On February 2, 2016 Pfizer Inc. (NYSE:PFE) reported financial results for fourth-quarter and full-year 2015 and provided 2016 financial guidance (Press release, Pfizer, FEB 2, 2016, View Source [SID1234508940]).
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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), full-year financial results for the year ended December 31, 2015 reflect four months of legacy Hospira U.S. operations and three months of legacy Hospira international operations, while financial results from fourth-quarter 2014 and full-year 2014 do not include any contribution from legacy Hospira operations. Fourth-quarter 2015 includes three months of legacy Hospira global 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.
Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. Results for fourth-quarter and full-year 2015 and 2014 are summarized below.
OVERALL RESULTS
($ in millions, except
per share amounts)
Fourth-Quarter Full-Year
2015 2014 Change 2015 2014 Change
Reported Revenues(1) $ 14,047 $ 13,118 7% $ 48,851 $ 49,605 (2%)
Adjusted Income(2) 3,306 3,441 (4%) 13,755 14,530 (5%)
Adjusted Diluted EPS(2) 0.53 0.54 (2%) 2.20 2.26 (3%)
Reported Net Income(1) 613 1,228 (50%) 7,745 9,135 (15%)
Reported Diluted EPS(1) 0.10 0.19 (47%) 1.24 1.42 (13%)
REVENUES
($ in millions) Fourth-Quarter Full-Year
2015 2014 % Change 2015 2014 % Change
Total Oper. Total Oper.
Innovative Products $ 7,637 $ 6,628 15% 22% $ 26,758 $ 24,005 11% 19%
GIP(4) 3,862 3,748 3% 10% 13,954 13,861 1% 9%
Global Vaccines(4) 1,917 1,318 45% 53% 6,454 4,480 44% 51%
Consumer Healthcare(4) 930 953 (2%) 4% 3,395 3,446 (1%) 5%
Global Oncology(4) 928 609 52% 61% 2,954 2,218 33% 43%
Established Products $ 6,264 $ 6,407 (2%) 5% $ 21,587 $ 25,149 (14%) (7%)
GEP(4) Standalone 5,082 6,407 (21%) (14%) 20,075 25,149 (20%) (13%)
Legacy Hospira 1,182 — * * 1,513 — * *
Other(5) 146 83 75% 98% 506 451 12% 20%
Total Company $ 14,047 $ 13,118 7% 14% $ 48,851 $ 49,605 (2%) 6%
Pfizer Excluding Legacy
Hospira
$ 12,865 $ 13,118 (2%) 5% $ 47,339 $ 49,605 (5%) 3%
* Indicates calculation not meaningful.
SELECTED TOTAL COMPANY ADJUSTED COSTS AND EXPENSES(2)
($ in millions)
(Favorable)/Unfavorable
Fourth-Quarter Full-Year
2015 2014 % Change 2015 2014 % Change
Total Oper. Total Oper.
Cost of Sales(2) $ 2,983 $ 2,584 15% 22% $ 9,021 $ 9,134 (1%) 10%
Percent of Revenues(1) 21.2 % 19.7
%
N/A N/A 18.5 % 18.4
%
N/A N/A
SI&A Expenses(2) 4,598 3,916 17% 24% 14,324 13,721 4% 11%
R&D Expenses(2) 2,318 2,039 14% 16% 7,653 7,153 7% 9%
Total $ 9,900 $ 8,539 16% 21% $ 30,998 $ 30,007 3% 10%
Effective Tax Rate(2) 19.6 % 26.2
%
24.0 % 26.5
%
2016 FINANCIAL GUIDANCE(6)
A reconciliation of Pfizer’s full-year 2015 financial results to certain components of its 2016 financial guidance is below. For 2016, the financial guidance includes the estimated significant negative currency impact related to Venezuela and excludes any impact from the pending combination with Allergan plc (Allergan).
Impact of Mid-
January 2016 FX
2016 Financial
Rates Compared
Currency Impact
Full-Year
Guidance at 2015
to 2015 FX Rates
Related to
2016 Financial
2015 Results
FX Rates
(Ex Venezuela)
Venezuela
Guidance
Reported Revenues(1) $48.9 billion $51.3 to $53.3 billion ($1.5 billion) ($0.8 billion) $49.0 to $51.0 billion
Reported Diluted EPS(1) $1.24
$1.70 to $1.83
($0.09) ($0.07) $1.54 to $1.67
Adjusted Diluted EPS(2) $2.20
$2.36 to $2.46
($0.09) ($0.07) $2.20 to $2.30
Pfizer’s complete 2016 financial guidance is summarized below.
Reported Revenues(1) $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) $13.2 to $14.2 billion
Adjusted R&D Expenses(2) $7.3 to $7.8 billion
Adjusted Other (Income)/Deductions(2) Approximately ($300 million) of income
Effective Tax Rate on Adjusted Income(2) Approximately 24.0%
Reported Diluted EPS(1) $1.54 to $1.67
Adjusted Diluted EPS(2) $2.20 to $2.30
EXECUTIVE COMMENTARY
Ian Read, Chairman and Chief Executive Officer, stated, "The just completed year was very productive in terms of business momentum, pipeline advancement and business development activity. I am particularly pleased with the performance of our Prevnar 13 adult and Ibrance launches in the U.S. In addition, Eliquis, Xeljanz and the Hospira portfolio, among other assets, along with operational growth in emerging markets, meaningfully enhanced the strength of our businesses.
"I believe that we are well positioned to deliver another strong year in 2016 as we expect that our key in-line products will continue to perform well while we expect to advance our product pipeline, notably our potential registrational programs in key therapeutic areas such as oncology, vaccines, cardiovascular and metabolic diseases, inflammation and rare diseases."
Mr. Read continued, "The integration of Hospira is well underway and we now look forward to completing the combination with Allergan, which we still expect to occur during the second half of this year. We see this transaction as a very effective driver of accelerating the growth potential of our Innovative business, strengthening our Established business and more efficiently allocating our capital globally, all factors which remain consistent with our overarching strategy of value creation.
"I want to thank our colleagues for their continued tireless work in an environment, that while challenging, continues to be very rewarding for our stakeholders," Mr. Read concluded.
Frank D’Amelio, Chief Financial Officer, stated, "2015 was a truly transformational year for Pfizer. In addition to our strong financial performance, we completed the Hospira acquisition, announced the pending combination with Allergan and continued to deliver shareholder value through prudent capital allocation. Regarding our financial performance, we exceeded our 2015 financial guidance for reported revenue(1) and met the top end of our 2015 financial guidance range for adjusted diluted EPS(2) despite an operating environment that remains challenging. Importantly, Pfizer-standalone revenues increased 3% operationally, marking Pfizer’s first year of operational revenue growth since entering a period of significant product losses of exclusivity. We believe the completion of the Hospira acquisition and the pending Allergan combination will strengthen our core businesses and better position the Company for sustainable revenue growth in the future.
"Today we are also providing our 2016 financial guidance, including ranges for reported revenues(1) of $49.0 to $51.0 billion and for adjusted diluted EPS(2) of $2.20 to $2.30. Our guidance for reported revenues(1) reflects anticipated mid-to-high-single digit operational revenue growth on an enterprise basis offset by the anticipated negative impact of $2.3 billion due to generic competition for products that recently lost or are expected to soon lose marketing exclusivity as well as $2.3 billion as a result of adverse changes in foreign exchange rates relative to the U.S. dollar compared to foreign exchange rates from last year, including $0.8 billion due to the estimated significant currency impact related to Venezuela. Our 2016 financial guidance excludes any impact from the pending combination with Allergan. Finally, our guidance for reported(1) and adjusted(2) diluted EPS also reflects anticipated share repurchases totaling $5 billion this year, consisting of our previously-announced plans to enter into a $5 billion accelerated share repurchase agreement that we expect to execute in the first half of 2016. These planned repurchases are expected to more than offset the potential dilution related to employee compensation programs," Mr. D’Amelio concluded.
QUARTERLY FINANCIAL HIGHLIGHTS (Fourth-Quarter 2015 vs. Fourth-Quarter 2014)
Reported revenues(1) totaled $14.0 billion, an increase of $930 million, or 7%, which reflects operational growth of $1.9 billion, or 14%, partially offset by the unfavorable impact of foreign exchange of $934 million, or 7%. Excluding the impact of legacy Hospira operations of $1.2 billion, foreign exchange and, to a lesser extent, the vaccines acquired from Baxter International Inc. (Baxter) of $35 million, Pfizer-standalone revenues increased by $646 million operationally, or 5%.
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 Prevnar 13 in adults and Ibrance in the U.S., Eliquis globally as well as Xeljanz and Lyrica primarily in the U.S. In emerging markets, revenues increased 5% operationally, favorably impacted by the addition of legacy Hospira operations, which contributed $73 million, as well as the performance of Prevenar 13 and certain other products.
Operational revenue growth was partially offset primarily by the loss of exclusivity and associated generic competition for Celebrex in the U.S. and certain other developed markets, Lyrica in certain developed Europe markets and Zyvox in the U.S.
Innovative Products Business Highlights
Revenues for the Innovative Products business increased 22% operationally, reflecting the following:
GIP(4) revenues increased 10% operationally, primarily due to the strong operational performance of Eliquis globally, Lyrica in the U.S. and Japan as well as Xeljanz primarily in the U.S.
VOC(4) revenues increased 38% operationally, reflecting the following:
Global Vaccines(4) revenues increased 53% operationally, driven by 102% growth of Prevnar 13 in the U.S., reflecting continued strong uptake among adults due to the continued success of commercial programs and increased demand during the flu season as well as by the timing of government purchases for the pediatric indication compared to the year-ago quarter.
Global Oncology(4) revenues increased 61% 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 globally.
Consumer Healthcare(4) revenues increased 4% operationally, primarily due to Nexium 24HR in the U.S., driven by strong demand following increased promotion and lower revenues in fourth-quarter 2014 as retailers reduced initial stocking levels following the May 2014 launch.
Established Products Business Highlights
GEP(4) revenues increased 5% 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 Celebrex in the U.S. and certain other developed markets, Lyrica in certain developed Europe markets and Zyvox in the U.S. Emerging markets revenues were flat operationally, driven by the inclusion of legacy Hospira operations and continued strong growth in China offset by declines in certain Middle East markets.
Income Statement Highlights
Adjusted cost of sales(2), adjusted SI&A expenses(2) and adjusted R&D expenses(2) in the aggregate increased $1.8 billion operationally, or 21%, reflecting the inclusion of legacy Hospira operations in fourth-quarter 2015 and the following Pfizer-standalone operational factors:
slightly lower adjusted cost of sales(2);
higher adjusted SI&A expense(2), primarily reflecting increased investments to support recently launched products, other in-line biopharmaceutical products and certain Consumer Healthcare brands; and
higher adjusted R&D expense(2), primarily due to incremental investments in certain late-stage pipeline programs.
The effective tax rate on adjusted income(2) declined 6.6 percentage points to 19.6% from 26.2%. This decline was primarily due to a favorable change in the jurisdictional mix of earnings as well as an increase in tax benefits associated with the resolution of certain tax positions pertaining to prior years primarily with various foreign tax authorities.
The diluted weighted-average shares outstanding declined by 125 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, fourth-quarter 2015 reported earnings were primarily impacted by the following:
Unfavorable impacts:
foreign currency losses related to Venezuela;
higher purchase accounting adjustments, acquisition-related costs, restructuring charges and asset impairment charges in fourth-quarter 2015 compared with the prior year quarter; and
non-recurring charges related to pension settlements.
Favorable impacts:
the non-recurrence of a charge associated with a collaborative arrangement with Merck KGaA, Darmstadt, Germany (Merck KGaA), announced in November 2014, to jointly develop and commercialize avelumab(7);
lower charges for certain legal matters, primarily the non-recurrence of a charge to resolve a securities class action in New York federal court that was incurred in the prior year quarter; and
a lower effective tax rate, primarily due to the aforementioned factors impacting the fourth-quarter 2015 effective tax rate on adjusted income(2) as well as benefits associated with certain tax initiatives, partially offset by the non-tax deductible charge for the aforementioned foreign currency losses related to Venezuela.
FULL-YEAR FINANCIAL HIGHLIGHTS (Full-Year 2015 vs. Full-Year 2014)
Reported revenues(1) decreased $754 million, or 2%, which reflects operational growth of $3.0 billion, or 6%, more than offset by the unfavorable impact of foreign exchange of $3.8 billion, or 8%. Excluding the impact of legacy Hospira operations of $1.5 billion, foreign exchange and, to a lesser extent, the vaccines acquired from Baxter of $178 million, Pfizer-standalone revenues increased by $1.3 billion operationally, or 3%, which reflects operational revenue growth from certain key products partially offset by product losses of exclusivity and co-promotion expirations that negatively impacted 2015 reported revenues(1) by $3.2 billion operationally.
Income Statement Highlights
Adjusted cost of sales(2), adjusted SI&A expenses(2) and adjusted R&D expenses(2) in the aggregate increased $3.0 billion operationally, or 10%, reflecting the inclusion of legacy Hospira operations from September 2015 and the following Pfizer-standalone operational factors:
higher adjusted cost of sales(2), primarily reflecting an increase in sales volume, partially offset by manufacturing efficiencies and a decrease in royalty expense associated with products that recently lost marketing exclusivity;
higher adjusted SI&A expense(2), primarily reflecting increased investments to support recently launched products, other in-line biopharmaceutical products and certain Consumer Healthcare brands, partially offset by lower expenses associated with certain products that have recently lost marketing exclusivity, continued benefits from cost-reduction and productivity initiatives as well as a lower cost for the Branded Prescription Drug Fee compared to the prior year; and
higher adjusted R&D expense(2), primarily due to higher clinical trial spend for certain oncology and GIP(4) pipeline programs, an upfront payment to OPKO Health, Inc. in first-quarter 2015 associated with a worldwide development and commercialization agreement and increased investment in biosimilar and sterile injectable development programs, partially offset by the non-recurrence of upfront payments associated with certain agreements entered into during third-quarter 2014.
The full-year 2015 effective tax rate on adjusted income(2) declined 2.5 percentage points to 24.0% from 26.5% in 2014. This decline was primarily due to a favorable change in the jurisdictional mix of earnings.
The diluted weighted-average shares outstanding declined by 167 million shares compared to the prior-year, primarily 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 full-year 2015 factors and the factors impacting fourth-quarter 2015 reported earnings, full-year 2015 reported earnings were primarily impacted by the following:
Unfavorable impacts:
higher acquisition-related costs, purchase accounting adjustments and restructuring charges, all primarily associated with the acquisition of Hospira in third-quarter 2015;
higher asset impairment charges, including an impairment loss related to Pfizer’s 49%-owned equity-method investment with Zhejiang Hisun Pharmaceuticals Co., Ltd. (Hisun) in China recorded in third-quarter 2015; and
higher charges incurred during 2015 for business and legal entity alignment activities.
Favorable impacts:
lower legal charges, primarily as a result of the non-recurrence of the aforementioned charge to resolve a securities class action recorded in fourth-quarter 2014 and the non-recurrence of a charge to resolve Neurontin-related matters recorded in first-quarter 2014;
lower implementation costs associated with restructuring activities and amortization expense related to intangible assets;
the non-recurrence of a charge incurred in third-quarter 2014 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 the aforementioned factors impacting the fourth-quarter and full-year 2015 effective tax rate as well as the non-recurrence in 2015 of the non-tax deductible charge for the aforementioned additional year of the Branded Prescription Drug Fee incurred in third-quarter 2014.
RECENT NOTABLE DEVELOPMENTS
Product Developments
Eliquis (apixaban)
Bristol-Myers Squibb Company (BMS) and Pfizer announced in December 2015 results from a post-hoc early time course subanalysis of the Phase 3 AMPLIFY (Apixaban for the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis as First-Line Therapy) trial. The subanalysis demonstrated Eliquis was comparable to conventional therapy (subcutaneous enoxaparin overlapped and followed by oral warfarin dose-adjusted to an international normalized ratio of 2.0 to 3.0) in recurrent venous thromboembolism (VTE) and VTE-related death with significantly less major bleeding during the first 7, 21 and 90 days after starting treatment. The results of the subanalyses at each pre-specified time interval were consistent with the overall results of the AMPLIFY trial at six months.
In November 2015, BMS and Pfizer presented 22 abstracts at the American Heart Association (AHA) Scientific Sessions 2015. The new data, including four oral presentations, contribute to the BMS and Pfizer Alliance’s research in nonvalvular atrial fibrillation and VTE in patients treated with Eliquis. Abstracts included new data analyses from the pivotal Phase 3 study, ARISTOTLE, as well as a number of real-world data analyses.
Ibrance (palbociclib) — Pfizer announced in December 2015 that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review for a supplemental New Drug Application (sNDA) for Ibrance. If approved, the sNDA would expand the approved use of Ibrance to reflect findings from the Phase 3 PALOMA-3 trial, which evaluated Ibrance in combination with fulvestrant versus fulvestrant plus placebo in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer, regardless of menopausal status, whose disease progressed after endocrine therapy, including those with and without prior treatment for their metastatic disease. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 2016.
Lyrica (pregabalin) — Pfizer announced in November 2015 top-line results of a Phase 3 study evaluating the efficacy and safety of Lyrica Capsules CV in adults with chronic post-traumatic peripheral neuropathic pain. The study did not meet its primary efficacy endpoint. The study was conducted as a 15-week, double-blind, placebo-controlled, parallel group study with a primary objective to evaluate the efficacy of pregabalin in the treatment of chronic post-traumatic peripheral neuropathic pain. The primary efficacy endpoint was mean pain reduction from baseline compared with placebo based on pain scores from patients’ daily pain diaries. The safety profile observed in this study was consistent with that known for pregabalin. The most common adverse events with pregabalin in this study were dizziness, somnolence, nausea and fatigue. There is currently no treatment approved by the FDA for post-traumatic neuropathic pain.
Xalkori (crizotinib)
In December 2015, the FDA accepted and granted Priority Review for a sNDA for Xalkori for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. In April 2015, Xalkori received Breakthrough Therapy designation by the FDA for this potential indication. If approved, Xalkori would be the first FDA-approved biomarker-driven therapy for the treatment of ROS1-positive metastatic NSCLC. Xalkori is currently indicated in the U.S. for patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The PDUFA goal date for a decision by the FDA is April 2016.
Pfizer announced in November 2015 that the European Commission (EC) approved a label update to expand use of Xalkori to first-line treatment of adults with ALK-positive advanced NSCLC. The Summary of Product Characteristics also has been updated to include efficacy data from PROFILE 1014, which demonstrated that Xalkori significantly prolonged progression-free survival (PFS) in previously untreated patients with ALK-positive advanced nonsquamous NSCLC when compared to standard platinum-based chemotherapy regimens.
In November 2015, Pfizer announced that PROFILE 1029, a Phase 3 study of Xalkori met its primary objective of significantly prolonging PFS in previously untreated East Asian patients with ALK-positive advanced NSCLC when compared to a standard chemotherapy doublet. In this study, Xalkori was used as the first systemic therapy for patients with advanced ALK-positive NSCLC, and patients could have received therapy and/or surgery for early stage disease before they were diagnosed with metastatic disease. The adverse events observed with Xalkori in the study were generally consistent with findings from previous trials. No unexpected adverse events were observed. Efficacy and safety data from PROFILE 1029 will be submitted for presentation at a future medical meeting.
Xeljanz (tofacitinib citrate) — Pfizer presented in November 2015 26 new scientific abstracts, including 20 presentations for Xeljanz in rheumatoid arthritis (RA) at the American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting. The new data continue to characterize the safety and efficacy of Xeljanz in the treatment of RA.
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.
ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) — The FDA has not taken action on Pfizer’s New Drug Application (NDA) for ALO-02, which had a PDUFA date in January 2016. The delay is not related to anything specific in the ALO-02 NDA, and no additional data analyses or data requests have been identified by the FDA. Pfizer is continuing discussions with the FDA to finalize the label. Pfizer cannot speculate on timing for the FDA decision.
Avelumab(7) (MSB0010718C)
Merck KGaA and Pfizer announced during fourth-quarter 2015 the initiation of five Phase 3 trials of avelumab(7), an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in various cancers, including:
JAVELIN Lung 100 is designed to assess the safety and efficacy of avelumab(7), compared with platinum-based doublet chemotherapy, in patients with late-stage NSCLC who have not previously received any treatment for their systemic lung cancer.
JAVELIN Gastric 100 is designed to compare the switch from first-line chemotherapy to maintenance therapy with avelumab(7) versus continuation of chemotherapy in patients with unresectable, locally advanced or metastatic gastric/gastro-esophageal junction cancers whose disease has not progressed with first-line platinum-based chemotherapy.
JAVELIN Gastric 300 is designed to evaluate the superiority (based on overall survival) of avelumab(7) in patients with unresectable, recurrent or metastatic gastric/gastro-esophageal junction cancers, compared with investigator’s choice of chemotherapy from a pre-specified list of therapeutic options.
JAVELIN Ovarian 200 is designed to evaluate the superiority of avelumab(7) as a monotherapy or in combination with pegylated liposomal doxorubicin (PLD), compared with PLD alone, in treating patients with platinum-resistant/refractory ovarian cancer. The JAVELIN Ovarian 200 trial is the first Phase 3 study of a PD-L1 inhibitor investigated in this setting.
JAVELIN Bladder 100 is designed to evaluate the safety and efficacy of avelumab(7) plus best supportive care (BSC) as a maintenance treatment, compared with BSC alone, in patients with unresectable, locally advanced or metastatic urothelial cancer whose disease did not progress on (or following) completion of first-line treatment with a platinum-containing chemotherapy.
Merck KGaA and Pfizer announced in November 2015 that the European Medicines Agency’s Committee for Orphan Medicinal Products issued a positive opinion for Orphan Drug designation for avelumab(7) for the treatment of patients with Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer. An official decision by the EC was granted in December 2015.
Merck KGaA and Pfizer announced in November 2015 that the FDA granted Breakthrough Therapy designation for avelumab(7) for the treatment of patients with metastatic MCC who have progressed after at least one previous chemotherapy regimen.
Merck KGaA and Pfizer announced in October 2015 that the FDA granted avelumab(7) Fast Track designation for the treatment of metastatic MCC.
Bococizumab (PF-04950615, RN316) — In January 2016, Pfizer received positive top-line results from the first of six Phase 3 studies evaluating the low-density lipoprotein cholesterol (LDL-C) reduction activity of bococizumab. The SPIRE-SI study evaluated the efficacy, safety, and tolerability of bococizumab in adults with dyslipidemia who are intolerant to statins. A total of 184 patients were randomized to receive either 150 mg of bococizumab every two weeks by subcutaneous injection, atorvastatin 40 mg once-daily or placebo once-daily for 12 weeks. The trial met its primary endpoint, as measured by the percent change in baseline LDL-C level at 12 weeks. No new or unexpected safety findings for bococizumab were observed in the study. Complete study results of the SPIRE-SI trial will be presented at an upcoming scientific congress. Results from other Phase 3 studies evaluating LDL-C reduction are expected throughout 2016.
Corporate Developments
BMS and Pfizer announced in February 2016 that the companies have entered into a collaboration agreement with Portola Pharmaceuticals Inc. (Portola) to develop and commercialize the investigational agent andexanet alfa in Japan. Andexanet alfa, which is in Phase 3 clinical development in the U.S. and Europe, is designed to reverse the anticoagulant activity of Factor Xa inhibitors, including Eliquis.
Pfizer announced in January 2016 an expansion of its R&D investment strategy to include early-stage companies on the leading edge of scientific innovation, providing them with both equity and access to resources for research in promising areas aligned with Pfizer’s core interests. The first four investments of the newly focused initiative include $46 million in financing to companies at early stages of the discovery process that are actively exploring Conditionally Active Biologics, immuno-oncology, neurodegenerative technologies and gene therapy. Additional opportunities will continue to be identified by Pfizer’s scientific leadership through their active involvement, and Pfizer will help recipient companies fully explore their platforms in the hopes of advancing new therapeutic pathways.
Pfizer and Adaptive Biotechnologies Corporation (Adaptive) announced in January 2016 that they have entered into a translational research collaboration to leverage next generation sequencing of the adaptive immune system to advance Pfizer’s growing immuno-oncology franchise. Under the terms of the agreement, Pfizer and Adaptive will seek to combine drug development and platform technology biomarker expertise to identify patients who may preferentially benefit from immunotherapy.
Merck KGaA, Pfizer and Syndax Pharmaceuticals, Inc. (Syndax) announced in January 2016 that they have entered into a collaboration agreement to evaluate avelumab(7) in combination with Syndax’s entinostat, an investigational oral small molecule that targets immune regulatory cells (myeloid-derived suppressor cells and regulatory T-cells), in patients with heavily pre-treated, recurrent ovarian cancer. This is an exclusive agreement between the Merck KGaA-Pfizer alliance and Syndax to study the combination of these two investigational agents in ovarian cancer. Syndax will be responsible for conducting the Phase 1b/2 clinical trial.
In December 2015, Pfizer announced that its Board of Directors declared a 30-cent first-quarter 2016 dividend on the Company’s common stock, payable March 2, 2016, to shareholders of record at the close of business on February 5, 2016. This represents an increase of 7% in the quarterly dividend per share, compared to 28 cents per share in first-quarter 2015.
In December 2015, the Board of Directors authorized a new $11 billion share repurchase program to be utilized over time. In November 2015, Pfizer announced that, consistent with 2015, it expects to execute an approximately $5 billion accelerated share repurchase program in the first half of 2016. As of December 31, 2015, Pfizer had $16.4 billion in aggregate remaining under its share repurchase authorizations.
In November 2015, Pfizer announced that it entered into a definitive merger agreement with Allergan, a global pharmaceutical company incorporated in Ireland, under which Pfizer agreed to combine with Allergan in a stock transaction valued at $363.63 per Allergan share, for a total enterprise value of approximately $160 billion, based on the closing price of Pfizer common stock of $32.18 on November 20, 2015 (the last trading day prior to the announcement). Allergan shareholders will receive 11.3 shares of the combined company for each of their Allergan shares by virtue of a share split, and Pfizer stockholders will have the option of receiving one share of the combined company for some or all of their Pfizer shares or to receive cash instead of shares of the combined company for some or all of their Pfizer shares, provided that the aggregate amount of cash to be paid in the merger will not be less than $6 billion or greater than $12 billion. In the event that elections to receive cash and shares in the merger would otherwise result in an aggregate of less than $6 billion or greater than $12 billion of cash being paid out in the merger, then the share elections and cash elections will be subject to proration. The completion of the transaction, which is expected in the second half of 2016, is subject to certain conditions, including receipt of regulatory approval in certain jurisdictions, including the U.S. and EU, the receipt of necessary approvals from both Pfizer and Allergan shareholders, and the completion of Allergan’s pending divestiture of its generics business to Teva Pharmaceuticals Industries Ltd. The merger agreement also provides that the businesses of Pfizer and Allergan will be combined under the existing Allergan entity, which, subject to approval by Allergan shareholders, will be renamed "Pfizer plc."
In response to the ongoing challenges patients face in paying their out-of-pocket costs for their prescription medicines, Pfizer announced in November 2015 that it has doubled the allowable income level for its patient assistance program, so that even more patients in need could be eligible to receive their Pfizer medicines for free. With this change, more than 40 medicines offered for free through the program are now available to eligible patients earning up to four times the Federal Poverty Level adjusted for family size ($47,080 for a single person; $97,000 for a family of four). Through the Pfizer RxPathways program, Pfizer offers patients, including those with health insurance and those without, a range of individual services to help them gain access to Pfizer medicines. From 2010 to 2014, Pfizer has helped nearly 2.5 million uninsured and underinsured patients get access to more than 30 million Pfizer prescriptions, making it the most comprehensive program of its kind.
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:
View Source
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