On January 30, 2024 Kite, a Gilead Company (Nasdaq: GILD), reported that the U.S. Food and Drug Administration (FDA) has approved a manufacturing process change resulting in a shorter manufacturing time for Yescarta (axicabtagene ciloleucel) (Press release, Gilead Sciences, JAN 30, 2024, View Source [SID1234639718]). With this approval, Kite’s median turnaround time (TAT) in the U.S. is anticipated to be reduced from 16 days to 14 days.

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Median TAT is defined as time from leukapheresis, when a patient’s T cells are collected, to product release; manufacturing is a key step within this process to prepare a patient’s cells for a one-time cell therapy infusion customized for each patient.

"For patients with relapsed or refractory large B-cell lymphoma, every day matters as the patient’s disease can be aggressive and worsen rapidly," said Cindy Perettie, Executive Vice President, Kite. "Yescarta is the first and only treatment to demonstrate superior overall survival over the standard of care as a second-line treatment with curative intent for these patients, and today’s decision by the FDA allows us to further shorten our delivery time of Yescarta so that patients have the best possible chance of survival."

CAR T-cell therapies are one-time treatments individually made starting from a patient’s own white blood cells, called T-cells. The cells are removed through leukapheresis and sent to Kite’s specialized manufacturing facilities where they are modified with a Chimeric Antigen Receptor (CAR). Once an individual therapy is created for a patient, the cells are carefully checked, preserved, packed and sent back to the hospital to be infused back into the patient. The CAR T-cell therapy process is a continuous one, from leukapheresis to the delivery of the final product, so the timing and scheduling of this process are critical to the supply. To see how this process works, please click here.

Industry experts agree that shortening the time to Yescarta product release and delivery can allow healthcare providers at Kite Authorized Treatment Centers to better support their patients.

"Since the first CAR T-cell therapies were approved more than five years ago and the volume of patients treated has grown from hundreds to several thousand patients each year, we have significantly strengthened our knowledge and understanding of cell therapy delivery," said David Miklos, MD, PhD, a Kite clinical investigator/Chief of Blood and Marrow Transplant and Cell Therapy at Stanford University. "Time is a critical factor in cell therapy, and it can make the difference between a patient being able to receive CAR T or their cancer progressing to the point where they are no longer strong enough for treatment. Therefore, optimizing steps in the process and ultimately reducing the time to CAR T-cell therapy infusion is paramount."

Stanford is one of Kite’s more than 135 authorized treatment centers (ATCs) in the U.S. and more than 400 total across the world.

More than 17,700 patients have been treated with Kite’s CAR T-cell therapies through these ATCs across the globe. Kite has taken a unique approach to scaling the technology of cell therapy, combining capacity, speed, and reliability and the largest in-house cell therapy manufacturing network in the world to rapidly deliver products to these authorized treatment centers.

"Given that each cell therapy batch is unique to each patient, manufacturing is central to how we deliver our therapies, and quality, reliability, and speed are critical," said Chris McDonald, SVP, Global Head of Technical Operations, Kite. "As the global leader in cell therapy, patients and physicians count on our 96% manufacturing success rate, and with a reduced manufacturing time in the U.S., we will continue to expand the reach of Yescarta to even more patients."

Kite has continued to increase its manufacturing network capacity to meet growing demand, ensuring scheduling availability to meet the needs of physicians and their patients.

About Yescarta (Axicabtagene Ciloleucel)

Please see full US Prescribing Information, including BOXED WARNING and Medication Guide.

YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Limitations of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.
Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on the response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial(s).
U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids as needed.
YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS Program.
CYTOKINE RELEASE SYNDROME (CRS)

CRS, including fatal or life-threatening reactions, occurred. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including ≥ Grade 3 in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 in 8%. Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and the median duration was 6 days (range: 1-27 days) for patients with iNHL.

Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing ≥ Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities.

Ensure that 2 doses of tocilizumab are available prior to YESCARTA infusion. Monitor patients for signs and symptoms of CRS at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES

Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life-threatening occurred. Neurologic toxicities occurred in 78% (330/422) of all patients with NHL receiving YESCARTA, including ≥ Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including ≥ Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including ≥ Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range: 1-133 days) and the median duration was 15 days in patients with LBCL in ZUMA-7. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including ≥ Grade 3 in 21%. The median time to onset was 6 days (range: 1-79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of infusion for 87% of affected patients with LBCL and 74% of affected patients with iNHL.

The most common neurologic toxicities (≥ 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41), and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those patients, 85% (33/39) developed neurologic toxicities, 8% (3/39) developed Grade 3, and 5% (2/39) developed Grade 4 neurologic toxicities. The median time to onset of neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in a higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset of and decrease the duration of CRS.

Monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly.

REMS

Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained in the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).

HYPERSENSITIVITY REACTIONS

Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA.

SERIOUS INFECTIONS

Severe or life-threatening infections occurred. Infections (all grades) occurred in 45% of patients with NHL; ≥ Grade 3 infections occurred in 17% of patients, including ≥ Grade 3 infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 36% of all patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS

Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. ≥ Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA

B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment.

SECONDARY MALIGNANCIES

Secondary malignancies may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

ADVERSE REACTIONS

The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with an unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting.

The most common adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with an unspecified pathogen, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with iNHL in ZUMA-5 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with an unspecified pathogen, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness.

On January 30, 2024 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, reported that it has expanded its out licensing transaction with Ewopharma AG. to include the pancreatic cancer indication of Can-Fite (Press release, Can-Fite BioPharma, JAN 30, 2024, View Source [SID1234639717]).

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During 2021, Can-Fite entered into an exclusive distribution agreement for Piclidenoson with Switzerland-based Ewopharma AG for the treatment of psoriasis and Namodenoson for the treatment of hepatocellular carcinoma (HCC) and nonalcoholic steatohepatitis (NASH). Under the terms of the distribution agreement, Ewopharma AG paid Can-Fite an upfront payment of US$2.25 million with up to an additional US$40.45 million, payable upon the achievement of regulatory and sales milestones, plus 17.5% royalties on net sales. In exchange, Ewopharma AG received the exclusive right to market and sell Piclidenoson in Central Eastern European (CEE) countries and Namodenoson in CEE countries and Switzerland.

Ewopharma AG exercised its right to expand the distribution agreement to include the indication of pancreatic cancer and the transaction terms of the distribution agreement are applicable to such indication.

Ewopharma is a pharmaceutical sales and marketing firm that helps pharma companies access markets in CEE and Switzerland. In addition to Can-Fite, Ewopharma AG has distribution agreements with many leading healthcare companies including Eisai and Biogen.

"We are very pleased to expand the distribution agreement with Ewopharma, a leader in pharmaceutical distribution in Central Eastern Europe and Switzerland and include the pancreatic cancer indication. We consider this to be an important transaction for Can-Fite that will enable penetration into Ewopharma’s territory right after approval of the drug for this indication, where there are no other efficacious drugs," stated Can-Fite VP Business Development Dr. Sari Fishman.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In the last 2 years Can-Fite started to develop Namodenoson for the treatment of pancreatic carcinoma. Based on pre-clinical studies which demonstrated robust anti-tumor effect of the drug on experimental models of pancreatic carcinoma, the company decided to initiate an exploratory Phase II study in patients with pancreatic carcinoma who failed first line treatment.

On January 30, 2024 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported preliminary Monjuvi (tafasitamab-cxix) U.S. net product sales and gross margin for Monjuvi U.S. net product sales for the full year of 2023 and provides its 2024 financial guidance (Press release, MorphoSys, JAN 30, 2024, View Source [SID1234639716]). In this context, MorphoSys reduces its financial liability from the collaboration with its partner Incyte and credits finance income accordingly.

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Preliminary Monjuvi U.S. net product sales are US$ 24.1 million (€ 22.4 million) for the fourth quarter and US$ 92.0 million (€ 85.0 million) for the full year of 2023. Fourth quarter and full year 2023 financial results will be published on March 13, 2024. For the full year of 2024, MorphoSys expects Monjuvi U.S. net product sales in the range of US$ 80 to 95 million, aligned with the company’s original 2023 guidance. MorphoSys anticipates Monjuvi’s potential growth to come from new indications. These new indications are currently being investigated in two Phase 3 studies, inMIND (relapsed or refractory follicular lymphoma and marginal zone lymphoma) and frontMIND (first-line diffuse large B-cell lymphoma). Further, preliminary 2023 gross margin for Monjuvi U.S. net product sales is 69%, which is impacted by the recognition of one-time write-offs for inventory.

"Patients with relapsed or refractory diffuse large B-cell lymphoma continued to benefit from Monjuvi in 2023, with sales reaching the higher end of our financial guidance. Beyond its approved indication, we believe Monjuvi’s potential growth will come from the new indications that are currently in Phase 3 studies, the first of which reads out later this year." said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "To maintain our strong financial position, we will continue to be judicious with our finances in 2024 by prioritizing areas that create the most immediate impact and value. As such, pelabresib in first-line myelofibrosis remains our primary focus following the positive Phase 3 MANIFEST-2 results. We are diligently preparing regulatory filings to submit to the U.S. Food and Drug Administration and the European Medicines Agency in the middle of 2024."

As a result of the latest Monjuvi sales expectations, the balance sheet item "Financial Liabilities from Collaborations" is being reduced from € 226 million (balance as of September 30, 2023) to approximately € 114 million (balance as of December 31, 2023; unaudited). Finance income is credited with the difference between the two amounts. The balance in the "Financial Liabilities from Collaborations" item reflects an accounting view of expected future profits from the U.S. net product sales of Monjuvi in the relapsed or refractory diffuse large B-cell lymphoma indication owed to Incyte. This reduction in the "Financial Liabilities from Collaborations" item has no impact on cash or cash runway. Monjuvi’s potential new indications are not and will not be reflected in the line item "Financial Liabilities from Collaborations."

With all of MorphoSys’ Phase 3 clinical programs now fully enrolled and additional cost optimization measures planned, MorphoSys’ anticipated 2024 operating expenses are expected to be lower compared to 2023. As a result, the company expects an anticipated 2024 cash burn of approximately € 250 million (excluding debt and interest payments).

Full Year 2024 Financial Guidance:

2024 Financial Guidance 2024 Guidance Insights
Monjuvi U.S. Net Product Sales US$ 80m to 95m 100% of Monjuvi U.S. net product sales are recorded on MorphoSys’ income statement and related profit/loss is split 50/50 between MorphoSys and Incyte.
R&D Expenses € 210m to 225m R&D expenses anticipated to be lower in 2024 than 2023 due to full enrollment of Phase 3 studies as well as cost optimization measures.
SG&A Expenses € 140m to 155m 45% to 50% of mid-point of SG&A expenses represent Monjuvi U.S. selling costs of which 100% are recorded in MorphoSys’ income statement. Incyte reimburses MorphoSys for half of these selling expenses.
Additional information related to 2024 Financial Guidance:

Tremfya royalties will continue to be recorded as revenue without any cost of sales in MorphoSys’ income statement. These royalties, however, will not contribute any cash to MorphoSys, as 100% of the royalties will be passed on to Royalty Pharma.
MorphoSys anticipates receiving royalties for Minjuvi sales outside of the U.S.
MorphoSys does not anticipate any significant cash-accretive revenues from the achievement of milestones in 2024.
MorphoSys anticipates sales of commercial and clinical supply of tafasitamab outside of the U.S. to its partner Incyte. Revenue from this supply is recorded in the "Licenses, milestones and other" category in MorphoSys’ income statement. These sales result in a zero gross profit/margin. As such, MorphoSys does not provide guidance for these sales.

On January 30, 2024 Sigyn Therapeutics, Inc. ("Sigyn" or the "Company") (OTCQB: SIGY), a development-stage medical technology company, reported that a 1-for-40 reverse split of its common stock will be implemented tomorrow, January 31, 2024 (Press release, Sigyn Therapeutics, JAN 30, 2024, View Source [SID1234639715]). As a result, the Company’s common stock will trade on a post-split basis at the beginning of the trading day on January 31st under its existing trading symbol "SIGY." The CUSIP number for the common stock following the reverse stock split will be 82674U205.

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The reverse stock split is intended to increase the market price per share of the Company’s common stock to gain compliance with the minimum bid listing requirement of The Nasdaq Capital Market in connection with the Company’s pending application for listing. Proportionate adjustments will be made to the conversion and exercise prices of the company’s warrants, restricted stock unit awards, stock options and to the number of shares issued and issuable under the Company’s equity incentive plans.

The proposed listing application has been submitted to Nasdaq, but it has not yet been approved. There can be no assurance that the listing application will be approved and there remain additional requirements which must be satisfied prior to any approval decision.

On January 30, 2024 Pfizer Inc. (NYSE: PFE) reported financial results for fourth quarter and full-year 2023 and reaffirmed its 2024 financial guidance(5) provided on December 13, 2023 (Press release, Pfizer, JAN 30, 2024, View Source [SID1234639714]).

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The fourth-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: "We are encouraged by the strong performance of our non-COVID products in the fourth quarter of 2023, including significant contributions from new launches and robust year-over-year growth for several key in-line brands. In 2023, Pfizer received a record number of nine new molecular entity approvals by the U.S. Food and Drug Administration (FDA)—medicines and vaccines that are expected to favorably impact Pfizer’s performance in the coming years.

"In addition, we completed the acquisition of Seagen in December 2023, a critical step toward our goal to achieve world-class Oncology leadership. With the combined strength of Pfizer’s and Seagen’s talent, portfolios and platforms, we believe we have the potential to transform outcomes by delivering cancer medicines that help patients live better and longer lives. We look forward to sharing the vision of the new Pfizer Oncology Division at our announced Oncology Innovation Day on Thursday, February 29.

"We are entering 2024 with a solid foundation. We believe our commitment to execution, maximizing the performance of our new products, and delivering the next wave of pipeline innovation will fuel Pfizer’s growth and make a difference in the lives of patients everywhere."

David Denton, Chief Financial Officer and Executive Vice President, stated: "We are pleased with the strong 8% operational revenue growth of Pfizer’s non-COVID products in the fourth quarter of 2023, achieving our full-year 2023 non-COVID operational revenue growth target of 6% to 8%. In addition, we are on track to deliver at least $4.0 billion in annual net cost savings by the end of 2024 from our cost realignment program. We are prepared to execute our commercial strategy to drive continued growth from our newly launched and acquired products, and to deliver on our targeted cost savings that we expect will expand our operating margins in 2024 and beyond."

Results for fourth-quarter and full-year 2023 and 2022(6) are summarized below.

OVERALL RESULTS

($ in millions, except

per share amounts)

Fourth-Quarter

Full-Year

2023

2022

Change

2023

2022

Change

Revenues

$ 14,249

$ 24,290

(41%)

$ 58,496

$ 100,330

(42%)

Reported(2) Net Income/(Loss)

(3,369)

4,995

*

2,119

31,372

(93%)

Reported(2) Diluted EPS/(LPS)

(0.60)

0.87

*

0.37

5.47

(93%)

Adjusted(3) Income

593

6,551

(91%)

10,501

37,717

(72%)

Adjusted(3) Diluted EPS

0.10

1.14

(91%)

1.84

6.58

(72%)

* Indicates calculation not meaningful.

REVENUES

($ in millions)

Fourth-Quarter

Full-Year

2023

2022

% Change

2023

2022

% Change

Total

Oper.

Total

Oper.

Global Biopharmaceuticals Business (Biopharma)

$ 13,867

$ 23,922

(42%)

(42%)

$ 57,186

$ 98,988

(42%)

(41%)

Primary Care

6,986

17,348

(60%)

(60%)

30,589

73,023

(58%)

(57%)

Specialty Care

3,949

3,566

11%

11%

14,970

13,833

8%

11%

Oncology

2,932

3,007

(3%)

(2%)

11,627

12,132

(4%)

(3%)

Business Innovation

$ 382

$ 368

4%

2%

$ 1,310

$ 1,342

(2%)

(2%)

TOTAL REVENUES

$ 14,249

$ 24,290

(41%)

(42%)

$ 58,496

$ 100,330

(42%)

(41%)

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, an offering that provides strategic guidance and end-to-end R&D services to select innovative biotech companies that align with Pfizer’s R&D focus areas. The prior period has been revised to conform to the current period presentation.

Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates(7).

CAPITAL ALLOCATION

During full-year 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:
$10.7 billion invested in internal research and development projects, and
Approximately $43.8 billion invested in completed business development transactions, net of cash acquired, including approximately $43 billion for the acquisition of Seagen Inc.
Returning capital directly to shareholders through $9.2 billion of cash dividends, or $1.64 per share of common stock.
No share repurchases were completed in 2023. As of January 30, 2024, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2024.

For the fourth quarter of 2023, basic weighted-average shares outstanding of 5,647 million were used to calculate Reported(2) LPS and diluted weighted-average shares outstanding of 5,692 million were used to calculate Adjusted(3) diluted EPS.

2024 FINANCIAL GUIDANCE(5)

Pfizer expects full-year 2024 revenues(2) to be in the range of $58.5 to $61.5 billion, which includes approximately $8 billion in anticipated revenues for Comirnaty(1) and Paxlovid (approximately $5 billion and $3 billion, respectively), approximately $3.1 billion in anticipated revenues from Seagen and approximately $1 billion related to the reclassification of Pfizer’s royalty income from Other (Income)/Deductions into the Revenue line.

Including the contribution from Seagen and excluding revenues from Comirnaty(1) and Paxlovid, Pfizer expects to achieve full-year 2024 operational revenue growth of 8% to 10% compared to 2023 revenues. Excluding revenues from Comirnaty(1) and Paxlovid and the expected contribution from Seagen, Pfizer expects to achieve full-year 2024 operational revenue growth of 3% to 5% compared to 2023 revenues. While the company will begin reporting royalty income in the revenue line in 2024, for growth rate purposes, the company has included royalty income in revenues in both 2023 and 2024. Consequently, there is no operational revenue growth attributable to the reclassification of royalty income.

Including the impact of Seagen, Pfizer anticipates full-year 2024 Adjusted(3) SI&A expenses to be in the range of $13.8 billion to $14.8 billion and full-year 2024 Adjusted(3) R&D expenses to be in the range of $11.0 to $12.0 billion. Consequently, total 2024 Adjusted(3) SI&A and R&D expenses are expected to be in the range of $24.8 to $26.8 billion. This range reflects an anticipated decline of approximately $4 billion by the end of 2024 versus the midpoint of Pfizer’s SI&A and R&D expense guidance provided on August 1, 2023, solely driven by Pfizer’s cost realignment program, partially offset by the impact of Seagen.

2024 Adjusted(3) diluted EPS is anticipated to be in a range of $2.05 to $2.25, which primarily reflects:

Expected operational revenue growth of 8% to 10% compared to 2023 revenues, excluding Comirnaty(1) and Paxlovid and including the impact of Seagen; and
Anticipated operating margin improvement from the company’s cost realignment activities; partially offset by
An expected $0.40 dilutive impact related to the Seagen acquisition, which is predominantly driven by costs to finance the transaction.
Pfizer’s 2024 financial guidance(5), including the impact of certain significant factors, is presented below.

2023
Results

2024 Legacy

Pfizer
Guidance

Anticipated
Impact of Royalty
Income Reclass
Included in 2024
Guidance

Anticipated 2024
Seagen Impact
Included in 2024
Guidance

2024 Financial
Guidance(5)

Revenues ($ in billions)

$58.5

$54.5 to $57.5

$1.0

$3.1

$58.5 to $61.5

Adjusted(3) SI&A Expenses ($ in billions)

$14.4

$13.8 to $14.8

Adjusted(3) R&D Expenses ($ in billions)

$10.6

$11.0 to $12.0

Effective Tax Rate on Adjusted(3) Income

9.0%

~15.0%

Adjusted(3) Diluted EPS

$1.84

$2.45 to $2.65

–

$(0.40)

$2.05 to $2.25

Financial guidance for Adjusted(3) diluted EPS is calculated using approximately 5.75 billion weighted average shares outstanding and assumes no share repurchases in 2024.

QUARTERLY FINANCIAL HIGHLIGHTS (Fourth-Quarter 2023 vs. Fourth-Quarter 2022)

Fourth-quarter 2023 revenues totaled $14.2 billion, a decrease of $10.0 billion, or 41%, compared to the prior-year quarter, reflecting an operational decline of $10.1 billion, or 42%, primarily due to a significant decrease in Comirnaty(1) and Paxlovid revenues globally, as well as a de minimis impact of foreign exchange. Excluding contributions from Comirnaty(1) and Paxlovid, company revenues grew $934 million, or 8%, operationally.

Fourth-quarter 2023 Comirnaty(1) revenues declined $6.1 billion, or 54%, operationally compared with the prior-year quarter, largely driven by lower U.S. government contracted deliveries following the transition to traditional U.S. commercial market sales, which began in September 2023, and by lower contracted deliveries and demand in international markets.

Fourth-quarter 2023 Paxlovid revenues declined $5.0 billion, to $(3.1) billion, compared with the prior-year quarter, primarily driven by a non-cash revenue reversal of $3.5 billion recorded in the fourth quarter of 2023, of which a portion was associated with sales recorded in 2022, related to the expected return of an estimated 6.5 million treatment courses of Emergency Use Authorization (EUA)-labeled U.S. government inventory; partially offset by sales under traditional commercial markets following transition, primarily in the U.S.

Excluding contributions from Comirnaty(1) and Paxlovid, fourth-quarter 2023 operational revenue growth was primarily driven by:

Abrysvo, which contributed $515 million in global revenues, driven primarily by launch of the older adult indication in the U.S. in July 2023;
Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 39% operationally, driven largely by continued strong uptake of the transthyretin amyloid cardiomyopathy (ATTR-CM) indication, primarily in the U.S. and developed Europe; and
Eliquis globally, up 9% operationally, driven primarily by continued oral anti-coagulant adoption and market share gains in the non-valvular atrial fibrillation indication in the U.S. and certain markets in Europe, partially offset by declines due to loss of exclusivity and generic competition in certain international markets;
partially offset primarily by lower revenues for:

Ibrance globally, down 13% operationally, driven primarily by lower demand globally due to competitive pressure and lower clinical trial purchases in certain international markets; and
Prevnar family (Prevnar 13 & 20) globally, down 7% operationally, driven primarily by the pediatric indication in emerging markets due to lower demand and unfavorable timing of customer orders.
GAAP Reported(2) Statement of Operations Highlights

SELECTED REPORTED(2) COSTS AND EXPENSES

($ in millions)

Fourth-Quarter

Full-Year

2023

2022

% Change

2023

2022

% Change

Total

Oper.

Total

Oper.

Cost of Sales(2)

$ 7,562

$ 9,648

(22%)

(24%)

$ 24,954

$ 34,344

(27%)

(29%)

Percent of Revenues

53.1%

39.7%

N/A

N/A

42.7%

34.2%

N/A

N/A

SI&A Expenses(2)

4,575

4,644

(1%)

(2%)

14,771

13,677

8%

9%

R&D Expenses(2)

2,815

3,615

(22%)

(22%)

10,679

11,428

(7%)

(6%)

Acquired IPR&D Expenses(2)

73

73

—

—

194

953

(80%)

(80%)

Other (Income)/Deductions––net(2)

(480)

(846)

(43%)

(51%)

(835)

217

*

*

Effective Tax Rate on Reported(2) Income/(Loss)

19.2%

4.4%

(105.4%)

9.6%

* Indicates calculation not meaningful.

Fourth-quarter 2023 Cost of Sales(2) as a percentage of revenues increased by 13.4 percentage points compared with the prior-year quarter, driven primarily by the $3.5 billion non-cash Paxlovid revenue reversal; unfavorable changes in sales mix, primarily due to lower sales of Paxlovid and Comirnaty(1); and the unfavorable impact of foreign exchange.

Fourth-quarter 2023 SI&A Expenses(2) decreased 2% operationally compared with the prior-year quarter, driven primarily by a decrease in marketing and promotional expenses for Paxlovid, a lower provision for U.S. healthcare reform fees related to Paxlovid and Comirnaty(1), and lower compensation-related expenses, partially offset by increases in marketing and promotional expenses, including those related to recently launched and acquired products, as well as increased investments to build new internal marketing capabilities.

Fourth-quarter 2023 R&D Expenses(2) decreased 22% operationally compared with the prior-year quarter, driven primarily by lower compensation-related expenses, as well as by lower spending across (i) vaccine programs, (ii) certain acquired assets and (iii) for ongoing rare disease programs.

The unfavorable period-over-period change in Other income—net(2) of $366 million for the fourth quarter of 2023, compared to the fourth quarter of 2022, was driven primarily by higher intangible asset impairment charges, partially offset by an increase in net gains on equity securities.

Pfizer’s positive effective tax rate for the fourth quarter of 2023 reflects a tax benefit on a pre-tax Reported(2) loss and includes changes in the jurisdictional mix of earnings and the resolution of uncertain tax positions in various markets.

Adjusted(3) Statement of Operations Highlights

SELECTED ADJUSTED(3) COSTS AND EXPENSES

($ in millions)

Fourth-Quarter

Full-Year

2023

2022

% Change

2023

2022

% Change

Total

Oper.

Total

Oper.

Adjusted(3) Cost of Sales

$ 7,265

$ 9,475

(23%)

(26%)

$ 23,988

$ 34,096

(30%)

(31%)

Percent of Revenues

51.0%

39.0%

N/A

N/A

41.0%

34.0%

N/A

N/A

Adjusted(3) SI&A Expenses

4,471

4,414

1%

1%

14,446

13,049

11%

12%

Adjusted(3) R&D Expenses

2,770

3,610

(23%)

(24%)

10,568

11,409

(7%)

(7%)

Adjusted(3) Other (Income)/Deductions––net

(815)

(656)

24%

14%

(2,281)

(1,954)

17%

8%

Effective Tax Rate on Adjusted(3) Income/(Loss)

(24.0%)

11.1%

9.0%

11.7%

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

FULL-YEAR REVENUE SUMMARY (Full-Year 2023 vs. Full-Year 2022)

Full-year 2023 revenues totaled $58.5 billion, a decrease of $41.8 billion, or 42%, compared to full-year 2022, reflecting an operational decline of $40.8 billion, or 41%, and an unfavorable impact of foreign exchange of $1.0 billion, or 1%. Excluding contributions from Comirnaty(1) and Paxlovid, revenues for the full-year grew 7% operationally.

The operational revenue decline compared to the prior year was driven primarily by significantly lower global revenues for Comirnaty(1) and Paxlovid and, to a much lesser extent, lower revenues for Ibrance, partially offset by an increase in revenues from Nurtec ODT/Vydura and Oxbryta, which were acquired in the fourth quarter of 2022; revenues from Abrysvo, primarily driven by the launch of the older adult indication in the U.S.; and continued growth from the Vyndaqel family and Eliquis.

RECENT NOTABLE DEVELOPMENTS (Since October 31, 2023)

Product Developments

Elrexfio (elranatamab-bcmm) – In December 2023, Pfizer announced the European Commission (EC) granted conditional marketing authorization for Elrexfio for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Padcev (enfortumab vedotin-ejfv)
In January 2024, Pfizer and Astellas Pharma Inc. (Astellas) announced that the European Medicines Agency (EMA) validated for review a Type II variation application for Padcev, an antibody-drug conjugate (ADC), with Keytruda(8) (pembrolizumab, a PD-1 inhibitor) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). The EMA’s Committee for Medicinal Products for Human Use (CHMP), and subsequently the EC, are expected to share their opinions and decisions on the Type II variation application in calendar year 2024.
In December 2023, Pfizer and Astellas announced that the FDA approved Padcev with Keytruda(8) for the treatment of adult patients with la/mUC based on the results from the Phase 3 EV-302 clinical trial. This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC.
Prevnar 20 (20-valent pneumococcal conjugate vaccine) – In January 2024, Pfizer announced the CHMP of the EMA adopted a positive opinion, recommending the granting of a marketing authorization for its 20-valent pneumococcal conjugate vaccine candidate for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age. The CHMP’s positive opinion will now be reviewed by the EC to decide whether to approve the vaccine. This decision is expected in the coming weeks and will apply to all 27 European Union (EU) member states plus Iceland, Liechtenstein and Norway.
Talzenna (talazoparib) – In January 2024, Pfizer announced that the EC approved Talzenna, an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide), for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. With this approval, Talzenna is now the first and only PARP inhibitor licensed in the EU for use with Xtandi for patients with mCRPC, with or without gene mutations. The approval is valid in all 27 EU member states plus Iceland, Liechtenstein and Norway.
Tivdak (tisotumab vedotin-tftv) – In January 2024, Pfizer and Genmab A/S announced the FDA accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of Tivdak, an ADC, to full approval, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy. The sBLA is supported by efficacy and safety data from the global, randomized, Phase 3 innovaTV 301 trial. The application was granted Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 9, 2024.
Velsipity (etrasimod) – In December 2023, Pfizer announced the EMA’s CHMP adopted a positive opinion for Velsipity, an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for the treatment of patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological agent. The EC will review the CHMP recommendation and is expected to make a final decision in the coming months.
Xtandi (enzalutamide) – In November 2023, Astellas and Pfizer announced the FDA approved a supplemental New Drug Application (sNDA) for Xtandi following FDA expedited development and review programs (Priority Review designation, Fast Track designation, Real-time Oncology Review), based on results from the Phase 3 EMBARK trial. With this approval, Xtandi becomes the first and only androgen receptor signaling inhibitor approved by the FDA for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). Patients with nmCSPC with high-risk BCR may be treated with Xtandi with or without a gonadotropin-releasing hormone (GnRH) analog therapy.
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.

Danuglipron – In December 2023, Pfizer announced topline data from the Phase 2b clinical trial investigating its oral glucagon-like peptide-1 receptor agonist (GLP-1RA) candidate danuglipron in adults with obesity and without type 2 diabetes. The study met its primary endpoint demonstrating statistically significant change in body weight from baseline. While the most common adverse events were mild and gastrointestinal in nature consistent with the mechanism, high rates were observed. High discontinuation rates were seen across all doses compared to placebo. No new safety signals were reported, and treatment with danuglipron was not associated with increased incidence of liver enzyme elevation compared to placebo. Future development of danuglipron will be focused on a once-daily formulation, with pharmacokinetic data anticipated in the first half of 2024, which will help to inform a potential path forward.
Marstacimab
In December 2023, Pfizer announced the FDA had accepted the company’s Biologics License Application (BLA) for its anti-tissue factor pathway inhibitor (anti-TFPI) candidate marstacimab for individuals living with hemophilia A or hemophilia B without inhibitors to Factor VIII (FVIII) or Factor IX (FIX). A marketing authorization application for marstacimab is also currently under review by the EMA. The FDA has set a PDUFA action date in the fourth quarter of 2024, and a decision from the EC is anticipated by the first quarter of 2025.
In December 2023, Pfizer presented results from the pivotal Phase 3 BASIS clinical trial evaluating marstacimab for the treatment of people with severe hemophilia A and moderately severe to severe hemophilia B without inhibitors to FVIII or FIX. Results from the BASIS trial, which were presented at the 2023 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, demonstrated a statistically significant and clinically meaningful effect on annualized bleeding rate. The safety profile for marstacimab was consistent with Phase 1/2 results, and treatment was generally well-tolerated in the study. No deaths were reported, and there have been no thromboembolic events or events of consumptive coagulopathy recorded in hemophilia patients in clinical trials investigating marstacimab.
Vepdegestrant (ARV-471) – In December 2023, Arvinas, Inc. and Pfizer presented interim results from the Phase 1b trial evaluating vepdegestrant, a novel oral PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, in combination with palbociclib (Ibrance). Study data from the combination cohort demonstrated encouraging clinical activity in heavily pre-treated patients with a median of four lines of therapy across disease settings with locally advanced or metastatic ER positive/human epidermal growth factor 2 (HER2) negative (ER+/HER2-) breast cancer. These data were presented in a spotlight presentation at the 2023 San Antonio Breast Cancer Symposium.
VLA15 (Lyme Disease Vaccine Candidate) – In December 2023, Pfizer and Valneva SE announced the completion of recruitment for the Phase 3 VALOR trial evaluating VLA15, an investigational multivalent protein subunit vaccine for Lyme disease. The trial builds on previous positive Phase 1 and 2 trial results and includes both adult and pediatric participants, with the aim to confirm the efficacy, safety, lot consistency and immunogenicity of VLA15. The VALOR trial is expected to be concluded by the end of 2025.
Corporate Developments

In December 2023, Pfizer announced the completion of its acquisition of Seagen for $229 per share, in cash. The total fair value of the consideration transferred was $44 billion ($43 billion, net of cash acquired). To address U.S. Federal Trade Commission concerns, Pfizer has chosen to irrevocably donate the rights of royalties from sales of Bavencio(9) (avelumab) in the U.S. to the American Association for Cancer Research (AACR) (Free AACR Whitepaper). With the addition of Seagen’s four in-line medicines, Adcetris (brentuximab vedotin), Padcev (enfortumab vedotin), Tivdak (tisotumab vedotin) and Tukysa (tucatinib), Pfizer’s industry-leading Oncology portfolio now includes over 25 approved medicines and biosimilars across more than 40 indications, including nine medicines that are either blockbuster or have the potential to be blockbuster.
In December 2023, Pfizer announced changes in its commercial organization to incorporate Seagen and improve focus, speed and quality of execution, effective January 1, 2024. Three new organizations have been created, each led by a member of Pfizer’s executive leadership team reporting to Dr. Albert Bourla, Chairman and Chief Executive Officer: (1) the Pfizer Oncology Division, which brings together U.S. oncology commercial operations from both Pfizer and Seagen and is led by Chris Boshoff, M.D., Ph.D., Chief Oncology Officer, Executive Vice President, who also leads Pfizer’s newly combined global oncology R&D operations; (2) the Pfizer U.S. Commercial Division, led by Aamir Malik, Chief U.S. Commercial Officer, Executive Vice President; and (3) the Pfizer International Commercial Division, led by Alexandre de Germay, who has joined Pfizer as Chief International Commercial Officer, Executive Vice President.
Please find Pfizer’s press release and associated financial tables, including reconciliations of certain GAAP reported to non-GAAP adjusted information, at the following hyperlink:

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