Full Press Release Details
PFIZER REPORTS SECOND-QUARTER 2022 RESULTS
Second-Quarter 2022 Revenues of $27.7 Billion, Reflecting 53% Operational Growth, Driven Primarily by Strong Contributions from Paxlovid and Comirnaty(1)
Second-Quarter 2022 Reported Diluted EPS(2) of $1.73, Reflecting 77% Growth Over Second-Quarter 2021
Second-Quarter 2022 Adjusted Diluted EPS(3) of $2.04, Reflecting 92% Growth Over Second-Quarter 2021 Excluding Foreign Exchange Impacts, Adjusted Diluted EPS(3) Grew 100%
Raises Full-Year 2022 Financial Guidance(4) for Revenues and Adjusted Diluted EPS(3) by $2 Billion and $0.24, Respectively, on an Operational Basis (Which Excludes the Impact of Foreign Exchange)
-Including Foreign Exchange Impacts, Pfizer Reaffirms Revenue Guidance of $98.0 to $102.0 Billion and Raises Lower End of Adjusted Diluted EPS(3) Guidance by $0.05 to a Range of $6.30 to $6.45
-Reaffirms 2022 Revenue Guidance for Comirnaty(1) and Paxlovid of $32 Billion and $22 Billion, Respectively, Despite Unfavorable Impacts from Foreign Exchange
Pipeline Programs That Have Achieved Milestones Since Previous Earnings Release Include Bivalent mRNA COVID-19 Vaccine, Enhanced mRNA COVID-19 Vaccine, Paxlovid, modRNA Influenza Vaccine, Once-Daily Oral GLP-1 Receptor Agonist and Anti-Interferon-
NEW YORK, NY, Thursday, July 28, 2022 - Pfizer Inc. (NYSE PFE) reported strong financial results for second-quarter 2022 and updated certain components of 2022 financial guidance(4). Pfizer reaffirmed its previous 2022 revenue guidance, despite unfavorable impacts from foreign exchange, while reaffirming its revenue guidance for Comirnaty(1), the Pfizer-BioNTech SE (BioNTech) COVID-19 vaccine, and for Paxlovid, its oral COVID-19 treatment.
The second-quarter 2022 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer's R D pipeline can be found at www.pfizer.com.
EXECUTIVE COMMENTARY
Dr. Albert Bourla, Chairman and Chief Executive Officer, stated "In multiple meaningful ways, we made significant progress this quarter on our strategies to bring value to our patients and shareholders, while also making commitments to prioritize the broader needs of the world, including those of the environment and our most vulnerable populations. For example, we set an ambitious goal for ourselves to achieve the Net-Zero Standard for greenhouse gas emissions by 2040, ten years ahead of the timeline described in the standard. We also launched an initiative to help bring all of our current and future patented medicines and vaccines to the 1.2 billion people living in 45 lower-income countries around the world at not-for-profit prices, a first in the industry."
Dr. Bourla continued "Even while launching these initiatives to support a healthier, more equitable world, we remain equally committed to strong financial execution on behalf of our shareholders. In the second quarter, we
recorded the largest amount of quarterly sales in our history. We also presented potentially best-in-class data for etrasimod and announced the proposed strategic acquisition of Biohaven, both of which are closely tied to our purpose Breakthroughs that change patients' lives."
David Denton, Chief Financial Officer and Executive Vice President, stated "I am very pleased with the performance of our business this quarter, with strong operational revenue and earnings growth driven by multiple therapeutic areas across the company, and our COVID-19 franchises continuing to serve patients in need while also propelling us to an all-time high in quarterly sales. We continue to prioritize high-value uses for our capital, with an emphasis on reinvesting in our business by funding both internally and externally developed science and innovation while also continuing to grow our dividend and buy back shares, when appropriate, to help offset dilution. I am confident that Pfizer is well-positioned to continue to deliver exceptional value for our patients and shareholders going forward."
Results for the second quarter and the first six months of 2022 and 2021(5) are summarized below.
| ($ in millions, except per share amounts) | Second-Quarter | Six Months | ||||||||||
| 2022 | 2021 | Change | 2022 | 2021 | Change | |||||||
| Revenues | $ 27,742 | $ 18,899 | 47% | $ 53,402 | $ 33,415 | 60% | ||||||
| Reported Net Income (2) | 9,906 | 5,563 | 78% | 17,769 | 10,440 | 70% | ||||||
| Reported Diluted EPS (2) | 1.73 | 0.98 | 77% | 3.10 | 1.84 | 68% | ||||||
| Adjusted Income (3) | 11,656 | 6,023 | 94% | 20,993 | 11,375 | 85% | ||||||
| Adjusted Diluted EPS (3) | 2.04 | 1.06 | 92% | 3.66 | 2.01 | 82% |
| ($ in millions) | Second-Quarter | Six Months | ||||||||||||
| 2022 | 2021 | % Change | 2022 | 2021 | % Change | |||||||||
| Total | Oper. | Total | Oper. | |||||||||||
| Pfizer Biopharmaceuticals Group (Biopharma) | $ 27,425 | $ 18,463 | 49% | 55% | $ 52,748 | $ 32,588 | 62% | 68% | ||||||
| Vaccines | 10,459 | 9,234 | 13% | 20% | 25,399 | 14,127 | 80% | 87% | ||||||
| Hospital | 9,714 | 1,745 | * | * | 12,905 | 3,630 | * | * | ||||||
| Oncology | 3,088 | 3,145 | (2%) | 1% | 6,055 | 6,007 | 1% | 3% | ||||||
| Internal Medicine | 2,405 | 2,403 | - | 5% | 4,846 | 4,997 | (3%) | 1% | ||||||
| Rare Disease | 909 | 895 | 2% | 7% | 1,872 | 1,720 | 9% | 15% | ||||||
| Inflammation Immunology | 850 | 1,041 | (18%) | (14%) | 1,671 | 2,107 | (21%) | (17%) | ||||||
| Pfizer CentreOne | $ 317 | $ 437 | (27%) | (25%) | 655 | 827 | (21%) | (18%) | ||||||
| TOTAL REVENUES | $ 27,742 | $ 18,899 | 47% | 53% | $ 53,402 | $ 33,415 | 60% | 66% |
* Indicates calculation not meaningful.
Beginning in the first quarter of 2022, Adjusted(3) financial measures include expenses for all acquired in-process research and development (IPR D) costs incurred in connection with upfront and milestone payments on collaboration and in-license agreements, including premiums on equity securities, as well as asset acquisitions of acquired IPR D and are reported as a separate income statement line item. Previously, these costs were recorded within the R D expenses line item and certain of these costs were excluded from Adjusted(3) results. The change to include all acquired IPR D expenses within Adjusted(3) results had no impact on Adjusted(3) diluted EPS in second-quarter 2022 and negatively impacted Adjusted(3) diluted EPS by $0.03 in second-quarter 2021.
Also in the first quarter of 2022, Pfizer implemented a change in policy to exclude all amortization of intangibles from Adjusted(3) income, which favorably impacted Adjusted(3) diluted EPS by $0.02 in second-quarter 2022 and by $0.03 in second-quarter 2021.
Prior period amounts have been revised to conform to the current period presentation for both amortization of intangibles and acquired IPR D.
Business development activities(6) completed in 2021 and 2022(5) impacted financial results in the periods presented. Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates(7).
2022 FINANCIAL GUIDANCE(4)
Pfizer raised its 2022 financial guidance, on an operational basis(7), for revenues and Adjusted diluted EPS(3) by approximately $2 billion and $0.24, respectively. After including the expected incremental unfavorable impacts of changes in foreign exchange rates since last quarter's earnings report, the guidance range for revenues remains unchanged and the bottom end of the guidance range for Adjusted diluted EPS(3) was increased by $0.05.
| Previous Guidance (as of May 3, 2022) | Operational Changes | Impact of Changes in Foreign Exchange Rates | Current Guidance (as of July 28, 2022) | |
| Revenues Operational Growth (7) vs. Prior Year Growth vs. Prior Year | $98.0 to $102.0 billion 25% to 30% 21% to 25% | $2 billion | ( $2 billion) | $98.0 to $102.0 billion 27% to 32% 21% to 25% |
| Adjusted Diluted EPS (3) Operational Growth (7) vs. Prior Year Growth vs. Prior Year | $6.25 to $6.45 59% to 64% 54% to 59% | $0.24 | ($0.19) | $6.30 to $6.45 63% to 67% 55% to 59% |
The midpoint of the guidance range for revenues reflects a 29% operational increase compared to 2021 revenues of $81.3 billion. This guidance includes the following assumptions related to Pfizer's COVID-19-related products
Comirnaty(1) revenues of approximately $32 billion, which reflects favorable operational updates compared to prior guidance, offset by unfavorable incremental impacts from foreign exchange. This guidance includes doses expected to be delivered in fiscal 2022(5), primarily under contracts signed as of mid-July 2022.
Paxlovid revenues of approximately $22 billion, which reflects favorable operational updates compared to prior guidance, offset by unfavorable incremental impacts from foreign exchange. This guidance includes treatment courses expected to be delivered in fiscal 2022(5), primarily relating to supply contracts signed or committed as of mid-July 2022.
The midpoint of the guidance range for Adjusted diluted EPS(3) reflects a 65% operational increase over the 2021 Adjusted diluted EPS(3) of $4.06, which has been revised from its original presentation to exclude all amortization of intangibles and to include the impact of all acquired IPR D expenses.
Financial guidance for Adjusted diluted EPS(3) is calculated using approximately 5.75 billion weighted average shares outstanding, and assumes no additional share repurchases in 2022. The expected increase in weighted average shares outstanding compared to 2021 of approximately 50 million shares has an unfavorable impact on 2022 Adjusted diluted EPS(3) of $0.03 at the midpoint of the guidance range.
Other components of Pfizer's 2022 financial guidance, all of which are presented with the expected impacts from changes in foreign exchange rates included, are presented below.
| Adjusted (3) Cost of Sales as a Percentage of Revenues | 32.0% to 34.0% | |
| Adjusted (3) SI A Expenses | $12.2 to $13.2 billion | |
| (previously $12.5 to $13.5 billion) | ||
| Adjusted (3) R D Expenses | $11.5 to $12.0 billion | |
| (previously $11.0 to $12.0 billion) | ||
| Acquired IPR D Expenses (4) | Approximately $0.9 billion | |
| Adjusted (3) Other (Income) Deductions | Approximately $1.9 billion of income | |
| Effective Tax Rate on Adjusted (3) Income | Approximately 15.5% | |
| (previously approximately 16.0%) |
Guidance for Adjusted(3) SI A expenses was decreased by $300 million compared to the previous guidance range, primarily reflecting lower expected selling expenses for certain products and geographies, as well as a decline in deferred compensation savings plan expenses, which are tied to market performance.
The midpoint of the guidance range for Adjusted(3) R D expenses was increased by $250 million compared to the previous guidance, primarily as a result of planned incremental investments in mRNA vaccine programs outside of COVID-19 as well as various other projects.
Guidance for the effective tax rate on Adjusted(3) income was lowered by 0.5 percentage points compared to the
previous guidance, reflecting favorability in the jurisdictional mix of earnings, settlements of global tax examinations and the expiration of local statutes of limitations, among other drivers.
During the first six months of 2022, Pfizer deployed its capital in a variety of ways, which primarily include the following two broad categories
Reinvesting capital into initiatives intended to enhance the future growth prospects of the company, including
$5.1 billion invested in internal research and development projects, and
More than $7 billion invested in completed business development transactions, including approximately $6.3 billion for the acquisition of Arena Pharmaceuticals, Inc.
Returning capital directly to shareholders through a combination of
$4.5 billion of cash dividends, or $0.80 per share of common stock, and
$2.0 billion, which was used to repurchase 39.1 million shares on the open market in March 2022, at an average cost of $51.10 per share.
In addition to the capital investments listed above, in the first six months of 2022, Pfizer announced the acquisitions of ReViral Ltd. (ReViral), which closed in the international third quarter of 2022, and Biohaven Pharmaceutical Holding Company Ltd. (Biohaven), which, upon completion, will require upfront capital investments totaling approximately $13.3 billion.
As of July 28, 2022, Pfizer's remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any additional share repurchases in 2022.
Second-quarter 2022 diluted weighted-average shares outstanding used to calculate Reported(2) and Adjusted(3) diluted EPS was 5,712 million shares, an increase of 35 million shares, primarily due to shares issued for employee compensation programs, partially offset by the impact of shares repurchased in first-quarter 2022, which resulted in a $0.01 reduction to Reported(2) and Adjusted(3) diluted EPS compared to the prior-year quarter.
QUARTERLY FINANCIAL HIGHLIGHTS (Second-Quarter 2022 vs. Second-Quarter 2021)
Second-quarter 2022 revenues totaled $27.7 billion, an increase of $8.8 billion, or 47%, compared to the prior-year quarter, reflecting operational growth of $10.1 billion, or 53%, as well as an unfavorable impact of foreign exchange of $1.3 billion, or 7%. Excluding growth from Paxlovid and Comirnaty(1), company revenues grew $128 million, or 1%, operationally.
Second-quarter 2022 operational growth was primarily driven by
Paxlovid, which contributed $8.1 billion in global sales, driven by the U.S. launch under emergency use authorization in December 2021 and international launches in late 2021 and early 2022 following regulatory approvals or emergency use authorizations
Comirnaty(1) globally, up 20% operationally, driven by strong operational growth in international markets, led by increased sales of doses to serve emerging markets and increased deliveries to certain international developed markets, partially offset by a slower pace of deliveries to the U.S. and Canada
Eliquis globally, up 23% operationally, driven primarily by continued oral anti-coagulant adoption and market share gains in non-valvular atrial fibrillation, particularly in the U.S. and certain markets in Europe, as well as favorable changes in channel mix in the U.S.
Prevnar family (Prevnar 13 20) in the U.S., up 41%, driven by strong stocking and patient demand following the launch of Prevnar 20 for the adult population, partially offset by unfavorable timing of government and private purchasing of Prevnar 13 for the pediatric indication and
Vyndaqel Vyndamax globally, up 16% operationally, driven by continued strong uptake of the transthyretin amyloid cardiomyopathy indication, primarily in the U.S. and developed Europe, partially offset by a planned price decrease which recently went into effect in Japan,
partially offset primarily by lower revenues for
Chantix globally, down 99% operationally, which continues to be negatively impacted by a global pause in shipments of Chantix due to the presence of N-nitroso-varenicline above an acceptable level of intake set by various global regulators, the ultimate timing for resolution of which may vary by country
Xeljanz in the U.S., down 35%, driven primarily by declines in net price due to unfavorable changes in channel mix, decreased prescription volumes resulting from ongoing shifts in prescribing patterns related to Janus kinase (JAK) class label changes, and unfavorable wholesaler inventory buying patterns and
Sutent globally, down 47% operationally, primarily reflecting lower volume demand in the U.S. and Europe following its loss of exclusivity in August 2021 and January 2022, respectively.
GAAP Reported(2) Income Statement Highlights
SELECTED REPORTED COSTS AND EXPENSES(2)
| ($ in millions) | Second-Quarter | Six Months | ||||||||||||
| 2022 | 2021 | % Change | 2022 | 2021 | % Change | |||||||||
| Total | Oper. | Total | Oper. | |||||||||||
| Cost of Sales (2) | $ 8,648 | $ 6,996 | 24% | 34% | $ 18,632 | $ 11,153 | 67% | 78% | ||||||
| Percent of Revenues | 31.2 | % | 37.0 | % | N A | N A | 34.9 | % | 33.4 | % | N A | N A | ||
| SI A Expenses (2) | 3,048 | 2,923 | 4% | 7% | 5,642 | 5,700 | (1%) | 1% | ||||||
| R D Expenses (2) | 2,815 | 2,239 | 26% | 27% | 5,116 | 4,233 | 21% | 22% | ||||||
| Acquired IPR D Expenses (2) | 1 | 219 | (100%) | (100%) | 356 | 238 | 50% | 50% | ||||||
| Other (Income) Deductions--net (2) | $772 | ($1,343) | * | * | $1,122 | ($2,347) | * | * | ||||||
| Effective Tax Rate on Reported Income (2) | 13.7% | 16.2 | % | 13.4 | % | 15.3 | % |
* Indicates calculation not meaningful.
Second-quarter 2022 Cost of Sales(2) as a percentage of revenues decreased 5.8 percentage points compared with the prior-year quarter. The drivers for the decrease include, among other things
favorable changes in sales mix, including significant sales of Paxlovid as well as higher alliance revenues, which have no associated cost of sales and
favorable impacts resulting from changes in foreign exchange rates,
higher sales of Comirnaty(1), which includes a charge for the 50% gross profit split with BioNTech and applicable royalty expenses and
a $450 million write-off of inventory related to COVID-19 products that have exceeded or are expected to exceed their approved shelf-lives prior to being used.
SI A Expenses(2) increased 7% operationally in second-quarter 2022 compared with the prior-year quarter, primarily reflecting higher investments for Paxlovid and Comirnaty and a higher provision for healthcare reform fees based on sales of Paxlovid and Comirnaty, partially offset by a decrease in deferred compensation savings plan expenses.
Second-quarter 2022 R D Expenses(2) increased 27% operationally compared with the prior-year quarter, primarily driven by increased investments across multiple late-stage clinical programs, including development costs and at-risk manufacturing for programs to prevent and treat COVID-19, as well as costs to develop recently acquired assets.
Acquired IPR D Expenses(2) decreased 100% operationally in second-quarter 2022 compared with the prior-year quarter, primarily reflecting the acquisition of Amplyx Pharmaceuticals, Inc. in second-quarter 2021, and no transactions giving rise to acquired IPR D expenses in second-quarter 2022.
Pfizer recorded $772 million of other deductions--net(2) in second-quarter 2022 compared with $1.3 billion of other income--net(2) in second-quarter 2021. The period-over-period change was primarily driven by
net losses on equity securities in second-quarter 2022 versus net gains on equity securities recognized in the prior-year quarter and
net periodic benefit costs associated with pension and postretirement plans incurred in second-quarter 2022 versus net periodic benefit credits recognized in second-quarter 2021.
Pfizer's effective tax rate on Reported income(2) for second-quarter 2022 decreased compared to the prior-year quarter primarily due to a favorable change in the jurisdictional mix of earnings.
Adjusted(3) Income Statement Highlights
SELECTED ADJUSTED(3) COSTS AND EXPENSES
| ($ in millions) | Second-Quarter | Six Months | ||||||||||||
| 2022 | 2021 | % Change | 2022 | 2021 | % Change | |||||||||
| Total | Oper. | Total | Oper. | |||||||||||
| Adjusted (3) Cost of Sales | $ 8,625 | $ 6,949 | 24% | 35% | $ 18,582 | $ 11,076 | 68% | 79% | ||||||
| Percent of Revenues | 31.1 | % | 36.8 | % | N A | N A | 34.8 | % | 33.1 | % | N A | N A | ||
| Adjusted (3) SI A Expenses | 2,900 | 2,778 | 4% | 7% | 5,396 | 5,421 | - | 2% | ||||||
| Adjusted (3) R D Expenses | 2,811 | 2,237 | 26% | 27% | 5,106 | 4,229 | 21% | 22% | ||||||
| Adjusted (3) Other (Income) Deductions--net | ($377) | ($576) | (34%) | (16%) | ($783) | ($1,177) | (33%) | (22%) | ||||||
| Effective Tax Rate on Adjusted Income (3) | 15.4 | % | 17.1 | % | 15.1 | % | 16.3 | % |
* Indicates calculation not meaningful.
Reconciliations of certain Reported(2) to Adjusted(3) financial measures and associated footnotes can be found in the financial tables section of this press release.
RECENT NOTABLE DEVELOPMENTS (Since May 3, 2022)
Product Developments
Comirnaty (COVID-19 vaccine, mRNA)(8)
Clinical and Research Developments
In May 2022, Pfizer and BioNTech announced topline safety, immunogenicity and vaccine efficacy data from a Phase 2 3 trial evaluating a third 3- g dose of the vaccine in children 6 months to under 5 years of age. Following a third dose in this age group, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. A formal analysis will be performed when at least 21 cases have accrued from seven days after the third dose, and will be shared once available.
In June 2022, Pfizer and BioNTech announced positive data evaluating the safety, tolerability and immunogenicity of two Omicron-adapted COVID-19 vaccine candidates one monovalent and the other bivalent, a combination of the current COVID-19 vaccine and a vaccine candidate targeting the spike protein of the Omicron BA.1 variant of concern. Data from the Phase 2 3 trial found that a booster dose of both Omicron-adapted vaccine candidates elicited a substantially higher immune response against Omicron BA.1 as compared to the companies' current COVID-19 vaccine. The robust immune response was seen across two investigational dose levels, 30- g and 60- g. One month after administration, a booster dose of the Omicron-adapted monovalent candidates (30- g and 60- g) increased neutralizing geometric mean titers (GMT) against Omicron BA.1 13.5 and 19.6-fold above pre-booster dose levels, while a booster dose of the Omicron-adapted bivalent candidates conferred a 9.1 and 10.9-fold increase in neutralizing GMTs against Omicron BA.1. Both Omicron-adapted vaccine candidates were well-tolerated in participants who received one or the other Omicron-adapted vaccine.
In July 2022, Pfizer and BioNTech announced the initiation of a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30- g dose level. This next-generation bivalent COVID-19 vaccine candidate, BNT162b5, consists of RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain (wild-type) and an Omicron variant. The enhanced spike protein encoded from the mRNAs in BNT162b5 have been modified with the aim of increasing the magnitude and breadth of the immune response that could better protect against COVID-19. This is the first of multiple vaccine candidates with an enhanced design which the companies plan to evaluate as part of a long-term scientific COVID-19 vaccine strategy to potentially generate more robust, longer-lasting and broader immune responses against SARS-CoV-2 infections and associated COVID-19.
Regulatory Developments
In May 2022, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for Comirnaty to include a booster dose after completion of the primary series of the vaccine in children 5 through 11 years of age. The 10- g booster dose is given at least five months after the second dose of the two-dose 10- g primary series.
In June 2022, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to include a SARS-CoV-2 Omicron component for COVID-19 boosters in the U.S. for the fall of 2022. Following the meeting, an official recommendation stated that the FDA has asked manufacturers, including Pfizer, to develop and begin clinical trials with a modified vaccine containing an Omicron BA.4 BA.5 component.
In June 2022, Pfizer and BioNTech announced that the European Medicines Agency (EMA) has initiated a rolling review for a variant-adapted version of the companies' COVID-19 vaccine. This rolling review is initially based on chemistry, manufacturing, and controls (CMC) data shared with EMA earlier in June. As clinical data become available, including data on immunogenicity against Omicron and its subvariants, it will be added to the rolling submission.
In June 2022, Pfizer and BioNTech announced the FDA granted EUA of Comirnaty as a three 3- g dose series for children 6 months through 4 years of age (also referred to as 6 months to less than 5 years of age). The 3- g dose was carefully selected as the preferred dose for children under 5 years of age based on safety, tolerability and immunogenicity data.
In July 2022, Pfizer and BioNTech announced that the companies have submitted a variation to the EMA requesting to update the Conditional Marketing Authorization (CMA) in the European Union (EU) with data supporting the vaccination of children ages 6 months to less than 5 years of age with the 3- g dose of Comirnaty as a three-dose series.
In July 2022, Pfizer and BioNTech announced the FDA approved the companies' supplemental Biologics License Application (sBLA) for Comirnaty to include individuals 12 through 15 years of age. The vaccine was previously made available to this age group in the U.S. under EUA, and to date more than 9 million 12- to 15-year-old adolescents in the U.S. have completed a primary series. Pfizer and BioNTech have also filed for regulatory approval of the vaccine for this age group with the EMA and other regulatory authorities around the world.
Commercial Developments
In May 2022, Pfizer and BioNTech announced an agreement with the European Commission (EC) to amend their originally agreed contractual delivery schedules for Comirnaty. The
amendment rephases planned deliveries to help support the EC and Member States' ongoing immunization programs and is aligned to the companies' commitment to working collaboratively to identify pragmatic solutions to address the evolving pandemic needs. Doses scheduled for delivery in June through August 2022 will now be delivered in September through fourth-quarter 2022. This change of delivery schedule did not impact the companies' full-year 2022 revenue guidance or the full-year commitment of doses to be delivered to EC Member States in 2022.
In June 2022, Pfizer and BioNTech announced a new vaccine supply agreement with the U.S. government to provide an additional 105 million COVID-19 doses (30- g, 10- g and 3- g) that may include adult Omicron-adapted COVID-19 vaccines, subject to authorization from the FDA. The doses are planned to be delivered as soon as late summer 2022 and continue into the fourth quarter of this year. The U.S. government will pay the companies $3.2 billion upon delivery of the first 105 million doses. The U.S. government also has the option to purchase up to 195 million additional doses, bringing the total number of potential doses to 300 million.
Ibrance (palbociclib)
In May 2022, Pfizer announced the presentation of real-world evidence of 2,888 patients demonstrating an associated benefit for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC) patients treated with Ibrance in combination with an aromatase inhibitor (AI), as compared to AI alone, in the first-line setting. After balancing for baseline demographic and clinical characteristics, palbociclib + AI versus AI alone was associated with a 24% reduction in the risk of death (HR 0.76 95% CI, 0.65-0.87 ) and a 30% reduction in the risk of disease progression (HR 0.70 95% CI, 0.62-0.78 ) in the observational, retrospective real-world analysis. Safety data were not collected as part of this analysis.