Key TakeawaysThe experimental COVID-19/flu vaccine from Pfizer and BioNTech missed one of two key endpoints in a Phase 3 study.The companies reported that while the shot worked against COVID-19 and influenza A, it fell short versus influenza B.Pfizer and BioNTech said they are evaluating adjustments to the vaccine. Shares of Pfizer (PFE) and American depositary receipts (ADRs) of BioNTech (BNTX) dropped in intraday trading Friday following disappointing results from a late-stage study of the drugmakers' co ...

Pfizer logo is seen on Pfizer World Headquarters in Manhattan, New York, United States of America, ... [+] on July 6th, 2024. (Photo by Beata Zawrzel/NurPhoto via Getty Images)NurPhoto via Getty ImagesWith Pfizer’s sales rising in Q2, despite falling sales of Covid-19 products, we think that it may well be the turning point for Pfizer stock. It has seen a decline of 15% from levels of $35 in early January 2021 to around $30 now, vs. an increase of about 65% for its peer, Merck stock (NYSE: MRK), over this p ...

Core Insights - Pfizer and BioNTech's Phase 3 trial for a combination vaccine against influenza and COVID-19 met one of its two primary immunogenicity objectives, specifically achieving robust responses against influenza A and comparable responses against COVID-19, but did not meet the non-inferiority objective for the influenza B strain [1][2][3] - The companies are considering adjustments to the combination vaccine candidate and will engage with health authorities regarding next steps [1][2] - Pfizer's separate Phase 2 trial for a second-generation trivalent influenza mRNA vaccine showed promising results, demonstrating strong immunogenicity against all strains compared to standard influenza vaccines [1][5] Phase 3 Trial Details - The Phase 3 trial enrolled over 8,000 adults aged 18-64 to assess the safety, tolerability, and immunogenicity of a single-dose combination vaccine [2] - The trial compared the combination vaccine to a licensed influenza vaccine and the companies' licensed COVID-19 vaccine, focusing on antibody responses to both influenza and SARS-CoV-2 [2] - The combination vaccine elicited robust responses for influenza A but lower geometric mean titers for influenza B, while showing comparable responses against SARS-CoV-2 [2] Company Statements - Pfizer expressed optimism about the results, highlighting the robust immunogenicity against influenza A and the commitment to developing vaccines that address respiratory diseases [3] - BioNTech emphasized the importance of the insights gained from the trial for future development of combination vaccines [3] Phase 2 Trial Insights - Pfizer's Phase 2 trial for second-generation influenza vaccines involved 450 participants and aimed to improve immunogenicity and breadth of protection [5] - The new trivalent formulations showed strong responses against influenza A and B, with no safety signals reported [5] Industry Context - Influenza causes significant health burdens in the U.S., with annual hospitalizations ranging from 140,000 to 710,000 and deaths between 12,000 and 52,000, leading to economic losses of approximately $25 billion [7] - Current influenza vaccines typically provide 40% to 60% protection, with lower efficacy in years of poor strain matching, highlighting the need for improved vaccine technologies like mRNA [7]

There are a number of pharmaceutical companies looking to make waves in the weight loss market.The diabetes and obesity care markets are under disruption. Glucagon-like peptide-1 (GLP-1) receptor agonists such as Ozempic, Wegovy, Mounjaro, and Zepbound have catapulted in popularity.The thing is that all of those treatments are manufactured by just two pharmaceutical companies, Novo Nordisk (NVO 1.54%) and Eli Lilly (LLY -0.30%). Yet despite limited competition at the moment, a number of companies of all siz ...

Pfizer (PFE) announced positive top-line data from substudy B of the ongoing pivotal late-stage MONeT study. The study is evaluating two doses of its RSV vaccine Abrysvo in immunocompromised adults who are at risk of developing severe RSV-associated lower respiratory tract disease (LRTD).While this substudy evaluated two 120 µg doses of Abrysvo, management reported that a single dose of the vaccine generated strong neutralizing responses against both RSV subtypes (RSV-A and RSV-B) across all cohorts and age ...

This pharmaceutical blue chip could be ready to rally higher.While the COVID-19 pandemic is an increasingly distant memory for most investors, Pfizer (PFE -0.73%) has struggled to move past the overhang of record vaccine sales and earnings in 2021 and 2022. The stock is down about 53% from its all-time high as the market wonders whether the pharmaceutical giant can find its next blockbuster drug.The good news is that the company's latest results highlighted a growth rebound. Sales momentum from several rece ...

Can this struggling stock turn things around?Demand for COVID-19 vaccines and drugs has been fading for a while now. And that has put a big dent in Pfizer's (PFE -1.60%) sales and profit numbers. On top of that, the stock is also facing headwinds due to losses in exclusivity for multiple drugs, which threaten to wipe off billions of dollars in revenue from its top line this decade.Recently, however, Pfizer reported some encouraging quarterly numbers. Also, the growth rate of many drugs was in double digits. ...

Finding the right stocks for investment can be a tricky game. While there are thousands of stocks to choose from, only a few can pass the test of time. Whether you have a solid portfolio or are only getting started, keep a few promising growth stocks on your radar. Don’t wait to accumulate thousands of dollars before you start your investment journey. It is possible to begin with cheap stocks under $50. The following highly reliable companies have strong fundamentals, impressive business structures and the ...

Emergency Use Authorizations (EUA) and Regulatory Updates - Comirnaty (COVID-19 Vaccine, mRNA) 2023-2024 Formula has been authorized for emergency use by the FDA under an EUA for individuals aged 6 months through 11 years[7] - 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 aged 12 years and older weighing at least 40 kg[7] - The emergency use authorization for Comirnaty and Paxlovid is contingent on the COVID-19 pandemic declaration under Section 564(b)(1) of the U.S. Federal Food, Drug and Cosmetics Act[7] - Clinical trial data discussed in the Form 10-Q are subject to differing interpretations and regulatory authorities may require additional data or deny approval[7] Financial Performance and Revenues - Total revenues for the three months ended June 30, 2024, were $13.283 billion, compared to $13.007 billion for the same period in 2023, representing a 2.1% increase[10] - Product revenues for the six months ended June 30, 2024, were $23.314 billion, down 13.6% from $26.988 billion in the same period in 2023[10] - Total revenues for Q2 2024 were $13.283 billion, compared to $13.007 billion in Q2 2023[131] - Total revenues for the six months ended June 30, 2024, were $28.162 billion, an 11% decrease compared to $31.492 billion in the same period in 2023[133] - Revenues from the U.S. government comprised 7% and 9% of total revenues for the six months ended June 30, 2024, and July 2, 2023, respectively[134] - Paxlovid recorded revenues of $251 million for the three months ended June 30, 2024, compared to $143 million in the same period in 2023[135] - Comirnaty recorded revenues of $195 million for the three months ended June 30, 2024, a significant decrease from $1.488 billion in the same period in 2023[135] - Oncology revenues for the three months ended June 30, 2024, were $3.956 billion, a 26% increase compared to $3.149 billion in the same period in 2023[138] - Ibrance recorded revenues of $1.130 billion for the three months ended June 30, 2024, a 9% decrease compared to $1.247 billion in the same period in 2023[138] - Xtandi recorded revenues of $495 million for the three months ended June 30, 2024, a 17% increase compared to $423 million in the same period in 2023[138] Research and Development (R&D) and Expenses - Research and development expenses for the six months ended June 30, 2024, were $5.189 billion, slightly up from $5.153 billion in the same period in 2023[10] - Selling, informational, and administrative expenses for the six months ended June 30, 2024, were $7.212 billion, up 4.3% from $6.914 billion in the same period in 2023[10] - Restructuring charges and certain acquisition-related costs for the six months ended June 30, 2024, were $1.356 billion, significantly higher than $222 million in the same period in 2023[10] - The company recorded a $240 million intangible asset impairment charge in Q2 2024 related to a Phase 3 study for DMD treatment in the Biopharma segment[41] Net Income and Comprehensive Income - Net income attributable to Pfizer Inc. common shareholders for the six months ended June 30, 2024, was $3.156 billion, a 59.9% decrease from $7.870 billion in the same period in 2023[10] - Comprehensive income attributable to Pfizer Inc. for the six months ended June 30, 2024, was $3.302 billion, down 59.2% from $8.072 billion in the same period in 2023[12] - Net income for Q2 2024 was $41 million, compared to $2,327 million in Q2 2023, reflecting a significant decline[15] - Total earnings for Q2 2024 were a loss of $103 million, compared to a gain of $2.269 billion in Q2 2023[131] - Total earnings for the first six months of 2024 were $3.318 billion, compared to $8.539 billion in the same period of 2023[131] Cash Flow and Financial Position - Cash and cash equivalents decreased to $1.052 billion as of June 30, 2024, from $2.853 billion as of December 31, 2023[13] - Net cash used in operating activities was $691 million for the six months ended June 2024, compared to $4 million provided in the same period in 2023[17] - Net cash provided by investing activities was $6,332 million for the six months ended June 2024, compared to $22,170 million used in the same period in 2023[17] - Net cash used in financing activities was $7,390 million for the six months ended June 2024, compared to $24,403 million provided in the same period in 2023[17] - Short-term investments increased to $6,048 million as of June 30, 2024, compared to $9,837 million as of December 31, 2023[57] - Long-term investments decreased to $3,119 million as of June 30, 2024, from $3,731 million as of December 31, 2023[57] - Equity-method investments decreased to $8,029 million as of June 30, 2024, from $11,637 million as of December 31, 2023[57] - Total assets decreased to $9,322 million as of June 30, 2024, from $13,943 million as of December 31, 2023[53] - Total liabilities decreased to $1,228 million as of June 30, 2024, from $1,420 million as of December 31, 2023[53] Debt and Equity - Long-term debt decreased to $57.506 billion as of June 30, 2024, from $61.538 billion as of December 31, 2023[13] - Total equity decreased from $92,558 million at the end of March 2024 to $87,975 million by June 30, 2024[15] - Retained earnings dropped from $121,318 million at the end of March 2024 to $116,596 million by June 30, 2024[15] - Share-based payment transactions contributed $196 million to equity in Q2 2024, compared to $164 million in Q2 2023[15] - Other comprehensive loss for Q2 2024 was $58 million, compared to a gain of $187 million in Q2 2023[15] - Total shareholders' equity decreased from $92,282 million at the end of March 2024 to $87,700 million by June 30, 2024[15] - Noncontrolling interests remained relatively stable at $275 million by June 30, 2024, compared to $276 million at the end of March 2024[15] - Accumulated other comprehensive loss increased from $7,758 million at the end of March 2024 to $7,816 million by June 30, 2024[15] - Treasury stock cost remained nearly unchanged at $114,757 million by June 30, 2024, compared to $114,755 million at the end of March 2024[15] Acquisitions and Investments - The company acquired Seagen for $44.2 billion ($43.4 billion, net of cash acquired) on December 14, 2023, with provisional amounts recognized for assets acquired and liabilities assumed[24] - Identifiable intangible assets, excluding in-process research and development, were $7,395 million as of the acquisition date, adjusted from $7,970 million[26] - In-process research and development was $20,750 million as of the acquisition date, adjusted from $20,800 million[26] - Goodwill was $16,803 million as of the acquisition date, adjusted from $16,126 million[26] - Total identifiable net assets were $27,431 million as of the acquisition date, adjusted from $28,108 million[26] - Pfizer sold 30% of its investment in Haleon for $3.5 billion, recognizing a gain of $150 million in Q1 2024, reducing its ownership to 23%[29] - The fair value of Pfizer's investment in Haleon as of June 30, 2024, was $8.4 billion[29] Litigation and Legal Matters - The company is involved in patent litigation, including challenges to the validity and coverage of patents on various products, processes, or dosage forms[88] - Adverse outcomes in patent litigation could result in loss of patent protection, significant revenue loss, or impairment of associated assets[88] - The company is subject to product liability and other product-related litigation, including personal injury, consumer, off-label promotion, securities, antitrust, and breach of contract claims[88] - Xeljanz (tofacitinib) patent-infringement actions against generic manufacturers, including Sinotherapeutics and Biocon, for 5 mg, 10 mg, 11 mg, and 22 mg dosage strengths[90] - Mektovi (binimetinib) patent-infringement actions against generic companies, including Teva, for method of use patents expiring in 2030, 2031, and 2033[91][93] - Vyndaqel-Vyndamax (tafamidis/tafamidis meglumine) patent-infringement actions against generic companies for 61 mg and 20 mg capsules[94] - Oxbryta (voxelotor) patent-infringement actions against Zydus and MSN for 300 mg and 500 mg tablets[95] - Nurtec (rimegepant) patent-infringement actions against multiple generic companies for 75 mg orally disintegrating tablets[96] - Comirnaty patent-infringement lawsuits filed by Alnylam, Moderna, Arbutus, and GlaxoSmithKline in multiple jurisdictions[97][98] - Paxlovid patent-infringement lawsuit filed by Enanta Pharmaceuticals for the active ingredient nirmatrelvir[99] - Abrysvo patent-infringement lawsuit filed by GlaxoSmithKline for the active ingredient in the RSV vaccine[100] - Comirnaty declaratory judgment actions and counterclaims involving CureVac in the U.S. and U.K.[101] - Effexor XR antitrust litigation settled in April 2024, involving claims of delayed generic launch and price overcharges[105] - Pfizer and Ranbaxy reached agreements to settle Lipitor-related litigation in April 2024, with certain settlements subject to court approval[106] - Pfizer settled EpiPen litigation in October 2023 on terms not material to the company, with court approval granted in July 2024[107] - Pfizer and Hospira face lawsuits related to Docetaxel, with the Mississippi Attorney General voluntarily dismissing a case in June 2024[110] - Pfizer has settled or entered into agreements to settle a substantial majority of Zantac-related state court cases as of July 2024[111] - Pfizer faces class actions related to Chantix recall, with federal cases consolidated in an MDL in December 2022[112] - New Monsanto continues to defend and indemnify Pharmacia for liabilities related to Former Monsanto's chemical businesses[114] - Pfizer assumed environmental remediation responsibilities at the Bound Brook facility following the 2009 Wyeth acquisition[115] - The U.S. Supreme Court granted certiorari in June 2024, vacating a Court of Appeals decision related to Pfizer's contracts with the Iraqi Ministry of Health[116] - Pfizer and BioNTech initiated proceedings against Poland, Romania, and Hungary in 2023 over COVID-19 vaccine order commitments[120] Segment Performance - Biopharma segment revenues for Q2 2024 were $12.991 billion, compared to $12.690 billion in Q2 2023[131] - Biopharma segment earnings for Q2 2024 were $5.897 billion, compared to $5.042 billion in Q2 2023[131] - Biopharma segment revenues for the first six months of 2024 were $27.595 billion, compared to $30.863 billion in the same period of 2023[131] - Biopharma segment earnings for the first six months of 2024 were $13.519 billion, compared to $14.559 billion in the same period of 2023[131] - Biopharma's earnings in Q2 2024 included a $74 million dividend income from the investment in ViiV, compared to $91 million in Q2 2023[130] Deferred Revenues and Contractual Obligations - Deferred revenues related to Paxlovid and Comirnaty totaled $4.3 billion as of June 30, 2024, with $2.5 billion in current liabilities and $1.8 billion in noncurrent liabilities[140] - Deferred revenues related to Paxlovid and Comirnaty decreased by $771 million in the first six months of 2024 due to a favorable final adjustment recorded in Q1 2024[140] - Revenue recognized from Paxlovid and Comirnaty deferred revenues was approximately $200 million in Q2 2024 and $1.2 billion in the first six months of 2024[140] - The $4.3 billion deferred revenues as of June 30, 2024, will be recognized in Product revenues proportionately as control of the products is transferred to customers[140] - Amounts in current liabilities ($2.5 billion) are expected to be recognized in Product revenues within the next 12 months[140] - Amounts in noncurrent liabilities ($1.8 billion) are expected to be recognized in Product revenues from 2025 through 2028[140] - Deferred revenues related to Paxlovid and Comirnaty totaled $5.1 billion as of December 31, 2023, with $2.6 billion in current liabilities and $2.5 billion in noncurrent liabilities[140] - The decrease in deferred revenues was partially offset by additional advance payments received in the first six months of 2024 as amended contracts were entered into[140] - Deferred revenues associated with contracts for other products were not significant as of June 30, 2024, or December 31, 2023[140] Tax and Repatriation - Pfizer's effective tax rate for Q2 2024 was 130.2%, a significant increase from (3.1)% in Q2 2023, primarily due to nonrecurrence of tax benefits[44] - The company paid $15 billion in repatriation tax liability over eight years, with the sixth installment paid by April 15, 2024, and the seventh due by April 15, 2025[45] - Pfizer's cash paid for income taxes in 2023 was $3.1 billion, with $1.9 billion paid in the U.S.[45] - The company recognized a $150 million gain on the partial sale of its investment in Haleon and $135 million in dividend income from ViiV in the first six months of 2024[41] - Pfizer's accumulated other comprehensive loss decreased to $7.816 billion as of June 30, 2024, from $7.961 billion at the end of 2023[50] - The company's tax provision on other comprehensive income was $22 million for Q2 2024, compared to $9 million in Q2 2023[47] Pension and Postretirement Plans - Net periodic benefit cost/(credit) for U.S. Pension Plans was $(69) million for the three months ended June 30, 2024, compared to $(37) million for the same period in 2023[83] - Net periodic benefit cost/(credit) for International Pension Plans was $23 million for the three months ended June 30, 2024, compared to $18 million for the same period in 2023[83] - Net periodic benefit cost/(credit) for Postretirement Plans was $(33) million for the three months ended June 30, 2024, compared to $(39) million for the same period in 2023[83] - The company contributed $83 million to U.S. Pension Plans and $98 million to International Pension Plans from general assets for the six months ended June 30, 2024[83] Derivative and Hedging Activities - The notional amount of outstanding foreign exchange contracts hedging intercompany forecasted inventory sales was $5.6 billion as of June 30, 2024, up from $4.9 billion as of December 31, 2023[67] - Derivative financial instruments designated as hedging instruments included foreign exchange contracts with a notional amount of $22,740 million and interest rate contracts with a notional amount of $6,750 million as of June 30, 2024[67] - Foreign exchange contracts not designated as hedging instruments had a notional amount of $22,055 million as of June 30, 2024, with a fair value asset of $97 million and a liability of $116 million[67] - Interest rate contracts in cash flow hedge relationships showed no gains or losses recognized in OID for the three months ended June 30, 2024[70] - Foreign exchange contracts in cash flow hedge relationships recognized gains of $117 million in OID for the three months ended June 30, 2024[70] - Interest rate contracts in fair value hedge relationships showed a loss of $36 million recognized in OID for the three months ended June 30, 2024[70] - Foreign exchange contracts in net investment hedge relationships recognized gains of $81 million in OID for the three months ended June 30, 2024[70] - Non-derivative financial instruments in net investment hedge relationships recognized gains of $31 million in OID for the three months ended June 30, 2024[70] - Net gain reclassified from OCI into COS: $38 million in Q2 2024, $70 million in the first six months of 2024, $55 million in Q2 2023, and $146 million in the first six months of 2023[71] - Expected pretax gain reclassification from OCI into income within the next

Lilly's revenue gains have helped its stock to roar higher.Eli Lilly (LLY -3.36%) stock has soared by double digits over the past year -- and for good reason. The pharma giant sells two of the most sought-after drugs today, weight loss treatments Mounjaro and Zepbound. Together, these drugs are adding billions of dollars to the company's top line, helping Lilly report double-digit gains in quarterly revenue.Today Eli Lilly shares the market with rival Novo Nordisk, which sells two weight loss drugs that wor ...