- Revenues: $476.8M (+3.4%).
- Product sales: Vimizim: $147.9M (-9.5%); Kuvan: $124.1M (+2.9%); Naglazyme: $76.3M (-19.2%); Palynziq: $46.1M (+91.3%); Aldurazyme: $40.9M (+79.4%); Brineura: $25.4M (+28.3%).
- Net income: $784.8M (+999%); non-GAAP net income: $98.7M (+26.4%); EPS: $4.01 (+999%).
- Increase in net income primary due to tax benefit of $835.1M related to an intra-entity transfer of IP rights to an Irish subsidiary.
- 2020 guidance: Revenues: $1,850M - 1,950M from $1,810M - 1,870M; Vimizim sales: $530M - 570M from $515M - 545M; Kuvan: $430M - 480M (unch); Naglazyme: $360M - 400M from $370M - 400M; Palynziq: $160M - 190M (unch); Brineura: $85M - 115M from $90M - 110M; net income: $720M - 980M from $760 - 820M; non-GAAP net income: $260M - 310M from $280M - 330M.
https://seekingalpha.com/news/3632658-biomarin-q3-non-gaap-earnings-up-26-revenue-guidance-raised
Thursday, November 5, 2020
BioMarin Q3 non-GAAP earnings up 26%, revenue guidance raised
Exelixis EPS beats by $0.03, beats on revenue
- Exelixis (NASDAQ:EXEL): Q3 Non-GAAP EPS of $0.04 beats by $0.03; GAAP EPS of -$0.10 misses by $0.11.
- Revenue of $231.09M (-14.9% Y/Y) beats by $15.69M.
- “In the third quarter of 2020, the Exelixis team built the foundation to accelerate revenue growth with CABOMETYX® (cabozantinib) in 2021,” said Michael M. Morrissey, Ph.D., President and CEO.
- Press Release
- https://seekingalpha.com/news/3632449-exelixis-eps-beats-0_03-beats-on-revenue
BAYER AG: Bernstein gives a Buy rating
Bernstein is positive on the stock with a Buy rating. The target price remains unchanged at EUR 73.
AstraZeneca aims to bring non-U.S. vaccine data before the FDA
AstraZeneca will start discussing emergency approval of its experimental COVID-19 vaccine with U.S. regulators once it has good trial data from Britain, South Africa and Brazil, as it has no indication the watchdog would favour U.S. data.
If and when AstraZeneca reaches the first statistically reliable efficacy and safety results from those trials, based on more than 25,000 volunteers in total, it would present them to the U.S. Food and Drug Administration (FDA) even though any read-out from an ongoing U.S. trial will be months later.
"If you hit those thresholds we are going to have a conversation with them," executive team member Mene Pangalos told Reuters.
"What the FDA has signalled is what their expectations of data are for an approval," he said, adding the company had not spoken to the U.S. watchdog about where the data should some from.
The future of the U.S. trial would not be called into question by any successful non-U.S. trial result, Pangalos stressed.
Some experts have argued that, once a successful vaccine is widely available or soon expected, the runners-up in the vaccine race may find it difficult to recruit volunteers willing to risk being randomly assigned to a control group on placebo.
Pangalos said a vaccine would not be available for everyone immediately following approval. "That is not how it happens. It will take months to vaccinate people (widely)," he said.
"By the time the (UK) study reads out, we submit regulatory documents, and assuming we get an approval and the vaccine starts to be distributed across the U.S, I think there will be more than enough time to get the study almost fully recruited."
"Being on a vaccine study is probably going to be a good way ... to get access to the vaccine," he said, adding that only one in three U.S. trial participants will be on placebo.
Fed: Virus Poses Considerable Risks, Maintaining Low-Rate Pledges
The Federal Reserve said the coronavirus pandemic poses considerable risks for the U.S. economy despite recent gains, and officials made no changes on Thursday to their commitment to provide sustained stimulus.
"The ongoing public health crisis will continue to weigh on economic activity, employment and inflation," the central bank said in a policy statement after concluding a two-day meeting.
In September, Fed officials pledged to support the recovery by setting a higher bar to raise interest rates and by signaling it expected to hold rates near zero for at least three more years.
At that meeting, the Fed laid out three thresholds for raising rates, including evidence of a tight labor market, annual inflation of at least 2%, and forecasts that inflation would run moderately above 2%.
Officials didn't make any changes to that policy on Thursday.
"Economic activity has continued to recover from its depressed second quarter level," said Fed Chairman Jerome Powell at a news conference after the meeting. "In recent months, however, the pace of improvement has moderated."
Fed officials likely continued discussions this week over how to provide more support to the economy should the recent rebound fizzle. They have had their eye on two prominent risks since the summer: that growth would falter amid rising virus infections and that Congress would fail to deliver additional spending to support unemployed workers, hard-hit businesses and state and local governments.
Mr. Powell said the recent upswing in virus cases was "particularly concerning" and urged Americans to stay vigilant in the coming months. "All of us have a role to play in our nation's response to the pandemic, " he said. Wearing masks in public "will help get the economy back to full strength."
The policy makers have been surprised through the late summer and early fall by the degree to which economic activity held up despite higher infection counts.
On the other hand, negotiations between Republicans and Democrats over how much more to spend on pandemic relief measures have stalled. Several Fed officials have said their forecasts for continued growth are premised on additional government spending; they met this week without knowing the outcome of Tuesday's elections, which will shape the contours and timing of any fiscal package.
"The elephant in the room is the fiscal outlook," said James Sweeney, chief economist at Credit Suisse.
One reason Fed officials have been so outspoken about the need for additional government spending is because their stimulus tools are reaching the limits of what they can provide and because those tools are poorly suited to addressing the fallout from the pandemic, economists said.
"Central banks are impotent in this. The only thing you can do from a governmental standpoint is transfer income," said Steven Blitz, chief U.S. economist at research firm TS Lombard.
Mr. Blitz said he worries about new weakness as state and local governments address large revenue declines by laying off workers. He also fears business failures will result in more defaults on commercial property debts held by small and midsize banks. "Fiscal failure at this juncture will lay bare the weakness in monetary policy, and with that will come bank failures -- on Main Street, first," said Mr. Blitz.
Central banks took aggressive actions earlier this year after the virus upended daily life and forced curbs on economic activity with no precedent in peacetime. With the virus surging again in Europe, some are expanding stimulus measures.
Earlier Thursday, the Bank of England announced another dose of bond purchases as officials said they expect the U.K. economy to shrink in the final quarter of 2020. England moved Thursday into a four-week lockdown to slow the rate of infections, following earlier measures by the rest of the country.
The BOE agreed to another GBP150 billion of U.K. government bond purchases, equivalent to $195 billion. It takes the overall size of the BOE's portfolio of government and corporate assets to GBP895 billion.
The Reserve Bank of Australia on Tuesday cut its official cash rate to near zero and announced a 100 billion Australian dollars, equivalent to $70.57 billion, quantitative-easing program as it seeks to shore up the economic recovery that is tentatively emerging across the country.
The European Central Bank last week said it intends to scale up its support of the eurozone's economy in December with a package that could include billions of dollars of new bond purchases as well as an interest-rate cut and cheaper loans for banks.
Fed officials cut interest rates to zero in March and expanded their asset portfolio to $7 trillion in June from $4 trillion before the pandemic hit. They launched an array of emergency lending programs in the spring. They unveiled a new policy framework in August and formalized new interest-rate guidance in September.
Officials have said they would resume deliberations over possible refinements to their buying of government assets, including the maturity profile of Treasury purchases and any guidance on how long those purchases might continue. The Fed has been buying $80 billion in Treasurys a month and $40 billion in mortgage bonds, net of redemptions, since June after buying even larger quantities beginning in March to curb market dysfunction.
Officials haven't indicated how long they plan to continue these purchases or whether they will change the composition of those purchases to target longer-term securities, as they did in their 2012-14 bond-purchase program. Several Fed officials have said the low level of long-term Treasury yields makes this a less pressing matter.
Analysts also said there was little urgency for the Fed to make further announcements Thursday given the central bank's recent steps to fortify its guidance on short-term rates.
"While there are obviously concerns" about reduced fiscal support slowing the economy, "those things haven't been strongly reflected in the data yet," said Lewis Alexander, chief U.S. economist at Nomura Securities. Moreover, as long as long-term rates remain near their current, historically low levels, "they don't have a lot more they can do," said Mr. Alexander.
A separate question surrounds what the Fed will do with the scheduled expiration on Dec. 31 of the central bank's emergency loan programs. While the programs have resulted in fewer direct loans to businesses, cities, and states than many anticipated when they were first announced, the Fed is likely to prefer an extension because they are a source of comfort for financial markets and the pandemic hasn't subsided.
Treasury Secretary Steven Mnuchin has committed $195 billion to backstop losses in several of the lending programs, but the Treasury last month indicated it supported allowing at least one of them, which provides short-term loans to cities and states, to lapse as scheduled at year-end. It is unclear if his approval, which is required to launch the program, is needed to extend the program.
Regeneron hopes U.S. will authorize coronavirus antibody drug soon
Regeneron Pharmaceuticals Inc REGN.O said U.S. health regulators were doing a careful analysis of its experimental antibody cocktail to treat COVID-19 and that it was hopeful the drug could be authorized for emergency use in the country soon.
The treatment, which was given to U.S. President Donald Trump during his COVID-19 infection, has been under review by the U.S. Food and Drug Administration since last month.
“We hope that it (review) will reach a successful conclusion. But we don’t know the timeline,” Regeneron Chief Executive Officer Leonard Schleifer said during a conference call to discuss the company’s earnings.
The company has said that clinical trial data shows the drug reduced medical visits in patients with mild-to-moderate cases. The antibody treatment would be the first drug designed specifically to fight COVID-19 and could become a tool in the coronavirus pandemic that has killed more than one million people globally.
Based on clinical trials, Regeneron expects emergency use authorization could be granted for outpatients, a group that it believes would benefit the most from the drug.
About 80,000 doses of the treatment could be ready by the end of this month, and 300,000 doses by the end of January, Regeneron said.
The company has been working to scale up production of the drug, and raised its forecast for 2020 research and development expenses to between $2.75 billion and $2.82 billion, from its prior forecast of $2.61 billion and $2.73 billion. It would also result in higher expenses in the first half of 2021.
The company said last week that COVID-19 patients receiving advanced care in the hospital are no longer being enrolled in clinical trials after a data panel signaled a potential safety signal and an unfavorable risk-benefit profile.
“I think theoretically, there is not really a great deal of rationale why there might be a safety signal,” said George Yancopoulos, Regeneron’s chief scientific officer.
On Thursday, a data committee for large UK trial that is testing several potential drugs for COVID-19, including Regeneron’s REGN-COV2, said the trial should continue enrolling all patients, including severe patients.
The committee said that its decision was prompted by data from over 15,000 patients, and available external information.
Aptevo: First Complete Remission in Ongoing APVO436 Phase 1 Clinical Trial
Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR™ platform, today provided an update on its ongoing APVO436 Phase 1 clinical trial.
APVO436 is a novel anti-CD123 x anti-CD3 targeted investigational bispecific antibody therapy being evaluated for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), in a Phase 1/1b open-label, dose-escalation study evaluating the safety and pharmacokinetic profile.
Aptevo is pleased to announce that, based on preliminary data, a patient in cohort 6 of the clinical trial has shown complete remission.
In summary:
Patient bone marrow blasts decreased from 29% at screen to 6% after the first cycle of treatment, and to 0% after the second cycle of treatment; and,
The patient's platelet count and absolute neutrophil count (ANC) met complete remission criteria (CR).
"We are greatly encouraged by the complete remission in the patient in cohort 6, which is a wonderful outcome for them," said Marvin White, President and CEO of Aptevo Therapeutics. "We are now in a critical phase of the study, as pharmacokinetic modelling suggests that dosing in cohorts 5 through 8 is in a therapeutic range, which could result in potential clinical activity of the drug. We look forward to continuing the dose escalation and monitoring potential clinical responses as we advance through the upcoming dose cohorts," concluded Mr. White.
https://finance.yahoo.com/news/aptevo-therapeutics-announces-first-complete-140000460.html
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