PF-07209960

Headline results for the second quarter: Revenue: $12.7 billion (forecasts of $13.3 billion), down 54% Profit: $2.3 billion, down 77%Note: All changes are versus the prior-year period unless otherwise statedWhat the company said:Chief financial officer David Denton remarked "the second quarter…delivered solid 5% operational revenue growth, excluding our COVID-19 products, and our year-to-date results are in line with our expectations." However, Denton said that despite expected accelerated growth of non-COVID products in the second half, the company may have to launch a cost-cutting programme if sales of Comirnaty and Paxlovid continue to underperform.According to Pfizer, it anticipates more clarity for COVID revenue in the second half on a likely rise in infections in the fall season and the US switching to a commercial market for the products from government contracts. "To that end, if our COVID-19 revenues are less than what we assumed, we are prepared to launch an enterprise-wide cost improvement programme," Denton explained.Meanwhile, CEO Albert Bourla noted that Pfizer continues "to make progress toward" closing the proposed $43-billion acquisition of Seagen later this year or in early 2024. The executive added that the drugmaker is working to fulfil requests for further information on the transaction from the US Federal Trade Commission.Other results: Primary care sales: $5.8 billion, down 72% Eliquis alliance revenue and direct sales: $1.8 billion, up 1% Comirnaty: $1.5 billion, down 83%, but ahead of forecasts of $1.4 billion Prevnar/Prevenar 13 & 20: $1.4 billion, down 3% Nurtec ODT/Vydura: $247 million Paxlovid: $143 million, down 98%, missing estimates of nearly $1.1 billion Specialty care sales: $3.7 billion, up 9% Vyndaqel/Vyndamax: $782 million, up 42% Xeljanz: $469 million, up 9% Enbrel (outside the US and Canada): $219 million, down 15% Sulperazon: $177 million, down 15% Oxbryta: $77 million Oncology product sales: $3 billion, down 4% Ibrance: $1.2 billion, down 6% Xtandi alliance revenue: $305 million, up 5% Inlyta: $262 million, down 4% Looking ahead:Pfizer now expects revenue for 2023 to be between $67 billion and $70 billion, with the top end lowered by $1 billion from prior guidance. The company reaffirmed that revenue from Comirnaty is seen reaching approximately $13.5 billion, down 64% from 2022, while Paxlovid sales are set to fall 58% to around $8 billion.Meanwhile, Pfizer reiterated that earnings per share for this year are still predicted to be between $3.25 and $3.45, which represents roughly a 50% drop from 2022.Commenting on the recent tornado damage to its manufacturing plant in Rocky Mount, North Carolina, the company said "there does not appear to be major damage to the production areas," with the majority of issues restricted to the warehouse facility. Pfizer indicated that it is working to move finished medicines – which include sterile injectables – to other nearby sites for storage, while it is also exploring alternative manufacturing locations.Pipeline updates:Pfizer disclosed a number of recently-discontinued programmes, led by the mid-stage vaccine PF-06842433 for invasive and non-invasive Pneumococcal infections in infants and children. The cull comprises six Phase I assets, including the topical soft JAK inhibitor PF-07295324 and the CD1a inhibitor PF-07242813, which were both under development for atopic dermatitis.Also on the chopping block were the AXL/MERTK inhibitor PF-07265807 and the IL-15 activator PF-07209960 in oncology, as well as the anti-E-selectin inhibitor PF-07209326 in sickle cell disease and the N-protein inhibitor PF-07923567/RV-299 for respiratory syncytial virus infection.

Asher Bio Chief Executive Officer, Craig Gibbs, Ph.D/Courtesy Asher Bio. Since entering the biotech arena five months ago with a $55 million funding round to develop a suite of immunotherapies that target specific cell types with cytokines, Asher Biotherapeutics has raised another $108 million in an oversubscribed Series B financing round. New investors Janus Henderson and biotech blue-chipper RA Capital Management were brought on board to join lead investor Wellington Management Company LLP and other existing investors. “We are pleased to announce this Series B financing and we are tremendously grateful to our new and existing investors for their support and commitment to our goal of delivering a new class of biotherapeutics, with superior selectivity and broad applicability across multiple tumor types, as well as infectious and autoimmune diseases,” said Asher Bio Chief Executive Officer, Craig Gibbs, Ph.D. This series B revenue number mirrors what California-based engineered cytokine therapeutics company Synthekine received in June to support clinical studies to proof-of-concept for selective IL-2 partial agonists, STK-012, and orthogonal IL-2 and CD-19 CAR-T systems, STK-009 and SYNCAR-001. Synthekine started two years ago and publicly launched in September 2020 with $82 million in funding to advance a pipeline of engineered cytokine therapeutics optimized for cancer and autoimmune diseases. Asher Bio also began two years ago and raised $55 million in a Series A financing round this March to take forward a series of engineered cytokines that aim to eliminate both the toxicities and the loss of efficacy in immunotherapy. Like Asher Bio, which is developing immunotherapies for cancer, autoimmune, and infectious diseases, Synthekine is attempting to rewrite the cytokine landscape with an interleukin-2 (IL-2) approach. In another interesting parallel, Janus Henderson co-led Synthekine's financing with the support of RA Capital Management and others, with the investors readily dipping into their pockets, enticed by the new set of encouraging statistics. Biotech companies in the cytokine space are clearly attracting investors. There have long been hopes that cytokines could be used to treat cancer, but their effectiveness has been limited due to the adverse effects they can cause in many types of cells. Their interactions with multiple cell types are the main hurdle. Asher Bio designs immune therapies that specifically target immune cells. To construct its treatments, it uses cis-targeting, a method of protein engineering. Cancer and autoimmune disorders are focal points for Synthekine. In the event Synthekine decides to formalize partnerships, it will look for Big Pharmas that have had experience with cytokine biology. Paris-based Sanofi's acquisition of San Diego-based Synthorx perfectly fits the bill, as does Bristol Myers Squibb’s partnership with Nektar Therapeutics’ pegylated interleukin-2 drug NKTR-214 (bempegaldesleukin). BMS has been working with Nektar on combination cancer therapies since 2018, expanding the multibillion-dollar alliance early last year. BMS paid $1.85 billion up front to license bempegaldesleukin, while Sanofi shelled out $2.5 billion for Synthorx. Other Big Pharmas in the IL-2 space include Amgen and Merck. In February, Merck struck a $1.9 billion deal to buy Pandion, gaining control of a pipeline of immune modulators. Pandion went public last year with $135 million funding to develop a pipeline led by an engineered IL-2 mutein fused to a protein backbone. Amgen's IL-2 mutein, efavaleukin alfa (formerly known as AMG 592) on the other hand, boosts the number and function of T regulatory cells, which are key modulators of the immune system. T regulatory axis dysfunction is common in many autoimmune diseases. Amgen anticipates sharing Phase Ib data in lupus towards the end of the year. As does Asher Bio, which has not yet published any of its research. The company has more IL-2 drugs in the pipeline. Two additional programs have shown preclinical proof of concept. In the third quarter of next year, the company is expected to submit an investigational new drug application for its lead program, utilizing funding from the Series B financing. Meanwhile, another Big Pharma is looking at different ways of homing in on tumors. Pfizer is using PF-07209960 to develop an interleukin 15 (IL15) activator solid tumors drug. Asher Bio was founded by Ivana Djuretic and Andy Yeung, who worked in cancer immunology and protein engineering at Pfizer. The duo left their jobs in 2019 to start the company. Gibbs' leadership team currently includes Chief Scientific Officer Ivana Djuretic and Chief Technology Officer Andy Yeung. Djuretic was head of cytokine biology at Pfizer's cancer immunology discovery unit. Could there be a homecoming of sorts in the works here?