News Details

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) reported financial results for first-quarter 2015. The company manages its commercial operations through 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. 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⁾

Pfizer's 2015 financial guidance was updated solely to reflect changes in foreign exchange rates in relation to the U.S. dollar from mid-January 2015 to mid-April 2015, primarily the weakening of the euro.

A reconciliation of Pfizer's full-year 2014 financial results to certain components of its updated 2015 financial guidance is below.

EXECUTIVE COMMENTARY

Ian Read, Chairman and Chief Executive Officer, stated, “We began the year with good performance on both the top and bottom line and I believe the company is well-positioned in terms of in-line products, recent product launches, geographic reach and product pipeline.”

“During the first quarter of 2015, our new products delivered strong performances. We continued to see strong uptake for our Prevnar 13 vaccine in older adults in the U.S. Ibrance, our recently approved therapy for first-line advanced breast cancer in the U.S., performed very well following its February launch. We also announced this month that a Phase 3 trial of Ibrance for recurrent breast cancer had met its primary endpoint of progression-free survival (PFS). Additionally, Eliquis delivered another strong quarter of growth as adoption among cardiologists continues to improve globally.”

“Also during the first quarter of 2015, we announced the proposed acquisition of Hospira, Inc. (Hospira). This business represents an excellent strategic fit in growing market segments and is expected to accelerate the growth trajectory of our Global Established Pharmaceuticals business. In addition to share repurchases and dividend payments, we continue to consider business development to be an attractive use of shareholder capital.”

“We continue to advance our product pipeline, which currently includes a competitive and diverse mix across small and large molecules and vaccines. I believe we are well-positioned in promising new areas of biology such as immune-oncology, anti-PCSK9 for improved cardiovascular outcomes associated with LDL cholesterol reduction and vaccines for the potential prevention of life threatening infections such as staphylococcus aureus and clostridium difficile.”

“During the remainder of 2015 and beyond, we will continue to focus on driving growth for our key products and geographies, accelerating innovation and continuing to allocate capital to value-creating opportunities,” Mr. Read concluded.

Frank D’Amelio, Chief Financial Officer, stated, “Overall, I am pleased with our first-quarter 2015 financial results and with our ability to continue delivering shareholder value through prudent capital allocation. We were able to grow revenues on an operational basis by 2% despite the significant negative impact from product losses of exclusivity, including Celebrex in the U.S., and the termination of the Spiriva co-promotion collaboration in the U.S. In addition, in first-quarter 2015, we entered into a definitive merger agreement with Hospira under which Pfizer agreed to acquire Hospira, the world’s leading provider of injectable drugs and infusion technologies and a global leader in biosimilars, for a total enterprise value of approximately $17 billion. We also continued to demonstrate our commitment to delivering significant value directly to shareholders by returning approximately $7.8 billion to shareholders through dividends and share repurchases so far this year, including entering into a $5 billion accelerated share repurchase agreement executed in February. After repurchasing $6.0 billion of our common stock in first-quarter 2015, we have already met our 2015 share repurchase target and do not currently expect to repurchase additional shares this year.”

“As a result of unfavorable changes in foreign exchange rates in relation to the U.S. dollar since mid-January 2015, primarily the weakening of the euro, we lowered our 2015 financial guidance for reported revenues⁽¹⁾ by $500 million, which resulted in a $0.05 negative impact to our guidance ranges for reported diluted EPS⁽¹⁾ and adjusted diluted EPS⁽²⁾. Importantly, our update to these guidance components is solely due to recent negative changes in foreign exchange rates and does not reflect any unfavorable changes to our operational outlook for the year,” Mr. D'Amelio concluded.

QUARTERLY FINANCIAL HIGHLIGHTS (First-Quarter 2015 vs. First-Quarter 2014)

Reported revenues⁽¹⁾ decreased $489 million, or 4%, which reflects operational growth of $250 million, or 2%, more than offset by the unfavorable impact of foreign exchange of $739 million, or 7%. Operational growth in developed markets was driven by the performance of certain key products, including Prevnar 13 and Eliquis, as well as Lyrica, Nexium 24HR, Xeljanz and Viagra primarily in the U.S., and the launch of Ibrance (palbociclib) in the U.S. in February 2015. Additionally, revenues in emerging markets increased 12% operationally, reflecting continued strong operational growth from Prevenar 13, Lipitor, Viagra and Norvasc. Operational growth was partially offset primarily by the loss of exclusivity and immediate multi-source generic competition for Celebrex in the U.S. in December 2014 as well as by other product losses of exclusivity in certain markets and the termination of the Spiriva co-promotion collaboration in certain countries.

Established Products Business Highlights

• GEP⁽³⁾ revenues decreased 10% operationally, primarily due to the loss of exclusivity and immediate launch of multi-source generic competition for Celebrex in the U.S. in December 2014 as well as generic competition for Zyvox IV in the U.S. beginning in January 2015 and for Lyrica in certain developed Europe markets beginning in first-quarter 2015. Revenues for Lipitor in developed markets declined as a result of continued generic competition. Additionally, the co-promotion collaboration for Spiriva has terminated in most countries, including in the U.S. in April 2014. These declines were partially offset by strong performance in emerging markets, where revenues increased 10% operationally, primarily driven by Lipitor, Viagra and Norvasc.

Innovative Products Business Highlights

Revenues for the Innovative Products business increased 16% operationally, reflecting the following:

• GIP⁽³⁾ revenues increased 7% 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. Operational growth was partially offset by generic competition for Rapamune in the U.S., which began in October 2014.
• VOC⁽³⁾ revenues increased 29% operationally, reflecting the following:
  • Global Vaccines⁽³⁾ revenues grew 51% operationally. Prevnar 13 revenue in the U.S. increased 80%, primarily driven by continued strong uptake among adults following the positive recommendation from the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) for use in adults aged 65 and over in third-quarter 2014 as well as the timing of government purchases for the pediatric indication compared to the year-ago quarter. International revenues increased 21% operationally, driven by Prevenar 13, which grew 15% 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, as well as the inclusion in first-quarter 2015 of revenues associated with the acquisition of Baxter International Inc.’s portfolio of marketed vaccines in Europe.
  • Consumer Healthcare⁽³⁾ revenues increased 12% operationally, primarily due to the launch of Nexium 24HR in the U.S. in late-May 2014, as well as growth in the base business in certain emerging markets.
  • Global Oncology⁽³⁾ revenues increased 17% operationally, primarily driven by the recent launch of Ibrance in the U.S. ($38 million) for advanced breast cancer as well as continued strong underlying demand for Xalkori and Inlyta globally.

Income Statement Highlights

• Adjusted cost of sales, adjusted SI&A expenses and adjusted R&D expenses⁽²⁾ in the aggregate increased $605 million operationally, or 9%, reflecting the following operational factors:
  • higher adjusted cost of sales⁽²⁾, primarily reflecting an unfavorable change in product mix and an increase in sales volume;
  • higher adjusted SI&A expense⁽²⁾, primarily as a result of increased investments to support several recent product launches and other in-line products as well as a higher cost for the Branded Prescription Drug Fee compared to the prior-year quarter, partially offset by continued benefits from cost-reduction and productivity initiatives; and
  • higher adjusted R&D expense⁽²⁾, primarily due to the $295 million upfront payment to OPKO in first-quarter 2015 associated with a worldwide development and commercialization agreement.
• The effective tax rate on adjusted income⁽²⁾ declined 0.6 percentage points to 24.4% from 25.0%. 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, primarily with various foreign tax authorities.
• The diluted weighted-average shares outstanding declined by 184 million shares compared to the prior-year quarter due to the company’s ongoing share repurchase program, including the partial-quarter impact of the $5 billion accelerated share repurchase agreement executed in February 2015.
• In addition to the aforementioned factors, first-quarter 2015 reported earnings were primarily impacted by the following:

Favorable impacts:

• lower legal charges, asset impairment charges and purchase accounting adjustments in first-quarter 2015 compared to the prior-year quarter.

Unfavorable impacts:

• higher charges incurred in first-quarter 2015 for business and legal entity alignment activities; and
• a higher effective tax rate, primarily due to a decline in tax benefits associated with the resolution of certain tax positions pertaining to prior years, primarily with various foreign tax authorities, partially offset by the favorable change in the jurisdictional mix of earnings.

RECENT NOTABLE DEVELOPMENTS

Product Developments

• Ibrance (palbociclib)
  • In February 2015, Pfizer announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval of Ibrance, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer as initial endocrine-based therapy for their metastatic disease. This indication is approved under accelerated approval based on PFS. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Pfizer announced in April 2015 that the Phase 3 PALOMA-3 trial for Ibrance met its primary endpoint of demonstrating an improvement in PFS for the combination of Ibrance plus fulvestrant compared with fulvestrant plus placebo in women with hormone receptor-positive/HER2- metastatic breast cancer following disease progression during or after endocrine therapy. The adverse events observed with Ibrance in combination with fulvestrant in PALOMA-3 were generally consistent with their respective known adverse event profiles. Detailed efficacy and safety results from PALOMA-3 will be presented at the American Society of Clinical Oncology 2015 Annual Meeting.
• Prevenar 13 -- Pfizer announced in March 2015 that the European Commission approved an expanded indication for the use of Prevenar 13 for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older. The Summary of Product Characteristics has also been updated to include efficacy data from Pfizer’s landmark Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), which demonstrated statistically significant reductions in first episodes of vaccine-type pneumococcal community-acquired pneumonia (CAP), including non-invasive/non-bacteremic CAP, and invasive pneumococcal disease in adults aged 65 and older.
• Trumenba
  • Pfizer announced in February 2015 that the CDC's ACIP voted to recommend serogroup B meningococcal vaccination to help protect individuals at increased risk. Specifically, the ACIP voted to recommend serogroup B meningococcal vaccination for persons aged 10 years and older at increased risk for meningococcal disease.
  • Pfizer announced in February 2015 positive top-line results of a Phase 2 study of Trumenba co-administered with FDA-approved, routine meningococcal (groups A, C, Y and W) (MCV4) and single-dose tetanus, diphtheria and pertussis (Tdap) vaccines in more than 2,600 healthy individuals 10 through 12 years of age. The study met its co-primary immunogenicity objectives regarding co-administration of Trumenba with MCV4 and Tdap vaccines. In addition, data from a recently completed Phase 3 study demonstrated the safety and tolerability of Trumenba in approximately 5,600 healthy individuals 10 through 25 years of age, and were consistent with data from studies that supported the October 2014 accelerated approval in the U.S. These data have been shared with the FDA. Pfizer plans to present the full results of both studies at upcoming medical meetings in 2015.
• Xeljanz
  • Pfizer announced in February 2015 that the FDA accepted for review a supplemental New Drug Application (sNDA) for Xeljanz 5 mg and 10 mg tablets for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in October 2015 for the sNDA.
  • Pfizer presented in March 2015 detailed pooled results from two pivotal Phase 3 studies from the Oral treatment Psoriasis Trials (OPT) program as well as an integrated safety analysis at the 73^rd American Academy of Dermatology (AAD) Annual Meeting. The detailed, pooled analysis of 16 week data from the OPT Pivotal #1 and OPT Pivotal #2 studies showed that tofacitinib 10 mg and 5 mg tablets twice daily met the co-primary efficacy endpoints of superiority over placebo at 16 weeks in the proportion of patients achieving a Physician’s Global Assessment response of “clear” or “almost clear,” and the proportion of patients achieving at least a 75% reduction in Psoriasis Area and Severity Index (PASI75), two commonly used measures of efficacy in psoriasis.
• Xalkori -- Pfizer announced in April 2015 that Xalkori (crizotinib) received Breakthrough Therapy designation by the FDA for the potential treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC). Occurring in approximately one percent of NSCLC cases, ROS1-positive NSCLC represents a particular molecular subgroup of NSCLC. Xalkori currently is approved in the U.S. for the treatment of patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by a FDA-approved test. Pfizer will work closely with the FDA on the development of Xalkori for ROS1-positive NSCLC and provide the information needed to support a potential regulatory submission.
• Rapamune -- Pfizer announced in February 2015 that the FDA accepted for priority review a sNDA for Rapamune for the treatment of lymphangioleiomyomatosis (LAM), a rare, progressive lung disease in women of childbearing age that is often fatal. This sNDA has a PDUFA action date in June 2015.

Pipeline Developments

A comprehensive update of Pfizer's development pipeline was published today and is now available at www.pfizer.com/pipeline. It includes an overview of our research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for candidates from Phase 2 through registration.

• Avelumab (MSB0010718C) -- Merck KGaA and Pfizer announced in April 2015 the initiation and first patient treated in a Phase 3 study designed to assess the efficacy and safety of the investigational cancer immunotherapy avelumab, compared with docetaxel, in patients with stage IIIb/IV NSCLC who have experienced disease progression after receiving a prior platinum-containing doublet therapy. The Phase 3 study is an open-label, multicenter, 1:1 randomized clinical trial where patients with stage IIIb/IV NSCLC will receive either avelumab or docetaxel, regardless of PD-L1 status. Approximately 650 patients will participate across 290 sites in more than 30 countries in North America, South America, Asia, Africa and Europe. The primary endpoint of the study is overall survival (OS) in patients with programmed death-ligand 1 positive (PD-L1+) stage IIIb/IV NSCLC who have experienced disease progression after receiving a prior platinum-containing doublet therapy. Secondary endpoints will be assessed across the entire study population regardless of PD-L1 status and include OS; overall response rate; PFS; and patient-reported outcomes. The study is part of the JAVELIN clinical trial program for avelumab.
• ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) -- In February 2015, Pfizer announced that the FDA accepted for review the New Drug Application (NDA) for ALO-02, extended-release capsules, an abuse-deterrent formulation opioid 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. ALO-02 is an extended-release oxycodone specifically designed to reduce abuse via the oral, intranasal (i.e., snorting) and intravenous (IV) routes when crushed. The FDA has assigned a PDUFA action date in October 2015.
• Tanezumab -- Pfizer and Eli Lilly and Company (Lilly) announced in March 2015 that the companies are preparing to resume the Phase 3 clinical program for tanezumab. As a result, Pfizer received a $200 million upfront payment from Lilly in accordance with the collaboration agreement between Pfizer and Lilly. This announcement followed a decision by the FDA to lift the partial clinical hold on the tanezumab development program after a review of nonclinical data characterizing the sympathetic nervous system response to tanezumab. A partial clinical hold had been in place for tanezumab since December 2012 due to adverse changes in the sympathetic nervous system of mature animals.
• Inotuzumab Ozogamicin -- Pfizer announced in April 2015 that the Phase 3 INO-VATE ALL study investigating the treatment of inotuzumab ozogamicin met the primary endpoint of complete response or complete response with incomplete blood count recovery (CR/CRi) demonstrating a higher complete hematologic remission rate in adult patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia compared to that achieved with standard of care chemotherapy. Pfizer is discussing these data with the FDA and other regulatory agencies. Pfizer is continuing the study to allow for the data on OS, a separate primary endpoint, to mature.
• PF-06439535 (biosimilar bevacizumab) -- In April 2015, Pfizer began recruiting patients in a multinational Phase 3 clinical trial of PF-06439535, a potential biosimilar to Avastin (bevacizumab). The Phase 3 clinical trial will evaluate the efficacy and safety of PF-06439535 plus paclitaxel and carboplatin against Avastin sourced from the EU plus paclitaxel and carboplatin by comparing the best confirmed objective response rate by week 19 in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.

Corporate Developments

• Pfizer announced in February 2015 that it has entered into a definitive merger agreement with Hospira under which Pfizer agreed to acquire Hospira, the world’s leading provider of injectable drugs and infusion technologies and a global leader in biosimilars, for $90 per share in cash, for a total enterprise value of approximately $17 billion. Pfizer expects to finance the transaction through a combination of existing cash and new debt, with approximately two-thirds of the value financed from cash and one-third from debt. The transaction is subject to customary closing conditions, including regulatory approvals in several jurisdictions and the approval of Hospira's shareholders, and is expected to close in the second half of 2015.
• In February 2015, Pfizer announced that it has entered into an accelerated share repurchase agreement with Goldman, Sachs & Co. to repurchase $5 billion of Pfizer’s common stock. Pursuant to the terms of the agreement, approximately 150 million shares of Pfizer common stock were received by Pfizer on February 11, 2015. Including shares repurchased under this program as well as other share repurchases to date in 2015, the current remaining share repurchase authorization is approximately $5.5 billion. Pfizer does not currently expect to repurchase additional shares this year.
• Pfizer and OPKO disclosed the closing of their worldwide agreement for the development and commercialization of hGH-CTP, a long-acting human growth hormone. The transaction closed on January 28, 2015, upon termination of the waiting period under the Hart-Scott Rodino Act.

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/Q1_2015_PFE_Earnings_Press_Release_foijsdflskd.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 March 29, 2015, including any one-time upfront payments associated with such transactions. 2015 financial guidance does not reflect any impact from the proposed acquisition of Hospira. The transaction is expected to close during the second half of 2015.
• Excludes the potential effects of the resolution of litigation-related matters not substantially resolved as of March 29, 2015.
• Exchange rates assumed are a blend of the actual exchange rates in effect during first-quarter 2015 and the mid-April 2015 exchange rates for the remainder of the year. Excludes the impact of a potential devaluation of the Venezuelan bolivar.
• Guidance for reported revenues⁽¹⁾ reflects the anticipated negative impact of $3.5 billion due to recent and expected generic competition for certain products that have recently lost or are anticipated to soon lose patent protection, partially offset by anticipated revenue growth from certain other products.
• Guidance for reported revenues⁽¹⁾ also reflects the anticipated negative impact of $3.3 billion as a result of unfavorable changes in essentially all foreign exchange rates relative to the U.S. dollar compared to foreign exchange rates from 2014, which results in an anticipated $0.22 negative impact to 2015 reported⁽¹⁾ and adjusted diluted EPS⁽²⁾.
• Guidance for the effective tax rate on adjusted income⁽²⁾ does not assume the renewal of the U.S. 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⁾.
• Guidance for reported⁽¹⁾ and adjusted diluted EPS⁽²⁾ assumes diluted weighted-average shares outstanding of approximately 6.25 billion shares, inclusive of share repurchases totaling $6 billion in 2015 composed of $1 billion of shares repurchased through January 30, 2015 and a $5 billion accelerated share repurchase agreement executed on February 9, 2015, partially offset by actual and projected dilution related to employee compensation programs.
• 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 April 28, 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 anticipated 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,” “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 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, including our and Hospira’s ability to satisfy the conditions to closing our merger agreement;
• 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 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 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, of the internal separation of our commercial operations into our new operating structure and of our proposed acquisition of Hospira.

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, 2014 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 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.