On October 31, 2023 Pfizer Inc. (NYSE: PFE) reported financial results for the third quarter of 2023 (Press release, Pfizer, OCT 31, 2023, View Source [SID1234636550]). The company reaffirms its 2023 revenue guidance(4) range of $58.0 to $61.0 billion and its outlook for Adjusted(3) diluted EPS of $1.45 to $1.65 provided on October 13, 2023.
The third-quarter 2023 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.
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EXECUTIVE COMMENTARY
Dr. Albert Bourla, Chairman and Chief Executive Officer, stated: "We are encouraged by the strong performance of Pfizer’s non-COVID products in the third quarter of 2023, including significant contributions from new launches and robust year-over-year growth for several key in-line brands. We also have achieved several recent milestones that speak to the underlying strength and breadth of our scientific pipeline, including the U.S. and European Commission (EC) approval and launch of Abrysvo in pregnant individuals, and EC approval and launch of Abrysvo in older adults; the U.S. approval and launch of Elrexfio; U.S. approvals of Penbraya, Velsipity and of the Braftovi+Mektovi combination in BRAF-mutated metastatic non-small cell lung cancer; and EC approval of Litfulo.
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"In addition, we continue to make progress toward our proposed acquisition of Seagen, a global leader in discovering, developing and commercializing transformative oncology medicines that we believe can help us conquer cancer in the coming years—and earlier this month, we received unconditional antitrust clearance from the EC on the proposed acquisition, a decision we believe confirms our view that the transaction is pro-competitive, reflective of our complementary portfolios and good for patients.
"With a significant uncertainty removed by our recently announced amended Paxlovid supply agreement with the U.S. government, our expectation of additional clarification on global vaccination and treatment rates by the end of the year, and the breakthroughs continuing to emerge from our pipeline, we look forward to concluding 2023 with positive momentum that showcases Pfizer’s long-term growth potential."
David Denton, Chief Financial Officer and Executive Vice President, stated: "We are extremely pleased by the strong 10% operational revenue growth of Pfizer’s non-COVID products in the third quarter of 2023. With expected contributions from our new product launches, this puts us squarely on track to meet our full-year non-COVID operational revenue growth target of 6% to 8%. In addition, we launched our cost realignment program, from which we expect to achieve at least $3.5 billion of net cost savings by the end of 2024. Combined with the momentum of our non-COVID product portfolio and U.S. commercialization of Paxlovid, we expect the program to yield improved operating margins this year and help drive Pfizer’s growth through the end of the decade and beyond."
Results for the third quarter of 2023 and 2022(5) are summarized below.
OVERALL RESULTS
($ in millions, except
per share amounts) Third-Quarter Nine Months
2023 2022 Change 2023 2022 Change
Revenues $ 13,232 $ 22,638 (42%) $ 44,247 $ 76,040 (42%)
Reported(2) Net Income/(Loss)
(2,382) 8,608 * 5,488 26,378 (79%)
Reported(2) Diluted EPS/(LPS)
(0.42) 1.51 * 0.96 4.60 (79%)
Adjusted(3) Income/(Loss)
(968) 10,172 * 9,908 31,165 (68%)
Adjusted(3) Diluted EPS/(LPS)
(0.17) 1.78 * 1.73 5.44 (68%)
* Indicates calculation not meaningful.
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REVENUES
($ in millions) Third-Quarter Nine Months
2023 2022 % Change 2023 2022 % Change
Total Oper. Total Oper.
Global Biopharmaceuticals Business (Biopharma)
$ 12,930 $ 22,319 (42%) (42%) $ 43,320 $ 75,066 (42%) (41%)
Primary Care
6,287 15,846 (60%) (60%) 23,602 55,676 (58%) (56%)
Specialty Care
3,757 3,404 10% 12% 11,021 10,267 7% 11%
Oncology
2,885 3,070 (6%) (5%) 8,696 9,124 (5%) (3%)
Business Innovation $ 302 $ 319 (5%) (7%) $ 928 $ 974 (5%) (4%)
TOTAL REVENUES $ 13,232 $ 22,638 (42%) (41%) $ 44,247 $ 76,040 (42%) (40%)
In the first quarter of 2023, Pfizer established an operating segment, Business Innovation, that includes Pfizer CentreOne (PC1), the company’s global contract development and manufacturing organization and a leading supplier of specialty active pharmaceutical ingredients; and Pfizer Ignite, a recently launched offering that provides strategic guidance and end-to-end R&D services to select innovative biotech companies that align with Pfizer’s R&D focus areas. The prior period has been revised to conform to the current period presentation.
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(6).
CAPITAL ALLOCATION
During the first nine months of 2023, Pfizer deployed its capital in a variety of ways, which primarily include the following two categories:
▪Reinvesting capital into initiatives intended to enhance the future growth prospects of the company, including $7.9 billion invested in internal research and development projects, and
▪Returning capital directly to shareholders through $6.9 billion of cash dividends, or $1.23 per share of common stock.
No share repurchases have been completed to date in 2023. As of October 31, 2023, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2023.
For the third quarter of 2023, basic weighted-average shares outstanding of 5,646 million were used to calculate Reported(2) and Adjusted(3) diluted LPS.
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2023 FINANCIAL GUIDANCE(4)
Pfizer reaffirms its full-year 2023 guidance(4) for Revenues, Adjusted(3) diluted EPS and Effective Tax Rate on Adjusted(3) Income provided on October 13, 2023, which is presented below. This guidance incorporates the impacts of certain one-time items, noted below.
2023 Financial Guidance(4)
One-Time Items Included in Guidance(a)
Revenues*
$58.0 to $61.0 billion
$(4.2) billion
Operational(6) Decline vs. Prior Year
(41%) to (38%)
Decline vs. Prior Year
(42%) to (39%)
Non-cash Inventory Write-offs(a)
$5.6 billion
Adjusted(3) Diluted EPS*
$1.45 to $1.65
$(1.47)
Operational(6) Decline vs. Prior Year
(75%) to (72%)
Decline vs. Prior Year
(78%) to (75%)
(a) One-time items include a non-cash revenue reversal of approximately $4.2 billion related to the return of an estimated 7.9 million treatment courses of U.S. government EUA-labeled Paxlovid expected in the fourth quarter of 2023 and a non-cash charge of $5.6 billion recorded to Cost of Sales in the third quarter of 2023 for COVID products inventory write-offs and other charges.
* Changes in foreign exchange rates have had a minimal incremental impact since full-year 2023 guidance was issued. Please refer to Press Release Footnote (4) for additional information.
The midpoint of the guidance range for revenues reflects a 40% operational decrease compared to 2022 revenues. Company revenues are anticipated to be lower in 2023 than in 2022 due to expected revenue declines for Pfizer’s COVID-19 products, partially offset by expected operational growth from our non-COVID-19 in-line portfolio, new product and indication launches and recently acquired products.
Excluding COVID-19 products, Pfizer is expecting 6% to 8% operational revenue growth in 2023. Revenue guidance for Pfizer’s COVID-19 products is as follows:
▪Comirnaty(1) revenues of approximately $11.5 billion, down 70% from 2022 results.
▪Paxlovid revenues of approximately $1 billion, down 95% from 2022 results.
▪In contrast to previous years, guidance for both products is no longer based primarily on expected deliveries under existing signed or committed supply contracts, but now also includes, among other things, for Comirnaty(1), transition to traditional commercial market sales in the U.S. in September 2023; and for Paxlovid, expected transition to traditional commercial markets in the U.S. in November 2023, with minimal uptake of New Drug Application (NDA)-labeled commercial product expected before January 1, 2024.
The midpoint of the guidance range for Adjusted(3) diluted EPS reflects a 74% operational decrease compared to 2022, primarily driven by the one-time items referenced in Footnote (a) above, anticipated lower revenues from COVID-19 products, higher spending to support new product and indication launches and greater investment in certain late-stage pipeline projects.
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Financial guidance for Adjusted(3) diluted EPS is calculated using approximately 5.72 billion weighted average shares outstanding, and assumes no share repurchases in 2023.
Pfizer also updated certain other components of its 2023 financial guidance, which are presented below. The increase in guidance for Adjusted Cost of Sales as a Percentage of Revenues reflects the impact of the non-cash charge of $5.6 billion recorded to Cost of Sales in the third quarter of 2023 for inventory write-offs and other charges. The decreases in guidance for Adjusted(3) SI&A and R&D Expenses are primarily due to Pfizer’s expectation to realize $1.0 billion of cost savings in 2023 as part of its enterprise-wide cost realignment program. The increase in guidance for Adjusted(3) Other (Income) is primarily due to an improved interest rate environment and anticipated higher income from equity-method investments.
Adjusted(3) Cost of Sales as a Percentage of Revenues
41.0% to 43.0%
(previously 28.0% to 30.0%)
Adjusted(3) SI&A Expenses
$13.3 to $14.3 billion
(previously $13.8 to $14.8 billion)
Adjusted(3) R&D Expenses
$11.9 to $12.9 billion
(previously $12.4 to $13.4 billion)
Acquired IPR&D Expenses(4)
Approximately $0.1 billion
Adjusted(3) Other (Income)/Deductions
Approximately $1.9 billion of income
(previously approximately $1.5 billion of income)
Effective Tax Rate on Adjusted(3) Income
Approximately 12.0%
Pfizer’s 2023 financial guidance is based on estimates and assumptions that are subject to significant uncertainties. See the Overview of Our Performance, Operating Environment, Strategy and Outlook — Our 2022 Performance and — The Global Economic Environment sections of Management’s Discussion and Analysis of Financial Condition and Results of Operations (MD&A) in Pfizer’s 2022 Annual Report on Form 10-K; and the Overview of Our Performance, Operating Environment, Strategy and Outlook — Our Second Quarter 2023 and First Six Months of 2023 Performance and — The Global Economic Environment sections of MD&A in Pfizer’s Quarterly Report on Form 10-Q for the quarterly period ended July 2, 2023 (available at www.pfizer.com); as well as Pfizer’s press release issued on October 13, 2023 (View Source), for additional information.
QUARTERLY FINANCIAL HIGHLIGHTS (Third-Quarter 2023 vs. Third-Quarter 2022)
Third-quarter 2023 revenues totaled $13.2 billion, a decrease of $9.4 billion, or 42%, compared to the prior-year quarter, reflecting an operational decline of $9.3 billion, or 41%, primarily due to a decrease in Paxlovid and Comirnaty(1) revenues globally, as well as a de minimis impact of foreign exchange. Excluding contributions from Comirnaty(1) and Paxlovid, company revenues grew $1.1 billion, or 10%, operationally.
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Third-quarter 2023 Paxlovid revenues declined $7.3 billion, or 97%, operationally compared with the prior-year quarter, primarily driven by no third quarter U.S. sales in anticipation of commercial transition and lower contractual deliveries in most international markets.
Third-quarter 2023 Comirnaty(1) revenues declined $3.1 billion, or 70%, operationally compared with the prior-year quarter, largely driven by lower U.S. government contracted deliveries and lower contracted deliveries and demand in international markets, due to anticipated transition to new variant vaccines globally and to traditional U.S. commercial market sales beginning in September 2023.
Excluding contributions from Comirnaty(1) and Paxlovid, third-quarter 2023 operational revenue growth was primarily driven by:
▪U.S. revenues from Abrysvo, which contributed $375 million following FDA approval of the older adult indication in May 2023 and publication of the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommendation in the CDC’s Morbidity and Mortality Weekly Report (MMWR) in July 2023.
▪Nurtec ODT/Vydura and Oxbryta, which were acquired in the fourth quarter of 2022 and contributed $233 million and $85 million in global revenues, respectively;
▪Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 47% operationally, largely driven by continued strong uptake of the transthyretin amyloid cardiomyopathy (ATTR-CM) indication, primarily in the U.S. and developed Europe; and
▪Prevnar family (Prevnar 13 & 20) globally, up 15% operationally, primarily driven by strong patient demand for Prevnar 20 (adult) in the U.S., the U.S. approval of Prevnar 20 (pediatric) and associated stocking, and growth of Prevenar 13 (pediatric) in certain emerging markets; partially offset by anticipated lower market share for Prevnar (pediatric) in the U.S. due to competitive entry.
RECENT NOTABLE DEVELOPMENTS (Since August 1, 2023)
Product Developments
▪Abrilada (adalimumab-afzb) – In October 2023, Pfizer announced the FDA designated Abrilada as an interchangeable biosimilar to Humira(7) (adalimumab). The interchangeable designation applies to all approved indications of Abrilada, including certain patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.
▪Abrysvo (Respiratory Syncytial Virus Vaccine)
•In August 2023, Pfizer announced the FDA approved Abrysvo, the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age. The CDC’s ACIP subsequently recommended Abrysvo for use in pregnant people during 32 through 36 weeks gestation, using seasonal administration, to prevent RSV lower respiratory tract infection in infants. This recommendation was published in the CDC’s MMWR in October 2023, triggering commercial and Medicaid coverage.
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•In August 2023, Pfizer announced the EC granted marketing authorization for Abrysvo for passive protection against LRTD caused by RSV in infants from birth through six months of age following maternal immunization during pregnancy (between weeks 24 and 36 of gestation) and for active immunization of individuals 60 years of age and older for the prevention of LRTD caused by RSV. The authorization is valid in all 27 European Union (EU) member states plus Iceland, Liechtenstein and Norway.
▪Braftovi (encorafenib) and Mektovi (binimetinib) – In October 2023, Pfizer announced the FDA approved Braftovi in combination with Mektovi for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. The approval was based on data from the ongoing Phase 2 PHAROS clinical trial, an open-label, multicenter, single‑arm study examining Braftovi + Mektovi combination therapy in both treatment-naïve and previously treated patients with BRAF V600E-mutant metastatic NSCLC.
▪Comirnaty (COVID-19 Vaccine, mRNA)(8)
•In September 2023, Pfizer and BioNTech SE (BioNTech) announced the FDA approved the companies’ supplemental Biologics License Application (Comirnaty 2023-2024 Formulation) for individuals 12 years and older and granted Emergency Use Authorization (EUA) for individuals 6 months through 11 years of age for the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine. The CDC’s ACIP subsequently recommended a COVID-19 vaccine updated for 2023-2024 for everyone aged 6 months and older; this recommendation was adopted by the CDC Director in September and is now official.
•In August 2023, Pfizer and BioNTech’s Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (Comirnaty Omicron XBB.1.5) received marketing authorization by the EC for individuals 6 months of age and older.
▪Elrexfio (elranatamab-bcmm)
•In October 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending marketing authorization for Elrexfio for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. The EC, which authorizes central marketing approvals in the EU, will take a legally binding decision based on the CHMP recommendation and is expected to make a final decision in the coming months. If granted, the decision will apply to all 27 EU member states plus Iceland, Liechtenstein and Norway.
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•In August 2023, Pfizer announced the FDA granted accelerated approval to Elrexfio for the treatment of adult patients with RRMM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Elrexfio is the first off-the-shelf (ready-to-use) fixed-dose, subcutaneous B-cell maturation antigen (BCMA)-directed agent in the U.S. with the option for every-other-week long-term dosing after 24 weeks of weekly treatment (for patients who have achieved a response and maintained it for at least two months). Approval was based on the results of the single-arm Phase 2 MagnetisMM-3 trial, and continued approval for this indication is contingent upon verification of clinical benefit in a confirmatory trial(s).
▪Litfulo (ritlecitinib) – In September 2023, Pfizer announced the EC granted marketing authorization for Litfulo, a once-daily oral capsule to treat adults and adolescents 12 years of age and older with severe alopecia areata. The marketing authorization for Litfulo is valid in all 27 EU member states and in Iceland, Liechtenstein and Norway. Litfulo is the first medicine authorized by the EC to treat individuals as young as 12 years of age with severe alopecia areata and is the first and only treatment to selectively inhibit Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases.
▪Paxlovid (nirmatrelvir tablets and ritonavir tablets)(8) – In October 2023, Pfizer announced an amended agreement with the U.S. government, which will facilitate the transition of Paxlovid to traditional commercial markets in November 2023 (with minimal uptake of NDA-labeled commercial product expected before January 1, 2024), with prices to be negotiated with commercial payers and a copay assistance program for eligible privately insured patients. Components of the agreement include:
•A non-cash return of any remaining EUA-labeled U.S. government inventory at the end of 2023, estimated to be 7.9 million treatment courses, with an associated revenue reversal of approximately $4.2 billion;
•The conversion of those remaining EUA-labeled treatment courses previously purchased by the U.S. government to a volume-based credit, which will support continued access to Paxlovid through a U.S. government patient assistance program (PAP) operated by Pfizer. The PAP will provide the estimated 7.9 million treatment courses of FDA-approved, NDA-labeled Paxlovid free of charge to all eligible uninsured, Medicare and Medicaid patients through 2024, and to eligible uninsured and underinsured patients through 2028; and
•The creation of a U.S. Strategic National Stockpile of 1.0 million treatment courses to enable future pandemic preparedness through 2028, to be managed and supplied by Pfizer at no cost to the U.S. government or taxpayers.
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For more information on the amended agreement, please visit View Source
▪Penbraya (meningococcal groups A, B, C, W and Y vaccine) – In October 2023, Pfizer announced the FDA approved Penbraya, the first and only pentavalent vaccine that provides coverage against the five most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age. Penbraya combines the components from Pfizer’s Trumenba (meningococcal group B vaccine) and Nimenrix (meningococcal groups A, C, W-135, and Y conjugate vaccine) to help protect against the five most common meningococcal serogroups that cause the majority of invasive meningococcal disease globally. The CDC’s ACIP subsequently recommended Penbraya for adolescents and young adults 16 to 23 years of age when both MenACWY and MenB vaccines are indicated at the same visit to help protect against the five leading causes of meningococcal disease.
▪Velsipity (etrasimod) – In October 2023, Pfizer announced the FDA approved Velsipity, an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC). The approval of Velsipity was based on favorable safety and efficacy data from the ELEVATE UC Phase 3 trials that were published by The Lancet in March 2023.
Pipeline Developments
A comprehensive update of Pfizer’s development pipeline was published today and is now available at www.pfizer.com/science/drug-product-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 some candidates in Phase 1 and all candidates from Phase 2 through registration.
▪Combination COVID-19 & Influenza mRNA Vaccine (PF-07926307) – In October 2023, Pfizer and BioNTech announced positive topline results from a Phase 1/2 study evaluating the safety, tolerability and immunogenicity of mRNA-based combination vaccine candidates for influenza and COVID-19 among healthy adults 18 to 64 years of age. In the clinical trial, the vaccine candidates were compared to a licensed influenza vaccine and the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine given at the same visit. The data from the trial showed that the companies’ lead formulations demonstrated robust immune responses to influenza A, influenza B and SARS-CoV-2 strains, and that the combination formulations evaluated had a safety profile consistent with the safety profile of the companies’ COVID-19 vaccine. A pivotal Phase 3 trial evaluating these lead formulations is expected to be initiated in the coming months.
▪First-Generation modFlu mRNA Influenza Vaccine Candidate (PF-07252220) – Today, Pfizer announces that both primary endpoints were met in the 18- to 64-year-old cohort of the ongoing Phase 3 trial evaluating its first-generation modFlu mRNA influenza vaccine candidate. In the cohort, the mRNA vaccine candidate demonstrated non-inferiority and superiority to a licensed flu vaccine at the time of the primary analysis. Efficacy was maintained through the trial’s end of season analysis for the 18- to 64-year-old cohort, with the vaccine candidate remaining non-inferior to the licensed comparator. Both the primary and end of season efficacy analyses considered both influenza A and B cases collectively, though the vast majority of cases recorded in this cohort, and during the 2022/2023 flu season overall, were influenza A cases. Secondary immunogenicity endpoints were achieved only for A strains, not B strains. The safety profile of the mRNA vaccine candidate in the 18- to 64-year-old cohort was similar to that of standard flu vaccine. A readout from the Phase 3 trial’s cohort in adults ages 65 and over is expected later this year.
▪VLA15 (Lyme Disease Vaccine Candidate) – In September 2023, Pfizer and Valneva SE announced positive pediatric and adolescent immunogenicity and safety data for their Lyme disease vaccine candidate, VLA15, when given as a booster. These results from the VLA15-221 Phase 2 study showed a strong anamnestic antibody response for all serotypes in pediatric (5 to 11 years of age) and adolescent (12 to 17 years of age) participants, as well as in adults (18 to 65 years of age), one month after administration of a booster dose (month 19). The safety and tolerability profile of VLA15 after a booster dose was consistent with previous studies, as the vaccine candidate was well-tolerated in all age groups regardless of the primary vaccination schedule. No vaccine-related serious adverse events and no safety concerns were observed by an independent Data Safety Monitoring Board.
Corporate Developments
▪In October 2023, Pfizer announced that it has launched a multi-year, enterprise-wide cost realignment program that aims to realign its costs with its longer-term revenue expectations. The program is expected to deliver annual net cost savings of at least $3.5 billion, of which approximately $1.0 billion is expected to be realized in 2023 and at least an additional $2.5 billion is expected to be realized in 2024 compared to the midpoint of SI&A and R&D expense guidance provided on August 1, 2023. The one-time costs to achieve the savings associated with the new cost realignment program are expected to be approximately $3.0 billion, of which the majority is expected to be cash. These costs will primarily include severance and implementation costs. Pfizer will continue to refine the estimated savings and their associated costs over the remainder of the year and will incorporate them into its full-year guidance for 2024.
Additional Developments
▪In September 2023, Pfizer announced it has restarted the majority of its manufacturing lines at its Rocky Mount, N.C., facility following severe damage from a tornado that hit the site in July 2023. The resumption of production also included the launch of one line in the site’s new sterile injectable manufacturing area referred to as R3, a state-of-the-art module approved earlier this year by the FDA. The first shipments of medicines to distribution centers are anticipated in the fourth quarter of 2023. The expedited restart is the first step toward full recovery for the facility as Pfizer restarts production through a phased approach, with full production across the site’s three manufacturing suites anticipated by the end of 2023. The supply of medicines impacted by the tornado is expected to be affected until at least mid-2024.