Contract drug manufacturer Lonza plans to double Swiss production capacity for Moderna's COVID-19 vaccine, helping the U.S. drugmaker boost total output to as many as 3 billion doses in 2022.
Thursday, April 29, 2021
Merck Backs Full-Year Guidance, Continues to See Pandemic Impact
Merck & Co. reaffirmed its full-year guidance Thursday, although the company said it expects the coronavirus pandemic to continue to have a negative affect on its revenue.
The Kenilworth, N.J.-based pharmaceutical company said it expects full-year revenue of $51.8 billion to $53.8 billion, and adjusted earnings of $6.48 to $6.68 a share.
Those guidance ranges are the same as those that Merck issued in February. Analysts polled by FactSet have been forecasting adjusted earnings of $6.49 a share, on revenue of $52 billion.
Merck said it expects that the negative impact from the Covid-19 pandemic on its results will persist, especially in the first half of the year. Overall, the pandemic will have a net unfavorable effect on 2021 revenue of 3%, the company forecast, with all of that hit attributable to the pharmaceutical segment.
Merck's guidance ranges assume that its Organon business will be part of the company for the full year, although Merck plans a spinoff of Organon effective June 2. If the spinoff occurs, Merck will update its guidance, the company said.
Baxter Forecasts Higher Annual Sales, Earnings After 1Q Profit Falls
Baxter International Inc. forecast higher earnings and sales this year despite a drop in first-quarter profit after being squeezed by one-time items including business optimization charges.
The medical products company reported net income of $298 million for the quarter, down from $332 million a year earlier, and a decline in earnings per share to 58 cents from 64 cents. The quarter included items totaling $88 million, which it said primarily related to intangible asset amortization, business optimization charges, and a proposed settlement of shareholder litigation following an investigation of foreign exchange gains and losses associated with certain intra-company transactions.
On an adjusted basis, Baxter's earnings were 76 cents a share, topping the company's earlier guidance range of 63 cents to 65 cents.
First-quarter sales rose to $2.95 billion from $2.8 billion, as international sales more than offset weakness in the U.S.
For the full year, Baxter forecast earnings of $2.85 to $2.93 a share, which would mark growth on the $2.13 recorded for 2020, and said it expects sales growth of 8% to 9%. On an adjusted basis, it anticipates earnings of $3.47 to $3.55 a share.
Analysts polled by FactSet had penciled in earnings of $3.40 a share and sales of $12.53 billion, up from $11.67 billion reported for 2020.
Sales growth for the second quarter is expected to be 14% to 15%, while earnings are forecast at 54 cents to 57 cents, or 72 cents to 75 cents before special items, the company said.
Adverum DME Gene Therapy Trial Derails On 1 Patient's Serious Adverse Event
Adverum Biotechnologies Inc (NASDAQ: ADVM) stock has cratered in reaction to a Suspected Unexpected Serious Adverse Reaction of hypotony (clinically-relevant decrease in ocular pressure).
The event was reported in the INFINITY Phase 2 trial evaluating ADVM-022 gene therapy to treat diabetic macular edema (DME).
The company said that a patient who received a high dose of their gene therapy experienced a loss of vision in a treated eye.
The patient was given a high dose (6 x 10^11 vg/eye) of ADVM-022, with a case of hypotony developing, characterized by a decrease in ocular pressure.
The company has immediately decided to unmask the 36-patient trial to determine if any other treated patients might have similar issues.
As of December 2020, the INFINITY study was fully enrolled, and all patients completed dosing of the single intravitreal (IVT) injection of ADVM-022.
Vaxart to Present at the World Vaccine Congress Washington 2021
Vaxart, Inc. (Nasdaq: VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced that its founder and chief scientific officer, Sean Tucker, Ph.D., will present at the upcoming World Vaccine Congress Washington that will be held virtually from May 4-6, 2021.
Dr. Tucker’s presentation titled, “Vaxart oral COVID-19 vaccine; hold the ice and the needles,” will provide insight into the Company’s response and approach to addressing the COVID-19 pandemic with a room temperature oral tablet vaccine that is potentially protective against new and emerging COVID-19 strains.
Presentation details are as follows:
Title: Vaxart oral COVID-19 vaccine; hold the ice and the needles
Track: COVID-19: vaccine response & approaches
Time: 5:00 p.m. ET
The World Vaccine Congress is the largest, most established meeting dedicated to vaccines. From basic research to commercial manufacture, this one meeting covers the whole vaccine value chain where science, government and manufacturers all come together to create groundbreaking progress.
To register for the virtual conference, which this year is free to attend, please click here.
https://finance.yahoo.com/news/vaxart-present-world-vaccine-congress-120000069.html
Galera Lead Candidate Shows Median OS Of 20 Months In Pancreatic Cancer Study
Galera Therapeutics Inc (NASDAQ: GRTX) has announced updated results from its Phase 1/2 pilot trial evaluating GC4419 in patients with locally advanced pancreatic cancer (LAPC) who are undergoing stereotactic body radiation therapy (SBRT).
The company plans to report final results from the trial during the second half of 2021.
As of this data analysis, median overall survival in the treatment arm was nearly twice as long as observed in the placebo arm (placebo + SBRT), 20.1 months compared to 10.9 months, respectively.
29% of patients in the treatment arm achieved a 30% or greater response (partial response) than 11% of patients in the placebo arm.
Positive results were also observed in local tumor control, time to metastases, and progression-free survival.
The data from this trial support the GRECO-2 Phase 2b trial to evaluate GC4711, Galera's second dismutase mimetic product candidate, combined with SBRT in patients with LAPC.
The primary endpoint of the Phase 2b trial is overall survival. Patient dosing will start in the first half of 2021, and the trial is expected to enroll approximately 160 patients.
GC4419, also referred to as avasopasem, is the company's lead candidate.
It is a small-molecule dismutase mimetic initially being developed for the reduction of radiation-induced severe oral mucositis.
Thermo Fisher Scientific: A winner
Thermo Fisher Scientific (NYSE:TMO) is one of the best life-sciences stocks you can buy now. This is the world's largest life-sciences company. With its tentacles wrapped around every facet of the life-sciences industry, though, investors who buy this stock now can reasonably expect positive returns over the long run.
In 2020, COVID-19 made it hard for scientists to work together in laboratories full of Thermo Fisher Scientific equipment. This was a nightmare for lots of life-sciences businesses, but explosive demand for COVID-19 diagnostics made up the difference and more. Total revenue surged 26% year over year in 2020, and adjusted earnings came in 58% higher.
Thermo Fisher Scientific expects demand for COVID-19 testing to drop off by the end of 2021, but a rebounding base business will allow total revenue and earnings to climb again this year.
Strong cash flow generation from a well-managed operation will give Thermo Fisher a chance to tighten its grip on the life-sciences industry. In April, the company offered $17.4 billion in cash to buy PPD, Inc. (NASDAQ:PPD), one of the world's largest contract research organizations.
Giving it back
Thermo Fisher Scientific rewards its shareholders with share buybacks and dividend raises. Thermo Fisher earmarked $1.5 billion for share buybacks in 2021 after returning $1.8 billion to shareholders in 2020.
There are no guarantees that Thermo Fisher Scientific will continue generating enormous profits to share with investors. Given all the right pieces in place, though, it sure seems likely.
https://www.fool.com/investing/2021/04/29/2-risky-life-science-stocks-to-avoid-and-1-to-buy
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