HORIZON PHARMA PLC FORM 8-K. (Current report filing) Filed 05/19/16 for the Period Ending 05/18/16

Transcription

1 HORIZON PHARMA PLC FORM 8-K (Current report filing) Filed 05/19/16 for the Period Ending 05/18/16 Telephone CIK Symbol HZNP SIC Code Pharmaceutical Preparations Industry Biotechnology & Drugs Sector Healthcare Fiscal Year 12/31 Copyright 2016, EDGAR Online, Inc. All Rights Reserved. Distribution and use of this document restricted under EDGAR Online, Inc. Terms of Use.

2 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C 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): May 18, 2016 Horizon Pharma Public Limited Company (Exact name of registrant as specified in its charter) Ireland Not Applicable (State or other jurisdiction (Commission (IRS Employer of incorporation) File No.) Identification No.) Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, Ireland (Address of principal executive offices) Registrant s telephone number, including area code: 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 ) Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR a-12) Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR d-2(b)) Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR e-4(c))

3 Item Other Events. On May 18, 2016, HZNP Limited ( Purchaser ), an indirect wholly-owned subsidiary of Horizon Pharma plc ( Horizon ), entered into an Asset Purchase Agreement (the Purchase Agreement ) with Boehringer Ingelheim International GmbH ( BI ), pursuant to which, among other things, Purchaser agreed to acquire from BI (i) its exclusive license rights from Genentech, Inc. relating to interferon gamma-1b (marketed as IMUKIN, IMUKINE, IMMUKIN and/or IMMUKINE by BI) in a territory defined as the entire world other than U.S., Canada and Japan, and (ii) BI s marketing authorizations, trademarks and inventory of interferon gamma-1b, for 25 million ( 5 million of which was paid upon signing the Purchase Agreement) plus a per unit price for all acquired inventory in cash. Under the Purchase Agreement, Horizon and BI are obligated to enter into a global supply agreement for interferon gamma-1b (including ACTIMMUNE) with terms substantially consistent with Horizon s existing agreement with BI for the supply of ACTIMMUNE. The acquisition is subject to the satisfaction of customary closing conditions, including receipt of regulatory approval for the transfer of marketing authorizations. Horizon anticipates that the acquisition will close by the end of In advance of the closing, Horizon expects to immediately begin investing in manufacturing, supply chain, regulatory and commercial activities for interferon gamma-1b, and as a result it is expected that operating expenses in 2016 will be incrementally higher than prior estimates. On May 19, 2016, Horizon issued a press release announcing the Purchase Agreement. A copy of the press release is attached hereto as Exhibit Item Financial Statements and Exhibits. (d) Exhibits Press Release dated May 19, Forward-Looking Statements This Current Report contains forward-looking statements, including, but not limited to, statements related to the anticipated consummation of the acquisition of the rights to IMUKIN and the timing thereof, the potential entry into a global supply agreement between Horizon and BI, expected activities and related expenses prior to closing the transaction, and other statements that are not historical facts. These forward-looking statements are based on Horizon s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to Horizon s ability to complete the transaction on the proposed terms and schedule, including whether the closing conditions are satisfied; risks associated with negotiating and executing a global supply agreement, such as the risk that the proposed terms will be unfavorable to Horizon, risks associated with acquisitions, such as the risk that completing the acquisition may be more difficult, time-consuming or costly than expected or that the expected benefits of the acquisition will not occur; as well as other risks related to Horizon s business detailed from time-to-time under the caption Risk Factors and elsewhere in Horizon s filings with the United States Securities and Exchange Commission, including in its Annual Report on Form 10-K for the year ended December 31, 2015 and subsequent Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this Current Report and Horizon undertakes no obligation to update or revise these statements, except as may be required by law.

4 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. Date: May 19, 2016 HORIZON PHARMA PUBLIC LIMITED COMPANY By: /s/ Paul W. Hoelscher Paul W. Hoelscher Executive Vice President and Chief Financial Officer

5 99.1 Press Release dated May 19, INDEX TO EXHIBITS

6 Exhibit 99.1 Horizon Pharma plc to Acquire Worldwide Rights to Interferon Gamma-1b from Boehringer Ingelheim International GmbH - Also Licenses Rights to Patents and Pending Applications Covering Methods for Treating Friedreich s ataxia with Interferon Gamma-1b - - Company currently owns the rights to interferon gamma-1b under the trade name ACTIMMUNE in the United States, Canada and Japan - DUBLIN, Ireland May 19, 2016 Horizon Pharma plc (NASDAQ: HZNP) ( Horizon Pharma ), a biopharmaceutical company focused on improving patients lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, today announced that its affiliate has entered into a definitive agreement with Boehringer Ingelheim International GmbH ( Boehringer Ingelheim ) to acquire the rights to interferon gamma-1b, which Boehringer Ingelheim commercializes under the trade names IMUKIN, IMUKINE, IMMUKIN and IMMUKINE in an estimated 30 countries primarily in Europe and the Middle East. Obtaining worldwide rights for interferon gamma-1b solidifies our continued investment in the medicine, and pending the outcome of clinical studies investigating it in Friedreich s ataxia and advanced solid tumors, such as kidney and bladder cancer, strengthens our ability to expand its potential global use, said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. Under the terms of the agreement, Horizon Pharma paid Boehringer Ingelheim 5 million upon signing and will pay 20 million upon closing for the rights for interferon gamma-1b in all territories outside of the United States, Canada and Japan. Horizon Pharma and Boehringer Ingelheim expect to close the transaction by year-end 2016, subject to the satisfaction of closing conditions. Under the terms of a separate agreement with an undisclosed third party, Horizon Pharma also licensed the U.S., European and Canadian intellectual property rights for interferon gamma-1b for the treatment of Friedreich s ataxia. Interferon gamma-1b is currently not indicated or approved for the treatment of Friedreich s ataxia. On May 5, 2016, the Company announced that it completed target enrollment of 90 patients in the Phase 3, randomized, double-blind, placebo controlled STEADFAST study evaluating ACTIMMUNE in patients with Friedreich s ataxia. Top-line results from the trial are expected by the end of As a result of the agreement with Boehringer Ingelheim, Horizon Pharma will immediately begin investing in related manufacturing, supply chain, regulatory and commercial activities for interferon gamma-1b. As a result, the Company anticipates a reduction to 2016 adjusted EBITDA of approximately $10 million versus prior guidance. About Horizon Pharma plc Horizon Pharma plc is a biopharmaceutical company focused on improving patients lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs. Horizon Pharma markets nine medicines through its orphan, rheumatology and primary Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland

7 care business units. Horizon Pharma s global headquarters are in Dublin, Ireland. For more information, please visit on Twitter or view careers on our LinkedIn page. Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to the anticipated consummation of the acquisition of the rights to interferon gamma-1b and the timing and benefits thereof, Horizon Pharma s strategy, plans, objectives, expectations (financial or otherwise) and intentions, the timing of results of the Phase 3 trial of ACTIMMUNE in Friedreich s ataxia, the potential for ACTIMMUNE as a treatment for Friedreich s ataxia and advanced solid tumors, future financial results and growth potential, anticipated product portfolio, development programs and other statements that are not historical facts. These forward-looking statements are based on Horizon s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to Horizon s ability to complete the transaction on the proposed terms and schedule; risks associated with acquisitions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; risks related to future opportunities and plans for the acquired rights and related products; disruption from the proposed transaction, making it more difficult to conduct business as usual or maintain relationships with customers, employees or suppliers; the calculations of, and factors that may impact the calculations of, the acquisition price and the allocation of such acquisition price to the net assets acquired in accordance with applicable accounting rules and methodologies; the possibility that if the acquired rights do not create the perceived benefits of the proposed transaction as rapidly or to the extent anticipated by financial analysts or investors, the market price of the Horizon s shares could decline, risks of delays in completing the Phase 3 trial, risks associated with pre-clinical and clinical development of drug candidates, and risks that the actual effect of additional investments in interferon gamma-1b may differ from its expectations, as well as other risks related to Horizon s business detailed from time-to-time under the caption Risk Factors and elsewhere in Horizon Pharma s SEC filings and reports, including in its Annual Report on Form 10-K for the year ended December 31, Horizon Pharma undertakes no duty or obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or changes in its expectations. Contacts: Investors: John Thomas Executive Vice President, Strategy and Investor Relations investor-relations@horizonpharma.com Tina Ventura Vice President, Investor Relations investor-relations@horizonpharma.com Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland

8 U.S. Media: Geoff Curtis Senior Vice President, Corporate Communications Ireland Media: Ray Gordon Gordon MRM Source: Horizon Pharma plc Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland