PFIZER REPORTS FOURTH-QUARTER AND FULL-YEAR 2016 RESULTS

PROVIDES 2017 FINANCIAL GUIDANCE

• Full-Year 2016 Revenues of $52.8 Billion, Reflecting 11% Operational Growth; Full-Year 2016 Revenues for Pfizer Standalone (Excluding Legacy Hospira and Legacy Medivation) of $48.1 Billion, Reflecting 5% Operational Growth
• Fourth-Quarter 2016 Revenues of $13.6 Billion, Reflecting 1% Operational Decline, Unfavorably Impacted by Four Fewer U.S. Selling Days and Three Fewer International Selling Days Compared to the Prior-Year Quarter; Fourth-Quarter 2016 Pfizer Standalone Revenues of $12.3 Billion, Reflecting 2% Operational Decline
• Full-Year 2016 Reported Diluted EPS⁽¹⁾ of $1.17, Adjusted Diluted EPS⁽²⁾ of $2.40; Fourth-Quarter 2016 Reported Diluted EPS⁽¹⁾ of $0.13, Adjusted Diluted EPS⁽²⁾ of $0.47
• Provides 2017 Financial Guidance, Including Revenues of $52.0 to $54.0 Billion and Adjusted Diluted EPS⁽²⁾ of $2.50 to $2.60; Reflects Pending Disposition of Hospira Infusion Systems, which Contributed $1.2 Billion of Revenues and $0.03 of Adjusted Diluted EPS⁽²⁾ in 2016

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) reported financial results for fourth-quarter and full-year 2016 and provided 2017 financial guidance.

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.

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 2^nd 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 52^nd American Society of Clinical Oncology (ASCO) 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 C_trough 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 58^th American Society of Hematology 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:

http://www.pfizer.com/system/files/presentation/Q4_2016_PFE_Earnings_Press_Release_dwerfks.pdf

(Note: If clicking on the above link does not open up a new web page, you may need to cut and paste the above URL into your browser's address bar.)

For additional details, see the associated financial schedules and product revenue tables attached to the press release located at the hyperlink referred to above and the attached disclosure notice.

^(1)	Revenues is defined as revenues in accordance with U.S. generally accepted accounting principles (GAAP). Reported net income/(loss) is defined as net income/(loss) attributable to Pfizer Inc. in accordance with U.S. GAAP. Reported diluted earnings per share (EPS) and reported loss per share (LPS) are defined as reported diluted EPS or LPS 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 (some of which may recur, such as restructuring or legal charges, but which management does not believe are reflective of ongoing core operations). 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 in the Management’s Discussion and Analysis of Financial Condition and Results of Operations––Non-GAAP Financial Measure (Adjusted Income) section of Pfizer’s Quarterly Report on Form 10-Q for the fiscal quarter ended October 2, 2016, management uses Adjusted income, among other factors, to set performance goals and to measure the performance of the overall company. Because Adjusted income is an important internal measurement for Pfizer, management believes that investors’ understanding of our performance is enhanced by disclosing this performance measure. Pfizer reports Adjusted income, and certain components of Adjusted income, in order to portray the results of major operations––the discovery, development, manufacture, marketing and sale of prescription medicines, vaccines and consumer healthcare (OTC) products––prior to considering certain income statement elements. See the accompanying reconciliations of certain GAAP Reported to Non-GAAP Adjusted information for the fourth quarter and twelve months ended December 31, 2016 and 2015. 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)	Effective in second-quarter 2016, Pfizer’s operating structure was reorganized from three segments to two to reflect changes to how the innovative pharmaceutical, vaccine and consumer healthcare operations are managed. Pfizer Innovative Health was previously known as the Innovative Products business, which was comprised of the Global Innovative Pharmaceutical (GIP) and Global Vaccines, Oncology and Consumer Healthcare (VOC) segments. Additionally, the name of Pfizer’s Established Products business, which consisted of the Global Established Pharmaceutical (GEP) segment, was changed to Pfizer Essential Health. For a description of each business, see the Notes to Operating Segment Information section of this press release, which can be found on page 27 of the press release located at the hyperlink above. Prior period segment operating results have been reclassified to conform to the current period presentation.
^(4)	Beginning in 2016, Pfizer’s contract manufacturing business, Pfizer CentreOne, is now part of Pfizer Essential Health. Pfizer CentreOne consists of (i) legacy Pfizer’s contract manufacturing and active pharmaceutical ingredient sales operation, including manufacturing and supply agreements with Zoetis Inc. (previously known as Pfizer CentreSource or PCS); and (ii) legacy Hospira’s One-2-One sterile injectables contract manufacturing operation. Prior to 2016, PCS was managed outside of Pfizer’s operating segments and its revenues were reported as other business activities. Prior period PCS operating results have been reclassified to conform to the current period presentation as part of Essential Health.
^(5)	Pfizer’s fiscal year-end for international subsidiaries is November 30 while Pfizer’s fiscal year-end for U.S. subsidiaries is December 31. Therefore, in accordance with Pfizer’s domestic and international reporting periods, Pfizer’s consolidated financial statements for the three and twelve months ended December 31, 2015 reflect only four months of legacy Hospira U.S. operations and three months of legacy Hospira international operations.
^(6)	References to operational variances in this press release pertain to period-over-period growth rates that exclude the impact of foreign exchange as well as the negative currency impact related to Venezuela. The operational variances are determined by multiplying or dividing, as appropriate, the current period U.S. dollar results by the current period average foreign exchange rates and then multiplying or dividing, as appropriate, those amounts by the prior-year period average foreign exchange rates. Pfizer believes that presenting these operational variances provides useful information in evaluating business results because exchange rate changes, while part of its ongoing business, can mask positive or negative trends in the business and are not within its control.
^(7)	The 2017 financial guidance reflects the following:

• Pfizer does not provide guidance for GAAP Reported financial measures (other than Revenues) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP Reported financial measures on a forward-looking basis because it is unable to predict with reasonable certainty the ultimate outcome of pending litigation, unusual gains and losses, acquisition-related expenses and potential future asset impairments without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP Reported results for the guidance period.
• Does not assume the completion of any business development transactions not completed as of December 31, 2016, including any one-time upfront payments associated with such transactions, except for the pending disposition of HIS, expected in February 2017.
• Exchange rates assumed are as of mid-January 2017.
• Reflects an anticipated negative revenue impact of $2.4 billion due to recent and expected generic and biosimilar competition for certain products that have recently lost or are anticipated to soon lose patent protection.
• Reflects the anticipated negative impact of $0.9 billion on revenues and $0.05 on adjusted diluted EPS⁽²⁾ as a result of unfavorable changes in foreign exchange rates relative to the U.S. dollar compared to foreign exchange rates from 2016.
• Guidance for adjusted diluted EPS⁽²⁾ assumes diluted weighted-average shares outstanding of approximately 6.1 billion shares, including anticipated share repurchases totaling $5.0 billion in 2017, which are expected to more than offset potential dilution related to employee compensation programs.

^(8)	The following are certain product categories within Essential Health:

• Sterile Injectable Pharmaceuticals include generic injectables and proprietary specialty injectables (excluding Peri-LOE Products).
• Peri-LOE Products include products that have recently lost or are anticipated to soon lose patent protection. These products primarily include Lyrica in certain developed Europe markets, Pristiq globally, Celebrex, Zyvox and Revatio in most developed markets, Vfend and Viagra in certain developed Europe markets and Japan, and Inspra in the EU.
• Legacy Established Products include products that have lost patent protection (excluding Sterile Injectable Pharmaceuticals and Peri-LOE Products).
• Biosimilars include Inflectra/Remsima (biosimilar infliximab) in the U.S. and certain international markets, Nivestim (biosimilar filgrastim) in certain Asian markets and Retacrit (biosimilar epoetin zeta) in certain international markets.

Definitions for all Essential Health product categories can be found in the footnotes to the product revenue tables on page 39 of the press release located at the hyperlink above.

^(9)	Epogen^® is a registered U.S. trademark of Amgen Inc.
^(10)	Procrit^® is a registered U.S. trademark of Johnson & Johnson Corporation.
^(11)	Herceptin^® is a registered U.S. trademark of Genentech, Inc.
^(12)	Humira^® is a registered U.S. trademark of Abbvie Biotechnology Ltd.

DISCLOSURE NOTICE: Except where otherwise noted, the information contained in this earnings release and the related attachments is as of January 31, 2017. We assume no obligation to update any forward-looking statements contained in this earnings release and the related attachments as a result of new information or future events or developments.

This earnings release and the related attachments contain forward-looking statements about our anticipated future operating and financial performance, business plans and prospects, in-line products and product candidates, strategic reviews, capital allocation, business-development plans, the benefits expected from our acquisitions of Hospira, Inc. (Hospira), Anacor Pharmaceuticals, Inc. (Anacor), Medivation, Inc. (Medivation) and AstraZeneca's small molecule anti-infectives business and the pending disposition of Hospira Infusion Systems, and plans relating to share repurchases and dividends, among other things, that involve substantial risks and uncertainties. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “target,” “forecast,” “goal,” “objective,” “aim” and other words and terms of similar meaning. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following:

• the outcome of research and development activities, including, without limitation, the ability to meet anticipated pre-clinical and clinical trial commencement and completion dates, regulatory submission and approval dates, and launch dates for product candidates, as well as the possibility of unfavorable pre-clinical and clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data;
• decisions by regulatory authorities regarding whether and when to approve our drug applications, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling, ingredients and other matters that could affect the availability or commercial potential of our products; and uncertainties regarding our ability to address the comments in complete response letters received by us with respect to certain of our drug applications to the satisfaction of the FDA;
• the speed with which regulatory authorizations, pricing approvals and product launches may be achieved;
• the outcome of post-approval clinical trials, which could result in the loss of marketing approval for a product or changes in the labeling for, and/or increased or new concerns about the safety or efficacy of, a product that could affect its availability or commercial potential;
• risks associated with interim data, including the risk that final results of studies for which interim data have been provided and/or additional clinical trials may be different from (including less favorable than) the interim data results and may not support further clinical development of the applicable product candidate or indication;
• the success of external business-development activities, including the ability to satisfy the conditions to closing of announced transactions in the anticipated time frame or at all, including our ability and the ability of ICU Medical, Inc. (ICU) to satisfy the conditions to closing the sale of Hospira Infusion Systems to ICU;
• competitive developments, including the impact on our competitive position of new product entrants, in-line branded products, generic products, private label products, biosimilars and product candidates that treat diseases and conditions similar to those treated by our in-line drugs and drug candidates;
• the implementation by the FDA and regulatory authorities in certain other countries of an abbreviated legal pathway to approve biosimilar products, which could subject our biologic products to competition from biosimilar products, with attendant competitive pressures, after the expiration of any applicable exclusivity period and patent rights;
• risks related to our ability to develop and launch biosimilars, including risks associated with "at risk" launches, defined as the marketing of a product by Pfizer before the final resolution of litigation (including any appeals) brought by a third party alleging that such marketing would infringe one or more patents owned or controlled by the third party;
• the ability to meet competition from generic, branded and biosimilar products after the loss of patent protection for our products or competitor products;
• the ability to successfully market both new and existing products domestically and internationally;
• difficulties or delays in manufacturing;
• trade buying patterns;
• the impact of existing and future legislation and regulatory provisions on product exclusivity;
• trends toward managed care and healthcare cost containment, and our ability to obtain or maintain timely or adequate pricing or formulary placement for our products;
• the impact of any significant spending reductions or cost controls affecting Medicare, Medicaid or other publicly funded or subsidized health programs or changes in the tax treatment of employer-sponsored health insurance that may be implemented, and/or any significant additional taxes or fees that may be imposed on the pharmaceutical industry as part of any broad deficit-reduction effort;
• the impact of any U.S. healthcare reform and legislation, including any repeal, substantial modification or invalidation of any or all of the provisions of the U.S. Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act;
• U.S. federal or state legislation or regulatory action and/or policy efforts affecting, among other things, pharmaceutical product pricing, reimbursement or access, including under Medicaid, Medicare and other publicly funded or subsidized health programs; patient out-of-pocket costs for medicines, manufacturer prices and/or price increases that could result in new mandatory rebates and discounts or other pricing restrictions; the importation of prescription drugs from outside the U.S. at prices that are regulated by governments of various foreign countries; restrictions on direct-to-consumer advertising; limitations on interactions with healthcare professionals; or the use of comparative effectiveness methodologies that could be implemented in a manner that focuses primarily on the cost differences and minimizes the therapeutic differences among pharmaceutical products and restricts access to innovative medicines; as well as pricing pressures for our products as a result of highly competitive insurance markets;
• legislation or regulatory action in markets outside the U.S. affecting pharmaceutical product pricing, reimbursement or access, including, in particular, continued government-mandated reductions in prices and access restrictions for certain biopharmaceutical products to control costs in those markets;
• the exposure of our operations outside the U.S. to possible capital and exchange controls, expropriation and other restrictive government actions, changes in intellectual property legal protections and remedies, as well as political unrest, unstable governments and legal systems and inter-governmental disputes;
• contingencies related to actual or alleged environmental contamination;
• claims and concerns that may arise regarding the safety or efficacy of in-line products and product candidates;
• any significant breakdown, infiltration or interruption of our information technology systems and infrastructure;
• legal defense costs, insurance expenses, settlement costs, the risk of an adverse decision or settlement and the adequacy of reserves related to product liability, patent matters, government investigations, consumer, commercial, securities, antitrust, environmental, employment, tax issues, ongoing efforts to explore various means for resolving asbestos litigation, and other legal proceedings;
• our ability to protect our patents and other intellectual property, both domestically and internationally;
• interest rate and foreign currency exchange rate fluctuations, including the impact of possible currency devaluations in countries experiencing high inflation rates and the volatility following the United Kingdom (U.K.) referendum in which voters approved the exit from the EU;
• governmental laws and regulations affecting domestic and foreign operations, including, without limitation, tax obligations and changes affecting the tax treatment by the U.S. of income earned outside the U.S. that may result from pending and possible future proposals;
• the end result of any negotiations between the U.K. government and the EU regarding the terms of the U.K.'s exit from the EU, which could have implications on our research, commercial and general business operations in the U.K. and the EU;
• any significant issues involving our largest wholesale distributors, which account for a substantial portion of our revenues;
• the possible impact of the increased presence of counterfeit medicines in the pharmaceutical supply chain on our revenues and on patient confidence in the integrity of our medicines;
• any significant issues that may arise related to the outsourcing of certain operational and staff functions to third parties, including with regard to quality, timeliness and compliance with applicable legal requirements and industry standards;
• any significant issues that may arise related to our joint ventures and other third-party business arrangements;
• changes in U.S. generally accepted accounting principles;
• uncertainties related to general economic, political, business, industry, regulatory and market conditions including, without limitation, uncertainties related to the impact on us, our customers, suppliers and lenders and counterparties to our foreign-exchange and interest-rate agreements of challenging global economic conditions and recent and possible future changes in global financial markets; and the related risk that our allowance for doubtful accounts may not be adequate;
• any changes in business, political and economic conditions due to actual or threatened terrorist activity in the U.S. and other parts of the world, and related U.S. military action overseas;
• growth in costs and expenses;
• changes in our product, segment and geographic mix;
• the impact of purchase accounting adjustments, acquisition-related costs, discontinued operations and certain significant items;
• the impact of acquisitions, divestitures, restructurings, internal reorganizations, product recalls, withdrawals and other unusual items, including our ability to realize the projected benefits of our cost-reduction and productivity initiatives, including those related to our research and development organization, and of the internal separation of our commercial operations into our current operating structure;
• the risk of an impairment charge related to our intangible assets, goodwill or equity-method investments;
• risks related to internal control over financial reporting; and
• risks and uncertainties related to our recent acquisitions of Hospira, Anacor, Medivation and AstraZeneca's small molecule anti-infectives business, including, among other things, the ability to realize the anticipated benefits of the acquisitions of Hospira, Anacor, Medivation and AstraZeneca's small molecule anti-infectives business, including the possibility that expected cost savings related to the acquisition of Hospira and accretion related to the acquisitions of Hospira, Anacor and Medivation will not be realized or will not be realized within the expected time frame; the risk that the businesses will not be integrated successfully; disruption from the transactions making it more difficult to maintain business and operational relationships; significant transaction costs; and unknown liabilities.

We cannot guarantee that any forward-looking statement will be realized. Achievement of anticipated results is subject to substantial risks, uncertainties and inaccurate assumptions. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors should bear this in mind as they consider forward-looking statements, and are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in our subsequent reports on Form 10-Q, in each case including in the sections thereof captioned “Forward-Looking Information and Factors That May Affect Future Results” and “Item 1A. Risk Factors”, and in our subsequent reports on Form 8-K.

The operating segment information provided in this earnings release and the related attachments does not purport to represent the revenues, costs and income from continuing operations before provision for taxes on income that each of our operating segments would have recorded had each segment operated as a standalone company during the periods presented.

This earnings release may include discussion of certain clinical studies relating to various in-line products and/or product candidates. These studies typically are part of a larger body of clinical data relating to such products or product candidates, and the discussion herein should be considered in the context of the larger body of data. In addition, clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate or a new indication for an in-line product, regulatory authorities may not share our views and may require additional data or may deny approval altogether.