Form S-1 (cid:9)
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`S-1 1 d880840ds1.htm FORM S-1
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`Table of Contents
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`As filed with the Securities and Exchange Commission on March 12, 2015
`
`Registration No. 333-
`
`UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`Washington, D.C. 20549
`
`FORM S-1
`REGISTRATION STATEMENT
`UNDER
`THE SECURITIES ACT OF 1933
`
`Par Pharmaceutical Holdings, Inc.
`
`Delaware (cid:9)
`(State or other jurisdiction of (cid:9)
`incorporation or organization) (cid:9)
`
`(Exact name of registrant as specified in its charter)
`2834 (cid:9)
`(Primary Standard Industrial (cid:9)
`Classification Code Number)
`One Ram Ridge Road
`Chestnut Ridge, New York 10977
`(845) 573-5500
`(Address, including zip code, and telephone number, including area code, of registrant's principal executive offices)
`
`46.0634834
`(I.R.S. Employer Identification Number)
`
`Paul V. Campanella
`Chief Executive Officer
`Par Pharmaceutical Holdings, Inc.
`One Ram Ridge Road
`Chestnut Ridge, New York 10977
`(845) 573-5500
`(Name, address, including zip code, and telephone number, including area code, of agent for service)
`
`Patrick O'Brien, Esq.
`Ropes & Gray LLP
`Prudential Tower
`800 Boylston Street
`Boston, MA 02199
`(617) 951-7000
`
`Copies to:
`Barry J. Gilman, Esq.
`Par Pharmaceutical Holdings, Inc.
`One Ram Ridge Road
`Chestnut Ridge, New York 10977
`(845) 573-5500
`
`William V. Fogg, Esq.
`Cravath, Swaine & Moore LLP
`Worldwide Plaza
`825 Eighth Avenue
`New York, New York 10019
`(212) 474-1000
`
`Approximate date of commencement of proposed sale to public: As soon as practicable after this Registration Statement is declared effective.
`If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933,
`check the following box. q
`If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act
`registration statement number of the earlier effective registration statement for the same offering.
`q
`If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration
`statement number of the earlier effective registration statement for the same offering.
`q
`If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration
`q
`statement number of the earlier effective registration statement for the same offering.
`Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the
`definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act.
`Large accelerated filer q (cid:9)
`q (cid:9)
`Accelerated filer
`Non-accelerated filer O (cid:9)
`(Do not check if a
`smaller reporting company)
`CALCULATION OF REGISTRATION FEE
`
`Smaller reporting company q
`
`(1) Estimated solely for the purpose of calculating the registration fee in accordance with Rule 457(o) of the Securities Act of 1933, amended.
`(2)
`Includes shares that may be sold upon exercise of the underwriters' option to purchase additional shares. See "Underwriting (conflicts of interest)."
`
`The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant
`shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8
`(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission,
`acting pursuant to said Section 8(a), may determine.
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`JAZZ EXHIBIT 2015
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-00554
`Part 1 of 4
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`

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`Form S-1 (cid:9)
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`Table of Contents
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`Page 2 of 270
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`The information in this prospectus is not complete and may be changed. These securities may not be sold until the
`registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an
`offer to sell these securities and we are not soliciting an offer to buy these securities in any jurisdiction where the
`offer or sale is not permitted.
`
`Subject to completion
`Preliminary prospectus dated March 12, 2015
`
`Prospectus
`shares
`F N M A F7 M A C E U i I C A L
`Par Pharmaceutical Holdings, Inc.
`Common stock
`This is the initial public offering of common stock of Par Pharmaceutical Holdings, Inc. We are selling (cid:9)
`shares of our
`common stock and the selling stockholders identified in this prospectus are selling (cid:9)
`shares of our common stock. We
`will not receive any proceeds from the sale of shares being sold by the selling stockholders.
`
`Prior to the offering, there has been no public market for our common stock. We expect the public offering price to be
`between $ (cid:9)
`and $ (cid:9)
`per share. We intend to apply to have our common stock listed on (cid:9)
`under the symbol
`"PRX."
`
`We and the selling stockholders have granted the underwriters an option to purchase up to an additional (cid:9)
`shares of
`our common stock at the public offering price, less the underwriting discount, for 30 days after the date of this prospectus.
`After the completion of this offering, investment funds affiliated with TPG Global, LLC will continue to own a majority of the
`voting power of our outstanding shares of common stock. As a result, we expect to be a "controlled company" within the
`meaning of the corporate governance standards of (cid:9)
`. See "Principal and selling stockholders."
`
`Investing in the common stock involves risks. See " Risk factors " beginning on page 18 of this prospectus.
`
`Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of
`these securities or determined if this prospectus is truthful and complete. Any representation to the contrary is a criminal
`offense.
`
`Per share (cid:9)
`
`Total
`
`Public offering price
`
`Underwriting discount
`
`Proceeds to us, before expenses(1)
`
`$ (cid:9)
`Proceeds to selling stockholders, before expenses (cid:9)
`(1) We have agreed to reimburse the underwriters for certain expenses in connection with this offering. See "Underwriting (conflicts of interest)."
`
`$
`
`The underwriters expect to deliver the shares of common stock to investors on or about (cid:9)
`2015.
`J.P. Morgan (cid:9)
`Goldman, Sachs & Co.
`Citigroup (cid:9)
`Morgan Stanley
`BofA Merrill Lynch (cid:9)
`Evercore ISI
`Deutsche Bank Securities (cid:9)
`RBC Capital Markets (cid:9)
`TPG Capital BD, LLC
`, 2015.
`Prospectus dated (cid:9)
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`

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`Page 3 of 270
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`Table of Contents
`
`Table of contents
`
`Prospectus summary
`Risk factors
`Cautionary note regarding forward-looking statements
`Use of proceeds
`Dividend policy
`Capitalization
`Dilution
`Selected historical consolidated financial data
`Management's discussion and analysis of financial condition and results of operations
`Business
`Management
`Executive compensation
`Certain relationships and related party transactions
`Principal and selling stockholders
`Description of indebtedness
`Description of capital stock
`Shares eligible for future sale
`Material United States federal income tax considerations for non-U.S. holders
`Underwriting (conflicts of interest)
`Legal matters
`Experts
`Where you can find more information
`Index to consolidated financial statements
`
`1
`18
`49
`51
`52
`53
`54
`56
`62
`99
`129
`136
`155
`157
`159
`164
`166
`168
`173
`181
`181
`181
`F-1
`
`You should rely only on the information contained in this prospectus or in any free writing prospectus that we
`authorize to be distributed to you. Neither we nor the underwriters have authorized anyone to provide you with
`different information, and neither we nor the underwriters take responsibility for any other information others may
`give you. We are not, and the underwriters are not, making an offer to sell these securities in any jurisdiction where
`the offer or sale is not permitted. You should not assume that the information contained in this prospectus is
`accurate as of any date other than the date on the front cover, regardless of time of delivery of this prospectus or
`of any sale of our common stock. Our business, prospects, financial condition and results of operations may have
`changed since that date.
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`Industry and market data
`This prospectus includes market share, ranking, industry data and forecasts that we obtained from industry publications and
`surveys, including from IMS Health Incorporated ("IMS Health") and EvaluatePharma, a service of Evaluate Ltd., public
`filings and internal company sources. Industry publications, surveys and forecasts generally state that the information
`contained therein has been obtained from sources believed to be reliable, but there can be no assurance as to the accuracy
`or completeness of included information. We have not independently verified any of the data from third-party sources, nor
`have we ascertained the underlying economic assumptions relied upon therein. Statements as to our market position and
`ranking are based on market data currently available to us, management's estimates, and assumptions we have made
`regarding the size of our markets within our industry.
`
`Trademarks and service marks
`We own or have rights to trademarks, service marks or trade names that we use in connection with the operation of our
`business. For example, our names and logos are protected. Some of the trademarks we own or have the right to use
`include "Par," "Par Pharmaceutical," "Par Pharmaceutical Companies, Inc.," "Par Formulations," "Nascobal," "Megace,"
`"Vasostrict," "Adrenalin" and "Aplisol." We have applied for trademarks of "Par Specialty Pharmaceuticals" and "Par Sterile
`Products." All other trademarks or service marks appearing in this prospectus that are not identified as marks owned by us
`are the property of their respective owners.
`
`Solely for convenience, the trademarks, service marks and trade names referred to in this prospectus may be listed without
`the ®, SM and TM symbols, but we will assert, to the fullest extent under applicable law, our rights or the rights of the
`applicable licensors to these trademarks, service marks and trade names.
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`Prospectus summary
`This summary highlights information contained in other parts of this prospectus. Because it is only a summary, it does
`not contain all of the information that you should consider before investing in shares of our common stock and it is
`qualified in its entirety by, and should be read in conjunction with, the more detailed information appearing elsewhere in
`this prospectus. You should read the entire prospectus carefully, especially "Risk factors" and our financial statements
`and the related notes, before deciding to buy shares of our common stock. This summary contains forward-looking
`statements that involve risks and uncertainties. Our actual results may differ significantly from the results discussed in
`the forward-looking statements as a result of certain factors, including those set forth in "Risk factors" and "Cautionary
`note regarding forward-looking statements."
`
`In this prospectus, the terms "we," "us," "our," "Company," `Issuer" and other similar terms refer to Par Pharmaceutical
`Holdings, Inc. and its subsidiaries, including Par Pharmaceutical Companies, Inc. ("Par Pharmaceutical Companies"),
`unless expressly stated otherwise or the context otherwise requires. References in this prospectus to fiscal years are to
`our fiscal years, which end on December 31.
`On September 28, 2012, pursuant to an Agreement and Plan of Merger, we were acquired by investment funds
`affiliated with TPG Global, LLC (together with its affiliates, "TPG" or the "Sponsor") and certain co-investors (the
`"Merger'). Please note that our discussion of certain financial information for the year ended December 31, 2012
`includes data from the "Predecessor" period, which covers the period preceding the Merger (January 1, 2012 to
`September 28, 2012) and data from the "Successor" period, which covers the period following the inception of the
`Company (July 12, 2012 (date of "inception') to December 31, 2012), on a combined basis. Although this presentation
`of financial information on a combined basis does not comply with U.S. generally accepted accounting principles
`("GAAP"), we believe it provides a reasonable method of comparison to the other periods presented in this prospectus.
`The data is being presented for analytical purposes only. Combined operating results (i) have not been prepared on a
`pro forma basis as if the Merger occurred on the first day of the period, (ii) may not reflect the actual results we would
`have achieved absent the Merger and (iii) may not be predictive of future results of operations.
`
`Our company
`We are a leading U.S. pharmaceutical company specializing in developing, licensing, manufacturing, marketing and
`distributing generic drugs. We have a generics portfolio of approximately 95 products across an extensive range of
`dosage forms and delivery systems, including immediate and extended release oral solids (tablets, orally disintegrating
`tablets, capsules and powders), injectables, nasal sprays, ophthalmics and transdermal patches. Our focus is on high-
`barrier-to-entry products that are difficult to formulate, difficult to manufacture or face complex legal and regulatory
`challenges. These products often see limited competition and tend to be more profitable than commoditized generic
`drugs. We have an integrated team-based approach to product development that combines our formulation, regulatory,
`legal, manufacturing and commercial capabilities. As of December 31, 2014, we had over 200 products in our pipeline,
`which included 115 Abbreviated New Drug Applications ("ANDA") pending with the U.S. Food and Drug Administration
`(the "FDA") representing $36.7 billion of combined annual sales for the corresponding branded products ("branded
`product sales") in 2014, including 32 potential first-to-file and six potential first-to-market opportunities.
`Our company operates in two business segments, Par Pharmaceutical, which includes generic products marketed
`under Par Pharmaceutical and sterile products marketed under Par Sterile Products, LLC ("Par Sterile," formerly known
`as JHP Pharmaceuticals, LLC), and Par Specialty Pharmaceuticals ("Par Specialty," formerly known as Strativa
`Pharmaceuticals), which markets two branded products. For the year ended
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`December 31, 2014, we had revenue of $1,308.6 million and adjusted EBITDA of $433.8 million. Our product
`development strategy and ability to execute strategic transactions has resulted in a compound annual revenue growth
`rate of 12.2% and an adjusted EBITDA compound annual growth rate of 20.4% over the last three years. Our goal is to
`strengthen our position as a leading pharmaceutical company by developing and commercializing generic drugs with
`limited competition, significant barriers to entry and longer life cycles.
`
`Our approach to product development is to target high-barrier-to-entry generic products, including first-to-file or first-to-
`market opportunities. A "first-to-file" product refers to an ANDA that is the first ANDA filed containing a Paragraph IV
`patent challenge to the corresponding branded product, which offers the opportunity for 180 days of generic marketing
`exclusivity if approved by the FDA and if we are successful in litigating the patent challenge. A "first-to-market" product
`refers to a product that is the first marketed generic equivalent of a branded product for reasons apart from statutory
`marketing exclusivity, such as the generic equivalent of a branded product that is difficult to formulate or manufacture.
`Our potential first-to-file and first-to-market opportunities account for 33% of our pipeline of 115 ANDAs, which we
`believe is one of the highest in the industry and demonstrates our differentiated development capabilities. As a result,
`more than half of our generic adjusted gross margin in 2014 was earned from products that are either exclusive or have
`two or fewer competitors, which we believe leads to more sustainable market share and profitability for our product
`portfolio.
`
`We have invested significant resources and focus to expand our technology capabilities to develop a range of products
`in-house, including immediate release oral solids and alternate dosage forms such as extended-release oral solids,
`injectables, topicals, nasal sprays, ophthalmics, films and transdermal patches. Our development pipeline reflects these
`efforts. As of December 31, 2014, our pipeline included over 200 products, 115 of which are pending at the FDA and
`approximately 100 of which are in development. In addition to development capabilities, we have acquired
`bioequivalence and clinical end point study capabilities, and we have entered into an agreement to acquire a dedicated,
`lower-cost active pharmaceutical ingredient ("API") development and manufacturing facility in India. As a result of these
`investments, we have the flexibility to more fully control the management and development of key products from
`formulation stage to commercialization. The following charts demonstrate our pipeline of new product opportunities and
`our portfolio of alternate dosage products:
`
`Potential (cid:9)
`FIrst• IO• Flle (cid:9)
`~x M (cid:9)
`
`Pntential
`Fir5blo
`Mar.xt'I (cid:9)
`
`} (cid:9)
`
`Other ANOds (cid:9)
`Tip, (cid:9)
`
`rImi1I'1
`
`u.
`
`Firm (cid:9)
`I Ihahnii 2% (cid:9)
`5`R
`
`I Iwi
`%
`
`M (cid:9)
`
`Nasal (cid:9)
`Sublinguai (cid:9)
`tiatnp;
`
`Tooical
`
`Immetf iate
`Release
`
`Extended'
`RLOvam- (cid:9)
`24% (cid:9)
`
``inlectat lei
`t5lb
`
`P (cid:9)
`
`1 (cid:9)
`
`t (cid:9)
`
`• rtts
`i l 1
`
`1 (cid:9)
`
`We are committed to high product quality standards and allocate significant resources and focus to quality assurance,
`quality control and manufacturing excellence. We operate five FDA approved manufacturing facilities, four of which are
`located in the United States and one in India, with ample capacity and room for
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`expansion. In addition, our facilities have passed all recent FDA inspections. As a result of our operational excellence
`and high quality and compliance standards, we have not received any warning letters from the FDA with respect to
`manufacturing plants we have operated since before 2000, which we believe differentiates us from other generic
`manufacturers. Our track record in high-quality manufacturing and supply reliability is most recently demonstrated by
`the 2014 CVS Health Supplier Partner Award based on providing innovative product offerings, commitment to customer
`service and consistency of supply.
`
`Our senior management team has a strong track record and established history of executing and integrating business
`development opportunities and strategic acquisitions. Since 2011, we have completed and integrated over 20 business
`development transactions and six company acquisitions. These transactions have enhanced and deepened our
`presence in the industry by expanding our portfolio of products in development and manufacturing capabilities. We
`believe we are a partner of choice to brand companies seeking an authorized generics partner. Authorized generics are
`generic versions of branded drugs licensed to generic drug companies by brand drug companies that may be sold
`during (and after) the statutory exclusivity period granted to the first-to-file generic equivalent to the branded product.
`We also believe we are a partner of choice to large generic companies for product divestitures that arise as a result of
`industry consolidation, and for smaller development organizations looking for a partner that has deep experience with
`product development, patent litigation strategy and a strong market presence.
`
`Recent performance
`
`Paul Campanelli was appointed as our Chief Executive Officer in September 2012 following the Merger. Prior to the
`Merger, Mr. Campanelli served as Par's Chief Operating Officer, having held positions of increasing responsibility since
`joining the Company in 2001. Over the past two years, under Mr. Campanelli's leadership, we have made significant
`investments in expanding our research, development and manufacturing capabilities. These investments have resulted
`in:
`
`submitting 61 ANDAs since the Merger, resulting in a total of 115 ANDAs pending at the FDA as of December 31,
`2014, compared to 89 ANDAs pending as of December 31, 2012;
`
`diversifying our development portfolio from 83 development projects with 60 alternate dosage forms (including
`extended release solid oral dose) at December 31, 2012 to approximately 100 products in development with 70
`alternate dosage forms (including extended release solid oral dose) at December 31, 2014;
`
`diversifying our manufacturing capabilities from largely solid oral dose capabilities in 2012 to capabilities covering
`almost all generic presentations, such as gels, nasal sprays, ophthalmics, films, transdermal patches and injectable
`products;
`
`• expanding our core competencies to provide us the flexibility to more fully control key product development by
`acquiring Par Biosciences Private Limited ("Par Biosciences" formerly known as Ethics Bio Lab Private Limited), a
`Chennai, India-based clinical research organization ("CRO") that conducts bioequivalence and clinical end point
`studies, and by lowering development and manufacturing costs for a portion of our product portfolio through the
`utilization of Par Formulations Private Limited (formerly known as Edict Pharmaceuticals Private Limited), a Chennai,
`India-based developer and manufacturer of generic pharmaceuticals;
`
`• enhancing our portfolio through business development and product acquisitions, including our November 2012
`acquisition of a mix of marketed products, ANDAs awaiting FDA approval and one late-stage development product in
`connection with Watson Pharmaceuticals, Inc.'s ("Watson") acquisition of Actavis Group;
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`• diversifying our revenue base such that over half of our total adjusted gross margin is derived from products that are
`either exclusive or have two or fewer competitors for the year ended December 31, 2014; and
`
`• establishing Par Laboratories Europe, Ltd. in 2015, a U.K.-based business office which will serve as an entry point
`into the European generics market.
`
`In addition, the following financial metrics highlight improvements since the fiscal year ended December 31, 2011:
`
`• total revenue increased from $926.1 million for the year ended December 31, 2011 to $1,308.6 million for the year
`ended December 31, 2014, representing a compounded annual growth rate ("CAGR") of 12.2%;
`
`• adjusted gross margin increased from $406.0 million for the year ended December 31, 2011 to $674.7 million for the
`year ended December 31, 2014, representing a CAGR of 18.5%;
`
`• adjusted gross margin as a percentage of revenue increased from 43.8% for the year ended December 31, 2011 to
`51.2% for the year ended December 31, 2014;
`
`• adjusted EBITDA increased from $248.5 million for the year ended December 31, 2011 to $433.8 million for the year
`ended December 31, 2014, representing a CAGR of 20.4%; and
`
`• adjusted EBITDA as a percentage of revenue increased from 26.8% for the year ended December 31, 2011 to
`33.1% for the year ended December 31, 2014.
`
`Adjusted gross margin and adjusted EBITDA are non-GAAP financial measures and should not be considered
`substitutes for and are not comparable with net income or net operating income as determined in accordance with
`GAAP. We recorded a net loss of $105.5 million for the year ended December 31, 2014, a net loss of $105.9 million for
`the year ended December 31, 2013 and a net loss of $33.5 million for the combined 2012 year-end period. For
`additional information regarding these financial measures, including an explanation and reconciliation of our non-GAAP
`measures to the most directly comparable measure presented in accordance with GAAP, see "Summary historical and
`pro forma condensed consolidated financial data" included elsewhere in this prospectus. The Merger was accounted
`for as a business combination and therefore resulted in a new accounting basis. Our results of operations for the year
`ended 2012 presented elsewhere in this prospectus are presented for the predecessor and successor periods, which
`relate to the periods preceding the Merger (January 1, 2012 through September 28, 2012) and succeeding (July 12,
`2012 (inception) through December 31, 2012) the inception date, respectively. The successor period reflects the new
`accounting basis established for us as of the inception date. In the discussion above, we present our net loss for the
`combined 2012 full year period for comparative purposes, using the mathematical sum of the net loss reported for the
`successor and predecessor periods. In addition, throughout the document we present certain other 2012 measures on
`a combined basis. Such information represents non-GAAP measures because Successor is on a new basis of
`accounting. These measures should not be considered substitutes for and are not compatible with GAAP measures.
`The information is presented in this manner as we believe it enables a reasonable comparison. This financial
`information may not reflect the actual financial results we would have achieved absent the Merger and may not be
`predictive of future financial results. For a presentation of our results of operations for the year ended 2012 on a GAAP
`basis, showing the separate predecessor and successor periods, see "Selected historical consolidated financial data."
`
`Our capabilities
`Since 2011, we have strategically expanded our technology, manufacturing, handling and development capabilities,
`shifting from primarily solid oral immediate and extended release products to a diversified array of dosage forms. These
`expanded technologies represent a sizeable market opportunity, with 2014
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`branded product sales utilizing these technologies of approximately $110 billion, according to IMS Health . As of
`December 31, 2014, our development product portfolio included 26 immediate-release oral solids, 24 injectables, 23
`extended-release oral solids, eight topicals, five ophthalmics, three nasal sprays and two films. As of December 31,
`2014, approximately 70% of our development portfolio targets alternate dosage forms such as extended-release oral
`solids, injectables, topicals, nasal sprays, ophthalmics, films and transdermal patches.
`
`The following graphic shows Par Pharmaceutical's current capabilities and new in-process opportunities:
`
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`Our comprehensive suite of technology, manufacturing and development capabilities increases the likelihood of
`success in commercializing high-barrier-to-entry products and obtaining first-to-file and first-to-market status on our
`products, yielding more sustainable market share and profitability.
`
`Our strengths
`Our senior executive team has a strong track record of product selection and development, and has launched 47 new
`products since 2011, eight of which have been first-to-file and one of which has been first-to-market. We have an
`integrated team-based approach to product development that combines our formulation, regulatory, legal,
`manufacturing and commercial capabilities. We believe that the strengths of Par are as follows:
`
`Focused approach to product selection targeting high-barrier-to-entry products with long-term value. We
`specialize in high-barrier-to-entry products that are difficult to formulate, difficult to manufacture or face complex legal
`and regulatory challenges. These products often see limited competition and tend to be more profitable than
`commoditized generic drugs. A large portion of our generics revenue comes from products where we are either the
`exclusive generic or have two or fewer competitors. As of December 31, 2014, among our top ten generic drugs by
`revenue, seven maintain market shares in excess of 50%.
`Full suite of technology capabilities. We have a full suite of dosage forms, including immediate release oral solids
`and alternate dosage forms such as extended release oral solids, injectables, topicals, nasal sprays, ophthalmics, films
`and transdermal patches. Our acquisition of Par Biosciences provides us with bioequivalence study capabilities, which
`allows us to control the speed, cost and execution of development. In addition, we are in the process of acquiring an
`API development and manufacturing facility. These expanded capabilities provide the flexibility to more fully control the
`management and development of key products from formulation stage to commercialization.
`
`Diverse portfolio of products. We have a generics portfolio of approximately 95 products across an extensive
`range of dosage forms and delivery systems. In addition to our current products, our pipeline consists of new products
`that will further expand and diversify our portfolio. We believe our broad suite of products has allowed us to increase
`our market presence and develop long term relationships with customers.
`
`http://www.sec.gov/Archives/edgar/data/1559149/000119312515089746/d880840ds1.htm (cid:9)
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`3/17/2015
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`Form S-1
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`Table of Contents
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`Page 10 of 270
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`Deep, targeted pipeline with high visibility into future launches. We have a large number of products pending
`regulatory approval and a robust pipeline of products in development. As of December 31, 2014, we had 115 ANDAs
`pending with the FDA representing $36.7 billion of combined branded product sales in 2014, including 32 potential first-
`to-file and six potential first-to-market opportunities representing $14.8 billion of combined branded product sales in
`2014. Our potential first-to-file and first-to-market opportunities account for 33% of our pending ANDA pipeline, which
`we believe is one of the highest in the industry and differentiates our development capabilities. As of December 31,
`2014, our Paragraph IV opportunities accounted for approximately 55% of our current development portfolio, and 70%
`of the development portfolio targets alternate dosage forms.
`Commitment to manufacturing excellence with a culture of quality and compliance. We have invested
`significant resources and focus on quality assurance, quality control and manufacturing excellence. As of
`December 31, 2014, we operated five FDA approved manufacturing facilities, four of which are located in the