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):    July 27, 2018

PERNIX THERAPEUTICS HOLDINGS, INC.
(Exact name of registrant as specified in its charter)

Maryland

 

001-14494

 

33-0724736

(State or Other Jurisdiction

 

(Commission File Number)

 

(IRS Employer Identification No.)

10 North Park Place, Suite 201, Morristown, NJ

 

07960

(Address of principal executive offices)

 

(Zip Code)

Registrant's telephone number, including area code: (800) 793-2145

(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 ( see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o 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      o     

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.      o     



Item 1.01     Entry into Material Definitive Agreements.

On July 27, 2018 (the "Closing Date"), Nalpropion Pharmaceuticals, Inc. ("Nalpropion"), a special purpose vehicle jointly owned by a wholly owned subsidiary of Pernix Therapeutics Holdings, Inc. (the "Company") and funds managed by Highbridge Capital Management, LLC ("Highbridge") and Whitebox Advisors LLC ("Whitebox"), closed the transactions contemplated by that certain Asset Purchase Agreement, dated April 23, 2018, by and between Orexigen Therapeutics, Inc. ("Orexigen") and Nalpropion (the "Asset Purchase Agreement"). On the Closing Date, Nalpropion acquired substantially all of the assets of Orexigen, including worldwide rights to Contrave ® (naltrexone HCl / bupropion HCl) ("Contrave"), a prescription-only weight loss medication (the "Orexigen Acquisition"). The final purchase price for the Orexigen Acquisition was $73.5 million.

Services Agreement

In connection with the Orexigen Acquisition, Nalpropion and Pernix Therapeutics, LLC ("Pernix LLC"), a wholly owned subsidiary of Pernix, entered into a services agreement (the "Services Agreement"), pursuant to which Nalpropion appointed Pernix LLC to perform certain services on behalf of Nalpropion. Pursuant to the Services Agreement, Pernix LLC will manage and operate Nalpropion, including as the exclusive distributor of Contrave in the United States, during the term of the Services Agreement. In further ance of such services, John A. Sedor, the Company's Chairman of the Board and Chief Executive Officer, Kenneth R. Pińa, the Company's Senior Vice President, Chief Legal & Compliance Officer and Corporate Secretary, and Angus W. Smith, the Company's Senior Vice President, Chief Business Officer and Principal Financial Officer, will serve as officers of Nalpropion and will allocate a portion of their time of employment with the Company to performing such services for Nalpropion.

In consideration for Pernix LLC's services, Nalpropion shall pay certain fees to Pernix LLC, including (i) certain shared services expenses related to the compensation and overhead expenses of Pernix LLC allocated to Nalpropion, which aggregate fees are capped at (x) $6 million per annum until December 31, 2023 (pro rated for any partial year) and (y) $4 million per annum from January 1, 2024 (pro rated for any partial year) until expiration or termination of the Services Agreement and (ii) a management fee equal to 5% of Nalpropion's net sales.

The initial term of the Services Agreement is two years, subject to automatic renewals of consecutive one-year terms unless Nalpropion elects not to renew the Services Agreement at least 90 days prior to the end of the then current term (the "Non-Renewal Right"), in which case Nalpropion will pay $4,000,000 to Pernix LLC within thirty business days after the expiration of the then current term. If at any time Pernix LLC holds at least 35% of the then outstanding capital stock of Nalpropion, then Nalpropion may not exercise the Non-Renewal Right without the prior written consent of Pernix LLC.

The Services Agreement may be terminated by either party upon written notice to the other party for, among other reasons, an uncured material breach. Nalpropion also has the right to terminate the Services Agreement upon 120 days' prior written notice; provided, however, that Nalpropion must pay $5,000,000 to Pernix LLC within thirty business days after the effective date of such termination. Nalpropion may also terminate the Services Agreement if, at any time, any two of John A. Sedor, Kenneth R. Pińa or Angus W. Smith are no longer employed by or hold substantially the same position at Pernix LLC, unless Pernix LLC replaces such individuals with persons reasonably acceptable to Nalpropion within a specified period of time.

The foregoing description of the Services Agreement does not purport to be complete and is qualified in its entirety by reference to the Services Agreement, a copy of which will be filed with the Company's Quarterly Report on Form 10-Q for the quarter ending September 30, 2018.


Stockholders' Agreement

In connection with the Orexigen Acquisition, Pernix Ireland Pain Designated Activity Company ("PIP DAC"), a wholly owned subsidiary of the Company, entered into a Stockholders' Agreement with Nalpropion, Highbridge and Whitebox (the "Stockholders' Agreement" and together with the Asset Purchase Agreement and the Services Agreement, the "Transaction Documents"), which sets forth the parties' agreement with respect to the funding, activities and management of Nalpropion. The Stockholders' Agreement contains customary provisions regarding board composition and authority, transfer restrictions, pre-emptive rights, rights of first refusal and drag-along and tag-along rights. In addition, PIP DAC has two purchase options to acquire up to 49.9% and 100% of Nalpropion at specified time periods and purchase prices.

The foregoing description of the Stockholders' Agreement does not purport to be complete and is qualified in its entirety by reference to the Stockholders' Agreement. The Company will seek from the Securities and Exchange Commission confidential treatment for portions of the Stockholders' Agreement, which Stockholders' Agreement, subject to such confidential treatment, will be filed with the Company's Quarterly Report on Form 10-Q for the quarter ending September 30, 2018.

Nalpropion Credit Agreement

In connection with the consummation of the Orexigen Acquisition, PIP DAC, and certain affiliates of

Highbridge and Whitebox, as lenders, entered into a certain credit agreement to provide Nalpropion with a loan

facility in the amount of $45,833,000 (the "Credit Agreement") to finance, in part, the Orexigen Acquisition and working capital for Nalpropion. PIP DAC's contribution is in the amount of $4,583,000.00. The Credit Agreement will mature on July 27, 2021 and will bear interest at the rate equal to 8% per annum. The Credit Agreement contains customary representations and warranties, affirmative and negative covenants and events of default applicable to Nalpropion and its subsidiaries that are customary for credit facilities of this type. The entire loan facility under the Credit Agreement was funded on the Closing Date.

Amendment to Existing ABL Credit Agreement

In connection with the Orexigen Acquisition, the Company and certain of its subsidiaries also entered into an amendment of the Company's existing asset-based revolving credit agreement (the "ABL Credit Agreement") with Cantor Fitzgerald Securities, ("Cantor") as agent, and the lenders party thereto to permit the Orexigen Acquisition and certain other transactions contemplated by the Transaction Documents, including the entry into and performance of its obligations under the Services Agreement by the Company's subsidiary, Pernix LLC.

The foregoing description of the amendment to the ABL Credit Agreement does not purport to be complete and is qualified in its entirety by reference to the amendment to the ABL Credit Agreement, a copy of which will be filed with the Company's Quarterly Report on Form 10-Q for the quarter ending September 30, 2018.

Amendment to the Existing Term Facility

In connection with the Orexigen Acquisition, PIP DAC utilized the proceeds of a new term loan in the aggregate principal amount of $9,167,000 (the "New Term Loan") incurred by PIP DAC under its existing delayed draw term loan facility (the "Existing Term Facility") among PIP DAC, Cantor, as agent, and the lenders party thereto. These funds were used to finance PIP DAC's investment in Nalpropion. PIP DAC also entered into an amendment of the Existing Term Facility to permit the New Term Loan, the Orexigen Acquisition and certain other transactions contemplated by the Transaction Documents.

The foregoing description of the amendment to the Existing Term Facility does not purport to be complete and is qualified in its entirety by reference to the amendment to the Existing Term Facility, a copy of which will be filed with the Company's Quarterly Report on Form 10-Q for the quarter ending September 30, 2018.


Supplemental Indenture

In connection with the Orexigen Acquisition, PIP DAC, as issuer, the Company and certain of the Company's wholly owned subsidiaries, as guarantors, and Wilmington Trust, National Association, as trustee, entered into a supplemental indenture (the "First Supplemental Indenture") to that certain indenture dated as of July 21, 2017 (the "Exchangeable Senior Notes Indenture") governing PIP DAC's 4.25%/5.25% Exchangeable Senior Notes due 2022. Pursuant to the First Supplemental Indenture, certain definitions and covenants in the Exchangeable Senior Notes Indenture were amended to facilitate the Orexigen Acquisition and the transactions contemplated by the Transaction Documents.

The foregoing description of the First Supplemental Indenture does not purport to be complete and is qualified in its entirety by reference to the First Supplemental Indenture, a copy of which will be filed with the Company's Quarterly Report on Form 10-Q for the quarter ending September 30, 2018.

Item 2.03     Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

The information set forth in Item 1.01 of this Form 8-K is incorporated by reference into this Item 2.03.

Item 8.01     Other Events.

On July 30, 2018, the Company issued a press release announcing the Orexigen Acquisition. A copy of the press release is attached as Exhibit 99.1 to this Form 8-K and is incorporated by reference into this Item 8.01.

Item 9.01     Financial Statements and Exhibits

(a) Financial Statements of Businesses Acquired.

Any financial statements required by this item will be filed by the Company by amendment to this Current Report on Form 8-K not later than 71 days after the date on which this Current Report on Form 8-K was required to be filed.

(b) Pro Forma Financial Information.

Any pro forma information required by this item will be filed by the Company by amendment to this Current Report on Form 8-K not later than 71 days after the date on which this Current Report on Form 8-K was required to be filed.

(d) Exhibits.

The following exhibits are being filed herewith: 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release dated July 30, 2018, issued by Pernix Therapeutics Holdings, Inc.

 


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.

 

PERNIX THERAPEUTICS HOLDINGS, INC.

 

 

 

 

 

Date:  July 31, 2018

By:

/s/ John A. Sedor

 

 

 

John A. Sedor

 

 

 

Chief Executive Officer

 

 

 


Exhibit 99.1

Pernix Therapeutics Announces Successful Closing of Transaction Regarding Worldwide Rights to Contrave ® for Weight Loss

MORRISTOWN, N.J. - July 30, 2018 - Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX), a specialty pharmaceutical company, today announced the closing of a transaction in which Nalpropion Pharmaceuticals, Inc. ("Nalpropion"), a special purpose vehicle ("SPV"), has acquired certain assets of Orexigen Therapeutics, Inc. ("Orexigen"), including worldwide rights to Contrave ® (naltrexone HCl / bupropion HCl), a market-leading, prescription-only weight loss medication. Nalpropion's investors are comprised of Pernix and funds managed by two leading investment management firms, Highbridge Capital Management, LLC and Whitebox Advisors LLC. Per terms of the transaction, Pernix will assume responsibility for the distribution of Contrave ® in the United States and manage Nalpropion for an initial term of two years.

"We are excited that Nalpropion prevailed in the auction and has now closed the transaction. We believe that our participation in the SPV provides an attractive opportunity to leverage our current commercial and corporate infrastructure and, as a result, has the potential to create significant value for our shareholders. Contrave ® is the #1 prescribed weight loss brand in the U.S., having generated more than 2.5 million prescriptions since launch in the third quarter of 2014, and delivered over 20% total prescription growth in 2017," said John Sedor, Chairman and Chief Executive Officer of Pernix. "In the near term, Pernix will recognize immediate benefits in the form of a management fee and reimbursement for shared services."

Pursuant to an amendment to the Asset Purchase Agreement, Nalpropion and Orexigen have agreed to a reduction in the purchase price from $75.0 million to $73.5 million. As part of Nalpropion's investor group, Pernix agreed to contribute 10% of the capital required for the purchase price and working capital needs, funded through its existing delayed draw term loan facility. Pernix will invest a total of approximately $9.2 million, consisting of $7.4 million for the purchase price and $1.8 million in working capital.

Going forward, under the terms of the transaction, Pernix will receive a management fee equal to 5% of Nalpropion's net sales and reimbursement of certain shared services expenses at cost in exchange for assuming responsibility for product distribution in the United States and managing Nalpropion for an initial term of two years.  In addition, Pernix will receive two purchase options to acquire up to 49.9% and 100% of Nalpropion at specified time periods and purchase prices.

About Contrave®

Contrave® is an extended-release, fixed dose combination of bupropion HCl, and naltrexone HCl. It was approved by the U.S. Food and Drug Administration (FDA) in 2014 as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m 2 or greater (obese), or 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbid condition. Net sales in the U.S. were approximately $75 million in 2017. Contrave®, known as Mysimba TM (naltrexone HCl and bupropion HCl prolonged release) in certain markets outside the U.S., is also marketed in 25 additional countries where it is distributed by a network of partners.


About Pernix Therapeutics

Pernix Therapeutics is a specialty pharmaceutical business with a focus on acquiring, developing and commercializing prescription drugs primarily for the U.S. market.  The Company is currently focused on the therapeutic areas of Pain and Neurology, and has an interest in expanding into additional specialty segments.  The Company promotes its branded products to physicians through its internal sales force and markets its generic portfolio through its wholly owned subsidiaries, Macoven Pharmaceuticals, LLC and Cypress Pharmaceuticals, Inc.

To learn more about Pernix Therapeutics, visit www.pernixtx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as "estimate," "plan," "project," "forecast," "intend," "expect," "anticipate," "believe," "seek," "target" or similar expressions are forward-looking statements. These statements reflect the Company's current views, expectations and beliefs concerning future events. In addition, any statements related to Pernix's future strategy and plans with respect to its intellectual property portfolio and other statements related to the outcome of pending litigation, settlement discussions or other adverse proceedings contained herein are forward-looking statements. Such plans, expectations and statements are as to future events and are not to be viewed as facts, and reflect various assumptions of management of the Company and are subject to significant business, financial, economic, operating, competitive, litigation and other risks and uncertainties and contingencies (many of which are difficult to predict and beyond the control of the Company) that could cause actual results to differ materially from the statements included herein. The inclusion of forward-looking statements should not be regarded as a representation by Pernix that any of its plans will be achieved. Investors should note that many factors, including the risks and uncertainties inherent in the outcome of pending litigation and settlement proceedings, as more fully described in Pernix's filings with the Securities and Exchange Commission ("SEC") (including, but not limited to, its Annual Report on Form 10-K for the year ended December 31, 2017, its Quarterly Report on Form 10-Q for the Quarterly Period ended March 31, 2018 and subsequent filings with the SEC), could affect the Company's future financial results and could cause actual results to differ materially from those expressed in forward-looking statements, such as those contained in this press release. The forward-looking statements in this press release are qualified by risk factors identified by the Company. These risk factors, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

CONTACT
Investor Relations
Bob Yedid
LifeSci Advisors, LLC
Bob@LifeSciAdvisors.com