On January 31, 2017 Pfizer Inc. (NYSE:PFE) reported financial results for fourth-quarter and full-year 2016 and provided 2017 financial guidance (Press release, Pfizer, JAN 31, 2017, View Source [SID1234517602]). Schedule your 30 min Free 1stOncology Demo! Pfizer manages its commercial operations through two distinct businesses: Pfizer Innovative Health (IH)(3) (formerly the Innovative Products business) and Pfizer Essential Health (EH)(3)(4) (formerly the Established Products business). Financial results for each of these businesses are presented in the Operating Segment Information section located at the hyperlink below.
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On September 3, 2015, Pfizer acquired Hospira, Inc. (Hospira). Consequently, financial results for the year ended December 31, 2016 reflect legacy Hospira global operations for the entire period while financial results for the year ended December 31, 2015 reflect only four months of legacy Hospira U.S. operations and three months of legacy Hospira international operations(5). Financial results for fourth-quarter 2016 and fourth-quarter 2015 include legacy Hospira global operations for both periods.
On June 24, 2016, Pfizer acquired Anacor Pharmaceuticals, Inc. (Anacor). Therefore, financial results for fourth-quarter and full-year 2016 reflect three months and approximately six months of legacy Anacor operations, respectively, which were immaterial.
On September 28, 2016, Pfizer acquired Medivation, Inc. (Medivation). Therefore, financial results for fourth-quarter and full-year 2016 reflect three months of legacy Medivation operations.
Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances(6) 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 the fourth quarter and full year 2016 and 2015 are summarized below.
OVERALL RESULTS
($ in millions, except
per share amounts)
Fourth-Quarter Full-Year
2016 2015 Change 2016 2015 Change
Revenues $ 13,627 $ 14,047 (3%) $ 52,824 $ 48,851 8%
Reported Net Income/(Loss)(1) 775 (172 ) * 7,215 6,960 4%
Reported EPS/(LPS)(1) 0.13 (0.03 ) * 1.17 1.11 5%
Adjusted Income(2) 2,894 3,306 (12%) 14,761 13,755 7%
Adjusted Diluted EPS(2) 0.47 0.53 (11%) 2.40 2.20 9%
* Indicates calculation not meaningful or greater than 100%.
REVENUES
($ in millions) Fourth-Quarter Full-Year
2016
2015 % Change 2016 2015 % Change
Total Oper. Total Oper.
Innovative Health $ 7,726 $ 7,637 1% 2% $ 29,197 $ 26,758 9% 11%
Essential Health $ 5,902 $ 6,410 (8%) (6%) $ 23,627 $ 22,094 7% 11%
EH Standalone
(Excl. Legacy Hospira)
4,735 5,228 (9%) (7%) 18,994 20,581 (8%) (3%)
Legacy Hospira 1,167 1,182 (1%) (1%) 4,634 1,513 * *
Total Company $ 13,627 $ 14,047 (3%) (1%) $ 52,824 $ 48,851 8% 11%
Pfizer Standalone
(Excl. Legacy Hospira
and Legacy Medivation) $ 12,322 $ 12,865 (4%) (2%) $ 48,050 $ 47,339 2% 5%
* Indicates calculation not meaningful or greater than 100%.
2017 FINANCIAL GUIDANCE(7)
Pfizer’s 2017 financial guidance is presented below. Financial guidance reflects the pending disposition of Hospira Infusion Systems (HIS), expected in February 2017, which contributed $1.2 billion of revenues and $0.03 of adjusted diluted EPS(2) in 2016.
Revenues $52.0 to $54.0 billion
Adjusted Cost of Sales(2) as a Percentage of Revenues 20.0% to 21.0%
Adjusted SI&A Expenses(2) $13.7 to $14.7 billion
Adjusted R&D Expenses(2) $7.5 to $8.0 billion
Adjusted Other (Income)/Deductions(2) Approximately $100 million of deductions
Effective Tax Rate on Adjusted Income(2) Approximately 23.0%
Adjusted Diluted EPS(2) $2.50 to $2.60
A reconciliation of Pfizer’s full-year 2016 financial results to certain components of its 2017 financial guidance, including certain significant factors impacting 2017 financial guidance, is below:
Full-Year
2016 Results
Full-Year
2016
Contribution
from HIS
Full-Year
2016 Results
Excluding HIS
Contribution
2017 Financial
Guidance at
2016 FX Rates
Impact of
Mid-January
2017 FX Rates
Compared to
2016 FX Rates
2017 Financial
Guidance
Revenues $52.8 billion $1.2 billion $51.7 billion
$52.9 to $54.9
billion
($0.9 billion)
$52.0 to $54.0
billion
Adjusted Diluted EPS(2) $2.40 $0.03 $2.37 $2.55 to $2.65 ($0.05) $2.50 to $2.60
EXECUTIVE COMMENTARY
Ian Read, Chairman and Chief Executive Officer, stated, "I was pleased with the company’s overall performance during 2016 and believe both of our businesses executed well despite a challenging operating environment. We generated attractive operational revenue and earnings growth driven by our major products within both the Innovative Health and Essential Health businesses. In addition to strong business performance, we allocated our shareholders’ capital to a variety of value-creating initiatives that included company and product portfolio acquisitions, share repurchases, an increase in our dividend and ongoing funding for our R&D and commercial organizations.
"We are operating with a highly focused business structure and management team, providing us with the best opportunity to generate attractive operating revenue and earnings growth as demonstrated by our 2017 financial guidance. Our strong in-market product portfolio and broad R&D pipeline include several potential first-in-class or best-in-class compounds in important therapeutic areas. I believe we are positioned for continued strong performance in 2017 and beyond, which will enhance our ability to deliver new therapies to patients and create value for our shareholders," Mr. Read concluded.
Frank D’Amelio, Executive Vice President, Business Operations and Chief Financial Officer, stated, "Pfizer-standalone revenues in 2016 grew 5% operationally, excluding the impact of foreign exchange as well as legacy Hospira and legacy Medivation operations, reflecting solid underlying growth despite significant headwinds from product losses of exclusivity and the decline in revenues for Prevnar 13 Adult in the U.S. During 2016, we completed the acquisitions of Anacor and Medivation which added important revenue growth drivers to our Innovative Health business while we continued to integrate legacy Hospira operations into our Essential Health business. Finally, during 2016 we returned $12.3 billion directly to shareholders through dividends and share repurchases.
"Our 2017 financial guidance at the midpoint of our ranges implies revenues slightly above 2016 and a 6% increase to adjusted diluted EPS(2) compared to 2016 results. We expect to achieve this despite absorbing revenue headwinds totaling $4.5 billion, comprised of $2.4 billion resulting from anticipated generic competition, $1.2 billion due to the pending disposition of HIS and $0.9 billion due to adverse changes in foreign exchange rates since 2016. Excluding the negative impacts of the pending disposition of HIS and foreign exchange, the midpoints of our 2017 revenue and adjusted diluted EPS(2) guidance ranges reflect 4% and 10% operational growth, respectively. Notably, our guidance for adjusted diluted EPS(2) anticipates share repurchases totaling $5.0 billion in 2017, which are expected to more than offset potential dilution related to employee compensation programs," Mr. D’Amelio concluded.
QUARTERLY FINANCIAL HIGHLIGHTS (Fourth-Quarter 2016 vs. Fourth-Quarter 2015)
Fourth-quarter 2016 revenues totaled $13.6 billion, a decline of $420 million, or 3% compared to the prior-year quarter, reflecting an operational decline of $191 million, or 1%, and the unfavorable impact of foreign exchange of $228 million, or 2%. Excluding the fourth-quarter 2016 contribution from legacy Medivation operations and foreign exchange, revenues declined by $330 million, or 2%.
Of note, there were four fewer selling days in the U.S. and three fewer selling days in international markets during fourth-quarter 2016 compared to fourth-quarter 2015, resulting in a negative impact on fourth-quarter 2016 revenues of approximately $750 million compared to the prior-year quarter.
Innovative Health Highlights
IH delivered 2% operational revenue growth in fourth-quarter 2016, driven by continued growth from key brands including Ibrance, primarily in the U.S., Eliquis globally, the addition of Xtandi revenues in the U.S. resulting from the acquisition of Medivation in September 2016, as well as Xeljanz and Lyrica, both primarily in the U.S. Global Ibrance revenue more than doubled operationally while global operational revenue growth for Xeljanz and Eliquis was 62% and 50%, respectively. Sequentially, fourth-quarter 2016 Ibrance revenues in the U.S. increased 15% compared to third-quarter 2016.
Global Prevnar/Prevenar 13 revenues declined 23% operationally. In the U.S., Prevnar 13 revenues decreased 33% due to the continued decline in revenues for the Adult indication due to a high initial capture rate of the eligible population following its successful fourth-quarter 2014 launch, which resulted in a smaller remaining "catch up" opportunity compared to the prior-year quarter, as well as the unfavorable impact from the timing of government purchases for the pediatric indication.
Fourth-quarter 2016 operational growth was also negatively impacted by lower revenues for Enbrel in most developed Europe markets, primarily due to continued biosimilar competition, as well as the loss of Rebif alliance revenues resulting from the year-end 2015 expiry of the collaboration agreement to co-promote Rebif in the U.S.
Essential Health Highlights
Fourth-quarter 2016 EH revenues decreased 6% operationally, resulting from a 20% operational decline from Peri-LOE Products(8) and a 3% operational decline from Legacy Established Products (LEP)(8) partially offset by 3% operational growth from the Sterile Injectable Pharmaceuticals (SIP)(8) portfolio and 48% operational growth from Biosimilars(8). EH revenues excluding the performance of HIS, which Pfizer expects to divest in February 2017, declined 5% operationally.
Revenues from legacy Hospira products declined 1% operationally. Excluding the performance of HIS, revenues from legacy Hospira products increased 2% operationally. Revenues from EH-standalone products (excluding legacy Hospira) declined 7% operationally.
Developed markets revenues declined 9% operationally, negatively impacted by a 28% operational decline from Peri-LOE Products(8) and a 7% operational decline from the LEP(8) portfolio, partially offset by 51% operational growth from Biosimilars(8).
Revenues in emerging markets grew 4% operationally, primarily driven by 3% operational growth from the LEP(8) portfolio and 9% operational growth from the SIP(8) portfolio.
GAAP Reported(1) Income Statement Highlights
SELECTED TOTAL COMPANY REPORTED COSTS AND EXPENSES(1)
($ in millions)
(Favorable)/Unfavorable
Fourth-Quarter Full-Year
2016 2015 % Change 2016 2015 % Change
Total
Oper. Total Oper.
Cost of Sales(1) $ 3,218 $ 3,410 (6%) (7%) $ 12,329 $ 9,648 28% 23%
Percent of Revenues
23.6
%
24.3 % N/A N/A 23.3 % 19.7 % N/A N/A
SI&A Expenses(1) 4,423 5,048 (12%) (11%) 14,837 14,809 — 3%
R&D Expenses(1) 2,512 2,348 7% 8% 7,872 7,690 2% 3%
Total $ 10,153 $ 10,807 (6%) (6%) $ 35,038 $ 32,147 9% 9%
Other
(Income)/Deductions––
net(1)
$841
$2,190
(62%)
(27%)
$3,655
$2,860
28%
53%
Effective Tax Rate on
Reported Income/(Loss)(1)
1.7
%
53.0 % 13.4 % 22.2 %
The decrease in fourth-quarter 2016 Other deductions––net(1) was primarily driven by the non-recurrence of foreign currency losses related to Venezuela and a charge to resolve a Protonix-related legal matter, both of which were incurred in the prior-year quarter, partially offset primarily by an impairment charge in fourth-quarter 2016 as a result of the pending HIS transaction, a loss resulting from the early redemption of certain outstanding debt securities in fourth-quarter 2016 and higher impairment charges compared to the prior-year quarter.
Adjusted(2) Income Statement Highlights
SELECTED TOTAL COMPANY ADJUSTED COSTS AND EXPENSES(2)
($ in millions)
(Favorable)/Unfavorable
Fourth-Quarter Full-Year
2016 2015 % Change 2016 2015 % Change
Total Oper. Total Oper.
Adjusted Cost of Sales(2) $ 3,046 $ 2,983 2% (2%) $ 11,630 $ 9,021 29% 24%
Percent of Revenues 22.4
%
21.2 % N/A N/A 22.0 % 18.5 % N/A N/A
Adjusted SI&A Expenses(2) 4,402 4,598 (4%) (3%) 14,745 14,324 3% 5%
Adjusted R&D Expenses(2)
2,505 2,318 8% 9% 7,841 7,653 2% 3%
Total $ 9,953 $ 9,900 1% — $ 34,215 $ 30,998 10% 10%
Adjusted Other
(Income)/Deductions––
net(2)
($182
)
$1
*
*
($729
)
($409
)
78%
*
Effective Tax Rate on
Adjusted Income(2)
24.1 % 19.6 % 23.0 % 24.0 %
* Indicates calculation not meaningful or greater than 100%.
The diluted weighted-average shares outstanding used to calculate adjusted diluted EPS(2) declined by 105 million shares compared to the prior-year quarter due to Pfizer’s share repurchase program, reflecting the impact of a $5 billion accelerated share repurchase agreement executed in March 2016 and completed in June 2016.
A full reconciliation of Reported(1) to Adjusted(2) financial measures and associated footnotes can be found starting on page 21 of the press release located at the hyperlink below.
FULL-YEAR FINANCIAL SUMMARY (Full-Year 2016 vs. Full-Year 2015)
Full-year 2016 revenues increased $4.0 billion, or 8%, reflecting operational growth of $5.5 billion, or 11%, partially offset by the unfavorable impact of foreign exchange of $1.5 billion, or 3%.
Excluding the 2015 and 2016 contributions from legacy Hospira operations, the unfavorable impact of foreign exchange and, to a lesser extent, legacy Medivation operations of $140 million, Pfizer-standalone revenues increased by $2.2 billion operationally, or 5%, reflecting operational growth from certain key products partially offset by product losses of exclusivity and co-promotion expirations that negatively impacted 2016 revenues by $1.8 billion operationally.
There was one additional selling day in international markets during full-year 2016 compared to full-year 2015, resulting in a favorable impact on full-year 2016 revenues of approximately $100 million compared to the prior year. In the U.S., there was no difference in selling days in full-year 2016 compared to full-year 2015.
RECENT NOTABLE DEVELOPMENTS (Since November 1, 2016)
Product Developments
Bosulif (bosutinib) — In December 2016, Pfizer and its partner Avillion LLP announced results from the Phase 3 BFORE (Bosutinib trial in First line chrOnic myelogenous leukemia tREatment) trial demonstrating superiority of Bosulif over imatinib as a first-line treatment for patients with chronic phase Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). Based on the results of the study, Pfizer will work with the U.S. Food and Drug Administration (FDA) and other regulatory authorities to potentially make Bosulif available for Ph+ CML patients in the first-line setting.
Celebrex (celecoxib) — In November 2016, Pfizer announced results of the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen) trial, which demonstrated similar rates of cardiovascular risk in patients treated with prescription doses of celecoxib, ibuprofen and naproxen who had a clinical diagnosis of osteoarthritis (OA) or rheumatoid arthritis (RA), were at high risk for cardiovascular disease, and required daily treatment with non-steroidal anti-inflammatory drugs (NSAIDs) to control symptoms of arthritis. In addition, patients treated with celecoxib experienced significantly fewer gastrointestinal events as compared with those receiving prescription doses of ibuprofen or naproxen. However, it is important to note that given the trial’s design – prescription doses and chronic use in patients with cardiovascular risk factors – no inferences are possible regarding the safety of intermittent use of low-dose, over-the-counter NSAIDs. The results of the PRECISION study were presented at the annual meeting of the American Heart Association by Dr. Steve Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and principal investigator of the PRECISION trial. In addition, the results were published in The New England Journal of Medicine.
Chantix/Champix (varenicline) — In December 2016, the FDA approved updates to the Chantix labeling, including removal of the boxed warning regarding serious neuropsychiatric events. The removal of the boxed warning is based on the outcomes of EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study), the largest smoking cessation clinical trial in patients without and with a history of psychiatric disorder, and is consistent with the recommendation of the FDA Psychopharmacologic Drugs and Drug Safety and Risk Management Advisory Committees. Additional labeling revisions based on EAGLES include updates to the corresponding warning regarding neuropsychiatric safety and the addition of information on the superior efficacy of Chantix compared to bupropion or nicotine patch.
Eucrisa (crisaborole ointment 2%) — Pfizer announced in December 2016 that the FDA approved Eucrisa, a novel non-steroidal topical phosphodieterase-4 (PDE-4) inhibitor for the treatment of mild to moderate atopic dermatitis (AD) in patients two years of age and older. AD, often called eczema, is a chronic condition impacting nearly 18 million children and adults in the U.S. Approximately 90% of people living with AD have the mild to moderate form of the condition. Eucrisa is expected to be available by prescription starting in early February 2017.
Ibrance (palbociclib)
In December 2016, the FDA accepted for review a supplemental New Drug Application (sNDA) for Ibrance that supports the conversion of the accelerated approval of Ibrance in combination with letrozole to regular approval and includes data from the Phase 3 PALOMA-2 trial, which evaluated Ibrance as initial therapy in combination with letrozole for postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) metastatic breast cancer. This is the same patient population as the randomized Phase 2 PALOMA-1 trial upon which the accelerated approval of Ibrance plus letrozole was granted in February 2015. The sNDA was granted Priority Review status and has a Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA in April 2017.
Pfizer announced in December 2016 results from a sub-analysis studying Asian patients from the Phase 3 PALOMA-2 trial. Results showed the combination of Ibrance and letrozole significantly extended progression-free survival (PFS) by more than 11 months compared with letrozole plus placebo, and demonstrated that the median PFS exceeded two years in these patients. Data from this sub-analysis was shared in an oral presentation at the 2nd European Society for Medical Oncology Asia (ESMO Asia) Congress in Singapore.
In November 2016, Pfizer announced that detailed results from the Phase 3 PALOMA-2 trial were published in The New England Journal of Medicine. These data, initially presented at the 52nd American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2016, demonstrate the clinical benefit of Ibrance as initial therapy for postmenopausal women with ER+, HER2- metastatic breast cancer.
Pfizer announced in November 2016 that the European Commission (EC) has approved Ibrance for the treatment of women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. The approval is for Ibrance to be used in combination with an aromatase inhibitor. The approval also covers the use of Ibrance in combination with fulvestrant in women who have received prior endocrine therapy.
Lyrica (pregabalin) — Pfizer announced in December 2016 positive top-line results of a study that evaluated the use of Lyrica Capsules CV and Oral Solution CV as adjunctive therapy for pediatric epilepsy patients four to 16 years of age with partial onset seizures. Results showed that adjunctive treatment with Lyrica 10 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo, the primary efficacy endpoint. Treatment with Lyrica 2.5 mg/kg/day resulted in a numerical reduction in seizure frequency, which was not statistically significant. Lyrica is not approved as adjunctive therapy for pediatric epilepsy patients with partial onset seizures.
Mylotarg (gemtuzumab ozogamicin) — A Biologics License Application (BLA) for Mylotarg was accepted for filing by the FDA in January 2017 and a Marketing Authorization Application (MAA) was validated for review by the European Medicines Agency (EMA) in December 2016. Mylotarg is being evaluated for the potential treatment of adult patients with acute myeloid leukemia (AML). Mylotarg was originally approved under the FDA’s accelerated approval program in 2000 for use as a single agent in first relapse patients with CD33-positive AML who were 60 years or older. In 2010, Pfizer voluntarily withdrew Mylotarg after a confirmatory Phase 3 trial did not show a clinical benefit and the fatal induction toxicity rate was significantly higher in the Mylotarg arm. The recent regulatory submissions are based on additional data from a Phase 3 randomized, open-label study (ALFA-0701) that evaluated the addition of Mylotarg to standard induction chemotherapy using an alternative fractionated dosing schedule in 280 adult, de novo, AML patients aged 50-70 years old, as well as a meta-analysis of patient-level data from over 3,000 patients in five randomized Phase 3 studies (including ALFA-0701) spanning 10 years of research. The PDUFA goal date for a decision by the FDA is in September 2017. Mylotarg originates from a collaboration between Pfizer and Celltech, now UCB. Pfizer has sole responsibility for all manufacturing and clinical development activities for this molecule.
Nimenrix (Meningococcal group A, C, W-135, and Y conjugate vaccine) — In December 2016, the EC approved an expanded indication for Nimenrix for active immunization against invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W-135, and Y (MenACWY) in infants as early as six weeks of age. Nimenrix is now the first and only MenACWY conjugate vaccine in the European Union (EU) that can be administered from six weeks of age with no upper age limit. Nimenrix was approved for administration in infants as a two dose primary series, with the first dose given from six weeks of age and with an interval of two months between doses, followed by a booster dose at 12 months.
Prevnar 13/Prevenar 13 (Pneumococcal 13-valent conjugate vaccine) — In November 2016, Pfizer China announced that it received approval from the Chinese Food and Drug Administration to market its pneumococcal 13-valent conjugate vaccine, Prevenar 13, in China for active immunization for the prevention of invasive diseases (including bacteremic pneumonia, meningitis, septicemia, and bacteremia) caused by Streptococcus pneumoniae (S. Pneumoniae) serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in infants and children aged 6 weeks to 15 months. S. pneumoniae is the most common cause of invasive disease as well as pneumonia and upper respiratory tract infections. In China, the recommended Prevenar 13 immunization series is a primary series administered at 2, 4 and 6 months of age with a fourth (booster) dose administered at approximately 12-15 months of age.
Retacrit (epoetin alpha) — In December 2016, Pfizer completed the resubmission of the BLA to the FDA for Retacrit, its proposed biosimilar of Epogen(9) and Procrit(10). This resubmission is in response to the FDA Complete Response Letter received in October 2015. Pfizer will continue to work closely with the agency on next steps and remains committed to bringing this important medicine to patients in the U.S. as quickly as possible.
Xeljanz (tofacitinib)
Pfizer announced in January 2017 that the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion recommending Xeljanz 5 mg twice daily (BID) for the treatment of patients with moderate to severe active rheumatoid arthritis (RA). If approved, Xeljanz in combination with methotrexate (MTX) will be indicated for the treatment of moderate to severe active RA in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs. Xeljanz can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. The CHMP’s opinion will now be reviewed by the EC, which has the authority to approve medicines for the EU.
In November 2016, Pfizer presented results from the Phase 3 Oral Psoriatic Arthritis TriaL (OPAL) studies, Broaden and Beyond, at the 2016 ACR/ARHP Annual Meeting. OPAL Broaden and OPAL Beyond evaluated the efficacy and safety of Xeljanz in adult patients with active psoriatic arthritis who had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs or to tumor necrosis factor inhibitors, respectively. OPAL Broaden and OPAL Beyond met their primary efficacy endpoints showing a statistically significant improvement with tofacitinib 5 mg and 10 mg twice daily compared to treatment with placebo at three months as measured by American College of Rheumatology 20 (ACR20) response and change from baseline in Health Assessment Questionnaire Disability Index score.
Xtandi (enzalutamide) — In December 2016, Pfizer and Astellas Pharma Inc. announced that the Phase 4 PLATO study, evaluating the efficacy and safety of continued treatment with Xtandi plus abiraterone acetate and prednisone compared to treatment with abiraterone acetate and prednisone alone, did not meet its primary endpoint of improvement in PFS in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer whose prostate-specific antigen has previously progressed on Xtandi.
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 (PF-06834635, MSB0010718C) — EMD Serono Inc. (EMD Serono), the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, and Pfizer announced in November 2016 that the FDA has accepted for Priority Review EMD Serono’s BLA for avelumab seeking approval for use in patients with metastatic Merkel cell carcinoma (MCC), based on results of the JAVELIN Merkel 200 trial. Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody and could be the first treatment indicated for metastatic MCC in the U.S., if approved. MCC is a rare and aggressive skin cancer, which impacts approximately 2,500 Americans a year.
PF-05280014 (proposed biosimilar trastuzumab) — In November 2016, Pfizer announced that the pivotal REFLECTIONS B3271002 study, a comparative safety and efficacy study of PF-05280014 versus Herceptin(11) (trastuzumab), met its primary endpoint. The trial demonstrated equivalence in the primary endpoint of objective response rate of PF-05280014 versus Herceptin(11), each taken in combination with paclitaxel, in first-line patients with HER2-positive metastatic breast cancer. A separate comparative, randomized, double-blind clinical trial in early breast cancer patients (REFLECTIONS B3271004) also met its primary endpoint of steady-state Ctrough concentrations (PK) in patients treated with PF-05280014 and Herceptin(11). PF-05280014 is being developed by Pfizer as a potential biosimilar to Herceptin(11).
PF-06410293 (proposed biosimilar adalimumab) — In January 2017, Pfizer announced that the comparative, confirmatory REFLECTIONS B538-02 study met its primary objective by demonstrating equivalent efficacy as measured by the ACR20 response rate at Week 12. This trial evaluated the efficacy, safety, and immunogenicity of PF-06410293 compared to Humira(12) (adalimumab), each taken in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis. PF-06410293 is being developed by Pfizer as a potential biosimilar to Humira(12).
PF-06425090 (Clostridium difficile (C. difficile) vaccine candidate) — Pfizer announced in January 2017 that its Phase 2 study evaluating PF-06425090 provided positive data based on a pre-planned interim analysis. The randomized Phase 2 study examined the safety, tolerability and immunogenicity of the vaccine in healthy adults 65 to 85 years of age. PF-06425090 is designed to help prevent C. difficile infection. Based on these findings, Pfizer will progress PF-06425090 into Phase 3 in the first half of 2017.
PF-06836922 (hGH-CTP, long-acting human growth hormone) — OPKO Health, Inc. (OPKO) announced in December 2016 that the primary endpoint was not met for its Phase 3, double-blind, placebo-controlled study of its investigational long-acting human growth hormone product (hGH-CTP) in adults with growth hormone deficiency. OPKO announced that it is undertaking further review of the study population as promptly as possible. The safety profile observed in this study was consistent with that known for growth hormone treatments. In December 2014, OPKO entered into a worldwide collaboration and license agreement with Pfizer for the development and commercialization of hGH-CTP.
SPK-9001 — Spark Therapeutics and Pfizer announced in December 2016 updated preliminary data from the ongoing Phase 1/2 clinical trial of investigational SPK-9001 in hemophilia B was presented during the Plenary Scientific Session at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The results suggested sustained therapeutic levels of factor IX activity among all study participants. Together, all nine participants reduced infusions of factor IX concentrates by 99% over a cumulative 1,650 days.
Corporate Developments
In January 2017, ICU Medical, Inc. (ICU Medical) and Pfizer modified the terms of the definitive agreement entered into on October 6, 2016, under which ICU Medical will acquire HIS from Pfizer. These modifications are a result of recent changes in performance of HIS that affect ICU Medical’s previously announced expectations for the transaction. Under the terms of the modified agreement, the aggregate purchase price will be adjusted to be up to $900 million (versus $1 billion as originally agreed). Upon closing, Pfizer will receive approximately $400 million in equity (based upon the 30-day volume weighted average price through October 5, 2016, the day prior to announcement of the proposed transaction) in the form of 3.2 million newly issued shares of ICU Medical common stock (as originally agreed) and $275 million in cash (versus $600 million as originally agreed), which will be financed with ICU Medical’s existing cash balances and a $75 million seller note. Pfizer is entitled to up to an additional $225 million based on achievement of performance targets for the combined company through December 31, 2019, which would be payable after that date if performance is within the agreed target range. The transaction is expected to close in February 2017.
In December 2016, Pfizer’s board of directors declared a 32-cent first-quarter 2017 dividend on the company’s common stock, representing an increase of approximately 7% compared to the company’s first-quarter 2016 dividend. The dividend is payable on March 1, 2017 to shareholders of record at the close of business on February 3, 2017.
In December 2016, which falls in the first fiscal quarter of 2017 for Pfizer’s international operations, Pfizer completed the acquisition of the development and commercialization rights to AstraZeneca’s small molecule anti-infective business, primarily outside the U.S. The agreement includes the commercialization and development rights to the newly approved EU drug Zavicefta (ceftazidime-avibactam), the marketed agents Merrem/Meronem (meropenem) and Zinforo (ceftaroline fosamil), and the clinical development assets aztreonam-avibactam (ATM-AVI) and CXL (ceftaroline fosamil-AVI).
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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