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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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Pipeline Prospector Feb 2022: Biotechs face cash crunch after stock market ‘bloodbath’

Our January 2022 update of the Pipeline Prospector highlighted how the Omicron variant of the novel coronavirus drove the pharma and biotech stocks down. In February too, the bearish trend continued. The ongoing Russia-Ukraine war further spooked the global markets. The Nasdaq Biotechnology Index (NBI) sank by 5.5 percent to US$ 3,996 last month. In January, NBI had dropped 11 percent to US$ 4,187. Similarly, the S&P Biotechnology Select Industry Index (SPSIBI) sank by 5.4 percent to US$ 6,992. In comparison, the S&P 500 Index (SPX) fell 3.8 percent to US$ 4,373.94. On the earnings side, several drug companies have already reported their fourth quarter (Q4) results. Broadly, the medical sector posted mixed results, with Q4 earnings expected to rise 25.8 percent on a sales increase of 13.9 percent. Access the Pipeline Prospector Dashboard for February 2022 Newsmakers Biotechs’ hopes to raise fresh funds hampered by market rout Over the last two years, several loss-making biotechs raised a record US$ 32.7 billion in initial public offerings (IPOs). Today, 83 percent of the recently listed US biotech and pharma stocks are trading below their IPO price, says a report published in Financial Times. Biotech groups that listed in 2021 are trading on average 37 percent below their IPO price, as compared to a 22 percent fall for all newly US-listed companies. Many of these companies were hoping to raise fresh funds from their investors through a subsequent share sale with their drugs marching ahead on the R&D cycle. But their ability to do so has been hampered by a market rout for biotech stocks. Retail investors and generalist money managers have turned sour towards the industry. There is a “complete bloodbath across the board,” says Geraldine O’Keeffe, a partner at healthcare investment firm LSP. As a result, dozens of biotech companies are running low on cash and face an uphill task to raise fresh funds. However, experts feel biotech stocks still hold plenty of attraction, because the right ones can make investors wealthy. Access the Pipeline Prospector Dashboard for February 2022 Newsmakers Covid drug, vaccine makers continue to see drop in stock prices Covid-19 vaccine and drugmakers — such as Pfizer, BioNTech, Merck, Moderna Therapeutics, J&J and Roche — continued to see a drop in their stock prices last month. With Covid cases plummeting from all-time highs, experts have been questioning whether vaccines will be a sustainable revenue stream in the years to come. On February 14, shares of Moderna touched its lowest level in nearly a year. The reason — a slew of regulatory filings revealed four Moderna executives — including billionaire CEO Stéphane Bancel — had sold 23,281 shares for about US$ 3.6 million in early February. Out of this, Bancel had offloaded 19,000 shares. Bancel had reportedly been selling shares of Moderna since late 2019. However, suspicions of insider trading were raised when he cancelled his Twitter account without prior warning. Similarly, Pfizer and BioNTech saw a drop in their shares by 2 percent and over 9 percent respectively around mid-February as the duo delayed their FDA application for an emergency use authorization (EUA) of their Covid-19 vaccine in children aged between six months and four years. Late last year, Johnson & Johnson had temporarily halted the production of its Covid-19 vaccine at its Leiden facility in the Netherlands. More negative news last month on J&J’s Covid vaccine led to a further 1.07 percent drop in its shares. According to a paper published in the New England Journal of Medicine, final analysis of a phase 3 study revealed that the vaccine provided only 52.9 percent protection against moderate to severe-critical Covid-19, and may be even less effective in the longer term. In the case of Merck, FDA’s revision of the EUA for Merck’s Covid-19 pill molnupiravir sent its shares down by 0.42 percent. The agency said it should only be used as a last line of defense if other treatments are available. Access the Pipeline Prospector Dashboard for February 2022 Newsmakers AbbVie, Astra, BMS, Lilly, Sanofi, Regeneron score wins When we look at mega cap gainers, AbbVie emerges as one of the top performers. AbbVie’s fortunes have hinged on Humira, and this autoimmune-disease drug is slated to face competition from biosimilars in the US market soon. However, experts are of the view that Humira won’t lose its mega-blockbuster tag anytime soon. Moreover, Humira’s successors — Rinvoq and Skyrizi — brought in sales of nearly US$ 4.6 billion in 2021. AbbVie projects combined global sales of US$ 15 billion from the two drugs in 2025, and the net increase could be enough to offset sales declines for Humira. Moreover, analysts see a lot of promise in its anti-psychotic drug Vraylar, which is awaiting add-on FDA approval for patients with major depressive disorder (MDD) who are already on antidepressants. Such an approval could take Vraylar beyond the expected US$ 4 billion in peak sales. In 2021, Vraylar generated just over US$ 1.7 billion in sales. Similarly, there was positive news from AstraZeneca, as the British-Swedish drugmaker and its Japanese partner Daiichi Sankyo scored a crucial win for their breast cancer drug Enhertu. Results from a phase 3 trial showed Enhertu boosted survival in patients with a type of tumor called HER2-low that had spread widely or couldn't be removed surgically. It’s the first time such a therapy has shown mortality benefit in patients with this kind of relatively common breast cancer. Riding on the success of its Covid vaccine, Astra reported 41 percent growth in its 2021 revenues. Its Covid-19 vaccine generated US$ 4 billion in 2021. Despite the FDA showing its unwillingness to approve Eli Lilly and its partner Innovent Biologics’ cancer treatment — Tyvyt — as the drug’s clinical data is solely from China, Lilly posted gains in February. The reasons were three-fold. One, the FDA issued an EUA for Eli Lilly’s antibody bebtelovimab to treat mild-to-moderate Covid-19 in patients above the age of 12. The company has claimed that bebtelovimab can neutralize the Omicron variant of coronavirus. Two, Lilly entered into an agreement with the US government to supply 600,000 doses of bebtelovimab for US$ 720 million. And three, the FDA approved Lilly and its partner Boehringer Ingelheim's drug, Jardiance, for expanded use in reducing the risk of death and hospitalization for all patients with heart failure. Other major gainers were Bristol Myers Squibb, Sanofi and Regeneron. While BMS announced a US$ 5 billion accelerated share buyback program, Sanofi bagged FDA approval for cold agglutinin disease (CAD) drug Enjaymo (sutimlimab). The disease affects around 5,000 people in the US. The French drugmaker also unveiled a new corporate identity. And Regeneron announced encouraging phase 2 results for high-dose aflibercept 8 mg in wet age-related macular degeneration (wet AMD). Among mid cap companies, Maravai LifeSciences’ stocks gained 30 percent after sources claimed that Germany-headquartered Sartorius has placed a US$ 11 billion bid for the Covid vaccine reagent vendor. Both the companies refused to comment about the bid. Access the Pipeline Prospector Dashboard for February 2022 Newsmakers Biocon acquires Viatris’ biosimilars business The biggest deal of the month was Biocon Biologics’ acquisition of Viatris’ biosimilars business for up to US$ 3.3 billion. The deal will be funded through a debt of US$ 1.2 billion, apart from stocks and cash. Biocon Biologics will acquire Viatris’ global commercial infrastructure in developed and emerging markets, its global biosimilars business and rights to Viatris’ biosimilar assets. Massachusetts-based Collegium Pharmaceutical acquired specialty pharmaceutical company BioDelivery Sciences International (BDSI) in a US$ 604 million all-cash transaction. BDSI has a portfolio of pain and neurology products that address serious and debilitating conditions. Other deals of February include Mersana Therapeutics’ research collaboration and license agreement worth US$ 1.04 billion with Janssen to advance antibody-drug conjugates (ADCs) targeting cancers, and Remix Therapeutics’ US$ 1.045 billion strategic collaboration with Janssen for the discovery and development of small molecule therapeutics. Similarly, ImmunoGen, a leader in ADCs for the treatment of cancer, announced a global, multi-year definitive licensing agreement with Eli Lilly. Under the deal, ImmunoGen is eligible to receive up to US$ 1.7 billion in potential target program exercise fees and milestone payments. And Takeda signed a US$ 2 billion biobucks deal with Code Biotherapeutics across four programs. In other major developments, Gilead reached a US$ 1.25 billion settlement with ViiV Healthcare to resolve a litigation pertaining to Biktarvy and ViiV’s Dolutegravir patents. In IPOs, Nuvectis Pharma, an oncology-focused biopharmaceutical company, announced the closing of its IPO of 3.2 million shares. Access the Pipeline Prospector Dashboard for February 2022 Newsmakers Our view The year 2022 began on a muted note, with bearish trends being witnessed due to the Omicron variant of the coronavirus. While there is hope that Covid-19 won’t play more havoc with our lives, the ongoing war between Russia and Ukraine has taken oil prices to record highs and sent stock markets into a tizzy. The war will have an impact on clinical trials — according to the FDA, 251 clinical trials for drugs and devices are underway in Ukraine. The war is also likely to impact the financial performance of drug companies across the world. The earlier the war ends, the better it is for everyone. For now, we can safely assume that next month’s Pipeline Prospector is unlikely to bring much cheer from the bourses. Though we certainly hope we are proved wrong. Access the Pipeline Prospector Dashboard for February 2022 Newsmakers

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

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