S1PR4

Pictured: Pfizer's sign at its head office in Quebec, Canada/iStock, JHVEPhoto Pfizer announced its first-quarter 2024 earnings on Wednesday, reporting a 20% year-over-year decline in revenue attributable to the steep drop in demand for its COVID-19 products. Nevertheless, the company’s first-quarter revenue of $14.88 billion beat analysts’ consensus estimates, which were at around $14 billion. Pfizer’s net income in the quarter was nearly $3.12 billion or $0.55 per share, a 44% plunge from its net income of a little more than $5.54 billion or $0.97 per share during the same time period in 2023. The strong performance of Pfizer’s product portfolio—excluding its COVID-19 franchise—helped the pharma exceed analyst expectations. If not for its coronavirus business, Pfizer’s revenues would have jumped 11%, according to the company. Looking ahead to the rest of 2024, Pfizer raised its profit guidance and now expects adjusted earnings per share of $2.15 to $2.35, up from a previous estimate of $2.05 to $2.25. The pharma now also forecasts a full-year revenue range of between $58.5 billion to $61.5 billion. Pfizer’s BMS-partnered anticoagulant Eliquis (apixaban) was its top-performing asset, generating $2.04 billion in Q1 2024, up 10% year-over-year. The company’s $43 billion Seagen acquisition, which closed in December 2023, also contributed heavily to the pharma’s financial performance in the quarter, bringing in $742 million in global legacy revenue. The Vyndaqel (tafamidis meglumine) family of products—which includes Vyndamax (tafamidis) and Vynmac (tafamidis) and which is indicated for cardiomyopathy—also performed well in Q1, with revenues growing 66% globally to nearly $1.14 billion. Meanwhile, its oncology franchise was led by the breast cancer treatment Ibrance (palbociclib), which was hit with a 7% sales decline but still brought in more than $1.05 billion in the quarter. Despite recording a 50% year-over-year drop in sales, Pfizer’s COVID-19 pill Paxlovid (nirmatrelvir/ritonavir) nevertheless earned almost $2.04 billion in Q1, suggesting a successful commercial transition in the U.S. The company’s coronavirus mRNA vaccine Comirnaty brought in $354 million in the quarter, down 88%. CEO Albert Bourla said in a statement that he is “encouraged” by these overall results in Q1 which point to a “well-executed quarter,” allowing the company to soften the blow of the COVID-19 earnings cliff. “We intend to build on this positive momentum in the quarters ahead.” To set the company up for sustainable growth this year, Pfizer on Wednesday also cleaned up its pipeline, announcing that four programs have been discontinued. The pharma terminated the development of VTX-801, a recombinant gene therapy being developed for Wilson disease, as well as Zavzpret (zavegepant) which it was trialing as an oral preventative treatment for migraine. Pfizer also axed two Phase II studies for the S1P blocker Velsipity (etrasimod)—one in atopic dermatitis and the other in alopecia areata. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Trial Meets Both Primary and Key Secondary Endpoints LAVAL, QC / ACCESSWIRE / December 21, 2023 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) ("Bausch Health" or the "Company") today announced positive topline results from the Company's Phase 2 study evaluating Amiselimod, an investigative S1P antagonist, for the treatment of ulcerative colitis (UC). "We are thrilled with these impressive topline results, and believe that this could offer a much needed improvement in therapy available for patients with ulcerative colitis," said Thomas J. Appio, Chief Executive Officer, Bausch Health. Amiselimod met the primary and key secondary endpoints including clinical and endoscopic measures in the double-blind period of the study; the open-label extension up to 52 weeks is currently ongoing. Efficacy results were similar for both dose groups (0.2 mg QD and 0.4 mg QD). The topline results for the key endpoints were as follows: The primary endpoint, mean change in modified Mayo Score at Day 85 (-2.3) versus placebo (-1.6), (p = 0.002). 32.4% of patients on Amiselimod achieved clinical remission, compared to 17.8% on placebo, (p=0.007) 42.7% of patients on Amiselimod achieved endoscopic improvement (Mayo endoscopy subscore of ≤ 1), compared to 23.4% on placebo, (p<0.001) Amiselimod was well-tolerated, with no unexpected adverse events; coupled with the previous thorough QT study, this indicates that Amiselimod has a favorable safety profile. The full data set from this trial will be available early next year. Bausch Health's Phase 2 clinical trial was a 12-week, double-blind, placebo-controlled, randomized, dose ranging study to evaluate the efficacy and safety of Amiselimod in 320 patients with mildly-to-moderately active UC. "Our R&D team will be presenting detailed results at upcoming medical conferences, and we plan to meet with regulatory agencies to advance the program into Phase 3," said Dr. Tage Ramakrishna, Chief Medical Officer, President, R&D, Bausch Health. About Amiselimod Amiselimod is a sphingosine-1-phosphate (S1P) receptor functional antagonist and, by inhibiting the receptor function of the lymphocyte sphingosine-1-phosphate (S1P) receptor, retains lymphocytes sequestered in the lymph nodes and prevents them from contributing to autoimmune reactions. 1 Due to this mechanism of action, Amiselimod may potentially be useful for various autoimmune diseases. 2 Affinity to S1P1, S1P4 and S1P5 receptor subtypes, suggests that Amiselimod could potentially have a more pronounced effect on ulcerative colitis related inflammation than compounds with restricted activity on S1P1 receptor subtype exclusively or combined activity on S1P1 and S1P5. 3 About Bausch Health Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our healthcare products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership interest in Bausch + Lomb Corporation. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit and connect with us on Twitter (X) and LinkedIn. Forward-looking Statements This news release contains forward-looking information and statements, within the meaning of applicable securities laws (collectively, "forward-looking statements"), including, but not limited to, statements relating to the Company's ongoing research and development efforts. Forward-looking statements may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions, and phrases or statements that certain actions, events or results may, could, should or will be achieved, received or taken, or will occur or result, and similar such expressions also identify forward-looking information. These forward-looking statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in the Company's most recent annual and quarterly reports and detailed from time to time in the Company's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which risks and uncertainties are incorporated herein by reference. Additional information regarding certain of these material factors and assumptions may be found in the Company's filings described above. The Company believes that the material factors and assumptions reflected in these forward-looking statements are reasonable in the circumstances, but readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law. References Kunio Sugahara, Yasuhiro Maeda. Amiselimod, a novel sphingosine 1‐phosphate receptor‐1 modulator, has potent therapeutic efficacy for autoimmune diseases, with low bradycardia risk. British Journal of Pharmacology. January 2017. Peyrin-Biroulet, Ronald Christopher Modulation of sphingosine-1-phosphate in inflammatory bowel disease. Autoimmunity Reviews. February 2017. BiseraStepanovska, AndreaHuwiler. Targeting the S1P receptor signaling pathways as a promising approach for treatment of autoimmune and inflammatory diseases. Pharmacological Research. February 2019. ### Media Contact: Kevin Wiggins corporate.communications@bauschhealth.com (908) 541-3785 Investor Contact: Lisa Wilson ir@bauschhealth.com (877) 281-6642 (toll free) SOURCE: Bausch Health Companies Inc. 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