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): March 21, 2016

 

 

ENDO INTERNATIONAL PLC

(Exact Name of Registrant as Specified in Its Charter)

 

 

 

Ireland		001-36326		68-0683755
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

 

First Floor, Minerva House, Simmonscourt Road, Ballsbridge, Dublin 4, Ireland		Not Applicable
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code 011-353-1-268-2000

Not Applicable

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))

 

 

 

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Item 7.01

Regulation FD Disclosure.

On March 21, 2016, Endo International plc (“Endo”) issued a press release and announced that it has posted an informational Frequently Asked Questions & Answers (Q&A) document (“Investor FAQ”) regarding the approval by the U.S. Food and Drug Administration of a competitor’s generic version of Voltaren^® Gel (diclofenac sodium topical gel) 1%. The Investor FAQ is posted on the Investor Relations section of Endo’s website at www.endo.com. A copy of the press release and Investor FAQ are attached hereto as Exhibits 99.1 and 99.2 respectively.

The information furnished under this item 7.01, including the exhibits, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities arising under that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by reference in such filing.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

 

99.1		Press Release of Endo International plc dated March 21, 2016
99.2		Investor FAQ dated March 21, 2016

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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.

 

Dated: March 21, 2016

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INDEX TO EXHIBITS

 

Exhibit Number		Description
99.1		Press Release of Endo International plc dated March 21, 2016
99.2		Investor FAQ dated March 21, 2016

Exhibit 99.1

ENDO PROVIDES STATEMENT REGARDING EXPECTED FDA APPROVAL OF

GENERIC VOLTAREN^® GEL PRODUCT

DUBLIN, March 21, 2016 — Endo International plc (NASDAQ: ENDP) (TSX: ENL) today provided a statement and a Frequently Asked Questions (FAQs) document regarding the expected approval by the U.S. Food and Drug Administration of a competitor’s generic version of Voltaren^® Gel (diclofenac sodium topical gel) 1%.

Endo is evaluating a number of options regarding Voltaren^® Gel focused on evolving its branded product strategy, determining the timing of a potential Authorized Generic product launch and maximizing overall value. The Company will provide additional detail regarding the potential financial impact of a generic entrant for Voltaren^® Gel no later than its first quarter 2016 earnings presentation in early May 2016.

Endo is also providing an FAQ document with more information. This FAQ is available on the Investor Relations section of Endo’s website at www.endo.com.

About Endo International plc

Endo International plc (NASDAQ: ENDP) (TSX: ENL) is a global specialty pharmaceutical company focused on improving patients’ lives while creating shareholder value. Endo develops, manufactures, markets and distributes quality branded and generic pharmaceutical products as well as over-the-counter medications though its operating companies. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities legislation. Statements including words such as “believes,” “expects,” “anticipates,” “intends,” “estimates,” “plan,” “will,” “may,” “look forward,” “intend,” “guidance,” “future” or similar expressions are forward-looking statements. Because these statements reflect Endo’s current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Although Endo believes that these forward- looking statements and information are based upon reasonable assumptions and expectations, readers should not place undue reliance on them, or any other forward- looking statements or information in this news release. Investors should note that many factors, as more fully described in the documents filed by Endo with securities regulators in the United States and Canada including under the caption “Risk Factors” in Endo’s Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and with securities regulators in Canada on System for Electronic Document Analysis and Retrieval (“SEDAR”) could affect Endo’s future financial results and could cause Endo’s actual results to differ materially from those expressed in the forward-looking statements contained in this press release. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities law.

Exhibit 99.2

 

Frequently Asked Questions & Answers

March 21, 2016

 

 

 

 

What is the new update for Voltaren® Gel? What has changed?				•    Endo has become aware of an expected approval for a competitor’s generic version of Voltaren® Gel (diclofenac sodium topical gel) 1% by the U.S. Food and Drug Administration (FDA).
What are the terms of Endo’s exclusive licensing agreement for Voltaren® Gel?				•    Under Endo’s December 2015 licensing agreement with Novartis AG and Sandoz Inc. (the Agreement), Endo secured exclusive U.S. marketing rights to Voltaren® Gel and the product’s Authorized Generic should Endo opt to commercially launch the Authorized Generic.   •    Endo agreed to pay royalties to Novartis or Sandoz (as designated by Sandoz) on annual net sales of Voltaren® Gel (subject to certain thresholds specified in the Agreement).   •    In addition, Endo agreed to make certain guaranteed minimum annual royalty payments and contingent royalty payments (subject to certain limitations specified in the Agreement) until the market entry of a competitive generic version of Voltaren® Gel.   •    The guaranteed annual minimum royalties due under the Agreement are creditable against royalties based on annual net sales of Voltaren® Gel such that Endo’s obligation is to pay the greater of the minimum royalties and the annual net sales royalties.   •    Endo and Novartis or Sandoz (as designated by Sandoz) will share profits relating to net sales of an Authorized Generic version of Voltaren® Gel as specified in the Agreement. Novartis or Sandoz (as designated by Sandoz) is also eligible to receive a one-time milestone payment of $25 million if annual sales of Voltaren® Gel and the Authorized Generic exceed $300 million.
What were annual sales for Voltaren® Gel in 2015?				•    2015 net revenues: $207.2 million, a 15% year-over-year increase versus 2014.   •    Endo’s adjusted gross margin for Voltaren® Gel in 2015 was above the Company’s overall adjusted gross margin average.

 

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Frequently Asked Questions & Answers

 

 

 

What assumptions are grounded in Endo’s guidance around a generic to Voltaren® Gel and what is the impact of a generic product launch to the Company’s full year 2016 guidance?				•    Endo’s guidance incorporates a risk-adjusted range of scenarios around potential generic and competitive entrants for select products, including Voltaren® Gel.   •    When Endo provided full year 2016 guidance in February 2016, the Company anticipated that a generic entrant would not materially impact Voltaren® Gel until the end of 2016.   •    In 2015, net revenues for Voltaren® Gel were $207.2 million out of total enterprise revenue of $3.269 billion (approximately 6%).   •    Should a generic entrant for Voltaren® Gel be approved, Endo will provide additional detail regarding the potential financial impact no later than its first quarter 2016 earnings presentation in early May 2016.
When will Endo next comment on 2016 guidance?				•    Should a generic entrant for Voltaren® Gel be approved, Endo will provide additional detail regarding the potential financial impact no later than its first quarter 2016 earnings presentation in early May 2016.
When was the earliest date that another company could launch a generic version of Voltaren® Gel? When is a generic product now expected to launch?				•    The patent exclusivity for Voltaren® Gel expired in October 2010.   •    Endo was aware that a competitive abbreviated new drug application (ANDA) had been filed with the U.S. Food and Drug Administration (FDA); however, because there was no patent exclusivity for Voltaren® Gel at the time of filing, the ANDA did not include a Paragraph IV certification. As with any application on file with the FDA that does not contain a Paragraph IV certification, it is difficult to predict if or when a final approval will be granted.   •    We believe an approval has now been granted to a competitor’s generic version of Voltaren® Gel; however Endo is unable to predict the exact timing or scope of a potential generic launch.
Will Endo launch an Authorized Generic (AG) of Voltaren® Gel? If so, when will that happen?				•    For competitive reasons, Endo cannot comment on the specifics of its commercial strategy.   •    The Company’s current focus is on understanding an approved competitor’s ability to launch a generic version of Voltaren® Gel and, importantly, to sufficiently supply the market with that product.   •    Endo is evaluating all options and is focused on executing a strategy that maximizes the value of Voltaren® Gel.

 

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Frequently Asked Questions & Answers

 

 

 

Do you expect another generic entrant to Voltaren® Gel in the future?				•    We are not aware of any other generic Voltaren® Gel products with filings at the FDA.
Does this impact Endo’s pain sales force size, shape or footprint in anyway?				•    Endo has no plans to reduce its pain sales force, which has been sized appropriately to support a successful launch of BELBUCA®.
				FORWARD LOOKING STATEMENTS
				Statements contained in this communication referring to future events or other non-historical facts are forward looking statements reflecting Endo’s current perspective of existing trends and information. If underlying assumptions prove inaccurate or unknown, or unknown risks or uncertainties materialize, actual results could vary materially from Endo’s expectations and projections. Risks and uncertainties include, among other things, the risks and uncertainties described in Endo’s periodic reports filed with the SEC and Canadian securities regulators, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which apply only as of the date of this communication. Endo expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information about Endo is available at www.endo.com or you can contact the Endo Investor Relations Department by calling 484-216-0000.

 

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