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Biotech indices inch up post SVB bloodbath; Covid drugmakers report drop in Q1 sales

In March, the collapse of Silicon Valley Bank (SVB) had dragged the biotech indices down. SVB had made considerable investments in the biotech space, and its downfall had left many life sciences and healthcare companies vulnerable.Within a month of the SVB storm, biotech indices have bounced back. The Nasdaq Biotechnology Index (NBI) gained 1 percent to end April at US$ 4,187.32. It was down 1.3 percent in March. The S&P Biotechnology Select Industry Index (SPSIBI) was up 2 percent at US$ 6,094.82, and the SPDR S&P Biotech ETF (XBI) increased 4 percent to US$ 80.20. Both SPSIBI and XBI had dropped by 8.3 percent and 8.2 percent, respectively, in March.In April, several drugmakers announced their first quarter (Q1) results. The month also saw three major M&A deals — Merck’s US$ 10.8 billion buyout of Prometheus Biosciences, Astellas Pharma’s US$ 5.9 billion acquisition of Iveric Bio and GSK’s US$ 2 billion deal to buy Bellus Health.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Pfizer reports 29% drop in Q1 revenues, falls behind GSK in RSV vaccine raceWe have seen this happening for many months now, with Pfizer’s stock consistently falling since January. The Q1 results only echoed that sentiment — Pfizer’s revenues fell 29 percent to US$ 18.3 billion due to a 77 percent drop in sales of its Covid-19 vaccine Comirnaty. This led to a further 5 percent drop in the drug behemoth’s stock in April. What was going right for Pfizer was its experimental respiratory syncytial virus (RSV) vaccine. But GSK raced ahead of Pfizer this month when the US Food and Drug Administration (FDA) approved its RSV vaccine — Arexvy — for adults aged 60 years and older. The Prescription Drug User Fee Act (PDUFA) date for the Pfizer jab for older adults is this month too. GSK also announced the acquisition of Canada-based drug developer Bellus Health (up 114 percent) for US$ 2 billion.Among other Covid drugmakers, Moderna’s stock also suffered a 17 percent loss last month. What was worse, its experimental messenger RNA-based influenza vaccine failed to demonstrate effectiveness against influenza B. Moderna is planning to go ahead with a phase 3 study of mRNA-4157 (its investigational individualized neo-antigen therapy) and Keytruda combo in patients with adjuvant melanoma this year.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel) Wegovy helps boost Novo’s Q1 revenues; Vabysmo brings gains for RocheIn April, both Novo Nordisk and Eli Lilly posted gains in the bourses. Wegovy’s success in the US helped Novo’s obesity care segment notch up a 131 percent increase in Q1 sales. Novo’s diabetes and obesity drug sales rose 33 percent and were at DKK 48.8 billion (US$ 7.11 billion). Overall, the Danish drugmaker posted an impressive 27 percent growth in its Q1 sales — which were at DKK 53.4 billion (US$ 7.7 billion) — while its stock rose 5 percent in April.Lilly is seeking to compete with Wegovy’s dominance in the obesity market with its own drug, Mounjaro. It recently posted favorable data from a late-stage trial, where Mounjaro achieved 21 percent weight reduction in non-diabetic patients, compared to 15 percent for Wegovy. Lilly is now conducting another Phase 3b trial to test Mounjaro against Wegovy. And in a separate trial, Mounjaro led to a 16 percent weight loss in patients with type 2 diabetes. The drugmaker‘s stock rose by a handsome 15 percent.Roche Group’s pharmaceutical division posted 9 percent growth in Q1 sales — at CHF 11.7 billion (US$ 12.7 billion) — due to strong demand for newer medicines. Eye diseases drug Vabysmo, approved last year, turned out to be the strongest growth driver, generating CHF 432 million (US$ 486 million) in global sales. Roche expects the drug to generate US$ 2 billion in revenue this year. The Swiss drugmaker also shared post-hoc analyses from four additional phase 3 studies showing Vabysmo to be more effective at drying retinal fluid than Regeneron’s Eylea in Age-related macular degeneration (AMD) and Diabetic Macular Edema (DME). Roche’s stock gained 11 percent.In addition, FDA approved Roche’s Polivy as part of a five-drug combination for previously untreated diffuse large B-cell lymphoma (DLBCL), the first new treatment in nearly 20 years to significantly improve outcomes in first-line DLBCL. In Q1, Roche reported a decline of 3 percent in group sales due to lower demand for Covid tests.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Higher sales of key drugs take Novartis’ Q1 sales up 8%; J&J lowers 2023 guidanceNovartis’ Q1 sales grew 8 percent to US$ 12.95 billion, driven by strong performance of its heart failure drug Entresto, cancer meds Pluvicto and Kisqali, and multiple sclerosis drug Kesimpta. Based on higher Q1 sales, the Swiss drugmaker has raised its outlook for 2023.Novartis and partner BeiGene’s experimental drug tislelizumab showed promising results in treating certain types of gastric cancer in a late-stage trial. The partners hope this data will help make tislelizumab the first-line therapy for patients with advanced forms of gastric cancer. While Novartis’ stock went up 11 percent, BeiGene’s stock gained 17 percent in April.Though J&J’s Q1 results exceeded analyst expectations, the drugmaker lowered the 2023 guidance for its pharmaceutical business. Leaked data from a phase 3 trial showed that J&J and Legend’s cancer drug Carvykti performed better-than-expected in patients with multiple myeloma. J&J’s stock went up 4 percent. Legend’s stock rose 46 percent.Among small cap companies, Madrigal’s stock rose 24 percent in April on news of a breakthrough therapy designation for its drug Resmetirom as a treatment for nonalcoholic steatohepatitis.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Merck acquires Prometheus for US$ 10.8 bn; Astellas buys Iveric Bio for US$ 5.9 bnApril proved to be a good month for both Merck and AstraZeneca, even though the two drugmakers reported a drop in their Q1 revenues due to decreased sales of their Covid-19 products.While Merck reported a 9 percent drop in Q1 sales (at US$ 14.5 billion), with sales of its Covid-19 antiviral pill Lagevrio (molnupiravir) dropping 88 percent, Astra reported a 4 percent decrease in revenue (at US$ 10.88 billion) in Q1. Stocks of both drugmakers rose by 6 percent.In early April, FDA had granted accelerated approval to Merck’s Keytruda in combination with Seagen and Astellas Pharma’s Padcev as a first-line treatment for adults with locally advanced or metastatic urothelial carcinoma. Later in the month, Merck announced it is acquiring San Diego-based biotech Prometheus Biosciences for US$ 10.8 billion to strengthen its immunology pipeline. Prometheus’ stock skyrocketed 76 percent on the news.A combination of AstraZeneca's cancer drugs — Imfinzi and Lynparza — met its main goal in a late-stage trial for patients with advanced epithelial ovarian cancer. Additionally, Astra’s Ultomiris also received a positive recommendation from the European Medicines Agency (EMA) for adult patients with neuromyelitis optica spectrum disorder.Japanese drugmaker Astellas Pharma announced its biggest deal last month when it acquired New Jersey-based eye drug developer Iveric Bio for US$ 5.9 billion, taking its stock up 9 percent. The deal will give Astellas access to Iveric Bio’s ophthalmology treatments, including its lead drug candidate for geographic atrophy — Zimura. Iveric Bio’s stock gained 22 percent.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Disappointing Q1 sales drag AbbVie, BMS stocks downBoth AbbVie and Bristol Myers Squibb reported a drop in Q1 sales. AbbVie was hit due to weaker-than-expected performance of its blockbuster drugs Skyrizi and Rinvoq and dwindling sales of Humira (which experienced a sales drop of 25.2 percent in the face of biosimilar competition in the US). Its Q1 sales fell by 9.7 percent to US$ 12.25 billion, and its stock was down 6 percent. In positive news, FDA expanded the approval of AbbVie’s Qulipta as a preventive treatment for chronic migraine in adults. Rinvoq also received an add-on authorization in the EU as a treatment for moderate-to-severe active Crohn’s disease.BMS’ Q1 sales dropped 3 percent to US$ 11.3 billion, primarily due to an erosion in Revlimid’s sales in the face of competition from generic drugs. Revlimid’s revenues fell by 37 percent in Q1 compared to the same period last year. BMS’ stock experienced a 4 percent drop.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Our viewThe collapse of three US banks over the last three months has dealt a blow to the US economy. Globally, the business scenario hasn’t improved much, with inflation, high interest rates, ongoing Russia-Ukraine war, supply chain kinks and other uncertainties continuing to pose challenges.If the biotech indices are able to hold up in these difficult times, it is an indication of strength and resilience within the sector.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)

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11 May 2023

Pipeline Prospector March 2023: Silicon Valley Bank collapse hits biotech indices; Pfizer buys out Seagen

Biotech indices have witnessed a lot of volatility throughout 2022 and 2023. Just when they were beginning to look up, the collapse of Silicon Valley Bank (SVB) in mid-March dragged them down once again. The bank's fall left many biotech firms uncertain about their future, as life sciences and healthcare accounted for 12 percent of SVB’s deposits of US$ 173 billion.The indices regained some ground by the end of the month — the Nasdaq Biotechnology Index (NBI) increased by 0.6 percent to US$ 4,125, but the S&P Biotechnology Select Industry Index (SPSIBI) and the SPDR S&P Biotech ETF (XBI) both registered declines, falling by 8.3 percent to US$ 5,898 and 8.2 percent to US$ 76.21, respectively. In February, the NBI had fallen by 6 percent, while the SPSIBI and XBI had both experienced declines of 7 percent and 8 percent, respectively.Several mega and large cap companies, such as Sanofi, Eli Lilly, Novartis, AstraZeneca, Novo Nordisk, GSK and Moderna, posted gains in March.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel)Sanofi’s Dupixent succeeds in COPD trial, buys Provention Bio for its diabetes drug The biggest mega cap gainer on the bourses was Sanofi (its stock rose 17 percent in March). Its blockbuster anti-inflammatory drug Dupixent, developed along with Regeneron, succeeded in a late-stage clinical trial for chronic obstructive pulmonary disease (COPD), a disease that causes a progressive decline in lung function. If approved, Dupixent would become the first biologic treatment for COPD. Analysts estimate the label expansion to add US$ 3.5 billion in peak sales for Dupixent. In a further boost, the European Commission approved Dupixent for children aged six months to five years with severe atopic dermatitis. Regeneron’s stock was up 6 percent.In mid-March, Sanofi said it will purchase US-based Provention Bio (up 167 percent) for US$ 2.9 billion. The deal builds on an existing co-promotion agreement between the two companies, with Sanofi gaining full ownership of Provention Bio’s type 1 diabetes therapy Tzield. Also, Sanofi and partner Sobi’s treatment for severe hemophilia A (a hereditary bleeding disorder) in previously treated patients under 12 years, efanesoctocog alfa, met its primary endpoint in a phase 3 pivotal study.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel) Novartis’ Kisqali proves effective in breast cancer trial; Astra’s Enhertu posts gainsNovartis (10 percent) and AstraZeneca (8 percent) were the other mega cap gainers in March. Novartis’ breast cancer drug Kisqali plus endocrine therapy following surgery proved to be effective in a phase 3 trial in treating patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer who are at risk of recurrence. The Swiss pharma also shared positive long-term data for its gene therapy, Zolgensma, as a treatment for spinal muscular atrophy, a genetic disease that affects muscle movement. Its subsidiary Sandoz received FDA approval for Hyrimoz, a biosimilar of adalimumab.AstraZeneca and partner Daiichi Sankyo (up 15 percent) announced positive results from a mid-stage trial of their blockbuster cancer drug Enhertu in multiple HER2-expressing advanced solid tumors. Astra and Merck’s Lynparza received authorization in the UK as a treatment for patients with metastatic castration-resistant prostate cancer (mCRPC).Similarly, AbbVie’s blockbuster drug Skyrizi achieved a win in a late-stage trial for adults with moderate-to-severe active ulcerative colitis, a type of bowel disease that affects the large intestine. The drug also showed positive results in a late-stage trial in adults with moderate-to-severe plaque psoriasis who still experience symptoms after six months of treatment with Novartis’ Cosentyx (secukinumab) and Lilly’s Taltz (ixekizumab).But AbbVie also faced a setback — FDA denied approval to AbbVie’s Parkinson’s therapy ABBV-951 and requested for more information on the device used to administer the medication. Overall, AbbVie’s stock rose 3 percent last month.In good news for Roche, a panel of external advisers to the FDA voted 11-2 in favor of expanding the use of its med Polivy in combination with other drugs for adults with diffuse large B-cell lymphoma. Roche also joined forces with Lilly to develop a blood test that can detect early signs of Alzheimer’s disease.Meanwhile, a combination of Roche’s immunotherapy Tecentriq and Exelixis’ cancer drug Cabometyx failed a late-stage trial in advanced renal cell carcinoma. Roche’s stock remained unchanged in March. Similarly, Merck’s anti-TIGIT therapy vibostolimab, in combination with Keytruda, failed to improve progression-free survival in patients with metastatic non-small cell lung cancer in a phase 2 trial. In a separate phase 2/3 study, Keytruda and chemotherapy significantly improved overall survival in patients with unresectable malignant pleural mesothelioma, a rapidly progressing cancer that develops in the lining of the lungs. Merck’s stock fell 1 percent. FDA brought out a draft guidance for accelerated approvals to improve clinical trials of cancer drugs.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel) GSK, Pfizer’s RSV jabs get FDA panel’s backing; Pfizer buys out Seagen for US$ 43 bnA panel of external experts to the FDA backed both GSK (6 percent) and Pfizer’s respiratory syncytial virus (RSV) experimental vaccines, setting the stage for a race between the two rivals to bring out the first shot in the US against the disease. The final results of a trial published in the New England Journal of Medicine showed that Pfizer’s experimental maternal RSV vaccine was 82 percent effective in preventing serious illnesses in children when given to pregnant mothers.Though Pfizer announced its biggest buyout in recent times, its stock saw no change in March. It is acquiring cancer treatment specialist Seagen (up 12 percent) for US$ 43 billion as part of its move to mitigate a hit in revenues from declining sales of its Covid-19 products and patent expirations of some top drugs in the coming years. FDA approved Pfizer’s Zavzpret nasal spray for the treatment of acute migraine. It, however, recalled 4.2 million units of its Nurtec ODT prescription migraine drug because it failed to meet child-resistant packaging requirements.In March, Moderna (11 percent) and partner Merck said they will present phase 2 data of their investigational personalized cancer vaccine, mRNA-4157, at an oncology conference in April. The experimental drug, in combination with Keytruda, received FDA’s breakthrough therapy designation in February. Meanwhile, the vaccine maker said it will open offices in South San Francisco and Seattle as part of its plan to rapidly advance its pipeline of messenger RNA medicines amid declining Covid-19 vaccine sales.BioNTech said it expected the sale of its Covid-19 vaccine to fall from €17.3 billion (US$ 18.7 billion) in 2022 to €5 billion (US$ 5.4 billion) this year. The German mRNA company will allocate up to €2.6 billion (US$ 2.8 billion) towards R&D this year. Its stock fell 5 percent.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel) Insulin makers cut prices by up to 75 percent; Vertex posts gains in cell therapy for diabetes March saw a lot of activity in the field of diabetes. FDA accepted Lilly’s application for Jardiance as a treatment for children 10 years and older who are suffering from type 2 diabetes. Last month, Lilly (9 percent) decided to slash the list prices of its commonly prescribed insulin products, Humalog and Humulin, by 70 percent in the US. Rival Novo Nordisk (11 percent) also said it would cut the US prices of its insulin therapies by up to 75 percent.Large cap biopharma Vertex Pharmaceuticals’ cell therapy candidate VX-264 received investigational new drug application clearance from the FDA as a potential treatment for type 1 diabetes. Vertex’s stock went up 8 percent. And small cap firm Biomea Fusion posted positive topline data from a phase 1/2 study evaluating its lead pipeline candidate — BMF-219 — in patients with type 2 diabetes. Biomea’s stock skyrocketed 129 percent.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel) Our viewDespite showing some signs of a revival in January, the first quarter of 2023 has been lackluster for biotech indices. In terms of M&As, the industry witnessed the Pfizer-Seagen deal and the Sanofi-Provention Bio deal. But we are expecting a lot more from 2023.In April, FDA is likely to take some important drug approval decisions — such as the one on the expanded use of Pfizer’s pneumococcal vaccine Prevnar 20 for use in infants and children, approval of Emergent BioSolutions’ anthrax vaccine and Daiichi Sankyo’s cancer drug quizartinib, which is under priority review, among many others. These decisions are bound to have an impact on the bourses. We are looking forward to an eventful month.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel)

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06 Apr 2023

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