|($ in millions, except per share amounts)||Third-Quarter||Nine Months|
|Reported Net Income (1)||2,840||1,355||*||9,034||6,440||40%|
|Reported Diluted EPS (1)||0.47||0.22||*||1.49||1.04||43%|
|Adjusted Income (2)||4,059||3,761||8%||12,313||11,867||4%|
|Adjusted Diluted EPS (2)||0.67||0.61||10%||2.03||1.92||6%|
|($ in millions)||Third-Quarter||Nine Months|
|2017||2016||% Change||2017||2016||% Change|
|Excluding HIS revenues from all periods:|
|Revenues||$52.4 to $53.1 billion|
|(previously $52.0 to $54.0 billion)|
|Adjusted Cost of Sales (2) as a Percentage of Revenues||20.0% to 20.5%|
|(previously 20.0% to 21.0%)|
|Adjusted SI&A Expenses (2)||$14.0 to $14.5 billion|
|(previously $13.7 to $14.7 billion)|
|Adjusted R&D Expenses (2)||$7.5 to $7.8 billion|
|(previously $7.5 to $8.0 billion)|
|Adjusted Other (Income)/Deductions (2)||Approximately $500 million of income|
|(previously approximately $200 million of income)|
|Effective Tax Rate on Adjusted Income (2)||Approximately 23.0%|
|Adjusted Diluted EPS (2)||$2.58 to $2.62|
|(previously $2.54 to $2.60)|
- During the first nine months of 2017, Pfizer returned $10.8 billion directly to shareholders, through a combination of:
- $5.8 billion of dividend payments, composed of a dividend of $0.32 per share of common stock in each of the first, second and third quarters of 2017; and
- a $5.0 billion accelerated share repurchase agreement executed in February 2017 and completed in May 2017, which resulted in a reduction of approximately 150 million shares of Pfizer's outstanding common stock.
- As of October 31, 2017, Pfizer's remaining share repurchase authorization was approximately $6.4 billion.
Frank D'Amelio, Executive Vice President, Business Operations and Chief Financial Officer, stated, "Overall, I am pleased with our third-quarter 2017 financial results, including 2% operational revenue growth after excluding the net impact of acquisitions and divestitures completed in 2016 and the first nine months of 2017. As a result of our strong performance to date in 2017, we narrowed the ranges for certain 2017 financial guidance components, including a $0.03 increase to the midpoint of our range for Adjusted diluted EPS (2) to a range of $2.58 to $2.62. The midpoint of our new guidance range for Adjusted diluted EPS (2) implies 8% growth compared with last year. Finally, earlier this month, we announced that we are reviewing strategic alternatives for our Consumer Healthcare business."QUARTERLY FINANCIAL HIGHLIGHTS (Third-Quarter 2017 vs. Third-Quarter 2016) Third-quarter 2017 revenues totaled $13.2 billion, an increase of $123 million, or 1% compared to the prior-year quarter, reflecting operational growth of $178 million, or 1%, slightly offset by the unfavorable impact of foreign exchange of $54 million. Excluding the revenues for HIS in the prior-year quarter and the unfavorable impact of foreign exchange, third-quarter 2017 revenues increased by $458 million, or 4%. Third-quarter 2017 revenues excluding the net impact of acquisitions and divestitures completed in 2016 and the first nine months of 2017 increased $264 million, or 2%, operationally compared to third-quarter 2016. Innovative Health Highlights
- IH revenues increased 11% operationally in third-quarter 2017, driven by continued growth from key brands including Ibrance and Eliquis globally, the addition of Xtandi revenues in the U.S. resulting from the September 2016 acquisition of Medivation, as well as Lyrica and Xeljanz, both primarily in the U.S. Global Ibrance revenues increased 59% operationally while global operational revenue growth for Eliquis and Xeljanz was 43% and 49%, respectively.
- Third-quarter 2017 operational growth was negatively impacted by lower revenues for Enbrel in most developed Europe markets due to continued biosimilar competition, and for Viagra in the U.S. primarily due to wholesaler destocking in advance of anticipated generic competition beginning in December 2017.
- Global Prevnar 13/Prevenar 13 revenues declined 1% operationally in third-quarter 2017. In the U.S., Prevnar 13 revenues decreased 4%, primarily due to the continued decline in revenues for the Adult indication due to a smaller remaining "catch up" opportunity compared to the prior-year quarter partially offset by growth from the pediatric indication. Prevenar 13 revenues in international markets increased 5% operationally, primarily due to the favorable overall impact of timing of government purchases in certain emerging markets for the pediatric indication.
- Third-quarter 2017 EH revenues declined 11% operationally, of which 5% operationally was due to the February 2017 divestiture of HIS. Third-quarter 2017 EH revenues were also negatively impacted by a 22% operational decline from Peri-LOE Products, including declines in Pristiq in the U.S. as well as Lyrica and Vfend, both primarily in developed Europe. EH revenues were also negatively impacted by a 12% operational decline from the Sterile Injectable Pharmaceuticals (SIP) portfolio, primarily due to legacy Hospira product shortages in the U.S. These declines were partially offset by 67% operational growth from Biosimilars.
- EH developed markets revenues declined 18% operationally, of which 6% operationally was due to the February 2017 divestiture of HIS. EH developed markets revenues were also negatively impacted by a 33% operational decline from Peri-LOE Products and a 20% operational decline from the SIP portfolio, primarily due to the aforementioned legacy Hospira product shortages in the U.S., partially offset by 65% operational growth from Biosimilars.
- EH revenues in emerging markets grew 7% operationally, primarily driven by 6% operational growth from the Legacy Established Products portfolio and 14% operational growth from the SIP portfolio. Excluding HIS from both periods, EH revenues in emerging markets grew 8% operationally.
|SELECTED TOTAL COMPANY REPORTED COSTS AND EXPENSES (1)|
|($ in millions) (Favorable)/Unfavorable||Third-Quarter||Nine Months|
|2017||2016||% Change||2017||2016||% Change|
|Cost of Sales (1)||$||2,847||$||3,085||(8%)||(8%)||$||7,980||$||9,111||(12%)||(10%)|
|Percent of Revenues||21.6||%||23.6||%||N/A||N/A||20.5||%||23.2||%||N/A||N/A|
|SI&A Expenses (1)||3,500||3,559||(2%)||(1%)||10,233||10,414||(2%)||(1%)|
|R&D Expenses (1)||1,859||1,881||(1%)||(1%)||5,346||5,360||—||—|
|Other (Income)/Deductions-net (1)||$||51||$||1,417||(96%)||(97%)||($16||)||$||2,815||*||(98%)|
|Effective Tax Rate on Reported Income (1)||20.3||%||15.5||%||20.1||%||14.6||%|
Adjusted (2) Income Statement Highlights
|SELECTED TOTAL COMPANY ADJUSTED COSTS AND EXPENSES (2)|
|($ in millions) (Favorable)/Unfavorable||Third-Quarter||Nine Months|
|2017||2016||% Change||2017||2016||% Change|
|Adjusted Cost of Sales (2)||$||2,699||$||2,957||(9%)||(9%)||$||7,729||$||8,584||(10%)||(7%)|
|Percent of Revenues||20.5||%||22.7||%||N/A||N/A||19.9||%||21.9||%||N/A||N/A|
|Adjusted SI&A Expenses (2)||3,478||3,531||(1%)||(1%)||10,151||10,342||(2%)||(1%)|
|Adjusted R&D Expenses (2)||1,851||1,873||(1%)||(1%)||5,326||5,336||—||—|
|Adjusted Other (Income)/Deductions-net (2)||($261||)||($168||)||55%||59%||($519||)||($547||)||(5%)||(17%)|
|Effective Tax Rate on Adjusted Income (2)||23.7||%||22.0||%||22.9||%||22.7||%|
- Bavencio (avelumab) -- In September 2017, Merck KGaA, Darmstadt, Germany (Merck KGaA) and Pfizer announced that the European Commission granted marketing authorization for Bavencio as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma, a rare and aggressive skin cancer. Bavencio will have marketing authorization in the 28 countries of the European Union in addition to Norway, Liechtenstein and Iceland. Bavencio has been launched in certain European markets and is expected to become commercially available in other European markets in the coming months. Additionally, in September 2017, Bavencio was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for curatively unresectable Merkel cell carcinoma in Japan.
- Besponsa (inotuzumab ozogamicin) -- In August 2017, Pfizer announced that the U.S. Food and Drug Administration (FDA) approved Besponsa for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Besponsa is the first and only CD22-directed antibody-drug conjugate approved for this indication.
- Bosulif (bosutinib) -- In August 2017, Pfizer and Avillion LLP announced that a supplemental New Drug Application (sNDA) for Bosulif was accepted for filing and granted Priority Review by the FDA. If approved, the sNDA would expand the approved use of Bosulif to include patients with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myeloid leukemia. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in December 2017. In addition, the European Medicines Agency (EMA) validated for review a Type II Variation application for use of Bosulif in the same patient population.
- Ibrance (palbociclib)
- In September 2017, Ibrance was approved by the Japanese MHLW for use in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative inoperable or recurrent breast cancer.
- In August 2017, the Alliance Foundation Trials, LLC, in conjunction with Pfizer and six international cancer research groups, announced the launch of PATINA - a randomized, open-label, Phase 3 clinical study of palbociclib. The PATINA trial will evaluate palbociclib in combination with anti-HER2 therapy and endocrine therapy versus standard therapy as a first-line treatment for patients with HR+, human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer. The trial randomized its first patient in July 2017.
- Inflectra (infliximab-dyyb, infliximab CT-P13) -- In October 2017, Pfizer and Celltrion Healthcare announced the secondary outcomes from a Phase 3 study of Inflectra that demonstrated that switching patients with Crohn's disease (CD) to Inflectra from Remicade ®(7) (infliximab) led to comparable efficacy, safety and tolerability to treatment with Remicade ®(7) over a 24 week period. The full 54-week results of the randomized controlled trial comparing Inflectra and Remicade ®(7) in biologic-naïve patients with active CD support the long-term effectiveness of treatment with Inflectra. The results also demonstrated that Inflectra was well-tolerated, with a similar safety profile to Remicade ®(7). Full results of this study were presented at the 25 th United European Gastroenterology Week conference.
- Lyrica CR (pregabalin) -- In October 2017, Pfizer announced that the FDA approved Lyrica CR extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy and the management of postherpetic neuralgia. Lyrica CR did not receive approval for the management of fibromyalgia. Pfizer expects Lyrica CR will be available in the U.S. beginning in January 2018.
- Mylotarg (gemtuzumab ozogamicin) -- In September 2017, Pfizer announced that the FDA approved Mylotarg for adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children 2 years and older with relapsed or refractory CD33-positive AML. Mylotarg is the first therapy with an indication that includes pediatric AML and is also the only AML therapy that targets CD33, an antigen expressed on AML cells in up to 90% of patients.
- Sutent (sunitinib malate) -- In September 2017, Pfizer announced that the FDA's Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for Sutent as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma after nephrectomy (surgical removal of the cancer-containing kidney). The role of the Advisory Committee is to provide recommendations to the FDA. The ODAC discussions were based on the sNDA currently under review by the FDA. The PDUFA goal date for a decision by the FDA is in January 2018.
- Xeljanz (tofacitinib citrate) -- In August 2017, Pfizer announced that the FDA's Arthritis Advisory Committee (AAC) voted 10 to 1 to recommend approval of the proposed dose of tofacitinib for the treatment of adult patients with active psoriatic arthritis. Pfizer submitted sNDAs for Xeljanz 5 mg twice daily and Xeljanz XR extended release 11 mg once daily for this pending indication. The PDUFA goal date for a decision by the FDA is in December 2017.
- Xtandi (enzalutamide) -- In September 2017, Astellas Pharma Inc. (Astellas) and Pfizer announced that the Phase 3 PROSPER trial evaluating Xtandi plus androgen deprivation therapy (ADT) versus ADT alone in patients with non-metastatic Castration-Resistant Prostate Cancer (CRPC) met its primary endpoint of improved metastasis-free survival. The preliminary safety analysis of the PROSPER trial appears consistent with the safety profile of Xtandi in previous clinical trials. Based on the results of PROSPER, the companies intend to discuss the data with global health authorities to potentially support expanding the label for Xtandi to cover all patients with CRPC.
- Lorlatinib (PF-06463922) -- In October 2017, Pfizer announced full results from the Phase 2 clinical trial of the investigational, next-generation tyrosine kinase inhibitor lorlatinib that exhibited clinically meaningful activity against lung tumors and brain metastases in a range of patients with ALK-positive and ROS1-positive advanced non-small cell lung cancer (NSCLC), including those who were heavily pretreated. Further, side effects were generally manageable and primarily mild to moderate in severity. The results were presented during an oral session at the International Association for the Study of Lung Cancer 18 th World Conference on Lung Cancer. Pfizer is currently evaluating lorlatinib in the Phase 3 CROWN study, an ongoing, open label, randomized, two-arm study comparing lorlatinib to crizotinib in the first-line treatment of patients with metastatic ALK-positive NSCLC.
- PF-04965842 -- In September 2017, positive results from a Phase 2b clinical trial of PF-04965842, Pfizer's JAK1 inhibitor for atopic dermatitis (AD), were presented at the 26 th Congress of the European Academy of Dermatology and Venereology. The 12-week, double-blind, placebo-controlled, dose-ranging study evaluated the efficacy and safety of 267 adult patients with moderate-to-severe AD who were randomized to receive either placebo or 10 mg, 30 mg, 100 mg or 200 mg of PF-04965842 once-daily. After evaluating the results of this trial, Pfizer intends to initiate pivotal studies of PF-04965842 in AD in the coming months.
- PF-05280014 (proposed biosimilar trastuzumab)
- In September 2017, Pfizer announced positive findings from REFLECTIONS B327-02, a pivotal Phase 3 randomized, double-blind comparative safety and efficacy study of the company's investigational trastuzumab biosimilar versus Herceptin ®(8) (trastuzumab), at the European Society for Medical Oncology (ESMO) 2017 Congress. Positive data from a supplemental study, REFLECTIONS B327-04, were also presented at the meeting. The REFLECTIONS B327-02 study achieved the primary objective for equivalence in the objective response rate of PF-05280014 versus Herceptin ®(8) in patients receiving first-line treatment, in combination with paclitaxel, for HER2+ metastatic breast cancer. The REFLECTIONS B327-04 study found there were no clinically meaningful differences between PF-05280014 and Herceptin ®(8) in terms of efficacy, safety, immunogenicity, and noninferiority in pharmacokinetics, as neoadjuvant treatment taken in combination with docetaxel and carboplatin for patients with operable HER2+ breast cancer. PF-05280014 is being developed by Pfizer as a potential biosimilar to Herceptin ®(8).
- In August 2017, the FDA accepted for review a Biologics License Application for PF-05280014. The Biosimilar User Fee Act goal date for a decision by the FDA is in April 2018. In addition, the EMA validated for review a Marketing Authorization Application for PF-05280014 in July 2017.
- PF-06482077 -- In October 2017, Pfizer initiated a Phase 2 clinical trial to evaluate the safety and immunogenicity of PF-06482077, Pfizer's next-generation multi-valent pneumococcal conjugate vaccine candidate in healthy adults. PF-06482077 is being studied to potentially extend coverage beyond the thirteen serotypes covered by Prevnar 13 to include seven additional serotypes prevalent in causing pneumococcal disease in adults and children. Results from a previously completed Phase 1 trial demonstrated that the vaccine candidate was safe and well tolerated and induced functional immune responses that could kill all twenty serotypes. The FDA granted Fast Track designation for PF-06482077 in May 2017 for use in an infant population and in October 2017 for use in an adult population. The FDA's Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.
- In October 2017, Pfizer announced that it is reviewing strategic alternatives for its Consumer Healthcare business. A range of options will be considered, including a full or partial separation of the Consumer Healthcare business from Pfizer through a spin-off, sale or other transaction, and Pfizer may ultimately determine to retain the business. This review is part of Pfizer's continuing efforts to allocate resources and capital to best serve patients and maximize value for its shareholders. Pfizer expects that any decision regarding strategic alternatives for Consumer Healthcare would be made during 2018. The company does not plan to make any further statements about the strategic review process until a decision has been reached or upon the completion of the strategic review.
|(1)||Revenues is defined as revenues in accordance with U.S. generally accepted accounting principles (GAAP). Reported net income is defined as net income attributable to Pfizer Inc. in accordance with U.S. GAAP. Reported diluted earnings per share (EPS) is defined as reported diluted EPS attributable to Pfizer Inc. common shareholders in accordance with U.S. GAAP.|
|(2)||Adjusted income and its components and Adjusted diluted EPS are defined as reported U.S. GAAP net income (1) and its components and reported diluted EPS (1) excluding purchase accounting adjustments, acquisition-related costs, discontinued operations and certain significant items (some of which may recur, such as restructuring or legal charges, but which management does not believe are reflective of ongoing core operations). Adjusted cost of sales, Adjusted selling, informational and administrative (SI&A) expenses, Adjusted research and development (R&D) expenses and Adjusted other (income)/deductions are income statement line items prepared on the same basis as, and therefore components of, the overall Adjusted income measure. As described in the "Management's Discussion and Analysis of Financial Condition and Results of Operations-Non-GAAP Financial Measure (Adjusted Income)" section of Pfizer's Quarterly Report on Form 10-Q for the fiscal quarter ended July 2, 2017, management uses Adjusted income, among other factors, to set performance goals and to measure the performance of the overall company. Because Adjusted income is an important internal measurement for Pfizer, management believes that investors' understanding of our performance is enhanced by disclosing this performance measure. Pfizer reports Adjusted income, certain components of Adjusted income, and Adjusted diluted EPS in order to portray the results of the Company's major operations--the discovery, development, manufacture, marketing and sale of prescription medicines, vaccines and consumer healthcare (OTC) products--prior to considering certain income statement elements. See the accompanying reconciliations of certain GAAP Reported to Non-GAAP Adjusted information for the third quarter and first nine months of 2017 and 2016. The Adjusted income and its components and Adjusted diluted EPS measures are not, and should not be viewed as, substitutes for U.S. GAAP net income and its components and diluted EPS.|
|(3)||Pfizer's fiscal year-end for international subsidiaries is November 30 while Pfizer's fiscal year-end for U.S. subsidiaries is December 31. Therefore, Pfizer's third quarter and first nine months for U.S. subsidiaries reflect the three and nine months ending on October 1, 2017 and October 2, 2016 while Pfizer's third quarter and first nine months for subsidiaries operating outside the U.S. reflect the three and nine months ending on August 27, 2017 and August 28, 2016.|
|(4)||The following acquisitions and divestitures impacted financial results for the periods presented:|
- On June 24, 2016, Pfizer acquired Anacor Pharmaceuticals, Inc. (Anacor). Therefore, financial results for the first nine months of 2017 reflect legacy Anacor operations while financial results for the first nine months of 2016 reflect approximately three months of legacy Anacor operations. Financial results for the third quarter of 2017 and 2016 both reflect legacy Anacor operations.
- On September 28, 2016, Pfizer acquired Medivation, Inc. (Medivation). Therefore, financial results for the third quarter and first nine months of 2017 reflect legacy Medivation operations while financial results for the third quarter and first nine months of 2016 reflect three business days of legacy Medivation operations, which were immaterial.
- On December 22, 2016, Pfizer completed the acquisition of the development and commercialization rights to AstraZeneca's small molecule anti-infective business, primarily outside the U.S. Therefore, financial results for the third quarter and first nine months of 2017 reflect contributions from certain legacy AstraZeneca anti-infective products.
- On February 3, 2017, Pfizer completed the sale of its global infusion therapy net assets, Hospira Infusion Systems (HIS). Therefore, financial results for the third quarter of 2017 do not reflect any contribution from legacy HIS operations, while the first nine months of 2017 reflect approximately one month of legacy HIS domestic operations and approximately two months of legacy HIS international operations. (3) Financial results for the third quarter and first nine months of 2016 reflect three and nine months of legacy HIS global operations, respectively.
|(5)||References to operational variances in this press release pertain to period-over-period growth rates that exclude the impact of foreign exchange. The operational variances are determined by multiplying or dividing, as appropriate, the current period U.S. dollar results by the current period average foreign exchange rates and then multiplying or dividing, as appropriate, those amounts by the prior-year period average foreign exchange rates. Although exchange rate changes are part of Pfizer's business, they are not within Pfizer's control. Exchange rate changes, however, can mask positive or negative trends in the business; therefore, Pfizer believes presenting operational variances provides useful information in evaluating the results of its business.|
|(6)||The 2017 financial guidance reflects the following:|
- Pfizer does not provide guidance for GAAP Reported financial measures (other than Revenues) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP Reported financial measures on a forward-looking basis because it is unable to predict with reasonable certainty the ultimate outcome of pending litigation, unusual gains and losses, acquisition-related expenses and potential future asset impairments without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP Reported results for the guidance period.
- Does not assume the completion of any business development transactions not completed as of October 1, 2017, including any one-time upfront payments associated with such transactions.
- Exchange rates assumed are a blend of the actual exchange rates in effect through September 2017 and mid-October 2017 exchange rates for the remainder of the year.
- Reflects an anticipated negative revenue impact of $2.3 billion due to recent and expected generic and biosimilar competition for certain products that have recently lost or are anticipated to soon lose patent protection.
- Reflects the anticipated negative impact of $0.1 billion on revenues and $0.01 on Adjusted diluted EPS (2) as a result of unfavorable changes in foreign exchange rates relative to the U.S. dollar compared to foreign exchange rates from 2016.
- Guidance for Adjusted diluted EPS (2) assumes diluted weighted-average shares outstanding of between 6.0 and 6.1 billion shares, which reflects the impact of the $5 billion accelerated share repurchase agreement executed in February 2017 and completed in May 2017.
|(7)||Remicade ® is a registered U.S. trademark of Janssen Biotech, Inc.|
|(8)||Herceptin ® is a registered U.S. trademark of Genentech, Inc.|
This earnings release and the related attachments contain forward-looking statements about our anticipated future operating and financial performance, business plans and prospects, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, approvals, performance, timing of exclusivity and potential benefits of Pfizer's products and product candidates, strategic reviews, capital allocation, business-development plans, the benefits expected from our acquisitions and other business development activities, manufacturing and product supply 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," "may," "could," "likely," "ongoing," "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 pre-clinical and clinical trial commencement and completion dates, regulatory submission and approval dates, and launch dates for product candidates, as well as the possibility of unfavorable pre-clinical and 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; decisions by regulatory authorities regarding labeling, ingredients and other matters that could affect the availability or commercial potential of our products; and uncertainties regarding our ability to address the comments in complete response letters received by us with respect to certain of our drug applications to the satisfaction of the FDA;
- 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 preliminary, early stage or interim data, including the risk that final results of studies for which preliminary, early stage or interim data have been provided and/or additional clinical trials may be different from (including less favorable than) the preliminary, early stage or 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 time frame or at all or to realize the anticipated benefits of such transactions;
- competitive developments, including the impact on our competitive position of new product entrants, in-line branded products, generic products, private label products, biosimilars 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 and regulatory authorities in certain other countries of an abbreviated legal pathway to approve biosimilar products, which could subject our biologic products to competition from biosimilar products, with attendant competitive pressures, after the expiration of any applicable exclusivity period and patent rights;
- risks related to our ability to develop and launch biosimilars, including risks associated with "at risk" launches, defined as the marketing of a product by Pfizer before the final resolution of litigation (including any appeals) brought by a third party alleging that such marketing would infringe one or more patents owned or controlled by the third party;
- the ability to meet competition from generic, branded and biosimilar products after the loss or expiration 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, including delays caused by natural events, such as hurricanes; supply shortages at our facilities; and legal or regulatory actions, such as warning letters, suspension of manufacturing, seizure of product, injunctions or voluntary recall of a product;
- trade buying patterns;
- the impact of existing and future legislation and regulatory provisions on product exclusivity;
- trends toward managed care and healthcare cost containment, and our ability to obtain or maintain timely or adequate pricing or formulary placement for our products;
- the impact of any significant spending reductions or cost controls 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 any U.S. healthcare reform or legislation, including any repeal, substantial modification or invalidation of any or all of the provisions of the U.S. Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act;
- U.S. federal or state legislation or regulatory action and/or policy efforts affecting, among other things, pharmaceutical product pricing, reimbursement or access, including under Medicaid, Medicare and other publicly funded or subsidized health programs; patient out-of-pocket costs for medicines, manufacturer prices and/or price increases that could result in new mandatory rebates and discounts or other pricing restrictions; the importation of prescription drugs from outside the U.S. at prices that are regulated by governments of various foreign countries; restrictions on direct-to-consumer advertising; limitations on interactions with healthcare professionals; or 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 for our products 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 reductions in prices and access restrictions for certain biopharmaceutical products to control costs in those markets;
- 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, unstable governments and legal systems and inter-governmental disputes;
- 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 and settlement costs;
- the risk of an adverse decision or settlement and the adequacy of reserves related to legal proceedings, including patent litigation, product liability and other product-related litigation, including personal injury, consumer, off-label promotion, securities, antitrust and breach of contract claims, commercial, environmental, government investigations, employment and other legal proceedings, including various means for resolving asbestos litigation, as well as tax issues;
- 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 and the volatility following the United Kingdom (U.K.) referendum in which voters approved the exit from the EU;
- 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 the U.S. that may result from pending and possible future proposals;
- any significant issues involving our largest wholesale distributors, 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;
- the end result of any negotiations between the U.K. government and the EU regarding the terms of the U.K.'s exit from the EU, which could have implications on our research, commercial and general business operations in the U.K. and the EU;
- 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;
- changes in interpretations of existing laws and regulations, or changes in laws and regulations, in the U.S. and other countries;
- 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;
- the impact of purchase accounting adjustments, acquisition-related costs, discontinued operations and certain significant items;
- the impact of acquisitions, divestitures, restructurings, internal reorganizations, product recalls, withdrawals and other unusual items, including our ability to realize the projected benefits of our cost-reduction and productivity initiatives and of the internal separation of our commercial operations into our current operating structure;
- the risk of an impairment charge related to our intangible assets, goodwill or equity-method investments;
- risks related to internal control over financial reporting;
- risks and uncertainties related to our acquisitions of Hospira, Inc. (Hospira), Anacor Pharmaceuticals, Inc. (Anacor), Medivation, Inc. (Medivation) and AstraZeneca's small molecule anti-infectives business, including, among other things, the ability to realize the anticipated benefits of those acquisitions, including the possibility that expected cost savings related to the acquisition of Hospira and accretion related to the acquisitions of Hospira, Anacor and Medivation will not be realized or will not be realized within the expected time frame; the risk that the businesses will not be integrated successfully; disruption from the transactions making it more difficult to maintain business and operational relationships; risks related to our ability to grow revenues for Xtandi and expand Xtandi into the non-metastatic castration-resistant prostate cancer setting; significant transactions costs; and unknown liabilities; and
- risks and uncertainties related to our evaluation of strategic alternatives for our Consumer Healthcare business, including, among other things, the ability to realize the anticipated benefits of any strategic alternatives we may pursue for our Consumer Healthcare business, including the potential for disruption to our business resulting from the evaluation of strategic alternatives for Pfizer Consumer Healthcare; the possibility that we may not be able to realize a higher value for Pfizer Consumer Healthcare through strategic alternatives; and unknown liabilities.
The operating segment information provided in this earnings release and the related 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 recorded 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.