SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): May 2, 2022
Endo International plc
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
(Commission File Number)
First Floor, Minerva House, Simmonscourt Road
Ballsbridge, Dublin 4,
(Address of principal executive offices)
Registrant's telephone number, including area code 011-353-1-268-2000
(Former name or former address, if changed since last report.)
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:
☐ 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))
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
|Ordinary shares, nominal value $0.0001 per share||ENDP||The NASDAQ Global Select Market|
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 8.01. Other Events.
On May 2, 2022, Endo International plc, a public limited company incorporated in Ireland (“Endo”), issued a press release announcing the acquisition by one of its subsidiaries of six development-stage ready-to-use injectable product candidates from Nevakar Injectables, Inc., a subsidiary of Nevakar, Inc., for an upfront cash payment of $35 million. A copy of the press release issued by Endo is attached as Exhibit 99.1 hereto and is incorporated herein by reference.
Endo expects to recognize a corresponding acquired in-process research and development charge of $35 million during the second quarter of 2022 in its consolidated statements of operations prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). Additionally, as previously disclosed, beginning with its first-quarter 2022 financial reporting, Endo will no longer exclude acquired in-process research and development charges from the non-GAAP performance measures utilized in connection with its quarterly financial reporting and, as a result, this charge is also expected to affect Endo’s non-GAAP performance measures.
Cautionary Note Regarding Forward-Looking Statements
Certain information in this Current Report on Form 8-K may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation, including with respect to the financial statement effects of the transaction described herein. Statements including words or phrases such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “plan,” “will,” “may,” “look forward,” “intend,” “guidance,” “future,” “potential” or similar expressions are forward-looking statements. Because forecasts are inherently estimates that cannot be made with precision, Endo’s performance at times differs materially from its estimates and targets, and Endo often does not know what the actual results will be until after the end of the applicable reporting period. Therefore, Endo will not report or comment on its progress during a current quarter except through public announcement. Any statement made by others with respect to progress during a current quarter cannot be attributed to Endo. All forward-looking statements in this Current Report on Form 8-K reflect Endo’s current analysis of existing trends and information and represent Endo’s judgment only as of the date of this Current Report on Form 8-K. Actual results may differ materially and adversely from current expectations based on a number of factors affecting Endo’s businesses. Therefore, the reader is cautioned not to rely on these forward-looking statements. Endo expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law.
Item 9.01. Financial Statements and Exhibits.
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document)|
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.
|ENDO INTERNATIONAL PLC|
|By:||/s/ Matthew J. Maletta|
|Name:||Matthew J. Maletta|
|Title:||Executive Vice President,|
Chief Legal Officer and Company Secretary
Dated: May 2, 2022
Endo Acquires Six Development-Stage, Ready-to-Use Injectable Product Candidates From Nevakar
DUBLIN, May 2, 2022 – Endo International plc (NASDAQ: ENDP) announced today that its subsidiary Endo Ventures Limited (EVL) acquired six development-stage, ready-to-use injectable product candidates from Nevakar Injectables Inc., a subsidiary of Nevakar, Inc.
“These six product candidates that would be used in critical care settings meaningfully expand Endo’s ready-to-use injectable product pipeline,” said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. “We look forward to further developing and bringing these durable and differentiated products to market—and to the healthcare providers and patients who need them.”
The product candidates are in various stages of development, with the first launch expected in 2025. With the acquisition, Endo controls all remaining development, approval, launch and commercialization activities for these product candidates. Endo’s Par Sterile Products business will commercialize the products in the United States.
Under the terms of the agreement, EVL purchased the six product candidates from Nevakar Injectables for a one-time payment of $35 million. The one-time payment is expected to be expensed immediately in the second quarter as acquired in-process research and development costs. This acquisition is separate from Endo’s previously announced exclusive licensing agreement with Nevakar.
Ready-to-use, or RTU, products help streamline operations for hospitals by eliminating the need to prepare or transfer the product before patient administration. This may reduce waste and costs, optimize convenience and workflow and reduce the chance for preparation error—all of which support quality patient care.
Endo (NASDAQ: ENDP) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at www.endo.com or connect with us on LinkedIn.
About Nevakar Injectables, Inc.
Nevakar Injectables, Inc. is a wholly owned subsidiary of Nevakar, Inc., a fully integrated privately held, late-stage biopharmaceutical company with an extensive portfolio of products in the ophthalmic and injectable areas. Nevakar Injectables is developing a broad portfolio of injectable products for use in the hospital and ambulatory care settings. The Company has active programs in critical patient care, acute pain management, long acting injectables, and hospital injectables. For additional information please visit www.nevakarinjectables.com.
Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation including, but not limited to, the statements by Mr. Sims and any statements related to the expansion of Endo’s product pipeline or the acquisition, timing,
development, approval, launch or commercialization of any products. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this press release reflect Endo's current expectations of future events based on existing trends and information and represent Endo's judgment only as of the date of this press release. Actual results may differ materially and adversely from current expectations based on a number of factors affecting Endo's businesses, including, among other things, the following: the outcome of our strategic review, contingency planning and any potential restructuring; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust matters; actual or contingent liabilities; settlement discussions or negotiations; the impact of competition including loss of exclusivity and generic competition; our ability to satisfy judgments or settlements or to pursue appeals including bonding requirements; our ability to adjust to changing market conditions; our inability to maintain compliance with financial covenants and operating obligations which would expose us to potential events of default under our outstanding indebtedness; our ability to incur additional debt or refinance our outstanding indebtedness; a significant reduction in our short-term or long-term revenues which could cause us to be unable to fund our operations and liquidity needs; the effectiveness of advertising and other promotional campaigns; unfavorable publicity regarding the misuse of opioids; and our ability to develop our product pipeline and to continue to develop the market for products. The occurrence or possibility of any such result has caused us to engage, and may result in further engagement, in strategic reviews that ultimately may result in our pursuing one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. Those remedial measures could include a potential corporate reorganization, restructuring or bankruptcy filing involving all or a portion of our business, asset sales or other divestitures, cost-saving initiatives, corporate realignments or strategic partnerships. Some of these measures could take significant time to implement and others may require judicial or other third-party approval. Any such actions may be complex, could entail significant costs and charges or could otherwise negatively impact shareholder value, and there can be no assurance that we will be able to accomplish any of these alternatives on terms acceptable to us, or at all, or that they will result in their intended benefits. Therefore, the reader is cautioned not to rely on any forward-looking statements. Endo expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo, as well as Endo's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in Endo's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission.
Endo International plc: