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`Registration No. 333
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`UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`Washington, D.C. 20549
`FORM F1
`REGISTRATION STATEMENT
`UNDER THE SECURITIES ACT OF 1933
`Iroko Pharmaceuticals Inc.
`(Exact name of registrant as specified in its charter)
`2834
`(Primary Standard Industrial
`Classification Code Number)
`Iroko Pharmaceuticals Inc.
`One Kew Place, 150 Rouse Boulevard, Philadelphia, PA 19112
`(267) 5463003
`(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
`Moji James
`General Counsel
`Iroko Pharmaceuticals Inc.
`One Kew Place, 150 Rouse Boulevard, Philadelphia, PA 19112
`(267) 5463003
`(Name, address, including zip code, and telephone number, including area code, of agent for service)
`
`British Virgin Islands
`(State or other jurisdiction of
`incorporation or organization)
`
`Not Applicable
`(I.R.S. Employer
`Identification No.)
`
`Carmelo M. Gordian
`Ted A. Gilman
`Andrews Kurth LLP
`111 Congress, Suite 1700
`Austin, TX 78701
`(512) 3209200
`
`Copies to:
`
`Richard D. Truesdell, Jr.
`Davis Polk & Wardwell LLP
`450 Lexington Avenue
`New York, NY 10017
`(212) 4504000
`
`Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this
`registration statement.
`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.
`If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please
`check the following box and list the Securities Act registration statement number of the earlier effective registration statement
`for the same offering.
`If this Form is a posteffective 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.
`If this Form is a posteffective amendment filed pursuant to Rule 462(d) 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.
`
`CALCULATION OF REGISTRATION FEE
`
`PROPOSED MAXIMUM
`AMOUNT OF
`AGGREGATE
`TITLE OF EACH CLASS OF
`REGISTRATION
`(1)
`OFFERING PRICE
`SECURITIES TO BE REGISTERED
`FEE
`$19,778
`$145,000,000
`Ordinary shares, par value $0.01
`(1)
` Estimated solely for the purpose of computing the registration fee in accordance with Rule 457(o) under the Securities Act of 1933, as amended. Includes the
`offering price of shares that the underwriters have the option to purchase to cover overallotments, if any.
`
`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, as amended,
`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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`Page 1
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`LUPIN EX. 1021
`Lupin v. iCeutica
`US Patent No. 9,017,721
`
`
`
`Table of Contents
`
`
`Preliminary Prospectus
`
`
`
`The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities
`until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary
`prospectus is not an offer to sell these securities and we are not soliciting an offer to buy these securities in any state
`or other jurisdiction where the offer or sale is not permitted.
`
`
`SUBJECT TO COMPLETION DATED , 2013
`
` Shares
`
`Iroko Pharmaceuticals Inc. is offering ordinary shares. This is our initial public offering and no public market currently
`exists for our shares. We expect that the initial public offering price will be between $ and $ per share.
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`We intend to apply to list our ordinary shares on the NASDAQ Global Select Market under the symbol “IRKO”.
`We are an “emerging growth company” under applicable federal securities laws and will be subject to reduced public
`company reporting requirements. Investing in our ordinary shares involves risks. See “ Risk Factors ” beginning on
`page 14 to read about risks you should consider before buying your ordinary shares.
`$ Per Ordinary Share
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`Price to the public
`Underwriting discounts and commissions
`Proceeds to us (before expenses)
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`PER SHARE
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`$
`$
`$
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`TOTAL
`$
`$
`$
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`To the extent that the underwriters sell more than ordinary shares, the underwriters have a 30day option to purchase
`up to an additional ordinary shares from us on the same terms as set forth above. See the section of this prospectus
`entitled “Underwriting.”
`The Securities and Exchange Commission and state securities commissions have not approved or disapproved of
`these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a
`criminal offense.
`The underwriters expect to deliver the ordinary shares to purchasers on , 2013.
`
` Jefferies
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`Canaccord Genuity
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`The date of this prospectus is , 2013
`
`William Blair
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`Table of Contents
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`PAGE
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`1
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`7
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`9
` 11
` 14
` 46
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` 56
` 83
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` 117
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` F1
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`Table of Contents
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`TABLE OF CONTENTS
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`Prospectus Summary
`Summary Of The Offering
`Summary Consolidated Financial Data
`Corporate Formation And Reorganization
`Risk Factors
`Special Note Regarding ForwardLooking Statements
`Industry And Market Data
`Use Of Proceeds
`Dividend Policy
`Capitalization
`Dilution
`Pricing Sensitivity Analysis
`Selected Consolidated Financial Data
`Management’s Discussion And Analysis Of Financial Condition And Results Of Operations
`Changes In And Disagreements With Accountants On Accounting And Financial Disclosure
`Business
`Management
`Executive Compensation
`Certain Relationships And Related Person Transactions
`Principal Shareholders
`Description Of Share Capital
`Shares Eligible For Future Sale
`Tax Considerations
`Underwriting
`Expenses Related To This Offering
`Service Of Process And Enforcement Of Liabilities
`Legal Matters
`Experts
`Where You Can Find More Information
`Index To Financial Statements
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`Page 5
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`Table of Contents
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`We have not authorized anyone to provide you with information other than that contained in this prospectus or in any
`free writing prospectus prepared by or on behalf of us or to which we have referred you. We take no responsibility for,
`and can provide no assurance as to the reliability of, any other information that others may give to you. This
`document may only be used where it is legal to sell these securities. The information in this document may only be
`accurate on the date of this document.
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`Dealer Prospectus Delivery Obligation
`Until (25 days after the commencement of the offering), all dealers that effect transactions in these
`securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to
`the dealer’s obligation to deliver a prospectus when acting as an underwriter and with respect to unsold allotments or
`subscriptions.
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`ii
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`Page 6
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`Table of Contents
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`IMPORTANT INTRODUCTORY INFORMATION
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`As described under “Corporate Formation and Reorganization,” we have effected a number of transactions, which we refer to
`as the Reorganization Transactions, which resulted in our issuance of convertible preference shares. See “Corporate
`Formation and Reorganization” for a complete description of the Reorganization Transactions. The conversion ratio of our
`convertible preference shares issued in connection with the Reorganization Transactions is dependent on the actual pershare
`initial public offering price in this offering and the timing of the offering. Accordingly, the number of our ordinary shares that will
`be outstanding as of the consummation of this offering cannot be determined at this time. Where information in this prospectus
`gives effect to the Reorganization Transactions, such information is presented assuming an initial public offering price of $
`per share, the midpoint of the price range set forth on the cover page of this prospectus, and a closing date of . For
`an analysis of how such information would change if the initial public offering price is not equal to the midpoint of the price
`range, see “Pricing Sensitivity Analysis.”
`Unless the context otherwise requires, references in this prospectus to “Iroko,” “we,” “our,” “us,” and the “company” refer to
`Iroko Pharmaceuticals Inc. together with its subsidiaries and, in the case of historical information, its predecessor entities.
`References in this prospectus to “iCeutica” refer to iCeutica Inc. and its subsidiaries. iCeutica is a company that is also
`controlled by our parent company.
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`iii
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`Page 7
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`Table of Contents
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`PROSPECTUS SUMMARY
`
`This summary highlights the information contained elsewhere in this prospectus and is a brief overview of the key aspects
`of the offering. Because this is only a summary, it does not contain all of the information that may be important to you.
`Before investing in our ordinary shares, you should read this entire prospectus, including the information set forth under the
`headings “Risk Factors,” “Selected Consolidated Financial Data,” “Management’s Discussion and Analysis of Financial
`Condition and Results of Operations,” “Business” and our consolidated financial statements and related notes thereto.
`Some of the statements in this prospectus constitute forwardlooking statements. Please read “Special Note Regarding
`ForwardLooking Statements” for more information.
`Overview
`We are a global, specialty pharmaceutical company focused on the development and commercialization of novel
`nonsteroidal antiinflammatory drug, or NSAID, therapeutics for patients with mild to moderate acute and chronic pain. Our
`pipeline includes six submicron NSAID product candidates, two of which have been submitted to the U.S. Food and Drug
`Administration or FDA for marketing approval. We use the iCeutica proprietary SoluMatrix™ technology platform, which we
`have exclusively licensed, or have the option to exclusively license, for all NSAIDs, to create submicron, lower dose
`formulations of established NSAIDs. NSAIDs are one of the largest classes of painrelieving medications and have been a
`mainstay of treatment for a variety of pain related conditions notwithstanding their potential adverse side effects. The
`proprietary technology platform we use has been shown, at a statistically significant level in clinical studies, to
`fundamentally change the absorption profile of our latestage NSAID product candidates so that they are quickly dissolved
`and absorbed to allow for rapid onset of pain relief at lower doses and lower systemic exposures, as measured by plasma
`levels of a drug over time, than the comparable commercially available NSAID, which are diclofenac, indomethacin, and
`naproxen. We are applying this proprietary technology platform to additional NSAID molecules in preclinical development
`and expect to experience similar results. We believe that our product candidates offer promising, efficacious pain treatment
`options for patients with the potential for an improved safety profile.
`The NSAID market is one of the largest therapeutic classes in the United States with approximately 106 million
`prescriptions written representing approximately 7 billion units in 2011. While NSAIDs are generally considered to be safe
`and effective, they have also been associated with doserelated serious, adverse events in some patients, including
`gastrointestinal, renal and cardiovascular events. The recognized correlation between systemic exposure to NSAIDs and
`these adverse events led the U.S. Food and Drug Administration, or FDA, to issue its 2005 public health advisory
`recommending that NSAIDs should be used at their lowest effective dose for the shortest duration of time. We believe that
`our lower dose submicron NSAIDs address the FDA’s 2005 public health advisory by offering lower overall systemic
`exposure and thereby potentially reducing the occurrence of adverse events.
`), submicron
`Our latestage product candidates are submicron diclofenac (Zorvolex
`), submicron indomethacin (Tiforbex
`™
`™
`meloxicam and submicron naproxen and are being developed for both acute pain (Zorvolex
`, Tiforbex
`) and
`™
`™
`osteoarthritis pain (Zorvolex
`, submicron meloxicam, submicron naproxen) indications in adult patients. We have
`™
`completed Phase 3 clinical trials for Zorvolex and Tiforbex
`for acute pain in adult patients. We received an Agreement
`™
`™
`Letter for our Special Protocol Assessment, or SPA, from the FDA for Zorvolex and filed a new drug application, or NDA,
`™
`with the FDA for the treatment of acute pain in adult patients in February 2013. We also intend to submit a supplemental
`NDA, or sNDA, with the FDA for Zorvolex
`for treatment of osteoarthritis pain in adult patients in late 2013. We submitted
`™
`an NDA for Tiforbex
`for the treatment of acute pain in adult patients in April 2013. Phase 3 clinical trials commenced for
`™
`the treatment of osteoarthritis pain in adult patients for submicron meloxicam in March 2013 and are planned to begin for
`submicron naproxen in 2014. The two product candidates in preclinical development are submicron celecoxib and
`submicron ibuprofen. We intend to continue advancing these and potentially other product candidates as we build our
`pipeline.
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`In addition to our submicron NSAID product pipeline, our two approved products, Indocin (indomethacin) and Aldomet
`®
`®
`(methyldopa), are marketed in 48 countries. The approved indications for Indocin (indomethacin) include moderate to
`®
`severe rheumatoid arthritis, including acute flares of chronic disease, moderate to severe ankylosing spondylitis, moderate
`to severe osteoarthritis, acute painful shoulder (bursitis and/or tendinitis) and acute gouty arthritis. The approved indication
`for Aldomet (methyldopa) includes the treatment of hypertension. These products generated approximately $20.0 million
`®
`in net sales globally in 2012, including $13.3 million in sales by our licensee, Aspen Pharmacare Holdings Limited and its
`subsidiaries, or Aspen. We sell these products in the U.S. and seven European countries (Austria, Belgium, France, Italy,
`Portugal, Spain and Switzerland), which generated $6.7 million of net sales in 2012. In addition, we received $3.2 million in
`royalties from rest of world net sales generated by Aspen in 2012. The operations and capabilities established to support
`these products have demonstrated our ability to manage the manufacture, distribution and sale of drug therapeutic
`products globally.
`NSAID Market Background
`The NSAID market is one of the largest therapeutic classes in the U.S. with approximately 106 million prescriptions written
`representing approximately 7 billion units in 2011. The prescribing of NSAIDs has increased by approximately 12% from
`2007 to 2011 primarily driven by an aging population, improvements in recognition and treatment of pain and increasing
`concerns with the use of other alternatives such as acetaminophen and opioids, including hydrocodoneNSAID
`combinations, oxycodoneNSAID combinations, hydrocodoneacetaminophen combinations and oxycodone
`acetaminophen combinations. This market is largely composed of offpatent products. The largest remaining onpatent
`branded NSAID, Celebrex (celecoxib), generated approximately 10 million prescriptions, resulting in U.S. sales of
`®
`approximately $1.9 billion in 2011. If all 106 million NSAID prescriptions were sold at pricing levels comparable to Celebrex
`, we believe that the aggregate U.S. NSAID market value would be approximately $20 billion annually.
`®
`NSAIDs are used to treat a variety of painful conditions including acute pain, back pain, gout, osteoarthritis, rheumatoid
`arthritis and ankylosing spondylitis. NSAIDs provide relief from symptoms of many of these conditions including pain and
`inflammation. While NSAIDs are generally considered to be safe and effective, they have also been associated with serious
`adverse events in some patients. These serious adverse events include gastrointestinal events such as bleeding and
`ulcers, cardiovascular events such as acute myocardial infarctions, or heart attacks, strokes and renal events. The serious
`gastrointestinal complications alone account for an estimated 3,200 to 16,000 deaths and 32,000 to 103,000
`hospitalizations per year in the U.S. Multiple studies have indicated a correlation between systemic exposure to NSAIDs
`and these adverse events. As a result, in 2005 the FDA issued a public health advisory titled “Important Changes and
`Additional Warnings for COX2 Selective and NonSelective NonSteroidal AntiInflammatory Drugs (NSAIDs)”. In this
`advisory the FDA requires manufacturers of all marketed prescription NSAIDs to revise the labeling (package insert) for
`their products to include a boxed warning (commonly referred to as a “black box” warning) and a medication guide. The
`boxed warning highlights the potential for increased risk of cardiovascular events with these drugs and the documented,
`serious, and potentially lifethreatening adverse health effects associated with their use. The FDA requires companies to
`provide a medication guide which informs patients of the need to discuss with their doctor the risks and benefits of using
`NSAIDs and the importance of using the lowest effective dose for the shortest duration possible if treatment with an NSAID
`is warranted for an individual. Health Canada also issued a guidance document to aid in the revision of the content of the
`NSAID Product Monograph and associated labeling materials by the pharmaceutical industry. This guidance indicated that
`the use of NSAID products “should be limited to the lowest effective dose for the shortest possible duration of treatment in
`order to minimize the potential risk for cardiovascular or gastrointestinal adverse events.” Additionally, the European
`Medicines Agency, or EMA, and other regulatory bodies and medical societies similarly have recommended that NSAIDs
`should be used at their lowest effective dose for the shortest duration of time.
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`™ ™ ™
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`Zorvolex
`Tiforbex
`Submicron meloxicam
`
`Our Strategy
`We use the proprietary SoluMatrix™ technology platform to create a suite of submicron, lower dose formulations of known
`NSAIDs. The proprietary technology platform we use has been shown to fundamentally change the absorption profile of our
`latestage NSAID product candidates so that they are quickly dissolved and absorbed to allow for rapid onset of pain relief
`at lower doses and lower systemic exposures than comparable commercially available NSAIDs. With improved dissolution,
`formulations using this technology may offer meaningful benefits: reduction of the amount of drug required to achieve,
`speed up or improve consistency of, the drug’s therapeutic effect. We are applying this proprietary technology platform to
`additional NSAID molecules in preclinical development and expect to experience similar results. We believe that our
`product candidates offer potentially promising, efficacious pain treatment options for patients with the potential for an
`improved safety profile.
`The key elements of our strategy are to:
` build a leading pain treatment company focused on our branded submicron NSAID franchise;
` build marketing and sales capabilities in the U.S.;
`
` maximize the value of our submicron NSAID franchise by launching in selected markets outside the U.S.; and
`
` maximize the value of our currently marketed products.
`
`Our Product Candidates
`Our product candidates address a critical need for new NSAIDs that provide efficacious pain relief while potentially
`reducing the risk of serious gastrointestinal, cardiovascular and renal events. They address FDA, EMA and other regulatory
`bodies’ and medical societies’ recommendations that NSAIDs should be used at their lowest effective dose for the shortest
`duration of time. The availability of these product candidates will provide physicians and patients with alternatives to
`currently available NSAIDs and other analgesic products, including, in some cases, opioid and acetaminophen products.
`The following table highlights the current stage of clinical development for each of our product candidates.
`SoluMatrix™ Technology Platform
`The proprietary SoluMatrix™ technology platform uses a dry milling process to reduce the drug particle size in our
`submicron NSAIDs by at least ten times compared to the particle size in the premilled NSAID. The smaller particle size
`results in increased surface area relative to mass, which increases the dissolution and absorption rates without changing
`the chemical structures of the drug molecules themselves. Because of this altered absorption profile, our latestage NSAID
`product candidates dissolve and are absorbed at a rate that allows for the rapid onset of pain relief at lower doses and
`lower systemic exposures than comparable commercially available NSAIDs. This technology has been licensed to us by
`iCeutica for exclusive use in the NSAID market.
`LateStage Pipeline
`
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`PRODUCT CANDIDATE
`Zorvolex
`
`DEVELOPMENT STATUS
`NDA filed
`February 2013
`
`
` Worldwide
` Phase 3 complete
` NDA submitted April 2013 Worldwide
`Phase 1 and phase 3
`Worldwide
`ongoing
`(1)
`
`
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`Submicron naproxen
` Worldwide
` Phase 2 complete
` Osteoarthritis pain
`(2)
`
`(1)
` We have begun, and are enrolling patients for, two Phase 3 clinical trials for submicron meloxicam. In addition, we have completed two Phase 1 clinical
`trials for submicron meloxicam and have commenced a third Phase 1 clinical trial, which is proceeding concurrently with the Phase 3 clinical trials.
`
`TARGET INDICATION
`Acute pain
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`COMMERCIAL RIGHTS
`Worldwide
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` Osteoarthritis pain
` Acute pain
`Osteoarthritis pain
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`(2)
` Phase 2 clinical trials have been completed for submicron naproxen. We are planning Phase 3 clinical trials with a potential start date in 2014.
`Zorvolex
`is a novel formulation of diclofenac developed using the proprietary SoluMatrix
`technology platform and is
`™
`TM
`being developed for the treatment of acute pain of mild to moderate severity in adult patients. Products containing
`diclofenac salts have been approved in the U.S. since 1988 and are indicated for a range of conditions, including primary
`dysmenorrhea, the treatment of mild to moderate pain, and for the relief of the signs and symptoms of osteoarthritis and
`rheumatoid arthritis. We have completed a Phase 3 trial for the treatment of acute pain. We have an SPA in place and have
`filed an NDA with the FDA for this initial product candidate for acute pain in February 2013. We believe we have followed all
`procedures and met all endpoints described in this SPA. We have completed the efficacy component of our Phase 3 trial
`program for osteoarthritis pain, have completed the open label safety study component and intend to file an sNDA with the
`FDA in late 2013.
`Tiforbex
`is a novel formulation of indomethacin using the proprietary SoluMatrix™ technology platform and is being
`™
`developed for the treatment of acute pain of mild to moderate severity in adult patients. Products containing indomethacin
`have been licensed in the U.S. since 1965 and are indicated for the treatment of moderate to severe rheumatoid arthritis,
`including acute flares of chronic disease, moderate to severe ankylosing spondylitis, moderate to severe osteoarthritis,
`acute painful shoulder (bursitis and/or tendinitis) and acute gouty arthritis. We have completed two Phase 3 clinical trials for
`the treatment of acute pain in adult patients. We have submitted an NDA for this product candidate for acute pain with the
`FDA in April 2013.
`Submicron meloxicam is a novel formulation of meloxicam using the proprietary SoluMatrix™ technology platform.
`Meloxicam is the active ingredient in Mobic Tablets, a product sold by Boehringer Ingelheim Pharmaceuticals Inc. Mobic
`®
`was approved in the U.S. in 2000 and is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid
`®
`arthritis and pauciarticular or polyarticular juvenile rheumatoid arthritis in patients two years of age and older. We are
`developing submicron meloxicam for the treatment of osteoarthritis pain in adult patients. We commenced Phase 3 clinical
`trials for this product candidate for this indication in March 2013. We plan to submit an NDA with the FDA in late 2014.
`Submicron naproxen is a novel formulation of naproxen using the proprietary SoluMatrix™ technology platform. Products
`containing naproxen have been available in the U.S. since 1976 and are indicated for the treatment of rheumatoid arthritis,
`osteoarthritis, ankylosing spondylitis, tendonitis, bursitis, acute gout, relief of mild to moderate acute pain and acute
`dysmenorrhea. We are developing submicron naproxen for the treatment of osteoarthritis pain in adult patients. We have
`completed Phase 2 clinical trials and plan to commence Phase 3 clinical trials for the treatment of osteoarthritis pain in
`adult patients in 2014.
`Preclinical Pipeline
`In addition to latestage product candidates, we have submicron formulations of celecoxib and ibuprofen. We intend to
`continue advancing these and potentially other submicron NSAID product candidates that we have the right to exclusively
`license from iCeutica as we build our pipeline.
`Our Marketing Strategy
`Our marketing plan involves increasing awareness among physicians of the rationale and the FDA’s and other regulatory
`bodies’ and medical societies’ recommendations for the use of the lowest effective doses of NSAIDs. Our submicron
`NSAID products will be positioned as uniquely offering effective pain relief at lower doses and systemic exposures.
`Zorvolex will be positioned as the effective lower dose NSAID that can be used both for short and long periods of time.
`™
`Tiforbex will be positioned as the effective lower dose NSAID best used for pain relief related with acute conditions and
`™
`for shorter periods of time. We believe that copositioning Zorvolex and Tiforbex
`, in part a reflection of existing medical
`™
`™
`practice, will allow these products to gain share from the different NSAID market segments.
`
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`Our marketing strategies for the submicron NSAIDs are based on extensive marketing research studies conducted with
`over 2,400 physicians, predominantly primary care physicians and rheumatologists. Market research studies were
`conducted with over 1,500 physicians for Zorvolex alone. These market research studies were conducted over the last
`™
`two and a half years beginning in the fall of 2010 and consisted of both qualitative and quantitative studies including
`conjoint studies, positioning, message testing and concept testing studies. The insights derived from these studies along
`with sophisticated analytics such as segmentation and core base statistical areas, or CBSA, mapping has shaped our focus
`on the appropriate targets of physicians matched to CBSAs where patients are likely to have relatively unrestricted
`managed care coverage and core product messages that will be compelling to those physicians. About $1.5 million has
`been spent over the past two and a half years for the primary market research studies to physicians and an additional $1.4
`million has been spent on data and analytics.
`The marketing strategy for our submicron NSAIDs has been developed to:
` ensure physicians have top of mind awareness of the rationale and numerous recommendations to use the lowest
`effective dose of NSAIDs for the shortest period of time;
` differentiate our submicron NSAIDs individually and as a portfolio from other NSAIDs;
`
` effectively coposition our submicron NSAID products for optimal share penetration;
`
` ensure formulary availability and optimize reimbursement of our submicron NSAID products; and
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` use sophisticated analytics for efficient segmentation, targeting and geographical allocation of resources.
`
`Reimbursement Strategy
`Our reimbursement strategy in the U.S. is to demonstrate the value proposition of our submicron NSAID products to
`managed care payors. Our payor targeting and strategies have been guided by extensive market intelligence studies and
`analytics. During the past two and a half years, qualitative and quantitative market research have been conducted with
`about 50 key managed care decision makers made of medical directors and pharmacy directors. An additional 14 managed
`care decision makers have provided guidance in advisory board settings. Detailed CBSA level analysis has been
`conducted indexing coverage by plan and copay levels allowing for prioritization of favorable areas. Also, detailed plan
`level analytics have been conducted for approximately 55 payor accounts, including managed care plans and pharmacy
`benefit managers, evaluating their formulary management strategies and the relative effectiveness of those strategies.
`Overall, approximately $500,000 has been spent over the past two and a half years towards the efforts to understand the
`payors’ perspectives that guide our payor strategies.
`The value proposition is as follows:
` provide effective pain relief at lower doses;
` provide products that facilitate the use of NSAIDs in accordance with the recommendations provided by the FDA,
`EMA, other regulatory bodies and medical societies;
` potentially reduce serious adverse events thereby improving the pharmacoeconomic advantage of using our
`submicron NSAID products; and
` provide an alternative that could reduce the usage of opioids.
`
`Suppliers/Manufacturing
`Our supply chain is composed of a network of thirdparty providers. This network consists of suppliers of raw material,
`excipients, active pharmaceutical ingredients, or APIs, contract manufacture operations and packaging. We do not own or
`operate facilities for the manufacturing or packaging of any of our current products. We do not have any current plans to
`establish our own manufacturing or packaging operations for our products.
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`5
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`Page 12
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`Table of Contents
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`Risks Affecting Our Business
`Our business is subject to a number of risks, including risks that may prevent us from achieving our business objectives or
`may adversely affect our business, financial condition, results of operations, cash flows and prospects, that you should
`consider before making a decision to invest in our ordinary shares. These risks are discussed more fully in the “Risk
`Factors” section of this prospectus, beginning on page 14.
`These risks include, but are not limited to, the following:
` we expect to incur losses in the near term and may never achieve or sustain profitability;
` we cannot be certain that Zorvolex
`, Tiforbex or any of our other product candidates will receive regulatory
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`approval, and without regulatory approval we will not be able to market our product candidates;
` our products, if approved, may not be accepted in the marketplace;
` we could be unsuccessful in obtaining or maintaining adequate patent protection for one or more of our product
`candidates and may be unable to maintain and protect our intellectual property assets, which could impair the
`advancement of our pipeline and commercial opportunities; and
` all of our rights to patents and patent applications are exclusively licensed from iCeutica and we currently do not
`own any issued U.S. patents or pending U.S. patent applications with respect to any of our proposed products.
`Corporate Information
`Iroko Pharmaceuticals, LLC, our primary operating company, was founded in 2007. Iroko Pharmaceuticals Inc. was
`incorporated on September 10,