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Assertio Holdings Inc

Assertio Holdings Inc (ASRT)

23.48
0.01
(0.04%)
Closed June 14 3:00PM
23.47
-0.01
(-0.04%)
After Hours: 5:11PM

Assertio Holdings Inc (ASRT) Options

Calls

StrikeBid PriceAsk PriceLast PriceMidpointChangeChange %VolumeOPEN INTLast Trade
13.007.6012.600.0010.100.000.00 %00-
14.008.1012.801.2510.450.000.00 %03-
15.005.6010.600.008.100.000.00 %00-
16.005.8010.802.508.300.000.00 %0122-
17.000.000.000.000.000.000.00 %00-
18.002.607.603.905.100.000.00 %00-
19.002.807.802.655.300.000.00 %010-
20.001.806.800.704.300.000.00 %017-
21.000.000.000.000.000.000.00 %00-
22.000.000.000.000.000.000.00 %00-
23.000.000.000.000.000.000.00 %00-
24.000.000.000.000.000.000.00 %00-
25.000.004.900.050.050.000.00 %04-

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Puts

StrikeBid PriceAsk PriceLast PriceMidpointChangeChange %VolumeOPEN INTLast Trade
13.000.004.900.000.000.000.00 %00-
14.000.004.900.000.000.000.00 %00-
15.000.004.901.981.980.000.00 %05-
16.000.004.900.000.000.000.00 %00-
17.000.000.000.000.000.000.00 %00-
18.000.004.900.000.000.000.00 %00-
19.000.004.903.203.200.000.00 %06-
20.000.004.905.005.000.000.00 %04-
21.000.000.000.000.000.000.00 %00-
22.000.000.000.000.000.000.00 %00-
23.000.000.000.000.000.000.00 %00-
24.000.000.000.000.000.000.00 %00-
25.000.004.900.000.000.000.00 %00-

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ASRT Discussion

View Posts
US Market News US Market News 1 month ago
Assertio and Garda Mutually Agree to Extend Tender Offer DeadlineApril 29, 2026 4:30 PM
Business Wire
Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), today announced that it has reached a mutual agreement with Garda Therapeutics, Inc. (“Garda”) to extend the deadline to commence the previously announced tender offer to acquire all outstanding shares of Assertio to May 4, 2026.


As previously announced on April 8, 2026, Assertio has entered into a definitive agreement (the “Garda Agreement”) to be acquired by Garda for $18.00 per share in cash, or a total cash consideration of $125.1 million, plus a contingent value right. The Garda Agreement includes a 20-day “window-shop” period. Under the terms of the window-shop provision, Assertio is free to engage with other parties who may provide superior value to shareholders. In the event the Board terminates the Garda Agreement in favor of a superior bid during the window-shop period, a reduced breakup fee would apply.


About Assertio


Assertio is a pharmaceutical company with comprehensive commercial capabilities offering differentiated products designed to address patients’ needs. Our focus is on supporting patients by marketing products primarily in the oncology market. To learn more about Assertio, visit www.assertiotx.com.


Additional Information and Where to Find It


The tender offer described in this communication has not yet commenced. This communication is for information purposes only and is neither an offer to buy nor a solicitation of an offer to sell any securities of Assertio Holdings, Inc. (“Assertio”), nor is it a substitute for the tender offer materials that Garda Therapeutics, Inc. (“Garda”) and its wholly owned acquisition subsidiary, Audi Merger Sub, Inc. (“Merger Sub”), will file with the Securities and Exchange Commission (the “SEC”). The solicitation and the offer to buy shares of Assertio’s common stock will only be made pursuant to a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and other related materials that Garda and Merger Sub intend to file with the SEC. In addition, Assertio will file with the SEC a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer.


Once filed, investors will be able to obtain the tender offer statement on Schedule TO, the offer to purchase, the Solicitation/Recommendation Statement of Assertio on Schedule 14D-9 and related materials with respect to the tender offer and merger, free of charge at the website of the SEC at www.sec.gov or from the information agent named in the tender offer materials. Investors may also obtain, at no charge, the documents filed with or furnished to the SEC by Assertio under the “Investors” section of Assertio’s website at www.assertiotx.com.


STOCKHOLDERS AND INVESTORS ARE STRONGLY ADVISED TO READ THESE DOCUMENTS WHEN THEY BECOME AVAILABLE, INCLUDING THE SOLICITATION/RECOMMENDATION STATEMENT OF ASSERTIO ON SCHEDULE 14D-9 AND ANY AMENDMENTS THERETO, AS WELL AS ANY OTHER DOCUMENTS RELATING TO THE TENDER OFFER AND THE MERGER THAT ARE FILED WITH THE SEC, CAREFULLY AND IN THEIR ENTIRETY PRIOR TO MAKING ANY DECISIONS WITH RESPECT TO WHETHER TO TENDER THEIR SHARES INTO THE TENDER OFFER BECAUSE THEY CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS AND CONDITIONS OF THE TENDER OFFER.


Cautionary Note Regarding Forward-Looking Statements


This communication contains forward-looking statements within the meaning of the federal securities laws. Forward-looking statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs. Forward-looking statements speak only as of the date they are made and should not be relied upon as predictions of future events, as there can be no assurance that the events or circumstances reflected in these statements will be achieved or will occur.


In particular, this communication includes forward-looking statements regarding Assertio Holdings, Inc. (“Assertio” or the “Company”), the proposed tender offer by Audi Merger Sub, Inc., a wholly owned subsidiary of Garda Therapeutics, Inc. (“Garda”), to acquire all outstanding shares of the Company’s common stock and the subsequent merger pursuant to which the Company would become a wholly owned subsidiary of Garda, including, without limitation, statements regarding the expected timing and completion of these transactions and the parties’ ability to satisfy the conditions to consummation.


Forward-looking statements can often, but not always, be identified by the use of forward-looking terminology such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “might,” “opportunity,” “plan,” “potential,” “project,” “seek,” “should,” “strategy,” “target,” “will,” or the negative of these words and phrases, other variations of these words and phrases or comparable terminology.


These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, many of which are beyond the Company’s control and subject to change. Actual results could differ materially from those expressed or implied by these forward-looking statements. Important factors that could cause actual results to differ materially include, among others: risks associated with the timing of the closing of the proposed transaction, including the risks that a condition to closing would not be satisfied within the expected timeframe or at all or that the closing of the proposed transaction will not occur in which case Rolvedon would be the Company’s only product; uncertainties as to how many of the Company’s stockholders will tender their shares in the offer; the possibility that competing offers will be made; the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the occurrence of any event, change or other circumstance that could give rise to the termination of the transaction; the outcome of any legal proceedings that may be instituted against the parties and others related to the transaction; unanticipated difficulties or expenditures relating to the proposed transaction; the effect of the announcement or pendency of the proposed transaction on the Company’s business and operating results (including the response of business partners and competitors and potential difficulties in employee retention as a result of the announcement and pendency of the proposed transaction); risks related to the diverting of management’s attention from the Company’s ongoing business operations; risks related to non-achievement of any contingent value right milestones and that holders will not receive payments in respect thereof; general economic and market conditions; and other risks and uncertainties identified in the Company’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10 K, Quarterly Reports on Form 10 Q and other filings. Many of these risks and uncertainties may be exacerbated by public health emergencies and general macroeconomic conditions.


The foregoing list of factors is not exhaustive. You should not place undue reliance on any forward-looking statements. The Company does not assume, and hereby disclaims, any obligation to update or revise any forward-looking statements, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260429514874/en/
Investor and Media Contact

Longacre Square Partners

assertio@longacresquare.com


Original: Assertio and Garda Mutually Agree to Extend Tender Offer Deadline
👍️0
US Market News US Market News 2 months ago
Assertio Provides Update on Garda Therapeutics Tender ProcessApril 21, 2026 5:00 PM
Business Wire
Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), today provided an update that Garda Therapeutics, Inc. (“Garda”) intends to commence the tender offer to acquire all outstanding shares of Assertio on April 29, 2026 – the day following the expiration of the 20-day “window-shop” period.


As previously announced on April 8, 2026, Assertio has entered into a definitive agreement (the “Garda Agreement”) to be acquired by Garda for $18.00 per share in cash, or a total cash consideration of $125.1 million, plus a contingent value right. The Garda Agreement includes a 20-day “window-shop” period. Under the terms of the window-shop provision, Assertio is free to engage with other parties who may provide superior value to shareholders. In the event the Board terminates the Garda Agreement in favor of a superior bid during the window-shop period, a reduced breakup fee would apply.


About Assertio


Assertio is a pharmaceutical company with comprehensive commercial capabilities offering differentiated products designed to address patients’ needs. Our focus is on supporting patients by marketing products primarily in the oncology market. To learn more about Assertio, visit www.assertiotx.com.


Additional Information and Where to Find It


The tender offer described in this communication has not yet commenced. This communication is for information purposes only and is neither an offer to buy nor a solicitation of an offer to sell any securities of Assertio Holdings, Inc. (“Assertio”), nor is it a substitute for the tender offer materials that Garda Therapeutics, Inc. (“Garda”) and its wholly owned acquisition subsidiary, Audi Merger Sub, Inc. (“Merger Sub”), will file with the Securities and Exchange Commission (the “SEC”). The solicitation and the offer to buy shares of Assertio’s common stock will only be made pursuant to a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and other related materials that Garda and Merger Sub intend to file with the SEC. In addition, Assertio will file with the SEC a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer.


Once filed, investors will be able to obtain the tender offer statement on Schedule TO, the offer to purchase, the Solicitation/Recommendation Statement of Assertio on Schedule 14D-9 and related materials with respect to the tender offer and merger, free of charge at the website of the SEC at www.sec.gov or from the information agent named in the tender offer materials. Investors may also obtain, at no charge, the documents filed with or furnished to the SEC by Assertio under the “Investors” section of Assertio’s website at www.assertiotx.com.


STOCKHOLDERS AND INVESTORS ARE STRONGLY ADVISED TO READ THESE DOCUMENTS WHEN THEY BECOME AVAILABLE, INCLUDING THE SOLICITATION/RECOMMENDATION STATEMENT OF ASSERTIO ON SCHEDULE 14D-9 AND ANY AMENDMENTS THERETO, AS WELL AS ANY OTHER DOCUMENTS RELATING TO THE TENDER OFFER AND THE MERGER THAT ARE FILED WITH THE SEC, CAREFULLY AND IN THEIR ENTIRETY PRIOR TO MAKING ANY DECISIONS WITH RESPECT TO WHETHER TO TENDER THEIR SHARES INTO THE TENDER OFFER BECAUSE THEY CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS AND CONDITIONS OF THE TENDER OFFER.


Cautionary Note Regarding Forward-Looking Statements


This communication contains forward-looking statements within the meaning of the federal securities laws. Forward-looking statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs. Forward-looking statements speak only as of the date they are made and should not be relied upon as predictions of future events, as there can be no assurance that the events or circumstances reflected in these statements will be achieved or will occur.


In particular, this communication includes forward-looking statements regarding Assertio Holdings, Inc. (“Assertio” or the “Company”), the proposed tender offer by Audi Merger Sub, Inc., a wholly owned subsidiary of Garda Therapeutics, Inc. (“Garda”), to acquire all outstanding shares of the Company’s common stock, the subsequent merger pursuant to which the Company would become a wholly owned subsidiary of Garda, and including, without limitation, statements regarding the expected timing and completion of these transactions and the parties’ ability to satisfy the conditions to consummation.


Forward-looking statements can often, but not always, be identified by the use of forward-looking terminology such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “might,” “opportunity,” “plan,” “potential,” “project,” “seek,” “should,” “strategy,” “target,” “will,” or the negative of these words and phrases, other variations of these words and phrases or comparable terminology.


These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, many of which are beyond the Company’s control and subject to change. Actual results could differ materially from those expressed or implied by these forward-looking statements. Important factors that could cause actual results to differ materially include, among others: risks associated with the timing of the closing of the proposed transaction, including the risks that a condition to closing would not be satisfied within the expected timeframe or at all or that the closing of the proposed transaction will not occur in which case Rolvedon would be the Company’s only product; uncertainties as to how many of the Company’s stockholders will tender their shares in the offer; the possibility that competing offers will be made; the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the occurrence of any event, change or other circumstance that could give rise to the termination of the transaction; the outcome of any legal proceedings that may be instituted against the parties and others related to the transaction; unanticipated difficulties or expenditures relating to the proposed transaction; the effect of the announcement or pendency of the proposed transaction on the Company’s business and operating results (including the response of business partners and competitors and potential difficulties in employee retention as a result of the announcement and pendency of the proposed transaction); risks related to the diverting of management’s attention from the Company’s ongoing business operations; risks related to non-achievement of any contingent value right milestones and that holders will not receive payments in respect thereof; general economic and market conditions; and other risks and uncertainties identified in the Company’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings. Many of these risks and uncertainties may be exacerbated by public health emergencies and general macroeconomic conditions.


The foregoing list of factors is not exhaustive. You should not place undue reliance on any forward-looking statements. The Company does not assume, and hereby disclaims, any obligation to update or revise any forward-looking statements, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260421787030/en/
Investor and Media Contact

Longacre Square Partners

assertio@longacresquare.com


Original: Assertio Provides Update on Garda Therapeutics Tender Process
👍️0
US Market News US Market News 2 months ago
Assertio Announces Agreement to be Acquired by Garda TherapeuticsApril 8, 2026 4:04 PM
Business Wire
All-Cash Tender Offer of $18 per share – or $125.1 Million – Plus Contingent Value Right


Tender Offer Price Represents 34.6% Premium to Unaffected Price and 46.6% Premium to Unaffected 30-day Volume-Weighted Average Price


Transaction Follows Comprehensive Strategic Review Process Initiated in First Quarter of 2025


Includes Additional “Shop” Period to Ensure Maximum Value for Shareholders


Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), today announced a definitive agreement (the “Garda Agreement”) to be acquired by Garda Therapeutics (“Garda” or the “Buyer”) for $18 per share in cash, or a total cash consideration of $125.1 million, (the “Garda Transaction”), plus a contingent value right (the “CVR”). In connection with the Garda Transaction, the Company today also announced that it has signed and closed an agreement (“Cosette Agreement”) to sell all non-Rolvedon assets to Cosette Pharmaceuticals (“Cosette”).


The Garda Transaction represents a 34.6% premium to the Company’s unaffected stock price on March 20, 2026 – the day before a significant share price and trading volume movement – a 46.6% premium to the 30-day unaffected volume-weighted average price (“VWAP”) and a 62.2% premium to the 60-day unaffected VWAP as of March 20. The Garda Transaction has been unanimously approved by the Boards of Directors of both companies.


Heather Mason, Chair of the Assertio Board of Directors, stated: “Over the course of this extensive multi-month process, the Board, management, and our advisors have conducted a disciplined and wide-ranging review of our business. We evaluated multiple strategic pathways – including a potential sale of the Company, merger opportunities, monetization of Rolvedon, and continuing as a standalone entity. The Company and its advisors engaged more than 35 counterparties, including both strategic and financial buyers. Following this thorough process – and with the addition under the agreement for an incremental shop period to ensure maximum value – the Board has determined that these transactions with Cosette and Garda provide the best outcome for our shareholders.”


Assertio will file a Schedule 14D-9 with respect to the tender offer in approximately 10 business days, which will include additional detailed information on the strategic review process.


Mark Reisenauer, CEO and a Director of Assertio, added: “These transactions provide our shareholders with a certain path to value realization amid a rapidly evolving regulatory, reimbursement, and macroeconomic environment. I would like to sincerely thank everyone involved for the hard work that helped the Company to achieve this outcome.”


Transaction Details


Under the terms of the Garda Agreement, Garda will promptly commence a tender offer to acquire all outstanding shares of Assertio Holdings at an upfront price of $18 per share in cash, or a total cash consideration of $125.1 million, plus a non-tradeable CVR related to potential future milestones for Sprix®. The Company’s Board of Directors unanimously recommends that Assertio stockholders tender their shares in the tender offer.


In connection with the Garda Agreement, Assertio divested the assets, properties, rights, title and interest in and to the Indocin® products, Sympazan®, Sprix®, Cambia®, Zipsor®, and the recently decommercialized Otrexup® to Cosette for an up-front payment of $35 million plus earnouts related to certain product milestones, all of which are included in the total consideration of the Garda Transaction. Other than the Sprix®-related milestones, which would be passed through to the Assertio shareholders through the CVR, the economics of the Cosette transaction will not further impact the $125.1 million purchase price.


The Garda Agreement includes a 20-day “window-shop” period. Under the terms of the window-shop provision, Assertio is free to engage with other parties who may provide superior value to our shareholders. In the event the Board terminates the Garda Agreement in favor of a superior bid during the window-shop period, a reduced breakup fee would apply.


The closing of the Garda Transaction is expected to occur in the second quarter of 2026 and is subject to customary closing conditions, including the tender of a majority of the outstanding shares of Assertio’s common stock. The Company does not expect any regulatory approvals to be required for closing. Following the successful closing of the tender offer, Garda will acquire all remaining shares of Assertio Holdings’ common stock that are not tendered in the tender offer through a second-step merger at the same price as the tender offer of $18 per share, plus the CVR.


Following the completion of the tender offer, Assertio’s common stock will no longer be listed for trading on Nasdaq.


Assertio will file a current report on Form 8-K with the U.S. Securities and Exchange Commission containing a summary of terms and conditions of the Garda Transaction.


Moelis & Company LLC acted as exclusive financial advisor, and Gibson, Dunn & Crutcher LLP served as legal counsel to Assertio on the sale to Garda and on the divestiture to Cosette. Longacre Square Partners serves as strategy and communications advisor to Assertio.


About Assertio


Assertio is a pharmaceutical company with comprehensive commercial capabilities offering differentiated products designed to address patients’ needs. Our focus is on supporting patients by marketing products primarily in the oncology market. To learn more about Assertio, visit www.assertiotx.com.


Additional Information and Where to Find It


The tender offer described in this communication has not yet commenced. This communication is for information purposes only and is neither an offer to buy nor a solicitation of an offer to sell any securities of Assertio Holdings, Inc. (“Assertio”), nor is it a substitute for the tender offer materials that Garda Therapeutics, Inc. (“Garda”) and its wholly owned acquisition subsidiary, Audi Merger Sub, Inc. (“Merger Sub”), will file with the Securities and Exchange Commission (the “SEC”). The solicitation and the offer to buy shares of Assertio’s common stock will only be made pursuant to a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and other related materials that Garda and Merger Sub intend to file with the SEC. In addition, Assertio will file with the SEC a Solicitation/ Recommendation Statement on Schedule 14D-9 with respect to the tender offer.


Once filed, investors will be able to obtain the tender offer statement on Schedule TO, the offer to purchase, the Solicitation/Recommendation Statement of Assertio on Schedule 14D-9 and related materials with respect to the tender offer and merger, free of charge at the website of the SEC at www.sec.gov or from the information agent named in the tender offer materials. Investors may also obtain, at no charge, the documents filed with or furnished to the SEC by Assertio under the “Investors” section of Assertio’s website at www.assertiotx.com.


STOCKHOLDERS AND INVESTORS ARE STRONGLY ADVISED TO READ THESE DOCUMENTS WHEN THEY BECOME AVAILABLE, INCLUDING THE SOLICITATION/RECOMMENDATION STATEMENT OF ASSERTIO ON SCHEDULE 14D-9 AND ANY AMENDMENTS THERETO, AS WELL AS ANY OTHER DOCUMENTS RELATING TO THE TENDER OFFER AND THE MERGER THAT ARE FILED WITH THE SEC, CAREFULLY AND IN THEIR ENTIRETY PRIOR TO MAKING ANY DECISIONS WITH RESPECT TO WHETHER TO TENDER THEIR SHARES INTO THE TENDER OFFER BECAUSE THEY CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS AND CONDITIONS OF THE TENDER OFFER.


Cautionary Note Regarding Forward-Looking Statements


This communication contains forward-looking statements within the meaning of the federal securities laws. Forward-looking statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs. Forward-looking statements speak only as of the date they are made and should not be relied upon as predictions of future events, as there can be no assurance that the events or circumstances reflected in these statements will be achieved or will occur.


In particular, this communication includes forward-looking statements regarding Assertio Holdings, Inc. (“Assertio” or the “Company”), the proposed tender offer by Audi Merger Sub, Inc., a wholly owned subsidiary of Garda Therapeutics, Inc. (“Garda”), to acquire all outstanding shares of the Company’s common stock, the subsequent merger pursuant to which the Company would become a wholly owned subsidiary of Garda, and the Company’s asset sale to Cosette Pharmaceuticals, Inc. (“Cosette”), including, without limitation, statements regarding the expected timing and completion of these transactions and the parties’ ability to satisfy the conditions to consummation.


Forward-looking statements can often, but not always, be identified by the use of forward-looking terminology such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “might,” “opportunity,” “plan,” “potential,” “project,” “seek,” “should,” “strategy,” “target,” “will,” or the negative of these words and phrases, other variations of these words and phrases or comparable terminology.


These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, many of which are beyond the Company’s control and subject to change. Actual results could differ materially from those expressed or implied by these forward-looking statements. Important factors that could cause actual results to differ materially include, among others: risks associated with the timing of the closing of the proposed transaction, including the risks that a condition to closing would not be satisfied within the expected timeframe or at all or that the closing of the proposed transaction will not occur in which case Rolvedon would be the Company’s only product; uncertainties as to how many of the Company’s stockholders will tender their shares in the offer; the possibility that competing offers will be made; the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the occurrence of any event, change or other circumstance that could give rise to the termination of the transaction; the outcome of any legal proceedings that may be instituted against the parties and others related to the transaction; unanticipated difficulties or expenditures relating to the proposed transaction; the effect of the announcement or pendency of the proposed transaction on the Company’s business and operating results (including the response of business partners and competitors and potential difficulties in employee retention as a result of the announcement and pendency of the proposed transaction); risks related to the diverting of management’s attention from the Company’s ongoing business operations; risks related to non-achievement of any contingent value right milestones and that holders will not receive payments in respect thereof; general economic and market conditions; and other risks and uncertainties identified in the Company’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10 K, Quarterly Reports on Form 10 Q and other filings. Many of these risks and uncertainties may be exacerbated by public health emergencies and general macroeconomic conditions.


The foregoing list of factors is not exhaustive. You should not place undue reliance on any forward-looking statements. The Company does not assume, and hereby disclaims, any obligation to update or revise any forward-looking statements, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260408108552/en/
Investor and Media Contact

Longacre Square Partners

assertio@longacresquare.com


Original: Assertio Announces Agreement to be Acquired by Garda Therapeutics
👍️0
US Market News US Market News 3 months ago
Assertio Reports Fourth Quarter and Full Year 2025 Financial ResultsMarch 16, 2026 4:05 PM
Business Wire
Delivers FY2025 Net Product Sales and Adjusted EBITDA Above Guidance


Expects Net Product Sales between $110M-$125M and Adjusted EBITDA between $28M-$40M in FY2026


Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities offering differentiated products designed to address patients’ needs, today reported financial results for the fourth quarter and full year ended December 31, 2025.


Mark Reisenauer, Chief Executive Officer, stated: “Our core asset, Rolvedon, continues to represent a meaningful revenue opportunity, as reflected in both our 2025 results and 2026 outlook, and our strong commercial infrastructure and market access capabilities provide a platform to expand and build an oncology portfolio in a disciplined way.


Since taking over as CEO, I’ve taken a close look at our business to understand where we have a real advantage and where we need to stay disciplined. That has reinforced our focus on finding products that leverage our existing capabilities rather than pursuing on-market specialty product acquisitions, which we do not view as a sustainable path for long-term growth. Our priorities are clear: leverage our core strengths, allocate capital thoughtfully, and build a differentiated oncology franchise that drives durable shareholder value.”


Fourth Quarter 2025 Financial Highlights



Rolvedon net product sales were $0.4 million for the fourth quarter of 2025, down from $15.4 million in the prior-year quarter. The expected decline in sales was driven by the sell-in, executed in the third quarter of 2025, which covered the next two quarters of demand to ensure uninterrupted patient supply of Rolvedon as product was transitioned to a new distribution partner and operations were consolidated under a single commercial entity. Rolvedon continues to be a leader in market share in the Medicare Part B clinic space and sales under the new label are expected to begin in the second quarter of 2026.



Sympazan net product sales grew to $3.1 million for the fourth quarter of 2025 from $2.5 million in the prior-year quarter, driven by higher volume and favorable payor mix.



Indocin net product sales were $5.5 million for both the fourth quarter of 2025 and the prior-year quarter, with volume decline from generic competition offset by higher net pricing.



Gross margin1 was 75%, up from 61% in the prior-year quarter, primarily due to the impact of sales product mix as well as inventory write-downs taken in the prior-year quarter.



SG&A expenses were $13.1 million, down from $21.4 million in the prior-year quarter, reflecting lower legal expenses following completion of litigation-related initiatives and lower personnel expenses as a result of restructuring activities in the fourth quarter.



Adjusted EBITDA2 was a loss of $4.1 million for the fourth quarter of 2025, compared with earnings of $3.4 million in the prior-year quarter, driven primarily by the impact of lower Rolvedon net product sales.



Cash, cash equivalents, and short-term investments totaled $63.4 million as of December 31, 2025, compared to $93.4 million as of September 30, 2025 primarily reflecting impacts from the Rolvedon third quarter sell-in. Cash and cash equivalents will be impacted by working capital variability from the Rolvedon sell-in through the first quarter of 2026.



Full-Year 2025 Financial Highlights



Rolvedon net product sales were $68.2 million for full-year 2025, up from $60.1 million in the prior year. The increase was primarily driven by higher volume, including the third quarter sell-in activity, and a $5.4 million favorable adjustment to prior period returns reserve established in connection with the Spectrum acquisition, partially offset by lower net pricing.



Sympazan net product sales grew to $11.3 million for full-year 2025 from $10.5 million in the prior year, driven by higher volume, partially offset by unfavorable payor mix.



Indocin net product sales were $18.9 million for full-year 2025, down from $26.8 million in the prior year, reflecting expected volume and pricing impacts from previously announced generic competition.



Gross margin was 70% in 2025, up from 68% in the prior year, primarily due to a year-over-year decrease in inventory write-downs, and prior year inventory step-up amortization not repeating.



SG&A expenses were $69.0 million for full-year 2025, down from $75.1 million in the prior year, driven by lower legal costs following completion of litigation-related initiatives, a one-time benefit from employee retention tax credits, and lower personnel-related expenses, partially offset by non-recurring Otrexup decommercialization costs.



Adjusted EBITDA3 for full-year 2025 was $22.7 million, up from $18.3 million in the prior year, driven primarily by the impacts of lower SG&A expenses and favorable gross margin.



Cash, cash equivalents, and short-term investments totaled $63.4 million as of December 31, 2025, compared to $100.1 million as of December 31, 2024, primarily reflecting working capital impacts from the Rolvedon third quarter sell-in and cash transferred with the divestment of Assertio Therapeutics.



2026 Full Year Financial Guidance


Assertio announced its initial 2026 operating guidance as follows:




Net Product Sales (GAAP)






$110.0 Million to $125.0 Million








Adjusted EBITDA (Non-GAAP)






$28.0 Million to $40.0 Million







Financial Highlights (unaudited):




 







Three Months Ended




December 31,






 






Year Ended




December 31,








(in millions, except per share amounts)







 






2025






 






 






 






2024






 






 






 






2025






 






 






 






2024






 








Net Product Sales (GAAP)







$






12.8






 






 






$






29.6






 






 






$






117.1






 






 






$






120.8






 








Net Loss (GAAP)







$






(11.9






)






 






$






(10.5






)






 






$






(30.4






)






 






$






(21.6






)








Diluted Net Loss Per Share (GAAP)*







$






(1.86






)






 






$






(1.65






)






 






$






(4.74






)






 






$






(3.40






)








Adjusted EBITDA (Non-GAAP)3







$






(4.1






)






 






$






3.4






 






 






$






22.7






 






 






$






18.3






 








Adjusted Earnings Per Share (Non-GAAP)*3







$






(1.06






)






 






$






0.01






 






 






$






1.42






 






 






$






0.90






 























 



(*) Diluted net loss per share and Adjusted earnings per share for the three months ended December 31, 2024 and the year ended December 31, 2024 have been adjusted to reflect the 1-for-15 reverse stock split effected on December 26, 2025.























 


1 Gross margin represents the ratio of net product sales less cost of sales to net product sales.

2 See "Non-GAAP financial measures" below for information about reconciling Adjusted EBITDA to Net Loss.

3 Non-GAAP measures are reconciled to the corresponding GAAP measures in the schedules attached.


Conference Call and Investor Presentation Information


Assertio’s management will host a conference call to discuss its fourth quarter and full year 2025 financial results today:




Date:






3/16/2026








Time:






4:30 p.m. Eastern Time








Webcast (live and archive):






http://investor.assertiotx.com/overview/default.aspx (Events & Webcasts, Investor Page)








Dial-in numbers:






1-646-307-1963, Conference ID 3278948







To access the live webcast, the recorded conference call replay, and other materials, please visit Assertio’s investor relations website at http://investor.assertiotx.com/overview/default.aspx. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. The replay will be available approximately two hours after the call on Assertio’s investor website.


About Assertio


Assertio is a pharmaceutical company with comprehensive commercial capabilities offering differentiated products designed to address patients’ needs. Our focus is on supporting patients by marketing products primarily in the oncology market. To learn more about Assertio, visit www.assertiotx.com.


Forward Looking Statements


The statements in this communication include forward-looking statements. Forward-looking statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs. Forward-looking statements speak only as of the date they are made or as of the dates indicated in the statements and should not be relied upon as predictions of future events, as there can be no assurance that the events or circumstances reflected in these statements will be achieved or will occur. Forward-looking statements can often, but not always, be identified by the use of forward-looking terminology such as “anticipate,” “approximate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “might,” “opportunity,” “plan,” “potential,” “project,” “prospective,” “pursue,” “seek,” “should,” “strategy,” “target,” “will,” or the negative of these words and phrases, other variations of these words and phrases or comparable terminology. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the statements, including: Assertio’s ability to grow sales and the commercial success and market acceptance of Rolvedon and Assertio’s other products, including the coverage of Assertio’s products by payors and pharmacy benefit managers; Assertio’s ability to successfully develop and execute its sales, marketing and promotional strategies using its sales force and omni-channel promotion model capabilities; the impact on sales and profits from the entry and sales of generics of Assertio’s products and/or other products competitive with any of Assertio’s products, including, but not limited to, biosimilars and indomethacin suppositories compounded by hospitals and other institutions and a 503B compounder which Assertio believes is violating certain provisions of the Federal Food, Drug and Cosmetic Act; the timing and impact of additional generic approvals and uncertainty around the recent approvals and launches of generic Indocin products, which are not patent protected and now face generic competition; Assertio’s ability to execute the planned simplification of its corporate structure, which includes the recent divestiture of Assertio Therapeutics and ongoing efforts to consolidate operations and align products under a single entity – while ensuring uninterrupted product supply for patients, in a manner that achieves on a timely basis the anticipated operating efficiencies and complies with applicable legal and regulatory requirements; Assertio’s ability to successfully identify and execute business development and other strategic transactions; Assertio’s ability to achieve the expected financial performance from product candidates and/or products we acquire as well as delays, challenges and expenses, and unexpected liabilities and costs associated with obtaining regulatory approval and launching or integrating, as applicable, and operating newly-acquired product candidates and/or products, including its expectations around its ability to grow the sales and profitability of ROLVEDON; expectations regarding changes in product volume and mix and the impact those changes may have on Assertio’s operating results; expectations regarding the recoverability of long-lived assets; expected industry trends, including pricing pressures and managed healthcare practices; Assertio’s ability to retain executive leadership and key employees; the ability of Assertio’s third-party manufacturers to manufacture adequate quantities of commercially salable inventory and active pharmaceutical ingredients for each of Assertio’s products on commercially reasonable terms and in compliance with their contractual obligations to Assertio, and Assertio’s ability to maintain its supply chain which relies on single-source suppliers; the outcome of, and Assertio’s intentions with respect to, any pending and potential future disputes, litigation or government investigations, as well as the costs and expenses associated therewith; the timing, cost and results of Assertio’s clinical studies and other research and development efforts, including the extent to which data from the Rolvedon same-day dosing trial, which was completed in the fourth quarter of 2024 and published in the January 2026 issue of the peer- reviewed journal, The Oncologist, may be subsequently included in the National Comprehensive Cancer Network guidelines to support Assertio’s ongoing commercialization efforts; Assertio’s compliance or non-compliance with, or being subject to, legal and regulatory requirements related to the development or promotion of pharmaceutical products in the U.S., the extent to which the current U.S. federal administration may impose or seek to impose leadership, rule and/or policy changes impacting Assertio’s business, including CMS’s recently proposed new drug payment models to lower drug prices for Medicare beneficiaries under which CMS would explore potential adjustments to Medicare drug inflation rebate calculations by comparison to international drug pricing information, as well as legal challenges and uncertainty around the funding, functioning, regulatory and policy priorities of U.S. federal regulatory agencies; Assertio’s ability to obtain and maintain intellectual property protection for its products and operate its business without infringing the intellectual property rights of others; variations in revenues obtained from commercialization agreements and the accounting treatment with respect thereto; Assertio’s common stock maintaining compliance with The Nasdaq Capital Market’s minimum closing bid requirement of at least $1.00 per share; and the potential impacts of changes to U.S. and international trade policies, especially in light of the tariffs recently announced or imposed by the new U.S. federal administration, including announced plans to impose up to 100% tariffs on imported branded or patented pharmaceuticals subject to certain exceptions, and tariffs and other retaliatory actions, including legal challenges, taken by other countries, which may be followed by further changes to existing trade agreements and the imposition of further tariffs. For a discussion of additional factors that could cause actual results to differ materially from those contemplated by forward-looking statements, see the risks described in Assertio’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Many of these risks and uncertainties may be exacerbated by public health emergencies and general macroeconomic conditions. Assertio does not assume, and hereby disclaims, any obligation to update forward-looking statements, except as may be required by law.


Non-GAAP Financial Measures


To supplement the Company’s financial results presented on a U.S. generally accepted accounting principles (“GAAP”) basis, the Company has included information about non-GAAP measures of EBITDA, adjusted EBITDA, adjusted earnings, and adjusted earnings per share as useful operating metrics. The Company believes that the presentation of these non-GAAP financial measures, when viewed with results under GAAP and the accompanying reconciliation, provides supplementary information to analysts, investors, lenders, and the Company’s management in assessing the Company’s performance and results from period to period. The Company uses these non-GAAP measures internally to understand, manage and evaluate the Company’s performance, and in part, in the determination of bonuses for executive officers and employees. These non-GAAP financial measures should be considered in addition to, and not a substitute for, or superior to, net income or other financial measures calculated in accordance with GAAP. Non-GAAP financial measures used by us may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.


Specified Items


Non-GAAP measures presented within this release exclude specified items. The Company considers specified items to be significant income/expense items not indicative of current operations. Specified items may include adjustments to interest expense and interest income, income tax expense (benefit), depreciation expense, amortization expense, sales reserves adjustments for products the Company is no longer selling, stock-based compensation expense, fair value adjustments to contingent consideration or derivative liability, expenses or gains recognized for legal settlements, net of any insurance proceeds, losses or other costs incurred upon the divestiture of subsidiaries or cessation of product lines, restructuring charges, amortization of fair value inventory step-up as a result of purchase accounting, transaction-related costs, gains, losses or impairments from adjustments to long-lived assets and assets not part of current operations, changes in valuation allowances on deferred tax assets, and gains or losses resulting from debt refinancing or extinguishment.


Revisions to Specified Items


Beginning with the first quarter of 2025, adjusted EBITDA excludes legal settlement costs incurred during the period, as these charges relate to non-recurring and non-operational matters. Management believes that excluding such items provides investors with a clearer understanding of the Company’s underlying operating performance by removing the impact of items that are not indicative of continuing operations. Prior period amounts of Adjusted EBITDA have been recast to conform to this presentation.




ASSERTIO HOLDINGS, INC.




CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS




(in thousands, except per share amounts)




(unaudited)








 






 






 






 






 








 






 






Three Months Ended




December 31,






 






Year Ended




December 31,








 






 






 






2025






 






 






 






2024






 






 






 






2025






 






 






 






2024






 








Revenues:







 






 






 






 






 






 






 








Product sales, net







$






12,823






 






 






$






29,587






 






 






$






117,100






 






 






$






120,849






 








Royalty revenue







 






719






 






 






 






495






 






 






 






1,613






 






 






 






2,012






 








Other revenue







 













 






 






 






2,100






 






 






 













 






 






 






2,100






 








Total revenues







 






13,542






 






 






 






32,182






 






 






 






118,713






 






 






 






124,961






 








Costs and expenses:







 






 






 






 






 






 






 








Cost of sales







 






3,266






 






 






 






11,611






 






 






 






35,383






 






 






 






39,227






 








Research and development expenses







 






486






 






 






 






1,286






 






 






 






1,690






 






 






 






3,822






 








Selling, general and administrative expenses







 






13,135






 






 






 






21,416






 






 






 






69,000






 






 






 






75,051






 








Change in fair value of contingent consideration







 













 






 






 






(544






)






 






 






(276






)






 






 






(244






)








Amortization of intangible assets







 






5,804






 






 






 






6,671






 






 






 






29,863






 






 






 






25,644






 








Impairment of intangible assets







 













 






 






 






5,217






 






 






 






1,700






 






 






 






5,217






 








Restructuring charges







 






2,600






 






 






 













 






 






 






2,889






 






 






 






720






 








Total costs and expenses







 






25,291






 






 






 






45,657






 






 






 






140,249






 






 






 






149,437






 








Loss from operations







 






(11,749






)






 






 






(13,475






)






 






 






(21,536






)






 






 






(24,476






)








Other income (expense):







 






 






 






 






 






 






 








Loss on Assertio Therapeutics divestiture







 













 






 






 













 






 






 






(8,174






)






 






 













 








Interest expense







 






(772






)






 






 






(763






)






 






 






(3,075






)






 






 






(3,039






)








Interest income







 






606






 






 






 






780






 






 






 






2,665






 






 






 






3,221






 








Other gain, net







 






168






 






 






 






2,709






 






 






 






180






 






 






 






2,765






 








Total other income (expense)







 






2






 






 






 






2,726






 






 






 






(8,404






)






 






 






2,947






 








Net loss before income taxes







 






(11,747






)






 






 






(10,749






)






 






 






(29,940






)






 






 






(21,529






)








Income tax (expense) benefit







 






(181






)






 






 






273






 






 






 






(435






)






 






 






(52






)








Net loss and comprehensive loss







$






(11,928






)






 






$






(10,476






)






 






$






(30,375






)






 






$






(21,581






)








 







 






 






 






 






 






 






 








Basic and diluted net loss per share*







$






(1.86






)






 






$






(1.65






)






 






$






(4.74






)






 






$






(3.40






)








Shares used in computing basic and diluted net loss per share*







 






6,420






 






 






 






6,367






 






 






 






6,403






 






 






 






6,351






 























 



(*) Basic and diluted net loss per share and shares used in computing basic and diluted net loss per share for the three months ended December 31, 2024 and the year ended December 31, 2024 have been adjusted to reflect the 1-for-15 reverse stock split effected on December 26, 2025.









ASSERTIO HOLDINGS, INC.




CONSOLIDATED BALANCE SHEETS




(in thousands, except share data)




(unaudited)








 






 






 








 






 






December 31,








 






 






 






2025






 






 






 






2024






 








ASSETS







 






 






 








Current assets:







 






 






 








Cash and cash equivalents







$






10,229






 






 






$






50,588






 








Short-term investments







 






53,176






 






 






 






49,466






 








Accounts receivable, net







 






120,110






 






 






 






54,120






 








Inventories, net







 






24,120






 






 






 






38,308






 








Prepaid and other current assets







 






9,011






 






 






 






10,067






 








Total current assets







 






216,646






 






 






 






202,549






 








Property and equipment, net







 






444






 






 






 






586






 








Intangible assets, net







 






48,908






 






 






 






80,471






 








Other long-term assets







 






972






 






 






 






1,126






 








Total assets







$






266,970






 






 






$






284,732






 








LIABILITIES AND SHAREHOLDERS’ EQUITY







 






 






 








Current liabilities:







 






 






 








Accounts payable







$






9,014






 






 






$






14,736






 








Accrued rebates, returns and discounts







 






99,366






 






 






 






76,304






 








Accrued liabilities







 






14,282






 






 






 






18,847






 








Contingent consideration, current portion







 













 






 






 






726






 








Other current liabilities







 






4,851






 






 






 






4,075






 








Total current liabilities







 






127,513






 






 






 






114,688






 








Long-term debt







 






39,124






 






 






 






38,813






 








Other long-term liabilities







 






6,381






 






 






 






10,150






 








Total liabilities







 






173,018






 






 






 






163,651






 








Commitments and contingencies







 






 






 








Shareholders’ equity:







 






 






 








Common stock, $0.0001 par value, 200,000,000 shares authorized; 6,421,899 and 6,369,133 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively*







 






1






 






 






 






1






 








Additional paid-in capital*







 






797,450






 






 






 






794,204






 








Accumulated deficit







 






(703,499






)






 






 






(673,124






)








Total shareholders’ equity







 






93,952






 






 






 






121,081






 








Total liabilities and shareholders' equity







$






266,970






 






 






$






284,732






 











 



(*) Shares issued and outstanding, common stock and additional paid-in capital as of December 31, 2024 have been adjusted to reflect the 1-for-15 reverse stock split effected on December 26, 2025.









ASSERTIO HOLDINGS, INC.




CONSOLIDATED STATEMENTS OF CASH FLOWS




(in thousands)




(unaudited)








 






 






 








 






 






Year Ended December 31,








 






 






 






2025






 






 






 






2024






 








Operating Activities







 






 






 








Net loss







$






(30,375






)






 






$






(21,581






)








Adjustments to reconcile net loss to net cash (used in) provided by operating activities:







 






 






 








Depreciation and amortization







 






30,005






 






 






 






25,829






 








Amortization of debt issuance costs







 






475






 






 






 






439






 








Accretion of interest income from short-term investments







 






93






 






 






 






(542






)








Impairment of intangible assets







 






1,700






 






 






 






5,217






 








Loss on Assertio Therapeutics divestiture







 






8,174






 






 






 













 








Recurring fair value measurements of assets and liabilities







 






(435






)






 






 






(397






)








Payment of contingent consideration







 






(450






)






 






 






(1,730






)








Stock-based compensation







 






3,454






 






 






 






5,009






 








Provisions for inventory







 






4,510






 






 






 






8,960






 








Changes in assets and liabilities, net of acquisition:







 






 






 








Accounts receivable







 






(65,990






)






 






 






(6,457






)








Inventories







 






9,678






 






 






 






(9,583






)








Prepaid and other assets







 






1,209






 






 






 






4,334






 








Accounts payable and other accrued liabilities







 






(13,292






)






 






 






(1,256






)








Accrued rebates, returns and discounts







 






23,062






 






 






 






18,166






 








Net cash (used in) provided by operating activities







 






(28,182






)






 






 






26,408






 








Investing Activities







 






 






 








Assertio Therapeutics divestiture







 






(8,174






)






 






 













 








Proceeds from maturities of short-term investments







 






115,383






 






 






 






49,694






 








Purchases of short-term investments







 






(119,197






)






 






 






(98,605






)








Net cash used in investing activities







 






(11,988






)






 






 






(48,911






)








Financing Activities







 






 






 








Payments related to the vesting and settlement of equity awards, net







 






(189






)






 






 






(350






)








Net cash used in financing activities







 






(189






)






 






 






(350






)








Net decrease in cash and cash equivalents







 






(40,359






)






 






 






(22,853






)








Cash and cash equivalents at beginning of year







 






50,588






 






 






 






73,441






 








Cash and cash equivalents at end of year







$






10,229






 






 






$






50,588






 








Supplemental Disclosure of Cash Flow Information







 






 






 








Cash paid for interest







$






2,600






 






 






$






2,600






 









RECONCILIATION OF GAAP NET LOSS TO NON-GAAP EBITDA and ADJUSTED EBITDA




(in thousands)




(unaudited)








 






 






 






 






 






 






 








 






 






Three Months Ended




December 31,






 






Twelve months ended




December 31,






 






 








 






 






 






2025






 






 






 






2024






 






 






 






2025






 






 






 






2024






 






 






Financial Statement Classification








GAAP Net Loss






 






$






(11,928






)






 






$






(10,476






)






 






$






(30,375






)






 






$






(21,581






)






 






 








Interest expense






 






 






772






 






 






 






763






 






 






 






3,075






 






 






 






3,039






 






 






Interest expense








Income tax expense (benefit)






 






 






181






 






 






 






(273






)






 






 






435






 






 






 






52






 






 






Income tax expense








Depreciation expense






 






 






36






 






 






 






38






 






 






 






142






 






 






 






184






 






 






Selling, general and administrative expenses








Amortization of intangible assets






 






 






5,804






 






 






 






6,671






 






 






 






29,863






 






 






 






25,644






 






 






Amortization of intangible assets








EBITDA (Non-GAAP)






 






 






(5,135






)






 






 






(3,277






)






 






 






3,140






 






 






 






7,338






 






 






 








Adjustments:






 






 






 






 






 






 






 






 






 






 








Legacy product reserves(1)






 






 













 






 






 






(2,100






)






 






 













 






 






 






(2,100






)






 






Other revenue








Stock-based compensation






 






 






97






 






 






 






1,098






 






 






 






3,454






 






 






 






5,009






 






 






Selling, general and administrative expenses








Change in fair value of contingent consideration (2)






 






 













 






 






 






(544






)






 






 






(276






)






 






 






(244






)






 






Change in fair value of contingent consideration








Employee Retention Credits (3)






 






 













 






 






 













 






 






 






(2,383






)






 






 













 






 






Selling, general and administrative expenses








Legal settlements, net of insurance proceeds (4)






 






 













 






 






 






3,965






 






 






 






3,543






 






 






 






1,149






 






 






Selling, general and administrative expenses








Loss on Assertio Therapeutics divestiture and related charges (5)






 






 













 






 






 













 






 






 






9,309






 






 






 













 






 






Multiple








Expenses related to decommercialization of Otrexup (6)






 






 






(900






)






 






 













 






 






 






4,160






 






 






 













 






 






Multiple








Impairment of intangible assets






 






 













 






 






 






5,217






 






 






 






1,700






 






 






 






5,217






 






 






Impairment of intangible assets








Restructuring costs (7)






 






 






2,600






 






 






 













 






 






 






2,889






 






 






 






720






 






 






Restructuring charges








Other (8)






 






 






(770






)






 






 






(920






)






 






 






(2,829






)






 






 






1,203






 






 






Multiple








Adjusted EBITDA (Non-GAAP)






 






$






(4,108






)






 






$






3,439






 






 






$






22,707






 






 






$






18,292






 






 






 









(1)






 






Represents removal of the impact of revenue adjustment to reserves for product sales allowances (gross-to-net-sales allowances) estimates related to previously divested products.








(2)






 






The fair value of the contingent consideration is remeasured each reporting period, with changes in the fair value resulting from changes in the underlying inputs being recognized as a benefit or expense in operating expenses until the contingent consideration arrangement is settled.








(3)






 






Amounts related to income recognized in the period from the lapsing of the statute of limitations for employee retention tax credits.








(4)






 






Legal settlements, net of insurance proceeds, represents the net impact of legal settlements reached in the period. For the twelve months ended December 31, 2025, amount primarily includes the net impact of the Luo securities class action. Prior period amounts of Adjusted EBITDA have been recast to conform to this presentation.








(5)






 






For the twelve months ended December 31, 2025, amount includes the $8.2 million loss recognized upon the divestiture of the Assertio Therapeutics subsidiary including approximately $1.0 million of one-time costs included in SG&A incurred associated with the closing of the transaction.








(6)






 






Amounts related to costs incurred by the Company related to its decision to cease commercializing Otrexup. For the twelve months ended December 31, 2025, amount includes SG&A costs of $1.7 million and cost of sales of $2.5 million. These costs were primarily associated with the write-off of inventory (including inventory held at the Company’s contract manufacturers for Otrexup), the write-off of certain prepaid assets and the recognition of an accrual for the minimum purchase obligation required under the Otrexup supply agreement with Antares Pharma, Inc., and expenses associated with the settlement of legal claims related to ceasing commercialization of Otrexup.








(7)






 






Restructuring costs represent non-recurring costs associated with the Company’s announced restructuring plans.








(8)






 






Other for the three and twelve months ended December 31, 2025 and 2024 represent the following adjustments (in thousands):








 
 

 






 






Three Months Ended




December 31,






 






Twelve months ended




December 31,






 






 







 
 

 






 






 






2025






 






 






 






2024






 






 






 






2025






 






 






 






2024






 






 






Financial Statement Classification







 
 

Amortization of inventory step-up






 






$













 






 






$













 






 






$













 






 






$






4,564






 






 






Cost of sales







 
 

Interest income






 






 






(606






)






 






 






(780






)






 






 






(2,665






)






 






 






(3,221






)






 






Interest income







 
 

Derivative fair value adjustment






 






 






(164






)






 






 






(140






)






 






 






(164






)






 






 






(140






)






 






Other income, net







 
 

Total Other






 






$






(770






)






 






$






(920






)






 






$






(2,829






)






 






$






1,203






 






 






 









RECONCILIATION OF GAAP NET LOSS and NET LOSS PER SHARE TO




NON-GAAP ADJUSTED EARNINGS and ADJUSTED EARNINGS PER SHARE (1)




(in thousands, except per share amounts)




(unaudited)








 






 






 








 






 






Three Months Ended December 31,








 






 






2025






 






2024








 






 






Amount






 






Diluted EPS (2)






 






Amount






 






Diluted EPS*(2)








Net loss per share (GAAP) (2)







$






(11,928






)






 






$






(1.86






)






 






$






(10,476






)






 






$






(1.65






)








Add: Convertible debt interest expense and other income statement impacts, net of tax(2)







 













 






 






 






 






 













 






 






 








Adjustments







 






 






 






 






 






 






 








Amortization of intangible assets







 






5,804






 






 






 






 






 






6,671






 






 






 








Legacy products revenue reserves







 













 






 






 






 






 






(2,100






)






 






 








Stock-based compensation







 






97






 






 






 






 






 






1,098






 






 






 








Legal settlements, net of insurance proceeds







 













 






 






 






 






 






3,965






 






 






 








Expenses related to decommercialization of Otrexup







 






(900






)






 






 






 






 













 






 






 








Change in fair value of contingent consideration







 













 






 






 






 






 






(544






)






 






 








Contingent consideration cash payable (3)







 













 






 






 






 






 






(1,099






)






 






 








Impairment of intangible assets







 













 






 






 






 






 






5,217






 






 






 








Restructuring charges







 






2,600






 






 






 






 






 













 






 






 








Other







 






(770






)






 






 






 






 






(920






)






 






 








Income tax expense, as adjusted (4)







 






(1,708






)






 






 






 






 






(1,768






)






 






 








Adjusted earnings (Non-GAAP)







$






(6,805






)






 






$






(1.06






)






 






$






44






 






 






$






0.01






 








 







 






 






 






 






 






 






 








Diluted shares used in calculation (GAAP) *(2)







 






6,420






 






 






 






 






 






6,367






 






 






 








Add: Dilutive effect of stock-based awards and equivalents *(2)







 













 






 






 






 






 






37






 






 






 








Add: Dilutive effect of 2027 Convertible Notes *(2)







 













 






 






 






 






 













 






 






 








Diluted shares used in calculation (Non-GAAP) *(2)







 






6,420






 






 






 






 






 






6,404






 






 






 









 






 






(*) Diluted EPS, Diluted shares used in the calculation of diluted EPS and Adjusted earnings per share for the three months ended December 31, 2024 have been adjusted to reflect the 1-for-15 reverse stock split effected on December 26, 2025.









 



(1)






 






Certain adjustments included here are the same as those reflected in the Company’s reconciliation of GAAP net loss to non-GAAP adjusted EBITDA and therefore should be read in conjunction with that reconciliation and respective footnotes.








(2)






 






The Company uses the if-converted method with respect to its convertible debt to compute GAAP and Non-GAAP diluted earnings per share when the effect is dilutive. Under the if-converted method, the Company assumes the 2027 Convertible Notes were converted at the beginning of each period presented and outstanding. As a result, interest expense, net of tax, and any other income statement impact associated with the 2027 Convertible Notes, net of tax, is added back to net income used in the diluted earnings per share calculation.








 






 






For the three months ended December 31, 2025, the Company’s potentially dilutive convertible debt under the if-converted method and stock-based awards under the treasury-stock method were not included in either the computation of GAAP net loss and diluted net loss per share or non-GAAP adjusted loss and adjusted loss per share, because to do so would be anti-dilutive.








 






 






For the three months ended December 31, 2024, the Company’s potentially dilutive convertible debt under the if-converted method and stock-based awards under the treasury-stock method were not included in the computation of GAAP net loss and diluted net loss per share, and the potentially dilutive convertible debt under the if-converted method were not included in non-GAAP adjusted earnings and adjusted earnings per share, because to do so would be anti-dilutive. However, the potentially dilutive stock-based awards under the treasury-stock method were included in the computation of non-GAAP adjusted earnings and adjusted earnings per share because the effect was dilutive.








(3)






 






Represents the accrued cash payable, if any, of the INDOCIN contingent consideration for the respective period based on 20% royalty for annual INDOCIN net sales over $20.0 million.








(4)






 






Represents the Company’s income tax expense adjustment from the tax effect of pre-tax adjustments excluded from adjusted earnings. The tax effect of pre-tax adjustments excluded from adjusted earnings is computed at the blended federal and state statutory rate of 25%.









RECONCILIATION OF GAAP NET LOSS and NET LOSS PER SHARE TO




NON-GAAP ADJUSTED EARNINGS and ADJUSTED EARNINGS PER SHARE (1)




(in thousands, except per share amounts)




(unaudited)








 






 






 








 






 






Twelve Months Ended December 31,








 






 






2025






 






2024








 






 






Amount






 






Diluted EPS (2)






 






Amount






 






Diluted EPS*(2)








Net loss (GAAP) (2)







$






(30,375






)






 






$






(4.74






)






 






$






(21,581






)






 






$






(3.40






)








Add: Convertible debt interest expense and other income statement impacts, net of tax (2)







 













 






 






 






 






 













 






 






 








Adjustments







 






 






 






 






 






 






 








Amortization of intangible assets







 






29,863






 






 






 






 






 






25,644






 






 






 








Legacy products revenue reserves







 













 






 






 






 






 






(2,100






)






 






 








Stock-based compensation







 






3,454






 






 






 






 






 






5,009






 






 






 








Employee Retention Credits







 






(2,383






)






 






 






 






 













 






 






 








Legal settlements, net of insurance proceeds







 






3,543






 






 






 






 






 






1,149






 






 






 








Loss on Assertio Therapeutics divestiture and related charges







 






9,309






 






 






 






 






 













 






 






 








Expenses related to decommercialization of Otrexup







 






4,160






 






 






 






 






 













 






 






 








Change in fair value of contingent consideration







 






(276






)






 






 






 






 






(244






)






 






 








Contingent consideration cash payable (3)







 













 






 






 






 






 






(1,352






)






 






 








Contingent consideration cash payable (3)







 






1,700






 






 






 






 






 






5,217






 






 






 








Restructuring charges







 






2,889






 






 






 






 






 






720






 






 






 








Other







 






(2,829






)






 






 






 






 






1,203






 






 






 








Income tax expense, as adjusted (4)







 






(9,889






)






 






 






 






 






(7,507






)






 






 








Adjusted earnings (Non-GAAP)







$






9,166






 






 






$






1.42






 






 






$






6,158






 






 






$






0.90






 








 







 






 






 






 






 






 






 








Diluted shares used in calculation (GAAP) *(2)







 






6,403






 






 






 






 






 






6,351






 






 






 








Add: Dilutive effect of stock-based awards and equivalents *(2)







 






34






 






 






 






 






 






516






 






 






 








Add: Dilutive effect of 2027 Convertible Notes *(2)







 













 






 






 






 






 













 






 






 








Diluted shares used in calculation (Non-GAAP) *(2)







 






6,437






 






 






 






 






 






6,867






 






 






 









 






 






(*) Diluted EPS, Diluted shares used in the calculation of diluted EPS and Adjusted earnings per share for the year ended December 31, 2024 have been adjusted to reflect the 1-for-15 reverse stock split effected on December 26, 2025.








 






 






 








(1)






 






Certain adjustments included here are the same as those reflected in the Company’s reconciliation of GAAP net loss to non-GAAP adjusted EBITDA and therefore should be read in conjunction with that reconciliation and respective footnotes.








(2)






 






The Company uses the if-converted method with respect to its convertible debt to compute GAAP and non-GAAP diluted earnings per share when the effect is dilutive. Under the if-converted method, the Company assumes the 2027 Convertible Notes were converted at the beginning of each period presented and outstanding. As a result, interest expense, net of tax, and any other income statement impact associated with the 2027 Convertible Notes, net of tax, is added back to net income used in the diluted earnings per share calculation.








 






 






For the twelve months ended December 31, 2025 and 2024, the Company’s potentially dilutive convertible debt under the if-converted method and stock-based awards under the treasury-stock method were not included in the computation of GAAP net loss and diluted net loss per share, and the potentially dilutive convertible debt under the if-converted method were not included in non-GAAP adjusted earnings and adjusted earnings per share, because to do so would be anti-dilutive. However, the potentially dilutive stock-based awards under the treasury-stock method were included in the computation of non-GAAP adjusted earnings and adjusted earnings per share because the effect was dilutive.








(3)






 






Represents the accrued cash payable, if any, of the INDOCIN contingent consideration for the respective period based on 20% royalty for annual INDOCIN net sales over $20.0 million.








(4)






 






Represents the Company’s income tax expense adjustment from the tax effect of pre-tax adjustments excluded from adjusted earnings. The tax effect of pre-tax adjustments excluded from adjusted earnings is computed at the blended federal and state statutory rate of 25%.







 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260316015407/en/
Investor Contact

Longacre Square Partners

assertio@longacresquare.com


Original: Assertio Reports Fourth Quarter and Full Year 2025 Financial Results
👍️0
US Market News US Market News 3 months ago
Assertio Holdings, Inc. to Report Fourth Quarter and Full Year 2025 Financial Results on March 16, 2026March 3, 2026 4:30 PM
Business Wire
Assertio Holdings, Inc. (“Assertio”) (Nasdaq: ASRT) today announced that it will release fourth quarter and full year 2025 financial results on Monday, March 16, 2026, after the market close. Following the release of its financial results, Assertio’s management will host a live webcast of the earnings conference call at 4:30 p.m. Eastern Time.


To access the live webcast, conference call information, and other materials, please visit Assertio’s investor relations website at http://investor.assertiotx.com/overview/default.aspx. Please connect at least 10 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. For those wishing to join by telephone only, please dial +1 (646) 307-1963. The call ID is 3278948.


A webcast replay of the call will be available approximately two hours after the call on Assertio’s investor website.


About Assertio


Assertio is a pharmaceutical company with comprehensive commercial capabilities offering differentiated products designed to address patients’ needs. Our focus is on supporting patients by marketing products in oncology, neurology, and pain management. To learn more about Assertio, visit www.assertiotx.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260303479892/en/
Investor Contact

Longacre Square Partners

assertio@longacresquare.com


Original: Assertio Holdings, Inc. to Report Fourth Quarter and Full Year 2025 Financial Results on March 16, 2026
👍️0
dcaf7 dcaf7 6 months ago
From the paper, "The incidence of severe neutropenia in this trial was 42.9% in cycle 1. In subsequent cycles, the incidence of severe neutropenia decreased consistently, reaching 27.3% in cycle 4. By comparison, the incidence of severe neutropenia during cycle 1 was 20.3% in RECOVER and 15.8% in ADVANCE.4, 5 Mean duration of severe neutropenia in this trial was 0.7 days compared with 0.3 days in RECOVER and 0.2 days in ADVANCE. These differences are likely attributable to the smaller sample size and other methodological variations between the randomized, active-controlled phase 3 trial design and this open-label trial." Looks like next day is the way to go.
👍️ 1
dcaf7 dcaf7 6 months ago
Rolvedon same day dosing data officially published. Now they can start discussionons on the inclusion of this regimen in NCCN Guidelines. https://academic.oup.com/oncolo/advance-article/doi/10.1093/oncolo/oyaf415/8380366
👍️ 1
glenn1919 glenn1919 7 months ago
ASRT..................................https://stockcharts.com/sc3/ui/?s=ASRT&p=W&b=5&g=0&id=p86431144783
👍️0
dcaf7 dcaf7 10 months ago
Hanmi Pharmaceutical develops autoinjector formulation for self-administration of Rolontis.
Hanmi Pharmaceutical announced on the 18th that it has submitted a New Drug Application (NDA) to the Ministry of Food and Drug Safety (MFDS) for the development of an auto-injector (AI) formulation of Rolontis, an existing prefilled syringe subcutaneous injection, to enhance self-administration convenience, and that it is currently reviewing the application. The specific submission date was not disclosed. The company aims for a domestic launch in the first half of next year.
Although existing prefilled syringe-type subcutaneous injection (SC) formulations are approved for self-injection, actual self-administration is difficult due to patients' aversion to injection needles and the risk of administration failure due to errors in usage.
The autoinjector formulation currently under development by Hanmi Pharmaceutical is a pen-type injection with an invisible needle. Designed to facilitate self-administration by patients with appropriate medical training, it allows patients to administer the drug themselves without visiting a hospital. The company anticipates this will reduce time and financial burdens for patients, increase treatment compliance, and lead to better treatment outcomes.
https://www.biospectator.com/news/view/26075
👍️ 1
dcaf7 dcaf7 11 months ago
Good review of neutropenia treatment market growth.
https://market.us/report/neutropenia-treatment-market/
👍️ 1
dcaf7 dcaf7 1 year ago
Pharmaceutical Manufacturer Assertio Therapeutics Inc. Agrees to Pay $3.6M to Resolve Allegations that It Violated the False Claims Act in Connection with Marketing its Fentanyl Product.
https://www.justice.gov/opa/pr/pharmaceutical-manufacturer-assertio-therapeutics-inc-agrees-pay-36m-resolve-allegations-it
👍️ 1
KIPK KIPK 1 year ago
KRISGO - What a POS.....💩
👍️0
dcaf7 dcaf7 1 year ago
I think to estimate the effect of inclusion of same day dosing in NCCN guidelines on sales of Rolvedon, you need to look at what happened to Neulasta. A same day dosing of Neulasta was studied in 266-patient double-blind trial and it demonstrated non-inferiority. Amgen submitted data to NCCN and NCCN guidelines state that "Neulasta same day administered the day after myelosuppressive chemotherapy is supported by category one evidence, however FDA approved dosing schedule is still recommended". With that, why would they go for Onpro? On the other hand, "a survey of physicians who administer Neulasta reported that 31.6% of patients were treated on a “same-day” schedule because of patient/caregiver travel distance and practice related consideration". If same is applicable to Rolvedon after including it in NCCN guidelines, we may expect ~30% increase in treatable patient population.
👍️0
ATLcitizen ATLcitizen 1 year ago
Hi dcaf7! We're still hanging in there on this company! What is your opinion about how this same day dosing will play out in terms of NCCN guideline possibility and sales with our without the NCCN guidelines? You sounded pessimistic in the past, but you apparently are still following this, so maybe you have not given up hope?
👍️0
dcaf7 dcaf7 1 year ago
On recently presented same day dosing data.
https://www.onclive.com/view/same-day-dosing-of-eflapegrastim-and-chemotherapy-is-safe-reduces-duration-of-severe-neutropenia-in-early-stage-breast-cancer
👍️ 1
dcaf7 dcaf7 1 year ago
I don't know. Possibly, they want to focus on business aspects of same day dosing in this poster presentation.
👍️ 1
ATLcitizen ATLcitizen 1 year ago
Interesting that they are presenting at a business summit, not scientific conference (which they have already done). What do they expect to gain? Is this for the insurance industry?
👍️ 1
dcaf7 dcaf7 1 year ago
Data from same day dosing trial will be presented at ACCC 51st Annual Meeting & Cancer Center Business Summit on March 5, 2025. Title: Eflapegrastim, a Long-Acting GCSF, Administered the Same Day as Chemotherapy in Patients with Early-Stage Breast Cancer: Results from a Multicenter, Open-Label, Study.
👍️ 2
dcaf7 dcaf7 1 year ago
Maxim Group analyst Naz Rahman has reiterated their bullish stance on ASRT stock, giving a Buy rating today.
Dec 16, 2024, 01:45 PM
Naz Rahman has given his Buy rating due to a combination of factors related to Assertio Therapeutics’ recent clinical study results. The same-day dosing study of Rolvedon, presented at the San Antonio Breast Cancer Symposium, demonstrated favorable outcomes for patients, including rapid recovery of neutrophil counts and a very low incidence of febrile neutropenia. This aligns well with the results from the Phase 3 trial, reinforcing the drug’s safety and efficacy profile.
Furthermore, there were no new safety concerns, and the adverse event profile remained consistent with previous trials. The potential for Rolvedon to be incorporated into the National Comprehensive Cancer Network guidelines could also boost its market penetration and sales growth. With these positive indicators, Rahman perceives significant sales potential for Rolvedon, contributing to the Buy rating for Assertio Therapeutics.
https://www.tipranks.com/news/blurbs/positive-clinical-results-and-market-potential-drive-buy-rating-for-assertio-therapeutics
👍️0
dcaf7 dcaf7 1 year ago
On Monday, H.C. Wainwright maintained its Buy rating and a price target of $4.00 for Assertio Therapeutics shares
The firm's stance follows Assertio Holdings' recent announcement of clinical trial results for ROLVEDON (eflapegrastim-xnst) injection. The trial focused on the drug's same-day dosing alongside chemotherapy in patients with early-stage breast cancer (ESBC).
The study, identified as NCT04187898, was an open-label, single-arm trial conducted at 13 U.S. sites. Participants were administered ROLVEDON 30 minutes after receiving chemotherapy for ESBC. Findings from the trial indicated a neutrophil count recovery time of 1.8 days and a febrile neutropenia rate of 2%.
The analyst from H.C. Wainwright highlighted the convenience and dosing flexibility of ROLVEDON, particularly its same-day dosing capability. This feature was seen as an incremental but potentially significant commercial differentiator.
https://www.investing.com/news/analyst-ratings/assertio-therapeutics-shares-get-buy-rating-on-clinical-trial-results-93CH-3774534
👍️0
dcaf7 dcaf7 1 year ago
End of same day dosing hype.
👍️0
ATLcitizen ATLcitizen 2 years ago
Now we have the PR.
👍️0
dcaf7 dcaf7 2 years ago
I think you know the answer.
👍️0
Grundle Grundle 2 years ago
So no chance of Rolvedon '24 (and 25) sales being more than 175m to pay out the CVR from Spectrum?
👍️0
KRISGO KRISGO 2 years ago
Here is ChatGPT comparing Rolvedon same day with Neulasta next day..
https://media.stocktwits-cdn.com/api/3/media/510403/medium.png
https://media.stocktwits-cdn.com/api/3/media/509105/medium.png
👍️0
dcaf7 dcaf7 2 years ago
If the data had been outstanding, the company would have issued a PR on Nov 25. No need to wait until Dec 13. Most importing findings are already described in the abstract. Actual presentation won't add much.
👍️ 1
KRISGO KRISGO 2 years ago
It looks like the company will be presenting these results at a conference on December 13th. The following message is from a poster named "D_S" on StockTwits.
"D_S: Nov 29, 2024 9:44 AM : $ASRT The abstract link showed back up again on the San Antonio Breast Conference website. ASRT's abstract is there. As such there is not an "embargo" on them releasing a pr. However, that pr can only discuss the abstract information, not fully discuss the research. It's part of the requirement to have research presented at this conference----they want the research discussed first there. So here is my opinion.....if same-day dosing results are only to be about the convenience of patients not having to go to a 2nd day visit, then ASRT puts out a simple pr on day of poster presentation (after market closes). If same-day dosing results are showing (as we think from analysis of abstract) that giving the infection on day of chemo reduces severe neutropenia vs next day dosing, then I think there could be chance of cc call (on top of pr) to discuss implications. CEO needs the stock price up to give him options for future large acquisition potentially, but at least to give investors confidence"
👍️0
dcaf7 dcaf7 2 years ago
The abstract is on SABCS website since Nov 25, 2024, not leaked. Data is OK, but Rolvedon won't be approved as same day injection. I don't think, it will boost sales much. Looks like market has same opinion. And ASRT doesn't even bother to issue a PR on these results.
👍️0
KRISGO KRISGO 2 years ago
I'm referring to the same-day dosing of Rovedon. The full abstract from ASRT has been leaked on San Antonio Breast Cancer Conference website, which is definitely positive news. It has the potential to boost sales and is gaining attention, but the stock doesn't seem to be moving upward. Any thoughts on why that is?
👍️0
dcaf7 dcaf7 2 years ago
Nothing really changed. Rolvedon doesn't look different from Neulasta and multiple biosimilars. Sales have remained flat over the last three quarters.
👍️0
dcaf7 dcaf7 2 years ago
REDWOOD CITY, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or the Company NASDAQ: CHRS,) today announced that it has entered into an asset purchase agreement (the Agreement) dated December 2, 2024, with Intas Pharmaceuticals Ltd. (Intas) for the divestiture of the UDENYCA (pegfilgrastim-cbqv) franchise for up to $558.4 million.
👍️0
KRISGO KRISGO 2 years ago
Hey guys, any idea why this stock isn't moving up? Rolvedon looks promising and definitely has long-term potential. The info seems to be out there, and the street is aware of it, but it’s not gaining any momentum. Any thoughts?
👍️0
KRISGO KRISGO 2 years ago
got it, thanks dcaf7!
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dcaf7 dcaf7 2 years ago
This trial was not design to demonstrate significant advantage. As you can read in the Conclusions, same day dosing "may be advantageous in reducing the time to ANC recovery". Just may be. This data will not result in label change, but it might be included in NCCN guidelines.
👍️0
KRISGO KRISGO 2 years ago
dcaf7, thanks for sharing this. I'm not an expert in this area, so I'm not sure if this study offers a significant advantage over existing ones. What’s your take on it?
👍️0
dcaf7 dcaf7 2 years ago
From the abstract
The primary endpoint was the time to recovery of absolute neutrophil counts (ANC) from nadir to ? 1.5×109/L in C1. Secondary endpoints included incidence of SN (ANC < 0.5×109/L) and FN (ANC < 1.0×109/L and temperature of > 38.3 oC or 2 consecutive readings ?
38.0 oC over 2 hours), duration of SN (DSN), and incidence of neutropenic complications, including use of antibiotics and/or hospitalizations.
Results: A total of 53 pts (mean [SD] age: 62.7 [11.9] years; female: 100%) from 13 sites across the US, were enrolled (White: 62.3%; Black or African American: 9.4%; others: 28.3%). Pts were relatively healthy (ECOG 0, 52.8% [n = 28] patients; ECOG 1, 47.2% [n =
25] patients). Efficacy in C1 was evaluable in 49 patients. Mean (SD) time to ANC recovery was 1.8 (1.1) days. Incidence of SN was 46.9% (n = 23) and mean (SD) DSN was 0.8 (1.0) days. Incidence of FN was 2% (n = 1). No neutropenic complications were observed during the study. Safety was assessed in all 53 patients who received at least 1 dose of eflapegrastim. Overall, 43 patients (81.1%) experienced any TEAE of musculoskeletal pain. Common musculoskeletal-related TEAEs experienced by ? 10% of patients were bone pain (52.8%; n = 28); back pain (26.4%; n = 14), arthralgia or pain in extremity (17.0%; n = 9 for each); and myalgia (13.2%; n = 7). No deaths were reported during the study.
Conclusions: These findings suggest that administration of eflapegrastim on the same day as TC chemotherapy may be advantageous in reducing the time to ANC recovery and related complications in pts with ESBC. The AEs observed in this study were consistent with those
generally observed in pts receiving TC and other GCSF products.
👍️ 1 🙏 1
KRISGO KRISGO 2 years ago
Thanks dcaf7 🙏
👍️0
dcaf7 dcaf7 2 years ago
They will get info about efficacy and safety but they won't be able to conclude whether this regimen works better or not.
👍️0
KRISGO KRISGO 2 years ago
Hello Dcaf7, based on the full abstract being released on Nov 25th, can the experts evaluate whether same-day dosing is effective and works better?
👍️0
dcaf7 dcaf7 2 years ago
Same day dosing data will be presented at SABCS meeting by Lee Schwartzberg on December 13, 2024.
Abstract title is "Eflapegrastim, a long-acting GCSF, administered the same day as chemotherapy in patients with early-stage breast cancer: Results from a multicenter, open-label, study". Full abstract release date is November 25, 2024.
👍️ 2
dcaf7 dcaf7 2 years ago
On earning call, they said that SPRIX might become an important asset due to NONPAIN act.
The NOPAIN Act expands patient and provider access to FDA-approved non-opioids in all outpatient surgical settings beginning in 2025 by providing separate Medicare reimbursement for non-opioid therapies.
👍️ 1
dcaf7 dcaf7 2 years ago
H.C. Wainwright starts Assertio at buy.
The investment bank said it believes Rolvedon could reach peak annual sales of around $140M in the early 2030s. It added that “long run positive traction” from products such as Rolvedon, Otrexup and Sympazan “ought to drive renewed interest from investors.”
The bank set its price target at $4.
👍️ 1
glenn1919 glenn1919 2 years ago
ASRT.......................https://stockcharts.com/h-sc/ui?s=ASRT&p=W&b=5&g=0&id=p86431144783
👍️0
glenn1919 glenn1919 2 years ago
ASRT................................https://stockcharts.com/h-sc/ui?s=ASRT&p=W&b=5&g=0&id=p86431144783
👍️0
ATLcitizen ATLcitizen 2 years ago
Heather Mason recently purchased 25K of ASRT shares.
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dcaf7 dcaf7 2 years ago
A meta-analysis of the effect of pegfilgrastim biosimilars and eflapegrastim on DSN was presented at ASCO. "Additionally, eflapegrastim, another long-acting granulocyte-colony stimulating factor agent, significantly reduced DSN compared to conventional pegfilgrastim (WMD, n = –0.13 days; 95% CI –0.24 to –0.03; P = .01). The researchers recommended “exploring the impact of the drug in clinical settings on costs and patient-reported outcomes could provide valuable insights into optimizing the management of chemotherapy-related neutropenia.”
https://www.centerforbiosimilars.com/view/asco-2024-posters-showcase-positive-data-on-denosumab-pegfilgrastim-biosimilars
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Propain Propain 2 years ago
bought some shares today. Gaurantee the stock will tumble now!
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dcaf7 dcaf7 2 years ago
Rolvedon/eflapegrastim is a new molecule. You cannot call it "novel formulation". Novel formulation of what? Neulasta? Nonsense.
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ATLcitizen ATLcitizen 2 years ago
dcaf7, please elaborate on what you mean?
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dcaf7 dcaf7 2 years ago
Listened to yesterday ASRT presentation. They call Rolvedon a "novel formulation" (slide 5). Looks like these guys don't know what Rolvedon really is.
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