PFIZER : REPORTS FOURTH-QUARTER AND FULL-YEAR 2014 RESULTS; PROVIDES 2015 FINANCIAL GUIDANCE

Pfizer Inc. (NYSE: PFE) reported financial results for fourth-quarter and full-year 2014. At the beginning of fiscal year 2014, the company began managing its commercial operations through a new global commercial structure consisting of two distinct businesses: an Innovative Products business and an Established Products business. The Innovative Products business is composed of two operating segments: the Global Innovative Pharmaceutical segment (GIP)⁽³⁾ and the Global Vaccines, Oncology and Consumer Healthcare segment (VOC)⁽³⁾. The Established Products business consists of the Global Established Pharmaceutical segment (GEP)⁽³⁾. Financial results for each of these segments are presented in the Operating Segment Information section.

As a result of the full disposition of Zoetis Inc. (Zoetis) on June 24, 2013, the financial results of the Animal Health business are reported as a discontinued operation in the consolidated statements of income for the twelve months ended December 31, 2013.

Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. Results are summarized below.

2015 FINANCIAL GUIDANCE⁽⁵⁾⁽⁶⁾

Pfizer's 2015 financial guidance is summarized below.

A reconciliation of Pfizer's full-year 2014 financial results to certain components of its 2015 financial guidance, including certain significant factors impacting 2015 financial guidance, is below.

EXECUTIVE COMMENTARY

Ian Read, Chairman and Chief Executive Officer, stated, “During 2014, despite significant continued revenue headwinds from product losses of exclusivity and co-promote expiries, we were able to deliver modest adjusted diluted EPS⁽²⁾ growth. This was achieved through a combination of incremental revenue generation from key in-line products and recent product launches, responsible expense management as well as supportive capital allocation.”

“We continued to focus on strengthening our innovative core and have made notable progress in this area through both internal advancements and strategic business development. As we look forward to 2015, we expect continued momentum with our pipeline, notably the potential U.S. approval of Ibrance (palbociclib) for advanced breast cancer, as well as anticipated strong growth in emerging markets and from our recent product launches in developed markets, including Eliquis, Xeljanz, Prevnar 13 in adults and Nexium 24HR. We are now in a position to commence over 20 registrational studies during the coming four years with candidates that are based upon strong science and target indications that have significant unmet need.”

Mr. Read continued, “On the commercial front, our innovative and established businesses continue to benefit from a sharp focus on execution in their respective markets and we expect each will demonstrate continued improvement in their competitive positioning.”

“Further, we remain in a strong financial position that will enable us to invest in our business at appropriate levels, continue to pursue attractive business development activities and also continue to return meaningful capital directly to our shareholders,” Mr. Read concluded.

Frank D’Amelio, Chief Financial Officer, stated, “For full-year 2014, I was pleased with our financial performance, the operational execution of our newly-formed businesses and our ability to continue delivering shareholder value through prudent capital allocation. Regarding our financial performance, we achieved or exceeded all elements of our 2014 financial guidance despite an operating environment that remains challenging. In addition, we began operating within our new commercial structure in 2014 and saw significant progress across each of our businesses. Finally, we continued to demonstrate our commitment to delivering significant value to shareholders by returning nearly $12 billion to shareholders through share repurchases and dividends in 2014.”

“We are also providing our 2015 financial guidance, including ranges for reported revenues⁽¹⁾ of $44.5 to $46.5 billion and for adjusted diluted EPS⁽²⁾ of $2.00 to $2.10. Our guidance for reported revenues⁽¹⁾ reflects the anticipated negative impact of $3.5 billion due to recent and expected product losses of exclusivity as well as $2.8 billion as a result of recent adverse changes in essentially all foreign exchange rates relative to the U.S. dollar compared to foreign exchange rates from last year, partially offset by anticipated revenue growth from certain other products. Our reported⁽¹⁾ and adjusted⁽²⁾ diluted EPS guidance reflects a $0.17 unfavorable impact as a result of adverse changes in foreign exchange rates from last year. In addition, our reported⁽¹⁾ and adjusted⁽²⁾ diluted EPS guidance reflects a $0.03 reduction for the planned upfront payment associated with the pending transaction with OPKO Health, Inc. (OPKO)⁽⁶⁾. Finally, our guidance for reported⁽¹⁾ and adjusted⁽²⁾ diluted EPS also reflects anticipated share repurchases totaling approximately $6 billion this year, including $715 million of our shares repurchased to date in 2015. These repurchases and planned repurchases will more than offset the potential dilution related to employee compensation programs,” Mr. D'Amelio concluded.

QUARTERLY FINANCIAL HIGHLIGHTS (Fourth-Quarter 2014 vs. Fourth-Quarter 2013)

Reported revenues⁽¹⁾ decreased $440 million, or 3%, which reflects slight operational growth of $9 million, and the unfavorable impact of foreign exchange of $449 million, or 3%. Operational growth in developed markets was driven by the performance of certain key products, including Lyrica, Prevnar and Eliquis, as well as Xeljanz primarily in the U.S. Additionally, revenues in emerging markets increased 7% operationally, including strong operational growth from Lipitor, primarily in China, as well as Prevenar and Enbrel. This operational growth was offset primarily by the loss of exclusivity and subsequent multi-source generic competition for Celebrex in the U.S., the expiration of the co-promotion term of the collaboration agreement for Enbrel in the U.S. and Canada, the termination of the Spiriva collaboration in certain countries as well as by other product losses of exclusivity in certain markets.

Established Products Business Highlights

• GEP⁽³⁾ revenues decreased 7% operationally, primarily due to declining revenues from Lipitor in developed markets resulting from continued generic competition as well as the loss of exclusivity and subsequent launch of multi-source generic competition for Celebrex in the U.S. in December 2014, Detrol LA in the U.S. in January 2014 as well as Aricept in Canada in December 2013. Additionally, the co-promotion collaboration for Spiriva has terminated in most countries, including the U.S. in April 2014, or has entered its final year in other markets, which, per the terms of the collaboration agreement, has resulted in a decline in Pfizer’s share of Spiriva revenues. These declines were partially offset by strong performance in emerging markets, where revenues increased 7% operationally, as well as by Lyrica in Europe.

Innovative Products Business Highlights

• GIP⁽³⁾ revenues increased 6% operationally, primarily due to strong operational growth from Lyrica, primarily in the U.S. and Japan, as well as the performance of recently launched products, including Eliquis globally and Xeljanz, primarily in the U.S. This growth was partially offset primarily by the expiration of the co-promotion term of the collaboration agreement for Enbrel in the U.S. and Canada on October 31, 2013; for a 36-month period thereafter, Pfizer is entitled to royalty payments that have been and are expected to continue to be significantly less than the share of Enbrel profits prior to the expiration of the co-promotion term, and those royalty payments are and will be included in Other (income)/deductions–net rather than in Revenues.
• VOC⁽³⁾ revenues increased 14% operationally, reflecting the following:
  • Global Vaccines⁽³⁾ revenues grew 22% operationally. Prevnar 13 revenue in the U.S. increased 33%, primarily driven by increased uptake among adults following the positive recommendation from the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices for use in adults aged 65 and over in third-quarter 2014, partially offset by lower revenues generated by the pediatric indication due to the timing of government purchases compared to the year-ago quarter. International sales of Prevenar 13 were up 11% operationally, primarily reflecting the favorable impact of Prevenar's inclusion in additional national immunization programs in certain emerging markets compared with the year-ago quarter.
  • Consumer Healthcare⁽³⁾ revenues increased 4% operationally, primarily due to the launch of Nexium 24HR in the U.S. in late-May 2014.
  • Global Oncology⁽³⁾ revenues increased 14% operationally, primarily driven by the continued strong underlying demand for Xalkori globally, Inlyta in most markets as well as operational growth from Sutent, primarily in the U.S. and emerging markets.

Income Statement Highlights

• Adjusted cost of sales, adjusted SI&A expenses and adjusted R&D expenses⁽²⁾ in the aggregate increased $336 million operationally, or 4%, reflecting the following operational factors:
  • higher adjusted cost of sales⁽²⁾, primarily reflecting an unfavorable change in product mix;
  • lower adjusted SI&A expense⁽²⁾, primarily as a result of continued benefits from cost-reduction and productivity initiatives, partially offset by investments to support several recent product launches and other in-line brands; and
  • higher adjusted R&D expense⁽²⁾, primarily due to incremental expenses associated with the ongoing Phase 3 programs for bococizumab, palbociclib, ertugliflozin and certain other new drug candidates, as well as potential new indications for previously approved products, especially for Xeljanz.
• The effective tax rate on adjusted income⁽²⁾ declined 1.5 percentage points to 26.2% from 27.7%. This decline was primarily due to a favorable change in the jurisdictional mix of earnings and the extension of the U.S. research and development (R&D) tax credit, which was signed into law in December 2014, partially offset by a decrease in the favorable impact of the resolution of certain tax positions, pertaining to prior years, with various foreign tax authorities.
• The diluted weighted-average shares outstanding declined by 159 million shares compared to the prior-year quarter, due to the company’s ongoing share repurchase program.
• In addition to the aforementioned factors, fourth-quarter 2014 reported earnings were primarily impacted by the following:

Unfavorable impacts:

• a charge associated with a collaborative arrangement with Merck KGaA, announced in November 2014, to jointly develop and commercialize an investigational anti-PD-L1 antibody currently in development as a potential treatment for multiple types of cancer. The charge includes an $850 million upfront cash payment as well as an additional amount of approximately $300 million reflecting the fair value for certain co-promotion rights for Xalkori granted to Merck KGaA;
• higher charges for certain legal matters, primarily reflecting a $400 million charge for an agreement in principle to resolve a securities class action pending against the company in New York federal court, which is subject to court approval; and
• a higher effective tax rate, primarily due to the non-recurrence of tax benefits recorded in fourth-quarter 2013 related to certain audit settlements in multiple jurisdictions covering various periods.

Favorable impacts:

• lower restructuring charges, expenses associated with cost-reduction initiatives and purchase accounting adjustments in fourth-quarter 2014 compared to the prior-year quarter.

FULL-YEAR FINANCIAL HIGHLIGHTS (Full-Year 2014 vs. Full-Year 2013)

• Reported revenues⁽¹⁾ decreased $2.0 billion, or 4%, which reflects an operational decline of $1.1 billion, or 2%, and the unfavorable impact of foreign exchange of $912 million, or 2%. The operational decline was primarily due to the expiration of the co-promotion term of the collaboration agreement for Enbrel in the U.S. and Canada, the ongoing termination of the Spiriva collaboration in certain countries as well as the loss of exclusivity and subsequent multi-source generic competition for Detrol LA in the U.S. as well as other product losses of exclusivity in certain markets. Revenues in developed markets were favorably impacted by the growth of certain key products, including Lyrica, Prevnar, Eliquis, Xeljanz, Xalkori, Inlyta as well as Nexium 24HR. Additionally, revenues in emerging markets increased 7% operationally, including strong operational growth from Prevenar as well as from Lipitor, primarily in China, and from Enbrel, primarily in Latin America.
• Adjusted cost of sales, adjusted SI&A expenses and adjusted R&D expenses⁽²⁾ in the aggregate increased $563 million operationally, or 2%, reflecting the following operational factors:
  • higher adjusted cost of sales⁽²⁾, primarily reflecting an unfavorable change in product mix;
  • lower adjusted SI&A expense⁽²⁾, primarily as a result of continued benefits from cost-reduction and productivity initiatives, partially offset by investments to support several recent product launches and other in-line brands; and
  • higher adjusted R&D expense⁽²⁾, primarily due to incremental expenses associated with the ongoing Phase 3 programs for bococizumab, palbociclib, ertugliflozin and certain other new drug candidates, as well as potential new indications for previously approved products, especially for Xeljanz.

• The effective tax rate on adjusted income⁽²⁾ declined 1.0 percentage point to 26.5% from 27.5%. This decline was primarily due to a favorable change in the jurisdictional mix of earnings, partially offset by a decrease in the favorable impact of the resolution of certain tax positions, pertaining to prior years, with various foreign tax authorities as well as a decrease in the favorable impact of the U.S. R&D tax credit compared to last year.
• The diluted weighted-average shares outstanding declined by 471 million shares compared to last year, due to the company’s ongoing share repurchase program and the impact of the Zoetis exchange offer, which was completed on June 24, 2013.
• In addition to the aforementioned full-year 2014 factors and the factors impacting fourth-quarter 2014 reported earnings, full-year 2014 reported earnings were also impacted primarily by the following:

Unfavorable impacts:

• the non-recurrence in 2014 of income from the gain associated with the transfer of certain product rights to Pfizer’s joint venture with Zhejiang Hisun Pharmaceuticals Co., Ltd. (Hisun) in China in first-quarter 2013;
• higher charges for certain legal matters, primarily driven by Neurontin-related matters in first-quarter 2014;140
• the non-recurrence in 2014 of income from discontinued operations attributable to the company’s Animal Health business in first-half 2013 through June 24, 2013, including the gain associated with the full disposition of Zoetis in second-quarter 2013;
• the non-recurrence in 2014 of income from a litigation settlement with Teva Pharmaceuticals Industries Ltd. and Sun Pharmaceutical Industries Ltd. in second-quarter 2013 for patent-infringement damages resulting from their “at-risk” launches of generic Protonix in the U.S.; and
• a non-tax deductible charge in third-quarter 2014 to account for an additional year of the Branded Prescription Drug Fee in accordance with final regulations issued by the U.S. Internal Revenue Service.

Favorable impacts:

• lower restructuring charges, acquisition-related costs, purchase accounting adjustments and asset impairment charges compared to the prior-year;
• the non-recurrence in 2014 of a loss in third-quarter 2013 related to an option to acquire the remaining interest in a 40%-owned generics company in Brazil, and the income recorded in third-quarter 2014 as a result of a decline in the loss from the option; and
• a lower effective tax rate.

RECENT NOTABLE DEVELOPMENTS

Product Developments

• Prevenar 13 -- Pfizer announced in January 2015 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending that the indication for Prevenar 13 be expanded to include the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults 18 years and older. Prevenar 13 is currently approved in Europe for the prevention of invasive pneumococcal disease in the same population. The CHMP’s positive opinion will now be reviewed by the European Commission (EC). The decision on whether to approve Prevenar 13 for this indication will be made by the EC and will be applicable to all European Union member states plus Iceland, Lichtenstein and Norway.
• Trumenba (rLP2086, Meningococcal Serogroup B Bivalent Recombinant Lipoprotein vaccine) -- Pfizer announced in October 2014 that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Trumenba for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. As part of the accelerated approval process under which Trumenba was approved, Pfizer will complete its ongoing Phase 3 studies to confirm the effectiveness of Trumenba against diverse serogroup B strains. Trumenba became available to healthcare providers in the U.S. in November 2014.
• Embeda -- Pfizer announced in October 2014 that the FDA approved an updated label for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release capsules, for oral use, to include abuse-deterrence studies. Embeda is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Embeda is expected to be reintroduced in the U.S. in February 2015.

Pipeline Developments

• Ibrance (palbociclib)
  • In January 2015, Pfizer announced that the FDA had informed the company that there was no plan for an Oncologic Drugs Advisory Committee meeting for Ibrance. Pfizer also reported that it had entered label discussions with the FDA. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 13, 2015.
  • Pfizer announced in October 2014 that the FDA accepted for filing Pfizer's New Drug Application (NDA) with Priority Review seeking approval for Ibrance, in combination with letrozole, as a first-line treatment for postmenopausal women with estrogen receptor positive, human epidermal growth factor receptor 2 negative advanced breast cancer who have not received previous systemic treatment for their advanced disease.
• Pregabalin Controlled-Release (CR) Formulation -- In December 2014, Pfizer announced top-line results from a double-blind Phase 3 study evaluating pregabalin CR formulation in adult patients with postherpetic neuralgia. The results showed that pregabalin CR resulted in a statistically significant positive effect compared to placebo in the primary endpoint, time to loss of therapeutic response (LTR) in pain reduction. This study was the final of three Phase 3 studies of the pregabalin CR formulation conducted to ascertain the potential use of pregabalin as a once-a-day therapy. The first study in adults with partial onset seizures with epilepsy did not meet its primary endpoint. In the second study in patients with fibromyalgia, pregabalin CR had a statistically significant positive effect compared to placebo in the primary endpoint, time to LTR in pain reduction. Pregabalin is the active ingredient for Lyrica.
• PF-06252616 -- Pfizer announced in December 2014 the enrollment of the first patient in a multicenter Phase 2 clinical trial of the investigational compound PF-06252616 in boys with Duchenne muscular dystrophy (DMD), a genetic disorder characterized by progressive muscle degeneration and weakness. The Phase 2 clinical trial will evaluate the safety, tolerability and efficacy of PF-06252616 in boys aged six to less than 10 years old diagnosed with DMD regardless of genotype. PF-06252616 was granted Orphan Drug designation in July 2012 and Fast Track Designation in November 2012 by the FDA. The EMA granted the investigational candidate Orphan Medical Product designation in February 2013.
• PF-06425090 (Clostridium difficile (C. difficile) vaccine candidate) -- Pfizer disclosed in November 2014 that it decided to halt further recruitment and vaccination for its ongoing Phase 2 study. This decision was driven by several observed cases of severe local reactogenicity (redness). There were no systemic symptoms in any of the subjects and the majority of local reactions have been fully resolved. Pfizer is evaluating potential next steps for the C. difficile clinical development program.
• PF-06290510 (Staphylococcus aureus (S. aureus) vaccine candidate) -- In October 2014, Pfizer presented data from a Phase 1/Phase 2 study evaluating the safety, tolerability and immunogenicity of a single-dose of its investigational 4-antigen S. aureus vaccine candidate in healthy adults. The study results demonstrated that PF-06290510 was well tolerated in the 456 healthy adults 18 to 64 years old who randomly received a single intramuscular injection of PF-06290510 or placebo. The study also showed rapid rises in functional antibody titers against S. aureus that were maintained through at least 12 months. PF-06290510, currently in Phase 2 clinical trials, was granted Fast Track designation by the FDA in February 2014.

Corporate Developments

• Pfizer announced in January 2015 that it acquired a controlling interest in Redvax GmbH, a spin-off from Redbiotec AG, a privately held Swiss biopharmaceutical company, based in Zurich-Schlieren. This transaction provides Pfizer with access to a preclinical human cytomegalovirus vaccine candidate, as well as intellectual property and a technology platform related to a second, undisclosed vaccine program.
• Pfizer announced in December 2014 that it entered into an agreement with OPKO to develop and commercialize OPKO's long-acting human growth hormone (hGH-CTP) for the treatment of growth hormone deficiency in adults and children, as well as for the treatment of growth failure in children born small for gestational age who fail to show catch-up growth by two years of age. hGH-CTP has the potential to reduce the required dosing frequency of human growth hormone to a single weekly injection from the current standard of one injection per day. The transaction is subject to customary Hart-Scott-Rodino approval and is expected to close during first-quarter 2015.
• In December 2014, Pfizer entered into a strategic collaboration with iTeos Therapeutics SA (iTeos) pursuant to which iTeos will license to Pfizer rights to iTeos' pre-clinical compounds targeting Indoleamine 2,3-dioxygenase (IDO1) and Tryptophan 2,3-dioxygenase (TDO2). Pfizer will be responsible for the development and commercialization of IDO1 and TDO2 drug candidates. Additionally, the parties will collaborate to discover and validate new targets that play key roles in the ability of tumors to evade immune responses. These new targets will be shared by iTeos and Pfizer for further independent or collaborative development. iTeos received from Pfizer an up-front payment of €24 million plus an equity investment and is eligible to receive future licensing fees and collaborative funding. Further, iTeos will be eligible to earn potential milestone payments from Pfizer based on the achievement of specific development, regulatory and commercial milestones across the IDO1 and TDO2 programs, in addition to royalties on sales. iTeos also has the opportunity to earn additional milestone and royalty payments for any of the new target programs that are advanced by Pfizer.
• Pfizer announced in December 2014 that it entered into an agreement with Spark Therapeutics to develop and commercialize SPK-FIX, a program incorporating a bio-engineered adeno-associated virus vector for the potential treatment of Hemophilia B expected to enter Phase 1/Phase 2 clinical trials in the first-half of 2015. Under the terms of the agreement, Spark Therapeutics will maintain responsibility for clinical development through Phase 1/Phase 2 studies. Pfizer will assume responsibility for pivotal studies, any regulatory approvals and potential global commercialization of the product.
• In December 2014, Pfizer announced that the Board of Directors declared a 28-cent first-quarter 2015 dividend on the company’s common stock, payable March 3, 2015, to shareholders of record at the close of business on February 6, 2015. This represents an increase of 8% in the quarterly dividend per share, compared to 26 cents per share in first-quarter 2014.
• In December 2014, Pfizer announced that it completed the acquisition of Baxter International Inc.’s (Baxter) portfolio of marketed vaccines for $635 million. The portfolio that was acquired consists of NeisVac-C and FSME-IMMUN/TicoVac. Pfizer also acquired a portion of Baxter’s facility in Orth, Austria, where these vaccines are manufactured.
• Pfizer announced in November 2014 that it entered into an agreement with Merck KGaA to jointly develop and commercialize MSB0010718C (proposed international non-proprietary name is avelumab), an investigational anti-PD-L1 antibody currently in development as a potential treatment for multiple types of cancer. Pfizer and Merck KGaA will explore the therapeutic potential of this novel anti-PD-L1 antibody as a single agent as well as in various combinations with Pfizer’s and Merck KGaA’s broad portfolio of approved and investigational oncology therapies. Both companies will collaborate on up to 20 high priority immuno-oncology clinical development programs expected to commence in 2015. These clinical development programs include up to six trials (Phase 2 or 3) that could be pivotal for potential product registrations. In addition, separate from the PD-L1 programs, Pfizer and Merck KGaA will also combine resources and expertise to advance Pfizer’s anti-PD-1 antibody into Phase 1 trials. The parties have also agreed to co-promote Pfizer’s Xalkori in the U.S. and several other key markets. Under the terms of the agreement, Merck KGaA received an upfront payment of $850 million and is eligible to receive regulatory and commercial milestone payments of up to approximately $2 billion. Both companies will jointly fund all development and commercialization costs, and split equally any profits generated from selling any anti-PD-L1 or anti-PD-1 products from this collaboration.
• In October 2014, Pfizer announced that the Board of Directors authorized a new $11 billion share repurchase program, to be utilized over time. Including share repurchases to date, the current remaining share repurchase authorization is approximately $10.8 billion.

Please find Pfizer’s press release and associated financial tables, including reconciliations of certain GAAP reported to non-GAAP adjusted information, at the following hyperlink:

http://www.pfizer.com/system/files/presentation/Q4_2014_PFE_Earnings_Press_Release_alksdjindfls.pdf

(Note: If clicking on the above link does not open up a new web page, you may need to cut and paste the above URL into your browser's address bar.)

For additional details, see the associated financial schedules and product revenue tables attached to the press release located at the hyperlink referred to above and the attached disclosure notice.

• Does not assume the completion of any business development transactions not completed as of December 31, 2014, including any one-time upfront payments associated with such transactions, except for the planned $295 million upfront payment to be made to OPKO upon completion of the transaction announced in December 2014, expected in first-quarter 2015.
• Excludes the potential effects of the resolution of litigation-related matters.
• Exchange rates assumed are as of mid-January 2015. Excludes the impact of a potential devaluation of the Venezuelan bolivar or any other currency.
• Guidance for the effective tax rate on adjusted income⁽²⁾ does not assume the renewal of the U.S. research and development (R&D) tax credit. The renewal of the R&D tax credit is not anticipated to have a material impact on the effective tax rate on adjusted income⁽²⁾.
• Assumes diluted weighted-average shares outstanding of approximately 6.2 billion shares.
• Reconciliation of the 2015 Adjusted Income⁽²⁾ and Adjusted Diluted EPS⁽²⁾ guidance to the 2015 Reported Net Income Attributable to Pfizer Inc. and Reported Diluted EPS Attributable to Pfizer Inc. common shareholders guidance:

DISCLOSURE NOTICE: The information contained in this earnings release and the attachments is as of January 27, 2015. We assume no obligation to update forward-looking statements contained in this earnings release and the attachments as a result of new information or future events or developments.

This earnings release and the attachments contain forward-looking statements about our future operating and financial performance, business plans and prospects, in-line products and product candidates, strategic reviews, capital allocation, business-development plans, and plans relating to share repurchases and dividends, among other things, that involve substantial risks and uncertainties. You can identify these statements by the fact that they use future dates or use words such as “will,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “target,” “forecast,” “goal,” “objective,” “aim” and other words and terms of similar meaning. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following:

• the outcome of research and development activities, including, without limitation, the ability to meet anticipated clinical trial commencement and completion dates, regulatory submission and approval dates, and launch dates for product candidates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data;
• decisions by regulatory authorities regarding whether and when to approve our drug applications, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; and decisions by regulatory authorities regarding labeling, ingredients and other matters that could affect the availability or commercial potential of our products;
• the speed with which regulatory authorizations, pricing approvals and product launches may be achieved;
• the outcome of post-approval clinical trials, which could result in the loss of marketing approval for a product or changes in the labeling for, and/or increased or new concerns about the safety or efficacy of, a product that could affect its availability or commercial potential;
• risks associated with interim data, including the risk that final results of studies for which interim data have been provided and/or additional clinical trials may be different from (including less favorable than) the interim data results and may not support further clinical development of the applicable product candidate or indication;
• the success of external business-development activities, including the ability to satisfy the conditions to closing of announced transactions in the anticipated timeframe or at all;
• competitive developments, including the impact on our competitive position of new product entrants, in-line branded products, generic products, private label products and product candidates that treat diseases and conditions similar to those treated by our in-line drugs and drug candidates;
• the implementation by the FDA of an abbreviated legal pathway to approve biosimilar products, which could subject our biologic products to competition from biosimilar products in the U.S., with attendant competitive pressures, after the expiration of any applicable exclusivity period and patent rights;
• the ability to meet generic and branded competition after the loss of patent protection for our products or competitor products;
• the ability to successfully market both new and existing products domestically and internationally;
• difficulties or delays in manufacturing;
• trade buying patterns;
• the impact of existing and future legislation and regulatory provisions on product exclusivity;
• trends toward managed care and healthcare cost containment;
• the impact of any significant spending reductions affecting Medicare, Medicaid or other publicly funded or subsidized health programs or changes in the tax treatment of employer-sponsored health insurance that may be implemented, and/or any significant additional taxes or fees that may be imposed on the pharmaceutical industry as part of any broad deficit-reduction effort;
• the impact of U.S. healthcare legislation enacted in 2010—the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act—and of any modification or repeal of any of the provisions thereof;
• U.S. federal or state legislation or regulatory action affecting, among other things, pharmaceutical product pricing, reimbursement or access, including under Medicaid, Medicare and other publicly funded or subsidized health programs; the importation of prescription drugs from outside the U.S. at prices that are regulated by governments of various foreign countries; direct-to-consumer advertising and interactions with healthcare professionals; and the use of comparative effectiveness methodologies that could be implemented in a manner that focuses primarily on the cost differences and minimizes the therapeutic differences among pharmaceutical products and restricts access to innovative medicines; as well as pricing pressures as a result of highly competitive insurance markets;
• legislation or regulatory action in markets outside the U.S. affecting pharmaceutical product pricing, reimbursement or access, including, in particular, continued government-mandated price reductions for certain biopharmaceutical products in certain European and emerging market countries and Japan and government-imposed access restrictions in certain countries;
• the exposure of our operations outside the U.S. to possible capital and exchange controls, expropriation and other restrictive government actions, changes in intellectual property legal protections and remedies, as well as political unrest and unstable governments and legal systems;
• contingencies related to actual or alleged environmental contamination;
• claims and concerns that may arise regarding the safety or efficacy of in-line products and product candidates;
• any significant breakdown, infiltration, or interruption of our information technology systems and infrastructure;
• legal defense costs, insurance expenses, settlement costs, the risk of an adverse decision or settlement and the adequacy of reserves related to product liability, patent protection, government investigations, consumer, commercial, securities, antitrust, environmental and tax issues, ongoing efforts to explore various means for resolving asbestos litigation, and other legal proceedings;
• our ability to protect our patents and other intellectual property, both domestically and internationally;
• interest rate and foreign currency exchange rate fluctuations, including the impact of possible currency devaluations in countries experiencing high inflation rates;
• governmental laws and regulations affecting domestic and foreign operations, including, without limitation, tax obligations and changes affecting the tax treatment by the U.S. of income earned outside of the U.S. that may result from pending and possible future proposals;
• any significant issues involving our largest wholesaler customers, which account for a substantial portion of our revenues;
• the possible impact of the increased presence of counterfeit medicines in the pharmaceutical supply chain on our revenues and on patient confidence in the integrity of our medicines;
• any significant issues that may arise related to the outsourcing of certain operational and staff functions to third parties, including with regard to quality, timeliness and compliance with applicable legal requirements and industry standards;
• any significant issues that may arise related to our joint ventures and other third-party business arrangements;
• changes in U.S. generally accepted accounting principles;
• uncertainties related to general economic, political, business, industry, regulatory and market conditions including, without limitation, uncertainties related to the impact on us, our customers, suppliers and lenders and counterparties to our foreign-exchange and interest-rate agreements of challenging global economic conditions and recent and possible future changes in global financial markets; and the related risk that our allowance for doubtful accounts may not be adequate;
• any changes in business, political and economic conditions due to actual or threatened terrorist activity in the U.S. and other parts of the world, and related U.S. military action overseas;
• growth in costs and expenses;
• changes in our product, segment and geographic mix; and
• the impact of acquisitions, divestitures, restructurings, internal reorganizations, product recalls and withdrawals and other unusual items, including our ability to realize the projected benefits of our cost-reduction and productivity initiatives, including those related to our research and development organization, and of the internal separation of our commercial operations into our new operating structure.

A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2013 and in our subsequent reports on Form 10-Q, in each case including in the sections thereof captioned “Forward-Looking Information and Factors That May Affect Future Results” and “Item 1A. Risk Factors”, and in our subsequent reports on Form 8-K.

The operating segment information provided in this earnings release and the attachments does not purport to represent the revenues, costs and income from continuing operations before provision for taxes on income that each of our operating segments would have reported had each segment operated as a standalone company during the periods presented.

This earnings release may include discussion of certain clinical studies relating to various in-line products and/or product candidates. These studies typically are part of a larger body of clinical data relating to such products or product candidates, and the discussion herein should be considered in the context of the larger body of data. In addition, clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate or a new indication for an in-line product, regulatory authorities may not share our views and may require additional data or may deny approval altogether.