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Pipeline Prospector Jan 2023: Mega cap drugmakers face rout at bourses even as biotech indices inch upwards

After facing the worst year since 2008, biotech indices opened 2023 on a positive note. All the three indices posted gains in January — while the Nasdaq Biotechnology Index (NBI) was up 4.4 percent (at US$ 4,360), the S&P Biotechnology Select Industry Index (SPSIBI) rose 8.7 percent to US$ 6,896 and SPDR S&P Biotech ETF (XBI) increased 9 percent to US$ 88.90. In December 2022, the NBI was down 3.4 percent to US$ 4,213, while XBI had risen only 0.1 percent and SPSIBI had witnessed no change.Several major drugmakers have shared their financial results for 2022 since last month. Pfizer posted an operational growth of 30 percent with 2022 revenues touching an all-time high of US$ 100.3 billion. Merck posted a 22 percent increase, with sales of Keytruda growing 22 percent to US$ 20.9 billion. GSK generated £29.3 billion (US$ 36.3 billion) in revenue in 2022, an increase of 13 percent over 2021 figures, and Amgen posted a gain of 1 percent.Drugmakers like Eli Lilly and Johnson & Johnson saw a huge drop in sales of their Covid-19 products. Lilly suffered a 9 percent drop and J&J saw a 4 percent decline in Q4 2022 revenue. More companies are expected to release their 2022 results this month.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel)Lower 2023 forecast, vaccine’s safety concern hammer Pfizer’s stockDespite the indices showing signs of recovery, stocks of several mega cap companies ended the month in the red. Pfizer’s stock suffered the biggest loss, dropping 14 percent in January, due to an interplay of various factors even as the drug behemoth reported best-ever sales in 2022, owing to its Covid-19 vaccine Comirnaty and antiviral pill Paxlovid. First, the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) launched an investigation into the possibility of a stroke in older adults who had received its updated Covid-19 booster shot. Second, despite the stellar results, Pfizer’s forecast for 2023 was lower by 33 percent, with an estimated revenue of US$ 67 to 71 billion. With the pandemic receding, there has been a considerable drop in demand for Covid products. Pfizer’s Covid vaccine partner BioNTech also saw its stock go down 6 percent. The other big loser was AbbVie (drop of 9 percent) – its blockbuster immunology drug Humira (adalimumab) saw its exclusive run come to an end in the US with Amgen launching a copycat — Amjevita. Seven other biosimilars are due to be launched later this year.A federal appeals court in Philadelphia blocked J&J’s plan to use the Texas two-step bankruptcy strategy to resolve around 40,000 lawsuits alleging that its talc products cause cancer. In another setback, its Janssen unit halted a late-stage global trial of its HIV vaccine after the drug was found to be ineffective at preventing infection. All these factors led to a 8 percent drop in J&J stocks.AstraZeneca’s stock tumbled 6 percent in January due to factors such as a second cancer lawsuit filed by Bristol Myers Squibb, wherein it claimed Astra’s cancer treatment Imjudo infringes on two patents related to its blockbuster drug Yervoy. FDA also revoked the emergency use authorization (EUA) for AstraZeneca’s Covid-19 treatment Evusheld, expecting it to fail against the currently dominant Omicron sub-variant.January wasn’t a great month for Merck either, whose stock plummeted 4 percent. The drugmaker halted a late-stage trial of its blockbuster immunotherapy drug Keytruda in prostate cancer after interim data showed that the drug failed to extend survival or help improve patients’ lives. Meanwhile, the drugmaker said it has identified the source of a potential cancer-causing agent – Nitroso-STG-19 – in its popular diabetes drugs Januvia and Janumet, and plans to resolve the issue by the end of the year.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel) Bayer gains on sales forecast for Kerendia, Nubeqa; lawsuit settlements benefit TevaThree large cap companies — Bayer AG (14 percent), Teva (10 percent) and Vertex Pharmaceuticals (12 percent) – posted double digit gains on the bourses last month. Bayer hiked sales targets for two of its meds – heart drug Kerendia and prostate cancer treatment Nubeqa – to US$ 3.2 billion each.Israeli drugmaker Teva said it has either already settled with or confirmed participation of 48 US states to move forward with its US$ 4.25 billion proposed national settlement agreement to resolve thousands of lawsuits over its alleged role in the US opioid crisis.Vertex Pharmaceuticals said it plans to file for the US approval of its CRISPR gene-editing therapy exa-cel as a treatment for beta-thalassemia and sickle cell disease in the first quarter. If approved, the drug is expected to generate peak annual sales of over US$ 2 billion. Vertex has already applied for the drug’s authorization in the EU and UK. Vertex is also testing a non-opioid drug, VX-548, for acute pain in a late-stage trial.Among small cap companies, Massachusetts-based Theseus Pharmaceuticals posted a 180 percent surge in its stock price in January. The drugmaker said it plans to release clinical data from a phase 1/2 trial of its lead candidate – THE-630 – for advanced gastrointestinal stromal tumor patients, later this year. Analysts expect THE-630 to compete against Pfizer’s Sutent (sunitinib), with projected sales of over US$ 1 billion by 2035. Theseus is also developing two other early-stage candidates.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel) Accelerated nods bring gains for Biogen, Seagen; Lilly loses on Alzheimer’s setback Biogen’s second Alzheimer’s drug – Leqembi (lecanemab) — received FDA’s accelerated approval to treat patients who are in the earliest stages of the neurodegenerative disease. However, Eli Lilly’s bid for an accelerated approval pathway for its experimental Alzheimer’s disease drug donanemab suffered a setback. FDA rejected the drug as Lilly did not provide enough data from patients who were treated for at least a year. However, days later Lilly’s cancer drug Jaypirca (pirtobrutinib) won accelerated approval as a treatment for mantle cell lymphoma, a rare form of blood cancer. FDA also accepted Lilly-Boehringer Ingelheim’s application for cancer drug Jardiance (empagliflozin) as a treatment for chronic kidney disease (CKD) in adult patients. Overall, while Biogen’s stock was up 5 percent in January, Lilly’s was down 7 percent.In another cancer drug update, FDA granted accelerated approval to Seagen’s Tukysa (tucatinib) to treat HER2-positive unresectable or metastatic colorectal cancer. Seagen’s stock rose 8 percent last month. And BeiGene’s cancer drug Brukinsa (zanubrutinib) received an approval in the US as a treatment for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), pushing its stock up 11 percent. The drug has also received authorization in the UK.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel) Our viewAs always, the new year began with the JP Morgan Healthcare Conference (San Francisco, January 9 to 12). For the last three years, the conference has been lackluster insofar as M&As were concerned. But this year, there were a number of buyouts – AstraZeneca said it will acquire US-based drug developer CinCor Pharma for up to US$ 1.8 billion. Italy’s privately-held Chiesi Farmaceutici announced it is buying Ireland-based rare diseases drugmaker Amryt Pharma for up to US$ 1.48 billion. And Ipsen picked up Albireo for US$ 952 million. Stocks of CinCor, Amryt and Albireo shot up by over 100 percent following the takeover news. While we do hope these buyouts signal an uptick in M&A activity, we also know that drugmakers who made billions from the pandemic are now facing a steep Covid cliff. Among these are Pfizer, BioNTech, Moderna, Gilead Sciences, AstraZeneca and Merck. The 2022 results announced so far confirm this trend. Insofar as biotech indices are concerned, we hope January has set the tone for the coming months.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel)

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