`
`Newsroom
`Shire to Acquire NPS Pharma as Further
`Step in Building a Leading Biotech
`
`January 11, 2015
`
`Transaction valued at $5.2 billion
`Enhances growth profile
`
`Shire plc (LSE: SHP, NASDAQ: SHPG) and NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) today
`announced that the companies have entered into a merger agreement pursuant to which Shire will
`acquire all the outstanding shares of NPS Pharma for $46.00 per share in cash, for a total consideration
`of approximately $5.2 billion. Shire will accelerate the growth of NPS Pharma’s innovative portfolio
`through its market expertise in gastrointestinal (GI) disorders, core capabilities in rare disease patient
`management, and global footprint. The transaction has been approved unanimously by the Boards of
`Directors of both Shire and NPS Pharma.
`
`NPS Pharma is a rare disease-focused biopharmaceutical company and its first product,
`GATTEX®/REVESTIVE® (teduglutide [rDNA origin]) for injection, is approved in the United States and
`Europe to treat adults with short bowel syndrome (SBS) who are dependent on parenteral support. NPS
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`Pharma also has a registration phase product, NATPARA®/NATPAR® (rhPTH -83) for the treatment of
`hypoparathyroidism (HPT).
`
`The $46.00 per share price in the transaction represents a 51% premium to NPS Pharma's unaffected
`share price of $30.47 on December 16, 2014.
`
`In Europe, Revestive is indicated for the treatment of adult patients with short bowel syndrome who
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`should be stable following a period of intestinal adaptation after surgery.
`
`TRANSACTION HIGHLIGHTS
`• Excellent strategic fit; strengthens Shire’s focus on rare diseases while leveraging industry-leading
`GI commercial capabilities and global footprint
`• Shire anticipates enhanced revenue and earnings growth profile
`• Adds innovative product portfolio with multiple growth catalysts:
`◦ GATTEX/REVESTIVE (teduglutide [rDNA origin]) with growing sales for the treatment of
`adults with SBS, a rare GI condition
`◦ NATPARA/NATPAR (rhPTH -83), if approved, would be the only bioengineered hormone
`replacement therapy for use in the treatment of HPT, a rare endocrine disease
`• Shire expects transaction to be accretive to Non GAAP EPS from 2016 onward
`• Acquisition to be effected by a tender offer and funded from Shire’s cash resources, as well as
`existing and new bank facilities
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`https://www.shire.com/newsroom/2015/january/shire-to-acquire-nps-pharma-as-further-step-in-building-a-leading-biotech
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`CFAD Exhibit 1055
`CFAD v. NPS
`IPR2015-00990
`
`1
`
`
`
`• Conference call for investors today (full details below)
`
`Shire’s Chief Executive Officer, Flemming Ornskov, MD, MPH, commented:
`
`“The acquisition of NPS Pharma is a significant step in advancing Shire’s strategy to become a leading
`biotechnology company. With our global strength and expertise in both rare diseases and GI, Shire is
`uniquely positioned to drive the continued success of GATTEX/REVESTIVE, and, if approved,
`commercialize NPS Pharma’s pipeline compound NATPARA/NATPAR.
`
`“We look forward to accelerating the growth of the NPS Pharma portfolio based on our proven track
`record of maximizing value from acquired assets and commercial execution. The NPS Pharma
`organization will be a welcome addition to Shire as we continue to help transform the lives of patients with
`rare diseases.”
`
`Francois Nader, MD, President, Chief Executive Officer and Director of NPS Pharma, stated:
`“Shire shares NPS Pharma’s commitment to patients with rare diseases. We believe that joining our two
`companies will drive value for shareholders and ensure we continue to transform the lives of patients with
`short bowel syndrome, hypoparathyroidism, and autosomal dominant hypocalcemia worldwide. I am
`confident that this transaction will accelerate our ambition of creating a world where every person living
`with a rare disease has a therapy.
`
`I would like to thank all of our employees for their continued outstanding contributions and steadfast
`commitment to the patients we serve.”
`
`INFORMATION ON NPS PHARMA
`NPS Pharma is a commercial-stage rare disease-focused biopharmaceutical company, whose first
`product, GATTEX (teduglutide [rDNA origin]) for injection, has been launched in the U.S. to treat adults
`with short bowel syndrome (SBS). NPS Pharma is in the process of launching the product in Europe
`under the trade name REVESTIVE. NPS Pharma’s second product rhPTH -83 (NATPARA in the U.S. /
`NATPAR in Europe) is currently under review in the U.S. and Europe for the treatment for
`hypoparathyroidism (HPT). NPS Pharma has an ongoing Phase 2a study evaluating its lead pipeline
`candidate NPSP795 for the treatment of adults with autosomal dominant hypocalcemia. NPS Pharma has
`an operational presence in the U.S., Canada, Europe, Latin America and Japan. The value of NPS
`Pharma’s gross assets were $282.2 million with net assets totaling $130.9 million as of September 30,
`2014. NPS Pharma’s losses before tax for the three and nine month periods ending September 30, 2014
`were $1.9 million and $6.2 million, respectively.
`
`INFORMATION ON GATTEX/REVESTIVE
`In the United States, GATTEX (teduglutide [rDNA origin]) for injection is approved for the long-term
`treatment of adults with short bowel syndrome (SBS) who need parenteral support. GATTEX is the first
`analog of GLP-2 approved to treat SBS, a disease which may require patients to get their nutrition
`intravenously through a central line.
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`https://www.shire.com/newsroom/2015/january/shire-to-acquire-nps-pharma-as-further-step-in-building-a-leading-biotech
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`SBS is a condition in which a large portion of the intestine has been removed by surgery. As a result,
`people can’t absorb enough nutrients or fluids from food and liquids to maintain good health. It can also
`be caused by disease or injury that prevents the small intestine from functioning properly despite normal
`length. To make up for the inadequate absorption, intravenous (IV) feeding (parenteral support) may be
`prescribed to help the patient stay healthy.
`
`In the U.S., approximately 6,000-7,000 SBS patients are dependent on parenteral support with a similar
`prevalence in Europe.
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`
`GATTEX has received orphan drug designation from the U.S. Food and Drug Administration (FDA) and
`was approved in December 2012. GATTEX generated sales of $67.9 million in the nine months ending
`September 30, 2014.
`
`In Europe, REVESTIVE has been launched in Germany and Sweden.
`
`INFORMATION ON NATPARA/NATPAR
`NATPARA/NATPAR, NPS Pharma’s parathyroid hormone (rhPTH -83) for the treatment of
`hypoparathyroidism (HPT), a rare endocrine disorder characterized by insufficient levels of parathyroid
`hormone (PTH), is currently under review in the U.S. with an FDA Prescription Drug User Fee Act
`(PDUFA) action date for the Biologics License Application (BLA) on January 24, 2015. In Europe, the
`European Medicines Agency (EMA) has validated and initiated its review of NPS Pharma’s marketing
`authorization application (MAA) for NATPAR.
`
`HPT is a rare condition in which the parathyroid glands fail to produce sufficient amounts of PTH or where
`PTH lacks biologic activity. PTH plays a central role in a variety of critical physiological functions in the
`body. In patients with HPT, insufficient levels of PTH lead to many physiological abnormalities, including
`low serum calcium and an inability to convert native vitamin D into its active state to properly absorb
`dietary calcium.
`
`In the U.S., approximately 75,000 patients are diagnosed with HPT with 41,000 having moderate to
`severe disease with a similar prevalence in EU5 (France, Germany, United Kingdom, Italy and Spain).
`
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`Acute symptoms of HPT are largely due to low serum calcium and range from muscle pain and tingling, to
`lack of focus or ability to concentrate, and anxiety and depression. In extreme cases, life-threatening
`events, such as arrhythmias and seizures, may occur. In the absence of an approved parathyroid
`replacement therapy, the standard approach focuses on using large doses of calcium and active vitamin
`D to increase calcium levels in the blood and reduce the severity of symptoms. However, balancing the
`administration of large doses of calcium and vitamin D is challenging due to calcium fluctuations and the
`long-term use of this regimen may lead to serious complications. In addition, calcium and vitamin D do not
`correct the abnormal bone metabolism due to PTH deficiency or enable the activation of vitamin D.
`
`NA HPEN Patient Registry. Oley Foundation. 1994
`Powers et al., Prev. and Incid. of HPT in the USA, large cohort study, DOI 10.1002/jbmr.2004, (2013)
`
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`ADDITIONAL VALUE FROM NPS PHARMA’S LICENCED PRODUCTS AND PIPELINE
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`NPS Pharma currently has several successful partnerships in place. Amgen markets cinacalcet HCl as
`Sensipar® in the U.S. and as Mimpara® in the EU; Janssen Pharmaceuticals markets tapentadol as
`Nucynta® in the U.S.; and Kyowa Hakko Kirin markets cinacalcet HCI as Regpara® in Japan, Hong
`Kong, Malaysia, Macau, Singapore, and Taiwan.
`
`NPS Pharma earned royalty revenues of $123.8 million for 2013 and $89.5 million for the first nine
`months ending September 30, 2014.
`
`NPS Pharma is developing teduglutide as a treatment for pediatric SBS. NPS Pharma is currently
`conducting a global study for teduglutide in pediatric patients with SBS who are dependent on parenteral
`support.
`
`NPS Pharma is also investigating NPSP795, a small molecule antagonist of the calcium-sensing receptor,
`which is believed to play a role in the distribution of PTH -83 throughout the body by antagonizing
`calcium-sensing receptors on the parathyroid gland to trigger a release of the body's stores of PTH -83.
`NPSP795 is in development as a treatment for autosomal dominant hypocalcemia (ADH). There is no
`approved therapy for this ultra-rare, life-long genetic disorder that affects both adults and children.
`
`Following the above transactions, Dr. Gillis holds 674 ADSs. One ADS is equal to three ordinary shares of
`5 pence each in the Company.
`
`FINANCIAL BENEFIT TO SHIRE
`The acquisition of NPS Pharma is expected to enhance Shire’s revenue and earnings growth profile.
`Shire expects the transaction to be accretive to Non GAAP EPS from 2016 onward.
`
`Related to the acquisition, Shire anticipates that it will realize operating synergies beginning in 2016 and
`growing substantially thereafter. Shire anticipates synergies approximating 25-35% of the Street’s
`consensus forecast of NPS Pharma’s standalone future operating cost base from 2017 onward.
`
`Shire also expects that the transaction will deliver ROIC in excess of its weighted average cost of capital.
`Financing
`Shire has secured an $850 million fully underwritten short-term bank facility, which, in addition to Shire’s
`cash and cash equivalents and its existing $2.1 billion five-year revolving credit facility, is available to
`finance the transaction and pay related fees and expenses. Shire plans to refinance the short-term bank
`facility through new debt issuances in due course.
`Closing
`The acquisition is structured as an all-cash tender offer for all of the outstanding shares of NPS Pharma
`at a price of $46.00 per share followed by a merger in which each remaining untendered share of NPS
`Pharma common stock would be converted into the same $46.00 cash per share consideration as in the
`tender offer.
`
`The closing of the transaction is subject to customary conditions, including the tender of a majority of the
`outstanding NPS Pharma shares and the receipt of Hart-Scott-Rodino clearance. Pending such closing
`conditions, it is anticipated that the transaction will close in the first quarter of 2015.
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`https://www.shire.com/newsroom/2015/january/shire-to-acquire-nps-pharma-as-further-step-in-building-a-leading-biotech
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`Citigroup Global Markets Limited and Lazard are acting as joint financial advisors to Shire. Goldman,
`Sachs & Co. and Leerink Partners LLC are acting as financial advisors to NPS Pharma. Davis Polk &
`Wardwell LLP and Slaughter & May are acting as legal advisors to Shire and Skadden, Arps, Slate,
`Meagher & Flom LLP is acting as legal advisor to NPS Pharma.
`
`CONFERENCE CALL WITH CEOS FROM SHIRE AND NPS PHARMA
`Live conference call for investors:
`Flemming Ornskov, MD, MPH, Chief Executive Officer; 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, all of Shire Pharmaceuticals; and Francois Nader, MD, MBA,
`President, Chief Executive Officer and Director, NPS Pharmaceuticals, Inc. will host a conference call for
`investors and analysts today (Sunday, January 11, 2015) at 6:00 p.m. GMT/1:00 .pm. EST/10:00 a.m.
`PST.
`
`The details of the conference call are as follows:
`
`UK dial in:
`U.S. dial in:
`
`International
`Access
`Numbers:
`
`0808 237 0030 or 020 3139 4830
`
`1 866 928 7517 or 1 718 873 9077
`
`Click here
`(http://wpc.1726.planetstream.net/001726/FEL_Events_International_Access_List.pdf)
`
`Password/Conf
`24757209#
`ID:
`
`Live Webcast:
`
`Click here (http://event.onlineseminarsolutions.com/r.htm?
`e=921726&s=1&k=D48F4A70850014B55E4E6A278F9EF343)
`
`Replay:
`A replay of the presentation will be available for two weeks by phone and by webcast for three months.
`UK dial in:
`0808 237 0026 or 020 3426 2807
`
`U.S. dial in:
`
`1 866 535 8030
`
`Password/Conf
`ID:
`
`653478#
`
`Webcast
`replay:
`
`Click here (http://event.onlineseminarsolutions.com/r.htm?
`e=921726&s=1&k=D48F4A70850014B55E4E6A278F9EF343)
`
`FOR FURTHER INFORMATION PLEASE CONTACT:
`
`https://www.shire.com/newsroom/2015/january/shire-to-acquire-nps-pharma-as-further-step-in-building-a-leading-biotech
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`Investor Relations
`For Shire:
`Sarah Elton-Farr
`seltonfarr@shire.com (mailto:seltonfarr@shire.com)
`+44 1256 894157
`+1 484 595 2220
`
`For NPS Pharma:
`Susan Mesco
`SMesco@npsp.com (mailto:SMesco@npsp.com) (mailto:seltonfarr@shire.com)
`+1 908 391 8283
`Media
`For Shire:
`Stephanie Fagan
`sfagan@shire.com (mailto:sfagan@shire.com) (mailto:seltonfarr@shire.com)
`+1 201 572 9581
`
`Jessica Cotrone
`jcotrone@shire.com (mailto:jcotrone@shire.com)
`+1 781 482 9538
`
`For NPS Pharma:
`Justine O’Malley
`JOMalley@npsp.com (mailto:JOMalley@npsp.com)
`+1 908 432 6051
`
`NOTES TO EDITORS
`Shire enables people with life-altering conditions to lead better lives.
`
`Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant
`unmet patient needs.
`
`We focus on providing treatments in Rare Diseases, Neuroscience, Gastrointestinal, and Internal
`Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in
`other targeted therapeutic areas, such as Ophthalmics.
`
`www.shire.com (http://www.shire.com/)
`
`ABOUT NPS PHARMA
`NPS Pharma is a global biopharmaceutical company pioneering and delivering therapies that transform
`the lives of patients with rare diseases. The company's current therapeutic areas of focus are
`gastrointestinal disease and endocrine disorders. These include Short Bowel Syndrome, a potentially fatal
`gastrointestinal disorder in which patients may have to rely on parenteral nutrition for their survival;
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`Hypoparathyroidism, a complex endocrine disorder in which the parathyroid glands are either absent or
`damaged, and the body produces insufficient or no parathyroid hormone; and Autosomal Dominant
`Hypocalcemia, an ultra-rare, genetic disorder of calcium homeostasis caused by mutations of the
`calcium-sensing receptor gene. NPS Pharma continues to seek in-licensing opportunities to develop new
`therapies for a broad range of rare diseases, and complements its proprietary programs with a royalty-
`based portfolio of products and product candidates that includes agreements with Amgen,
`GlaxoSmithKline, Janssen Pharmaceuticals, and Kyowa Hakko Kirin. NPS Pharma has operations in the
`U.S., Canada, Europe, Latin America and Japan. Learn more at: www.npsp.com (http://www.npsp.com/).
`
`"NPS Pharma" and "NPS Pharmaceuticals" are the company's trademarks.
`
`ABOUT GATTEX® (TEDUGLUTIDE [RDNA ORIGIN]) FOR INJECTION
`Gattex® (teduglutide [rDNA origin]) for injection for subcutaneous use is a novel, recombinant analog of
`human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining. Gattex is
`indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on
`parenteral support. Significant reductions in mean PN/IV infusion volume from baseline to end of
`treatment were seen in the Phase 3 studies of Gattex. In addition, some patients were able to achieve
`independence from PN/IV support during these trials. The most common side effects of Gattex include
`stomach area (abdomen) pain or swelling, skin reaction where the injection was given, nausea,
`headache, cold or flu like symptoms, vomiting, and holding too much fluid in the body (swelling of face,
`ankles, hands or feet).
`
`The European Commission granted European market authorization on August 30, 2012 for the medicinal
`product teduglutide (trade name in Europe: Revestive®) as a once-daily treatment for adult patients with
`SBS.
`
`Teduglutide has orphan drug designation for the treatment of SBS from the European Medicines Agency
`(EMA) and the FDA.
`
`IMPORTANT SAFETY INFORMATION
`What is the most important information I should know about GATTEX?
`
`GATTEX may cause serious side effects, including:
`
`Making abnormal cells grow faster
`
`GATTEX can make abnormal cells that are already in your body grow faster. There is an increased risk
`that abnormal cells could become cancer. If you get cancer of the bowel (intestines), liver, gallbladder or
`pancreas while using GATTEX, your healthcare provider should stop GATTEX. If you get other types of
`cancers, you and your healthcare provider should discuss the risks and benefits of using GATTEX.
`
`Polyps in the colon (large intestine)
`
`Polyps are growths on the inside of the colon. Your healthcare provider will have your colon checked for
`polyps within 6 months before starting GATTEX and have any polyps removed.
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`To keep using GATTEX, your healthcare provider should have your colon checked for new polyps at the
`end of 1 year of using GATTEX. If no polyp is found, your healthcare provider should check you for polyps
`as needed and at least every 5 years and have any new polyps removed. If cancer is found in a polyp,
`your healthcare provider should stop GATTEX.
`
`Blockage of the bowel (intestines)
`
`A bowel blockage keeps food, fluids, and gas from moving through the bowels in the normal way. Tell
`your healthcare provider if you have any of these symptoms of a bowel blockage:
`
`• trouble having a bowel movement or passing gas
`• stomach area (abdomen) pain or swelling
`• nausea
`• vomiting
`• swelling and blockage of your stoma opening, if you have a stoma
`
`If blockage is found, your healthcare provider may temporarily stop GATTEX.
`
`Swelling (inflammation) or blockage of your gallbladder or pancreas
`
`Your healthcare provider will do tests to check your gallbladder and pancreas within 6 months before
`starting GATTEX and at least every 6 months while you are using GATTEX. Tell your healthcare provider
`right away if you get stomach area (abdomen) pain and tenderness, chills, fever, change in your stools,
`nausea, vomiting, dark urine, or yellowing of your skin or the whites of eyes.
`
`Fluid overload
`
`Your healthcare provider will check you for too much fluid in your body. Too much fluid in your body may
`lead to heart failure, especially if you have heart problems. Tell your healthcare provider if you get
`swelling in your feet and ankles, you gain weight very quickly (water weight), or you have`troubl%
`breathing.
`
`The most common side effects of GATTEX include:
`• stomach area (abdomen) pain or swelling
`• skin reaction where the injection was given
`• nausea
`• headache
`• cold or flulike symptoms
`• vomiting
`
`Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
`
`What should I tell my healthcare provider before using GATTEX?
`
`Tell your healthcare provider if you:
`• Have cancer or a history of cancer
`• Have or had polyps anywhere in your bowel (intestines) or rectum
`• Have heart problems
`• Have high blood pressure
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`• Have problems with your gallbladder, pancreas, kidneys
`• Have any other medical condition
`• Are pregnant or planning to become pregnant. It is not known if GATTEX will harm your unborn
`baby. Tell your healthcare provider right away if you become pregnant while using GATTEX.
`• Are breastfeeding or plan to breastfeed. It is not known if GATTEX passes into your breast milk.
`You and your healthcare provider should decide if you will use GATTEX or breastfeed. You should not do
`both.
`
`Tell your healthcare providers about all the medicines you take, including prescription or over-the-counter
`medicines, vitamins, and herbal supplements. Using GATTEX with certain other medicines may affect
`each other causing side effects. Your other healthcare providers may need to change the dose of any oral
`medicines you take while using GATTEX. Tell the healthcare provider who gives you GATTEX if you will
`be taking a new oral medicine.
`
`Call your doctor for medical advice about side effects. To report suspected side effects, contact NPS
`Pharma at 1-855-5GATTEX (1-855-542-8839) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
`(http://www.fda.gov/medwatch).
`
`ADDITIONAL INFORMATION AND WHERE TO FIND IT
`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 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 THE CONTACT INFORMATION
`LISTED ABOVE. NPS PHARMA WILL ALSO PROVIDE A COPY OF THESE MATERIALS WITHOUT
`CHARGE ON ITS WEBSITE AT WWW.NPSP.COM UNDER THE “INVESTORS” SECTION.
`
`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.
`
`SHIRE FORWARD-LOOKING STATEMENTS
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`Statements included herein 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;
`• 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;
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`• 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
`Securities and Exchange Commission, including their respective most recent Annual Reports on Form
`10-K.
`
`NPS PHARMA CAUTIONARY NOTE REGARDING FORWARD-LOOKING
`STATEMENTS
`This communication contains forward-looking statements. These forward-looking statements include,
`without limitation, statements with respect to the tender offer and related transactions, including the
`benefits expected from the acquisition and the expected timing of the completion of the transaction. In
`many cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,”
`“plan,” “expect,” “anticipate,” “estimate,” “predict,” “intend,” “potential” or “continue” or the negative of
`these terms or other words of similar import, although some forward-looking statements are expressed
`differently. These statements reflect our current views concerning future events and are based on a
`number of assumptions that could ultimately prove inaccurate. Important factors that could cause actual
`results to differ materially from those in the forward-looking statements include: the timing of the filings
`and approvals relating to the transaction and the expected timing of the completion of the transaction;
`uncertainties as to the percentage of NPS Pharma's stockholders tendering their shares of NPS Pharma
`common stock in the tender offer; the possibility that competing offers will be made; the possibility that
`various closing conditions for the transaction may not be satisfied or waived, including that a
`governmental entity may prohibit, delay or refuse to grant approval for the consummation of the
`transaction that may result in a termination of the merger agreement; the effects of disruption caused by
`the transaction making it more difficult to maintain relationships with employees, collaborators, vendors
`and other business partners; the risk that stockholder litigation in connection with the transaction may
`result in significant costs of defense, indemnification and liability; and other risks and uncertainties
`discussed in NPS Pharma's filings with the SEC, including the “Risk Factors” sections of NPS Pharma's
`most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q, as well as the
`tender offer documents to be filed by a subsidiary of Shire, and the Solicitation/Recommendation
`Statement to be filed by NPS Pharma. These risks and uncertainties and other factors, individually or in
`the aggregate, could cause actual results and events to differ materially from those referred to in the
`forward-looking statements. NPS Pharma undertakes no obligation to update or revise any such forward-
`looking statements.
`
`Click here
`(https://www.shire.com/~/media/shire/shireglobal/shirecom/pdffiles/newsroom/2015/january/20150111-
`shiretoacquirenpspharmapressrelease-final.pdf?la=en) for the PDF version of this press release.
`
`PREV
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`(https://www.shire.com/newsroom/2015/january/shire-
`added-to-global-100-sustainability-index)
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`share-january-2015-part-2)
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