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. Pfizer will seek to present and publish outcomes from this clinical trial at a future date once safety and immunogenicity data have been fully analyzed. Therefore, Pfizer recorded its share of the JV’s earnings generated in first-quarter 2020 in its second-quarter 2020 operating results.
About Pfizer: Breakthroughs That Change Patients’ Lives. 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. Total Company(7) financial guidance reflects a full year of revenue and expense contributions from Biopharma and Upjohn and is presented below. Financial guidance for New Pfizer operating cash flow includes a $1.25 billion voluntary contribution to the U.S. qualified pension plans, planned for the second half of 2020. Ibrance in developed Europe, down 10% operationally, primarily reflecting continued strong demand, more than offset by pricing pressures in certain markets. New Pfizer will be a smaller, science-based company with a singular focus on innovation while also continuing to allocate significant capital directly to shareholders, primarily through dividends,” Mr. D’Amelio concluded.
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. 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. In May 2020, Pfizer announced positive top-line results from a second Phase 3 study (NCT03828617), which described the safety and evaluated the consistency of immune responses elicited across three different lots of PF-06482077 in adults 18 through 49 years of age not previously vaccinated against pneumococcal disease. Achievement of anticipated results is subject to substantial risks, uncertainties and inaccurate assumptions. Pfizer also made an equity investment of $113 million in BioNTech common stock. Approximately 99.6% of votes cast were voted in favor of the combination.
GAAP Reported(2) Income Statement Highlights, SELECTED TOTAL COMPANY REPORTED COSTS AND EXPENSES(2). Adjusted Cost of Sales(3) as a Percentage of Revenues. Both studies will expand the data on the safety and tolerability of the investigational vaccine in infants and include a control group of Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). References to operational variances pertain to period-over-period growth rates that exclude the impact of foreign exchange(5). Investors Second-quarter 2020 revenues included an estimated net unfavorable impact of approximately $500 million, or 4%, due to COVID-19, primarily reflecting unfavorable disruptions to wellness visits for pediatric and adult patients in the U.S. and lower demand for certain products in China, partially offset by increased U.S. demand for certain sterile injectable products as well as increased adult demand for Prevenar 13 in certain international markets. But Pfizer is ahead in some important ways. Pfizer Inc. (NYSE: PFE) announced today that it will be holding its rescheduled Investor Day virtually over two days: Monday, September 14, 2020 from 1:00 p.m. EDT to approximately 4:00 p.m. EDT and Tuesday, September 15, 2020 from 10:00 a.m. EDT to approximately 1:00 p.m. EDT. The forward-looking statements in the webcast speak only as of the original date of the webcast. This clinical lot consistency study is expected to satisfy licensure requirements for manufacturing consistency by the FDA, and other countries’ regulatory agencies. Exchange rate changes, however, can mask positive or negative trends in the business; therefore, Pfizer believes presenting operational variances provides useful information in evaluating the results of its business. Upjohn(10) financial guidance reflects a full-year 2020 contribution from the Upjohn business as it is presently being managed. Second-quarter 2020 Upjohn revenues in China grew 17% operationally, primarily driven by Lipitor and Norvasc.
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. Pfizer Inc. (NYSE: PFE) announced today that it will be holding its rescheduled Investor Day virtually over two days: Monday, September 14, 2020 from 1:00 p.m. EDT to approximately 4:00 p.m. EDT and Tuesday, September 15, 2020 from 10:00 a.m. EDT to approximately 1:00 p.m. EDT. Financial guidance for Adjusted diluted EPS(3) continues to assume no share repurchases in 2020. Patient visits with physicians, vaccination rates and the number of elective surgical procedures will gradually increase from second-quarter 2020 levels, beginning in third-quarter 2020; New-to-brand prescription trends for certain key products will gradually improve from second-quarter 2020 levels, beginning in third-quarter 2020; Gradual improvement in access to U.S. healthcare professionals for sales force colleagues; Clinical trial enrollment, including new study starts, continues throughout the remainder of 2020; Pfizer’s manufacturing and supply chain activities continue to not be materially disrupted; and. In July 2020, Pfizer and BioNTech announced an agreement with the United Kingdom for 30 million doses of BNT162, to be delivered in 2020 and 2021, subject to clinical success and regulatory approval or authorization. Some amounts in this press release may not add due to rounding. Pfizer Investor Day 2020 - Day 2. (1) The following acquisitions and other business development activity impacted financial results for the periods presented: (2) Revenues is defined as revenues in accordance with U.S. generally accepted accounting principles (GAAP). Second-quarter 2020 R&D Expenses(2) increased primarily due to upfront payments associated with two R&D agreements executed during the quarter. 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.
During the first six months of 2020, Pfizer paid $4.2 billion of dividends, composed of dividends of $0.38 per share of common stock in each of the first and second quarters of 2020. On June 8, 2020, Valneva SE (Valneva) announced that the antitrust-related condition precedent was met and, consequently, the agreement between Valneva and Pfizer that was previously announced in April 2020 became effective. Pfizer reports Adjusted income, certain components of Adjusted income, and Adjusted diluted EPS in order to portray the results of the company’s major operations––the discovery, development, manufacture, marketing and sale of prescription medicines and vaccines––prior to considering certain income statement elements. Therefore, Pfizer’s second quarter and first six months for U.S. subsidiaries reflects the three and six months ending on June 28, 2020 and June 30, 2019 while Pfizer’s second quarter and first six months for subsidiaries operating outside the U.S. reflects the three and six months ending on May 24, 2020 and May 26, 2019. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Adjusted EBITDA as defined is not a measurement of financial performance under GAAP, and should not be considered as an alternative to net income(2) or cash flow from operations determined in accordance with GAAP.
The U.S. government can acquire up to 500 million additional doses.
With this validation, the application is complete, and the EMA will now begin the review procedure. QUARTERLY FINANCIAL HIGHLIGHTS (Second-Quarter 2020 vs. Valneva and Pfizer will work closely together throughout the development of VLA15. Pfizer and Mylan expect the transaction to be completed in fourth-quarter 2020. The Form 10 was declared effective on June 30, 2020. (10) Financial guidance for Upjohn reflects a full-year 2020 contribution from the Upjohn business as it is presently being managed, which includes contributions from Pfizer’s Meridian subsidiary and the Pfizer-Mylan strategic collaboration in Japan (Mylan-Japan). This webcast may contain forward-looking statements about, among other things, 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 the reorganization of our commercial operations into three businesses effective at the beginning of our 2019 fiscal year, our acquisitions and other business development activities, our proposed transaction with GSK to combine our respective consumer healthcare businesses into a new consumer healthcare joint venture, our ability to successfully capitalize on growth opportunities or prospects, manufacturing and product supply and plans relating to share repurchases and dividends, among other things, that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.
Selecta Biosciences Down But Not Out, Pfizer Takes 9.9% Stake In CStone, ZSAN Plunges, AMAG On The Block? In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. Bryan Dunn 212.733.8917, www.pfizer.com/science/drug-product-pipeline, https://investors.Pfizer.com/financials/sec-filings/default.aspx, Second-Quarter 2020 Revenues of $11.8 Billion, Reflecting 9% Operational Decline; Excluding the Impact from Consumer Healthcare, 6% Operational Growth from Biopharma, Primarily Driven by Vyndaqel/Vyndamax, Eliquis, Ibrance, Inlyta and Xtandi, 31% Operational Decline from Upjohn, Primarily Due to U.S. Loss of Exclusivity of Lyrica in 2019, Partially Offset by 17% Operational Growth in China, Primarily Due to Lipitor and Norvasc, Raised Midpoint of 2020 Financial Guidance for Revenues by $0.1 Billion to $48.6 to $50.6 Billion and Adjusted Diluted EPS, Initiated Four Different Registration-Enabling Vaccine Candidate Programs Since May 2020, Including for Pneumococcal 20-Valent in Infants, Meningococcal Pentavalent, Respiratory Syncytial Virus and for COVID-19, Which Started Dosing Patients in the U.S. Why Pfizer Could Be a Bigger Coronavirus Winner Than Moderna Moderna had a head start in advancing its COVID-19 vaccine into clinical testing.
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