UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A
(RULE 14a-101)
SCHEDULE 14A INFORMATION
Proxy Statement Pursuant to Section 14(a) of the
Securities Exchange Act of 1934
Filed by the Registrant ¨ Filed by a Party other than the Registrant x
Check the appropriate box:
¨ | Preliminary Proxy Statement | |
¨ | Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) | |
¨ | Definitive Proxy Statement | |
¨ | Definitive Additional Materials | |
x | Soliciting Material Pursuant to 240.14a-12 |
DEPOMED, INC.
(Name of Registrant as Specified in Its Charter)
HORIZON PHARMA PUBLIC LIMITED COMPANY
HORIZON PHARMA, INC.
(Name of Persons(s) Filing Proxy Statement, if Other Than the Registrant) Payment of Filing Fee (Check the appropriate box):
x | No fee required. | |||
¨ | Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11. | |||
(1) | Title of each class of securities to which transaction applies:
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(2) | Aggregate number of securities to which transaction applies:
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(3) | Per unit price or other underlying value of transaction computed pursuant to Exchange Act Rule 0-11 (set forth the amount on which the filing fee is calculated and state how it was determined):
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(4) | Proposed maximum aggregate value of transaction:
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(5) | Total fee paid:
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¨ | Fee paid previously with preliminary materials. | |||
¨ | Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing. | |||
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(4) | Date Filed:
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Filed pursuant to Rule 14a-12
of the Securities Exchange Act of 1934, as amended
Filing by: Horizon Pharma Public Limited Company
Subject Company: Depomed, Inc.
SEC File No. of Depomed, Inc.: 001-13111
Horizon Pharma plc (Horizon Pharma) has filed a preliminary proxy statement with the Securities and Exchange Commission (the SEC) and accompanying WHITE proxy card in connection with the removal and bylaw amendments special meeting of shareholders of Depomed, Inc. (Depomed).
This Schedule 14A filing consists of an investor presentation released by Horizon Pharma on November 9, 2015.
Forward-Looking Statements
This communication contains forward-looking statements, including, but not limited to, statements related to Horizon Pharmas strategy, plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, expected impact and potential benefits from recent and future transactions, development programs and clinical plans, and other statements that are not historical facts. These forward-looking statements are based on Horizon Pharmas 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 Pharmas ability to complete any future acquisitions on anticipated terms; risks associated with business combination transactions, 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 any acquisition will not be realized; risks related to future opportunities and plans for Horizon Pharma and/or the combined company, including, without limitation, uncertainty of the expected financial performance and results of Horizon Pharma and/or the combined company following completion of any acquisition; disruption from any future acquisition, making it more difficult to conduct business as usual or maintain relationships with customers, employees or suppliers; and the possibility that if the combined company does not achieve the perceived benefits of any future acquisition as rapidly or to the extent anticipated by financial analysts or investors, the market price of Horizon Pharmas shares could decline, as well as other risks related to Horizon Pharmas business, including the ability to grow sales and revenues from existing medicines and its ability to increase sales of its existing medicines; Horizon Pharmas ability to successfully execute its commercial strategy and achieve projected financial results for 2015, 2016 and other long-term financial metrics; the fact that past financial or operating results are not a guarantee of future results; competition, including potential generic competition; the ability to protect intellectual property and defend patents; regulatory obligations and oversight, including potential changes in healthcare laws and regulations; the availability of coverage and adequate reimbursement and pricing from government and third-party payers and risks relating to the success of Horizons patient support program; risks associated with clinical development and
regulatory approvals, including the anticipated timing of initiating and completing studies and filing for and obtaining regulatory approvals, whether data from clinical studies will support regulatory approval, and whether clinical results will be consistent with data from animal models; and those risks detailed from time-to-time under the caption Risk Factors and elsewhere in Horizon Pharmas and Depomeds respective filings and reports with the SEC, including in their respective Annual Report on Form 10-K for the year ended December 31, 2014, and subsequent quarterly reports on Form 10-Q. Horizon Pharma undertakes no duty or obligation to update any forward-looking statements contained in this communication as a result of new information, except as required by applicable law or regulation.
Additional Information
This communication does not constitute an offer to buy or solicitation of any offer to sell or vote securities and is for informational purposes only. It relates to the offer commenced by Horizon Pharma to exchange each issued and outstanding share of Depomed common stock for 0.95 Horizon ordinary shares. The offer will be made only through the Tender Offer Statement on Schedule TO or the Prospectus/Offer to Exchange included in the Registration Statement on Form S-4 (including the Letter of Transmittal and related documents and as amended from time to time, the Exchange Offer Documents) that Horizon Pharma has filed with the SEC. This communication also relates to a solicitation by Horizon Pharma of Depomeds shareholders to (i) call two special shareholder meetings (the Special Meetings) to consider the principal proposals described in the Special Meetings Solicitation Statement (as defined below) and (ii) vote in favor of the principal proposals described in the Special Meetings Proxy Statements (as defined below) if the two special shareholder meetings are called and held. This communication also relates to a solicitation by Horizon Pharma of its shareholders to vote in favor of the principal proposals described in the Extraordinary General Meeting Proxy Statement (as defined below). On September 8, 2015, Horizon Pharma filed a definitive solicitation statement and accompanying WHITE and BLUE proxy cards with the SEC with respect to the solicitation of proxies to call two related special meetings of shareholders (including any amendments and supplements, the Special Meetings Solicitation Statement). On October 13, 2015, Horizon Pharma also filed two preliminary proxy statements and accompanying WHITE and BLUE proxy cards for the two related special meetings of shareholders with the SEC with respect to the solicitation of proxies to vote in favor of the proposals described in the Special Meetings Solicitation Statement (including any amendments and supplements, the Special Meetings Proxy Statements). On October 15, 2015, Horizon Pharma filed a definitive proxy statement and accompanying proxy card for the extraordinary general meeting of Horizon Pharma shareholders (the Extraordinary General Meeting) with the SEC with respect to the solicitation of proxies to vote in favor of the proposals described therein (including any amendments and supplements, the Extraordinary General Meeting Proxy Statement). Subject to further developments, Horizon Pharma may file one or more further supplements to the Special Meetings Solicitation Statement, one or more amendments and supplements to the Special Meetings Proxy Statements, one or more amendments and supplements to the Extraordinary General Meeting Proxy Statement and additional solicitation statements and/or proxy statements or other documents with the SEC in connection with the Special Meetings and/or the Extraordinary General Meeting, and Horizon Pharma (and, if a negotiated transaction is agreed upon, Depomed) may file one or more registration statements, prospectuses, proxy statements,
Exchange Offer Documents or other documents with the SEC in connection with the offer or any other proposed transaction involving Horizon Pharma and Depomed. This communication is not a substitute for any solicitation statement, proxy statement or other document filed with the SEC in connection with the Special Meetings, the Extraordinary General Meeting or any registration statement, prospectus, proxy statement, Exchange Offer Documents or other documents Horizon Pharma and/or Depomed may file with the SEC in connection with the offer or any other proposed transaction involving Horizon Pharma and Depomed.
If your shares are held by a bank, broker or other nominee, you are considered the beneficial owner of shares held in street name. Only your broker or other nominee, as the holder of record of your shares, may submit a WHITE proxy card and/or a BLUE proxy card to join us in calling the Special Meetings, a WHITE proxy card and/or a BLUE proxy card to vote in favor of the proposals described in the Special Meetings Proxy Statements or a proxy card to vote in favor of the proposals described in the Extraordinary General Meeting Proxy Statement, as applicable, and your bank, broker or other nominee may do so only with your specific instructions to do so. YOUR BANK, BROKER OR OTHER NOMINEE HAS PROVIDED YOU WITH A SINGLE VOTING INSTRUCTION FORM FOR PURPOSES OF VOTING ON THE MATTERS SET FORTH IN BOTH THE WHITE PROXY CARD AND THE BLUE PROXY CARD ACCOMPANYING THE SPECIAL MEETINGS SOLICITATION STATEMENT. PLEASE READ AND FOLLOW SUCH SINGLE VOTING INSTRUCTION FORM CAREFULLY IF YOU WISH TO JOIN US IN CALLING ONE OR BOTH OF THE SPECIAL MEETINGS. PLEASE NOTE THAT THE SINGLE VOTING INSTRUCTION FORM PERMITS BENEFICIAL OWNERS TO ABSTAIN FROM VOTING ON THE MATTERS SET FORTH ON THE WHITE AND BLUE PROXY CARDS ACCOMPANYING THE SPECIAL MEETINGS SOLICITATION STATEMENT; IF YOU, AS A BENEFICIAL OWNER SO ABSTAIN ON EITHER OR BOTH PROXY CARDS ACCOMPANYING THE SPECIAL MEETINGS SOLICITATION STATEMENT, YOUR ABSTENTION WILL RESULT IN YOUR SHARES NOT BEING COUNTED TOWARDS OUR OBTAINING THE SPECIAL MEETING PERCENTAGE FOR CALLING THE APPLICABLE SPECIAL MEETING.
INVESTORS AND SECURITY HOLDERS OF HORIZON PHARMA AND DEPOMED ARE URGED TO READ CAREFULLY THE SPECIAL MEETINGS SOLICITATION STATEMENT (INCLUDING ANY AMENDMENTS AND SUPPLEMENTS), THE WHITE AND BLUE PROXY CARDS ACCOMPANYING THE SPECIAL MEETINGS SOLICITATION STATEMENT, THE SPECIAL MEETINGS PROXY STATEMENTS (INCLUDING ANY AMENDMENTS AND SUPPLEMENTS), THE WHITE AND BLUE PROXY CARDS ACCOMPANYING THE SPECIAL MEETINGS PROXY STATEMENTS, THE EXTRAORDINARY GENERAL MEETING PROXY STATEMENT (INCLUDING ANY AMENDMENTS AND SUPPLEMENTS), THE PROXY CARD ACCOMPANYING THE EXTRAORDINARY GENERAL MEETING PROXY STATEMENT AND OTHER SOLICITATION STATEMENTS, PROXY STATEMENTS AND DOCUMENTS FILED WITH THE SEC IN CONNECTION WITH THE SPECIAL MEETINGS AND THE EXTRAORDINARY GENERAL MEETING AND THE EXCHANGE OFFER DOCUMENTS (INCLUDING ANY AMENDMENTS AND SUPPLEMENTS) AND ANY OTHER REGISTRATION STATEMENTS, PROSPECTUSES, PROXY STATEMENTS AND OTHER
DOCUMENTS FILED WITH THE SEC IN CONNECTION WITH THE OFFER OR ANY OTHER PROPOSED TRANSACTION INVOLVING HORIZON PHARMA AND DEPOMED WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT HORIZON PHARMA, DEPOMED, THE SPECIAL MEETINGS, THE OFFER OR ANY OTHER PROPOSED TRANSACTION INVOLVING HORIZON PHARMA AND DEPOMED, AS APPLICABLE.
Investors and security holders may obtain free copies of the Special Meetings Solicitation Statement, the Special Meetings Proxy Statements, the Extraordinary General Meeting Proxy Statement, the Exchange Offer Documents and any other related documents (when they are available) filed with the SEC at the SECs web site at www.sec.gov or by directing a request to Horizon Pharmas Investor Relations department at Horizon Pharma, Inc., Attention: Investor Relations, 520 Lake Cook Road, Suite 520, Deerfield, IL 60015 or to Horizon Pharmas Investor Relations department at 224-383-3400 or by email to investor-relations@horizonpharma.com. Investors and security holders may obtain free copies of the documents filed with the SEC on Horizon Pharmas website at www.horizonpharma.com under the heading Investors and then under the heading SEC Filings.
Special Note Regarding Litigation
As described in the Special Meetings Solicitation Statement, the Special Meetings Proxy Statements and the Extraordinary General Meeting Proxy Statement, Horizon Pharma is currently challenging Depomeds bylaw-mandated process for calling a special meeting of shareholders as contrary to California law in a judicial proceeding seeking to protect Depomed shareholders franchise rights. With that judicial challenge pending, the Special Meetings Solicitation Statement and accompanying WHITE and BLUE proxy cards that have been distributed to Depomed shareholders and the Special Meetings Proxy Statements and accompanying WHITE and BLUE proxy cards that will be distributed to Depomed shareholders reflect Horizon Pharmas good faith effort to nevertheless comply with what we believe is an onerous process for calling a special meeting of shareholders imposed by the Depomed board of directors. The Superior Court of the State of California, County of Santa Clara, where our judicial challenge is pending, calendared for November 5, 2015 a hearing on a preliminary injunction motion by a subsidiary of Horizon Pharma to enjoin, among other things, the enforcement of Depomeds bylaws that mandate what we believe to be the onerous process for calling a special meeting of shareholders. The Court subsequently continued the hearing from November 5, 2015 to November 19, 2015. On that same date, the Court is also scheduled to hold a hearing on a preliminary injunction motion by Depomed for its claims against Horizon Pharma and its subsidiary.
Certain Information Regarding Participants
Horizon Pharma and/or Depomed and their respective directors, executive officers and certain other employees and the Horizon Pharma nominees may be deemed participants in the solicitations of proxies in connection with the requests to call the Special Meetings, to vote in favor of the principal proposals described in the Special Meetings Proxy Statements if the Special Meetings are called and held and to vote in favor of the principal proposals described in the Extraordinary General Meeting Proxy Statement. You can find information about Horizon
Pharmas directors, executive officers and such certain other employees and any individuals Horizon Pharma is seeking to nominate for election to the Depomed board of directors, as described in the Special Meetings Solicitation Statement and the Special Meetings Proxy Statements, in Horizon Pharmas Annual Report on Form 10-K for the year ended December 31, 2014, which was filed with the SEC on February 27, 2015, Horizon Pharmas definitive proxy statement filed with the SEC on May 6, 2015, Horizon Pharmas Current Report on Form 8-K/A filed with the SEC on July 27, 2015, the Special Meetings Solicitation Statement, the Special Meetings Proxy Statements and the Extraordinary General Meeting Proxy Statement and in such other solicitation statements, proxy statements or other documents that would be filed with the SEC in connection with the Special Meetings. You can find information about Depomeds directors, executive officers and its employees who are participants in such solicitation in Depomeds definitive proxy statement filed with the SEC on April 16, 2015, Depomeds definitive revocation statement filed with the SEC on September 30, 2015 and as may be supplemented from time to time, the Special Meetings Solicitation Statement, the Special Meetings Proxy Statements and in such other solicitation statements, proxy statements or other documents that would be filed with the SEC in connection with the Special Meetings. These documents are available free of charge at the SECs web site at www.sec.gov and, with respect to Horizon Pharma, from Investor Relations at Horizon Pharma as described above. Additional information regarding the interests of such potential participants is included in the Special Meetings Solicitation Statement, the Special Meetings Proxy Statements and the Extraordinary General Meeting Proxy Statement and will be included in one or more registration statements, proxy statements or other documents filed with the SEC if and when they become available.
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Horizon Pharma plc
Investor Day Presentation
November 9 2015
Non Confidential Information Horizon Pharma plc
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Introduction
John B. Thomas
Executive Vice President Corporate Strategy and Investor Relations
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Non Confidential Information Horizon Pharma plc |
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Agenda (1 of 2)
1. Introduction
2. Executive Summary
3. Orphan Business Unit Review
Business Overview and Update
Clinical Development Opportunities
4. Q&A
John Thomas
Executive vice president corporate strategy and investor relations
Tim Walbert
Chairman president and chief executive officer
George Hampton
Executive vice president global orphan business unit and international operations
Jeff Sherman M.D. FACP
Executive vice president research and development and chief medical officer
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Non Confidential Information Horizon Pharma plc |
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Agenda (2 of 2)
5. Primary Care / Specialty Business Unit Review
Business Model Overview and Update
DUEXIS and VIMOVO Doctors Perspective
6. U.S. Reimbursement Environment
7. HorizonCares Overview
8. Business Development Strategy
9. Financial Review 10. Wrap up
11. Q&A
3 Non Confidential Information Horizon
John Kody
Executive vice president chief commercial officer
Al Bello M.D. MHS FACP FACR DABPM
Rheumatologist
Terry Evans
Senior vice president and general manager managed care and trade
Steve Curtis
Vice president and general manager
Bob Carey
Executive vice president chief business officer
Paul Hoelscher
Executive vice president chief financial officer
Tim Walbert
Chairman president and chief executive officer
Pharma plc
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Forward Looking Statements
This presentation contains forward looking statements including but not limited to statements related to Horizon Pharmas strategy plans objectives expectations (financial or otherwise) and intentions future financial results and growthpotential expected impactand potential benefits from recent and future transactions developmentprograms and clinical plans and other statements that are not historical facts. These forward looking statements are based on Horizon Pharmas current expectations and inherently involve significant risks and uncertainties. Actualresults 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 Pharmas ability to complete any future acquisitions on anticipated terms; risks associated with business combination transactions such as the risk that the businesses will not be integrated successfully that such integration maybemore difficult time consuming or costly than expected or that the expected benefits of any acquisition will not be realized; risks related to future opportunities and plans for Horizon Pharma and/or the combined company including without limitation uncertainty of the expected financial performance and results of Horizon Pharma and/or the combined company following completion of any acquisition; disruption from any future acquisition making it more difficult to conduct business as usual or maintain relationships with customers employees or suppliers; and the possibility that if the combined company does not achieve the perceived benefits of any future acquisition as rapidly or to the extent anticipated by financial analysts or investors the market price of Horizon Pharmas shares could decline as well as other risks related to the Horizon Pharmas business including the ability to grow sales and revenues from existing medicines and its ability to increase sales of itsexisting medicines; Horizon Pharmas ability to successfully execute its commercial strategy and achieve projected financial results for 2015 2016 and other long term financial metrics; the fact that past financial or operating results are not a guarantee of future results; competition including potential generic competition; the ability to protect intellectual property and defend patents; regulatory obligations and oversight including potential changes in healthcare laws and regulations; the availability of coverage and adequate reimbursement and pricing from government and third party payers and risks relating to the success of Horizons patient support program; risks associated with clinical development and regulatory approvals including the anticipated timing of initiating and completing studies and filing for and obtaining regulatory approvals whether data from clinical studies will support regulatory approval and whether clinical results will be consistent with data from animal models; and those risks detailed from time to time under the caption Risk Factors and elsewhere in Horizon Pharmas and Depomeds respective filings and reports with the SEC including in their respective Annual Report on Form 10 K for the year ended December 31 2014 and subsequent quarterly reports on Form 10 Q. Horizon Pharma undertakes no duty or obligation to update any forward looking statements contained in this presentation as a result of new information except as required by applicable law or regulation.
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Non Confidential Information Horizon Pharma plc |
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Note Regarding Use of Non GAAP Financial Measures
Horizon Pharma provides certain financial measures such as adjusted non GAAP net income (loss) adjusted non GAAP net income (loss) per share non GAAP gross profit margins and non GAAP cash from operations that include adjustments to GAAP figures. These adjustments to GAAP exclude the bargain purchase gain related to the acquisition of Vidara acquisition transactionrelatedexpenses lossoninduceddebtconversion lossondebtextinguishment secondaryofferingexpenses aswell as non cash items such as stock compensation depreciation and amortization accretion non cash interest expense and other non cash adjustments such as the increase or decrease in the fair value of the embedded derivative associated with the Companys prior convertible senior notes. Certain other special items or substantive events may also be included in the non GAAP adjustments periodically when their magnitude is significant within the periods incurred. EBITDA or earnings before interest taxes depreciationandamortization andadjustedEBITDAarealsousedandprovidedbyHorizonasnon GAAPfinancial measures.
Horizonbelievesthatthesenon GAAPfinancialmeasures whenconsideredtogetherwiththeGAAPfigures canenhance an overall understanding of Horizons financial performance. The non GAAP financial measures are included with the intent of providing investors with a more complete understanding of the Companys operational results trends and expectations. In addition thesenon GAAPfinancialmeasuresareamongtheindicatorsHorizonsmanagementusesforplanningandforecasting purposesandmeasuringtheCompanysperformance.Thesenon GAAPfinancialmeasuresshouldbe considered inaddition to and not as a substitute for or superior to financial measures calculated in accordance with GAAP. The non GAAP financial measures used by the Company may be calculated differently from and therefore may not be comparable to non GAAP financial measures used by other companies. The Company has not provided a reconciliation of full year 2015 2016 or 2020 adjustedEBITDAoutlooktoanetincome(loss)outlookbecausecertainitemsthatareacomponentofnetincome(loss)butnot part of adjusted EBITDA such as the gain (loss) on derivative revaluation associated with the convertible senior notes stock compensation acquisition related expenses and certain purchase accounting items such as intangibles and step up inventory cannot be reasonably projected either due to the significant impact of changes in Horizons stock price on derivative revaluation and stock compensation or the variability associated with acquisition related expenses and purchase accounting items due to timingandotherfactors.
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Non Confidential Information Horizon Pharma plc |
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Additional Information
This presentation does not constitute an offer to buy or solicitation of any offer to sell or vote securities and is for informational purposes only. It relates to the offer commenced by Horizon Pharma to exchange each issued and outstanding share of Depomed common stock for 0.95 Horizon ordinary shares. The offerwill be made only through the Tender Offer Statement on Schedule TO or the Prospectus/Offer to Exchange included in the Registration Statement on Form S 4 (including the Letter of Transmittal and related documents and as amended from time to time the Exchange Offer Documents) that Horizon Pharma has filed with the SEC. This communication also relates to a solicitation by Horizon Pharma of Depomeds shareholders to (i) call two special shareholder meetings (the Special Meetings) to consider the principal proposalsdescribed in the Special Meetings Solicitation Statement (as defined below) and (ii) vote in favor of the principal proposals described in the Special Meetings Proxy Statements (as defined below) if the two special shareholder meetings are called and held. This presentation also relates to a solicitation by Horizon Pharma of its shareholders to vote in favor of the principal proposals described in the Extraordinary General Meeting Proxy Statement (as defined below). On September8 2015 Horizon Pharma filed a definitive solicitation statement and accompanying WHITE and BLUE proxy cards with the SEC with respect to the solicitation of proxies to call two related special meetings of shareholders (including any amendments and supplements the Special Meetings Solicitation Statement). On October 13 2015 Horizon Pharma also filed two preliminary proxy statements and accompanying WHITE and BLUE proxy cards for the two relatedspecial meetings of shareholders with the SEC with respect to the solicitation of proxies to vote in favor of the proposals described in the Special Meetings Solicitation Statement (including any amendments and supplements the Special Meetings Proxy Statements). On October 15 2015 Horizon Pharma filed a definitive proxy statement and accompanying proxy card for the extraordinary general meeting of Horizon Pharma shareholders (the Extraordinary General Meeting) with the SEC with respect to the solicitation of proxies to vote infavor of the proposals described therein (including any amendments and supplements the Extraordinary General Meeting Proxy Statement). Subject to further developments Horizon Pharma may file one or more further supplements to the Special Meetings Solicitation Statement one or more amendments and supplements to the Special Meetings Proxy Statements oneormore amendments and supplements to the Extraordinary General Meeting Proxy Statement and additional solicitation statements and/or proxy statements or other documents with the SEC in connection with the Special Meetings and/or the Extraordinary General Meeting and Horizon Pharma (and if a negotiated transaction is agreed upon Depomed) may fileone or more registration statements prospectuses proxy statements Exchange Offer Documents or other documents with the SEC in connection with the offer or any other proposed transaction involving Horizon Pharma and Depomed. This presentation is not a substitute for any solicitation statement proxy statement or other document filed with the SEC in connection with the Special Meetings the Extraordinary General Meeting or any registration statement prospectus proxy statement Exchange Offer Documents or other documents Horizon Pharma and/or Depomed may file with the SEC in connection with the offer or any other proposed transaction involving Horizon Pharma and Depomed.
If your shares are held by a bank broker or other nominee you are considered the beneficial owner of shares held in street name. Only your broker or other nominee as the holder of record of your shares may submit a WHITE proxy card and/or a BLUE proxy card to join us in calling the Special Meetings a WHITE proxy card and/or a BLUE proxy card to vote in favor of the proposals described in the Special Meetings Proxy Statements or a proxy card to vote in favor of the proposals described in the Extraordinary General Meeting Proxy Statement as applicable and your bank broker or other nominee may do so only with your specific instructions to do so. YOUR BANK BROKEROR OTHER NOMINEE HAS PROVIDED YOU WITH A SINGLE VOTING INSTRUCTION FORM FOR PURPOSES OF VOTING ON THE MATTERS SET FORTH IN BOTH THE WHITE PROXY CARD AND THE BLUE PROXY CARD ACCOMPANYING THE SPECIAL MEETINGS SOLICITATION STATEMENT. PLEASE READ AND FOLLOW SUCH SINGLE VOTING INSTRUCTION FORM CAREFULLY IF YOU WISH TO JOIN US IN CALLING ONE OR BOTH OF THE SPECIAL MEETINGS.PLEASE NOTE THAT THE SINGLE VOTING INSTRUCTION FORM PERMITS BENEFICIAL OWNERS TO ABSTAIN FROM VOTING ON THE MATTERS SET FORTH ON THE WHITE AND BLUE PROXY CARDS ACCOMPANYING THE SPECIAL MEETINGS SOLICITATION STATEMENT; IF YOU AS A BENEFICIAL OWNER SO ABSTAIN ON EITHER OR BOTH PROXY CARDS ACCOMPANYING THE SPECIAL MEETINGS SOLICITATION STATEMENT YOUR ABSTENTION WILL RESULT IN YOUR SHARES NOT BEING COUNTED TOWARDS OUR OBTAINING THE SPECIAL MEETING PERCENTAGE FOR CALLING THE APPLICABLE SPECIAL MEETING.
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Non Confidential Information Horizon Pharma plc |
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Additional Information
INVESTORS AND SECURITY HOLDERS OF HORIZON PHARMA AND DEPOMED ARE URGED TO READ CAREFULLY THE SPECIAL MEETINGS SOLICITATION STATEMENT (INCLUDING ANY AMENDMENTS AND SUPPLEMENTS) THE WHITE AND BLUE PROXY CARDS ACCOMPANYING THE SPECIAL MEETINGS SOLICITATION STATEMENT THE SPECIAL MEETINGS PROXY STATEMENTS (INCLUDING ANY AMENDMENTS AND SUPPLEMENTS) THE WHITE AND BLUE PROXY CARDS
ACCOMPANYING THE SPECIAL MEETINGS PROXY STATEMENTS THE EXTRAORDINARY GENERAL MEETINGPROXY STATEMENT (INCLUDING ANY AMENDMENTS AND SUPPLEMENTS) THE PROXY CARD ACCOMPANYING THE EXTRAORDINARY GENERAL MEETINGPROXY STATEMENT AND OTHER SOLICITATION STATEMENTS PROXY STATEMENTS AND DOCUMENTS FILED WITH THE SEC IN CONNECTION WITH THE SPECIAL MEETINGS AND THE EXTRAORDINARY GENERAL MEETINGAND THE EXCHANGE OFFER DOCUMENTS (INCLUDING ANY AMENDMENTS AND SUPPLEMENTS) AND ANY OTHER REGISTRATION STATEMENTS PROSPECTUSES PROXY STATEMENTS AND OTHER DOCUMENTS FILED WITH THE SEC IN CONNECTION WITH THE OFFER OR ANY OTHER PROPOSED TRANSACTION INVOLVING HORIZON PHARMA AND DEPOMED WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT HORIZON PHARMA DEPOMED THE SPECIAL MEETINGS THE OFFER OR ANY OTHER PROPOSED TRANSACTION INVOLVING HORIZON PHARMA AND DEPOMED AS APPLICABLE.
Investors and security holders may obtain free copies of the Special Meetings Solicitation Statement the Special Meetings Proxy Statements the Extraordinary General Meeting Proxy Statement the Exchange Offer Documents and any other related documents (when they are available) filed with the SEC at the SECs web site at www.sec.gov or by directing a request to Horizon Pharmas Investor Relations department at Horizon Pharma Inc. Attention: Investor Relations 520 Lake Cook Road Suite 520 Deerfield IL 60015 or to Horizon Pharmas Investor Relations department at 224 383 3400 or by email to investor relations@horizonpharma.com. Investors and security holders may obtain free copies of the documents filed with the SEC on Horizon Pharmas website at www.horizonpharma.com under the heading Investors and then under the heading SEC Filings.
Special Note Regarding Litigation
As described in the Special Meetings Solicitation Statement the Special Meetings Proxy Statements and the Extraordinary GeneralMeeting Proxy Statement Horizon Pharma is currently challenging Depomeds bylaw mandated process for calling a special meeting of shareholders as contrary to California law in a judicial proceeding seeking to protect Depomed shareholders franchise rights. With that judicial challenge pending the Special MeetingsSolicitation Statement and accompanying WHITE and BLUE proxy cards that have been distributed to Depomed shareholders and the Special Meetings Proxy Statements and accompanying WHITE and BLUE proxy cards that will be distributed to Depomed shareholders reflect Horizon Pharmas good faith effort to nevertheless comply with what we believe is an onerous process for calling a special meeting of shareholders imposed by the Depomed board of directors. The Superior Court of the State of California County of Santa Clara where our judicial challenge is pending calendared for November5 2015 a hearing on a preliminary injunction motion by a subsidiary of Horizon Pharma to enjoin among other things the enforcement of Depomeds bylaws that mandate what we believe to be the onerous process for calling a special meeting of shareholders. The Court subsequently continued the hearing from November 5 2015 to November 19 2015. On that same date theCourt is also scheduled to hold a hearing on a preliminary injunction motion by Depomed for its claims against Horizon Pharma and its subsidiary.
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Certain Information Regarding Participants
Horizon Pharma and/or Depomed and their respective directors executive officers and certain other employees and the Horizon Pharma nominees may be deemedparticipantsinthesolicitationsofproxiesinconnectionwiththerequeststocalltheSpecialMeetings tovoteinfavoroftheprincipalproposalsdescribedinthe Special Meetings Proxy Statements if the Special Meetings are called and held and to vote in favor of the principal proposals described in the Extraordinary General MeetingProxyStatement.YoucanfindinformationaboutHorizonPharmasdirectors executive officersandsuchcertainotheremployeesandanyindividualsHorizon Pharma is seeking to nominate for election to the Depomed board of directors as described in the Special Meetings Solicitation Statement and the Special Meetings ProxyStatements inHorizonPharmasAnnualReportonForm10 KfortheyearendedDecember31 2014 whichwasfiledwiththeSEConFebruary27 2015 Horizon PharmasdefinitiveproxystatementfiledwiththeSEConMay6 2015 HorizonPharmasCurrentReportonForm8 K/AfiledwiththeSEConJuly27 2015 theSpecial Meetings Solicitation Statement the Special Meetings Proxy Statements and the Extraordinary General Meeting Proxy Statement and in such other solicitation statements proxystatementsorotherdocumentsthatwouldbefiledwiththeSECinconnectionwiththeSpecialMeetings.YoucanfindinformationaboutDepomeds directors executive officers and its employees who are participants in such solicitation in Depomeds definitive proxy statement filed with the SEC on April 16 2015 DepomedsdefinitiverevocationstatementfiledwiththeSEConSeptember30 2015andasmaybesupplementedfromtimetotime theSpecialMeetingsSolicitation Statement theSpecialMeetingsProxyStatementsandinsuchothersolicitationstatements proxystatementsorotherdocumentsthatwouldbefiled withthe SECin connection withthe Special Meetings. These documents areavailable free of charge attheSECs web site at www.sec.gov and withrespect to Horizon Pharma from InvestorRelationsatHorizonPharmaasdescribedabove.AdditionalinformationregardingtheinterestsofsuchpotentialparticipantsisincludedintheSpecialMeetings SolicitationStatement theSpecialMeetingsProxyStatementsandtheExtraordinaryGeneralMeetingProxyStatementandwillbeincludedinoneormoreregistration statements proxystatementsorotherdocumentsfiledwiththeSECifandwhentheybecomeavailable.
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Executive Summary
Timothy P. Walbert
Chairman President and Chief Executive Officer
9 Non Confidential Information Horizon Pharma plc
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Exceptional Net Sales Growth
Net Sales CAGR of 125%
($ in millions)
$250
$200
Sales $150 Net $100
$50
$0
$227
$173
$113 $104
$52
$30 $24
$9 $11
Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015
DUEXIS
RAYOS/LODOTRA VIMOVO
ACTIMMUNE PENNSAID 2% BUPHENYL RAVICITI
Net Sales CAGR of 125%
Strong quarterly net sales growth and diversification over the last 11 quarters
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Diversify Mix of Orphan and Primary Care/Specialty
Continue transformation to a predominantly orphan business by 2020
Complement orphan business with strong primary care /specialty business units providing significant cash flows to invest
Net Sales Mix
1 Year Ago Today Future
(Q3 2014) (Q3 2015) (2020 LRP)
4%
29%
40%
60% 71% 96%
Orphan Primary Care / Specialty
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$2B+ in 2020 Net Sales in Long Range Plan
($ in millions)
$2 400 $1 900 $1 400 $900 $400 $(100)
Net Sales
Adjusted EBITDA
$74 $19
$297
$87
$950 $975
$750 $760
$460 $475 $350 $360
$2 000+
$(73) $(28)
2012 2013 2014 2015(1) 2016(2) 2020(3)
Excludes any future business development activities
Note: Excludes any future business development activities
(1) Estimate based on financial guidance issued November 6 2015 (2) Estimate based on financial guidance issued November 9 2015
(3) Horizon internal goals based on long range plan presented November 9 2015 does not include ACTIMMUNE in certain cancers
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Todays Focus
Issuing first time 2016 net sales and adjusted EBITDA guidance
Companys long range plan estimates $2B+ in net sales in 2020(1)
Orphan business and development pipeline with net sales potential of
~$1 $1.5B+ in 2020 not including potential for ACTIMMUNE in cancer
Differentiated and clinically important Primary Care and Specialty medicines combined with innovative patient support should lead to ~$800M $1B in net sales in 2020
HorizonCares Patients receive the medicines their doctors prescribe
Diversified growth strategy with expected 20%+ annual organic growth complemented with disciplined incremental business development
Strong balance sheet and cash flows enable significant incremental financing capacity
Note: Horizon estimates donot include any incremental business development contribution
(1) Horizon internal goals based on long range plan presented November 9 2015 does not include ACTIMMUNE in certain cancers
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Orphan Business Unit Review
Business Overview and Update
George P. Hampton
Executive Vice President Global Orphan Business Unit and International Operations
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Evolve into a Leading Orphan Business
RAVICTI and ACTIMMUNE address significant unmet needs
Valuable growing orphan business in current indications
$265M annual net sales run rate
Long life assets
Expansion opportunities Ex U.S.
Annual U.S. net sales opportunity of ~$500M(1) in 2020
Attractive contribution margins
Significant potential upside with additional indications
Friedreichs ataxia Phase 3 trial underway(2)
Combination therapy with PD 1/PD L1s in cancer(3)
Annual U.S. net sales opportunity of ~$800M $1.5B(1) in 2020
(1) Horizon estimate
(2) Use of ACTIMMUNE in Friedreichs ataxia (FA) is investigational only and safety and efficacy has not been established for use in Friedrichs ataxia (FA). For further information see www.ACTIMMUNE.com.
(3) Use of ACTIMMUNE with PD 1 and PD L1 inhibitors is investigational only and safety and efficacy has not been established for use with any PD 1 and PD L1 inhibitor. For further information see www.ACTIMMUNE.com.
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Global Orphan Disease Focus
Current Indications
Marketing Status
Dev. Programs
IP Position
Rights Owned
Urea cycle disorders (UCDs)
Chronic granulomatous disease (CGD) Severe malignant osteopetrosis (SMO)
U.S.: Approved (>2 yrs)
EU: In Registration (>2 months)
FDA PMR Studies
Label expansion:
Birth 2 months
2 months 2 years
4allowed and 3 OB listed patents with protection to 2032
Global
U.S. Canada Japan Sweden other ex U.S.: Approved (all ages)
n/a n/a U.S.; Ex U.S. partnered
U.S.: Approved
Friedreichs ataxia: Phase 3 ADO: Phase 2 PD 1 combination: Phase 1(2) Formulation enhancement
2 U.S. patents to 2022; perpetual Genentech know how license Orphan Drug Designation for FA
U.S. Canada Japan
(1) BUPHENYL is known as AMMONAPS outside the United States (2) Anticipated to begin before year end 2015
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Attractive Global Market Opportunity in UCDs
Patients born with genetic defect of urea synthesis
Ultra orphan disease with an estimated U.S. prevalence of about 2 000 cases and incidence of about 1 in every 8 500 to 25 000 newborns Europe and Japan prevalence of about 2 000 cases total Variable age of diagnosis (newborn to adulthood) with neurological deficits ranging from mild mental retardation to coma and death In general with prompt diagnosis and careful management involving dietary restriction alternative pathway therapy can lead to good clinical outcomes Outcomes are poor for untreated severely affected individuals
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Superior Profile of RAVICTI Drives Improved Adherence
Patent / Exclusivity # Form Max Daily Dose Taste and Smell Sodium Content
Oral liquid 3 teaspoons Virtually none None
Tablets or powder 40 tablets Repellant High levels
Note: RAVICTI is based upon a non inferiority study and conclusions between RAVICTI and BUPHENYL may not be made. The information provided are fixed properties in the respective labels and not meant as a comparator or statement of efficacy between the two medicines.
(1) |
|
BUPHENYL is known as AMMONAPS outside the United States |
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Significant Advancement for Patients with UCDs
1996
Up to 40 tabs/day
0 1 2 3 4
Buphenyl (Phenylbyutrate) tab 500 mg
17 YEARS
2013
3 teaspoons/day
(1) BUPHENYL is known as AMMONAPS outside the United States
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Chronic Granulomatous Disease (CGD)
Disease of the immune system and described as a primary immunodeficiency disorder
Patients are more likely to experience recurrent severe bacterial and fungal infections and chronic inflammatory conditions
~1 600 patients in the U.S.
May become apparent any time from infancy to late adulthood
>75% are diagnosed before the age of five years
Under diagnosed and can be misdiagnosed
Diagnostic testing is readily available
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ACTIMMUNE in CGD
Indications
Dosing/Route of Administration
CGD Treatment Protocols
Reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD)
Subcutaneous injection three times weekly
ADVANCES IN ANTIINFECTIOUS PROPHYLACTIC THERAPY POTENTIAL Single Dual Triple CURE
Antibiotic
Antibiotic OR Antibiotic AND Bone Marrow antifungal AND antifungal antifungal Transplant ACTIMMUNE
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Orphan Business Focus
Find and Manage Patients
Patient identification in conjunction with doctors
14 clinical sales associates
Covering key U.S. medical centers
Increase adherence rates
Utilize a range of patient support programs
Nurse educators work directly with patients
HUB implementation
Single point of contact for the patient
Help patients battle disease through education
Data capture and reporting in real time
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Patient Programs Drive Improved Adherence
ACTIMMUNE in CGD and SMO
76% 74% 79% 85% 80% 78% 84% 88% 81% 85% 81% 90%
Adherence Promotional Piece
Intense Adherence Outreach to HCPs Monitor Patient Watch List
Clinical Nurse Program Email Reminders Total Text Reminders Outbound Calls
Sep 14 Oct 14 Nov 14 Dec 14 Jan 15 Feb 15 Mar 15 Apr 15 May 15 Jun 15 Jul 15 Aug 15
14 percentage point improvement in adherence = $14M of annualized net sales
Note: Adherence defined as vials shipped vs. prescribed vials
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Orphan Business at $265M Annual Net Sales Run Rate
$300 000 $250 000 $200 000 $150 000 $100 000 $50 000 $0
BUPHENYL RAVICTI ACTIMMUNE
$23M $25M $3M
Hyperion close May 7th 2015
$49M
Q3 first full quarter of RAVICTI sales
$66M
$265M
Annual Run Rate Based on Q3 2015
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U.S. Orphan Growth Drivers
2020 Annual Net Sales Opportunity of ~$500M(1)
RAVICTI
Continue to transition patients from BUPHENYL to RAVICTI
Further penetration into diagnosed PBA (phenylbutyrate) treatment naïve and newly diagnosed patient populations
Label expansion in patients <2 years
- Anticipate sNDA filing in Q2 2016 for 2 month 2 years
Increase diagnosis rates
ACTIMMUNE Increase diagnosis
- 30% penetrated in CGD
Increase adherence in existing patients
Increase acceptance of triple prophylaxis (oral antibiotic + oral anti fungal + ACTIMMUNE)
(1) Horizon estimate for current approved indications
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Global Expansion
Build or buy infrastructure to capitalize on current and future approvals and acquired medicines
EU RAVICTI
CHMP positive opinion September 24 2015
Anticipate European Commission approval by year end 2015
Potential for significantly enhanced EU label
Commercial launch expected in 2017
Future Medicines
Orphan and specialty focus
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Friedreichs Ataxia (FA)
~$500M $1B(1) U.S. Annual Net Sales Opportunity
Debilitating and progressive genetic neurological disease
85% of diagnosed patients exhibit symptoms before the age of 25
Life shortening
Life span is 30 to 40 years of age
No FDA approved treatment
Monitor symptoms
Most patients take vitamins and antioxidants
Neurological examinations and genetic testing in specialized care centers
Prevalence: ~15 000 worldwide ~3 700 U.S.
Patients in FARA registry: 2 400 worldwide 1 400 U.S.
Note: Use of ACTIMMUNE in Friedreichs ataxia (FA) is investigational only and safety and efficacy has not been established for use in Friedrichs ataxia (FA). For further information see www.ACTIMMUNE.com.
(1) Horizon estimate
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ACTIMMUNE with PD 1/PD L1 Inhibitors
~$300M $500M(1) U.S. Annual Net Sales Opportunity
Analysts project PD 1/PD L1 checkpoint inhibitors market >$30B
Significant investments by pharma in PD 1/PD L1 checkpoint inhibitors
Two currently approved medicines
KEYTRUDA® (pembrolizumab) Merck(2)
OPDIVO® (nivolumab) BMS(3)
Initial focus: combination therapy in selected bladder and renal cancers
Possible combination therapy with PD 1/PD L1 which are considered among the most promising breakthroughs in cancer therapy
Note: Use of ACTIMMUNE with PD 1 and PD L1 inhibitors is investigational only and safety and efficacy has not been established for use with any PD 1 and PD L1 inhibitor. For further information see www.ACTIMMUNE.com.
(1) Horizon estimate in renal and bladder cancers (2) Registered trademark of Merck (3) Registered trademark of Bristol Myers Squibb
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Orphan Business Long Range Plan
~$1.3 $2B+(1) Annual U.S. Net Sales Opportunity in 2020
Net Sales
($ in millions)
$1 800 $1 600 $1 400 $1 200 $1 000 $800 $600 $400 $200 $0
Cancer FA
Existing Indications
~$300 $500 ~$1 300 $2 000
~$500 $1 000
~$500
Existing Indications FA Cancer Total
Midpoint of ranges are represented on chart for FA and cancer (1) Horizon estimate
Non
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Orphan Business Unit Review
Clinical Development Opportunities
Jeffrey W. Sherman M.D. FACP
Executive Vice President Research and Development and Chief Medical Officer
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Commitment to Clinical Development
Clinical development is a vital part of our mission to provide innovative medicines to help patients live better lives
Primary goals
Address unmet medical needs
Develop medicines with differentiated clinical features and benefits
Create sustainable long term value through medicines we bring to market
Comprehensive evaluation of our medicines for additional indications
Engage regulatory agencies health care professionals and patient groups to facilitate clinical development
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Robust Development Pipeline
Friedreichs ataxia
Autosomal Dominant Osteopetrosis
Combo cancer therapy w/ PD 1/PD L1
Next generation formulation
Urea Cycle Disorders
2 months to 2 years of age
Birth to 2 months of age
PMR (Dose sparing)
Lupus (Address fatigue)
Collaborator
FARA
UCLA/Indiana U
Fox Chase
UCDC
UCDC
OMERACT
ALR
Pre Post Phase 1 Phase 2 Phase 3 clinical Market
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ACTIMMUNE (Interferon gamma 1b)
Single chain polypeptide containing 140 amino acids synthesized in the 1980s
Molecular weight: ~33 kDa
Expressed in E. coli bacterium
Specific activity of 20 million IU/mg
Differs from other interferons (alpha and beta)
Treatment targets appear to not overlap
Differs from natural human interferon gamma by the presence of an N terminal methionine and lack of glycosylation
Binds to interferon gamma cell surface receptor (Type II)
5.9 hours mean half life in vivo for subcutaneous dosing with 100 mcg/m2; three times weekly dosing targeted for FA
Note: Use of ACTIMMUNE in Friedreichs ataxia (FA) is investigational only and safety and efficacy has not been established for use in Friedrichs ataxia (FA). For further information see www.ACTIMMUNE.com.
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What is FA
FA is a hereditary disease caused by a genetic mutation in the frataxin (FXN) gene
- FXN gene first identified in 1996
GAA triplet in the FXN gene is repeated 5 33 times in healthy subjects but 66 1000+ times in FA patients Abnormal GAA triplet repeat disrupts production of frataxin Low frataxin = mitochondrial dysfunction and energy deprivation = multi system disease
Normal Cell
FA-affected cell
Mitochondrion
Frataxin
Nucleus
Iron
Chelator
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Moderate Increases in Frataxin May Produce a Therapeutic Benefit
FXN % of control
100 80 60 40 20 0
p <<< 0.0001 p <<< 0.0001
p <<< 0.0001
Controls (n=40) Carriers (n=81) Patients (n=195)
Carriers are asymptomatic and have approximately 50% of the frataxin levels of controls
Source: A rapid noninvasive immunoassay for frataxin: Utility in assessment of Friedreichs ataxia; Eric C. Deutsch Avni B. Santani Susan L. Perlman Jennifer M. Farmer Catherine A. Stolle Michael F. Marusich and David R. Lynch 2012
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Why Interferon gamma 1b for FA
Note: Use of ACTIMMUNE in Friedreichs ataxia (FA) is investigational only and safety and efficacy has not been established for use in Friedrichs ataxia (FA). For further information see www.ACTIMMUNE.com.
Source: A rapid noninvasive immunoassay for frataxin: Utility in assessment of Friedreichs ataxia; Eric C. Deutsch Avni B. Santani Susan L. Perlman Jennifer M. Farmer Catherine A. Stolle Michael F. Marusich and David R. Lynch 2012
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Why Interferon gamma 1b for FA
FRDA mouse model
Half treated with interferon gamma (40 mcg/kg TIW)
Half with placebo for 10 weeks
Results
IFN treated mice significantly improved both locomotor activity and motor coordination
IFN mechanism of action postulated to be upregulation of frataxin gene expression and neuronal preservation in dorsal root ganglion
Source: A rapid noninvasive immunoassay for frataxin: Utility in assessment of Friedreichs ataxia; Eric C. Deutsch Avni B. Santani Susan L. Perlman Jennifer M. Farmer Catherine A. Stolle Michael F. Marusich and David R. Lynch 2012
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ACTIMMUNE Phase 2 Trial in FA
Pilot Study in Children with FA
Investigator initiated study at CHOP
Goals
Safety and tolerability of IFN
Effect on frataxin protein levels
Effect on neurologic function
Design: Open label pilot study
12 Individuals with genetic confirmation of FA ages 5 17 enrolled September December 2013
Dose escalation every two weeks based on tolerability
10mcg/m2 25mcg/m2 50mcg/m2 TIW 3xwk
Overall treatment phase was 12 weeks
Reevaluation 1 month post treatment; last study visit March 2014
Note: Use of ACTIMMUNE in Friedreichs ataxia (FA) is investigational only and safety and efficacy has not been established for use in Friedrichs ataxia (FA). For further information see www.ACTIMMUNE.com.
Source: Open label pilot study of interferon gamma 1b in Friedreich ataxia; Seyer L Greeley N Foerster D Strawser C Gelbard S Dong Y Schadt K Cotticelli MG Brocht A Farmer J Wilson RB Lynch DR. 2014
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ACTIMMUNE Phase 2 Trial in FA
Demographics and Safety
Demographics
8 17 years old mean age of 12
Mean GAA repeat length 835
Mean age of onset was 6
12 of 12 subjects screened met criteria
Two subjects did not follow dose escalation protocol due to adverse events
Two subjects withdrawn from the study for inability to complete study procedures due to travel challenges
Safety and Tolerability
No drug related serious adverse events (SAE) occurred
11 of 12 subjects experienced at least 1 AE
Low grade not dose related
Largely known side effects of IFN
Two subjects were unable to continue with full dose escalation of IFN due to moderate to severe flu like symptoms
Note: Use of ACTIMMUNE in Friedreichs ataxia (FA) is investigational only and safety and efficacy has not been established for use in Friedrichs ataxia (FA). For further information see www.ACTIMMUNE.com.
Source: Open label pilot study of interferon gamma 1b in Friedreich ataxia; Seyer L Greeley N Foerster D Strawser C Gelbard S Dong Y Schadt K Cotticelli MG Brocht A Farmer J Wilson RB Lynch DR. 2014
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ACTIMMUNE Phase 2 Trial in FA
Variable Frataxin Measurements Buccal Cells as a Surrogate for Nerve Cells
Note: Use of ACTIMMUNE in Friedreichs ataxia (FA) is investigational only and safety and efficacy has not been established for use in Friedrichs ataxia (FA). For further information see www.ACTIMMUNE.com.
Source: Open label pilot study of interferon gamma 1b in Friedreich ataxia; Seyer L Greeley N Foerster D Strawser C Gelbard S Dong Y Schadt K Cotticelli MG Brocht A Farmer J Wilson RB Lynch DR. 2014
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ACTIMMUNE Phase 2 Trial in FA
Clinical Outcome Measure by Patient
4.98 change in FARS score with a p value of 0.0078 (equates to reversing 18 to 24 months of disease progression) plus patient decline upon therapy termination support initiation of Phase 3 Study
Note: Use of ACTIMMUNE in Friedreichs ataxia (FA) is investigational only and safety and efficacy has not been established for use in Friedrichs ataxia (FA). For further information see www.ACTIMMUNE.com.
Source: Open label pilot study of interferon gamma 1b in Friedreich ataxiaSeyer L Greeley N Foerster D Strawser C Gelbard S Dong Y Schadt K Cotticelli MG Brocht A Farmer J Wilson RB Lynch DR. 2014
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ACTIMMUNE Phase 2 Trial in FA
Summary
IFN was considered safe and well tolerated
Variable increase in frataxin levels
Presence of increased levels through treatment
Sampling limited to unaffected tissue
Timing of sampling was variable short half life of IFN
Limited to FDA approved dose for other diseases
Clinically significant neurologic improvement
Probability of result occurring by chance < 1%
Limitations
The small size of the study
Absence of a placebo group
Single center
Note: Use of ACTIMMUNE in Friedreichs ataxia (FA) is investigational only and safety and efficacy has not been established for use in Friedrichs ataxia (FA). For further information see www.ACTIMMUNE.com.
Source: Open label pilot study of interferon gamma 1b in Friedreich ataxia; Seyer L Greeley N Foerster D Strawser C Gelbard S Dong Y Schadt K Cotticelli MG Brocht A Farmer J Wilson RB Lynch DR. 2014
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ACTIMMUNE Phase 3 Trial in FA
Randomized Multicenter Double-Blind Placebo-Controlled Efficacy Safety and Pharmacokinetic Study of ACTIMMUNE® (interferon -1b) in Children and Young Adults with Friedreichs Ataxia Short title:
Safety Tolerability and Efficacy of ACTIMMUNE Dose Escalation in Friedreichs Ataxia Study
Clinicaltrials.gov: NCT02415127
Note: Use of ACTIMMUNE in Friedreichs ataxia (FA) is investigational only and safety and efficacy has not been established for use in Friedrichs ataxia (FA). For further information see www.ACTIMMUNE.com.
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ACTIMMUNE Phase 3 Trial in FA
STEADFAST Trial Design
Patients randomized 1:1 to receive subcutaneous doses of either ACTIMMUNE or placebo three times a week for a total of 26 weeks
Approximately 90 patients will be enrolled at four sites in the U.S. CHOP University of Florida University of Iowa and UCLA
Primary endpoint will measure the change in neurological outcome and evaluate the effect of ACTIMMUNE versus placebo as measured by the modified Friedreichs Ataxia Rating Scale (FARS mNeuro) focused on objective neurologic measures
FARS mNeuro is a subset of the total FARS score removing components viewed by FDA to be more subjective and effort dependent
FARS mNeuro score in the Phase 2 study (p=0.0117) is consistent with the previously reported total FARS score (p=0.0078)
Note: Use of ACTIMMUNE in Friedreichs ataxia (FA) is investigational only and safety and efficacy has not been established for use in Friedrichs ataxia (FA). For further information see www.ACTIMMUNE.com.
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ACTIMMUNE Phase 3 Trial in FA
Progress Update & Milestones
Patient enrollment
More than one third enrolled to date
In line with our expectations
Target date for full enrollment of 90 patients: mid year 2016
FARA collaboration to enroll through its patient registry
Potential clinical and regulatory milestones
Data available: Late 2016 sBLA submission: Q1 2017
FDA approval: Q3 2017 (Fast Track designation)
Note: Use of ACTIMMUNE in Friedreichs ataxia (FA) is investigational only and safety and efficacy has not been established for use in Friedrichs ataxia (FA). For further information see www.ACTIMMUNE.com.
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Example of Clinical Response
Before Treatment 6 Months 10 Months
(200mcg 3x/week (200mcg 3x/week [2x CGD Dose]) [2x CGD Dose])
Source: Patient Blog http://fafysio.wordpress.com/2014/08/21/amazing ilva/#comments
ACTIMMUNE is currently approved by the U.S. Food and Drug Administration (FDA) to reduce the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD) and to slow the worsening of severe malignant osteopetrosis (SMO). ACTIMMUNE is not approved for other indications including the treatment of Friedreichs ataxia (FA) and its use with patients suffering from FA is 50 investigational as safety and efficacy have not been established in FA. For further information see www.ACTIMMUNE.com.
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Checkpoint Inhibitors (PD 1/PD L1 Immunotherapy) Role in Cancer Therapy
Normal immunologic surveillance mechanisms programmed cell death
Tumor cells up regulate so called checkpoint inhibitors with effect of turning off immune systems ability to kill cells
Allows cancer cells to multiply and divide unchecked
Potential in multiple tumor types
Use of ACTIMMUNE with PD 1 and PD L1 inhibitors is investigational only and safety and efficacy has not been established for use with any PD 1 and PD L1 inhibitor. For further information see www.ACTIMMUNE.com.
Source: Pardoll D.M. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer 2012. 12(4): p. 252 64.
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Mechanistic Rationale Why ACTIMMUNE May Enhance Activity of PD 1/PD L1 Inhibitors
Interferon gamma (IFN ) may promote or enhance the effect of the PD 1 or PD L1 inhibitors
IFN exhibited superior and more durable enhancement of PD L1 expression in endothelial cell lines vs. IFN and IFN (1)
Tumor PD L1 upregulation appears to be a factor most strongly correlated with response to PD 1 blockade(2)
Interferon gamma will be used to induce PD L1 upregulation in tumor cells to increase the likelihood of response to a PD 1 inhibitor
Note: Use of ACTIMMUNE with PD 1 and PD L1 inhibitors is investigational only and safety and efficacy has not been established for use with any PD 1 and PD L1 inhibitor. For further information see www.ACTIMMUNE.com.
(1) Eppihimer M.J. et al. Expression and regulation of the PD L1 immunoinhibitory molecule on microvascular endothelial cells. Microcirculation 2002. 9(2): p. 133 145.
(2) Taube J.M. et al. Association of PD 1 PD 1 ligands and other features of the tumor immune microenvironment with response to antiPD 1 therapy. Clinical Cancer Research 2014. 20(19): p. 5064 5074.
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ACTIMMUNE PD 1/PD L1 Approach
Phase 1 trial in combination with PD 1 inhibitor in certain cancers
Collaboration with Fox Chase Cancer Center
Assess dose and sequencing of the combination of medicines
Initiate trial by year end 2015
Advance to Phase 2/3 trials
Dependent upon Phase 1 results
Step #1
Step #2
Note: Use of ACTIMMUNE with PD 1 and PD L1 inhibitors is investigational only and safety and efficacy has not been established for use with any PD 1 and PD L1 inhibitor. For further information see www.ACTIMMUNE.com.
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RAVICTI (Glycerol Phenylbutyrate)
Glycerol phenylbutyrate is a nitrogen binding agent
Triglyceride containing 3 molecules of PBA linked to a glycerol backbone
Glycerol is 7% of molecular weight
Sodium and sugar free
Nearly odorless and tasteless
Requires digestion to release PBA in contrast to sodium phenylbutyrate that is a salt and releases PBA immediately after ingestion PBA
~3 teaspoons = 40 tablets of Buphenyl (NaPBA)
PBA Glycerol
PBA
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RAVICTI Label Expansion
Birth 2 years of age
Design: Open label design to assess the safety efficacy and PK of RAVICTI in pediatric patients under 2 years of age
Subjects: UCD patients up to 2 years
Sites: U.S. sites
Target dates:
2 months 2 years
sNDA submission: Q2 2016
Birth 2 months
sNDA submission: Q1 2018
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Exploring Additional RAVICTI Indications
Conducting assessment similar to what was done with ACTIMMUNE to determine possibilities for RAVICTI
IP feasibility
Technical hurdles
Commercial timing
Areas for collaboration with study consortiums and patient groups to facilitate development such as with FARA in FA
Use of ACTIMMUNE in Friedreichs ataxia (FA) is investigational only and safety and efficacy has not been established for use in Friedrichs ataxia (FA). For further information see www.ACTIMMUNE.com.
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Key Takeaways Clinical Development Opportunities
We have a robust clinical development pipeline
Multiple opportunities for possible expansion in use of our products
ACTIMMUNE for FA(1)
Pre clinical data supports mechanism of action Clinical data is supportive of disease modifying activity Anecdotal data
Combination therapy with PD 1/PD L1s in cancer(2)
RAVICITI in younger patients (<2 years of age) with UCDs(3) and other potential indications
(1) Use of ACTIMMUNE in Friedreichs ataxia (FA) is investigational only, and safety and efficacy has not been established for use in Friedrichs ataxia (FA). For further information see www.ACTIMMUNE.com.
(2) Use of ACTIMMUNE with PD 1 and PD L1 inhibitors is investigational only, and safety and efficacy has not been established for use with any PD 1 and PD L1 inhibitor. For further information see www.ACTIMMUNE.com.
(3) Use of RAVICTI for patients less than two years of age is investigational only, and safety and efficacy has not been established in patients less than two years of age. For further
(1) Use of ACTIMMUNE in Friedreichs ataxia (FA) is investigational only, and safety and efficacy has not been established for use in Friedrichs ataxia (FA). For further information see www.ACTIMMUNE.com.
(2) Use of ACTIMMUNE with PD 1 and PD L1 inhibitors is investigational only, and safety and efficacy has not been established for use with any PD 1 and PD L1 inhibitor. For further information see www.ACTIMMUNE.com.
(3) Use of RAVICTI for patients less than two years of age is investigational only, and safety and efficacy has not been established in patients less than two years of age. For further
information see www.ravicti.com.
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Primary Care and Specialty Business Unit Review
Business Overview and Update
John Kody
Executive Vice President, Chief Commercial Officer
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Primary Care/Specialty Commercial Business Model
Patient Focused, Best in Class Execution
Clinically Differentiated Evolving Differentiated Commercial Payer and PBM
Medicines Execution Environment Patient Support Program
.
Primary Care Brands Specialty Brand
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Our Objective is to Grow PC & Specialty Business into $800M $1B in Annual Net Sales by 2020
RAYOS PENNSAID 2% VIMOVO DUEXIS TOTAL
(1) |
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2014 2015 2020
(1) |
|
Estimate based on financial guidance issued November 6, 2015 |
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Large and Growing NSAID Market
117M TRx/Year, Growing ~3%/year, Topical Market +15% Growth
Ibuprofen = 36M TRx/Year
Naproxen = 17M TRx/Year
40 35 30 25 20 15 10 5 0
Ibuprofen TRx
40 35 30 25 20 15 10 5 0
Naproxen TRx
Topical NSAIDs = 6M TRx/year
6 |
|
5 4 3 2 1 0 |
Topical TRx
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TRx Growth Driven By Commercial Model with Clinically Differentiated Medicines
Definition
No recent TRx (called on)
TRx in recent weeks
TRx in most recent week
5+ TRx in most recent week
Current State = 380k Doctors Rx NSAIDs Each Week
Qualifying
INITIAL Trial
NICHE (Trial) 10k Prescribers
ADOPTION
1k Prescribers
>$500M(1) 2015 PC/Specialty Sales
(1) |
|
Estimate based on financial guidance issued November 6, 2015 |
Key Tactics
Focus sales effort on PAR doctors:
Potential for high TRx Access to call on weekly Receptive to clinical message
Apply Horizon differentiated sales model to drive acceleration of adopters
Non Confidential Information Horizon Pharma plc
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Effective Promotion + Differentiated Clinical Benefits Drive Rapid Acceleration of Adopters(1)
# Doctor Adopters
1,000 900 800 700 600 500 400 300 200 100 0
2015 01 09 2015 01 16 2015 01 23 2015 01 30 2015 02 06 2015 02 13 2015 02 20 2015 02 27 2015 03 06 2015 03 13 2015 03 20 2015 03 27 2015 04 03 2015 04 10 2015 04 17 2015 04 24 2015 05 01 2015 05 08 2015 05 15 2015 05 22 2015 05 29 2015 06 05 2015 06 12 2015 06 19 2015 06 26 2015 07 03 2015 07 10 2015 07 17 2015 07 24 2015 07 31 2015 08 07 2015 08 14 2015 08 21 2015 08 28 2015 09 04 2015 09 11 2015 09 18 2015 09 25 2015 10 02
The number of adopters (>5 TRx/week) has TRIPLED in 2015
Source: IMS Xponent
(1) |
|
For Horizons four Primary Care and Specialty medicines |
Non Confidential Information Horizon Pharma plc
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Primary Care/Specialty(1) Volume +189% vs. Price +16%
Last 7 Quarter Net Sales Growth Driven by Volume Growth
Average net realized price (ANRP) has increased 9% annualized, 16% cumulatively since Q1 2014
Prescription growth of 189% since Q1 2014
Quarterly ANRP and Prescription Volumes 1/1/14 to 9/30/15
390,000 340,000 290,000 240,000 190,000 140,000 90,000
Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015
$1,400 $1,200 $1,000 $800 $600 $400 $200 $0
ANRP Aggregate TRx
362,808
319,357
$561
$540 $539
$468 $496 $462
$464
181,964
163,331
154,929
143,338
125,631
(1) |
|
For Horizons four Primary Care and Specialty medicines |
Non Confidential Information Horizon Pharma plc
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Commercial Execution Expected to Drive Achievement of 2020 Long Range Plan
Doctor adoption via execution of commercial business model
Education of the clinical benefit of our medicines
Prescription growth with relatively constant net realized price should allow achievement of LRP
Significant incremental market opportunity for each of our medicines
Commitment to ensure commercially insured patients get the medicines their doctors prescribe at the lowest out of pocket cost possible
Non Confidential Information Horizon Pharma plc
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Primary Care and Specialty Business Unit Review
DUEXIS and VIMOVO Doctors Perspective
Alfonso E. Bello, M.D., MHS, FACP, FACR, DABPM
Rheumatologist
Non Confidential Information Horizon Pharma plc
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Objectives
Background of NSAID use
Review the scope of gastrointestinal (GI) related NSAID toxicities Compare and contrast current gastroprotective strategies DUEXIS® and VIMOVO® review
Please see Important Safety Information in appendix.
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The Increasing Burden of Arthritis
Osteoarthritis (OA) is the most common type of arthritis 26.9 million adults ( 25 years of age) in the U.S. have clinical OA1 Approximately 2.8 million adults ( 18 years of age) in the US have rheumatoid arthritis (RA)2
Prevalence in U.S. is expected to increase with the aging of the population3
NSAIDs are commonly prescribed to treat OA/RA4
NSAID = nonsteroidal anti inflammatory drug. OA = osteoarthritis, RA = rheumatoid arthritis, U.S. = United States.
1. Lawrence RC et al. Arthritis Rheum. 2008;58:26 35. 2. Data Monitor 2011. 3. Helmick CG et al. Arthritis Res Ther.
2008;58:15 25. 4. Crofford LJ. Arthritis Res Ther. 2013;15:S2 S11.
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Incidence of Chronic Pain Compared with Other Disease States in the U.S.
Millions of Americans
0 20 40 60 80 100 120 140
116.0 25.8 23.3 11.7
Chronic pain1 Diabetes2 CHD/Stroke3 Cancer 4
1. Institute of Medicine Report from the Committee on Advancing Pain Research, Care, and Education: Relieving Pain in America, A Blueprint for Transforming Prevention, Care, Education and Research. The National Academies Press, 2011. http://books.nap.edu/openbook.php record_id=13172&page=17. Accessed August 10, 2011.
2. American Diabetes Association. http://www.diabetes.org/diabetes basics/diabetes statistics/. Accessed August 10, 2011.
3. Roger VL, et al. Circulation. 2011;123:e18 e209.
4. American Cancer Society, Prevalence of Cancer: http://www.cancer.org/docroot/CRI/content/CRI_2_6x_Cancer_Prevalence_How_Many_People_Have_Cancer.asp. Accessed August 10, 2011.
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Serious Consequences of NSAID Use
As many as 25% of chronic NSAID users will develop ulcer disease1
2% to 4% will develop a bleed or perforation1,2
Serious GI complications such as inflammation, bleeding, ulceration and perforation can occur at any time, with or without warning symptoms2 In patients with arthritis who are taking NSAIDs3:
>107,000 hospitalizations per year for serious GI complications >16,500 deaths per year
Managing and preventing NSAID associated gastropathy has been estimated to cost more than $4 billion annually4
Lanza FL et al. Am J Gastroenterol. 2009;104:728 738. 2. DUEXIS [package insert]. Pharmaceutics International Inc; 2011.
Singh G. Am J Med. 1998;105:31s 38s. 4. Kendall BJ et al. Practical Gastroenterol. 1993;17:13 29.
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NSAID Induced GI Damage
Superficial damage (i.e., mucosal hemorrhages and erosions) Endoscopically documented non symptomatic silent ulcers Ulcers causing complications, i.e., GI hemorrhage
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Relative Risk of Upper GI Bleeding
Past Complicated Ulcer
Multiple NSAIDs*
High Dose NSAIDs
Anticoagulant
Past Uncomplicated Ulcer
Age 70 80 Years
Steroids
13.5
8.9
7.0
6.4
6.1
5.6
2.2
0 15
Relative Risk Of Upper GI Bleeding
* |
|
Including low dose aspirin |
Dalton et al. Arch Intern Med. 2003;163:59; Garcia Rodriguez and Jick. Lancet. 1994;343:769.
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Mortality From NSAID Induced GI Complications* Versus Other Diseases in the United States
Heroin Viral Hepatitis Opioid Analgesics NSAID Induced Ulcers
2 |
|
4 6 8 10 12 14 16 18 |
Deaths (000s)
Sources
1. CDC Selected Causes of Death 2012 (Table 10) http://www.cdc.gov/nchs/data/nvsr/nvsr63/nvsr63_09.pdf
2. NSAID Induced Deaths M.Wolfe, et.al.; Gastrointestinal Toxicity of Nonsteroidal Anti inflammatory Drugs; NEJM; vol. 340; no. 24; June 1999 3. Opioid and Heroin Deaths for 2012 https://www.drugabuse.gov/related topics/trends statistics/overdose death rates
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NSAID Gastroprotection Strategies and Issues
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American College of Rheumatology Prescribing Guidelines for NSAIDs
Prescribing guidelines for treating OA and RA call for gastroprotective agents to be taken along with NSAIDs to lessen the risk of serious GI side effects such as ulcers.
Risk factors Include: Age 65 years A history of uncomplicated ulcer
High-does NSAID therapy Concurrent of aspirin (including low does), corticosteroids or anticoagulants
High Risk Moderate Risk Low Risk
2 |
|
risk factors History of complicated ulcer, especially recent 1-2risk factors No risk factors |
Lanza FL et al. Am J Gastroenterol. 2009;104:728 738.
American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum.2000;43:1905 1915. Risser A et al. Am Fam Physician. 2009;80:1371 1378.
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Use of Unprotected NSAIDs Post COX 2 Issues Caused Increase in Serious GI Ulcers*
* G. Singh, 2007 American College of Rheumatology Annual Meeting Presentation
Gastroprotection Gap
Serious GI Ulcers/100,000 NSAID Users
800
700 Users 600 NSAID 500
Users
NSAID
Ulcers/100,000
Serious
90% 80% 70% 60% 50% 40% 30% 20% 10% 0%
1997 1998 1999 2000 2001 2002 2003 2004 2005
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Utilization of Gastroprotective Strategies Among New NSAID Users
1 GI Risk Factor
0.1% 2.5% 10.8%
2 GI Risk Factors
0.2% 4% 14.7%
86.6%
81.2%
COX 2/Celebrex alone
NSAID + GPA COX 2/Celebrex No gastroprotection
+ GPA
GPA: Gastroprotective agent
Sturkenboom MC, et al. Rheumatology. 2003;42(Suppl 3):iii23 iii31.
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Provider Adherence To Recommended Guidelines For High Risk Patients*
NSAID Alone NSAID+GPA COX 2 (i.e., Celebrex)
9%
18%
73%
GPA: Gastroprotective agent.
* |
|
Age 65, history of upper GI event, high dose NSAID, corticosteroid use and anticoagulant use. |
Abraham et al. Gastroenterology. 2005;129:1171.
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Gastroprotective Non adherence by Number of Repeat NSAID Prescriptions
70.0
60.0
(%)
50.0
Population 40.0 adherent 30.0
Non 20.0 10.0
32/331 (9.6%)
83/165 (50.3%)
175/288 (60.8%)
2 |
|
3 |
Number of Repeat Prescriptions
Sturkenboom M, et al. Aliment Pharmacol Ther. 2003:18:11371147.
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GI Toxicity Associated With Traditional NSAIDs
Most Patients Are Asymptomatic
N = 1,921
Without symptoms With symptoms
81%
19%
Singh, et al. Arch Intern Med. 1996;156:15301536.
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DUEXIS® (Ibuprofen/famotidine) Clinical Development Program
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DUEXIS Overview
DUEXIS is an innovative 2 in 1 combination tablet with 800 mg ibuprofen and 26.6 mg famotidine1 TID dosing provides 2400 mg ibuprofen and 80 mg famotidine2 daily1
1. DUEXIS (ibuprofen and famotidine) [package insert]. Hunt Valley, MD: Pharmaceutics International, Inc; 2012.
2. Generic famotidine is not approved to reduce upper GI ulcers
Please see Important Safety Information in appendix.
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DUEXIS
Indications and Usage
DUEXIS is indicated for
The relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers in patients who are taking ibuprofen for those indications
In the clinical trials, upper GI ulcer was defined as a gastric and/or duodenal ulcer
The clinical trials primarily enrolled patients <65 years of age without a prior history of GI ulcer. Controlled trials did not extend beyond 6 months
Please see Important Safety Information in appendix.
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DUEXIS Phase 3 Clinical Program
REDUCE 1 and REDUCE 2
The primary objective was to evaluate the efficacy of DUEXIS in reducing the proportion of patients who develop endoscopically diagnosed upper gastrointestinal ulcers during the 24 week treatment period, as compared to ibuprofen, in subjects at risk for NSAID induced ulcers
Please see Important Safety Information in appendix.
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DUEXIS Phase 3 Trial Design
DUEXIS vs. Ibuprofen
DUEXIS TID
Require 24 wk NSAID Use
NSAID Washout (30 days)
Week
Baseline 24 Endoscopy X X X X*
DUEXIS was evaluated in 2 randomized, double blind, multicenter, comparator controlled clinical trials enrolling more than 1500 patients with mild to moderate chronic pain1,2
The trials compared the efficacy of DUEXIS with ibuprofen alone in reducing endoscopically diagnosed ulcers during a 24 week treatment period1,2
*At week 24 or at early termination.
1. DUEXIS (ibuprofen and famotidine) [package insert]. Hunt Valley, MD: Pharmaceutics International, Inc; 2012.
2. Data on file. Horizon Pharma, Inc.
Please see Important Safety Information in appendix.
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DUEXIS Phase 3: REDUCE 1 and REDUCE 2
Patient Demographics and Risk Factors1
All Patients Characteristic (N=1533) Patient Demographics
Median age (range) 55 years (39 to 80)* Female 68% Race: Caucasian 79%
GI Risk Factors
65 years 18% Use of low dose aspirin 15% Positive upper GI ulcer history 6%
* The clinical trials primarily enrolled patients <65 years of age without prior history of GI ulcers.
1. DUEXIS (ibuprofen and famotidine) [package insert]. Pharmaceutics International, Inc; 2012. Please see Important Safety Information in appendix.
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DUEXIS Phase 3: REDUCE 1 and REDUCE 2
Incidence of Upper GI Ulcers*
REDUCE 1 (Study 303)
25
(%) 20
P<0.0001
15
Patients 10 21.3%
5
10.1%
0
Ibuprofen DUEXIS
n=216 (ibuprofen and famotidine)
n=447
REDUCE 2 (Study 301)
25
(%) 20
15 P=0.002
10
Patients 20.0%
5
10.5%
0
Ibuprofen DUEXIS n=190 (ibuprofen and famotidine) n=380
DUEXIS significantly reduced the risk of developing ibuprofen induced upper GI ulcers
by ~50% in two 24 week pivotal trials1
Patients without an endoscopic evaluation within 14 days of their last dose were not
counted as having an ulcer1§
* This analysis excludes patients who dropped out of the study prior to the first endoscopy (at 8 weeks).
In REDUCE 1 (Study 303), the secondary endpoint was incidence of upper GI ulcers.
In REDUCE 2 (Study 301), the primary endpoint was incidence of upper GI ulcers.
§ See Prescribing Information for alternative statistical analyses relating to such patients.
1. DUEXIS (ibuprofen and famotidine) [package insert]. Pharmaceutics International, Inc; 2012.
Please see Important Safety Information in appendix.
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Lower Incidence of Dyspepsia Reported in Controlled Clinical Trials When Taking DUEXIS
Incidence of Dyspepsia1,2
10
(%) 8
P<0.0086
6 |
|
Patients 4 8%
2 |
|
5% |
0
Ibuprofen DUEXIS
(ibuprofen and famotidine)
In controlled clinical trials, DUEXIS was associated with ~40% (P=0.0086) fewer adverse event reports of dyspepsia vs. ibuprofen alone1,2 Although reported incidences of dyspepsia were 5% (DUEXIS) and 8% (ibuprofen), the discontinuation rate due to adverse events was similar for both groups1 The adverse events observed for DUEXIS are consistent with the known safety profiles of ibuprofen and famotidine1,2
1. DUEXIS (ibuprofen and famotidine) [package insert]. Pharmaceutics International, Inc; 2012. 2. Data on file. Horizon Pharma, Inc. Please see Important Safety Information in appendix.
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Adverse Events
The Most Common Adverse Reactions in 2% of Patients in Clinical Trials1
DUEXIS (ibuprofen
Ibuprofen
Adverse Event and famotidine)
(n=511) %
(n=1022) %
Nausea 6 5
Dyspepsia 5 8
Diarrhea 5 4
Constipation 4 4
Upper respiratory tract 4 4
infection
Upper abdominal pain 3 3
Headache 3 3
Hypertension 3 2
Gastroesophageal 2 3
reflux disease
Nasopharyngitis 2 3
Sinusitis 2 3
Vomiting 2 2
DUEXIS
(ibuprofen and Ibuprofen Adverse Event famotidine) (n=511) % (n=1022) %
Stomach discomfort 2 2 Abdominal pain 2 2 Edema peripheral 2 2 Urinary tract infection 2 2
Influenza 2 2 Cough 2 2 Anemia 2 1 Bronchitis 2 1 Back pain 2 1
Pharyngolaryngeal 2 1 pain
Arthralgia 1 2
1. DUEXIS (ibuprofen and famotidine) [package insert]. Pharmaceutics International, Inc; 2012. Please see Important Safety Information in appendix.
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VIMOVO®
(naproxen/esomeprazole) Clinical Development Program
Please see Important Safety Information in appendix.
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VIMOVO Overview
First and only, 2 in 1 tablet to combine an NSAID with a PPI BID dosing provides up to 1000 mg naproxen and 40 mg esomeprazole daily
Please see Important Safety Information in appendix.
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VIMOVO
Indications and Usage
VIMOVO is indicated for
The relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID associated gastric ulcers VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen containing products. Controlled studies do not extend beyond 6 months
Please see Important Safety Information in appendix.
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VIMOVO Phase 3 Study Design
Scheduled endoscopy, tolerability and safety evaluations
VIMOVO (naproxen/esomeprazole)
Please see Important Safety Information in appendix.
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Patient Demographics and Baseline Clinical Features
VIMOVO VIMOVO
Please see Important Safety Information in appendix.
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Please see Important Safety Information in appendix.
VIMOVO
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VIMOVO1 Showed a Significant Reduction in Gastric Ulcers
Cumulative observed incidence of Gastric Ulcers
Study 301 Study 302
* |
|
* |
*P<0.001 EC Naproxen vs.
VIMOVO
1. VIMOVO (naproxen/esomeprazole magnesium) [package insert]. Horizon Pharma USA, Inc; December 2014.
Please see Important Safety Information in appendix.
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VIMOVO Was Well Tolerated
4% of patients taking VIMOVO discontinued treatment1 12% of patients taking EC naproxen discontinued treatment1
67% LESS DISCONTINUATION DUE TO ANY UPPER GI ADVERSE EVENT, INCLUDING DUODENAL ULCERS
1. VIMOVO (naproxen/esomeprazole magnesium) [package insert]. Horizon Pharma USA, Inc; December 2014. Please see Important Safety Information in appendix.
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Most Common Treatment Emergent Adverse Events
1. VIMOVO (naproxen/esomeprazole magnesium) [package insert]. Horizon Pharma USA, Inc; December 2014.
Please see Important Safety Information in appendix.
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U.S. Reimbursement Environment
Terry Evans
Senior Vice President and General Manager, Managed Care and Trade
Non Confidential Information Horizon Pharma plc
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Doing the Right Thing for Patients
What you have heard today
The success of Horizons business model
The clinical differentiation of Horizons medicines
The patients journey in the drug distribution channel is increasingly complex
Multiple interested parties intervening between the doctors prescribing and the patients receiving the prescribed medicine
Non Confidential Information Horizon Pharma plc
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Ensure Patients with Commercial Insurance Receive the Medicine their Doctor Prescribed
Overcome payer/PBM attempts to prevent patients from receiving the medicine their doctor prescribed based on its clinical benefits
Our Mission
Patients receive the medicine their doctor prescribed at the lowest out of pocket cost possible
Our Strategy
Support doctor prescribing through education of the clinical benefits of our medicines
Remove the barriers put in place by payers, PBMs and pharmacies to access our medicines
Ensure patient receives medicine at the lowest out of pocket cost possible
Utilize open distribution through wholesalers to pharmacies
Non Confidential Information Horizon Pharma plc
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Preferred Patient Journey to Access
Access Strategy
Support doctors prescribing through education of the clinical benefits of our medicines
Ensure patient receives medicine at the lowest out of pocket cost possible
Utilize open distribution through wholesalers to pharmacies
Patient:
Improved
Outcome
Pharmacy: Doctor:
Affordable
Medicine Rxs
Dispensed Medicine
Non Confidential Information Horizon Pharma plc
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Five Stakeholders in Every Commercial Prescription
but their interests are not always aligned
Patient Doctor Horizon
Non Confidential Information Horizon Pharma plc
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Payer/PBMs Actively Manage Cost by Limiting Access
Patient Prescription Journey Interrupted
Doctor Access
Horizon Pharma takes action when patients with commercial insurance are prevented from receiving the medicine prescribed by their doctor
Ensure affordable copays and patient access to the medicine the doctor prescribed
Align interest of doctor and patient to ensure adherence and improve outcomes
Non Confidential Information Horizon Pharma plc
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How Payers/PBMs Control Access
Exclusion
Exclude certain medicines from formularies based on costs to PBM rather than clinical benefits and value to patient
Remove medicines from formulary, which limits the doctors choice of medicine
Medication Therapy Management
Step Edits
Prior Authorization
Quantity Limits
Therapeutic Interchange
Non Confidential Information Horizon Pharma plc
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Cost of Medicines is the Smallest Component of the U.S. Healthcare Spend
However, medicines costs are a convenient target
Estimated 2015 Healthcare Spend Per Capita Total Healthcare Expenditures Increase Year over Year
10%
90%
$ 5,000 $4,744
Expenditures $ 4,000
$ 2,909
Healthcare $ 3,000
$ 2,000
$1,398
Capita
$ 1,000 $861
Per
$
2013 2015 2017 2019 2021 2023
Professional services & dental Medical products
Robust pharmacy management systems make medicine spend easier to control and therefore a target for criticism
Medicine Cost Home health care/nursing home Hospital care Other(1)
Source: CMS, National Expenditure Projections 20132023; Health Strategies Group, Strategic Accounts, June 2015.
(1) Other includes government administration, net cost of private health insurance, government public health activities, investment.
Non Confidential Information Horizon Pharma plc
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While Avoidable Healthcare Costs Should be the Focus
100%
90%
35%
80%
70%
1%
60% 6% $213B
$105B
(1)
Non adherence to medicine by patients is largest potentially avoidable cost in the healthcare system
(1) Other levers include delayed evidence based treatment, antibiotic misuse
Non Confidential Information Horizon Pharma plc
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Patient Support Programs
HorizonCares Overview
Steve Curtis
Vice President and General Manager
Non Confidential Information Horizon Pharma plc
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Genesis of Horizon Patient Support Programs
Patients Often Do Not Receive the Medicines their Doctor Prescribes
High Patient
Pharmacy Payer/PBM Out of Pocket
Issues Issues Cost
(Percent of Patients)
100
90
80
70
60
50
40
30
20
10
0
Rx Written Doesnt Go To Pharmacy Switch Managed Care Abandons Due to Rx Filled
Pharmacy Rejection Cost
Creates barriers to patient care
Often the medicine the doctor prescribed was not being received by the patient
Source: Horizon internal market research and analysis post DUEXIS launch
Non Confidential Information Horizon Pharma plc
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Patients Receive Horizons Clinically Differentiated Medicines with Minimal Out of Pocket Costs
Primary Care & Copay Minimal Patient Copays Specialty(1) Assistance for Rejected Rxs
Orphan Reimbursement Clinical Nurse Patient Copay
Support Program Assistance Assistance
(1) Available to commercial patients only
110 Non Confidential Information Horizon Pharma plc
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HorizonCares Patient Support Pathways
Traditional Pharmacies
Hassle
Doctor
Rx
Pharmacy
Claim
Payer/PBM
Approved Denials
Pharmacy
Rx
Participating Pharmacies
Doctor
Rx
Pharmacy
Claim
Payer/PBM
Approved HorizonCares Denials
Pharmacy
Rx Rx
HUB
Doctor
Rx
BI PAs Appeal
HUB Denials
Rx
Payer/PBM
Approved HorizonCares
Claim
Pharmacy
Rx Rx
Primary Care & Specialty
Orphan
Note: Illustrative purposes only
111 Non Confidential Information Horizon Pharma plc
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Medicine Flow to Patients
Horizon
Medicine
Wholesaler Wholesaler Wholesaler
Retail Mail Order Hospital Institutional
Pharmacy Pharmacy Pharmacy Pharmacy
Payer / PBM
Patients
Open Distribution Model
Horizon contracts with a broad number of wholesalers to deliver medicine to pharmacies Ensures medicine availability at pharmacies Enables continuity of care for patients
PBM Controls Cost of Rx
Electronic claim is passed through PBM system for copay of patient Formulary position of medicine dictates copay HorizonCares assists commercially insured patients to receive an affordable copay or free medicine
112 Non Confidential Information Horizon Pharma plc
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Relationship with Pharmacies
Number of pharmacies in which Horizon has
0
ownership or option for ownership
Number of pharmacies that are exclusive to
0
Horizon
Number of pharmacies that have ever
0
purchased Horizon medicines on consignment
113 Non Confidential Information Horizon Pharma plc
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Evolution of Horizon Patient Access Programs
2013 2014 2015 2016
Pilot
Initiated PME access program with two pharmacies
Expanded to ~75 territories and additional pharmacies in the 2nd half of 2014
Expand
Launched in all Primary Care and Specialty territories Established the support team
Optimize
Improved rep training Improved doctor targeting Added additional participating pharmacies
Execute
HorizonCares established to expand patient access Increase the number of participating pharmacies Assess and implement alternative routes of ensuring patient access
114 Non Confidential Information Horizon Pharma plc
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Business Development Strategy
Robert F. Carey
Executive Vice President Chief Business Officer
115 Non Confidential Information Horizon Pharma plc
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Successful Acquisition Track Record
(1) |
|
(3) |
|
November 2013 September 2014 October 2014(2) May 2015 Acquired from Vidara Acquired from Hyperion AstraZeneca Therapeutics Nuvo Research Therapeutics acquisition acquisition
$111M $35M $567M $45M $958M(4)
Note: Dollar figures represent enterprise or asset values and do not include fees and other expenses associated with the respective acquisition (1) RAYOS is known as LODOTRA outside the United States.
(2) Medicine was re launched by Horizon sales force in January 2015 (3) BUPHENYL is known as AMMONAPS outside the United States.
(4) |
|
Fair value of consideration paid less cash and cash equivalents short term investments and long term investments |
116 Non Confidential Information Horizon Pharma plc
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~$2.1B in Value Created Through Organic Growth and Acquisitions
($ in millions) $4 500 $4 000 $3 500 $3 000 $2 500 $2 000 $1 500 $1 000 $500 $0
Acquired $1.6B in assets from 11/6/2013 to 11/6/2015
$958
$45
$567
$35
$243
EV 11/6/2013(1) VIMOVO Vidara PENNSAID 2% Hyperion Value Created EV 11/6/2015 (1)
$2 086
$3 934
DUEXIS & $1 605 Value Acquired RAYOS
(1) |
|
value based on November 6 closing share price and September 30th basic shares outstanding for respective years |
117 Non Confidential Information Horizon Pharma plc
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Business Development Strategy has Contributed to Net Sales Increasing Tenfold over the Past Two Years
($ in millions)
$700 $600 $500 $400 $300 $200 $100 $0
9% 21%
55% 6%
$73 9% 23%
81% 28%
2013 2014 2015
20%
16%
14%
$297
2013 2014 2015
(1) |
|
DUEXIS RAYOS/LODOTRA VIMOVO ACTIMMUNE PENNSAID 2% RAVICITI / BUPHENYL
Based on current guidance net sales will increase tenfold from 2013 to 2015
Addition of five medicines and accelerated organic growth
Significant revenue diversification
No single medicine expected to be more than 23% of total net revenues
DUEXIS was ~81% of net revenues in 2013 and will be ~23% in 2015
(1) Horizon estimate based on 2015 run rate net revenues (Q3 2015 annualized for RAVCITI /BUPHENYL YTD Q3 2015 annualized for all other medicines)
118 Non Confidential Information Horizon Pharma plc
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Significant Value Created through Acquisitions
Diversification of net sales
Expected that no single medicine contributes more than 23% of total 2015 net sales(1)
Enhanced growth rate in net sales and adjusted EBITDA
165% and 360% respectively YTD Q3 2015 over YTD Q3 2014
Enhanced operating margins
Adjusted EBITDA margin from 27% YTD Q3 2014 to 47% YTD Q3 2015
Substantially increased commercial and financial scale
Approaching ~$1 billion in net sales in 2016(2)
Lowered cost of and improved access to capital
Raised ~$1.75 billion in 2015
Average borrowing rate is 4.7%
(1) Based on 2015 run rate net sales (Q3 2015 annualized for RAVCITI /BUPHENYL YTD Q3 2015 annualized for all other medicines) (2) Horizon issued financial guidance including net revenues of $950 $975 for 2016
119 Non Confidential Information Horizon Pharma plc
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Business Development Focus
BD Criteria Prior Focus Todays Focus
Minimum
$20M $20M
Net Sales
Clinically Clinically
Maintain Product Profile
differentiated differentiated
Other Financial Immediate accretion Immediate accretion
Metrics positive NPV positive NPV(1)
Increased focus on
IP Life Long life focus
extending avg. LOE
Business Unit 1. Orphan
Agnostic
Priority 2. Specialty 3. PC
Evolution
Geography U.S. only WW for Orphan
Stage of Late stage dev. +
Marketed only
Development marketed
Business model execution enables an expansion and evolution in BD focus and priorities
120 (1) Development stage
|
Long Range Plan Plus Possible Acquisitions
~20% Annual Organic Growth Plus Acquire ~25% of Prior Years Net Sales
Annual Net Sales
($ in millions)
$3 500 $3 000 $2 500 $2 000 $1 500 $1 000 $500 $0
Acquisition Net Sales
Organic Net Sales
(3) |
|
$2 000+
(2) |
|
$950 $975
(1) |
|
$750 $760
2015 2016 2017 2018 2019 2020
Note: Unlabeled bars are illustrative only
(1) Estimate based on financial guidance issued November 6 2015 (2) Estimate based on financial guidance issued November 9 2015
(3) |
|
Horizon internal goals base on long range plan presented November 9 2015 |
121 Non Confidential Information Horizon Pharma plc
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Current Enterprise Value Doesnt Reflect Sum of the Parts
11/6/2015 Enterprise Value(1)
Fixed Orphan Multiple at Median of ~18% or ~$800M Discount to the EV 8.0x Net Sales Based on Median Multiples for Each of Orphan and Primary Care / Specialty
$1 889 $$1 889 $2 046 3.2x
3.8x Implied 31% Discount to Comparable Company Multiples
Fixed Primary Care / Specialty Multiple at Median of 5.5x Net Sales
$1 204
5.5x 4.7x $2 730 5.5x
31% 72% 5.5x
4.2x 76%
69%
28%
Implied 59% Discount to Comparable Company Multiples
$2 046 $2 730 8.0x
5.5x 43% 57%
(1) |
|
Based on $3.9 billion enterprise value as of November 6 2015 and median EV /Net Revenue trading multiples |
122 Non Confidential Information Horizon Pharma plc
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8 |
|
43% .0x |
3.5x 8.0xFuture Value Primarily Driven by Orphan Growth(1)
Potential 2020 Enterprise Value Allocation
3.2x 8.0x
57% ~5.5x
843% .0x
54% ~33% 8.0x 43%
~8.0x ~67%
3.5x
4.2x 24% 28% 5.5x 76%
72%
(1) Based on Horizon internal goals from the long range plan presented November 9 2015 and comparable company market multiples
123 Non Confidential Information Horizon Pharma plc
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Financial Review
Paul W. Hoelscher
Executive Vice President Chief Financial Officer
124 Non Confidential Information Horizon Pharma plc
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Third Quarter Net Sales
Strong Y o Y and sequential growth from Q2 2015
Net sales up 202% compared to Q3 2014 and 31% sequential vs Q2 2015
Strong sales growth across all three business units
Y o Y Q o Q Q3 2015 Q3 2014 % Change Q2 2015 % Change Primary Care $147 649 $65 959 $113 441
DUEXIS® 56 902 22 753 44 205 VIMOVO® 46 855 43 206 39 805 PENNSAID® 2% (1) 43 892 0 29 431
Orphan 66 126 2 707 48 688
ACTIMMUNE® (2) 28 737 2 707 25 835 RAVICTI® (3) 33 427 0 18 993 BUPHENYL® (3) 3 962 0 3 860
Specialty 12 769 6 460 10 692
RAYOS® 11 670 5 652 10 316 LODOTRA® 1 099 808 376
Total net sales $75 126 $172 821
(1) PENNSAID 2% was acquired on October 17 2014 (2) ACTIMMUNE was acquired on September 19 2014. (3) RAVICTI and BUPHENYL were acquired on May 7 2015.
125 Non Confidential Information Horizon Pharma plc
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Third Quarter 2015 Overview
Adjusted EBITDA was $131M for Q3 2015; LTM adjusted EBITDA was at $274M
Non GAAP diluted EPS was 70 cents up 268% compared to Q3 2014
Non GAAP operating cash flow of $101M up 183% compared to Q3 2014
($ in millions except share and per
share amounts) Q3 2015 Q3 2014
U.S. GAAP Adjustments Non GAAP U.S. GAAP Adjustments Non GAAP
Net sales $226.5 $226.5 $75.1 $ 75.1
Adjusted EBITDA(1) 99.0 32.1 15.1 7.0 22.1
Net income 3.3 113.7 117.0 2.1 17.3 19.4
Basic EPS $0.23 $ 0.72 $0.74 $0.03 $ 0.22 $ 0.25
Diluted EPS $0.23 $ 0.68 $0.02 $ 0.17 $ 0.19
Operating Cash Flow $88.4 $ 12.4 $1.5 $ 34.1 $ 35.6
(1) EBITDA is a non GAAP measure
See Non GAAP reconciliations in the appendix.
126 Non Confidential Information Horizon Pharma plc
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Exceptional Net Sales Growth
Net Sales CAGR of 125%
($ in millions)
$250
$200
Sales $150
Net
$100
$50
$0
$227
$173
DUEXIS
RAYOS/LODOTRA VIMOVO $113 ACTIMMUNE $104
PENNSAID 2% BUPHENYL
$52 RAVICITI $30 $24
$9 $11
Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015
Strong quarterly net sales growth and diversification over the last 11 quarters
127 Non Confidential Information Horizon Pharma plc
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Increasing Diversification of Net Sales
Q3 2015 Net Sales of $226.5 million
Q3 2014 Q3 2015
4%
21% 13% 30% 5% 57% 25%
15% 9%
19% 2%
ACTIMMUNE DUEXIS PENNSAID 2% BUPHENYL RAVICITI RAYOS / LODOTRA VIMOVO
Significant diversification of net sales over past year with no single medicine greater than 25% in Q3 2015
128 Non Confidential Information Horizon Pharma plc
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Transformational Growth in Net Sales and EBITDA in 2015
Increased full year 2015 guidance on November 5 2015
Increased sales guidance to $750 $760M from $660 $680M
Increased adjusted EBITDA guidance to $350 $360M (47% margin) from $265 $280M (41% margin)
$850.0
$750.0
$650.0
$550.0
$450.0
millions) $350.0
in
$
$250.0
$150.0
$50.0
$(50.0)
$(150.0)
$750 $760
Net Sales Adjusted EBITDA
$350 $360 $297
$74 $87 $19
($73) ($28)
2012 2013 2014 2015(1)
Note: Excludes any future business development activities
(1) Estimate based on financial guidance issued November 6 2015
129 Non Confidential Information Horizon Pharma plc
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Fiscal Year 2016 Guidance
Significant Growth with Additional Margin Expansion Expected in 2016
Sales guidance of $950 $975M (increase of 28% at midpoint)
Adjusted EBITDA guidance of $460 $475M (margin of 49% at midpoint)
$1 200.0
$1 000.0
$800.0
$600.0
millions)
in
$
( $400.0
$200.0
$
100%
Net Sales
90%
Adjusted EBITDA $950 $975
80%
Adjusted EBITDA %
70%
$750 $760
60%
47% 49% 50%
$460 $475
40%
29% $350 $360
$297 30%
20%
$87
10%
0%
2014 2015(1) 2016(2)
Note: Excludes any future business development activities
(1) Estimate based on financial guidance issued November 6 2015 (2) Estimate based on financial guidance issued November 9 2015
130 Non Confidential Information Horizon Pharma plc
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2020 Long Range Plan
Business Doubles Over Next Five Years with Orphan Becoming Majority
Sales potential could exceed $2.0 billion(1)
Adjusted EBITDA margin expected to reach ~60% by 2020(1)
($ in millions)
$2 500
$2 000
$1 500
$1 000
$500
$0
100%
Net Sales
90%
Adjusted EBITDA $2 000+
80%
Adjusted EBITDA %
70%
~60%
60%
~49%
47% 50%
$950 $975
40%
29% $750 $760
30%
$460 $475
$350 $360 20%
$297
$87 10%
0%
2014 2015(1) 2016(2) 2020(3)
Note: Excludes any future business development activities
(1) Estimate based on financial guidance issued November 6 2015 (2) Estimate based on financial guidance issued November 9 2015
(3) Horizon internal goals based on long range plan presented November 9 2015 does not include ACTIMMUNE in certain cancers
131 Non Confidential Information Horizon Pharma plc
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2020 Long Range Plan
Adjusted EBITDA Margins Expected to Expand as Orphan Becomes Majority of Business
Potential $2B+ business from existing portfolio of medicines
Assumes sales from potential approval of ACTIMMUNE for FA
Does not include $300 $500M of potential sales for ACTIMMUNE in
various cancer treatments if approved in cancer indications
Does not include any acquisition net sales
Adjusted EBITDA margin expected to expand to ~60% driven by
decreases in:
Sales and marketing as a percent of sales assuming the Orphan
business unit becomes a majority of the business
G&A as a percent of sales as the G&A infrastructure that we are
currently building is leveraged
Note: Use of ACTIMMUNE in Friedreichs ataxia (FA) is investigational only and safety and efficacy has not been established for use in Friedrichs ataxia (FA). For
further information see www.ACTIMMUNE.com.
Note: Use of ACTIMMUNE with PD 1 and PD L1 inhibitors is investigational only and safety and efficacy has not been established for use with any PD 1 and PD L1 inhibitor. For
further information see www.ACTIMMUNE.com.
132 Non Confidential Information Horizon Pharma plc
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Diversify Mix of Orphan and Primary Care/Specialty
Continue transformation to a predominantly orphan business by 2020
Complement orphan business with strong primary care /specialty business units providing significant cash flows to invest
Net Sales Mix
1 Year Ago Today Future
(Q3 2014) (Q3 2015) (2020 LRP)
4%
29%
40%
60%
71%
96%
Orphan Primary Care / Specialty
133 Non Confidential Information Horizon Pharma plc
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Strong Financial Position
September 30 2015
($ in millions) September 30 2015
Cash and cash equivalents $684
Senior secured term loans Due 2021 399
2.5% exchangeable senior notes Due 2022 400
Senior notes Due 2023 475
Total Debt (Face Amount) $1 274
Less debt discount (133)
Total Debt (Book Value) $1 141
Shares outstanding 159 267 370
Strong capital structure with net debt of $590M at September 30 2015
134 Non Confidential Information Horizon Pharma plc
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Strong Cash Flows Improving Leverage Position
Significant Acquisition Funding from Existing Cash and Borrowing Capacity(1)
LTM 2015 2016
($ in millions)
9/30/2015 Guidance Guidance
Leverage Position:
Adjusted EBITDA $274 $350 $360 $460 $475
Leverage ratio based on 9/30/15
debt and cash balances:
Acquisition Funding Available(2):
Senior secured debt maximum at 3.5x EBITDA(3) $959 $1 242 $1 636
Current senior secured debt (399) (399) (399)
Incremental senior secured debt available $560 $843 $1 237
Total debt at 5.75x EBITDA(3) $1 576 $2 041 $2 688
Current total debt (1 274) (1 274) (1 274)
Incremental total debt available $302 $767 $1 414
Current cash and cash equivalents 684 684 684
(1) |
|
Subject to Horizons ability to meet various covenants as well as market conditions |
(2) Does not include any post Q3 2015 cash flow generation or the EBITDA from any acquired medicines or businesses (3) 3.5x senior secured and 5.75x total are covenants in our current debt agreement
135 Non Confidential Information Horizon Pharma plc
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Wrap Up
Timothy P. Walbert
Chairman President and Chief Executive Officer
136 Non Confidential Information Horizon Pharma plc
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Todays Focus
Issuing first time 2016 net sales and adjusted EBITDA guidance
Companys long range plan estimates $2B+ in net sales in 2020(1)
Orphan business and development pipeline with net sales potential of
~$1 $1.5B+ in 2020 not including potential for ACTIMMUNE in cancer
Differentiated and clinically important Primary Care and Specialty medicines
combined with innovative patient support should lead to ~$800M $1B in
net sales in 2020
HorizonCares Patients receive the medicines their doctors prescribe
Diversified growth strategy with expected 20%+ annual organic growth
complemented with disciplined incremental business development
Strong balance sheet and cash flows enable significant incremental
financing capacity
Note: Horizon estimates donot include any incremental business development contribution
(1) Horizon internal goals based on long range plan presented November 9 2015 does not include ACTIMMUNE in certain cancers
137 Non Confidential Information Horizon Pharma plc
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Horizon Pharma plc
Investor Day Presentation
November 9 2015
|
GAAP to Non GAAP Reconciliation
Net Income
Three Months Ended Sept. 30 Nine Months Ended Sept. 30
2015 2014 2015 2014
(Unaudited) (Unaudited)
Adjusted Non GAAP Net Income:
GAAP Net Income (Loss) $ 3 277 $ 2 063 $ 15 538 $ (231 956)
Non GAAP Adjustments:
Remeasurement of royalties for products acquired through business combinations 14 277 13 033
Acquisition related costs 14 498 31 477 64 841 45 651
Loss on derivative revaluation 214 995
Loss on induced conversion of debt and debt extinguishment 77 624
Bargain purchase gain (22 171) (22 171)
Amortization and accretion:
Intangible amortization expense 41 707 6 413 91 217 16 469
Amortization of debt discount and deferred financing costs 5 480 2 421 13 328 7 087
Accretion of royalty liabilities 6 551 2 664 13 571 5 617
Amortizaton of inventory step up adjustment 4 140 1 540 10 635 1 540
Share based compensation 26 457 4 024 57 796 10 111
Depreciation expense 1 578 413 2 808 1 193
Royalties for products acquired through business combinations (1) (8 854) (6 366) (20 890) (12 062)
Total of pre tax non GAAP adjustments 91 557 20 415 325 207 281 463
Income tax adjustments (2) 22 178 (3 042) (137 328) (3 267)
Total of non GAAP adjustments 113 735 17 373 187 879 278 196
Adjusted Non GAAP Net Income $ 117 012 $ 19 436 $ 203 417 $ 46 240
Adjusted Non GAAP Earnings Per Share:
Weighted average shares Basic 159 035 580 78 392 971 145 208 252 73 109 603
Adjusted Non GAAP Earnings Per Share Basic:
GAAP earnings (loss) per share Basic $ 0.02 $ 0.03 $ 0.11 $ (3.17)
Non GAAP adjustments 0.72 0.22 1.29 3.80
Adjusted Non GAAP earnings per share Basic $ 0.74 $ 0.25 $ 1.40 $ 0.63
Weighted average shares Diluted
Weighted average shares Basic 159 035 580 78 392 971 145 208 252 73 109 603
Ordinary share equivalents 7 795 220 35 258 496 8 797 419 35 577 854
Weighted average shares Diluted 166 830 800 113 651 467 154 005 671 108 687 457
Adjusted Non GAAP Net Income Diluted
Adjusted Non GAAP Net Income $ 117 012 $ 19 436 $ 203 417 $ 46 240
Add: Convertible debt interest expense net of taxes 1 875 5 625
Adjusted Non GAAP Net Income Diluted $ 117 012 $ 21 311 $ 203 417 $ 51 865
GAAP earnings (loss) per share Diluted $ 0.02 $ 0.02 $ 0.10 $ (3.17)
Non GAAP adjustments 0.68 0.20 1.22 3.81
Diluted earnings per share effect of ordinary share equivalents (0.03) (0.16)
Adjusted Non GAAP earnings per share Diluted $ 0.70 $ 0.19 $ 1.32 $ 0.48
(1) Royalties for products acquired through business combinations relate to VIMOVO ACTIMMUNE RAVICTI and BUPHENYL.
(2) Adjustments to convert the income tax benefit/expense to the estimated amount of taxes that are payable in cash.
139
|
GAAP to Non GAAP Reconciliation
EBITDA
Three Months Ended Sept. 30 Nine Months Ended Sept. 30
2015 2014 2015 2014
(Unaudited) (Unaudited)
EBITDA and Adjusted EBITDA:
GAAP Net Income (Loss) $ 3 277 $ 2 063 $ 15 538 $ (231 956)
Depreciation 1 578 413 2 808 1 193
Amortization and accretion:
Intangible amortization expense 41 707 6 413 91 217 16 469
Accretion of royalty liabilities 6 551 2 664 13 571 5 617
Amortization of deferred revenue (490) (156) (753) (478)
Amortizaton of inventory step up adjustment 4 140 1 540 10 635 1 540
Interest expense net (including amortization of
debt discount and deferred financing costs) 20 300 5 194 49 780 13 608
Expense (benefit) for income taxes 21 979 (3 042) (136 788) (3 267)
EBITDA $ 99 042 $ 15 089 $ 46 008 $ (197 274)
Non GAAP adjustments:
Remeasurement of royalties for products acquired through business combinations 14 277 13 033
Acquisition related costs 14 498 31 477 64 841 45 651
Loss on derivative revaluation 214 995
Loss on induced conversion and debt extinguishment 77 624
Bargain purchase gain (22 171) (22 171)
Share based compensation 26 457 4 024 57 796 10 111
Royalties for products acquired through business combinations (1) (8 854) (6 366) (20 890) (12 062)
Total of Non GAAP adjustments $ 32 101 $ 6 964 $ 193 648 $ 249 557
Adjusted EBITDA $ 131 143 $ 22 053 $ 239 656 $ 52 283
Non GAAP Gross Profit:
GAAP net sales $ 226 544 $ 75 126 $ 512 506 $ 193 114
GAAP cost of goods sold 61 250 13 644 151 929 46 073
GAAP gross profit $ 165 294 $ 61 482 $ 360 577 $ 147 041
GAAP gross profit % 73.0% 81.8% 70.4% 76.1%
Non GAAP Gross Profit:
GAAP gross profit $ 165 294 $ 61 482 $ 360 577 $ 147 041
Non GAAP gross profit adjustments:
Remeasurement of royalties for products acquired through business combinations 14 277 13 033
Intangible amortization expense (COGS only) 41 506 6 386 90 610 16 442
Accretion of royalty liabilities 6 551 2 664 13 571 5 617
Amortizaton of inventory step up adjustment 4 140 1 540 10 635 1 540
Depreciation (COGS only) 65 90 268 264
Royalties for products acquired through business combinations (1) (8 854) (6 366) (20 890) (12 062)
Total of Non GAAP adjustments $ 43 408 $ 4 314 $ 108 471 $ 24 834
Non GAAP gross profit $ 208 702 $ 65 796 $ 469 047 $ 171 875
Non GAAP gross profit % 92.1% 87.6% 91.5% 89.0%
Non GAAP Cash Provided By Operating Activities:
GAAP cash (used in) provided by operating activities $ 88 383 $ 1 466 $ 59 228 $ 17 470
Cash payments of acquistion related costs 12 464 34 142 49 152 43 150
Cash payments for induced debt conversion 10 472
Cash payment for debt extinguishment 45 367
Payment of original issue discount on debt extinguishment 3 000
Non GAAP cash provided by operating activities $ 100 847 $ 35 608 $ 167 219 $ 60 620
140 (1) Royalties for products acquired through business combinations relate to VIMOVO ACTIMMUNE RAVICTI and BUPHENYL. Non Confidential Information Horizon Pharma plc
|
GAAP to Non GAAP Reconciliation
EBITDA (Continued)
141 Non Confidential Information Horizon Pharma plc
|
Important Safety Information for
DUEXIS and VIMOVO
142 Non Confidential Information Horizon Pharma plc
|
Selected Safety Information
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
See full Prescribing Information for complete boxed warning.
Ibuprofen a component of DUEXIS may increase the risk of serious cardiovascular (CV) thrombotic events myocardial infarction and stroke which can be fatal. Risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
DUEXIS is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
NSAIDs including ibuprofen a component of DUEXIS increase the risk of serious gastrointestinal (GI) adverse reactions including bleeding ulceration and perforation of the stomach or intestines which can be fatal. Reactions can occur at any time without warning symptoms. Elderly patients are at greater risk.
NSAIDs including ibuprofen which is a component of DUEXIS tablets can lead to onset of new hypertension or worsening of preexisting hypertension either of which may contribute to the increased incidence of cardiovascular events. Monitor blood pressure closely during treatment with DUEXIS
As with other NSAIDs the use of aspirin and DUEXIS may increase the risk of adverse events including GI bleeding The most common adverse reactions ( 1% and greater than ibuprofen alone) were nausea diarrhea constipation upper abdominal pain and headache
143
|
Selected Safety Information (contd)
DUEXIS should not be given to patients who have experienced asthma urticaria or allergic reactions after taking aspirin or other NSAIDs. Severe rarely fatal anaphylaxis with NSAIDs has been reported in such patients. DUEXIS is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft surgery. DUEXIS is contraindicated in patients in late stages of pregnancy as premature closure of the ductus arteriosus in the fetus may occur.
DUEXIS should not be administered to patients with a history of hypersensitivity to other H2 receptor antagonists. Cross sensitivity with other H2 receptor antagonists has been observed When active and clinically significant bleeding from any source occurs in patients receiving DUEXIS the treatment should be withdrawn Fluid retention and edema have been observed in some patients taking NSAIDs. DUEXIS should be used with caution in patients with fluid retention or heart failure
144
|
DUEXIS
Indications and Usage
DUEXIS is indicated for:
The relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers in patients who are taking ibuprofen for those indications
In the clinical trials upper GI ulcer was defined as a gastric and/or duodenal ulcer The clinical trials primarily enrolled patients <65 years of age without a prior history of GI ulcer. Controlled trials did not extend beyond 6 months
145
|
DUEXIS Important Safety Information
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
See full Prescribing Information for complete boxed warning.
Ibuprofen a component of DUEXIS may increase the risk of serious cardiovascular (CV) thrombotic events myocardial infarction and stroke which can be fatal. Risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
DUEXIS is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
NSAIDs including ibuprofen a component of DUEXIS increase the risk of serious gastrointestinal (GI) adverse reactions including bleeding ulceration and perforation of the stomach or intestines which can be fatal.
Reactions can occur at any time without warning symptoms. Elderly patients are at greater risk.
146
|
DUEXIS Important Safety Information (contd)
DUEXIS should not be given to patients who have experienced asthma urticaria or allergic reactions after taking aspirin or other NSAIDs. Severe rarely fatal anaphylaxis with NSAIDs has been reported in such patients. DUEXIS is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft surgery. DUEXIS is contraindicated in patients in late stages of pregnancy as premature closure of the ductus arteriosus in the fetus may occur.
DUEXIS should not be administered to patients with a history of hypersensitivity to other H2 receptor antagonists. Cross sensitivity with other H2 receptor antagonists has been observed When active and clinically significant bleeding from any source occurs in patients receiving DUEXIS the treatment should be withdrawn NSAIDs including ibuprofen which is a component of DUEXIS tablets can lead to onset of new hypertension or worsening of preexisting hypertension either of which may contribute to the increased incidence of cardiovascular events. Monitor blood pressure closely during treatment with DUEXIS
147
|
DUEXIS Important Safety Information (contd)
Fluid retention and edema have been observed in some patients taking NSAIDs. DUEXIS should be used with caution in patients with fluid retention or heart failure Long term administration of NSAIDs including ibuprofen which is a component of DUEXIS tablets has resulted in renal papillary necrosis and other renal injury. Use DUEXIS with caution in patients at risk (eg the elderly; those with renal impairment heart failure or liver impairment; and those taking diuretics or ACE inhibitors) Hepatic injury ranging from transaminase elevations to liver failure can occur.
If clinical signs and symptoms consistent with liver disease develop if abnormal liver tests persist or worsen or if systemic manifestations occur DUEXIS should be discontinued immediately Anaphylaxis may occur in patients with the aspirin triad or in patients without prior exposure to DUEXIS. If an anaphylactoid reaction occurs DUEXIS should be discontinued immediately
148
|
DUEXIS Important Safety Information (contd)
Serious skin reactions including exfoliative dermatitis Stevens Johnson syndrome and toxic epidermal necrolysis which can be fatal can occur. Discontinue DUEXIS if rash or other signs of local skin reaction occur
Nursing mothers should use DUEXIS with caution as it is not known if ibuprofen is excreted in human milk and famotidine is excreted in human milk
The most common adverse reactions ( 1% and greater than ibuprofen alone) were nausea diarrhea constipation upper abdominal pain and headache
For further information on DUEXIS please see full Prescribing Information at
www.DUEXIS.com/PI.
149
|
REDUCING THE RISK OF GASTRIC ULCERS FROM NAPROXEN
THE SMARTER NAPROXEN DUE
TO ADDED GASTROPROTECTION
|
VIMOVO Important Safety Information
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS
Cardiovascular Risk
Naproxen a component of VIMOVO may cause an increased risk of serious cardiovascular thrombotic events myocardial infarction and stroke which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk VIMOVO is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery
Gastrointestinal Risk
NSAIDs including naproxen a component of VIMOVO cause an increased risk of serious gastrointestinal adverse events including bleeding ulceration and perforation of the stomach or intestines which can be fatal.
These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events
151
|
Selected Safety Information (contd)
Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. As with all NSAIDs concurrent administration of VIMOVO and aspirin is not generally recommended because of the potential of increased adverse events.
NSAIDs including VIMOVO can cause serious GI adverse events which can be fatal.
The risk is greater in patients with a prior history of ulcer disease or GI bleeding and in patients at high risk for GI events especially the elderly. VIMOVO should be used with caution in these patients Several studies and literature reports indicate that long term proton pump inhibitor (PPI) therapy is associated with an increased risk for osteoporosis related fractures of the hip wrist or spine The most commonly observed adverse events in clinical trials (experienced by >5% patients in the VIMOVO group) were erosive gastritis dyspepsia gastritis diarrhea gastric ulcer upper abdominal pain and nausea
152
|
VIMOVOTHE SMARTER NAPROXEN DUE TO ADDED GASTROPROTECTION
INDICATIONS
VIMOVO is indicated for the relief of signs and symptoms of osteoarthritis rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID associated gastric ulcers
VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen containing products. Controlled studies do not extend beyond 6 months
153
|
VIMOVO Dosing and Administration
The recommended dose of VIMOVO is 1 tablet administered orally twice daily (BID)1
Available as 375 mg/20 mg and 500 mg/20 mg of naproxen and esomeprazole magnesium1
VIMOVO tablets should be swallowed whole with liquid1
Do not split chew crush or dissolve tablets1
VIMOVO should be taken at least 30 minutes before meals1
1. VIMOVO (naproxen/esomeprazole magnesium) [package insert]. Horizon Pharma USA Inc; December 2014.
154
|
VIMOVO Important Safety Information (contd)
VIMOVO is contraindicated in patients with known hypersensitivity to any component of VIMOVO or substituted benzimidazoles; in patients with a history of asthma urticaria or other allergic type reactions after taking aspirin or other NSAIDs; in patients during the perioperative period in the setting of coronary artery bypass graft (CABG) surgery; or in patients in the late stages of pregnancy Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals Treatment should be withdrawn when active and clinically significant bleeding from any source occurs
155
|
VIMOVO Important Safety Information (contd)
As with all NSAIDs VIMOVO can lead to the onset of new hypertension or worsening of preexisting hypertension either of which may contribute to the increased incidence of CV events. Blood pressure should be monitored closely. NSAIDs including VIMOVO may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors and angiotensin II antagonists beta blockers and in some patients can reduce the natriuretic effect of furosemide and thiazides Fluid retention and edema have been observed in some patients taking NSAIDs including VIMOVO.
NSAIDs should be used with caution in patients with fluid retention or heart failure Two large controlled clinical trials of a COX 2 selective NSAID for the treatment of pain in the first 10 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke
156
|
VIMOVO Important Safety Information (contd)
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. As with all NSAIDs concurrent administration of VIMOVO and aspirin is not generally recommended because of the potential of increased adverse events.
NSAIDs including VIMOVO can cause serious GI adverse events which can be fatal. The risk is greater in patients with a prior history of ulcer disease or GI bleeding and in patients at high risk for GI events especially the elderly. VIMOVO should be used with caution in these patients
157
|
VIMOVO Important Safety Information (contd)
Epidemiological studies have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding.
In two studies concurrent use of an NSAID COX 2 inhibitor or aspirin potentiated the risk of bleeding. Although these studies focused on upper gastrointestinal bleeding bleeding at other sites cannot be ruled out NSAIDs should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis Crohns disease) as their condition may be exacerbated Symptomatic response to esomeprazole a component of VIMOVO does not preclude the presence of gastric malignancy Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole of which VIMOVO contains an enantiomer Anaphylactoid reactions may occur in patients without known prior exposure to either component of VIMOVO. NSAIDs should not be given to patients with aspirin triad
158
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VIMOVO Important Safety Information (contd)
NSAIDs can cause serious skin adverse reactions such as exfoliative dermatitis Stevens Johnson syndrome and toxic epidermal necrolysis which can be fatal. These serious events may occur without warning. Discontinue VIMOVO at first appearance of skin rash or any other sign of hypersensitivity In late pregnancy as with other NSAIDs VIMOVO should be avoided because it may cause premature closure of the ductus arteriosus VIMOVO is not recommended in patients with moderate or severe renal insufficiency.
In addition NSAIDs may cause renal toxicity
VIMOVO is not recommended in patients with severe hepatic insufficiency. Consider dose reduction in mild/moderate hepatic insufficiency. If abnormal liver enzymes persist or worsen discontinue use immediately Several studies and literature reports indicate that long term proton pump inhibitor (PPI) therapy is associated with an increased risk for osteoporosis related fractures of the hip wrist or spine PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea
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VIMOVO Important Safety Information (contd)
Avoid concomitant use of esomeprazole with clopidogrel due to a reduction in plasma concentrations of the active metabolite of clopidogrel. When using esomeprazole consider alternative anti platelet therapy Hypomagnesemia has been reported rarely with prolonged treatment with PPIs Avoid concomitant use of VIMOVO with St Johns Wort or rifampin due to the potential reduction in esomeprazole levels Esomeprazole a component of VIMOVO inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg ketoconazole iron salts and digoxin) Concomitant use of VIMOVO and warfarin may result in increased risk of bleeding complications. Monitor for increases in INR and prothrombin time The most commonly observed adverse events in clinical trials (experienced by >5% patients in the VIMOVO group)were erosive gastritis dyspepsia gastritis diarrhea gastric ulcer upper abdominal pain and nausea
For further information on VIMOVO please see the full Prescribing Information at www.VIMOVO.com/PI.
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