The target price is increased from GBX 7500 to GBX 8000.
Thursday, February 25, 2021
Bayer flags lower earnings as agriculture arm disappoints
Pharma and pesticides group Bayer's earnings guidance for this year fell short of investors' expectations on Thursday, raising questions about the strength of the agriculture business it boosted with the $63 billion takeover of Monsanto.
Based on exchange rates at the end of 2020, Bayer said it expected 2021 adjusted earnings before interest, tax, depreciation and amortisation (EBITDA) of 10.5-10.8 billion euros ($12.8-$13.2 billion), down from 11.45 billion last year.
Its shares were down 3.5% at 53.17 euros by 1300 GMT, erasing gains over the three previous trading sessions, as analysts said the lower-than-expected guidance pointed to a weaker seeds and pesticides unit.
"Guidance may reflect more price pressure as Bayer competes with Coreteva's new offering in soy," said Credit Suisse's Trung Huynh.
Bayer's stock was battered last year by litigation worries, billions of euros in writedowns, and a bleaker profit outlook, in large part related to the 2018 Monsanto deal.
The German company also reported a bigger-than-expected fall in fourth-quarter adjusted EBITDA, dragged down by a weaker Brazilian real and U.S. dollar and competition in the North American agriculture market.
Quarterly EBITDA, adjusted for one-offs, fell 3.4% to 2.39 billion euros, below an average estimate of 2.45 billion euros in a poll of analysts on the company's website.
Bayer's drugs business was shored up by strong prescription growth in stroke prevention pill Xarelto, but the coronavirus pandemic also put women off seeking appointments for Bayer's Mirena-branded birth control devices, it said.
Bayer added it remained "strongly committed" to a comprehensive settlement of claims in the United States that Roundup and other glyphosate-based herbicides cause cancer.
Bayer on Feb. 3 came to terms with plaintiffs' lawyers in a $2 billion pledge to resolve future legal claims, as the products will remain on the market.
That would add $750 million to the total bill of an outline settlement agreed in June 2020, tallied at up to $11 billion at the time.
A judge still has to sign off on the deal and Bayer said on Thursday a key court hearing was scheduled for March 31 and the presiding judge would issue an assessment afterwards.
Merck to buy drug developer Pandion Therapeutics for $1.85B
Merck & Co Inc said on Thursday it would buy drug developer Pandion Therapeutics Inc for about $1.85 billion in cash, expanding its portfolio of drugs that target autoimmune diseases.
The $60-per-share deal represents about 134% premium to Pandion's closing price on Wednesday.
Shares of Pandion rose 131.6% to a record high of $59.37 before the bell, while Merck shares were up about 1%.
Pandion's lead drug candidate, PT101, met its main goals of safety and tolerability last month in an early-stage trial in patients with autoimmune diseases.
In November, Merck agreed to buy privately-held VelosBio for $2.75 billion to strengthen its cancer drug portfolio as the drugmaker looks to reduce its reliance on its blockbuster cancer therapy Keytruda.
The deal between Merck and Pandion is expected to close in the first half of 2021, the companies said in a joint statement.
Merck was represented by Credit Suisse Securities, Covington & Burling, while Centerview Partners LLC and Skadden, Arps, Slate, Meagher & Flom LLP represented Pandion.
NY officials downplay concern over new coronavirus variant
Mayor Bill de Blasio’s chief medical adviser on Thursday downplayed the results of two studies showing that a new coronavirus variant found in New York City in November may be more resistant to vaccines now being administered.
Dr. Jay Varma said it was premature to infer from laboratory results how effective the vaccines would be on the variant, echoing concerns of other scientists who questioned why preliminary studies are given to the media ahead of academics.
“We really don’t know enough about human immunity to draw those direct conclusions,” Varma said at a briefing along with the mayor. “That’s why we do clinical trials. That’s where we collect data continuously”
Clinical trials of the vaccines, Varma noted, including those done in other countries, such as Brazil and South Africa, have shown that they are “incredibly effective” at preventing death and severe illness.
Highly contagious variants of the virus first discovered and now prevalent in South Africa, the United Kingdom, and Brazil have been spreading widely to other countries.
In the United States, where the virus has taken more than 500,000 lives over the past 13 months, new infections and deaths have been on the decline in recent weeks.
Hospitalizations - a key indicator for public officials worried about overwhelming local healthcare systems - were down nearly 60% from their Jan. 6 peak at 53,938 patients, according to a Reuters tally.
Even with the declining trend, deaths mounted in California, where total fatalities topped 50,000 on Wednesday, followed by New York, the early epicenter of the U.S. outbreak, with 46,871.
The Centers for Disease Control and Prevention (CDC) had estimated that 45.2 million people in the United States have received at least one dose of the authorized two-shot COVID-19 vaccines from Pfizer Inc and partner BioNTech SE or Moderna Inc. Johnson & Johnson’s one-shot vaccine is widely expected to be authorized for emergency use within days.
‘SAFE AND EFFECTIVE’
President Joe Biden, marking the 50 millionth dose to be administered since he took office, said his administration plans to launch a massive campaign to educate Americans about coronavirus vaccines in anticipation of a period later this year where supply may outstrip demand because of vaccine hesitancy.
Biden alluded to skepticism in Black communities because of a history of “terrible medical and scientific abuse.”
“But if there is one message that needs to cut through, it’s this: the vaccines are safe and effective,” he said.
The new variant, called B.1.526, represented about 12% of New York City cases by mid-February, according to researchers at Columbia University Vagelos College of Physicians and Surgeons.
Another study published online this week by the California Institute of Technology also described the new variant. Neither study has been peer-reviewed.
The Columbia researchers found that B.1.526 shares some worrying characteristics with the South Africa and Brazil variants, that several studies have suggested are more resistant to some existing vaccines than earlier versions of the coronavirus.
The CDC has identified more than 1,900 cases of coronavirus variants spread across most states in the country, mostly the B.1.1.7 variant first identified in the UK, which has been shown to be more transmissible than earlier versions of the virus.
Varma urged readers to be “a little skeptical” of reports of the latest studies, adding that not all variants rise to the level of public health concerns. He characterized the latest discovery as a “variant of interest” that should be studied more closely.
New York City Health Commissioner Dave Chokshi called the studies “quite exploratory with respect to the real-world effects,” adding that there is no indication that the new variant reduces vaccine effectiveness.
Earlier, Varma took to Twitter to urge researchers to share their work with government health departments before releasing them to the press, adding, “Pathogen porn isn’t helping public health.”
California cardiologist Eric Topol echoed Varma’s concerns about unnecessarily spreading fear, calling the New York variant a “scariant.”
Yale University Professor Nathan Grubaugh called conclusions drawn from the two studies “an absolute mess.”
Assembly Biosciences prioritizes pipeline
Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV), today announced that it is foregoing its plans to initiate Phase 3 registrational studies of vebicorvir (VBR, or ABI-H0731) as a chronic suppressive therapy (CST) to concentrate its research and development efforts on finite and curative HBV therapies. As part of this focused strategy on finite and curative HBV therapies, Assembly Bio will prioritize its portfolio of potent next generation core inhibitors and combinations of VBR with complementary mechanisms of action, and plans to rapidly advance multiple research programs focused on novel targets and new mechanisms to the clinic.
The decision to not initiate the global registrational studies of VBR as CST followed extensive discussions with leading experts in the field and regulatory agencies, and with respect to the China territory, discussions and agreement with the company’s partner, BeiGene, Ltd. By redirecting the company’s resources previously reserved for the CST registrational studies and other activities to concentrate fully on pursuing finite and curative therapies, Assembly Bio expects to be able to advance these initiatives faster, while simultaneously extending its cash runway into 2023
Assembly Bio will host a webcast and conference call today at 5:00 p.m. ET/2:00 p.m. PT. The live audio webcast may be accessed through the “Events & Presentations” page in the “Investors” section of Assembly Bio’s website at https://investor.assemblybio.com/events-presentations. Alternatively, participants may dial (888) 771-4371 (domestic) or +1 (847) 585-4405 (international) and refer to conference ID 50110189. To ensure timely access to the event, participants are encouraged to connect to the call 15 minutes before the start time or to utilize the webcast link for listen-only access.
The archived webcast will be available on Assembly Bio’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.
Bluebird bio: NEJM Publishes Results from Pivotal Phase 2 on IBCMA-Directed CAR T Cell Therapy
First pivotal study of BCMA-directed CAR T cell therapy in triple-class exposed relapsed and refractory multiple myeloma
Biologics License Application (BLA) for ide-cel was accepted by FDA for Priority Review, with a target action date of March 27, 2021
Results from the pivotal Phase 2 KarMMa study evaluating the efficacy and safety of bluebird bio, Inc. (Nasdaq: BLUE) and Bristol Myers Squibb’s (NYSE: BMY) investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, idecabtagene vicleucel (ide-cel; bb2121), in adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, were published today in The New England Journal of Medicine.
The KarMMa study met its primary endpoint of overall response rate and key secondary endpoint of complete response rate. The data from the study demonstrates deep and durable responses with ide-cel treatment in triple-class exposed RRMM patients (n=128).
“The publication of KarMMa, the first pivotal study of a CAR T cell therapy in multiple myeloma, in The New England Journal of Medicine, underscores the importance of these data and the unprecedented outcomes observed in this triple-class exposed patient population, following a single infusion of ide-cel,” said David Davidson, M.D., chief medical officer, bluebird bio. “Together with our partners at Bristol Myers Squibb, we look forward to the prospect of bringing this first-in-class BCMA-directed CAR T therapy to patients.”
Clinically meaningful responses were reported in heavily pre-treated patients across all dose levels and in multiple high-risk subgroups, including those with high-risk cytogenetics, triple- or penta-refractory disease, high tumor burden at baseline, and extramedullary disease. Clinically meaningful improvement was also observed across measures for median duration of response, median progression-free survival and overall survival in treated patients.
Subscribe to:
Posts (Atom)