On August 1, 2023 Sorrento Therapeutics presented its corporate presentation (Presentation, Sorrento Therapeutics, AUG 1, 2023, View Source [SID1234633598]).

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On August 1, 2023 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported financial results for the second quarter ended June 30, 2023, including sales of TAVALISSE (fostamatinib disodium hexahydrate) tablets for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment and sales of REZLIDHIA (olutasidenib) capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test (Press release, Rigel, AUG 1, 2023, View Source [SID1234633597]).

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"We are encouraged by the progress we made in the second quarter in building our hematology/oncology company," said Raul Rodriguez, Rigel’s president and CEO. "We delivered strong year-over-year revenue growth for TAVALISSE in ITP and hired our dedicated institutional sales team to drive our commercial launch of REZLIDHIA with a focus on awareness and education with healthcare professionals. We also continued to advance our current development programs while evaluating opportunities to expand our hematology/oncology business through internal and external opportunities."

Business Update

In the second quarter of 2023, a total of 2,191 bottles of TAVALISSE were sold in the U.S. During the quarter, 2,265 bottles were shipped directly to patients and clinics, representing the highest number of bottles shipped to patients and clinics in a quarter since launch.
During the second full quarter of launch, a total of 200 bottles of REZLIDHIA were sold in the U.S., representing a 77% increase over Q1 2023. Of those bottles, 187 were shipped directly to patients and clinics.
In June, Rigel presented promising data from an analysis of the Phase 2 clinical trial evaluating REZLIDHIA in 17 patients with mIDH1 AML who were relapsed/refractory to prior venetoclax-based regimens at the European Hematology Association (EHA) (Free EHA Whitepaper) 2023 Hybrid Congress. The data showed clinically meaningful activity with REZLIDHIA, a potent, selective, oral, small-molecule inhibitor of mIDH11, representing an encouraging therapeutic advance in the treatment of this molecularly defined, poor-prognosis patient population.
Rigel also announced the publication in June of an expert review article in Blood Advances examining the development path and positioning of REZLIDHIA in the mIDH1 R/R AML treatment landscape. The authors concluded, "The approval of olutasidenib is a critical addition to the mIDH1 AML treatment landscape with encouragingly durable responses." They recommended treatment with olutasidenib in venetoclax plus HMA failures, based on the available data.
Rigel continues to advance its open-label, Phase 1b clinical trial of R2892, an investigational, potent, and selective IRAK1/4 inhibitor, in patients with lower-risk myeloid dysplastic syndrome (LR-MDS) who are refractory/resistant to prior therapies. Target enrollment in the second cohort of the trial has been completed and Rigel expects to begin enrollment in the third cohort in the near future.
R552, an investigational, potent, and selective RIPK1 inhibitor, is being advanced by Rigel’s partner Eli Lilly. The Phase 2a clinical trial (NCT05848258) studying R552 in adult patients with moderately to severely active rheumatoid arthritis (RA) has been initiated. The trial plans to enroll 100 patients globally.
Financial Update
For the second quarter of 2023, Rigel reported a net loss of $6.6 million, or $0.04 per basic and diluted share, compared to a net loss of $13.5 million, or $0.08 per basic and diluted share, for the same period of 2022.

For the second quarter of 2023, total revenues were $26.9 million, consisting of $21.3 million in TAVALISSE net product sales, $2.6 million in REZLIDHIA net product sales, $2.0 million in contract revenues from collaborations, and $1.0 million in government contract revenue. TAVALISSE net product sales of $21.3 million increased by $2.8 million or 15% compared to $18.6 million in the same period of 2022. Contract revenues from collaborations for the second quarter of 2023 consisted primarily of revenue from Grifols S.A., related to the delivery of drug supplies of $1.2 million and a royalty of $0.8 million. Government contract revenue for the second quarter of 2023 was related to income recognized pursuant to the agreement with the U.S. Department of Defense (DOD) to support Rigel’s ongoing Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19.

For the second quarter of 2023, total costs and expenses were $32.2 million, compared to $42.8 million for the same period of 2022. The decrease in costs and expenses was primarily due to decreased research and development costs due to trial completion activities related to the Phase 3 clinical trial of fostamatinib for wAIHA and the Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19, as well as timing of activities related to Rigel’s IRAK 1/4 inhibitor program.

For the six months ended June 30, 2023, Rigel reported a net loss of $20.1 million, or $0.12 per basic and diluted share, compared to a net loss of $40.9 million, or $0.24 per basic and diluted share, for the same period of 2022.

For the six months ended June 30, 2023, total revenues were $52.9 million, consisting of $43.6 million in TAVALISSE net product sales, $4.0 million in REZLIDHIA net product sales, $4.3 million in contract revenues from collaborations, and $1.0 million in government contract revenue. TAVALISSE net product sales of $43.6 million increased by $8.9 million or 26% compared to $34.7 million in the same period of 2022. Contract revenues from collaborations for the six months ended June 30, 2023, consisted primarily of revenue from Grifols S.A., related to the delivery of drug supplies of $2.8 million and a royalty of $1.5 million. Government contract revenue for the six months ended June 30, 2023, was related to the income recognized pursuant to the previously mentioned agreement with the DOD.

For the six months ended June 30, 2023, total costs and expenses were $70.9 million, compared to $85.8 million for the same period of 2022. The decrease in costs and expenses was primarily due to decreased research and development costs due to trial completion activities related to the Phase 3 clinical trial of fostamatinib for wAIHA and the Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19, as well as timing of activities related to Rigel’s IRAK 1/4 inhibitor program.

As of June 30, 2023, Rigel had cash, cash equivalents and short-term investments of $64.4 million, compared to $58.2 million as of December 31, 2022.

Conference Call and Webcast with Slides Today at 4:30pm Eastern Time
Rigel will hold a live conference call and webcast today at 4:30pm Eastern Time (1:30pm Pacific Time).

Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

About ITP
In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About AML
Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that in the United States alone, there will be about 20,380 new cases, most in adults, in 2023.3

Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.4 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.5 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need.

About TAVALISSE
Indication
TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information
Warnings and Precautions

Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to ≥3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.
Drug Interactions

Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.
Adverse Reactions

Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.
Please see www.TAVALISSEUSPI.com for full Prescribing Information.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

TAVALISSE and TAVLESSE are registered trademarks of Rigel Pharmaceuticals, Inc.

About REZLIDHIA
INDICATION
REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME
Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and hemodynamic monitoring until symptom resolution.

WARNINGS AND PRECAUTIONS
Differentiation Syndrome
REZLIDHIA can cause differentiation syndrome. In the clinical trial of REZLIDHIA in patients with relapsed or refractory AML, differentiation syndrome occurred in 16% of patients, with grade 3 or 4 differentiation syndrome occurring in 8% of patients treated, and fatalities in 1% of patients. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. Symptoms of differentiation syndrome in patients treated with REZLIDHIA included leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, fever, edema, pyrexia, and weight gain. Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption of REZLIDHIA. Differentiation syndrome occurred as early as 1 day and up to 18 months after REZLIDHIA initiation and has been observed with or without concomitant leukocytosis.

If differentiation syndrome is suspected, temporarily withhold REZLIDHIA and initiate systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours) for a minimum of 3 days and until resolution of signs and symptoms. If concomitant leukocytosis is observed, initiate treatment with hydroxyurea, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms. Differentiation syndrome may recur with premature discontinuation of corticosteroids and/or hydroxyurea treatment. Institute supportive measures and hemodynamic monitoring until improvement; withhold dose of REZLIDHIA and consider dose reduction based on recurrence.

Hepatotoxicity
REZLIDHIA can cause hepatotoxicity, presenting as increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased blood alkaline phosphatase, and/or elevated bilirubin. Of 153 patients with relapsed or refractory AML who received REZLIDHIA, hepatotoxicity occurred in 23% of patients; 13% experienced grade 3 or 4 hepatotoxicity. One patient treated with REZLIDHIA in combination with azacitidine in the clinical trial, a combination for which REZLIDHIA is not indicated, died from complications of drug-induced liver injury. The median time to onset of hepatotoxicity in patients with relapsed or refractory AML treated with REZLIDHIA was 1.2 months (range: 1 day to 17.5 months) after REZLIDHIA initiation, and the median time to resolution was 12 days (range: 1 day to 17 months). The most common hepatotoxicities were elevations of ALT, AST, blood alkaline phosphatase, and blood bilirubin.

Monitor patients frequently for clinical symptoms of hepatic dysfunction such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Obtain baseline liver function tests prior to initiation of REZLIDHIA, at least once weekly for the first two months, once every other week for the third month, once in the fourth month, and once every other month for the duration of therapy. If hepatic dysfunction occurs, withhold, reduce, or permanently discontinue REZLIDHIA based on recurrence/severity.

ADVERSE REACTIONS
The most common (≥20%) adverse reactions, including laboratory abnormalities, were aspartate aminotransferase increased, alanine aminotransferase increased, potassium decreased, sodium decreased, alkaline phosphatase increased, nausea, creatinine increased, fatigue/malaise, arthralgia, constipation, lymphocytes increased, bilirubin increased, leukocytosis, uric acid increased, dyspnea, pyrexia, rash, lipase increased, mucositis, diarrhea and transaminitis.

DRUG INTERACTIONS

Avoid concomitant use of REZLIDHIA with strong or moderate CYP3A inducers.
Avoid concomitant use of REZLIDHIA with sensitive CYP3A substrates unless otherwise instructed in the substrates prescribing information. If concomitant use is unavoidable, monitor patients for loss of therapeutic effect of these drugs.
LACTATION
Advise women not to breastfeed during treatment with REZLIDHIA and for 2 weeks after the last dose.

GERIATRIC USE
No overall differences in effectiveness were observed between patients 65 years and older and younger patients. Compared to patients younger than 65 years of age, an increase in incidence of hepatotoxicity and hypertension was observed in patients ≥65 years of age.

HEPATIC IMPAIRMENT
In patients with mild or moderate hepatic impairment, closely monitor for increased probability of differentiation syndrome.

Click here for Full Prescribing Information, including Boxed WARNING.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

REZLIDHIA is a registered trademark of Rigel Pharmaceuticals, Inc.

On August 1, 2023 Revolution Medicines, Inc. ("Revolution Medicines" or the "Company") (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, and EQRx, Inc. ("EQRx") (Nasdaq: EQRX) reported a definitive agreement through which Revolution Medicines plans to acquire EQRx in an all-stock transaction intended to add more than $1 billion in net cash to Revolution Medicines’ balance sheet (Press release, Revolution Medicines, AUG 1, 2023, View Source [SID1234633596]). The total number of shares of Revolution Medicines common stock to be issued to EQRx security holders will be determined in close proximity to the closing of the stockholder votes on the transaction based on the formula described below (see Transaction Details section). The deal, which was overseen by independent committees of Revolution Medicines’ and EQRx’s respective boards of directors, has been approved by the directors of each company. The transaction, which is subject to customary closing conditions, will enhance Revolution Medicines’ efforts to fulfill its vision to discover, develop and deliver pioneering RAS(ON) Inhibitor drugs on behalf of patients with RAS-addicted cancers.

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This proposed transaction is intended to reinforce and sustain Revolution Medicines’ parallel development approach for its extensive RAS(ON) Inhibitor pipeline in multiple RAS-driven cancers by enhancing its balance sheet, increasing financial certainty in a challenging macroenvironment. With encouraging data trends thus far for its RASMULTI(ON) Inhibitor RMC-6236, planning is underway for one or more single agent pivotal clinical trials potentially to begin in 2024. Likewise, with encouraging initial clinical experience with its KRASG12C(ON) Inhibitor RMC-6291, planning is underway for a Phase 1/1b clinical trial to evaluate the combination of RMC-6236 and RMC-6291 potentially to begin in early 2024, while continuing single agent evaluation of RMC-6291. Revolution Medicines’ acquisition of EQRx reflects both companies’ confidence in Revolution Medicines’ ability to deploy this amount of capital effectively. With the additional capital, Revolution Medicines will be positioned to maximize the potential clinical impact of its targeted drug pipeline across multiple oncology indications, and thereby offers the potential for shareholder value creation while retaining strategic control of its RAS(ON) Inhibitor pipeline.

"This deal marks a decisive step toward advancing Revolution Medicines’ vision as a self-sufficient organization that discovers and develops highly innovative drug candidates with the goal of delivering high-impact targeted medicines into oncology practice on behalf of patients with RAS-addicted cancers," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "This singular acquisition of a sizable quantum of capital signifies the growing confidence we have in our RAS-focused drug candidate pipeline, and substantially increases our capacity to continue advancing high-performing oncology assets, particularly our priority clinical-stage RAS(ON) Inhibitors, RMC-6236, RMC-6291 and RMC-9805, with the potential to create significant long-term value for our shareholders."

"Today’s announcement is a result of a rigorous process run by an independent committee of directors of the EQRx board that thoroughly explored and considered strategic alternatives to maximize value to EQRx stockholders," said Melanie Nallicheri, president and chief executive officer of EQRx. "With its pioneering portfolio of RAS(ON) inhibitors, designed to defeat RAS-addicted cancers which represent 30% of all human cancers, Revolution Medicines has the opportunity to address one of the largest areas of unmet need in oncology. Deploying our significant capital not only enhances this important vision, it also provides a compelling opportunity for our stockholders to participate in the upside potential of both near-term and long-term value catalysts."

Transaction Details

Under the terms of the merger agreement, Revolution Medicines will acquire EQRx in an all-stock transaction. The stock exchange ratio formula in the merger agreement uses a blended average to account for developments in Revolution Medicines’ ongoing business and potential movement in its stock price. Approximately 80% of the stock exchange ratio is based on Revolution Medicines’ public market stock price measured in close proximity to the EQRx stockholder vote and the remaining 20% of the exchange ratio is a determined price per share of Revolution Medicines’ stock as of the signing of the merger agreement. Specifically, at closing, EQRx stockholders will receive the number of shares of Revolution Medicines common stock equal to the sum of 7,692,308 Revolution Medicines shares (determined as $200 million divided by $26.00 per share) plus a number of shares equal to $870 million divided by a price that is a 6% discount to the 5-day volume-weighted average Revolution Medicines share price measured in close proximity to the stockholder vote.

Certain EQRx stockholders, representing more than 40% of voting shares of EQRx, have entered into support and voting agreements to vote their shares in favor of the transaction. At the close of the transaction, one EQRx director will be designated by Revolution Medicines to serve on its board of directors.

The transaction is expected to close in November 2023, subject to satisfaction of customary closing conditions, including regulatory review, and approval by Revolution Medicines’ and EQRx’s stockholders. Upon completion of the transaction, EQRx shares will cease trading on the Nasdaq Global Market.

Updates on Clinical-Stage RAS(ON) Inhibitors

Revolution Medicines announces today that an update on the clinical antitumor activity of RMC-6236 (RASMULTI) in patients with non-small cell lung cancer (NSCLC) or pancreatic cancer will be presented as a Proffered Paper (oral presentation) during the Developmental Therapeutics session on Sunday, October 22 at the 2023 European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper), and supporting clinical data will be presented at the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) ("Triple Meeting") in October. Revolution Medicines is an invited speaker in a plenary session at the Triple Meeting delivering a presentation entitled "Targeting RAS-addicted Cancers with Investigational RAS(ON) Inhibitors". Furthermore, a first report on initial clinical findings with RMC-6291 (KRASG12C), including preliminary evidence of differentiation from RAS(OFF) inhibitors, will be presented at the Triple Meeting. Additional details on the above presentations will be provided when available. The company also announces that study site activation is ongoing under an investigational new drug (IND) application for a Phase 1/1b trial of RMC-9805 (KRASG12D).

Pipeline Focus and Disposition of Other Assets

To maximize the likelihood of success and the breadth of potential impact for Revolution Medicines’ most promising R&D assets, the company has made the strategic decision to concentrate its post-merger financial and human capital on its three priority RAS-focused assets (RMC-6236, RMC-6291 and RMC-9805), as well as its deep pipeline of mutant-selective RAS(ON) Inhibitors.

In line with Revolution Medicines’ continued prioritization and focus of its resources on novel drug mechanisms of action targeting RAS-addicted cancers, Revolution Medicines does not intend to advance EQRx’s research and development portfolio following closing of the transaction. EQRx will commence a process to wind down these programs and return the associated intellectual property to its partners, which would have the opportunity to independently decide the next steps on development.

Advisors

Guggenheim Securities, LLC is acting as Revolution Medicines’ financial advisor and Latham & Watkins LLP is serving as legal counsel. Goldman Sachs & Co. LLC is acting as lead financial advisor to EQRx. MTS Health Partners, L.P. is also acting as financial advisor to EQRx. Goodwin Procter LLP is acting as legal counsel for EQRx.

Webcast

Revolution Medicines will host an Investor Call today, Tuesday, August 1, at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss the proposed transaction and the other business updates noted above. Participants may register for the conference call here View Source A live webcast of the call will also be available on the Investors section of Revolution Medicines’ website at View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

On August 1, 2023 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed oncolytic immunotherapies, reported that members from the Replimune management team will present and host investor meetings at the following two conferences (Press release, Replimune, AUG 1, 2023, View Source [SID1234633595]):

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BTIG Virtual Biotechnology Conference 2023
Date: Tuesday, August 8, 2023
Fireside Chat Time: 1:30 pm EDT

2023 Wedbush PacGrow Healthcare Conference
Date: Wednesday, August 9, 2023
Location: Lotte Palace Hotel, New York, NY
In-person 1×1 investor meetings only

On August 1, 2023 Pfizer Inc. (NYSE: PFE) reported financial results for the second quarter of 2023 (Press release, Pfizer, AUG 1, 2023, View Source [SID1234633593]). The company narrowed its 2023 revenue guidance(4) range to $67 to $70 billion, while maintaining its outlook for Adjusted diluted EPS(3) of $3.25 to $3.45.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The second-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.

EXECUTIVE COMMENTARY

Dr. Albert Bourla, Chairman and Chief Executive Officer, stated: "Pfizer has made significant progress toward our goal to launch 19 new products and indications in an 18-month span, having executed eleven launches thus far. We continue to build momentum in 2023, recently attaining key milestones for several products, including the U.S. launches of Prevnar 20 in pediatric patients and Zavzpret; U.S. approvals and launches for Abrysvo in older adults, Litfulo and the Talzenna plus Xtandi combination; U.S. approvals for Ngenla (expected to be available for prescribing this month) and Paxlovid; and U.S. regulatory filing acceptance for fidanacogene elaparvovec (Hemophilia B Gene Therapy).

Supporting our expectation to deliver robust operational growth in 2025 and beyond, we also reported data from several exciting pipeline candidates we believe have the potential to be significant future value-drivers, including Phase 3 data from marstacimab, Pfizer’s novel, investigational anti-TFPI antibody being studied for the treatment of hemophilia A or B; further data from elranatamab, Pfizer’s investigational BCMA CD3-targeted bispecific antibody currently being investigated in multiple myeloma; and first-in-human data from our pipeline of potential next-generation breast cancer treatments, including our novel CDK4, CDK2, and KAT6 inhibitors.
Finally, we continue to make progress toward our proposed acquisition of Seagen, a global biotechnology company that discovers, develops and commercializes transformative oncology medicines. In addition to receiving approval of the transaction from Seagen shareholders and planning for the potential integration of the two companies, we continue to work closely with regulators, including the Federal Trade Commission (FTC) and the European Commission (EC), and are working diligently to fulfill requests for further information from the FTC.
We look forward to continuing our progress in the second half of 2023, driven by commercial execution, scientific innovation and our never-ending commitment to delivering breakthroughs for patients."
David Denton, Chief Financial Officer and Executive Vice President, stated: "The second quarter of 2023 delivered solid 5% operational revenue growth, excluding our COVID-19 products, and our year-to-date results are in line with our expectations. Despite a few near-term individual product revenue challenges, we believe the company is well positioned for accelerated growth of our non-COVID products in the second half of 2023. The COVID environment continues to evolve rapidly and remains highly unpredictable. In spite of this uncertainty, the company is maintaining its focus on ensuring successful fall vaccinations during the respiratory infection season.
During the second quarter we successfully closed a $31 billion debt offering, the net proceeds of which we intend to use as part of the financing for Pfizer’s proposed acquisition of Seagen. We continue to expect the transaction to close in late 2023 or early 2024, subject to the satisfaction of customary closing conditions. As we de-lever our capital structure after the close, we expect our strong balance sheet will continue to provide the flexibility for future dividend increases and share repurchases, as well as additional business development activity."
Results for the second quarter of 2023 and 2022(5) are summarized below.
OVERALL RESULTS
($ in millions, except
per share amounts) Second-Quarter Six Months
2023 2022 Change 2023 2022 Change
Revenues $ 12,734 $ 27,742 (54%) $ 31,015 $ 53,402 (42%)
Reported Net Income(2)
2,327 9,906 (77%) 7,870 17,769 (56%)
Reported Diluted EPS(2)
0.41 1.73 (77%) 1.38 3.10 (56%)
Adjusted(3) Income
3,839 11,656 (67%) 10,876 20,993 (48%)
Adjusted(3) Diluted EPS
0.67 2.04 (67%) 1.90 3.66 (48%)

– 2 –

REVENUES
($ in millions) Second-Quarter Six Months
2023 2022 % Change 2023 2022 % Change
Total Oper. Total Oper.
Global Biopharmaceuticals Business (Biopharma)(6)
$ 12,418 $ 27,425 (55%) (54%) $ 30,389 $ 52,748 (42%) (40%)
Primary Care(6)
5,810 20,979 (72%) (72%) 17,315 39,830 (57%) (55%)
Specialty Care(6)
3,653 3,358 9% 12% 7,264 6,863 6% 10%
Oncology(6)
2,956 3,088 (4%) (3%) 5,811 6,055 (4%) (2%)
Business Innovation $ 316 $ 317 — — $ 626 $ 655 (4%) (3%)
TOTAL REVENUES $ 12,734 $ 27,742 (54%) (53%) $ 31,015 $ 53,402 (42%) (40%)

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 and indication launches. These changes included establishing a new commercial structure within Biopharma focused on three broad customer groups (primary care, specialty care and oncology)(6), optimizing Pfizer’s end-to-end R&D operations and further prioritizing its internal R&D portfolio, as well as realigning certain enabling and platform functions across the organization to ensure alignment with this new operating structure.
In addition, 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.
Prior period amounts have been revised to conform to the current period presentation for all changes discussed above.
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).

CAPITAL ALLOCATION

During the first six 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 $5.2 billion invested in internal research and development projects, and
▪Returning capital directly to shareholders through $4.6 billion of cash dividends, or $0.82 per share of common stock.
No share repurchases have been completed to date in 2023. As of August 1, 2023, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2023.
Second-quarter 2023 diluted weighted-average shares outstanding used to calculate Reported(2) and Adjusted(3) diluted EPS were 5,713 million shares.
2023 FINANCIAL GUIDANCE(4)
Pfizer narrowed its 2023 revenue guidance range to $67 to $70 billion, while maintaining its guidance for Adjusted diluted EPS(3). The Company’s updated guidance is presented below.
Revenues $67.0 to $70.0 billion
(previously $67.0 to $71.0 billion)
Adjusted(3) Cost of Sales as a Percentage of Revenues
28.0% to 30.0%
Adjusted(3) SI&A Expenses
$13.8 to $14.8 billion
Adjusted(3) R&D Expenses
$12.4 to $13.4 billion
Acquired IPR&D Expenses(4)
Approximately $0.1 billion
Adjusted(3) Other (Income)/Deductions
Approximately $1.5 billion of income
Effective Tax Rate on Adjusted(3) Income
Approximately 15.0%
Adjusted(3) Diluted EPS
$3.25 to $3.45

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 31% 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, anticipated new product and indication launches and recently acquired products.
Excluding COVID-19 products, Pfizer is now expecting 6% to 8% operational revenue growth in 2023. This reduction of the Company’s previously stated expectation of 7% to 9% non-COVID operational revenue growth reflects certain short-term headwinds, such as the U.S. approval for the Talzenna plus Xtandi combination for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), versus an approval in the all-comers population; a shared clinical decision-making recommendation for Abrysvo from the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), versus a routine recommendation; and recent tornado damage to Pfizer’s manufacturing facility in Rocky Mount, N.C. Over the longer term, the Company expects these short-term headwinds to be resolved, with its revenue outlook remaining intact versus its 2030 ambitions.
Revenue guidance for Pfizer’s COVID-19 products is as follows:
▪Comirnaty(1) revenues of approximately $13.5 billion, down 64% from 2022 results.
▪Paxlovid revenues of approximately $8 billion, down 58% 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, an anticipated transition to traditional commercial markets in the U.S. in the second half of 2023.
The midpoint of the guidance range for Adjusted(3) diluted EPS reflects a 47% operational decrease compared to 2022, primarily driven by anticipated lower revenues from COVID-19 products, higher spending to support anticipated near-term launches and greater investment in certain late-stage pipeline projects.
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.
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Pfizer’s 2023 financial guidance is based on estimates and assumptions that are subject to significant uncertainties, particularly with regard to the anticipated performance of Comirnaty(1) and Paxlovid. 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; the Overview of Our Performance, Operating Environment, Strategy and Outlook — Our First Quarter Financial Performance and — The Global Economic Environment sections of MD&A in Pfizer’s Quarterly Report on Form 10-Q for the quarterly period ended April 2, 2023; and Pfizer’s fourth-quarter 2022 earnings press release (available at www.pfizer.com) for additional information.
QUARTERLY FINANCIAL HIGHLIGHTS (Second-Quarter 2023 vs. Second-Quarter 2022)
Second-quarter 2023 revenues totaled $12.7 billion, a decrease of $15.0 billion, or 54%, compared to the prior-year quarter, reflecting an operational decline of $14.7 billion, or 53%, primarily due to a decrease in Paxlovid and Comirnaty(1) revenues globally, as well as an unfavorable impact of foreign exchange of $283 million, or 1%. Excluding contributions from Comirnaty(1) and Paxlovid, company revenues grew $537 million, or 5%, operationally.
Second-quarter 2023 Paxlovid revenues declined $8.0 billion, or 98%, operationally compared with the prior-year quarter, primarily driven by no second quarter U.S. sales in anticipation of transition to traditional commercial markets in the second half of 2023, and lower contractual deliveries in most international markets.
Second-quarter 2023 Comirnaty(1) revenues declined $7.3 billion, or 82%, operationally compared with the prior-year quarter, largely driven by lower contracted deliveries and demand in international markets and lower U.S. government contracted deliveries, with anticipated transition to new variant vaccines globally and to traditional U.S. commercial market sales in the second half of 2023.
Excluding contributions from Comirnaty(1) and Paxlovid, second-quarter 2023 operational revenue growth was primarily driven by:
▪Recently acquired products, Nurtec ODT/Vydura and Oxbryta, which contributed $247 million and $77 million in global revenues, respectively; and
▪Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 43% operationally, largely driven by continued strong uptake of the transthyretin amyloid cardiomyopathy (ATTR-CM) indication, primarily in the U.S. and developed Europe;
partially offset primarily by lower revenues for:
▪Inflectra in the U.S., down 81%, primarily driven by lower net price as a result of unfavorable changes in channel mix; and
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▪Ibrance, down 4% operationally, primarily driven by lower demand globally due to competitive pressure, lower clinical trial purchases internationally and planned price decreases in certain international developed markets.
GAAP Reported(2) Income Statement Highlights
SELECTED REPORTED COSTS AND EXPENSES(2)
($ in millions) Second-Quarter Six Months
2023 2022 % Change 2023 2022 % Change
Total Oper. Total Oper.
Cost of Sales(2)
$ 3,237 $ 8,648 (63%) (65%) $ 8,122 $ 18,632 (56%) (57%)
Percent of Revenues
25.4 % 31.2 % N/A N/A 26.2 % 34.9 % N/A N/A
SI&A Expenses(2)
3,497 3,048 15% 16% 6,914 5,642 23% 25%
R&D Expenses(2)
2,648 2,815 (6%) (5%) 5,153 5,116 1% 2%
Acquired IPR&D Expenses(2)
33 1 * * 55 356 (85%) (85%)
Other (Income)/Deductions––net(2)
(347) 772 * * (277) 1,122 * *
Effective Tax Rate on Reported Income(2)
(3.1 %) 13.7 % 7.5 % 13.4 %

Second-quarter 2023 Cost of Sales(2) as a percentage of revenues decreased by 5.8 percentage points compared with the prior-year quarter, primarily driven by favorable changes in sales mix, including lower sales of Comirnaty(1) and, to a much lesser extent, by lower write-offs for Comirnaty(1) inventory that exceeded or was expected to exceed its approved shelf life prior to being used; partially offset by lower sales of Paxlovid.
Second-quarter 2023 SI&A Expenses(2) increased 16% operationally compared with the prior-year quarter, primarily reflecting increased investments to support recently acquired and launched products and the expected Paxlovid commercial launch, as well as an increase in deferred compensation savings plan expenses, partially offset by a lower provision for U.S. healthcare reform fees associated with lower sales of Paxlovid and Comirnaty(1).
Second-quarter 2023 R&D Expenses(2) decreased 5% operationally compared with the prior-year quarter, primarily driven by lower spending on programs to prevent and treat COVID-19 and a decrease in the value of the portfolio performance share grants reflecting the decrease in the price of Pfizer’s common stock in the second quarter of 2023; partially offset by increased investments to develop recently acquired assets and certain vaccine programs, as well as activities to support upcoming product launches.
Pfizer recorded $347 million of other income––net(2) in the second quarter of 2023 compared with $772 million of other deductions––net(2) in the second quarter of 2022. The period-over-period change was primarily driven by:
▪net gains on equity securities in the second of quarter 2023 versus net losses on equity securities recognized in the prior-year quarter; and
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▪net periodic benefit credits associated with pension and postretirement plans incurred in the second quarter of 2023 versus net periodic benefit costs recognized in the second quarter of 2022.
Pfizer’s effective tax rate on Reported income(2) for the second quarter of 2023 is negative primarily due to tax benefits in the second quarter of 2023 related to global income tax resolutions in multiple tax jurisdictions spanning multiple tax years and a favorable change in the jurisdictional mix of earnings.
Adjusted(3) Income Statement Highlights
SELECTED ADJUSTED(3) COSTS AND EXPENSES
($ in millions) Second-Quarter Six Months
2023 2022 % Change 2023 2022 % Change
Total Oper. Total Oper.
Adjusted(3) Cost of Sales
$ 3,072 $ 8,625 (64 %) (66 %) $ 7,818 $ 18,582 (58%) (58%)
Percent of Revenues 24.1 % 31.1 % N/A N/A 25.2 % 34.8 % N/A N/A
Adjusted(3) SI&A Expenses
3,419 2,900 18 % 20 % 6,769 5,396 25% 28%
Adjusted(3) R&D Expenses
2,627 2,811 (7 %) (6 %) 5,118 5,106 — 1%
Adjusted(3) Other (Income)/Deductions––net
(551) (377) 46 % 25 % (1,079) (783) 38% 24%
Effective Tax Rate on Adjusted(3) Income
6.8 % 15.4 % 11.6 % 15.1 %

Reconciliations of certain Reported(2) to non-GAAP Adjusted(3) financial measures and associated footnotes can be found in the financial tables section of this press release.
RECENT NOTABLE DEVELOPMENTS (Since May 2, 2023)
Product Developments
▪Abrysvo (Respiratory Syncytial Virus Vaccine) – Older Adults
•In May 2023, Pfizer announced the U.S. Food and Drug Administration (FDA) approved Abrysvo, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older. The CDC’s ACIP subsequently recommended Abrysvo for use in adults 60 years of age and older, using shared clinical decision making. This recommendation was published in the CDC’s Morbidity and Mortality Weekly Report (MMWR) in July 2023, triggering the initiation of Medicare and Commercial coverage.
•In July 2023, Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for RSVpreF for older adults. The CHMP’s positive opinion will now be reviewed by the EC. The EC will take the CHMP’s recommendation under advisement to decide whether to approve RSVpreF, whose trade name in the European Union (EU) will be Abrysvo. The EC’s final decision is expected in the coming weeks.
•In June 2023, Pfizer presented for the first time an analysis of initial vaccine efficacy data for mid-RSV season two in the Northern Hemisphere from the ongoing pivotal Phase 3 trial in older adults, as well as presented positive top-line results from a Phase 3 study that support the coadministration of Abrysvo with flu vaccine in older adults at the CDC’s ACIP June meeting.
▪Abrysvo (Respiratory Syncytial Virus Vaccine) – Maternal Immunization for Infants
•In July 2023, Pfizer announced that the CHMP of the EMA adopted a positive opinion, recommending the granting of a marketing authorization for RSVpreF for maternal immunization to help protect infants. The CHMP’s positive opinion will now be reviewed by the EC. The EC will take the CHMP’s recommendation under advisement to decide whether to approve RSVpreF, whose trade name in the EU will be Abrysvo. The EC’s final decision is expected in the coming weeks.
•In May 2023, Pfizer announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that available data are adequate to support the efficacy and safety of its RSVpreF vaccine candidate for pregnant individuals to help prevent RSV disease in infants. The vaccine is currently under FDA review for the prevention of medically attended lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals. The role of the VRBPAC is to provide recommendations to the FDA; however, these recommendations are not binding. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in August 2023, followed by discussion at a meeting of the ACIP.
▪Braftovi (encorafenib) and Mektovi (binimetinib) – In June 2023, Pfizer announced the first detailed results from the Phase 2 PHAROS study, which is evaluating the efficacy and safety of Braftovi given in combination with Mektovi to patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC). The results were presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in the Journal of Clinical Oncology. The FDA is reviewing the company’s Supplemental New Drug Applications (sNDAs) for Braftovi + Mektovi for patients with metastatic NSCLC with a BRAF V600E mutation based on the results from the PHAROS trial with a PDUFA goal date for a decision by the FDA in fourth quarter 2023.
▪Comirnaty (COVID-19 vaccine, mRNA)(8)
•In June 2023, Pfizer and BioNTech SE (BioNTech) announced the companies have submitted
regulatory applications to the FDA and EMA for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for the 2023-2024 fall and winter season. These filings follow guidance from the FDA’s VRBPAC, EMA and other health authorities that updated vaccines targeting Omicron XBB.1 sublineages may help to protect against COVID-19 during the upcoming fall and winter season. The companies expect to be ready to ship the adapted vaccines immediately upon regulatory authorization/approval.
•In May 2023, Pfizer and BioNTech announced they have reached an agreement with the EC to amend their existing contract to deliver COVID-19 vaccines to the EU. The amended agreement includes rephasing of delivery of doses annually through 2026 and an aggregate volume reduction, providing additional flexibility for EU Member States. The EC will maintain access to future adapted COVID-19 vaccines and the ability to donate doses, in alignment with the original agreement.
▪Litfulo (ritlecitinib)
•In July 2023, Pfizer announced that the CHMP of the EMA adopted a positive opinion for Litfulo—a kinase inhibitor that inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases—recommending marketing authorization of once-daily 50 mg for individuals 12 years of age and older with severe alopecia areata. The EC will review the CHMP recommendation and is expected to make a final decision in the coming months.
•In June 2023, Pfizer announced the FDA approved Litfulo, a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. Litfulo is the first and only treatment approved by the FDA for adolescents (12+) with severe alopecia areata.
▪Ngenla (somatrogon-ghla) – In June 2023, Pfizer and OPKO Health Inc. announced the FDA approved Ngenla, a once-weekly, human growth hormone analog for the treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone. Ngenla is approved for the treatment of pediatric growth hormone deficiency in more than 40 markets including Canada, Australia, Japan, and EU Member States.
▪Paxlovid (nirmatrelvir tablets and ritonavir tablets)(8) – In May 2023, Pfizer announced the FDA approved Paxlovid for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid has been available in the U.S. since December 2021 under Emergency Use Authorization (EUA), and the overall benefit/risk profile and indication for use in eligible adults remain consistent with the EUA. At this time, the U.S. government will continue to oversee the distribution of Paxlovid, but Pfizer expects a transition to traditional commercial markets in the second half of the year.
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▪Prevnar 20 (20-valent pneumococcal conjugate vaccine) – In June 2023, Pfizer announced the CDC’s ACIP unanimously voted to recommend Prevnar 20 for routine vaccination for all children under two years of age, for eligible children aged 2-18 years with certain underlying medical conditions, and a catch-up dose for children with an incomplete pneumococcal conjugate vaccine vaccination status.

▪Talzenna (talazoparib) – In June 2023, Pfizer announced the FDA approved Talzenna, an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide), for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The approval was based on the statistically significant and clinically meaningful radiographic progression-free survival (rPFS) data from the Phase 3 TALAPRO-2 trial. A Marketing Authorization Application (MAA) for the Talzenna and Xtandi combination has been accepted for review by the EMA, and Pfizer has shared data with additional regulatory agencies to support regulatory filings.

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.
▪Aztreonam-avibactam (PF-06947387) – In June 2023, Pfizer announced positive results from the Phase 3 program comprising the REVISIT (NCT03329092) and ASSEMBLE (NCT03580044) studies evaluating the efficacy, safety and tolerability of the novel investigational antibiotic combination aztreonam-avibactam (ATM-AVI) in treating serious bacterial infections due to Gram-negative bacteria, including metallo-β-lactamase (MBL)-producing multidrug-resistant pathogens for which there are limited or no treatment options. Data support that ATM-AVI is effective and well-tolerated, with no new safety findings and a similar safety profile to aztreonam alone. Data from the REVISIT and ASSEMBLE studies are expected to form the basis for planned regulatory filings in the EU, United Kingdom, China and the U.S. in the second half of 2023. Pfizer holds the global rights to commercialize ATM-AVI outside of the U.S. and Canada, where the rights are held by its development partner, AbbVie.

▪Danuglipron (PF-06882961) – In June 2023, Pfizer announced its decision to continue to advance its oral glucagon-like peptide-1 receptor agonist (GLP-1RA) candidate danuglipron toward late-stage development for the potential treatment of adults with obesity and Type 2 diabetes mellitus, subject to results from the ongoing Phase 2 trial; and to discontinue the clinical development of a second GLP-1RA candidate lotiglipron (PF-07081532). The company expects to finalize plans for the danuglipron late-stage program by the end of 2023 and also is developing a once-daily modified release version.
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▪Elranatamab (PF-06863135) – In June 2023, Pfizer announced updated data from the MagnetisMM clinical development program for elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb) currently being investigated in multiple myeloma (MM). Data across 13 abstracts were shared at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting, including new data from the Phase 2 MagnetisMM-3 clinical trial in patients with relapsed or refractory multiple myeloma (RRMM) who were previously treated with BCMA-directed therapy, supporting the safety and efficacy of elranatamab regardless of prior BCMA-directed treatment history. Additional presentations included new 15-month data from BCMA-naïve patients, subgroup analyses among difficult-to-treat patient populations, real-world treatment patterns for triple-class refractory MM and indirect comparisons/comparative effectiveness between elranatamab and other therapies. Elranatamab is currently under review by regulatory agencies, including the FDA, which has granted priority review for the company’s Biologics License Application (BLA) in RRMM with a PDUFA date in August 2023.

▪Fidanacogene elaparvovec (Hemophilia B Gene Therapy) – In June 2023, Pfizer announced the FDA accepted for review the company’s BLA for fidanacogene elaparvovec for the treatment of adults with hemophilia B and that the European MAA for fidanacogene elaparvovec also has been accepted and is under review by the EMA. Fidanacogene elaparvovec is a novel investigational gene therapy that contains a bio-engineered adeno-associated virus capsid and a high-activity variant of human coagulation Factor IX gene. The FDA has set a PDUFA goal date in the second quarter of 2024.
▪GBS6 (PF-06760805, Group B Streptococcus Vaccine) – In July 2023, Pfizer announced data from a Phase 2 study investigating its hexavalent capsular polysaccharide (CPS) conjugate Group B Streptococcus (GBS) vaccine candidate, GBS6, being developed for maternal administration to protect infants against invasive GBS disease. In stage two of the three-part study, which enrolled 360 healthy pregnant individuals, GBS6 generated robust maternal antibody responses against the six GBS CPS serotypes included in the vaccine, and these antibodies were efficiently transferred to infants at ratios of ~0.4-1.3 depending on GBS6 group. Based on a parallel natural history study conducted in South Africa, the Phase 2 study immunogenicity data suggest that GBS6 may offer meaningful protection against invasive GBS disease in newborns and young infants. The results were published in The New England Journal of Medicine and will inform a planned Phase 3 clinical development program. GBS6 was granted PRIME designation by the EMA’s CHMP and has received Breakthrough Therapy Designation from the U.S. FDA.
▪Marstacimab (PF-06741086) – In May 2023, Pfizer announced that the pivotal Phase 3 BASIS clinical trial (NCT03938792) evaluating marstacimab met its primary endpoints, having demonstrated statistically significant and clinically meaningful effects. Marstacimab is a novel, investigational anti-tissue factor pathway inhibitor (anti-TFPI) being studied for the treatment of hemophilia A or B for people with and without inhibitors to Factor VIII or Factor IX. The BASIS trial demonstrated that prophylactic treatment with marstacimab resulted in a statistically significant and clinically relevant effect on annualized bleeding rate in people living with severe hemophilia A and moderately severe to severe hemophilia B without inhibitors. Analyses of the full Phase 3 dataset are ongoing, and results will be presented at an upcoming scientific conference. Pfizer will discuss these data with regulatory authorities, with the goal of initiating regulatory filings in the coming months. The inhibitor cohort of the BASIS trial is completing enrollment and is expected to read out as early as late 2024.

Corporate Developments

▪In July 2023, Pfizer announced changes to its executive leadership team to further advance its aspirations to discover and develop new medicines and vaccines, with an emphasis on oncology. Chris Boshoff, M.D., Ph.D., has joined Pfizer’s Executive Leadership Team as Chief Oncology Research and Development Officer and Executive Vice President reporting to Chairman and Chief Executive Officer, Albert Bourla. Under his leadership, Pfizer will continue to invest in its fight against cancer, and Dr. Boshoff will be the single point of accountability for the entire oncology pipeline—from discovery to early- and late-phase clinical development. Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer, President, Pfizer Research & Development, has expanded his role to lead all discovery, early- and late-stage clinical development for all non-oncology therapeutic areas, including Vaccines, Inflammation and Immunology, Internal Medicine and Infectious Diseases as well as non-malignant hematology and rare neuromuscular diseases. As a result of these moves, William Pao, M.D., Ph.D., Chief Development Officer and Executive Vice President, will be leaving Pfizer to pursue new opportunities outside the company.
▪In July 2023, Pfizer and Flagship Pioneering, Inc. (Flagship) announced the companies have partnered to create a new pipeline of innovative medicines. Under the terms of the novel agreement, Flagship and Pfizer will each invest $50 million upfront to explore opportunities to develop 10 single-asset programs by leveraging Flagship’s ecosystem of more than 40 human health companies and multiple biotechnology platforms. Pfizer will fund and have an option to acquire each selected development program. Flagship and its bioplatform companies will be eligible to receive up to $700 million in milestones and royalties for each successfully commercialized program.
▪In May 2023, Pfizer completed a $31 billion debt offering consisting of eight tranches of notes (collectively, the "Notes"). The Notes were issued by Pfizer’s wholly-owned subsidiary, Pfizer Investment Enterprises Pte. Ltd., and are fully and unconditionally guaranteed on a senior unsecured basis by Pfizer. Pfizer intends to use the net proceeds of the offering as part of the financing for Pfizer’s proposed acquisition of Seagen Inc.
▪In May 2023, Pfizer and Thermo Fisher Scientific Inc. announced they have entered into a collaboration agreement to help increase local access for next-generation sequencing (NGS)-based testing for lung and breast cancer patients in more than 30 countries across Latin America, Africa, the Middle East and Asia where advanced genomic testing has previously been limited or unavailable. Under the agreement, Pfizer will explore ways to enable affordable patient access for NGS testing in these cancers and work to raise healthcare provider awareness regarding the benefits of advanced testing.

Additional Developments

▪In July 2023, Pfizer announced the company’s immediate efforts to provide relief and repair the damage caused to its manufacturing facility in Rocky Mount, N.C., after a tornado swept through the town. The facility is a key producer of sterile injectables and is responsible for manufacturing nearly 25 percent of all Pfizer’s sterile injectables—including anesthesia, analgesia, therapeutics, anti-infectives and neuromuscular blockers—which is nearly eight percent of all the sterile injectables used in U.S. hospitals. Most of the damage was caused to the warehouse facility, which stores raw materials, packaging supplies and finished medicines. The company is working diligently to move product to other nearby sites for storage and to identify sources to replace damaged raw materials and supplies. It also is exploring alternative manufacturing locations for production across its significant manufacturing presence in the U.S. and internationally and across its partner network. After an initial assessment, there does not appear to be major damage to the production areas, and Pfizer is committed to rapidly restoring full function to the site. Pfizer and the Pfizer Foundation also are providing financial support to help local communities affected by the natural disaster.
▪In June 2023, Pfizer announced it entered into a manufacturing capacity reservation agreement with the European Health and Digital Executive Agency of the EC, which provides the EU access to doses of an mRNA-based vaccine should one be developed to protect against a future pandemic-causing disease. The company will continue to pursue similar agreements with other countries and multi-lateral organizations, building on the reliability and partnerships forged during the COVID-19 pandemic response.

For additional details, see the attached financial schedules, product revenue tables and disclosure notice.
(1)As used in this document, "Comirnaty" refers to, as applicable, and as authorized or approved, the Pfizer-BioNTech COVID-19 Vaccine, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), the Comirnaty Original/Omicron BA.1 Vaccine, and Comirnaty Original/Omicron BA.4/BA.5 Vaccine. In the U.S., the original monovalent mRNA COVID-19 vaccine is no longer emergency use authorized or CDC-recommended, although Comirnaty remains a licensed vaccine. "Comirnaty" includes direct sales and alliance revenues related to sales of the above-mentioned vaccines, which are recorded within Pfizer’s Primary Care customer group. It does not include revenues for certain Comirnaty-related manufacturing activities performed on behalf of BioNTech, which are included in the Pfizer CentreOne contract development and manufacturing organization. Revenues related to these manufacturing activities totaled $6 million and $10 million for the second quarter and the first six months of 2023, respectively, and $55 million and $101 million for the second quarter and the first six months of 2022, respectively.
(2)Revenues is defined as revenues in accordance with U.S. generally accepted accounting principles (GAAP). Reported net income and its components are defined as net income attributable to Pfizer Inc. common shareholders and its components in accordance with U.S. GAAP. Reported diluted earnings per share (EPS) is defined as diluted EPS attributable to Pfizer Inc. common shareholders in accordance with U.S. GAAP.
(3)Adjusted income and Adjusted diluted EPS are defined as U.S. GAAP net income attributable to Pfizer Inc. common shareholders and Reported diluted EPS attributable to Pfizer Inc. common shareholders before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items. See the accompanying reconciliations of certain GAAP Reported to Non-GAAP Adjusted information for the second quarter and the first six months of 2023 and 2022. Adjusted income and its components and Adjusted diluted EPS measures are not, and should not be viewed as, substitutes for U.S. GAAP net income and its components and diluted EPS(2). See the Non-GAAP Financial Measure: Adjusted Income section of Management’s Discussion and Analysis of Financial Condition and Results of Operations in Pfizer’s 2022 Annual Report on Form 10-K and the accompanying Non-GAAP Financial Measure: Adjusted Income section of this press release for a definition of each component of Adjusted income as well as other relevant information.
(4)Pfizer does not provide guidance for GAAP Reported financial measures (other than revenues and acquired in-process R&D (IPR&D) expenses) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP Reported financial measures on a forward-looking basis because it is unable to predict with reasonable certainty the ultimate outcome of unusual gains and losses, certain acquisition-related expenses, gains and losses from equity securities, actuarial gains and losses from pension and postretirement plan remeasurements, potential future asset impairments and pending
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litigation without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP Reported results for the guidance period.
Financial guidance for full-year 2023 reflects the following:
▪Does not assume the completion of any business development transactions not completed as of July 2, 2023, except for signed transactions, if any, through mid-July 2023, which are expected to give rise to acquired IPR&D expenses during fiscal 2023.
▪Reflects an anticipated negative revenue impact of approximately $0.2 billion due to recent and expected generic and biosimilar competition for certain products that have recently lost patent protection or that are anticipated to lose patent protection during fiscal-year 2023.
▪Reflects expected impacts from certain short-term headwinds, such as the U.S. approval for the Talzenna plus Xtandi combination for the treatment of adult patients with HRR gene-mutated mCRPC, versus an approval in the all-comers population; a shared-clinical decision-making recommendation for Abrysvo from the CDC’s ACIP, versus a routine recommendation; and recent tornado damage to Pfizer’s facility in Rocky Mount, N.C.
▪Exchange rates assumed are a blend of actual rates in effect through the second quarter of 2023 and end of June 2023 rates for the remainder of the year. Financial guidance reflects the anticipated unfavorable impact of approximately $0.7 billion on revenues and approximately $0.16 on Adjusted(3) diluted EPS as a result of changes in foreign exchange rates relative to the U.S. dollar compared to foreign exchange rates from 2022.
▪Guidance for Adjusted(3) diluted EPS assumes diluted weighted-average shares outstanding of approximately 5.72 billion shares, and assumes no share repurchases in 2023.
(5)Pfizer’s fiscal year-end for international subsidiaries is November 30 while Pfizer’s fiscal year-end for U.S. subsidiaries is December 31. Therefore, Pfizer’s second quarter and first six months for U.S. subsidiaries reflects the three and six months ended on July 2, 2023 and July 3, 2022, while Pfizer’s second quarter and first six months for subsidiaries operating outside the U.S. reflects the three and six months ended on May 28, 2023 and May 29, 2022.
(6)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 and indication launches. Biopharma, Pfizer’s innovative science-based biopharmaceutical business, is operating under a new commercial structure designed to better support and optimize performance across three broad customer groups:
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▪Primary Care, consisting of the former Internal Medicine and Vaccines product portfolios, products for COVID-19 prevention and treatment, and potential future mRNA and antiviral products.
▪Specialty Care, consisting of the former Inflammation & Immunology, Rare Disease and Hospital (excluding Paxlovid) product portfolios.
▪Oncology, consisting of the former Oncology product portfolio.
(7)References to operational variances in this press release pertain to period-over-period changes that exclude the impact of foreign exchange rates. Although exchange rate changes are part of Pfizer’s business, they are not within Pfizer’s control, and because they can mask positive or negative trends in the business, Pfizer believes presenting operational variances excluding these foreign exchange changes provides useful information to evaluate Pfizer’s results.
(8)The Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) and certain uses of Paxlovid have not been approved or licensed by the FDA. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent has been authorized by the FDA under an EUA to prevent COVID-19 in individuals aged 6 months and older. Paxlovid has been authorized for emergency use by the FDA under an EUA for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product during the COVID-19 pandemic under Section 564(b)(1) of the FFDCA unless the declaration is terminated or authorization revoked sooner. Please see the EUA Fact Sheets at www.covid19oralrx.com and www.cvdvaccine-us.com.