weeks in and currently reviewing with the team all of the current strategies.

Mark Reisenauer: Yeah. Thank you for the question. What I would say, yes, it's a couple of weeks in, and currently reviewing with the team all of the current strategies. As we come up with any refinements, we'll certainly let you know. I think I'm certainly approaching this from the position of looking for any way that we can drive additional growth on our growth assets.

So as we come up with any refinements, we'll certainly let you know, but I think I'm certainly approaching this.

The position of looking for any way that we can drive additional growth on our growth assets.

And so as we come up with any refinements, we'll certainly let you know, but I think I'm certainly approaching this.

Thank you and just one follow up is just on the gross.

Some of the position of looking for any way that we can drive additional growth on our growth assets.

Margins so it looks like the gross margins somewhat stabilized this quarter, but what the rover on pull through what are you sort of expect app into gross margins going forward for the next two quarters or do you think this is kind of stabilize around here.

Thank you and just one follow up is just on the gross margins. So it looks like the gross margins somewhat stabilized this quarter, but what the rover on pull through what are you sort of expect app into gross margins going forward for the next two quarters or do you think this is kind of stabilize around here.

Naz Rahman: Thank you. Just one follow-up is just on the gross margins. It looks like the gross margins somewhat stabilized this quarter. With the ROLVEDON pull-through, what do you sort of expect to happen to gross margins going forward for the next two quarters? Do you think these kind of stabilize around here?

Okay.

And as this is AJ I can take that so obviously, we haven't given full guidance for next year, yet yet and we'll plan to do that at our March conference call.

And as this is AJ I can take that so obviously, we haven't given a full guidance for next year, yet and we'll plan to do that at our March conference call.

Ajay Patel: Hey, Naz, this is AJ. I can take that. Obviously we haven't given a full guidance for next year yet, and we'll plan to do that at our March conference call. I would say the targeted gross margin we had this year, which aligns with the guidance range we just give, is in line with where kind of Q3 landed.

I would say that targeted gross margin, we had this year, which aligns with the guidance range. We just gave is in line with where kind of Q3 landed.

I'd say the targeted gross margin, we had this year, which aligns with the guidance range. We just gave is in line with where kind of Q3 landed.

Got it thank you for taking my questions.

Thank you.

And as a reminder, it is star one if you would like to ask a question and our next question comes from the line of ROM Selvaggio with H C. Wainwright. Your line is open.

Got it thank you for taking my questions.

Naz Rahman: Got it. Thank you for taking my questions.

Thank you.

And as a reminder, it is star one if you would like to ask a question.

Mark Reisenauer: Thank you.

Operator: As a reminder, it is star 1 if you would like to ask a question. Our next question comes from the line of Raghuram Selvaraju with H.C. Wainwright. Your line is open.

Thanks, so much for taking my questions. Firstly, a broad spectrum one for Mark I was wondering if you could comment on the kind of differences in strategic priorities and core business objectives under the new direction.

And our next question comes from the line of ROM Selvarasa with H C. Wainwright. Your line is open.

Thanks, so much for taking my questions. Firstly, a broad spectrum one for Mark I was wondering if you could comment on the kind of differences in strategic priorities and core business objectives under the new direction.

Raghuram Selvaraju: Thanks so much for taking my questions. Firstly, a broad spectrum one for Mark. I was wondering if you could comment on the kind of differences in strategic priorities and core business objectives under the new direction, as opposed to what historically was being prioritized, particularly with respect to business developments. Secondly, on a product front, I was just wondering if you could provide us with any color on emergent market trends that may be favorable towards SYMPAZAN uptake and what you expect the generalized prospects for SYMPAZAN sales acceleration in the coming quarters. Thank you.

As opposed to what historically was being prioritized, particularly with respect to business development and then secondly on a product front I was just wondering if you could provide us with any color on emergent market trends that may be favorable towards <unk> uptake and what you expect the generalized prospects.

As opposed to what historically was being prioritized, particularly with respect to business development and then secondly on a product front I was just wondering if you could provide us with any color on emerging market trends that may be favorable towards <unk> uptake and what you expect the generalized prospects.

<unk> sales acceleration in the coming quarters. Thank you.

Yes. Thank you for your thank you for your questions I'll take the first one and I'll, let Paul talk about the <unk> question.

For simpler sale.

Sales acceleration in the coming quarter. Thank you.

So regarding future strategy.

Yes. Thank you for your thank you for your questions I'll take the first one and I'll, let Paul talk about the <unk> question.

Mark Reisenauer: Yes. Thank you for your questions. I'll take the first one and I'll let Paul talk about the SYMPAZAN question. Regarding future strategy, what I am doing, along with the management team and as well as with the board, is currently reviewing and refining our strategies moving forward. When we have updates there, I will certainly provide that more broadly, it's very early days in terms of that effort. Paul, you wanna handle the SYMPAZAN question?

What I am doing along with the management team and as well as with the board.

So regarding future strategy.

Is currently reviewing and refining.

What I am doing along with the management team as well as with the board is currently reviewing and refining.

Our strategies moving forward when we have updates there I will certainly.

The buyback more broadly, but it's very early days in terms of that effort.

Our strategies moving forward when we have updates there I will certainly.

Paul you want to handle the <unk> question sure.

Provide that more broadly, but it's very early days in terms of that effort.

As it stands right now symposium is competing in a generic market.

Paul you want to handle the <unk> question sure as it.

We're not seeing any.

Significant changes to that market in the near future, but our differentiator is our delivery mechanism being the oral film.

Sounds right now symposium is competing in a generic market.

Paul Schwichtenberg: Sure. As it stands right now, SYMPAZAN is competing in a generic market. We're not seeing any significant changes to that market in the near future. Our differentiators, our delivery mechanism being the oral film. What we're doing right now is we're focused on raising awareness of our product and getting the message out there. We've got reps in the field concentrated in the high prescribing areas. We're also trying to raise awareness through our digital promotion as well. That's our focus right now for SYMPAZAN.

We're not seeing any.

What we're doing right now.

Significant changes to that market in the near future, but our differentiators are delivery mechanism being the oral film.

We're focused on raising awareness of our products and getting the message out there we've got reps in the field concentrated and high prescribing areas.

What we're doing right now.

We're focused on raising awareness of our products and getting the message out there we've got reps in the field concentrated and high prescribing areas.

And we're also trying to raise awareness of our digital promotion as well.

So that's that's our focus right now for <unk>.

And we're also trying to raise awareness of our digital promotion as well.

Thank you.

Thank you.

So that's that's our focus right now for <unk>.

And ladies and gentlemen that concludes our question and answer session and today's call. We thank you for your participation and you may now disconnect.

Thank you.

Thank you.

Raghuram Selvaraju: Thank you.

And ladies and gentlemen that concludes our question and answer session and today's call. We thank you for your participation and you may now disconnect.

Mark Reisenauer: Thank you.

Operator: Ladies and gentlemen, that concludes our question and answer session and today's call. We thank you for your participation, and you may now disconnect.

Q3 2025 Assertio Holdings Inc Earnings Call

Demo

Assertio Holdings

Earnings

Q3 2025 Assertio Holdings Inc Earnings Call

ASRT

Monday, November 10th, 2025 at 9:30 PM

Transcript

No Transcript Available

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