0001104659-21-150193.txt : 20211216 0001104659-21-150193.hdr.sgml : 20211216 20211216060515 ACCESSION NUMBER: 0001104659-21-150193 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20211215 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Completion of Acquisition or Disposition of Assets ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20211216 DATE AS OF CHANGE: 20211216 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Assertio Holdings, Inc. CENTRAL INDEX KEY: 0001808665 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 850598378 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39294 FILM NUMBER: 211495912 BUSINESS ADDRESS: STREET 1: 100 S. SAUNDERS ROAD STREET 2: SUITE 300 CITY: LAKE FOREST STATE: IL ZIP: 60045 BUSINESS PHONE: (224) 419-7106 MAIL ADDRESS: STREET 1: 100 S. SAUNDERS ROAD STREET 2: SUITE 300 CITY: LAKE FOREST STATE: IL ZIP: 60045 8-K 1 tm2135560d1_8k.htm FORM 8-K
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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)
December 16, 2021 (December 15, 2021)

 

 

 

ASSERTIO HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-39294   85-0598378
(State or other jurisdiction of
incorporation)		   (Commission
File Number)		   (IRS Employer
Identification No.)

 

100 South Sanders Rd., Suite 300,
Lake Forest, IL 60045

(Address of principal executive offices, including 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:

 

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.      ¨

 

 

 

 

 

  

Item 1.01 Entry into a Material Definitive Agreement.

 

On December 15, 2021, Assertio Holdings, Inc. (the “Company”), through its newly-formed subsidiary, Otter Pharmaceuticals, LLC, entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Antares Pharma, Inc. (“Antares”), and concurrently consummated the transactions contemplated by the Purchase Agreement (the “Closing”).

 

Pursuant to the terms of the Purchase Agreement, the Company acquired Antares’ rights, title and interest in and to Otrexup® (methotrexate), a drug device combination single-dose once weekly auto-injector for subcutaneous use (“Otrexup”), including certain related assets, intellectual property and product inventory (the “Transaction”) for (i) $18.0 million in cash payable at the Closing, (ii) $16.0 million in cash payable on May 31, 2022 and (iii) and $10.0 million in cash payable on December 15, 2022. Pursuant to the terms of the Purchase Agreement, the Company also assumed certain contracts, liabilities and obligations of Antares relating to Otrexup.

 

The Purchase Agreement contains customary representations, warranties and covenants, as well as indemnification provisions subject to specified limitations. In connection with the Transaction, the Company (i) received an exclusive, fully paid-up, royalty-free, irrevocable, transferable license, with the right to sublicense, to certain intellectual property of Antares pursuant to the terms of a license agreement and (ii) entered into a supply agreement with Antares for the certain components of Otrexup and the manufacture of products.

 

The foregoing summary of the Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the Purchase Agreement, a copy of which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2021.

 

Item 2.01 Completion of Acquisition or Disposition of Assets.

 

The disclosure set forth above in Item 1.01 of this Current Report on Form 8-K with respect to the Transaction is incorporated by reference herein. 

 

Item 7.01 Other Events

 

On December 15, 2021, the Company issued a press release announcing certain of the matters described in this Current Report on Form 8-K. A copy of this press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K. The information set forth in this Item 7.01 and in Exhibit 99.1 shall not be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.

 

 

 

 

Special Note Regarding Forward Looking Statements

 

Statements included herein that are not historical facts are forward-looking statements that reflect the Company’s management’s current expectations, assumptions and estimates of future performance and economic conditions. These forward-looking statements are made in reliance on the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, future events or the future performance or operations of the Company. All statements other than historical facts may be forward-looking statements and can be identified by words such as “anticipate,” “believe,” “could,” “design,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “imply,” “intend,” “may”, “objective,” “opportunity,” “outlook,” “plan,” “position,” “potential,” “predict,” “project,” “prospective,” “pursue,” “seek,” “should,” “strategy,” “target,” “would,” “will,” “aim” or other similar expressions that convey the uncertainty of future events or outcomes are used to identify forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors, some of which are beyond the control of the Company. Factors that could cause the Company actual results to differ materially from those implied in the forward-looking statements include: (1) risks related to the Company’s commercialization of Otrexup using its non-personal and digital promotion strategies; (2) the Company’s ability to realize the anticipated benefits of the Transaction, including the possibility that the expected benefits from the Transaction will not be realized or will not be realized within the expected time period; (3) potential liabilities and/or litigation related to the Transaction, including risks associated with the supply agreement between the Company and Antares and/or third-party contracts assumed by the Company in the Transaction; (4) risks related to disruption of management time from ongoing business operations due to the Transaction, the restructuring of the Company’s workforce announced on December 15, 2020 (the “Restructuring”) and/or the integration of the merger with Zyla Life Sciences (the “Merger”); (5) unexpected costs, charges or expenses resulting from the Transaction, the Restructuring and/or the Merger; (6) the ability of the Company to retain key personnel; (7) potential adverse changes to business relationships resulting from the Transaction and/or the Merger; (8) the Company’s ability to achieve the growth prospects and synergies expected from the Transaction and the Merger, as well as delays, challenges and expenses associated with integrating the Company’s businesses; (9) negative effects of the Transaction and/or Merger on the market price of the Company’s common stock, credit ratings and operating results; (10) legislative, regulatory and economic developments, including changing business conditions in the industries in which the Company operates; (11) the Company’s ability to successfully pursue and complete business development, strategic partnerships, and investment opportunities to build and grow for the future; (12) the commercial success and market acceptance of the Company’s products; (13) coverage of the Company’s products by payors and pharmacy benefit managers; (14) the Company’s ability to execute on its sales, marketing and non-personal and digital promotion strategies, including developing relationships with customers, physicians, payors and other constituencies; (15) the entry of any generic products for any of the Company’s products; (16) the outcome of the Company’s opioid-related investigations, the Company’s opioid-related litigation and related claims for insurance coverage, and the Company’s securities class action and other disputes and litigation, and the costs and expenses associated therewith; (17) the outcome of the Company’s antitrust litigation relating to the drug Glumetza®; (18) the Company’s estimates regarding expenses, future revenues, capital requirements and needs for additional financing; (19) the Company’s ability to generate sufficient cash flow from its business to make payments on its indebtedness; (20) the Company’s ability to restructure or refinance its indebtedness and the Company’s compliance with the terms and conditions of the agreements governing its indebtedness; (21) compliance or non-compliance with legal and regulatory requirements related to the development or promotion of pharmaceutical products in the U.S.; (22) the Company’s plans to acquire, in-license or co-promote other products, and/or acquire companies; (23) the Company’s ability to raise additional capital, if necessary; (24) variations in revenues obtained from collaborative agreements; (25) the Company’s counterparties’ compliance or non-compliance with obligations under agreements; (26) the ability of the Company’s common stock to maintain compliance with Nasdaq’s minimum closing bid requirement of at least $1.00 per share; (27) obtaining and maintaining intellectual property protection for the Company’s products; (28) the Company’s ability to operate its business without infringing the intellectual property rights of others; (29) the impact of disasters, acts of terrorism or global pandemics, including COVID-19; (30) general market conditions; and (31) other risks listed in the Company’s filings with the United States Securities and Exchange Commission (“SEC”). These risks are more fully described in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC and in other filings the Company makes with the SEC from time to time. Investors and potential investors are urged not to place undue reliance on forward-looking statements in this communication, which speak only as of this date. While the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to update or revise any forward-looking-statements contained herein whether as a result of new information or future events, except as may be required by applicable law. Nothing contained herein constitutes or will be deemed to constitute a forecast, projection or estimate of the future financial performance or expected results of the Company.

 

 

 

 

Item 9.01 Financial Statements and Exhibits.

 

(a) Financial statements of business acquired.

 

The financial statements required by this Item 9.01(a) are not included in this Current Report on Form 8-K. The Company intends to file such financial statements by amendment to this Current Report on Form 8-K not later than 71 calendar days after the date this Current Report on Form 8-K is required to be filed.

 

(b) Pro forma financial information.

 

The pro forma financial information required by this Item 9.01(b) is not included in this Current Report on Form 8-K. The Company intends to file such pro forma financial information by amendment to this Current Report on Form 8-K not later than 71 calendar days after the date this Current Report on Form 8-K is required to be filed.

 

(d)       Exhibits

 

99.1       Assertio Holdings, Inc. Press Release issued on December 15, 2021

 

104       Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: December 16, 2021

 

  ASSERTIO HOLDINGS, INC.
   
  /s/ Dan Peisert
  Dan Peisert
  President and Chief Executive Officer

 

 

 

 

 EX-99.1 2 tm2135560d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

Assertio Holdings, Inc. Announces the Acquisition of Otrexup® (methotrexate) a Drug Device Combination from Antares Pharma, Inc.

 

Trailing 12 Month Reported Revenues of Otrexup Were $15.5 Million

 

Assertio will Pay Antares $18.0 Million Upfront and an Additional $26.0 Million in Deferred Payments

 

Raises Full Year Net Product Sales and Non-GAAP Adjusted EBITDA Guidance 

 

LAKE FOREST, IL. – December 15, 2021 – Assertio Holdings, Inc., (“Assertio” or “the Company”) (Nasdaq: ASRT), a leading commercial pharmaceutical company bringing differentiated products to patients, today announced it has acquired Otrexup (methotrexate), a drug device combination single dose once weekly auto-injector, from Antares Pharma, Inc. (“Antares”) in the Company’s first new product acquisition since 2015. The acquisition was made through a subsidiary of the Company.

 

“The acquisition of Otrexup is a strategic and synergistic fit with our unique digital platform and a growth driver for Assertio for years to come,” said Dan Peisert, President and Chief Executive Officer of Assertio. “With nearly ten years of patent life remaining, we intend to invest in the further commercialization of Otrexup and see potential by leveraging our platform and expertise for growth. This acquisition represents yet another milestone in our transformation, will be accretive to adjusted EBITDA in 2022, and is the first step towards our goal of acquiring new products to deliver at least $50 million in gross profit by 2024”.

 

Under the terms of the definitive agreements, Assertio acquired Otrexup from Antares in a partially seller financed transaction for a total purchase price of $44.0 million inclusive of working capital investments. Payment terms are as follows:

 

•$18.0 million in cash on December 15, 2021
•$16.0 million in cash on May 31, 2022
•$10.0 million in cash on December 15, 2022

 

Updated 2021 Financial Guidance:

 

Due to strong sales of its existing portfolio of products, the Company announces it has further raised its full-year net product sales and non-GAAP adjusted EBITDA guidance:

 

  11/4/21 Guidance Updated Guidance
Net Product Sales (GAAP) Greater than $103.0 Million Greater Than $108.0 Million
Adjusted EBITDA (Non-GAAP) (1) Greater than $43.0 Million Greater Than $48.0 Million

  

(1) See “Non-GAAP Financial Measures” below for additional information.

 

About Otrexup

 

Trade Name

Otrexup

(methotrexate) injection for subcutaneous use

Device VIBEX® auto-injector
Last to Expire Orange Book Listed Patent May 2031
Trailing 12 Months Revenue Ended 9/30/21 $15.5 Million
Approximate Gross Margin Percent Low 70%’s

 

Otrexup is a once weekly single dose auto-injector containing a prescription medicine, methotrexate, which is indicated for:

 

·Certain adults with severe, active rheumatoid arthritis, and children with active polyarticular juvenile idiopathic arthritis (pJIA), after treatment with other medicines including non-steroidal anti-inflammatory drugs (NSAIDS) have been used and did not work well.
·Control the symptoms of severe, resistant, disabling psoriasis in adults when other types of treatment have been used and did not work well.

 

Otrexup should not be used for the treatment of cancer.

Otrexup should not be used for the treatment of children with psoriasis

 

Please see full prescribing information including important safety information at www.otrexup.com.

 

 

 

 

About Assertio

 

Assertio is a leading commercial pharmaceutical company bringing differentiated products to patients. The Company has a robust portfolio of branded prescription products in three areas: neurology, hospital and pain and inflammation. Assertio has grown through business development including licensing, mergers, and acquisitions. To learn more about Assertio, visit www.assertiotx.com.

 

About Antares Pharma

 

Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s FDA-approved products include XYOSTED® (testosterone enanthate) injection and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® (desmopressin acetate) in the U.S. and expects to commercially launch TLANDO® (testosterone undecanoate) in the U.S. pending final FDA approval.

 

Investor Contact

 

Max Nemmers

Head, Investor Relations and Administration

investor@assertiotx.com

 

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 and adjusted EBITDA 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.

 

This release also includes estimated non-GAAP adjusted EBITDA 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 reconciliation of estimated non-GAAP adjusted EBITDA to estimated net income is provided in this release because some of the information necessary for estimated net income 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 estimated net income without unreasonable effort.

 

2 

 

 

Forward Looking Statements

 

Statements in this communication that are not historical facts are forward-looking statements that reflect Assertio's current expectations, assumptions and estimates of future performance and economic conditions. These forward-looking statements are made in reliance on the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, future events or the future performance or operations of Assertio. All statements other than historical facts may be forward-looking statements and can be identified by words such as "anticipate," "believe," "could," "design," "estimate," "expect," "forecast," "goal," "guidance," "imply," "intend," "may", "objective," "opportunity," "outlook," "plan," "position," "potential," "predict," "project," "prospective," "pursue," "seek," "should," "strategy," "target," "would," "will," "aim" or other similar expressions that convey the uncertainty of future events or outcomes are used to identify forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors, some of which are beyond the control of Assertio. Factors that could cause Assertio's actual results to differ materially from those implied in the forward-looking statements include: (1) risks related to the Company’s commercialization of Otrexup using its non-personal and digital promotion strategies; (2) the Company’s ability to realize the anticipated benefits of the acquisition of Otrexup (the “Transaction”), including the possibility that the expected benefits from the Transaction will not be realized or will not be realized within the expected time period; (3) potential liabilities and/or litigation related to the Transaction, including risks associated with the supply agreement between the Company and Antares and/or third-party contracts assumed by the Company in the Transaction; (4) risks related to disruption of management time from ongoing business operations due to the Transaction and/or restructuring of Assertio’s workforce announced on December 15, 2020 (the “Restructuring”) and/or the integration of the merger with Zyla Life Sciences (the “Merger”); (5) unexpected costs, charges or expenses resulting from the Transaction, the Restructuring and/or the Merger; (6) the ability of the Assertio to retain key personnel; (7) potential adverse changes to business relationships resulting from the Transaction and/or the Merger; (8) the Company's ability to achieve the growth prospects and synergies expected from the Transaction and/or the Merger, as well as delays, challenges and expenses associated with integrating the Company’s businesses; (9) negative effects of the Transaction and/or the Merger on the market price of Assertio's common stock, credit ratings and operating results; (10) legislative, regulatory and economic developments, including changing business conditions in the industries in which Assertio operates; (11) Assertio's ability to successfully pursue and complete business development, strategic partnerships, and investment opportunities to build and grow for the future; (12) the commercial success and market acceptance of Assertio's products; (13) coverage of Assertio’s products by payors and pharmacy benefit managers; (14) Assertio’s ability to execute on its sales, marketing and non-personal and digital promotion strategies, including developing relationships with customers, physicians, payors and other constituencies; (15) the entry of any generic products for any of Assertio’s products; (16) the outcome of Assertio’s opioid-related investigations, Assertio’s opioid-related litigation and related claims for insurance coverage, and Assertio’s securities class action and other disputes and litigation, and the costs and expenses associated therewith; (17) the outcome of Assertio’s antitrust litigation relating to the drug Glumetza®; (18) Assertio's estimates regarding expenses, future revenues, capital requirements and needs for additional financing; (19) Assertio's ability to generate sufficient cash flow from its business to make payments on its indebtedness; (20) Assertio's ability to restructure or refinance its indebtedness and Assertio's compliance with the terms and conditions of the agreements governing its indebtedness; (21) compliance or non-compliance with legal and regulatory requirements related to the development or promotion of pharmaceutical products in the U.S.; (22) Assertio's plans to acquire, in-license or co-promote other products, and/or acquire companies; (23) Assertio's ability to raise additional capital, if necessary; (24) variations in revenues obtained from collaborative agreements; (25) Assertio's counterparties’ compliance or non-compliance with obligations under agreements; (26) the ability of Assertio's common stock to maintain compliance with Nasdaq's minimum closing bid requirement of at least $1.00 per share; (27) obtaining and maintaining intellectual property protection for Assertio’s products; (28) Assertio’s ability to operate its business without infringing the intellectual property rights of others; (29) the impact of disasters, acts of terrorism or global pandemics, including COVID-19; (30) general market conditions; and (31) other risks listed in Assertio's filings with the United States Securities and Exchange Commission ("SEC"). These risks are more fully described in Assertio's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC and in other filings Assertio makes with the SEC from time to time. Investors and potential investors are urged not to place undue reliance on forward-looking statements in this communication, which speak only as of this date. While Assertio may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to update or revise any forward-looking-statements contained in this press release whether as a result of new information or future events, except as may be required by applicable law. Nothing contained herein constitutes or will be deemed to constitute a forecast, projection or estimate of the future financial performance or expected results of Assertio.

 

3 

 

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Cover
Dec. 15, 2021
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Dec. 15, 2021
Entity File Number 001-39294
Entity Registrant Name ASSERTIO HOLDINGS, INC.
Entity Central Index Key 0001808665
Entity Tax Identification Number 85-0598378
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 100 South Sanders Rd
Entity Address, Address Line Two Suite 300
Entity Address, City or Town Lake Forest
Entity Address, State or Province IL
Entity Address, Postal Zip Code 60045
City Area Code 224
Local Phone Number 419-7106
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $0.0001 par value
Trading Symbol ASRT
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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