bhc-20220729

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

July 29, 2022

Date of report (Date of earliest event reported)

Bausch Health Companies Inc.

(Exact name of registrant as specified in its charter)

British Columbia

Canada

001-14956

98-0448205

(State or other jurisdiction of incorporation)

(Commission file number)

(IRS Employer Identification No.)

2150 St. Elzéar Blvd. West, Laval, Québec, Canada H7L 4A8

(Address of Principal Executive Offices) (Zip Code)

(514) 744-6792

(Registrant's telephone number, including area code)

N/A

(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
Common Shares, No Par Value	BHC	New York Stock Exchange	Toronto Stock Exchange

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 July 28, 2022, Bausch Health Companies Inc. (the “Company” or “Bausch Health”), and its gastroenterology business, Salix Pharmaceuticals, issued a press release announcing that the U.S. District Court of Delaware (the “Court”) issued an oral order in the matter of Salix Pharmaceuticals, Ltd. et al v. Norwich Pharmaceuticals, Inc., regarding the infringement and validity of certain U.S. Patents protecting the composition and use of XIFAXAN® (rifaximin) 550 mg tablets for the treatment of irritable bowel syndrome with diarrhea (IBS-D) and reduction in risk of overt hepatic encephalopathy (HE) recurrence. The oral order indicates that the Court will find certain of the Company’s U.S. patents protecting the use of XIFAXAN® (rifaximin) 550 mg tablets for the reduction in risk of HE recurrence valid and infringed, and U.S. patents protecting the composition, and use of XIFAXAN® for treating IBS-D invalid. The Company strongly disagrees with any conclusion that its patents are not valid. When the Court enters a final order, the Company will consider all available options to vigorously defend the intellectual property protecting XIFAXAN® and intends to appeal the Court’s decision to the U.S. Court of Appeals for the Federal Circuit.

A copy of the press release is attached as Exhibit 99.1 to this Current Report Form 8-K and is incorporated herein by reference.

This Current Report on Form 8-K contains forward-looking statements, including statements about the Company’s intention to file an appeal with respect to, and consideration of options to vigorously defend, its intellectual property. Forward-looking statements may generally be identified by the use of the words “anticipates,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, Bausch Health can offer no assurance that the Court will issue a final judgment consistent with the oral order, as to the timing of any approval by the FDA of any ANDA or amended ANDA and as to the outcome of any appeal. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health’s overall business, including those more fully described in Bausch Health’s most recent annual report on Form 10-K and detailed from time to time in Bausch Health’s other filings with the U.S. Securities and Exchange Commission and the Canadian securities administrators, which factors are incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits



99.1						Press release issued by the Company on July 28, 2022.
104						Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

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:July 29, 2022


			BAUSCH HEALTH COMPANIES INC.


By:			/s/ Seana Carson
			Name: Seana Carson
			Title: Executive Vice President, General Counsel

Investor Contact: Media Contacts:

Christina Cheng Kevin Wiggins

[email protected] [email protected]

(514) 856-3855 (848) 541-3785

(877) 281-6642 (toll free)

Bausch Health Provides Update Following Oral Order in XIFAXAN® Patent Litigation

-- Company to Appeal Expected Court Decision on Certain XIFAXAN® Patents –

LAVAL, Quebec, July 28, 2022 – Bausch Health Companies Inc. (NYSE/TSX: BHC), and its gastroenterology business Salix Pharmaceuticals, today announced the U.S. District Court of Delaware issued an Oral Order in the matter of Salix Pharmaceuticals, Ltd. et al v. Norwich Pharmaceuticals, Inc. regarding the infringement and validity of certain U.S. Patents protecting the composition and use of XIFAXAN® (rifaximin) 550 mg tablets for the treatment of irritable bowel syndrome with diarrhea (IBS-D) and reduction in risk of overt hepatic encephalopathy (HE) recurrence.

The Oral Order indicates that the Court will find certain U.S. Patents protecting the use of XIFAXAN® (rifaximin) 550 mg tablets for the reduction in risk of HE recurrence valid and infringed and U.S. Patents protecting the composition, and use of XIFAXAN® for treating IBS-D invalid. While the Court has not yet entered any final judgement, absent Norwich’s removal of the HE indication and data from their Abbreviated New Drug Application (ANDA), it is expected that the Court will enjoin Norwich’s pending ANDA until expiration of the XIFAXAN® HE Patents in 2029. The Company intends to vigorously oppose any attempt by Norwich to remove the HE safety data from its ANDA in an effort to avoid the XIFAXAN® HE Patents.

The FDA has stated that they plan to make a major revision to the rifaximin product specific guidance to add an in vivo bioequivalency study. Until an approval of a revised ANDA is granted by the FDA and the expected injunction modified by the Court, Norwich is not permitted to launch a generic equivalent of XIFAXAN®.

When the Court enters a final order, Bausch Health will consider all available options to vigorously defend the intellectual property protecting XIFAXAN® and will appeal the Court’s decision to the U.S. Court of Appeals for the Federal Circuit.

“We are disappointed with today’s development. We strongly disagree with any conclusion that our patents are not valid and intend to file an appeal to any such order,” Thomas J. Appio, CEO, Bausch Health, said. “As a leader in gastrointestinal health, protecting our intellectual property is essential to our ability to continue to develop innovative therapies. We intend to vigorously pursue all available

options to challenge any final ruling, while also continuing to drive growth and innovation for our XIFAXAN® franchise.”

Bausch Health has previously entered into settlement agreements with Teva, Sun Pharmaceuticals, and Sandoz to permit a generic rifaximin product entry in 2028 or upon an earlier approval and launch of a generic rifaximin product. Until, and if, Norwich secures FDA approval for its generic rifaximin product and subsequently launches a generic rifaximin product, Teva, Sun Pharmaceuticals, and Sandoz will not be permitted to launch a generic version of XIFAXAN® tablets before 2028.

The Company intends to file an appeal immediately after any final order is issued, assuming it is consistent with the Oral Order.

About XIFAXAN
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

About Salix

Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.

About Bausch Health

Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our approximately 90% ownership of Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.

Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions, including statements about the timing and details of the future plans for Solta and its future performance. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, Bausch Health can offer no assurance that the Court will issue a final judgment consistent with the Oral Order, as to the timing of any approval by the FDA of any ANDA or amended ANDA and as to the outcome of any appeal. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian securities administrators, which factors are incorporated herein by reference.

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