`Further step in building a leading biotech
`Transaction valued at $5.2 billion
`Enhances growth profile
`
`Flemming Ornskov, MD, MPH
`CEO, Shire plc
`
`Francois Nader, MD, MBA
`CEO, NPS Pharmaceuticals, Inc.
`
`January 11, 2015
`
`CFAD Exhibit 1056
`CFAD v. NPS
`IPR2015-00990
`
`
`
`“SAFE HARBOR” statement under the Private Securities
`Litigation Reform Act of 1995 and tender offer materials
`
`•
`
`Statements included in this communication that are not historical facts are forward-looking statements. Such forward-looking statements involve
`a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results
`could be materially adversely affected. The risks and uncertainties include, but are not limited to, that:
`•
`Shire’s products may not be a commercial success;
`•
`revenues from ADDERALL XR and INTUNIV are subject to generic erosion;
`•
`the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payors in a timely manner for
`Shire’s products may impact future revenues, financial condition and results of operations;
`Shire conducts its own manufacturing operations for certain of its products and is reliant on third party contract manufacturers to
`manufacture other products and to provide goods and services. Some of Shire’s products or ingredients are only available from a single
`approved source for manufacture. Any disruption to the supply chain for any of Shire’s products may result in Shire being unable to
`continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of
`time;
`the development, approval and manufacturing of Shire’s products is subject to extensive oversight by various regulatory agencies.
`Submission of an application for regulatory approval of any of our product candidates, such as our planned submission of a New Drug
`Application to the FDA for Lifitegrast, may be delayed for any number of reasons and, once submitted, may be subjected to lengthy review
`and ultimately rejected. Moreover, regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or
`manufacturing processes could lead to significant delays, increase in operating costs, lost product sales, an interruption of research
`activities or the delay of new product launches;
`the actions of certain customers could affect Shire 's ability to sell or market products profitably. Fluctuations in buying or distribution
`patterns by such customers can adversely impact Shire’s revenues, financial condition or results of operations;
`investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire’s activities in the highly
`regulated markets in which it operates may result in significant legal costs and the payment of substantial compensation or fines;
`adverse outcomes in legal matters and other disputes, including Shire’s ability to enforce and defend patents and other intellectual
`property rights required for its business, could have a material adverse effect on Shire’s revenues, financial condition or results of
`operations;
`Shire faces intense competition for highly qualified personnel from other companies, academic institutions, government entities and other
`organizations. Shire is undergoing a corporate reorganization and the consequent uncertainty could adversely impact Shire’s ability to
`attract and/or retain the highly skilled personnel needed for Shire to meet its strategic objectives;
`failure to achieve Shire’s strategic objectives with respect to the acquisition of ViroPharma Incorporated may adversely affect Shire’s
`financial condition and results of operations;
`
`•
`
`•
`
`1 1
`
`•
`
`•
`
`•
`
`•
`
`
`
`“SAFE HARBOR” statement under the Private Securities
`Litigation Reform Act of 1995 and tender offer materials
`
`•
`
`•
`
`•
`
`•
`
`•
`
`Shire’s proposed acquisition of NPS Pharma may not be consummated due to the occurrence of an event, change or other circumstances
`that gives rise to the termination of the merger agreement;
`a governmental or regulatory approval required for the proposed acquisition of NPS Pharma may not obtained, or may be obtained
`subject to conditions that are not anticipated, or another condition to the closing of the proposed acquisition may not be satisfied;
`NPS Pharma may be unable to retain and hire key personnel and/or maintain its relationships with customers, suppliers and other
`business partners pending the consummation of the proposed acquisition by Shire, or NPS Pharma’s business may be disrupted by the
`proposed acquisition, including increased costs and diversion of management time and resources;
`difficulties in integrating NPS Pharma into Shire may lead to the combined company not being able to realize the expected operating
`efficiencies, cost savings, revenue enhancements, synergies or other benefits at the time anticipated or at all;
`and other risks and uncertainties detailed from time to time in Shire’s or NPS Pharma’s filings with the U.S. Securities and Exchange
`Commission, including their respective most recent Annual Reports on Form 10-K.
`
`
`THIS COMMUNICATION IS FOR INFORMATIONAL PURPOSES ONLY AND DOES NOT CONSTITUTE AN OFFER TO PURCHASE OR A
`SOLICITATION OF AN OFFER TO SELL NPS PHARMA COMMON STOCK. THE OFFER TO BUY NPS PHARMA COMMON STOCK WILL
`ONLY BE MADE PURSUANT TO A TENDER OFFER STATEMENT (INCLUDING THE OFFER TO PURCHASE, LETTER OF TRANSMITTAL
`AND OTHER RELATED TENDER OFFER MATERIALS). INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE
`TENDER OFFER STATEMENT (WHICH WILL BE FILED BY SHIRE AND A SUBSIDIARY OF SHIRE WITH THE SECURITIES AND
`EXCHANGE COMMISSION (SEC)) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 WITH RESPECT
`TO THE TENDER OFFER (WHICH WILL BE FILED BY NPS PHARMA WITH THE SEC) WHEN THEY BECOME AVAILABLE BECAUSE
`THEY WILL CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS AND CONDITIONS OF THE OFFER. INVESTORS AND
`SECURITY HOLDERS MAY OBTAIN A FREE COPY OF THESE MATERIALS (WHEN AVAILABLE) AND OTHER DOCUMENTS FILED BY
`Shire AND NPS PHARMA WITH THE SEC AT THE WEBSITE MAINTAINED BY THE SEC AT WWW.SEC.GOV. THE TENDER OFFER
`STATEMENT AND RELATED MATERIALS, AND THE SOLICITATION/RECOMMENDATION STATEMENT, MAY ALSO BE OBTAINED
`(WHEN AVAILABLE) FOR FREE BY CONTACTING SHIRE INVESTOR RELATIONS AT +1 484 595 2220 IN THE US AND +44 1256 894157
`IN THE UK.
`
`COPIES OF THESE MATERIALS AND ANY DOCUMENTATION RELATING TO THE TENDER OFFER ARE NOT BEING, AND MUST NOT
`BE, DIRECTLY OR INDIRECTLY, MAILED OR OTHERWISE FORWARDED, DISTRIBUTED OR SENT IN, INTO OR FROM ANY
`JURISDICTION WHERE TO DO SO WOULD BE UNLAWFUL.
`
`2 2
`
`
`
`Shire and NPS Pharma – Leadership in rare diseases
`
`Shire is acquiring NPS Pharma, a significant step on our
`journey to become a leading biotechnology company
`
`Building on NPS Pharma’s success, we will use our GI
`market expertise, rare disease patient identification and
`management capabilities, and global footprint to deliver
`NPS Pharma’s products to patients worldwide
`
`The transaction will enhance Shire’s growth profile and
`is expected to be accretive to Non GAAP EPS from 2016
`onward
`
`3 3
`
`
`
`NPS Pharma is a biopharmaceutical company
`focused on rare diseases
`• Founded in 1986, with an early focus on osteoporosis and thyroid disorders
`• Acquired Allelix Pharmaceuticals in 1999 to specialize in rare disease with
`first-in or best-in-class disease therapies
`
`History
`
`Key Products
`
`• GATTEX®/REVESTIVE® (teduglutide) for the treatment of short bowel
`syndrome (SBS), a rare GI condition, launched in the U.S. (Q1 2013), and
`Europe (Q3 2014)
`• NATPARA®/NATPAR® (recombinant parathyroid hormone) for the treatment
`of hypoparathyroidism (HPT), a rare endocrine disease, in registration
`phase in the U.S. and EU
`
`General Facts
`
`• NASDAQ listed (NASDAQ: NPSP)
`• Headquarters: Bedminster, NJ, U.S.
`• Operations in the U.S., Canada, Europe, Latin America, and Japan
`• More than 350 employees
`
`4 4
`
`
`
`Acquisition is aligned to our strategy and adds
`significant upside to 10 x 20 aspirations
`
`Clear and focused strategy
`
`To become a leading
`global biotech
`delivering innovative
`medicines to patients
`with rare diseases and
`other specialty
`conditions
`
`10 x 20 aspirational product sales
`$ billions
`
`>10
`
`Upside potential
`NPS Pharma, Lumena,
`Fibrotech, BIKAM,
`Cinryze new uses, early
`stage pipeline, and future
`BD
`
`Pipeline
`$3 billion expected from
`existing pipeline(1)
`
`In-Line
`$7 billion expected from
`on-market products
`
`+10% CAGR
`
`5
`
`3
`
`7
`
`2013
`
`2020
`
`(1) Products included on pipeline as of February 2014, as reported on Q4 2013 quarterly results
`
`5 5
`
`
`
`Acquisition of NPS Pharma adds to innovative portfolio
`
`NPS Pharma’s main products NPS Pharma strengthens our
`GI and Internal Medicine
`franchise with two innovative
`products and leverages our
`rare disease expertise and
`patient management
`capabilities
`
`• GATTEX®/REVESTIVE®: A
`commercialized product for a
`rare GI condition
`
`• NATPARA®/NATPAR®: A
`product in registration for a
`rare endocrine disease
`
`6 6
`
`GATTEX®/REVESTIVE®
`NATPARA®/NATPAR®
`
`
`
`GATTEX®/REVESTIVE® - The first recombinant GLP-2
`for long term treatment of short bowel syndrome (SBS)
`Disease
`• SBS results from resection of the small
`intestine; leads to body being unable
`to absorb sufficient nutrients
`Health impact
`• Associated with life-threatening
`complications, including infections,
`blood clots, and liver damage
`Current treatment
`• More than 55% of SBS patients require
`parenteral nutrition support
`– High constraints to lifestyle (80% of
`patients require between 3 and 6 days of
`support per week)
`– High cost (~$185-568K per year(1))
`– Does not address the issue of malabsorption
`Prevalence
`• ~6-7K parenteral support dependent SBS
`adults in the U.S. (similar number in the EU5)
` SOURCE: NA HPEN Patient Registry. Oley Foundation. 1994;
`Weiser, Lancet. 2008;372:139; HCUP.net;
` (1) Annual mean costs of lifelong, complex home healthcare associated with PS, not
`including the indirect costs associated with disability (Piamjariyakul 2010, NIH).
`
`• First analog of GLP-2 approved to:
`– Increase absorption of remaining bowel
`– Decrease or eliminate the need for
`parenteral support
`• During pivotal phase 3 trial >60% of
`patients achieved at least 20% reduction
`in the volume of weekly parenteral
`nutrition
`• Stimulates intestinal lining growth,
`resulting in increased fluid and nutrient
`absorption
`• Launched in the U.S. in 2013; ex-U.S.
`launch underway since Q3 2014
`• Strong growth expected given opportunity
`to identify new SBS patients
`Gattex®/Revestive® are copyrights of NPS Pharma
`
`7 7
`
`
`
`NATPARA®/NATPAR® - In registration for the treatment
`of hypoparathyroidism (HPT)
`Disease
`• HPT is a disease in which patients’
`parathyroid glands fail to produce
`sufficient levels of parathyroid hormone
`leading to low calcium levels
`
`Health impact
`• Low calcium levels can lead to
`problems with the heart, nervous system,
`kidneys, bones and teeth
`
`Current treatment
`• Widespread treatment practice involves
`high-dose oral calcium and vitamin D
`– High pill burden
`– Inadequate control of symptoms
`Prevalence
`• ~75K patients in the U.S., 41K
`with moderate or severe disease (similar
`number in the EU5)
`
` SOURCE: Powers et al., Prev. and Incid. of HPT in the USA, large cohort study,
`DOI 10.1002/jbmr.2004, (2013); Sun et al., Trends in U.S. Thyroidectomy,
`Thyroid 23 (6), 2013;
`
`• If approved, the only bioengineered hormone
`replacement therapy indicated for use in the
`treatment of HPT
`• Pivotal phase 3 clinical trial showed clinically
`meaningful efficacy:
`– Maintenance of serum calcium in the
`target range
`– 50% decrease in calcium and vitamin D
`supplements
`• PDUFA date in the U.S. is January 24, 2015
`• MAA submitted on November 5, 2014;
`anticipated approval with standard review in
`Q1 2016
`
`Natpara®/Natpar® are copyrights of NPS Pharma
`
`8 8
`
`
`
`Shire will accelerate the growth of NPS Pharma’s
`portfolio
`GI and rare disease expertise
`• #2 GI sales force as
`ranked by U.S. GI’s(1)
`• #1 prescribed 5-ASA
`(Lialda) in U.S.(2)
`• Leader in enzyme /
`protein replacement
`• #1 position in HAE(3)
`market
`• Deep development
`portfolio, including
`SHP625 for rare GI /
`hepatic diseases
`
`Commercial excellence
`• Broad international
`commercial footprint
`with products marketed
`in over 50 countries
`• Innovative services to
`identify, support and
`manage patients
`• Best-in-class market
`access and launch
`capabilities
`
`(1) IMS Attributable Ranking Study 2013
`(2) IMS NPA Weekly Date Reports for week ending February 7, 2014
`(3) Seeking Alpha “Dyax And ViroPharma: An Overview Of Hereditary Angioedema (HAE) Space”, September 18, 2012
`
`9 9
`
`
`
`Combination will create shareholder value
`
`Extend rare disease model to GI franchise, by pairing innovative
`products with best-in-class patient support services
`
`Accelerate the growth of GATTEX® in the U.S. by leveraging Shire’s
`#2 ranked GI sales force and rare disease commercial expertise
`
`Efficiently launch REVESTIVE® ex-U.S. through Shire’s extensive
`international commercial infrastructure
`
`Maximize value of NATPARA®/NATPAR® (if approved) through
`Shire’s proven development and launch capabilities
`
`Realize operating synergies by integrating NPS Pharma into Shire’s
`organization, leveraging previous experience with similar acquisitions
`
`10 10
`
`
`
`Transaction highlights
`• $46.00 per share in cash (a 51% premium to NPS Pharma's
`Consideration
`unaffected share price of $30.47 on December 16, 2014)
`• Approximately $5.2 billion total consideration
`• Expected to enhance revenue growth from 2015 onward
`• Expected to be accretive to Non GAAP EPS from 2016 onward
`• Funded using cash on hand, existing $2.1 billion committed bank
`facility and a newly arranged $850 million short term bank facility
`• The transaction is not subject to any financing contingency
`• Closing expected in Q1 of 2015
`
`Financial
`impact
`
`Financing
`
`Timing
`
`Expected
`operating
`synergies
`
`• Realization of operating synergies beginning in 2016 and
`growing substantially thereafter
`• Anticipated synergies of approximately 25-35% of the Street’s
`consensus forecast of NPS Pharma’s standalone future
`operating cost base from 2017 onward
`
`11 11
`
`
`
`This acquisition will allow NPS Pharma’s products to
`transform the lives of even more patients
`
`12 12
`
`
`
`Shire and NPS Pharma – Leadership in rare diseases
`
`Shire is acquiring NPS Pharma, a significant step on our
`journey to become a leading biotechnology company
`
`Building on NPS Pharma’s success, we will use our GI
`market expertise, rare disease patient identification and
`management capabilities, and global footprint to deliver
`NPS Pharma’s products to patients worldwide
`
`The transaction will enhance Shire’s growth profile and
`is expected to be accretive to Non GAAP EPS from 2016
`onward
`
`13 13
`
`
`
`NPS Pharmaceuticals
`
`Francois Nader, MD, MBA
`CEO
`
`Q&A
`
`Shire
`
`Flemming Ornskov, MD, MPH
`CEO
`
`Jeff Poulton
`Interim Chief Financial Officer
`
`Mark Enyedy
`Head of Corporate Development and
`Interim General Counsel
`
`Roger Adsett
`Senior Vice President, GI Business Unit
`Leader
`
`
`
`
`Appendix
`Appendix
`
`We enable people with life-altering conditions to lead better lives.
`
`Our purpose
`
`
`
`NPS Pharma’s financials (in $ thousands)
`
`GATTEX® Sales
`Royalties and license fees
`
`Total Revenues
`
`Gross Profit
`
`R&D
`SG&A
`
`Operating income
`
`2012
`
`-
`130,644
`
`130,644
`
`130,644
`
`94,839
`36,929
`
`(1,124)
`
`2013
`
`2014
`(first 3 quarters)
`
`31,752
`123,804
`
`155,592
`
`151,996
`
`85,421
`68,070
`
`(1,495)
`
`67,917
`89,450
`
`157,367
`
`149,573
`
`66,238
`79,142
`
`4,193
`
`Outline prepared using historic company data under US GAAP
`
`16 16
`
`
`
`NPS Pharma’s additional pipeline
`
`REVESTIVE®
`geographic
`expansion
`
`Teduglutide
`label
`extension
`
`NPSP795
`
`• Japan
`• Canada
`• Switzerland
`
`• Global study for teduglutide in pediatric
`patients with SBS who are dependent
`on parenteral support
`
`• Ongoing phase 2a study of NPSP795
`in adults with autosomal dominant
`hypocalcemia; an ultra-rare, life-long
`genetic disorder that affects both
`adults and children
`
`17 17