Pfizer Reports Strong Third-Quarter 2022 Results And Raises 2022 Outlook

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) reported solid financial results for third-quarter 2022 and updated certain components of 2022 financial guidance⁽⁴⁾. Pfizer raised the lower end of its 2022 revenue guidance range, while raising and narrowing its Adjusted diluted EPS⁽³⁾ guidance, despite unfavorable impacts from foreign exchange. Revenue guidance for Comirnaty⁽¹⁾ was raised by $2 billion, and was reaffirmed for Paxlovid.

The third-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: “I continue to be proud of our colleagues’ excellence, ingenuity and unwavering commitment to bringing breakthroughs to patients. Over the next 18 months, we expect to have up to 19 new products or indications in the market – including the five for which we have already begun co-promotion or commercialization earlier this year. Many of these 19 programs are already largely de-risked from a clinical perspective, the majority were discovered in-house, and nearly all would be for indications outside of COVID-19. This quarter, we set the stage for these potential launches by reorganizing our commercial operations to better capitalize on these opportunities. We also reported positive pivotal data for several of these exciting pipeline programs, including our RSV vaccine candidate for older adults and for infants through maternal vaccination, Prevnar 20 for children, the potential combination treatment of Talzenna and Xtandi in men with metastatic castration-resistant prostate cancer, and our pentavalent meningococcal vaccine candidate for adolescents and young adults. If approved, we expect each of these to be key contributors to our growth aspirations through 2025 and beyond.”

David Denton, Chief Financial Officer and Executive Vice President, stated: “Third-quarter results demonstrated commercial strength across many areas of our business, but was somewhat obscured by the incredibly strong performance in the prior year. We saw strong operational performance this quarter from key brands such as Paxlovid and Eliquis, particularly in the U.S., as well as the continued impressive launch of Prevnar 20 for adults in the U.S. In addition, we continue to make progress toward our goal of adding at least $25 billion in risk-adjusted 2030 revenues to Pfizer’s portfolio through business development. Since we last reported earnings, we completed the acquisitions of Biohaven and Global Blood Therapeutics, each of which bring significant scientific breakthroughs to Pfizer and which present opportunities where we believe we can add great value. I look forward to continuing to execute on Pfizer’s strategies to deliver breakthroughs to patients and value to shareholders.”

Results for the third quarter and the first nine months of 2022 and 2021⁽⁵⁾ are summarized below.

OVERALL RESULTS

REVENUES

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 negatively impacted Adjusted⁽³⁾ diluted EPS in the third quarters of 2022 and 2021 by $0.07 and $0.09, respectively.

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 $0.01 in third-quarter 2022 and by $0.02 in third-quarter 2021.

Beginning in the third quarter of 2022, Pfizer made several organizational changes to further transform its operations to better leverage its expertise in certain areas and in anticipation of potential future new product launches. These changes include establishing a new commercial structure within its Biopharma operating segment focused on three broad therapeutic areas (primary care, specialty care and oncology) and realigning certain enabling and platform functions across the organization to ensure alignment with this new operating structure⁽⁶⁾.

Prior period amounts have been revised to conform to the current period presentation for all changes discussed above.

Business development activities⁽⁷⁾ 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⁽⁸⁾.

2022 FINANCIAL GUIDANCE⁽⁴⁾

Pfizer raised its 2022 financial guidance, on an operational basis⁽⁸⁾, for revenues and Adjusted diluted EPS⁽³⁾ by approximately $1.7 billion and $0.19, respectively. After including the expected incremental unfavorable impacts of changes in foreign exchange rates since last quarter’s earnings report, the midpoints of the guidance ranges for revenues and Adjusted diluted EPS⁽³⁾ were increased by $750 million and $0.075, respectively.

Financial guidance ranges now reflect the closing of the Biohaven Pharmaceutical Holding Company Ltd. (Biohaven) and Global Blood Therapeutics, Inc. (GBT) acquisitions, which occurred early in the fourth quarter of 2022.

The midpoint of the guidance range for revenues reflects a 31% 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 $34 billion, which reflects favorable operational updates compared to prior guidance, partially 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-October 2022.
• Paxlovid revenues of approximately $22 billion, which remains unchanged from prior guidance. This guidance includes treatment courses expected to be delivered in fiscal 2022⁽⁵⁾, primarily relating to supply contracts signed or committed as of mid-October 2022.

The midpoint of the guidance range for Adjusted diluted EPS⁽³⁾ was raised by $0.075, despite an unfavorable $0.06 impact due to incremental acquired IPR&D expenses. This updated guidance reflects a 70% operational increase at the midpoint 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 $0.04 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.

Guidance for Adjusted⁽³⁾ cost of sales as a percentage of revenues was tightened around the higher end of the previous range, primarily reflecting the increase in revenue expectations for Comirnaty⁽¹⁾.

Guidance for Adjusted⁽³⁾ SI&A expenses was raised by $350 million at the midpoint and now includes additional spending related to recent acquisitions.

Guidance for acquired IPR&D expenses⁽⁴⁾ was increased by $500 million, primarily as a result of the acquisition of Biohaven early in the fourth quarter of 2022.

Guidance for the effective tax rate on Adjusted⁽³⁾ income was lowered by 3.0 percentage points compared to the previous guidance, reflecting tax benefits recorded in the third quarter of 2022 related to global income tax resolutions in multiple tax jurisdictions spanning multiple tax years, among other drivers.

CAPITAL ALLOCATION

During the first nine 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:
  • $7.8 billion invested in internal research and development projects, and
  • Approximately $8 billion invested in completed business development transactions, including approximately $6.4 billion⁽⁷⁾ for the acquisition of Arena Pharmaceuticals, Inc. and approximately $0.4 billion for the acquisition of ReViral Ltd. (ReViral).
• Returning capital directly to shareholders through a combination of:
  • $6.7 billion of cash dividends, or $1.20 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, early in the fourth quarter of 2022, Pfizer completed the acquisitions of Biohaven and GBT requiring total upfront capital deployments of approximately $12.8 billion and $5.6 billion, respectively, which includes the amounts paid for the acquired companies’ common shares, employee stock awards, outstanding debt and any preferred shares, less any cash acquired.

As of November 1, 2022, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any additional share repurchases in 2022.

Third-quarter 2022 diluted weighted-average shares outstanding used to calculate Reported⁽²⁾ and Adjusted⁽³⁾ diluted EPS were 5,718 million shares, a decrease of 7 million shares compared to the prior-year quarter, primarily due to shares repurchased in first-quarter 2022, partially offset by shares issued for employee compensation programs.

QUARTERLY FINANCIAL HIGHLIGHTS (Third-Quarter 2022 vs. Third-Quarter 2021)

Third-quarter 2022 revenues totaled $22.6 billion, a decrease of $1.4 billion, or 6%, compared to the prior-year quarter, reflecting an operational decline of $441 million, or 2%, as well as an unfavorable impact of foreign exchange of $957 million, or 4%. Excluding contributions from Paxlovid and Comirnaty⁽¹⁾, company revenues grew $213 million, or 2%, operationally.

Third-quarter 2022 operational decline was primarily driven by:

• Comirnaty⁽¹⁾ outside the U.S., down 86% operationally, driven primarily by a previously announced amendment to the supply agreement with the European Commission (EC) whereby all doses scheduled for delivery in June through August 2022 would instead be delivered in the fourth quarter of 2022 and similar shifts in scheduled deliveries to other developed countries, as well as slower demand in emerging markets;
• Lower revenues for certain Comirnaty-related manufacturing activities⁽¹⁾ performed on behalf of BioNTech SE (BioNTech), which decreased 96% operationally compared to the prior-year quarter;
• Xeljanz globally, down 14% operationally, driven primarily by decreased prescription volumes resulting from ongoing shifts in prescribing patterns related to Janus kinase (JAK) class label changes; and
• Sutent globally, down 43% operationally, primarily driven by lower volume demand in Europe following its loss of exclusivity in January 2022,

partially offset primarily by higher revenues for:

• Paxlovid, which contributed $7.5 billion in global revenues, driven by the U.S. launch under emergency use authorization (EUA) in December 2021 and international launches in late 2021 and early 2022 following regulatory approvals or EUAs;
• Comirnaty⁽¹⁾ in the U.S., up 83%, driven primarily by deliveries of the Omicron BA.4/BA.5-adapted bivalent booster, following its EUA in late-August 2022, as well as the granting of an EUA in June 2022 for a primary vaccination series for children 6 months to less than 5 years of age;
• Prevnar family (Prevnar 13 & 20) in the U.S., up 28%, driven by strong patient demand following the launch of Prevnar 20 for the eligible adult population, partially offset by unfavorable timing of government and private purchasing of Prevnar 13 for the pediatric indication;
• Eliquis in the U.S., up 33%, driven primarily by continued oral anti-coagulant adoption and market share gains in non-valvular atrial fibrillation, as well as favorable changes in channel mix; and
• Vyndaqel/Vyndamax globally, up 29% 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 that went into effect in Japan in second-quarter 2022.

GAAP Reported⁽²⁾ Income Statement Highlights

SELECTED REPORTED COSTS AND EXPENSES⁽²⁾

* Indicates calculation not meaningful.

Third-quarter 2022 Cost of Sales⁽²⁾ as a percentage of revenues decreased 14.5 percentage points compared with the prior-year quarter. The decrease was primarily driven by favorable changes in sales mix, including significant sales of Paxlovid and lower sales of Comirnaty⁽¹⁾, as well as favorable impacts resulting from changes in foreign exchange rates, partially offset by a charge of approximately $400 million related to excess raw materials for Paxlovid.

SI&A Expenses⁽²⁾ increased 21% operationally compared with the prior-year quarter, primarily reflecting increased spending for Paxlovid and Comirnaty⁽¹⁾ and a higher provision for U.S. healthcare reform fees based on sales of Paxlovid and Comirnaty⁽¹⁾, as well as additional investments to support recently launched products.

Third-quarter 2022 R&D Expenses⁽²⁾ increased 2% operationally compared with the prior-year quarter, primarily driven by increased costs to develop recently acquired assets, as well as investments for certain oncology and non-COVID-19 vaccines programs, partially offset by lower spending on programs to prevent and treat COVID-19 and various late-stage clinical programs.

Acquired IPR&D Expenses⁽²⁾ decreased 31% operationally compared with the prior-year quarter. In third-quarter 2022, Acquired IPR&D Expenses⁽²⁾ primarily included the upfront payment related to the closing of the acquisition of ReViral. In third-quarter 2021, it mainly included an upfront payment related to Pfizer’s global collaboration agreement with Arvinas, Inc.

Other income––net⁽²⁾ decreased 99% operationally in third-quarter 2022 compared with third-quarter 2021, primarily driven by:

• lower net periodic benefit credits associated with pension and postretirement plans incurred in third-quarter 2022 compared to the prior-year quarter;
• net losses on equity securities in third-quarter 2022 versus net gains on equity securities recognized in the prior-year quarter; and
• a $200 million intangible asset impairment charge in third-quarter 2022 associated with the discontinuation of the PF-07265803 (lamin A/C protein (LMNA)-related dilated cardiomyopathy) clinical program.

Pfizer’s effective tax rate on Reported income⁽²⁾ for third-quarter 2022 was impacted by tax benefits related to global income tax resolutions in multiple tax jurisdictions spanning multiple tax years that included the closing of U.S. Internal Revenue Service audits covering five tax years. Pfizer’s effective tax rate for third-quarter 2021 was negative, primarily as a result of certain initiatives executed in third-quarter 2021 associated with Pfizer’s investment in the Consumer Healthcare joint venture with GlaxoSmithKline plc.

Adjusted⁽³⁾ Income Statement Highlights

SELECTED ADJUSTED⁽³⁾ COSTS AND EXPENSES

Reconciliations of certain Reported⁽²⁾ to Adjusted⁽³⁾ financial measures and associated footnotes can be found in the financial tables section of the press release located at the hyperlink below.

RECENT NOTABLE DEVELOPMENTS (Since July 28, 2022)

Product Developments

• Comirnaty (COVID-19 vaccine, mRNA)⁽⁹⁾
  • Clinical and Research Developments
    • In August 2022, Pfizer and BioNTech announced updated efficacy results from a Phase 2/3 trial evaluating a three 3-µg dose series of Comirnaty in children 6 months through 4 years of age, reinforcing previously reported interim vaccine efficacy data collected in March and April 2022. Vaccine efficacy, a secondary endpoint in the trial, was 73.2% (2-sided 95% CI: 43.8%, 87.6%) among children 6 months through 4 years of age without evidence of prior COVID-19 infection. This analysis was based on 13 cases in the vaccine group (n=794) and 21 cases in the placebo group (n=351), diagnosed from March to June 2022. Three 3-µg doses of Comirnaty continued to be well-tolerated in this age group.
    • In October 2022, Pfizer and BioNTech announced early data from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of the companies’ Omicron BA.4/BA.5-adapted bivalent vaccine. A 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine demonstrated a substantial increase in the Omicron BA.4/BA.5 neutralizing antibody response above pre-booster levels based on sera taken 7 days after administration, with similar responses seen across individuals aged 18 to 55 years of age and those older than 55 years of age (40 participants in each age group). Together, these data suggest a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine is anticipated to provide better protection against the Omicron BA.4 and BA.5 variants than the original vaccine for younger and older adults. The Omicron BA.4/BA.5-adapted bivalent vaccine was well tolerated with early data indicating a favorable safety profile, similar to that of the original vaccine.
  • U.S. Regulatory Developments
    • In August 2022, Pfizer and BioNTech announced the U.S. Food and Drug Administration (FDA) granted EUA of a 30-µg booster dose of an Omicron-adapted bivalent vaccine for individuals ages 12 years and older. The authorization of the bivalent COVID-19 vaccine is based on clinical data from Pfizer and BioNTech’s Omicron BA.1-adapted bivalent vaccine as well as pre-clinical and manufacturing data from their Omicron BA.4/BA.5-adapted bivalent vaccine. Clinical data from a Phase 2/3 trial showed a booster dose of the Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 subvariant compared to Comirnaty, with a favorable safety profile. Additionally, pre-clinical data showed a booster dose of the BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against the Omicron BA.1, BA.2, BA.4 and BA.5 subvariants, as well as the original virus.
    • In October 2022, Pfizer and BioNTech announced the FDA granted EUA for a 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age. The EUA is supported by safety and immunogenicity data from the companies’ 30-µg bivalent Omicron BA.1-adapted bivalent vaccine, non-clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted bivalent vaccine, and pre-clinical data from the 30-µg Omicron BA.4/BA.5-adapted bivalent vaccine. The companies will supply the original and bivalent vaccines under their existing supply agreement with the U.S. government.
  • European Union (EU) Regulatory Developments
    • In September 2022, Pfizer and BioNTech announced a 30-µg booster dose of the Omicron BA.1 bivalent vaccine (Comirnaty Original/Omicron BA.1 15/15 µg) was recommended for conditional marketing authorisation (CMA) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals 12 years and older. The recommendation was subsequently endorsed by the EC.
    • In September 2022, Pfizer and BioNTech announced a 30-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent vaccine (Comirnaty Original/Omicron BA.4/BA.5 15/15 µg) was recommended for CMA by the EMA’s CHMP for individuals ages 12 years and older. The recommendation was subsequently endorsed by the EC.
    • In September 2022, Pfizer and BioNTech announced that the CHMP of the EMA has recommended converting the CMA for Comirnaty to standard (also referred to as “full”) marketing authorization for all authorized indications and formulations. The EC subsequently endorsed the CHMP’s recommendation. The conversion to full marketing authorization applies to all existing Comirnaty indications and formulations authorized in the EU, including the companies’ bivalent vaccines (Comirnaty Original/Omicron BA.1 and Comirnaty Original/Omicron BA.4/BA.5) as booster doses for individuals aged 12 and older in the EU.
    • In September 2022, Pfizer and BioNTech announced they have completed a submission to the EMA for a 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent vaccine (Comirnaty Original/Omicron BA.4/BA.5 5/5 µg) for children 5 through 11 years of age.
    • In October 2022, the CHMP recommended marketing authorization for a 3-µg dose of Comirnaty as a three-dose series for children ages 6 months to less than 5 years of age. The recommendation was subsequently endorsed by the EC.
• Myfembree (relugolix 40 mg, estradiol 1.0 mg and norethindrone acetate 0.5 mg) — In August 2022, Myovant Sciences (Myovant) and Pfizer announced the FDA approved Myfembree as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months. Myovant and Pfizer will continue to jointly commercialize Myfembree in the U.S.
• Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets)⁽⁹⁾ — In September 2022, Pfizer announced an agreement to supply up to six million treatment courses of Paxlovid to Global Fund as part of its COVID-19 Response Mechanism. Paxlovid treatment courses will be available for procurement through this mechanism, subject to local regulatory authorization or approval, by the 132 grant-eligible countries determined by Global Fund based on income classification and disease burden. Through Global Fund’s framework and mechanism, eligible countries will be offered treatment courses according to Pfizer’s tiered pricing approach, where all low- and lower-middle-income countries will pay a not-for-profit price while upper-middle-income countries will pay the price defined in Pfizer’s tiered pricing approach.
• Prevnar 20/Apexxnar (pneumococcal 20-valent conjugate vaccine)
  • In August 2022, Pfizer announced positive top-line results from its pivotal U.S. Phase 3 study in infants evaluating its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine for the pediatric population. The study had two co-primary objectives, associated with immunogenicity responses one month after the third and fourth doses of the four-dose vaccination series.
    • All 20 serotypes met the co-primary objective of non-inferiority (NI) of immunoglobin G (IgG) geometric mean concentrations (GMCs) after Dose 4.
    • Fourteen of the 20 serotypes met the co-primary objective of NI of the percentage of participants with predefined serotype-specific IgG concentrations after Dose 3 (two serotypes missed by a wider margin while four narrowly missed).
    • All serotypes met NI for the key secondary objective of IgG GMCs after Dose 3.
    • All 20 serotypes elicited robust functional responses (OPA) and increases in antibody responses after Dose 4, with the totality of data supporting the potential benefit of all serotypes in this 20-valent vaccine candidate.
    • Overall, the safety profile of the 20vPnC candidate was consistent with Prevnar 13 given in the same schedule.
  • In September 2022, Pfizer announced positive top-line results from its pivotal EU Phase 3 study in infants evaluating 20vPnC for the prevention of IPD, pneumonia, and acute otitis media caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine for the pediatric population. The study had three co-primary outcomes, associated with immunogenicity responses one month after the second and third doses of a three-dose vaccination series.
    • For the NI co-primary objective of IgG GMCs one month after Dose 3 at 11-12 months of age, 19 of the 20 serotypes met the NI criteria with only one serotype narrowly missing.
    • For the NI co-primary objective of IgG GMCs one month after Dose 2, 16 of the 20 serotypes met NI.
    • For the NI co-primary objective of the percentage of participants with predefined serotype-specific IgG concentrations one month after Dose 2, nine of the 20 serotypes met the NI criteria.
    • All 20 serotypes showed increased booster responses from post dose 2 to post dose 3, which are indicative of immunological memory and long-term protection. All 20 vaccine serotypes also showed strong functional antibody responses (OPA) post-dose 2 and post dose 3 similar to Prevenar and Prevenar 13.
    • The safety profile of 20vPnC was similar to Prevenar 13 in this schedule.
  • In October 2022, Pfizer announced the Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) voted to recommend a single dose of Prevnar 20 to help protect adults previously vaccinated with Prevnar 13 or both Prevnar 13 and PPSV23 against invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in Prevnar 20.
  • In October 2022, Pfizer submitted and is awaiting acceptance of a supplemental Biologics License Application (sBLA) to the FDA for the pediatric population, based on the results of the Phase 3 clinical program, and is looking forward to working with the FDA on their review of the application.
• Talzenna (talazoparib) — In October 2022, Pfizer announced positive topline results from the Phase 3 TALAPRO-2 study of Talzenna, an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide) compared to placebo plus Xtandi in men with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene mutations. The study met its primary endpoint with a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared with placebo plus Xtandi, exceeding the pre-specified hazard ratio of 0.696. At the time of topline analysis, the safety of Talzenna plus Xtandi were generally consistent with the known safety profile of each medicine.
• Xeljanz (tofacitinib) — In October 2022, Pfizer announced that the Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA has concluded their assessment of JAK inhibitors authorized for the treatment of certain inflammatory diseases in the EU and has provided updated recommendations for their use. PRAC recommended that risk minimization measures, including special warnings and precautions for use, should be revised for all JAK inhibitors approved in the EU, including Xeljanz and Cibinqo. No changes were recommended to the currently approved indications for all JAK inhibitors.

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.

• Giroctocogene fitelparvovec (Hemophilia A Gene Therapy) — In September 2022, Pfizer and Sangamo Therapeutics announced that the Phase 3 AFFINE study evaluating giroctocogene fitelparvovec, an investigational gene therapy for patients with moderately severe to severe hemophilia A, has re-opened recruitment. Trial sites resumed enrollment in September, and dosing is expected to resume shortly. All trial sites are anticipated to be active by the end of 2022 and a pivotal readout is expected in the first half of 2024.
• PF-06760805 (GBS6, Group B Streptococcus Vaccine Candidate) — In September 2022, Pfizer announced its investigational Group B Streptococcus (GBS) vaccine candidate, PF-06760805, received Breakthrough Therapy Designation from the FDA for the prevention of invasive GBS disease due to the vaccine serotypes in newborns and young infants by active immunization of their mothers during pregnancy. The FDA decision was informed by the interim analysis of a placebo-controlled Phase 2 study, evaluating the safety and immunogenicity of PF-06760805 in healthy pregnant women aged 18 to 40 years, who were vaccinated during the second or early third trimester of pregnancy. The study remains ongoing, and Pfizer will publish outcomes from this clinical trial when it is completed.
• PF-06886992 (Pentavalent (MenABCWY) Meningococcal Vaccine Candidate) — In September 2022, Pfizer announced positive top-line results from the pivotal Phase 3 trial assessing the safety, tolerability, and immunogenicity of its investigational pentavalent meningococcal vaccine (MenABCWY) in healthy individuals 10 through 25 years of age. The trial met all primary and secondary endpoints, with the investigational vaccine demonstrating non-inferiority to licensed vaccines for the five meningococcal serogroups that cause the majority of invasive meningococcal disease. Based on these Phase 3 results, which meet pre-determined criteria for licensure, Pfizer intends to submit a Biologics License Application (BLA) to the FDA in the fourth quarter of this year. Submissions to additional regulatory authorities outside the U.S. are also planned. If approved, PF-06886992 could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine.
• PF-07252220 (Influenza mRNA Vaccine Candidate) — In September 2022, Pfizer announced that the first participants have been dosed in a pivotal Phase 3 clinical trial to evaluate the efficacy, safety, tolerability and immunogenicity of the company’s quadrivalent modified RNA (modRNA) influenza vaccine candidate in approximately 25,000 healthy U.S. adults. The quadrivalent modRNA vaccine candidate will encode World Health Organization recommended strains for the Northern Hemisphere 2022-23 cell culture- or recombinant-based influenza vaccines.
• PF-07265803 (LMNA-Related Dilated Cardiomyopathy) — In August 2022, Pfizer announced that an interim futility analysis of the global Phase 3 trial, REALM-DCM, designed to evaluate the efficacy and safety of PF-07265803 in patients with symptomatic dilated cardiomyopathy (DCM) due to a mutation of the gene encoding the lamin A/C protein (LMNA), indicated the trial is unlikely to meet its primary endpoint upon completion. Based on these results, the Phase 3 trial and further development of PF-07265803 have been discontinued. This decision was not based on safety concerns.
• Ritlecitinib (PF-06651600) — In September 2022, Pfizer announced the FDA accepted for filing the New Drug Application (NDA) for ritlecitinib for adults and adolescents 12 years of age and older with alopecia areata. The FDA is expected to make a decision in the second-quarter 2023. The EMA has also accepted the Marketing Authorisation Application for ritlecitinib in the same patient population with a decision anticipated in fourth-quarter 2023. Additionally, Pfizer has completed regulatory submissions for ritlecitinib in the United Kingdom, China and Japan, and expects decisions in 2023. Ritlecitinib is an investigational oral once-daily treatment that is the first in a new class of oral highly selective kinase inhibitors that is a dual inhibitor of the TEC family of tyrosine-protein kinases and of Janus kinase 3 (JAK3).
• RSVpreF (Respiratory Syncytial Virus (RSV) Bivalent Vaccine Candidate)
  • In August 2022, Pfizer announced positive top-line data from the Phase 3 clinical trial RENOIR (RSV vaccine Efficacy study iN Older adults Immunized against RSV disease) investigating its bivalent RSV prefusion F vaccine candidate, RSVpreF, when administered to adults 60 years of age or older. The bivalent vaccine candidate is composed of two preF proteins selected to optimize protection against RSV A and B strains. A pre-planned, interim analysis of efficacy conducted by an independent, external Data Monitoring Committee (DMC) to assess protection against RSV-associated lower respiratory tract illness (LRTI-RSV) defined by two or more symptoms demonstrated vaccine efficacy of 66.7% (96.66% CI: 28.8%, 85.8%). This positive result enabled Pfizer to look at the more severe disease primary endpoint of LRTI-RSV defined by three or more symptoms, where vaccine efficacy of 85.7% (96.66% CI: 32.0%, 98.7%) was observed. The DMC also indicated the investigational vaccine was well-tolerated, with no safety concerns.
  • Earlier today, Pfizer announced positive top-line data from the Phase 3 MATISSE (MATernal Immunization Study for Safety and Efficacy) trial investigating RSVpreF when administered to pregnant participants to help protect their infants from RSV disease after birth. The observed efficacy for severe medically attended lower respiratory tract illness (severe MA-LRTI) was 81.8% (CI: 40.6%, 96.3%) through the first 90 days of life. Substantial efficacy of 69.4% (CI: 44.3%, 84.1%) was demonstrated for infants over the six-month follow-up period. Although the statistical success criterion was not met for the second primary endpoint, clinically meaningful efficacy was observed for MA-LRTI of 57.1% (CI: 14.7%, 79.8%) in infants from birth through the first 90 days of life. Efficacy for MA-LRTI of 51.3% (CI: 29.4%, 66.8%) was observed over the six-month follow up period. Pre-planned safety reviews indicate the investigational vaccine is well-tolerated with no safety concerns for both the vaccinated individuals and their newborns. Based on these positive results, Pfizer plans to submit a BLA to the FDA by the end of 2022, followed by other regulatory authorities in the coming months. Pfizer is the only company with an investigational vaccine being prepared for regulatory applications for both infants through maternal immunization and older adults to help protect against RSV.
• TTI-622 (Signal-Regulatory Protein α-Fc Fusion Protein) — In August 2022, Pfizer and Sanofi U.S. Services Inc. (Sanofi) entered into a clinical trial collaboration and supply agreement to investigate the immunotherapeutic combination of Pfizer’s TTI-622, a novel SIRPα-Fc fusion protein, and SARCLISA⁽¹⁰⁾ (isatuximab-irfc) plus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM) after 1-3 prior lines of therapy. Under the terms of the agreement, Pfizer will determine the recommended dose of TTI-622 in the multicenter, Phase 1b/2 study of TTI-622 with SARCLISA plus carfilzomib and dexamethasone for patients with RRMM. Sanofi will provide SARCLISA for the study, which is sponsored and funded by Pfizer and conducted in North America.
• VLA15 (Lyme Disease Vaccine Candidate) — In August 2022, Pfizer and Valneva SE (Valneva) announced the initiation of a Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR), to investigate the efficacy, safety and immunogenicity of their investigational Lyme disease vaccine candidate, VLA15. The randomized, placebo-controlled, Phase 3 VALOR study is planned to enroll approximately 6,000 participants 5 years of age and older at up 50 sites located in areas where Lyme disease is highly endemic, including Finland, Germany, the Netherlands, Poland, Sweden and the U.S.

Corporate Developments

• In October 2022, Pfizer announced the completion of its acquisition of all the outstanding shares of Biohaven not already owned by Pfizer for $148.50 per share in cash, for payments of approximately $11.5 billion, plus repayment of third-party debt of $863 million and redemption of Biohaven’s redeemable preferred stock for $495 million. Biohaven brings to Pfizer a portfolio of promising calcitonin gene-related peptide (CGRP) antagonists including rimegepant (marketed as Nurtec ODT in the U.S. and Vydura in Europe), zavegepant (currently under FDA review with a potential regulatory decision expected in the first quarter of 2023) and a portfolio of pre-clinical CGRP assets. Effective immediately prior to the closing of the acquisition, Biohaven completed the spin-off of Biohaven Ltd. (NYSE: BHVN), a new company that retained Biohaven’s non-CGRP development stage pipeline compounds. Shares of Biohaven Ltd. were distributed to Biohaven’s shareholders. Pfizer, a Biohaven shareholder, received a pro rata portion of the company’s shares in the distribution and currently owns approximately 1.5% of Biohaven Ltd.
• In October 2022, Pfizer announced the completion of its acquisition of Global Blood Therapeutics, Inc. (GBT) for $68.50 per share, in cash, for payments of approximately $5.3 billion, net of cash acquired, plus repayment of third-party debt of $331 million. The acquisition reinforces Pfizer’s commitment to patients with sickle cell disease (SCD), building on a 30-year legacy in the rare hematology space. GBT brings to Pfizer a portfolio and pipeline that has the potential to address the full spectrum of critical needs for this underserved community, including Oxbryta (voxelotor) tablets, a first-in-class medicine that directly targets the root cause of SCD, as well as GBT021601 (GBT601) and inclaclumab, both of which have received Orphan Drug and Rare Pediatric Disease designations from the FDA.