0001808665false00018086652024-11-072024-11-07
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Form 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): November 07, 2024
ASSERTIO HOLDINGS, INC.
(Exact name of registrant as specified in its charter)
| | | | | | | | | | | | | | |
| Delaware | | 01-39294 | | 85-0598378 |
(State or Other Jurisdiction of
Incorporation) | | (Commission File Number) | | (IRS Employer Identification No.) |
100 S. Saunders Road, Suite 300, Lake Forest, IL 60045
(Address of Principal Executive Offices; Zip Code)
(224) 419-7106
(Registrant’s telephone number, including area code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Securities registered pursuant to Section 12(b) of the Act:
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| Title of each class: | | Trading Symbol(s): | | Name of each exchange on which registered: |
| Common Stock, $0.0001 par value | | ASRT | | The Nasdaq Stock Market LLC |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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| Item 2.02 | | Results of Operations and Financial Condition. |
On November 11, 2024, Assertio Holdings, Inc. (the “Company”) issued a press release announcing, and held a conference call to discuss, its financial results for the three and nine months ended September 30, 2024. The press release and transcript of the conference call are attached hereto as Exhibits 99.1 and 99.2, respectively, and are incorporated by reference herein.
The information in Item 2.02 of this Current Report on Form 8-K ("Form 8-K") shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. The information contained herein shall not be incorporated by reference into any filing with the Securities and Exchange Commission (the "SEC") made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
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| Item 5.02 | | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
Departure of Peter Staple and Jeffrey Vacirca from the Board of Directors
On November 7, 2024, Peter Staple notified the Board of Directors (the “Board”) of the Company of his intent to retire as a member of the Board, effective November 7, 2024 (the “Effective Date”). Mr. Staple’s retirement from the Board was not the result of any dispute or disagreement with the Company on any matter relating to the Company’s operations, policies or practices.
On November 7, 2024, Jeffrey Vacirca also notified the Board of the Company of his intent to retire as a member of the Board and its committees, effective as of the Effective Date. Dr. Vacirca’s retirement from the Board was not the result of any dispute or disagreement with the Company on any matter relating to the Company’s operations, policies or practices.
Appointment of David Stark to the Board of Directors
On November 7, 2024, the Board appointed David Stark to the Board, effective as of the Effective Date. In connection with his appointment to the Board, Mr. Stark was appointed as a member of the Nominating and Corporate Governance Committee of the Board.
Mr. Stark, 56, served as Chief Legal Officer of Teva Pharmaceutical Industries Ltd. (“Teva Pharmaceuticals”) from 2016 to 2024. Mr. Stark joined Teva Pharmaceuticals in 2002 and served in a series of roles with increasing responsibilities in Teva North America and Teva Americas, including as Senior Director, Deputy General Counsel, Vice President and General Counsel, and Senior Vice President and General Counsel, Global Specialty Medicines. Prior to joining Teva, Mr. Stark was an associate attorney in the litigation departments at Willkie Farr & Gallagher LLP between 1998 and 2002, Chadbourne & Parke between 1997 and 1998 and Haight, Gardner, Poor & Havens between 1994 and 1997. Mr. Stark is Founder and CEO of Stark Creative Solutions LLC, specializing in innovative solutions to legal challenges. The Board considered Mr. Stark’s experience and expertise within the following areas relevant to the Company and its business in concluding that he should serve on the Board: Legal Experience, Mergers and Acquisitions, Corporate Management, and Corporate Strategy. Mr. Stark holds a J.D. from New York University School of Law and a B.A. in Political Science from Northeastern University, summa cum laude.
In connection with his service on the Board, Mr. Stark is entitled to receive the compensation and equity awards applicable to all of the Company’s non-employee directors, as more particularly described in the Company’s Non-Employee Director Compensation and Grant Policy filed as Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 7, 2024. The Company has also entered into its standard form of indemnification agreement with Mr. Stark.
Forward Looking Statements
The statements included in and incorporated by reference into this Form 8-K 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 including “anticipates,” “approximates,” “believes,” “could,” “designed,” “estimates,” “expects,” “goal,” “intends,” “may,” “might,” “opportunity,” “outlook,” “plans,” “potential,” “projects,” “prospective,” “pro forma,” “pursues,” “seeks,” “should,” “strategy,” “targets,” “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: the Company’s ability to grow sales of, and the commercial success and market acceptance of, Rolvedon and the Company’s other products; the Company’s ability to successfully develop and execute its sales, marketing and promotion strategies using its sales force and non-personal promotion model capabilities; the impact on sales and profits from the entry and sales of generics of the Company’s products and/or other products competitive with any of the Company’s products (including indomethacin suppositories compounded by hospitals and other institutions including a 503B compounder which the Company believes to be violation of certain provisions of the 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 as a result of the August 2023 approval and launch of generic indomethacin suppositories and January 2024 approval and subsequent launch of a generic indomethacin oral suspension product); risks that any new businesses will not be integrated successfully or that the combined company will not realize estimated cost savings, value of certain tax assets, synergies and growth, or that such benefits may take longer and/or cost more to realize than expected; expected industry trends, including pricing pressures and managed healthcare practices; the Company’s ability to attract and retain executive leadership and key employees; the ability of the Company’s third-party manufacturers to manufacture adequate quantities of commercially salable inventory and active pharmaceutical ingredients for each of the Company’s products on commercially reasonable terms and in compliance with their contractual obligations to the Company, and the Company’s ability to maintain its supply chain which relies on single-source suppliers; the outcome of, and the Company’s intentions with respect to, any litigation or government investigations, including pending and potential future shareholder litigation relating to the Spectrum Merger and/or the recent approval and launch of generic indomethacin suppositories, opioid-related government investigations and opioid-related litigation, the recently unsealed qui tam litigation, as well as Spectrum’s legacy shareholder and other litigation, and other disputes and litigation, and the costs and expenses associated therewith; the Company’s financial cost and outcomes of clinical trials, including the extent to which data from the Rolvedon same-day dosing trial may support ongoing commercialization efforts; the Company’s compliance with legal and regulatory requirements related to the development or promotion of its products; variations in revenues obtained from commercialization agreements and the accounting treatment with respect thereto; the Company’s common stock maintaining compliance with The Nasdaq Capital Market’s minimum closing bid requirement of at least $1.00 per share, particularly in light of our stock trading below or only slightly above $1.00 per share recently as well as recent market activity by a short seller; and the Company’s ability to obtain and maintain intellectual property protection for its products and operate its business without infringing the intellectual property rights of others. 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 the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings with the SEC. Many of these risks and uncertainties may be exacerbated by public health emergencies and general macroeconomic conditions. The Company 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 and/or incorporated by reference into this Form 8-K information about non-GAAP measures of EBITDA, adjusted EBITDA, adjusted earnings, adjusted earnings per share, and adjusted operating expenses as useful operating metrics. The Company believes that the presentation of these non-GAAP financial measures, when viewed with results under GAAP 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 the Company may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.
The statements included in and/or incorporated by reference into this Form 8-K also include estimated full-year non-GAAP adjusted EBITDA and estimated full-year non-GAAP operating expense information, which the Company believes enables investors to better understand the anticipated performance of the business, but should be considered a supplement to, and not as a substitute for or superior to, financial measures calculated in accordance with GAAP. No reconciliations of these non-GAAP metrics are provided because some of the information necessary to estimate the most directly comparable financial measures calculated in accordance with GAAP, such as income taxes, fair value change in contingent consideration, and stock-based compensation, is not yet ascertainable or accessible and the Company is unable to quantify these amounts that would be required to be included in such estimates without unreasonable efforts.
Specified Items
Non-GAAP measures included in and/or incorporated by reference into this Form 8-K 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, 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.
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| Item 9.01 | | Financial Statements and Exhibits. |
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| (d) | | Exhibits |
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| | 99.1 | | |
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| | 99.2 | | |
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| | 104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| | ASSERTIO HOLDINGS, INC. |
| | | |
Date: November 12, 2024 | By: | /s/ Brendan P. O’Grady |
| | | Brendan P. O’Grady |
| | | Chief Executive Officer
(Principal Executive Officer) |
Exhibit 99.1
Assertio Reports Third Quarter 2024 Financial Results
Third Quarter Total Net Product Sales of $28.7 Million
Rolvedon Net Product Sales of $15.0 Million
Cash and Short-Term Investments of $88.6 Million
LAKE FOREST, IL. – November 11, 2024 – Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients, today reported financial results for the third quarter ended September 30, 2024.
“Third quarter results reflected solid performance as we continue to establish Rolvedon as our lead asset and drive economic returns from our commercial portfolio,” said Brendan O’Grady, Chief Executive Officer. “Rolvedon has been well received by physicians, posting another quarter of stable performance and the continued expansion of our customer base. The Rolvedon same day dosing trial has concluded and the results have been accepted for presentation at the San Antonio Breast Cancer Symposium in December 2024.”
“Additionally, we have implemented new sales and marketing tactics for Sympazan, which are designed to drive prescriber awareness and prescription growth in key markets. We are maintaining our share of Indocin and working to maximize the value of this product and our other commercial assets moving forward. We are also evaluating new approaches to grow existing assets as well as the acquisition of additional assets to fuel further growth.”
Financial Highlights (unaudited):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended | | Nine Months Ended |
| (in millions, except per share amounts) | September 30, 2024 | | June 30, 2024 | | September 30, 2023 | | September 30, 2024 | | September 30, 2023 |
| Net Product Sales (GAAP) | $ | 28.7 | | | $ | 30.7 | | | $ | 35.1 | | | $ | 91.3 | | | $ | 117.0 | |
| | | | | | | | | |
| Net Loss (GAAP) | $ | (2.9) | | | $ | (3.7) | | | $ | (279.5) | | | $ | (11.1) | | | $ | (274.6) | |
| Loss Per Share (GAAP) | $ | (0.03) | | | $ | (0.04) | | | $ | (3.42) | | | $ | (0.12) | | | $ | (4.35) | |
| Adjusted EBITDA (Non-GAAP)1 | $ | 5.3 | | | $ | 5.0 | | | $ | 12.9 | | | $ | 17.7 | | | $ | 63.3 | |
Adjusted Earnings Per Share (Non-GAAP)1 | $ | 0.03 | | | $ | 0.02 | | | $ | 0.01 | | | $ | 0.09 | | | $ | 0.46 | |
Third quarter results included the following highlights (our discussion below focuses on a comparison of third quarter 2024 to second quarter 2024 given the acquisition of Spectrum and the generic competition of Indocin introduced in the third quarter 2023):
▪Rolvedon net product sales were stable at $15.0 million in the third quarter, from $15.1 million in the second quarter, driven by continued volume growth offset by lower net pricing.
▪Indocin net product sales in the third quarter were $5.7 million, decreased from $6.9 million in the second quarter, due to the previously announced generic competition affecting pricing.
•Gross margin2 in the third quarter increased to 74%, from 71% in the second quarter, primarily due a decrease in the level of inventory write downs in late life-cycle stage products and the completion of Rolvedon inventory step-up amortization.
•SG&A expense in the third quarter was $16.7 million, decreased from $18.4 million in the second quarter. The decrease was primarily due to lower sales and marketing and other general and administrative costs, partially offset by net higher legal related charges.
1 Non-GAAP measures are reconciled to the corresponding GAAP measures in the schedules attached.
2 Gross margin represents the ratio of net product sales less cost of sales to net product sales.
•Adjusted EBITDA3 was $5.3 million in the third quarter, increased from $5.0 million in the second quarter, primarily due to lower SG&A expense, partially offset by lower net product sales.
Balance Sheet and Cash Flow
•For the quarter ended September 30, 2024, cash, cash equivalents and short-term investments were $88.6 million, compared with $88.4 million at June 30, 2024. Cash flow generation during the quarter was impacted by the timing of working capital as well as lower net product sales.
•Debt at September 30, 2024 was $40.0 million, comprised of the Company’s 6.5% convertible notes, with no maturities until September 2027.
Board Updates
Peter Staple retired from the board after more than 20 years as an independent director. Also, Dr. Jeffrey Vacirca has elected to depart from the board to focus on his other business interests. Both departures were effective November 7, 2024.
Assertio announced the appointment of Heather Mason as Board Chair. Mason has served as an independent director since 2019 and as interim CEO of Assertio from January to May of 2024. Further, David Stark was appointed to the board as an independent director and member of the Nominating and Corporate Governance Committee. Stark was previously Executive Vice President and Chief Legal Officer at Teva Pharmaceutical Industries Limited.
“I want thank Jeff and Peter for their service to Assertio and its shareholders,” said Mason. “Jeff’s insight into the oncology market since joining the board as part of the Spectrum transaction has been invaluable. Peter has served for more than 20 years on the Assertio board, offering calm leadership and wise counsel through transitions and challenges faced by the organization during his tenure. I also appreciate Peter extending his board service during the time of transition to Brendan O’Grady as the new CEO. I want to welcome David to the board and look forward to his partnership. David brings extensive litigation, compliance and acquisition experience from his time at Teva and earlier in private law firm practice.”
Conference Call and Investor Presentation Information
Assertio’s management will host a conference call to discuss its third quarter 2024 financial results today:
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| Date: | Monday, November 11, 2024 |
| 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 commercial pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients. We have built our commercial portfolio through acquisition or licensing of approved products. Our commercial capabilities include marketing through both a sales force and a non-personal promotion model, market access through payor contracting, and trade and distribution. To learn more about Assertio, visit www.assertiotx.com.
3 See “Non-GAAP Financial Measures” below for information about reconciling our Adjusted EBITDA guidance to Net Loss.
Investor Contact
Matt Kreps, Managing Director
Darrow Associates
M: 214-597-8200
mkreps@darrowir.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 of, and the commercial success and market acceptance of, Rolvedon and Assertio’s other products; Assertio’s ability to successfully develop and execute its sales, marketing and promotion strategies using its sales force and non-personal 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 indomethacin suppositories compounded by hospitals and other institutions including a 503B compounder which we believe to be violation of certain provisions of the 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 as a result of the August 2023 approval and launch of generic indomethacin suppositories and January 2024 approval and subsequent launch of a generic indomethacin oral suspension product); risks that any new businesses will not be integrated successfully or that the combined company will not realize estimated cost savings, value of certain tax assets, synergies and growth, or that such benefits may take longer and/or cost more to realize than expected; expected industry trends, including pricing pressures and managed healthcare practices; Assertio’s ability to attract and 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 litigation or government investigations, including pending and potential future shareholder litigation relating to the Spectrum Merger and/or the recent approval and launch of generic indomethacin suppositories, opioid-related government investigations and opioid-related litigation, the recently unsealed qui tam litigation, as well as Spectrum’s legacy shareholder and other litigation, and other disputes and litigation, and the costs and expenses associated therewith; Assertio’s financial cost and outcomes of clinical trials, including the extent to which data from the Rolvedon same-day dosing trial may support ongoing commercialization efforts; Assertio’s compliance with legal and regulatory requirements related to the development or promotion of its products; 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, particularly in light of Assertio’s stock trading below or only slightly above $1.00 per share recently as well as recent market activity by a short seller; and 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. 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, 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.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands, except per share amounts)
(unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended | | Nine Months Ended |
| September 30, 2024 | | June 30, 2024 | | September 30, 2023 | | September 30, 2024 | | September 30, 2023 |
| Revenues: | | | | | | | | | |
| Product sales, net | $ | 28,705 | | | $ | 30,695 | | | $ | 35,137 | | | $ | 91,262 | | | $ | 116,989 | |
| Royalties and milestones | 499 | | | 431 | | | 490 | | | 1,516 | | | 1,910 | |
| Other revenue | — | | | — | | | — | | | — | | | 185 | |
| Total revenues | 29,204 | | | 31,126 | | | 35,627 | | | 92,778 | | | 119,084 | |
| Costs and expenses: | | | | | | | | | |
| Cost of sales | 7,550 | | | 8,889 | | | 7,060 | | | 27,616 | | | 17,299 | |
| Research and development expenses | 1,005 | | | 798 | | | 1,316 | | | 2,536 | | | 1,819 | |
| Selling, general and administrative expenses | 16,726 | | | 18,385 | | | 21,005 | | | 53,635 | | | 54,680 | |
| Change in fair value of contingent consideration | 300 | | | — | | | (17,532) | | | 300 | | | (8,124) | |
| Amortization of intangible assets | 6,671 | | | 6,671 | | | 10,184 | | | 18,973 | | | 22,752 | |
| Loss on impairment of intangible assets | — | | | — | | | 238,831 | | | — | | | 238,831 | |
| Restructuring charges | — | | | — | | | 3,034 | | | 720 | | | 3,034 | |
| Total costs and expenses | 32,252 | | | 34,743 | | | 263,898 | | | 103,780 | | | 330,291 | |
| Loss from operations | (3,048) | | | (3,617) | | | (228,271) | | | (11,002) | | | (211,207) | |
| Other income (expense): | | | | | | | | | |
| Debt-related expenses | — | | | — | | | — | | | — | | | (9,918) | |
| Interest expense | (761) | | | (758) | | | (752) | | | (2,276) | | | (2,625) | |
| Interest income | 887 | | | 842 | | | 605 | | | 2,441 | | | 1,713 | |
| Other gain (loss) | 45 | | | 8 | | | (467) | | | 57 | | | (112) | |
| Total other income (expense) | 171 | | | 92 | | | (614) | | | 222 | | | (10,942) | |
| Net loss before income taxes | (2,877) | | | (3,525) | | | (228,885) | | | (10,780) | | | (222,149) | |
| Income tax expense | (44) | | | (149) | | | (50,659) | | | (325) | | | (52,409) | |
| Net loss and comprehensive loss | $ | (2,921) | | | $ | (3,674) | | | $ | (279,544) | | | $ | (11,105) | | | $ | (274,558) | |
| | | | | | | | | |
| Basic net loss per share | $ | (0.03) | | | $ | (0.04) | | | $ | (3.42) | | | $ | (0.12) | | | $ | (4.35) | |
| Diluted net loss per share | $ | (0.03) | | | $ | (0.04) | | | $ | (3.42) | | | $ | (0.12) | | | $ | (4.35) | |
| Shares used in computing basic net loss per share | 95,352 | | | 95,240 | | | 81,713 | | | 95,191 | | | 63,066 | |
| Shares used in computing diluted net loss per share | 95,352 | | | 95,240 | | | 81,713 | | | 95,191 | | | 63,066 | |
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
| | | | | | | | | | | |
| (Unaudited) | | |
| September 30, 2024 | | December 31, 2023 |
| ASSETS | | | |
| Current assets: | | | |
| Cash and cash equivalents | $ | 37,981 | | | $ | 73,441 | |
| Short-term investments | 50,598 | | | — | |
| Accounts receivable, net | 44,944 | | | 47,663 | |
| Inventories, net | 39,788 | | | 37,686 | |
| Prepaid and other current assets | 7,845 | | | 12,272 | |
| Total current assets | 181,156 | | | 171,062 | |
| Property and equipment, net | 624 | | | 770 | |
| Intangible assets, net | 92,359 | | | 111,332 | |
| | | |
| | | |
| Other long-term assets | 1,860 | | | 3,255 | |
| Total assets | $ | 275,999 | | | $ | 286,419 | |
| LIABILITIES AND SHAREHOLDERS’ EQUITY | | | |
| Current liabilities: | | | |
| Accounts payable | $ | 13,153 | | | $ | 13,439 | |
| Accrued rebates, returns and discounts | 60,482 | | | 58,137 | |
| Accrued liabilities | 12,964 | | | 18,213 | |
| | | |
| Contingent consideration, current portion | 3,000 | | | 2,700 | |
| Other current liabilities | 505 | | | 954 | |
| Total current liabilities | 90,104 | | | 93,443 | |
| Long-term debt | 38,840 | | | 38,514 | |
| | | |
| Other long-term liabilities | 16,537 | | | 16,459 | |
| Total liabilities | 145,481 | | | 148,416 | |
| Commitments and contingencies | | | |
| Shareholders’ equity: | | | |
Common stock, $0.0001 par value, 200,000,000 shares authorized; 95,360,756 and 94,668,523 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively. | 9 | | | 9 | |
| Additional paid-in capital | 793,157 | | | 789,537 | |
| Accumulated deficit | (662,648) | | | (651,543) | |
| | | |
| Total shareholders’ equity | 130,518 | | | 138,003 | |
| Total liabilities and shareholders' equity | $ | 275,999 | | | $ | 286,419 | |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
| | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2024 | | 2023 |
| Operating Activities | | | |
| Net loss | $ | (11,105) | | | $ | (274,558) | |
| Adjustments to reconcile net loss to net cash from operating activities: | | | |
| Depreciation and amortization | 19,118 | | | 23,321 | |
| Amortization of debt issuance costs and Royalty Rights | 326 | | | 350 | |
| Accretion of interest income from short-term investments | (538) | | | — | |
| Loss on impairment of intangible assets | — | | | 238,831 | |
| Recurring fair value measurements of assets and liabilities | 269 | | | (7,612) | |
| Debt-related expenses | — | | | 9,918 | |
| Provisions for inventory and other assets | 4,982 | | | 2,129 | |
| Stock-based compensation | 3,911 | | | 6,516 | |
| Deferred income taxes | — | | | 47,192 | |
| Changes in assets and liabilities, net of acquisition: | | | |
| Accounts receivable | 2,719 | | | 33,865 | |
| Inventories | (7,084) | | | (8,898) | |
| Prepaid and other assets | 5,822 | | | 6,769 | |
| Accounts payable and other accrued liabilities | (5,255) | | | (21,523) | |
| Accrued rebates, returns and discounts | 2,345 | | | (11,027) | |
| Interest payable | (650) | | | (1,376) | |
| Net cash provided by operating activities | 14,860 | | | 43,897 | |
| Investing Activities | | | |
| Purchases of property and equipment | — | | | (528) | |
| Purchase of Sympazan | — | | | (280) | |
| Net cash acquired in Spectrum Merger | — | | | 1,950 | |
| Proceeds from sale of short-term investments | — | | | 2,194 | |
| Proceeds from maturities of short-term investments | 23,534 | | | — | |
| Purchases of short-term investments | (73,563) | | | — | |
| Net cash (used in) provided by investing activities | (50,029) | | | 3,336 | |
| Financing Activities | | | |
| | | |
| Payments in connection with 2027 Convertible Notes | — | | | (10,500) | |
| | | |
| Payment of direct transaction costs related to convertible debt inducement | — | | | (1,119) | |
| | | |
| Payment of contingent consideration | — | | | (15,408) | |
| | | |
| | | |
| Payments related to the vesting and settlement of equity awards, net | (291) | | | (7,770) | |
| | | |
| Other financing activities | — | | | (489) | |
| Net cash used in financing activities | (291) | | | (35,286) | |
| Net (decrease) increase in cash and cash equivalents | (35,460) | | | 11,947 | |
| Cash and cash equivalents at beginning of year | 73,441 | | | 64,941 | |
| Cash and cash equivalents at end of period | $ | 37,981 | | | $ | 76,888 | |
| Supplemental Disclosure of Cash Flow Information | | | |
| Net cash paid for income taxes | $ | 1,388 | | | $ | 3,424 | |
| Cash paid for interest | $ | 2,600 | | | $ | 3,651 | |
| | | |
RECONCILIATION OF GAAP NET LOSS TO NON-GAAP EBITDA and ADJUSTED EBITDA
(in thousands)
(unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended | | |
| | September 30, 2024 | | June 30, 2024 | | September 30, 2023 | | September 30, 2024 | | September 30, 2023 | | Financial Statement Classification |
| GAAP Net Loss | | $ | (2,921) | | | $ | (3,674) | | | $ | (279,544) | | | $ | (11,105) | | | $ | (274,558) | | | |
| Interest expense | | 761 | | | 758 | | | 752 | | | 2,276 | | | 2,625 | | | Interest expense |
| Income tax expense | | 44 | | | 149 | | | 50,659 | | | 325 | | | 52,409 | | | Income tax expense |
| Depreciation expense | | 40 | | | 40 | | | 172 | | | 145 | | | 569 | | | Selling, general and administrative expenses |
| Amortization of intangible assets | | 6,671 | | | 6,671 | | | 10,184 | | | 18,973 | | | 22,752 | | | Amortization of intangible assets |
| EBITDA (Non-GAAP) | | $ | 4,595 | | | $ | 3,944 | | | $ | (217,777) | | | $ | 10,614 | | | $ | (196,203) | | | |
| Adjustments: | | | | | | | | | | | | |
| Legacy product reserves | | — | | | — | | | — | | | — | | | (185) | | | Other revenue |
| Stock-based compensation | | 1,296 | | | 1,408 | | | 1,864 | | | 3,911 | | | 6,516 | | | Selling, general and administrative expenses |
Change in fair value of contingent consideration (1) | | 300 | | | — | | | (17,532) | | | 300 | | | (8,124) | | | Change in fair value of contingent consideration |
Debt-related expenses (2) | | — | | | — | | | — | | | — | | | 9,918 | | | Debt-related expenses |
Transaction-related expenses (3) | | — | | | — | | | 2,736 | | | — | | | 8,539 | | | Selling, general and administrative expenses |
Loss on impairment of intangible assets (4) | | — | | | — | | | 238,831 | | | — | | | 238,831 | | | Loss on impairment of intangible assets |
Restructuring costs(5) | | — | | | — | | | 3,034 | | | 720 | | | 3,034 | | | Restructuring charges |
Other (6) | | (887) | | | (366) | | | 1,755 | | | 2,123 | | | 967 | | | Multiple |
| Adjusted EBITDA (Non-GAAP) | | $ | 5,304 | | | $ | 4,986 | | | $ | 12,911 | | | $ | 17,668 | | | $ | 63,293 | | | |
(1)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.
(2)Debt-related expenses consist of an induced conversion expense of approximately $8.8 million and direct transaction costs of approximately $1.1 million incurred as a result of the privately negotiated exchange of $30.0 million principal amount of the Company’s 6.5% Convertible Senior Notes due 2027 in the first quarter of 2023.
(3)Represents transaction-related expenses associated with the acquisition of Spectrum, which closed effective July 31, 2023.
(4)Represents the charge in the period for the impairment of intangible assets resulting from the revaluation of the Company’s long-lived assets.
(5)Restructuring costs represent non-recurring costs associated with the Company’s announced restructuring plans.
(6)Other for the three and nine months ended September 30, 2024 and 2023, and the three months ended June 30, 2024, represents the following adjustments (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended | | |
| | September 30, 2024 | | June 30, 2024 | | September 30, 2023 | | September 30, 2024 | | September 30, 2023 | | Financial Statement Classification |
| Amortization of inventory step-up | | $ | — | | | $ | 476 | | | $ | 1,848 | | | $ | 4,564 | | | $ | 2,168 | | | Cost of sales |
| Interest income | | (887) | | | (842) | | | (605) | | | (2,441) | | | (1,713) | | | Interest income |
| Derivative fair value adjustment | | — | | | — | | | 512 | | | — | | | 512 | | | Other gain (loss) |
| Total Other | | $ | (887) | | | $ | (366) | | | $ | 1,755 | | | $ | 2,123 | | | $ | 967 | | | |
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 |
| September 30, 2024 | | June 30, 2024 | | September 30, 2023 |
| Amount | | Diluted EPS (2) | | Amount | | Diluted EPS (2) | | Amount | | Diluted EPS (2) |
Net loss (GAAP)(2) | $ | (2,921) | | | $ | (0.03) | | | $ | (3,674) | | | $ | (0.04) | | | $ | (279,544) | | | $ | (3.42) | |
Add: Convertible debt interest expense and other income statement impacts, net of tax(2) | — | | | | | — | | | | | — | | | |
| Adjustments: | | | | | | | | | | | |
| Amortization of intangible assets | 6,671 | | | | | 6,671 | | | | | 10,184 | | | |
| | | | | | | | | | | |
| Stock-based compensation | 1,296 | | | | | 1,408 | | | | | 1,864 | | | |
| | | | | | | | | | | |
| Change in fair value of contingent consideration | 300 | | | | | — | | | | | (17,532) | | | |
Contingent consideration cash payable (3) | (253) | | | | | — | | | | | (3,590) | | | |
| Transaction-related expenses | — | | | | | — | | | | | 2,736 | | | |
Loss on impairment of intangible assets(4) | — | | | | | — | | | | | 238,831 | | | |
| Restructuring costs | — | | | | | — | | | | | 3,034 | | | |
| Other | (887) | | | | | (366) | | | | | 1,755 | | | |
Increase in deferred tax asset valuation allowance (5) | — | | | | | — | | | | | 43,035 | | | |
Income tax benefit expense, as adjusted (6) | (1,782) | | | | | (1,928) | | | | | 387 | | | |
| Adjusted earnings (Non-GAAP) | $ | 2,424 | | | $ | 0.03 | | | $ | 2,111 | | | $ | 0.02 | | | $ | 1,160 | | | $ | 0.01 | |
| | | | | | | | | | | |
Diluted shares used in calculation (GAAP)(2) | 95,352 | | | | | 95,240 | | | | | 81,713 | | | |
Add: Dilutive effect of stock-based awards and equivalents(2) | 933 | | | | | 394 | | | | | 2,191 | | | |
Add: Dilutive effect of 2027 Convertible Notes(2) | — | | | | | — | | | | | — | | | |
Diluted shares used in calculation (Non-GAAP)(2) | 96,285 | | | | | 95,634 | | | | | 83,904 | | | |
(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 September 30, 2024, June 30, 2024, and September 30, 2023, 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.
For the three months ended September 30, 2023, the Company’s potentially dilutive convertible debt under the if-converted method was not included in the computation of both non-GAAP adjusted earnings per share and GAAP diluted net loss 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 charge in the period for the impairment of intangible assets resulting from the revaluation of the Company’s long-lived assets.
(5)Represents the amount of income tax expense related to the recognition of a full valuation allowance against deferred tax assets in the period.
(6)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)
| | | | | | | | | | | | | | | | | | | | | | | |
| Nine Months Ended |
| September 30, 2024 | | September 30, 2023 |
| Amount | | Diluted EPS (2) | | Amount | | Diluted EPS (2) |
Net loss (GAAP)(2) | $ | (11,105) | | | $ | (0.12) | | | $ | (274,558) | | | $ | (4.35) | |
Add: Convertible debt interest expense and other income statement impacts, net of tax(2) | — | | | | | 1,969 | | | |
| Adjustments: | | | | | | | |
| Amortization of intangible assets | 18,973 | | | | | 22,752 | | | |
| Legacy products revenue reserves | — | | | | | (185) | | | |
| Stock-based compensation | 3,911 | | | | | 6,516 | | | |
| Debt-related expenses, net | — | | | | | 9,639 | | | |
| Change in fair value of contingent consideration | 300 | | | | | (8,124) | | | |
Contingent consideration cash payable (3) | (253) | | | | | (11,274) | | | |
| Transaction-related expenses | — | | | | | 8,539 | | | |
Loss on impairment of intangible assets(4) | — | | | | | 238,831 | | | |
| Restructuring costs | 720 | | | | | 3,034 | | | |
| Other | 2,123 | | | | | 967 | | | |
Increase in deferred tax asset valuation allowance (5) | — | | | | | 43,035 | | | |
Income tax benefit expense, as adjusted (6) | (6,444) | | | | | (5,556) | | | |
| Adjusted earnings (Non-GAAP) | $ | 8,225 | | | $ | 0.09 | | | $ | 35,585 | | | $ | 0.46 | |
| | | | | | | |
Diluted shares used in calculation (GAAP)(2) | 95,191 | | | | | 63,066 | | | |
Add: Dilutive effect of stock-based awards and equivalents(2) | 503 | | | | | 3,770 | | | |
Add: Dilutive effect of 2027 Convertible Notes(2) | — | | | | | 11,324 | | | |
Diluted shares used in calculation (Non-GAAP)(2) | 95,694 | | | | | 78,160 | | | |
(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 nine months ended September 30, 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.
For the nine months ended September 30, 2023, 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 diluted net income per share, because to do so would be anti-dilutive. However, the potentially dilutive convertible debt under the if-converted method and 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 charge in the period for the impairment of intangible assets resulting from the revaluation of the Company’s long-lived assets.
(5)Represents the amount of income tax expense related to the recognition of a full valuation allowance against deferred tax assets in the period.
(6)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%.
ASSERTIO HOLDINGS INC. (NASDAQ:ASRT)
Q3 2024 EARNINGS CONFERENCE CALL
NOVEMBER 11, 2024 4:30 PM ET
CORPORATE SPEAKERS:
Matthew Kreps
Assertio Holdings; Investor Relations
Brendan O’Grady
Assertio Holdings; Chief Executive Officer
Ajay Patel
Assertio Holdings; Chief Financial Officer
PARTICIPANTS:
Thomas Flaten
Lake Street Capital Markets; Analyst
Nazibur Rahman
Maxim Group; Analyst
Scott Henry
AGP; Analyst
Raghuram Selvaraju
HC Wainwright; Analyst
PRESENTATION:
Operator
Thank you for standing by. My name is John and I’ll be your conference operator today. At this time, I would like to welcome everyone to the Assertio Holdings third quarter Results Conference Call. [Operator Instructions] I would now like to turn the call over to Matt Kreps, Investor Relations. Please go ahead.
Matthew Kreps
Thank you, John. Good afternoon. Thank you, all for joining us today to discuss Assertio's third quarter 2024 financials. The news release covering our results for this period is now available on the Investor page of our website at investor.assertiotx.com.
I would encourage you to review the release and tables in conjunction with today's discussion. With me today are Brendan O'Grady, our Chief Executive Officer; and Ajay Patel, Chief Financial Officer.
In just a moment, Brendan will open the remarks and provide an overview of the business. Then Ajay will cover our financial results. After that, we will take questions from our covering research analysts.
Please note that during this call management will make projections and other forward-looking statements regarding our future performance.
Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties including those noted in this afternoon's press release as well as Assertio's filings with the SEC.
These and other risks are more fully described in the risk factors section and other sections of our Annual Report on Form 10-K and in our Form 10-Q filings.
Our actual results may differ materially from those projected in the forward-looking statements.
Assertio specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law.
With that, I will now turn the call over to Brendan.
Please go ahead.
Brendan O'Grady
Thanks, Matt.
Welcome, everyone, to today's call and thank you for joining.
I'd like to start by wishing you all a Happy Veterans Day, especially to our retired and active service members and their families.
In addition to our usual quarterly performance, there are two other relevant issues that I would like to begin my remarks by addressing. The first is the unwarranted attack on Assertio stakeholders by Mr.Alex Parker of Buxton Helmsley Group that was launched this past Friday November 8th.
I'm sure many, if not most of you have seen the letter I released this morning addressing Mr. Parker's rambling manifesto that he put out last Friday. Normally, I would not validate such conduct by speaking about it.
But because of the numerous falsehoods and baseless allegations that had such an impact on our share price, I want to use this opportunity to address this head on.
While we have taken Mr. Parker's allegations seriously and have looked into every single one of them, we found them all to be without merit.
We have communicated that to Mr. Parker on numerous occasions while at the same time refusing to bow to his demands of cash payments or a seat on Assertio's Board to which he would add zero, and I stress zero, value. And most importantly, neither of which would be in the best interest of shareholders.
If you happen to take the time to read through his less than cogent 24-page document, he is essentially making three baseless claims.
While I do not want to rehash my entire letter, I do want to take a minute to set the record straight specifically on those claims.
First and foremost, Rolvedon is a safe and effective product.
I am 100% confident in that.
Assertio was aware of the whistleblower claims around Rolvedon before the acquisition of Spectrum.
In fact, those claims were investigated by three different professional outside firms. The experts involved in those investigations determined that the FDA was supplied with all relevant and required data that led to Rolvedon's approval. Rolvedon has now been in the market in the U.S. and South Korea for two and a half years and has demonstrated its safety and efficacy in the clinic with patients in real-world settings.
It is well tolerated by patients and has been well received by providers.
Second, the impairment charges had nothing to do with any purported Rolvedon safety claims.
Assertio simply followed clearly established accounting principles, as we always do, in regards to any asset.
Our disclosures clearly explain the impairment and how any and why it was calculated the way that it was.
It is that simple. Third, no payment to the alleged whistleblower were ever made.
The proposed payments Mr. Parker is referring to related to -- is related to an employment claim that was raised by a disgruntled former employee. That employee brought claims forward about Rolvedon as leverage to boost the value of a settlement or reverse their pending termination. After a thorough investigation, it was determined those claims and allegations were false and without merit. The employee was subsequently terminated as part of a reduction in force and the case was later dismissed without any payment ever being made.
Finally, Mr. Parker's rambling rehash of connecting dots where none exist or misrepresenting long past settled issues, is ripe with false statements and mischaracterizations that we have pointed out to him numerous times including the circumstances and reasons for the departure of a former Board member.
While I don't expect his desperate attacks will stop, you should know that there is nothing here and we will vigorously defend our reputation using all legal and regulatory means at our
disposal. Today will be my last comments on this matter as I turn 100% of my focus to the business.
So now with that out of the way I'd like to focus my comments back to the business and the progress we are making in stabilizing the company and positioning it for transformational growth in the coming months.
As noted in our earnings release today I would like to announce that during the November 7th Board of Directors' Meeting, Chairman of the Board, Peter Staple, retired from the Board after twenty-one years of dedicated service and leadership. Peter was instrumental in bringing me to Assertio and although our time together was short, I appreciated his calm demeanor, deep expertise and presence on the Board.
I cannot thank him enough.
In addition, Dr. Jeff Vacirca has stepped back from the Board to focus on his many other business interests.
We thank Dr. Vacirca for his service and providing continuity through the acquisition and integration of Spectrum. His insight into the GCF -- G-CSF and oncology markets were invaluable, and we will miss his contributions to the Board. Both of these departures and continued transition of the Board have long been in the planning. With that, I'm also happy to announce that Heather Mason, Independent Director, has been appointed as Chairwoman of the Board.
Heather has been on the Assertio Board for over five years, serving as interim CEO prior to my joining and she has a wealth of industry experience.
I look forward to continuing to work with Heather in her newly expanded role.
I am also excited to announce that David Stark has joined the Assertio Board effective November 7th. David is an experienced litigator and senior pharmaceutical executive recently retiring from Teva as Chief Legal Officer. David brings a wealth of industry and relevant legal expertise from his 20-plus years at Teva.
David and I were colleagues at Teva, and I'm excited to be working with him again in this new capacity.
Now on to the business.
First and foremost, let me just say I'm very pleased with where we are today as a starting line for growth.
As I've said previously this year is about stabilizing the organization as we transition from Indocin as our lead product to Rolvedon and at the same time, positioning ourselves for more transformational growth in the coming months.
It is worth restating that we have a solid balance sheet, modest debt on favorable terms and a good stable of growth, core and legacy assets led by Rolvedon.
We also have an excellent team of dedicated professionals who know this industry extremely well, giving us the opportunity to add or enhance key capabilities as we grow.
Also important to note is that our capabilities and lean model will allow us to be relatively sector-agnostic, broadening the landscape for new assets and letting us focus on those that best fit our commercial parameters.
For all these reasons, we are well positioned to deliver value for patients and providers we serve, as well as shareholders and employees, as we build a significant branded specialty business through acquisition, integration and a focused go-to-market strategy.
As I said on my first call with you in August, our focus will remain on steady execution, driving cash flow and identifying new assets we can add to bring further scale to the Assertio's platform.
Now turning to performance, and I'll first address Rolvedon.
Rolvedon Q3 sales were essentially steady quarter-over-quarter, showing continued solid demand.
We continue to retain a stable share, around 33% in the oncology community -- community oncology clinic space where we have primarily focused.
We did see a dip in demand due to some typical seasonality that can occur in the third quarter as well as some shift in the community oncology clinic space, specifically Part B. This was offset by the addition of new customers, enabling further expansion into the hospital space and community oncology clinics where we did not have a presence. There are segments -- these are segments that will be important for further future growth.
We remain focused on using our position, a safe and effective non-biosimilar G-CSF, to offer stability to providers and patients, positioning ourselves as a predictable, reliable solution at a more stable price and of course this is a market dynamic, but our message continues to resonate.
Additionally, Rolvedon same-day dosing trial wrapped up in early Q2 and I'm excited to announce that the data will be presented as a poster exhibit at the San Antonio Breast Cancer Symposium in December.
I'm excited about Rolvedon as it's going to play a key role for us over the next several years, both in our current clinic-focused market as well as hospital -- as well as the hospital market, as we prepare to expand into those additional opportunities.
As the only available G-CSF approved under a BLA without biosimilar copies, there may also be opportunities for label expansion.
We're in the very early phases of making that assessment.
Now a couple of words about Indocin.
On Indocin, we continue to manage the life cycle process and drive cash flow generating from the asset. Although there is some compounding activity, to date, we have only one generic competitor.
Our share of the market is holding steady at our internal target levels, which is around 50% of the ex-compounding market.
We will compete to hold our rightful share of the market and at the same time, we will work to maintain our share and optimize price.
Having worked at Teva for more than 20 years, this is something I am very familiar with and know how to do.
Looking at Sympazan, while this is a smaller asset, we believe that it has underpenetrated the market and there is room for growth.
We also understand that Sympazan is especially responsive to key opinion leader awareness and support.
I think I mentioned on the last call that we're piloting and executing sales and marketing tactics designed to drive prescriber awareness and prescription growth in key markets. Although early, we have seen record demand levels in Sympazan prescriptions in July and August as a result of these activities.
This is a product I liked from the beginning of my time at Assertio.
It serves a specific unmet medical need, we have a broad coalition of growing support among patients, caregivers and providers and look to expand both awareness and use of Sympazan going forward.
And then lastly, just a quick word about some of our remaining assets.
I'd like to just talk a little bit about how to characterize the business.
I see it really in three main buckets.
I see a growth asset bucket, this is clearly Rolvedon, and I've spoken about it.
I see a core asset bucket, this is Sympazan and SPRIX.
While I discussed Sympazan in our plan there, I've not said much about SPRIX.
What I will say about SPRIX is that it serves a significant unmet medical need by providing opioid-level pain relief.
In fact, our indication states that SPRIX is indicated in moderate to moderately severe pain that requires analgesia at the opioid level.
There continues to be a focus on non-opioid pain relief and the NOPAIN Act, which expands reimbursement for non-opioid post surgical options starting January 1, 2025, could be an opportunity that we are looking at very seriously for SPRIX.
If nothing else, it brings the need for non-opioid pain relief back to the forefront and reason to believe that SPRIX could be a bigger asset for us than it currently is. The last bucket is our legacy assets. These are our tail products that have lost exclusivity or face very difficult market dynamics.
In this bucket, it's all about asset optimization and includes Indocin and Cambia, among others.
I understand how to extract maximum value out of assets like this, and we'll continue to focus on cash generation in this bucket. With that, I'll conclude my remarks, and I'll hand it over to Ajay Patel, our Chief Financial Officer.
Ajay Patel
Thanks, Brendan. Today I would like to cover our financial results for the third quarter of 2024. Before I begin, I want to note that my commentary will focus on sequential comparisons to the prior quarter. Comparisons to the prior year are less relevant given the acquisition of Spectrum and generic competition of Indocin that occurred in the prior year third quarter.
Also I want to remind everyone that Rolvedon is now our lead asset and brings with it the associated changes in margin, operating cost structure and cash flows that you are seeing in our results throughout this year.
For the third quarter of 2024, our total product sales were $28.7 million, down slightly from $30.7 million in the second quarter, primarily due to Rolvedon sales being offset by the expected decline in Indocin. Rolvedon sales were $15 million in the third quarter compared to $15.1 million in the second quarter. The change was driven by continued volume growth, offset by lower net pricing.
We continue to hold about a one third share in our served markets. Indocin sales were $5.7 million in the third quarter, down from $6.9 million in the second quarter, driven by lower net pricing as a result of generic competition.
In terms of volume, we continue to target and hold an approximate market share split. Reported gross margin in the third quarter improved to 74% compared to 71% in the second quarter primarily due to level of inventory step-up amortization and write-downs from prior quarter not repeating. Turning to operating expenses, SG&A expense was $16.7 million in the third quarter, decreased from $18.4 million in the second quarter. R&D expense in the third quarter was relatively flat at approximately $1 million.
On an adjusted basis, excluding stock compensation, D&A and change in fair value, adjusted operating expense was $16.4 million in the third quarter, down from $17.7 million in the second quarter. The decrease was primarily due to lower sales and marketing and other G&A costs, partially offset by net higher legal-related charges. GAAP net income for the third quarter was a loss of $2.9 million, down from a loss of $3.7 million in the second quarter.
Because GAAP net income includes a number of noncash expenses, we also use adjusted EBITDA as a good indicator of the operating performance of core business. Q3 adjusted EBITDA was a positive $5.3 million, increased from $5 million in the second quarter due to lower operating expenses, partially offset by lower product sales.
Please refer to our press release for a detailed reconciliation of our adjusted EBITDA results. Crossing over to cash flow and our balance sheet.
As a reminder, we invest cash into short-term investments. Therefore, our reference to total cash position includes both cash and cash equivalents and short-term investments. Total cash at the end of the quarter was $88.6 million, effectively flat to the $88.4 million in the second quarter and debt remained unchanged at $40 million.
As we previously noted, quarterly operating cash flows will fluctuate due to timing of working capital in terms of cash receipts and payments due to shift in product mix from Indocin to Rolvedon. Third quarter operating cash flows were negligible and were impacted by timing of working capital from cash collection and lower product sales. Year-to-date, we have generated $15 million in cash flows from operations. With that, we will open the floor to questions from our covering research analysts.
Operator, please go ahead with the instructions.
QUESTION AND ANSWER:
Operator
Our first question comes from the line of Thomas Flaten with Lake Street Capital Markets. Please go ahead.
Thomas Flaten
Hey, good afternoon guys. Congrats on the good quarter. Ajay, you didn't mention anything about guidance. Any thoughts on that for us?
Ajay Patel
Yes. Thanks for the question, Thomas. You're right. At this point, we would have liked to narrow the range, but we still see a flux in a few key areas for the remainder of the year. Therefore, we're going to keep the remaining guidance range that's out there.
Some of the areas we're continuing to focus on is, first, focus on stabilizing the business as we cross over from Indocin to Rolvedon.
Secondly, as we continue to monitor the generic competitive landscape of Indocin.
Then third is the dynamic pricing and volume activity occurring in the G-CSF market landscape.
Thomas Flaten
Great.
Then as a follow-up -- or not a follow-up. Brendan, you had spoken in the last quarterly call and I think in some investor conferences about your desire to maybe do a smaller deal this year and then maybe something more transformative in 2025.
Could you give us your updated thoughts on that?
Brendan O'Grady
Yea, no.
So we continue to look at the landscape of what's available and what's out there.
There are assets that are -- that we think we could execute whether they're smaller, whether they're larger.
But the further we go, I'm starting to think maybe we do something a little bit more robust in the near term than maybe a small tuck-in.
So it really kind of depends on what's out there, what the price is, what we can get and how we think it fits with our model.
So I'm optimistic.
I think there's lots of doable deals out there.
But I said before, I want to make sure it's the right fit.
So I don't want to jump into something just because we feel like we need to. I want to make sure that it's the right thing for Assertio and we're paying the right price for it.
Thomas Flaten
Excellent. Appreciate you taking the questions. Thank you.
Operator
Your next question comes from the line of Naz Rahman with Maxim Group.
Nazibur Rahman
Hi, thanks for answering my question. They're both on Rolvedon. I'll just start with this, in regards to pricing, where do you think the pricing decline sort of stabilize out?
Do you think you -- you've reached stable prices?
Or do you think there's still room for the pricing -- net pricing to decline?
Ajay Patel
Yes. Hey Naz, this is Ajay. Thanks for the question. I would say the G-CSF landscape is very competitive, especially with the biosimilars and some of the more recent entrants in the last few years really driving pricing. Therefore, in this market, we are somewhat hindered by what the market competitors will continue to do.
We have seen pricing declines over the last few quarters, which we anticipate the trend would continue as market share starts to equalize.
But one of the things we're absolutely focused on is the market that we operate in from a Medicare Part B perspective and maintaining one of our leading market share position there.
Nazibur Rahman
Got it. That was helpful. And my follow-up question is, following the same-day dosing data, could you talk a little bit about the logistics and potential timeline to get that into NCCN guidelines?
Like what has to happen there?
And how long does that take?
Brendan O'Grady
Yes.
So thanks for the question.
So again we'll make the data public here in December.
Then I think it is roughly about a six-month window for us to work with NCCN for them to consider. That doesn't mean that it would be midyear, but I think the earliest it could potentially be is midyear.
So we haven't had those discussions or those conversations yet, but I think it will be somewhere between the middle and the back end of next year.
Nazibur Rahman
Got it, thanks for taking my question.
Operator
Our next question comes from the line of Scott Henry with AGP.
Scott Henry
Thank you and good afternoon. A couple of questions. First, on Rolvedon, first quarter roughly $14.5 million; second quarter, $15.1 million; third quarter, $15 million. Guidance, I assume, is still in place of roughly $60 million for 2024.
So we've got about four quarters right around that $15 million mark. Do you think it's basing out here for future growth?
Or will maybe the growth be slower?
Just trying to get your sense of -- there's a lot of moving parts here in that market, of how we should think about growth for Rolvedon in 2025 and beyond.
Brendan O'Grady
Yes. No. It's a great question.
So thank you.
You're right, right?
You've seen about $15 million first quarter, second quarter, third quarter, it has been relatively stable.
I think if you think about the year that roughly $60 million in sales is right about where we think we'll be.
But as we enter 2025, I mean in 2024, we've been very focused in the community oncology clinic space, as Ajay said, focusing in the Medicare Part B space where we maintain about a third of that market share.
As we move into 2025, we do think that further growth is not only possible, but that's what we're planning for, as we expand beyond that clinic space into hospitals and so forth.
So we are planning for growth, and we're approaching this category, and we're approaching Rolvedon is a long-term play.
We're not looking for a dramatic spike in any one particular quarter. We're looking at this asset over the long term.
So we do think that we'll see continued growth, and we have plans to drive continued growth with Rolvedon.
Scott Henry
Okay. Great.
SG&A in the quarter was on the -- it seemed pretty low. It's a good thing. Do you think that's a fair number to extrapolate going forward?
Is that kind of the run rate you have currently?
Ajay Patel
Yes, Scott, good question. Yes. I would say generally, in our business, the second half of the year from an SG&A is generally lower as a lot of our S&M initiatives occur in the first half of the year. With that, we also additionally had additional kind of restructuring and re-transition we did with the company in the beginning in the first quarter of the year.
So that kind of reflected on a higher run rate. I would say the average of the last two quarters is sufficient for the remainder of the year.
Scott Henry
Okay. Great.
The final question, I just wanted to ask on the Board update. Yes. I've covered the company for a while. I believe there was a retirement -- a mandatory retirement age for Board members.
Was that a factor in Peter Staple retiring, if I recall that correctly.
If you could give any color on Dr. Vacirca retiring. I think you said something earlier, but I might have missed it.
Brendan O'Grady
Yes. Sure, I'd be happy to address both.
So I mean Peter has been on the Board for 21 years. He's seen a lot of different versions of Assertio and I think he's worked with six, seven or eight CEOs.
So while I think Peter was approaching the term age or had approached it. I think there was a plan for Peter to step back for a while and retire from the Board.
He stayed on largely because there was the transition between the former CEO, Heather, becoming the Interim CEO, to bring me on board.
Then after I was on board, this transition between Peter and Heather was planned to take place.
So this has been a while in the making.
I think Peter has been phenomenal, and he served Assertio well over the years. He's, as I said in my opening comments, very calm demeanor, very experienced professional and really, really what I believe, a great Board member, and I appreciate his contributions.
In regards to Dr. Vacirca. Dr. Vacirca came from Spectrum. He was on the Spectrum Board, I believe, and I think what Dr. Vacirca did for Assertio was really help with that integration and provide continuity as we integrated Spectrum into Assertio and started to really understand the G-CSF market and the oncology market and the oncology clinic space.
So I don't think -- and I don't want to speak for Dr. Vacirca, but I don't think it was ever his long-term intention to stay on the Assertio Board forever.
In fact, he probably stayed longer than planned.
But I think he's thinking that he has a lot of outside other business interests that he needs to pay attention to.
So this was a good time for him to step back from the Board as well.
Scott Henry
Great. Thank you for that color. And thank you for taking the questions.
Operator
Our next question comes from the line of Ram Selvaraju with HC Wainwright.
Raghuram Selvaraju
Thanks very much for taking my questions. I just wanted to ask, first and foremost, about what the underlying market dynamics are that you're seeing that are driving new customers to choose Rolvedon?
If you could comment on that in some additional granularity, please?
Brendan O'Grady
Well I'll just give you my take first, and then Ajay if you want to jump in and say anything, you're welcome to.
But look, I think that Rolvedon is -- competes, as we said, in a very dynamic marketplace.
It competes with other six or seven or eight other G-CSFs.
It depends upon the actual slice of the market that you're competing in. You know that we compete in the clinic Medicare Part B space.
We've been successful there.
I think physicians recognize and providers recognize that Rolvedon is a very safe and effective product.
I think that, that will be underscored when we see the results of the same-day dosing. Having said that, a lot of this is a contract play. And a lot of it is about access and a lot of it is about do you have the right ASP formula, how are you managing ASP erosion, all of those things.
So I think at the end of the day a lot of times this comes to a to a contract play that is largely sometimes not even a physician that is making that choice, it might be a practice manager.
So patients may be unaware of the particular G-CSF they're getting.
Some may be aware, some may not be aware.
But overall, it's decided kind of at the clinical level a lot of times by decision makers that way. Ajay anything else to add?
Ajay Patel
No. I think Brendan hit it spot on.
The former, in terms of the appeal of the product itself helps us get kind of into the door and then the second on the contracting side, it helped us with the stickiness of sustaining our leading market share in the oncology space.
Raghuram Selvaraju
Then just as a follow-up, I just wanted to see if, Ajay, you wanted to comment on what you see as future trends on the gross margin front, if you think that sustainably maintaining gross margins in the sort of low to mid-70s is possible as the product and revenue mix evolves?
Ajay Patel
Yep, no. Thanks for that question. Yea, as I think as I mentioned to Thomas, right, I think we're keeping our previously announced guidance for '24 in line. We're not ready yet to comment anything beyond kind of '24 here.
So previously stated comments on gross margin that year-over-year, there will be a gross margin erosion as we shift from Indocin, which was a highly accretive gross margin product with very little commercial activity behind it, to Rolvedon, which is a biologic and carries a higher COGS rate.
And additionally has the commercial spend behind it.
So we do continue to see that shift occurring into Q4 as well.
But we are absolutely focused on from a pricing standpoint, maintaining that blended between 70% and 75% gross margin rate for 2024.
Raghuram Selvaraju
Thank you.
Operator
As there are no further questions, that concludes the Q&A session. I would like to turn the conference back over to Brendan O'Grady for any closing remarks.
Brendan O'Grady
Thank you.
I appreciate everyone who has joined us today. I just want to reiterate that I believe we have a great platform, an excellent team, and a sound strategy, as well as a balance sheet that will help support further growth.
I hope that today's call has continued to demonstrate our ability to deliver steady execution on the commercial business we have today, as well as our commitment to finding the right assets to further grow the platform.
If you'd like to arrange a meeting or at an upcoming event or an update call with management, please contact Matt Kreps directly using his information provided in the press release, and we'll be happy to schedule a time to speak.
Thank you, all again for joining us today.
Operator
That concludes today's meeting. Thank you for your participation. You may now disconnect.
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Assertio (NASDAQ:ASRT)
過去 株価チャート
から 11 2024 まで 12 2024
Assertio (NASDAQ:ASRT)
過去 株価チャート
から 12 2023 まで 12 2024
