On October 27, 2015 Pfizer Inc. (NYSE: PFE) reported financial results for third quarter 2015 and announced increases to the midpoints of its 2015 financial guidance ranges for reported revenues(1) and adjusted diluted EPS(2) (Press release, Pfizer, OCT 27, 2015, View Source [SID:1234507806]).
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On September 3, 2015, Pfizer acquired Hospira, Inc. (Hospira). Consequently, and in accordance with Pfizer’s domestic and international reporting periods(3), financial results for third-quarter 2015 and the nine months ended September 27, 2015 reflect Pfizer’s operations as well as one month of legacy Hospira U.S. operations but do not include any financial results from legacy Hospira international operations.
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)(4) and the Global Vaccines, Oncology and Consumer Healthcare segment (VOC)(4). The Established Products business consists of the Global Established Pharmaceutical segment (GEP)(4), which includes all legacy Hospira commercial operations. Financial results for each of these segments are presented in the Operating Segment Information section.
2015 FINANCIAL GUIDANCE(6)
Financial guidance ranges for reported revenues(1) and reported(1) and adjusted(2) diluted EPS were updated on September 30, 2015 solely to reflect the anticipated impact of legacy Hospira operations in Pfizer’s financial results from September 3, 2015 through fiscal year-end 2015(3).
The ranges for certain components of Pfizer’s 2015 financial guidance have been updated today as set forth below, primarily reflecting the following:
operational factors impacting Pfizer-standalone (excluding legacy Hospira) operations, including strong performance to date coupled with an improved business outlook for the remainder of the year;
the anticipated impact of legacy Hospira operations from September 3, 2015 through fiscal year-end 2015(3) on financial guidance components other than reported revenues(1) and adjusted diluted EPS(2); and
a minimal favorable impact from foreign exchange rates since mid-July 2015.
EXECUTIVE COMMENTARY
Ian Read, Chairman and Chief Executive Officer, stated, "Our business continues to demonstrate strength across key product lines and geographies which has resulted in another quarter of strong financial performance. We have been intently focused on seeking to generate a greater portion of our earnings from increased revenues and I see our product portfolio, product pipeline and recent business development activity as supporting this objective. Importantly, our research pipeline continues to advance with a focus on therapeutic areas of high unmet need where we also have seen advances in biology which could support the development of potential important new therapies to further strengthen our Innovative Products business. The recent addition of the Hospira business nicely augments our Established Products business, which has a strong presence in both sterile injectables and biosimilars. Overall, I see Pfizer as well positioned both financially and strategically to continue delivering value to patients and shareholders."
Frank D’Amelio, Chief Financial Officer, stated, "Overall, I am very pleased with our financial results to date in 2015. During third-quarter 2015, we were able to grow revenues by 4% operationally, excluding the impact of foreign exchange and legacy Hospira operations, despite the continued significant negative impact from product losses of exclusivity, primarily Celebrex and Zyvox in the U.S. and Lyrica in certain developed Europe markets.
"We raised our 2015 financial guidance for reported revenues(1) and adjusted diluted EPS(2) to reflect the strong performance to date of Pfizer-standalone (excluding legacy Hospira) operations coupled with an improved business outlook for Pfizer-standalone for the remainder of the year. Changes in foreign exchange rates since mid-July 2015 did not materially impact our updated guidance. Additionally, we updated our 2015 financial guidance ranges for adjusted cost of sales(2) as a percentage of reported revenues(1), adjusted SI&A expenses(2),adjusted R&D expenses(2) and reported diluted EPS(1) to reflect the anticipated impact of legacy Hospira operations from September 3, 2015 through fiscal year-end 2015(3) as well as the impact of Pfizer-standalone operations. For the remainder of 2015 and into 2016, we expect to continue to advance the Hospira integration while remaining focused on delivering strong operating results."
QUARTERLY FINANCIAL HIGHLIGHTS (Third-Quarter 2015 vs. Third-Quarter 2014)
Reported revenues(1) decreased $274 million, or 2%, which reflects operational growth of $795 million, or 6%, more than offset by the unfavorable impact of foreign exchange of $1.1 billion, or 9%. Excluding the impact of legacy Hospira operations and foreign exchange, Pfizer-standalone reported revenues(1) increased by $465 million operationally, or 4%.
Operational revenue growth in developed markets was driven primarily by the performance of several key products, including Prevnar 13 in adults, Ibrance and Eliquis — all products that are early in their life cycles — as well as from Lyrica primarily in the U.S., and the inclusion of one month of legacy Hospira U.S. operations. In emerging markets, revenues increased 5% operationally, reflecting continued strong operational growth, primarily from the Innovative Products business.
Operational revenue growth was partially offset primarily by the loss of exclusivity and associated generic competition for Celebrex in the U.S., Zyvox in the U.S. and Lyrica in certain developed Europe markets.
Innovative Products Business Highlights
Revenues for the Innovative Products business increased 21% operationally, reflecting the following:
GIP(4) revenues increased 10% operationally, primarily due to the strong operational performance of Eliquis globally, Lyrica primarily in the U.S., Enbrel in most international markets as well as Xeljanz and Viagra, both 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(4) revenues increased 37% operationally, reflecting the following:
Global Vaccines(4) revenues increased 50% operationally. Revenues in the U.S. increased 78%, driven by continued strong uptake of Prevnar 13 among adults due to the success of commercial programs and increased demand in preparation for the upcoming flu season. International revenues increased 19% operationally, primarily driven by Prevenar 13, which grew 10% operationally, primarily in emerging markets compared with the year-ago quarter.
Consumer Healthcare(4) revenues increased 7% operationally, primarily due to Nexium 24HR in the U.S. driven by increased demand and lower revenues in third-quarter 2014 as retailers reduced initial stocking levels following the May 2014 launch.
Global Oncology(4) revenues increased 54% operationally, primarily driven by continued strong momentum following the February 2015 U.S. launch of Ibrance for advanced breast cancer and, to a lesser extent, stronger demand for Sutent, Xalkori and Inlyta in most markets.
Established Products Business Highlights
GEP(4) revenues decreased 8% operationally, primarily due to the loss of exclusivity and associated launch of multi-source generic competition for Celebrex in the U.S. in December 2014, for Zyvox in the U.S. beginning in first-half 2015 and for Lyrica in certain developed Europe markets beginning in first-quarter 2015. These declines were partially offset by the inclusion of one month of legacy Hospira U.S. operations, which contributed $330 million, and growth in emerging markets, where revenues increased 1% operationally.
Income Statement Highlights
Adjusted cost of sales(2), adjusted SI&A expenses(2) and adjusted R&D expenses(2) in the aggregate increased $380 million operationally, or 5%, reflecting the following operational factors:
higher adjusted cost of sales(2), primarily reflecting the inclusion of one month of legacy Hospira U.S. operations in third-quarter 2015 and an increase in sales volume, partially offset by a decrease in royalty expense and manufacturing efficiencies;
higher adjusted SI&A expense(2), primarily reflecting increased investments to support recently launched products and certain other in-line products as well as the inclusion of one month of legacy Hospira U.S. operations in third-quarter 2015, partially offset by lower expenses associated with certain products that have recently lost marketing exclusivity, as well as continued benefits from cost-reduction and productivity initiatives; and
lower adjusted R&D expense(2), primarily due to the non-recurrence of upfront payments associated with certain agreements entered into during third-quarter 2014, partially offset by higher clinical trial spend for certain oncology and GIP(4) pipeline programs as well as the inclusion of one month of legacy Hospira U.S. operations in third-quarter 2015.
The effective tax rate on adjusted income(2) declined 1.0 percentage point to 25.8% from 26.8%. This decline was primarily due to an increase in tax benefits associated with the resolution of certain tax positions pertaining to prior years with various foreign tax authorities, partially offset by an unfavorable change in the jurisdictional mix of earnings.
The diluted weighted-average shares outstanding declined by 160 million shares compared to the prior-year quarter due to Pfizer’s share repurchase program, including the impact of the $5 billion accelerated share repurchase agreement executed in February 2015 and completed in July 2015.
In addition to the aforementioned factors, third-quarter 2015 reported earnings were primarily impacted by the following:
Unfavorable impacts:
higher purchase accounting adjustments, restructuring charges and acquisition-related costs primarily associated with the acquisition of Hospira in third-quarter 2015; and
higher asset impairment charges in third-quarter 2015, including an impairment loss related to Pfizer’s 49%-owned equity-method investment with Zhejiang Hisun Pharmaceuticals Co., Ltd. (Hisun) in China.
Favorable impacts:
the non-recurrence of a charge incurred in the prior-year quarter for an additional year of the Branded Prescription Drug Fee in accordance with final regulations issued in third-quarter 2014 by the U.S. Internal Revenue Service; and
a lower effective tax rate, primarily due to an increase in tax benefits associated with the resolution of certain tax positions pertaining to prior years with various foreign tax authorities and the non-recurrence in 2015 of the non-tax deductible charge for the aforementioned additional year of the Branded Prescription Drug Fee incurred in the prior-year quarter, partially offset by the unfavorable change in the jurisdictional mix of earnings.
RECENT NOTABLE DEVELOPMENTS
Product Developments
Ibrance (palbociclib)
Pfizer announced in August 2015 that the European Medicines Agency (EMA) validated for review the Marketing Authorization Application (MAA) for palbociclib in combination with endocrine therapy for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. The submission was based on the final results of the PALOMA-1 and PALOMA-3 trials in metastatic breast cancer. Both trials demonstrated that palbociclib in combination with an endocrine therapy improved progression-free survival compared to endocrine therapy alone.
Pfizer, with Alliance Foundation Trials, LLC and the Austrian Breast & Colorectal Cancer Study Group, announced in August 2015 the launch of the Palbociclib Collaborative Adjuvant Study, or PALLAS. This global Phase 3 clinical trial for patients with early-stage breast cancer is being conducted in conjunction with Breast International Group, German Breast Group, National Surgical Adjuvant Breast and Bowel Project and PrECOG, LLC. The PALLAS trial is designed to evaluate whether the addition of palbociclib to standard therapy will improve disease-free survival and prevent the disease from recurring. Approximately 4,600 people are expected to enroll in the trial.
Trumenba (rLP2086, Meningococcal Serogroup B Bivalent Recombinant Lipoprotein vaccine)
Pfizer announced in August 2015 positive topline results of two Phase 3 studies of Trumenba. One study included approximately 3,600 healthy individuals 10 through 18 years of age, and the other study included approximately 3,300 healthy individuals 18 through 25 years of age. Both studies met all primary immunogenicity endpoints, demonstrating robust immune responses against certain invasive meningococcal B strains after the vaccine dose series. Safety and tolerability data from both studies were also consistent with data from previous studies.
Pfizer presented in October 2015 data from a randomized, controlled Phase 2 study of Trumenba, coadministered with routine meningococcal (groups A, C, Y and W) (MCV4) and tetanus, diphtheria and pertussis (Tdap) vaccines in adolescents. The data, which were released in an oral presentation at IDWeek 2015 in San Diego, are based on a study conducted in more than 2,600 healthy individuals 10 through 12 years of age that evaluated the safety, tolerability and immunogenicity of Trumenba when coadministered with MCV4 and Tdap. Data demonstrated that immune responses following Trumenba, MCV4 and Tdap vaccines given concomitantly were noninferior to immune responses to MCV4 and Tdap alone or Trumenba alone.
Xeljanz (tofacitinib citrate)
Pfizer announced in October 2015 that it received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib citrate) for the treatment of adult patients with moderate to severe chronic plaque psoriasis. The FDA’s recommendations are specific to the moderate to severe chronic plaque psoriasis sNDA.
Pfizer regularly reviews the Xeljanz development portfolio and recently decided not to advance indications for Crohn’s disease and ankylosing spondylitis. Pfizer will focus its future investments and development programs on indications for rheumatoid arthritis (RA), psoriatic arthritis and ulcerative colitis (UC). Pfizer also has a broad developmental portfolio of other Janus kinase (JAK) inhibitors and new mechanisms of action in inflammation and immunology.
Pfizer intends to re-submit a MAA to the EMA for Xeljanz for the treatment of moderate to severe active RA by first-quarter 2016. The re-submission will include additional safety results and analyses requested by the Agency following the initial review and subsequent discussions, intended to strengthen the characterization of the benefit-risk profile.
Pfizer announced in September 2015 positive top-line results from two of its four Phase 3 studies of Xeljanz (tofacitinib 10 mg, twice daily tablets) for the treatment of adults with moderate to severe UC. Both studies met their primary endpoints as measured by the proportion of patients receiving Xeljanz in remission at week 8 compared to patients receiving placebo. No new or unexpected safety findings for Xeljanz were observed in the studies. Detailed analyses of these induction studies, including additional efficacy and safety data, will be submitted for presentation at a future scientific meeting. The two remaining studies in the Phase 3 UC program are ongoing.
Pfizer announced in July 2015 that the FDA accepted for review Pfizer’s new drug application (NDA) for Xeljanz 11 mg once daily modified release tablets for the treatment of patients with moderate to severe RA who have had an inadequate response or intolerance to methotrexate. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in February 2016.
Xalkori (crizotinib) — In October 2015, the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion recommending extension of the current indication of Xalkori to include first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. This recommendation is based on efficacy and safety data from the Phase 3 PROFILE 1014 trial that supports Xalkori as a standard of care in the first-line setting for patients with ALK-positive advanced NSCLC. In Europe, Xalkori is currently indicated for the treatment of adults with previously treated ALK-positive advanced NSCLC.
Eliquis (apixaban)
Bristol-Myers Squibb Company (BMS) and Pfizer presented new data for Eliquis at the ESC Congress 2015 in August and September 2015. The new data reinforce the commitment of the BMS-Pfizer alliance to the ongoing evaluation of Eliquis in both the nonvalvular atrial fibrillation (NVAF) and venous thromboembolism patient populations. In addition, data from the AEGEAN (Assessment of an Educational and Guidance Programme for Eliquis Adherence in Nonvalvular Atrial Fibrillation) study evaluating adherence among NVAF patients further extends the BMS-Pfizer alliance’s commitment to patient care.
BMS and Pfizer announced in September 2015 that the first patient has been enrolled into a Phase 4 clinical trial, AUGUSTUS, designed to evaluate the safety of Eliquis versus warfarin or other vitamin K antagonists in patients with NVAF and a recent acute coronary syndrome or undergoing percutaneous coronary intervention, also known as a stent. AUGUSTUS is anticipated to enroll 4,600 patients from 30 countries, and is one of several new clinical trials that will help provide additional information on the safe and appropriate use of Eliquis for certain types of patients within currently approved indications.
Pipeline Developments
A comprehensive update of Pfizer’s development pipeline, including assets from the recently-completed Hospira acquisition, was published today and is now available at www.pfizer.com/pipeline. It includes an overview of Pfizer’s 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(7) (MSB0010718C)
Merck KGaA, Darmstadt, Germany (Merck KGaA) and Pfizer announced in October 2015 that the FDA granted avelumab(7), an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Fast Track designation for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer. The designation relates to the clinical development program for avelumab(7) in metastatic MCC, which includes the Phase 2 study, JAVELIN Merkel 200, to assess the safety and efficacy of avelumab(7) in patients with metastatic MCC who have progressed after at least one prior chemotherapy regimen.
Merck KGaA and Pfizer announced in September 2015 that the FDA granted orphan drug designation for avelumab(7) for the treatment of MCC.
Merck KGaA and Pfizer presented in September 2015 data from six studies evaluating the potential role of PD-L1 inhibition and the safety and efficacy of the investigational cancer immunotherapy avelumab(7) at European Cancer Congress 2015. New data were presented in urothelial (e.g., bladder), mesothelioma and gastric/gastroesophageal cancers. Additional data were also presented from Phase 1b trials in NSCLC and ovarian cancer that built on interim results previously presented at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).
Inotuzumab ozogamicin — In October 2015, Pfizer announced that its investigational antibody-drug conjugate, inotuzumab ozogamicin, received Breakthrough Therapy designation from the FDA for acute lymphoblastic leukemia (ALL). The Breakthrough Therapy designation was based on the results of the Phase 3 INO-VATE ALL trial, which enrolled 326 adult patients with relapsed or refractory CD22-positive ALL and compared inotuzumab ozogamicin to standard of care chemotherapy.
ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) — Pfizer recently received notification from the FDA that the October 2015 PDUFA action date was extended by three months to January 2016 with respect to the NDA for ALO-02, an extended-release opioid with abuse deterrent properties 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. The NDA for ALO-02 remains under review by the FDA.
PF-06290510 (Staphylococcus aureus (S. aureus) vaccine candidate) — In July 2015, Pfizer announced enrollment of the first patient in a Phase 2b clinical trial of its investigational S. aureus multi-antigen vaccine in adults undergoing elective spinal fusion surgery. The purpose of the study, named STRIVE (STaphylococcus aureus SuRgical Inpatient Vaccine Efficacy), is to evaluate the safety and efficacy of the vaccine to determine if it prevents postoperative invasive S. aureus infections in patients undergoing elective spinal surgery. The trial is expected to enroll approximately 2,600 patients, with final results expected in 2017. PF-06290510 was granted Fast Track designation by the FDA in February 2014.
PF-06410293 — In July 2015, Pfizer began dosing patients in a multinational Phase 3 clinical trial of PF-06410293, a potential biosimilar to Humira(8) (adalimumab). The Phase 3 clinical trial will evaluate the efficacy, safety and immunogenicity of PF-06410293 plus methotrexate and adalimumab sourced from the EU plus methotrexate in subjects with moderately to severely active RA who have had an inadequate response to methotrexate monotherapy.
Corporate Developments
Pfizer announced in October 2015 that it completed its previously announced acquisition of GlaxoSmithKline’s quadrivalent meningococcal ACWY vaccines, Nimenrix and Mencevax, for total consideration of approximately $130 million (€115 million). The transaction was completed on September 30, 2015 and adds two high-quality and complementary vaccines to Pfizer’s portfolio, allowing the company to reach a broader global population. This transaction is not expected to have any significant impact on Pfizer’s 2015 financial performance.
In September 2015, Pfizer completed its previously announced acquisition of Hospira. As previously disclosed, Pfizer continues to expect the transaction to be immediately accretive to adjusted diluted EPS(2) upon closing, and accretive by $0.10 – $0.12 per share in the first full year after the close, with additional accretion anticipated thereafter. In addition, Pfizer expects the transaction will deliver $800 million in annual cost synergies by 2018. On September 30, 2015, Pfizer updated certain components of its 2015 financial guidance solely to reflect the anticipated impact of Hospira operations on 2015 financial results.
In September 2015, in order to eliminate certain redundancies in Pfizer’s biosimilar drug products pipeline created as a result of the acquisition of Hospira, Pfizer opted to return rights to Celltrion, Inc. and Celltrion Healthcare, Co., Ltd. that Hospira had previously acquired to potential biosimilars to Rituxan(8) (rituximab) and Herceptin(8) (trastuzumab).
In August 2015, Pfizer and Synthon entered into an agreement whereby Pfizer has acquired the exclusive U.S. commercialization rights to glatiramer acetate, a potential generic version of the originator medicine Copaxone(8) for the treatment of relapsing remitting multiple sclerosis. Under the terms of the agreement, Pfizer will have exclusive rights to commercialize both the once-daily 20 mg/ml dosage formulation and the three-times-per-week 40 mg/ml dosage formulation of Synthon’s glatiramer acetate in the U.S. Synthon is responsible for the clinical development, manufacture and supply of glatiramer acetate. Pfizer is solely responsible for the commercialization of glatiramer acetate in the U.S. Financial terms of the agreement were not disclosed.
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:
(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.
(1) Reported 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. Adjusted revenue, 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 under Adjusted income in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of Pfizer’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 28, 2015, management uses Adjusted income, among other factors, to set performance goals and to measure the performance of the overall company. We believe that investors’ understanding of our performance is enhanced by disclosing this measure. See the accompanying reconciliations of certain GAAP Reported to non-GAAP Adjusted information for the third quarter and first nine months of 2015 and 2014, as well as reconciliations of full-year 2015 guidance for Adjusted income and Adjusted diluted EPS to full-year 2015 guidance for Reported net income(1) and Reported diluted EPS(1). 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, 2015, and Pfizer’s fiscal year-end for U.S. subsidiaries is December 31, 2015. In accordance with Pfizer’s domestic and international reporting periods, Pfizer’s consolidated financial statements for the three and nine months ended September 27, 2015 reflect one month of legacy Hospira U.S. operations but do not include any financial results from legacy Hospira international operations.
(4) For a description of the revenues in each business, see the "Our Strategy––Commercial Operations" sub-section in the Overview of Our Performance, Operating Environment, Strategy and Outlook section of Pfizer’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 28, 2015.
(5) Other includes revenues from Pfizer CentreSource, our contract manufacturing and bulk pharmaceutical chemical sales organization, and revenues related to our transitional manufacturing and supply agreements with Zoetis Inc.
(6) The 2015 financial guidance reflects the following:
Does not assume the completion of any business development transactions not completed as of September 27, 2015, including any one-time upfront payments associated with such transactions.
Excludes the potential effects of the resolution of litigation-related matters not substantially resolved as of September 27, 2015.
Exchange rates assumed are a blend of the actual exchange rates in effect through third-quarter 2015 and the mid-October 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 $3.3 billion due to recent and expected generic competition for certain Pfizer-standalone (excluding legacy Hospira) products that have recently lost or are anticipated to soon lose patent protection.
Guidance for Pfizer-standalone (excluding legacy Hospira) reported revenues(1) also reflects the anticipated negative impact of $3.1 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. The anticipated negative impact on Pfizer-standalone (excluding legacy Hospira) reported(1) and adjusted(2) diluted EPS resulting from unfavorable changes in foreign exchange rates compared to foreign exchange rates from 2014 is approximately $0.18.
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.
Reconciliation of the 2015 Adjusted income(2) and Adjusted diluted EPS(2) guidance to the 2015 Reported net income attributable to Pfizer Inc.(1) and Reported diluted EPS attributable to Pfizer Inc.(1) common shareholders guidance:
(7) Avelumab is the proposed International Nonproprietary Name for the anti-PD-L1 monoclonal antibody, MSB0010718C.
(8) Humira is a registered U.S. trademark of Abbvie Biotechnology Ltd. Rituxan is a registered U.S. trademark of Biogen Idec Inc. Herceptin is a registered U.S. trademark of Genentech, Inc. Copaxone is a registered trademark of Teva Pharmaceuticals Industry Ltd.