On May 3, 2016 Pfizer Inc. (NYSE: PFE) reported financial results for first-quarter 2016 and updated certain components of its 2016 financial guidance (Press release, Pfizer, MAY 3, 2016, View Source [SID:1234511822]).

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On September 3, 2015, Pfizer acquired Hospira, Inc. (Hospira). Consequently, first-quarter 2016 financial results include three months of legacy Hospira global operations while first-quarter 2015 financial results do not include any contribution from legacy Hospira operations.

The Company manages its commercial operations through two distinct businesses: an Innovative Products(3) business and an Established Products(3) business. The Innovative Products(3) business is composed of two operating segments: the Global Innovative Pharmaceutical segment (GIP) and the Global Vaccines, Oncology and Consumer Healthcare segment (VOC). The Established Products(3) business consists of the Global Established Pharmaceutical segment (GEP), which includes all legacy Hospira commercial operations. 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. References to operational variances pertain to period-over-period growth rates that exclude the impact of foreign exchange as well as the negative currency impact related to Venezuela. Results for first-quarter 2016 and 2015 are summarized below.

OVERALL RESULTS

($ in millions, except
per share amounts)
First-Quarter
2016 2015 Change
Reported Revenues(1) $ 13,005 $ 10,864 20%
Adjusted Income(2) 4,155 3,196 30%
Adjusted Diluted EPS(2) 0.67 0.51 32%
Reported Net Income(1) 3,016 2,376 27%
Reported Diluted EPS(1) 0.49 0.38 29%


REVENUES

($ in millions) First-Quarter
2016 2015 % Change
Total Oper.
Innovative Products(3) $ 7,033 $ 5,738 23% 28%
GIP 3,640 3,075 18% 25%
Global Vaccines 1,570 1,328 18% 22%
Global Oncology 1,001 528 90% 95%
Consumer Healthcare 822 808 2% 10%
Established Products(3)(4) $ 5,972 $ 5,125 17% 24%
GEP(4) Standalone 4,773 5,125 (7%) 1%
Legacy Hospira 1,199 — * *
Total Company $ 13,005 $ 10,864 20% 26%

Pfizer Standalone
(Excl. Legacy Hospira)
$ 11,806 $ 10,864 9% 15%

* Indicates calculation not meaningful.

SELECTED TOTAL COMPANY ADJUSTED COSTS AND EXPENSES(2)

($ in millions)
(Favorable)/Unfavorable
First-Quarter
2016 2015
% Change
Total Oper.
Cost of Sales(2) $ 2,565 $ 1,807 42% 45%
Percent of Revenues(1) 19.7 % 16.6 % N/A N/A
SI&A Expenses(2) 3,368 3,078 9% 14%
R&D Expenses(2) 1,723 1,877 (8%) (8%)
Total $ 7,656 $ 6,762 13% 16%

Effective Tax Rate(2) 23.8 % 24.4 %


2016 FINANCIAL GUIDANCE(5)

The ranges for certain components of Pfizer’s 2016 financial guidance have been updated today as set forth below, primarily reflecting the following:

Operational Factors: Strong performance to date coupled with an improved business outlook for 2016, which favorably impacted the midpoint of the guidance range for reported revenue(1) by approximately $1.0 billion and for reported(1) and adjusted(2) diluted EPS by $0.12.
Foreign Exchange: Favorable changes in foreign exchange rates since mid-January 2016, which favorably impacted the midpoint of the guidance range for reported revenue(1) by approximately $1.0 billion and for reported(1) and adjusted(2) diluted EPS by $0.06.
Pfizer’s complete 2016 financial guidance, including today’s updates, is summarized below:

Reported Revenues(1) $51.0 to $53.0 billion
(previously $49.0 to $51.0 billion)
Adjusted Cost of Sales(2) as a Percentage of Reported Revenues(1) 21.0% to 22.0%
Adjusted SI&A Expenses(2) $13.7 to $14.7 billion
(previously $13.2 to $14.2 billion)
Adjusted R&D Expenses(2) $7.4 to $7.8 billion
(previously $7.3 to $7.8 billion)
Adjusted Other (Income)/Deductions(2) Approximately ($500 million) of income
(previously approx. ($300 million) of income)
Effective Tax Rate on Adjusted Income(2) Approximately 24.0%
Reported Diluted EPS(1) $1.72 to $1.85
(previously $1.54 to $1.67)
Adjusted Diluted EPS(2) $2.38 to $2.48
(previously $2.20 to $2.30)

EXECUTIVE COMMENTARY

Ian Read, Chairman and Chief Executive Officer, stated, "We began the year with very strong operational performance across both our Innovative and Established businesses and this has served as a key driver of an increase in both our revenue and earnings per share guidance for the remainder of the year. I believe this performance results from our Company being well positioned in terms of product portfolio, organizational structure and leadership, as well as by our continued strong financial flexibility. In addition, our late stage product pipeline is increasingly ready to deliver our next set of prospective growth drivers with competitive positions in high-potential therapeutic areas where I believe Pfizer can be a leader.

"In addition, we have made excellent progress integrating the legacy Hospira operations and now expect to achieve $1.0 billion of Hospira cost savings by 2018, 25% more than our initial cost savings target of $800 million. Overall, we remain focused on delivering continued revenue growth both through internal and external opportunities, managing an efficient operating structure and making shareholder-friendly capital allocation and business portfolio decisions," Mr. Read concluded.

Frank D’Amelio, Chief Financial Officer, stated, "Overall, I am very pleased with our first-quarter 2016 financial results and with our ability to continue delivering shareholder value through prudent capital allocation. We grew revenues by 15% operationally, excluding the impact of foreign exchange and legacy Hospira operations. We also continued to deliver significant value directly to shareholders by paying $1.9 billion in first-quarter 2016 dividends and executing a $5 billion accelerated share repurchase agreement in March 2016.

"We raised our 2016 financial guidance for reported revenues(1) and adjusted diluted EPS(2) to reflect the strong operational performance to date coupled with an improved business outlook for 2016. Changes in foreign exchange rates since mid-January 2016 also favorably impacted our updated guidance. For the remainder of 2016, we expect to continue to advance the Hospira integration while remaining focused on delivering strong operating results," Mr. D’Amelio concluded.

QUARTERLY FINANCIAL HIGHLIGHTS (First-Quarter 2016 vs. First-Quarter 2015)

Reported revenues(1) totaled $13.0 billion, an increase of $2.1 billion, or 20%, which reflects operational growth of $2.9 billion, or 26%, partially offset by the unfavorable impact of foreign exchange of $729 million, or 7%. Excluding the impact of legacy Hospira operations of $1.2 billion and foreign exchange, Pfizer-standalone revenues increased by $1.7 billion operationally, or 15%. Compared with the prior-year quarter, first-quarter 2016 revenues were favorably impacted by approximately $900 million as a result of first-quarter 2016 having five additional selling days in the U.S. and four additional selling days in international markets. This imbalance in selling days will be offset in fourth-quarter 2016 resulting in essentially the same number of selling days in full-year 2016 as 2015.

Operational revenue growth in developed markets was driven primarily by the inclusion of $1.1 billion of revenues from legacy Hospira operations and continued strong performance of several key products, notably Ibrance, Prevnar 13, Eliquis, Xeljanz and Lyrica — all primarily in the U.S. In emerging markets, revenues increased 14% operationally, favorably impacted by the addition of legacy Hospira operations, which contributed $78 million, as well as the performance of Enbrel, Prevenar 13 and continued strong volume growth from certain other products.

Operational revenue growth was partially offset primarily by the loss of exclusivity and associated generic competition for Zyvox, primarily in the U.S. and certain developed Europe markets, and Lyrica in certain developed Europe markets.

Innovative Products(3) Business Highlights

Revenues for the Innovative Products(3) business increased 28% operationally, reflecting the following:

GIP revenues increased 25% operationally, primarily due to strong operational growth from Eliquis globally, Lyrica and Xeljanz both primarily in the U.S., Enbrel in most international markets and Chantix primarily in the U.S. Operational growth was slightly offset by the expiration of the collaboration agreement to co-promote Rebif in the U.S., which expired at the end of 2015.
VOC revenues increased 33% operationally, reflecting the following:
Global Vaccines revenues increased 22% operationally, driven by growth from Prevnar 13, primarily in the U.S., reflecting the timing of government purchases for the pediatric indication and continued strong uptake among adults due to the overall success of commercial programs.
Global Oncology revenues increased 95% 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 and Xalkori in most markets.
Consumer Healthcare revenues increased 10% operationally, primarily due to Nexium 24HR and Advil, both in the U.S., reflecting strong demand following increased promotion and the launch of a tablet form for Nexium 24HR in first-quarter 2016.
Established Products(3)(4) Business Highlights

GEP(4) revenues increased 24% operationally due to the inclusion of legacy Hospira operations, which contributed $1.2 billion, partially offset by the loss of exclusivity and associated generic competition for certain Peri-LOE Products(6), primarily Zyvox in the U.S. and certain developed Europe markets as well as Lyrica in certain developed Europe markets. Revenues excluding the contribution from the legacy Hospira portfolio (GEP(4) Standalone) increased 1% operationally, reflecting 7% operational growth from Legacy Established Products(6) and 11% operational growth from the Sterile Injectable Pharmaceuticals(6) portfolio, partially offset by an 18% operational decline from Peri-LOE Products(6). GEP(4) revenues in emerging markets increased 10% operationally, driven by the inclusion of legacy Hospira operations and reflecting operational growth from Legacy Established Products(6) and the GEP(4) Standalone Sterile Injectable Pharmaceuticals(6) portfolio.

Income Statement Highlights

Adjusted cost of sales(2), adjusted SI&A expenses(2) and adjusted R&D expenses(2) in the aggregate increased $1.1 billion operationally, or 16%, reflecting the inclusion of legacy Hospira operations in first-quarter 2016 and the following Pfizer-standalone operational factors:
higher adjusted cost of sales(2) primarily due to higher sales volumes;
higher adjusted SI&A expense(2), primarily reflecting higher general and administrative expenses as well as increased investments to support certain recently launched products and other in-line biopharmaceutical products; and
lower adjusted R&D expense(2), primarily reflecting the non-recurrence of a $295 million upfront payment to OPKO Health, Inc. 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 23.8% from 24.4%. This decline was primarily due to a favorable change in the jurisdictional mix of earnings, an increase in tax benefits associated with the resolution of certain tax positions pertaining to prior years with various foreign tax authorities, as well as an increase in tax benefits due to the permanent extension of the U.S. R&D tax credit on December 18, 2015.

The diluted weighted-average shares outstanding declined by 78 million shares compared to the prior-year quarter due to Pfizer’s share repurchase program, including the impact of a $5 billion accelerated share repurchase agreement executed in February 2015 and completed in July 2015 and another reduction of 136 million shares associated with an accelerated share repurchase agreement executed in March 2016.

In addition to the aforementioned factors, first-quarter 2016 reported earnings were primarily impacted by the following:

Favorable impacts:
a lower effective tax rate, primarily due to tax benefits related to the final resolution (pending court approval) of an agreement in principle reached in February 2016 to resolve certain claims related to Protonix and tax benefits associated with our Venezuela operations, partially offset by an unfavorable change in the jurisdictional mix of earnings; and
lower charges incurred during first-quarter 2016 for business and legal entity alignment activities compared with the prior-year quarter.

Unfavorable impacts:

higher acquisition-related costs, legal charges and purchase accounting adjustments in first-quarter 2016 compared with the prior-year quarter; and
higher asset impairment charges associated with losses on certain equity-method investments in first-quarter 2016.

RECENT NOTABLE DEVELOPMENTS

Product Developments

Chantix/Champix (varenicline) — In April 2016, Pfizer announced publication in The Lancet of results from the largest clinical trial of approved smoking cessation medicines, called EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study). This smoking cessation trial included 8,144 adult smokers and was designed to compare the neuropsychiatric safety of Chantix/Champix (varenicline) and bupropion with placebo and nicotine patch in adult smokers with and without a history of psychiatric disorders. The authors concluded that the trial did not show a significant increase in serious neuropsychiatric adverse events with Chantix/Champix or bupropion compared to placebo and nicotine patch. There were more neuropsychiatric adverse events in the psychiatric cohort than the non-psychiatric cohort across all treatment arms including placebo. Results also showed that smokers treated with Chantix/Champix had significantly higher quit rates than those treated with bupropion, nicotine patch or placebo. Full results of the EAGLES trial were published in The Lancet on April 22, 2016.

Ibrance (palbociclib)
In April 2016, Pfizer announced positive top-line results from the Phase 3 PALOMA-2 trial for Ibrance. The study met its primary endpoint by demonstrating an improvement in progression-free survival (PFS) for the combination of Ibrance plus letrozole compared with letrozole plus placebo in post-menopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer who had not received previous systemic treatment for their advanced disease. The PALOMA-2 trial provides confirmatory evidence for Ibrance in combination with letrozole in the first-line setting, which was first studied in the Phase 2 PALOMA-1 trial. These data will support additional planned global regulatory submissions and a request for conversion of the accelerated approval for Ibrance to regular approval in the U.S. Detailed efficacy and safety results from the PALOMA-2 trial will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting.

Pfizer announced in February 2016 that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) expanding the use of Ibrance 125 mg capsules to include the treatment of hormone receptor-positive, HER2- advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy.

Inflectra (infliximab-dyyb) — In April 2016, the FDA approved Celltrion’s Inflectra (infliximab-dyyb) across all eligible indications of the reference product, Remicade(7) (infliximab). Inflectra is now the first and only biosimilar monoclonal antibody therapy to be approved in the U.S. Hospira, now a Pfizer company, entered into an agreement with Celltrion Inc. and Celltrion Healthcare, Co., Ltd. in 2009 for several potential biosimilar products, including Inflectra. As a result, Pfizer holds exclusive commercialization rights to Inflectra in the U.S.

Xalkori (crizotinib) — Pfizer announced in March 2016 that the FDA approved a sNDA for Xalkori to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. Additionally, the European Medicines Agency (EMA) is reviewing an application to extend the marketing authorization of Xalkori to include the treatment of adult patients with ROS1-positive advanced NSCLC.

Xeljanz (tofacitinib citrate)
Pfizer announced in April 2016 top-line results from its first Phase 3 study investigating tofacitinib for the treatment of psoriatic arthritis (PsA), Oral Psoriatic Arthritis triaL (OPAL) Broaden. This study evaluated the efficacy and safety of tofacitinib 5 mg and 10 mg twice daily (BID) in adult patients with active PsA who had an inadequate response to at least one conventional synthetic disease-modifying antirheumatic drug and who were tumor necrosis factor inhibitor-naïve. OPAL Broaden met its primary efficacy endpoints demonstrating that both tofacitinib 5 mg BID and 10 mg BID were superior to treatment with placebo at 3 months as measured by American College of Rheumatology 20 response and Health Assessment Questionnaire Disability Index score. Overall safety findings in this study were consistent with those observed in the broader rheumatology clinical development program for tofacitinib.

In March 2016, Pfizer announced that the EMA has accepted for review the Marketing Authorization Application for Xeljanz 5 mg tablets twice daily for the treatment of patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX).

In February 2016, Pfizer announced that the FDA has approved Xeljanz XR extended-release 11 mg tablets for the once-daily treatment of moderate to severe RA in patients who have had an inadequate response or intolerance to MTX. Xeljanz XR is the first and only once-daily oral RA treatment in its class, known as Janus kinase (JAK) inhibitors.

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 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 (MSB0010718C) — Merck KGaA, Darmstadt, Germany (Merck KGaA) and Pfizer announced in April 2016 the treatment of the first patient in a Phase 3 study of avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in an advanced renal cell carcinoma (RCC) setting. The study, JAVELIN Renal 101, is the first pivotal trial investigating avelumab in combination with Inlyta (axitinib), Pfizer’s tyrosine kinase inhibitor (TKI), in patients with previously untreated advanced RCC, and the only Phase 3 trial currently evaluating an anti-PD-L1 immunotherapy in combination with a vascular endothelial growth factor-receptor TKI in this setting. JAVELIN Renal 101 is a multicenter, international, randomized (1:1), open-label trial designed to evaluate the potential superiority, assessed by PFS, of first-line avelumab combined with Inlyta compared with Sutent (sunitinib malate) monotherapy, Pfizer’s oral, small-molecule, multi-targeted receptor TKI, in patients with unresectable, locally advanced or metastatic RCC with clear cell component. The study is expected to enroll 583 patients across approximately 170 sites in Asia, Europe, Latin America and North America.

Bococizumab (PF-04950615, RN316)
Pfizer announced in April 2016 the completion of patient enrollment for the global SPIRE-2 cardiovascular outcome trial for bococizumab, an investigational Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i). SPIRE-2 is evaluating the efficacy and safety of bococizumab compared to placebo in reducing the risk of major cardiovascular events among 10,600 patients at high risk for cardiovascular disease – including those without a prior history of cardiovascular events – who are on highly-effective statins or with documented statin intolerance. Many factors impact the duration of cardiovascular outcome studies, including that they are time-to-event trials, which can make it difficult to predict when the studies will accrue the required number of events. Based on current estimates, the SPIRE-2 study is expected to complete in the second half of 2017.

In April 2016, Pfizer announced positive top-line results from the second of six Phase 3 studies evaluating the low-density lipoprotein cholesterol (LDL-C) reduction activity of bococizumab. The SPIRE-AI (AutoInjector) trial of bococizumab administered with a pre-filled pen met its co-primary endpoints: percent change from baseline in LDL-C reduction at 12 weeks compared to placebo and proportion of patients successfully operating the pre-filled pen. The results of the SPIRE-AI trial are expected to be part of a potential regulatory filing for bococizumab.

Corporate Developments

In April 2016, Pfizer announced that the merger agreement between Pfizer and Allergan plc (Allergan) entered into on November 22, 2015 was terminated by mutual agreement of the companies. The decision was driven by the actions announced by the U.S. Department of Treasury on April 4, 2016, which the companies concluded qualified as an "Adverse Tax Law Change" under the merger agreement. In connection with the termination of the merger agreement, on April 8, 2016 (which falls into Pfizer’s second fiscal quarter), Pfizer paid Allergan $150 million for reimbursement of Allergan’s expenses associated with the terminated transaction.

Pfizer announced in March 2016 that it entered into an accelerated share repurchase agreement with Goldman, Sachs & Co. (GS&Co.) to repurchase $5 billion of Pfizer’s common stock. Pursuant to the terms of the agreement, on March 10, 2016, Pfizer paid $5 billion to GS&Co. and received an initial delivery of approximately 136 million shares of Pfizer common stock from GS&Co. At settlement of the agreement, which is expected to occur during the second quarter of 2016, GS&Co. may be required to deliver additional shares of common stock to Pfizer, or, under certain circumstances, Pfizer may be required to deliver shares of its common stock or may elect to make a cash payment to GS&Co., with the number of shares to be delivered or the amount of such payment based on the volume-weighted average price, less a discount, of Pfizer’s common stock during the term of the transaction.
Pfizer reported in February 2016 that its Wyeth subsidiary reached an agreement in principle to resolve claims alleging that Wyeth’s practices relating to the calculation of Medicaid rebates for its drug Protonix (pantoprazole sodium) between 2001 and 2006, several years before Pfizer acquired Wyeth in 2009, violated the Federal Civil False Claims Act and other laws. As a result, in February 2016, Pfizer reissued its fourth-quarter and full-year 2015 financial results prepared in accordance with U.S. generally accepted accounting principles (GAAP) to reflect a charge of $784.6 million. In April 2016, this agreement was finalized and Wyeth made a payment of this amount to resolve these claims. The final agreement is subject to court approval and does not include an admission of liability by Wyeth. As previously mentioned, a tax benefit related to this resolution was recorded in Pfizer’s first-quarter 2016 GAAP financial results.