DeBeurs.nl

wijzerplaat 12 april 2020 23:37

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www.thestreet.com/investing/gilead-su...

Endless 13 april 2020 13:12

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Pre + 3% hopelijk blijft dat bij opening vanmiddag

Ralph01A 13 april 2020 23:00

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Ja hopen dat het vanaf hier weer omhoog gaat. Met positieve hoop uitkijken naar uitkomst clinical trials.

Endless 14 april 2020 18:38

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Seeking Alpha
Summary
I previously identified Gilead's Remdesivir as very promising because of expert commentary and other scuttlebutt.

Gilead's CEO issued a letter about remdesivir announcing the company is giving away 1.5 million doses and describing how it is ramping up production.

Yesterday, president Trump talked about promising results by remdesivir.

Today, a new study is out showing promising results by getting the mortality rate down to 13% in severely ill patients.

This idea was discussed in more depth with members of my private investing community, Special Situation Report. Get started today »

Gilead Sciences (GILD) antiviral remdesivir that's widely tested for patients with severe Covid-19 infections appears to have a positive effect on the health of severely ill patients. A report in the New England Journal of Medicine reviewed 53 people on ventilators, oxygen and even several on a heart-lung by-pass machine. 68% of the patients improved. 13% died. At first glance, the mortality rate seems high but not if you look closely at the subset of very ill patients that were studied here.

Before diving in; let me emphasize that 1) I'm not an MD 2) I'm not a biotech expert 3) I didn't even take a lot of biology in high school 4) I'm reviewing all this through the glasses of a speculator.

it is unknown how lethal COVID-19 is. It is also highly dependent on circumstances and should come down as the medical community gains knowledge and increasingly effective treatments are developed. Here's one study that's specifically on the subject of mortality rate. They highlight the case of the Princess One because it gave us some of the most reliable data to get to a case fatality rate:

A unique situation has arisen for quite an accurate estimate of the CFR of COVID-19. Among individuals onboard the Diamond Princess cruise ship, data on the denominator are fairly robust. The outbreak of COVID-19 led passengers to be quarantined between Jan 20, and Feb 29, 2020. This scenario provided a population living in a defined territory without most other confounders, such as imported cases, defaulters of screening, or lack of testing capability. 3711 passengers and crew were onboard, of whom 705 became sick and tested positive for COVID-19 and seven died, giving a CFR of 0·99%. If the passengers onboard were generally of an older age, the CFR in a healthy, younger population could be lower.
CFR may be as low as 0.4%. You can get to this kind of numbers if you look at the CFRs in countries that do mass testing.

Mortality rates are higher in older patients:

Data: Worldometer

Comorbidities also seem to have an impact on mortality rates:

Endless 14 april 2020 18:39

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Data: Worldometer

An early study put the mortality rate at 15% among the hospitalized.

But mortality rates are vastly different once you get to the ICU.

The mortality rate in the ICU in the U.K. was reported to be 50%. That number related to a small number of early patients.

The Mortality rate in the ICU in Italy is about 26%. 88% received invasive ventilation.

A paper from China involved 710 Covid-19 patients; 52 were admitted to an ICU. Of the 22 who eventually required invasive ventilation, 19 (86%) died.

Early study Seattle showed a 50% mortality rate for ICU patients. 75% required invasive ventilation.

The above studies give you some context to interpret the first published study into Remdesivir results on COVID-19 patients.

The first study into remdesivir

The study describes Remdesivir as a nucleotide analogue prodrug that inhibits viral RNA polymerases and has shown in vitro activity against SARS-CoV-2.

In this study remdesivir was provided on a compassionate-use basis to patients hospitalized with Covid-19. Compassionate use is when a new, unapproved drug is used to treat a seriously ill patient when no other treatments are available. This is usually a last resort.

The way I understand Remdesivir to work, from listening and reading the commentary of experts in this field, is that the antiviral messes with the ability of this virus to replicate. I think it makes sense that a therapy like this is more effective the earlier it is administered. It messes with the replicating but it does not reverse the damage that is already done. Compassionate use is not generally granted at an early stage of the disease or when a case is mild.

I may be biased as I'm long Gilead and I've written extensively on remdesivir on Seeking Alpha. Read my earlier articles for context why I've suspected the drug would prove effective and what that means for Gilead:

Gilead and the economics of Remdesivir
Gilead And The Economics Of Remdesivir

6-4-2020
What The First 12 U.S. COVID-19 Patients Tell Us About Remdesivir
What The First 12 U.S. COVID-19 Patients Tell Us About Remdesivir

25-3-2020
12 Reasons Remdesivir is my best COVID-19 bet
12 Reasons Gilead With Remdesivir Is My Best COVID-19 Bet

16-3-2020
Economics of Remdesivir Gilead: Remdesivir's Potential Most Dependent On COVID-19 Spread 1-3-2020
17 reasons I'm confident Remdesivir is effective 17 Reasons Why I'm Confident Gilead's Remdesivir Will Work Against COVID-19 27-2-2020
Market is underestimating COVID-19 and Gilead is an opportunity Gilead: Potential Hedge If Covid-19 Is Taken More Seriously 17-2-2020
5 reasons why Remdesivir is likely to be effective Gilead Sciences: 5 Reasons Remdesivir Is Likely To Be Effective Against The Wuhan Coronavirus 10-2-2017
Patients in this study were confirmed to have a SARS-CoV-2 infection. They also had oxygen saturation of 94% or less (while breathing ambient air or receiving oxygen support). The patients received a 10-day course of remdesivir.

To quote the study directly:

Of the 53 patients whose data were analyzed, 22 were in the United States, 22 in Europe or Canada, and 9 in Japan. At baseline, 30 patients (57%) were receiving mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation. During a median follow-up of 18 days, 36 patients (68%) had an improvement in oxygen-support class, including 17 of 30 patients (57%) receiving mechanical ventilation who were extubated. A total of 25 patients (47%) were discharged, and 7 patients (13%) died; mortality was 18% (6 of 34) among patients receiving invasive ventilation and 5% (1 of 19) among those not receiving invasive ventilation.
and

In this cohort of patients hospitalized for severe Covid-19 who were treated with compassionate-use remdesivir, clinical improvement was observed in 36 of 53 patients (68%). Measurement of efficacy will require ongoing randomized, placebo-controlled trials of remdesivir therapy. (Funded by Gilead Sciences.)

Endless 14 april 2020 18:39

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therapy. (Funded by Gilead Sciences.)
Here is a table included in the study showing the demographics and characteristics of the patients:

Seven of the 53 patients or 13% died between 9 and 17 days after the completion of remdesivir treatment. Of those 6 of 34 patients (18%) were receiving invasive ventilation and 1 of 19 or 5% were on oxygen.

Given the data from the studies into the hospital and ICU mortality rates a mortality rate of 13% looks like an important improvement to me. This is below the mortality rate that one study found for hospitalization. It is about half of even the 25% ICU mortality rate out of Italy and 1/4 of the numbers out of the U.K. and Seattle.

The researchers of the preliminary study contrast against lopinavir-ritonavir (with a much healthier patient population) and versus general mortality rates from China(emphasis mine):

In a recent randomized, controlled trial of lopinavir–ritonavir in patients hospitalized for Covid-19, the 28-day mortality was 22%.10 It is important to note that only 1 of 199 patients in that trial were receiving invasive ventilation at baseline.

In case series and cohort studies, largely from China, mortality rates of 17 to 78% have been reported in severe cases, defined by the need for admission to an intensive care unit, invasive ventilation, or both.23-28 For example, among 201 patients hospitalized in Wuhan, China, mortality was 22% overall and 66% (44 of 67) among patients receiving invasive mechanical ventilation.7 By way of comparison, the 13% mortality observed in this remdesivir compassionate-use cohort is noteworthy...
Adverse events

One very important dataset is that of the adverse events:

Let me re-emphasize that 1) I'm not an MD 2) I know nothing about biotech 3) I didn't even take a lot of biology in high school 4) I'm reviewing all this through the glasses of a speculator

Because of the path to mortality in COVID-19 I think it will be hard to distinguish whether some of the more important adverse events were caused by the medication or occurred because of the disease. I think renal impairment, acute kidney injury and septic shock are adverse events to watch in follow-up papers.

Because remdesivir has also been tested on Ebola patients I lean towards the notion that is probably safe enough (probably not for certain subsets of the patient population):

"Clinical trials have also been conducted in Ebola survivors in West Africa, and in patients with acute Ebola virus disease in the Democratic Republic of Congo. As of January 18, 2020, more than 500 individuals have received at least a single IV dose of remdesivir, of which 400 were patients in the DRC with acute Ebola and were treated either in a Phase 2/3 trial or in emergency investigatioanl protocols, or MEORI. In these studies, no significant adverse events or laboratory abnormalities were attributed to remdesivir by study investigators."]

Endless 15 april 2020 00:42

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Gilead Sciences: Analyzing Remdesivir's Potential In A Difficult Time

Apr. 14, 2020 6:10 PM ET | About: Gilead Sciences, Inc. (GILD)
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Summary
Gilead Sciences has an impressive portfolio of assets. Remdesivir is performing incredibly well, with the initial data very promising.

Past this, the remainder of Gilead Sciences' portfolio is exciting. That portfolio should support Gilead Sciences depending on what happens.

The company has a strong history of shareholder returns. Its mid-single digit returns should continue or grow going forward.

I do much more than just articles at The Energy Forum: Members get access to model portfolios, regular updates, a chat room, and more. Get started today »

Gilead Sciences (NASDAQ: GILD) is increasingly one of the most important pharmaceutical companies in the world as a result of COVID-19. With Gilead Sciences recently announcing its first official press release of results from Remdesivir, the purpose of this article is to announce, in a difficult time, how this drug can provide rewards for Gilead Sciences shareholders. At the same time, we'll see how, outside of these rewards, Gilead Sciences is still a strong investment.

Gilead - Fierce Pharma

Gilead Sciences Remdesivir Data Announcement

Gilead Sciences announced the first batch of data from Remdesivir treatment in COVID-19 and there were some impressive results here.

Gilead Sciences 53 Patients - Gilead Sciences

To start, I want to note that I am not a licensed medical professional and that the results of Gilead Sciences' conference are fundamentally non-decisive because the drug was provided on a compassionate use basis without properly accounting for the normal things that are taken into account in drug trials. However, with all of that said, there were some promising results.

However, there are some comparisons we can make that show some promise for Remdesivir. An initial study from the University of Washington discussing initial patient data for 24 patients stated critically ill COVID-19 patients on a ventilator saw a 50% mortality rate, spending an average of 10 days each on ventilators, with no one coming off of ventilators in the first week.

In contrast, for the 53 compassionate use patients in Gilead Sciences' study, saw an improvement in oxygen class for 68% of patients, with more than half extubated, and nearly half discharged from the hospital following treatment. At a 28 day follow up point, a relatively impressive 84% of patients had seen either a 2 point improvement in their oxygen scale or were discharged from the hospital.

Again, proof isn't here, but initial data is promising for Remdesivir.

Endless 15 april 2020 00:43

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COVID-19 Remdesivir Supply - Gilead Sciences

Gilead Sciences is planning to significantly ramp up capacity and sales of Remdesivir. The details of the company's operations and profits aren't public. No company would want to publicly discuss how much it's making from COVID-19 amid one of the most difficult and trying diseases of our time. However, there are three important things for investors to keep in mind.

The first is that even while breaking even, investments in Remdesivir R&D will pay off. The second is that as COVID-19 spreads, any profits will be multiplied dramatically. The third is that the public R&D from being the face of a potential COVID-19 cure has enormous marketing benefits.

Looking at the first one, it's important to note that, even if the company breaks even on this ramp-up, it will still get to keep the resulting manufacturing facilities. For example, Gilead Sciences will be able to invest in new manufacturing facilities and add that to the cost of Remdesivir that it charges customers. Effectively, the company can break-even on manufacturing costs without the social judgements of profits.

The second is that COVID-19 is spreading rapidly. There are almost 2 million cases worldwide, and estimates are for the disease to spread across a significant part of the world's population. In Germany, estimates are for 70% of the population to get the disease, and there's no reason that this can't spread similarly across the rest of the world. That's ~4-5 billion people with the disease.

Gilead Sciences only needs to make $15 / dose in profit, and treat everyone, to make its market capitalization in profits. Even Tamiflu made >$1 billion in its best year, something that Remdesivir should be able to comfortably pass.

Lastly, there are significant press and social benefits from the company's work on COVID-19. This has already been clearly evidenced given the amount of mainstream press Gilead Sciences has received so far from its COVID-19 efforts. Even if the above two categories don't pan out, Gilead Sciences could redirect this free press to the company's other drug offerings. That could have the benefits of what would otherwise cost millions in marketing.

Gilead Sciences' Other Businesses

At the same time, even if the company's Remdesivir efforts don't pan out, the company has a number of other impressive businesses.

Gilead Sciences' Other Businesses - Gilead Sciences Investor Presentation

The company has a number of significant businesses that support almost $8 billion in annual Non-GAAP net income for the company. For a company with a $95 billion market capitalization, that's an incredibly significant amount of profit. That gives the company a P/E ratio of roughly 12 - a low P/E ratio that allows the company to give significant annual shareholder rewards.

More importantly, the company is part of a number of businesses with significant opportunities. HIV is one of the deadliest diseases in human history, and Gilead Sciences has been revolutionary in treating the disease. As a result, the company's drugs now treat the majority of people with HIV and the company continues to benefit from improved detection of the disease. Earnings have grown and will continue to.

At the same time, the company has a number of exciting other alternative drugs. The company's Yescarta drugs, Filgotinib, and recent drugs from the Forty Seven acquisition all have significant potential. Filgotinib is expected to have peak sales close to $6 billion annually and CD47 (from Forty Seven) is expected to have peak sales of almost $3 billion annually.

The company's portfolio of drugs will mean strong income and revenue well into the 2020s going into the 2030s.

Gilead Sciences Shareholder Reward Potential

At the same time, Gilead Sciences has a long history in shareholder returns that should be able to continue going forward.

Endless 15 april 2020 00:44

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Gilead Sciences Shareholder Returns - Gilead Sciences Investor Presentation

Gilead Sciences had a strong history of shareholder returns in 2019. The company paid out more than $3.2 billion worth of dividends resulting in an almost 4% dividend yield. The company also repurchased a significant $1.75 billion of shares resulting in total YTD 2019 shareholder rewards of almost $5 billion. That puts a total mid-single digit shareholder return. The company can continue this for the long term.

The company, as we saw above, has $8 billion in annual net income. It has made significant acquisitions recently, however, as that slows down, it'll have the cash to increase shareholder rewards.

Gilead Sciences Risk

Gilead Sciences has only one major risk to pay attention to. The company's major risk is the fact that biotech requires constant investment on the order of billions of dollars. Even with that billions of dollars of investment, there's a chance of the drugs not properly panning out. While sometimes there's slam dunks, oftentimes drugs fail. There's always some tiny luck / probability element that could hurt shareholder returns and that shareholders should pay attention to.

Conclusion

Gilead Sciences is an incredibly impressive company that's worth paying close attention to. The company's initial Remdesivir data is incredibly promising, with the company seeing 84% improvement at the 1-month market, versus a more than 50% death rate for the non-treated patients. While the data isn't definitive, the initial results are promising.

Additionally, even if Remdesivir doesn't pan out in the ways expected, there are significant additional other benefits. Past that, the company's other businesses remain incredibly strong. These businesses and the company's other acquisitions have significant growth potential. The company is also working on increasing shareholder returns, with a strong history.

Together that makes Gilead Sciences a strong investment at this time.

Endless 15 april 2020 16:49

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seeking Alpha
Gilead slips on suspension of second remdesivir study in China

Apr. 15, 2020 8:58 AM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor
Gilead Sciences (NASDAQ:GILD) slips 3% premarket on modest volume on reports that the second study of remdesivir in China, the one in mild-to-moderately ill COVID-19 patients, has been suspended.

The trial in severely ill patients was terminated earlier due to low enrollment.

Update: The second study was also suspended for low enrollment. RBC's Brian Abrahams believes that preliminary results were probably inconclusive since a relatively high number of patients (n=237) had been enrolled, adding that the probability that remdesivir shows substantial efficacy in COVID-19 is a coin toss.

Ralph01A 15 april 2020 23:35

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finance.yahoo.com/news/gilead-said-ho...

Ralph01A 16 april 2020 17:29

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www-fool-com.cdn.ampproject.org/v/s/w... %251%24s&ampshare=https%3A%2F%2Fwww.fool.com%2Finvesting%2F2020%2F04%2F16%2Fgilead-sciences-remdesivir-data-release-brings-muc.aspx

Endless 16 april 2020 17:50

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Arcus Biosciences up 84% on rumored Gilead interest

Apr. 16, 2020 11:15 AM ET|About: Arcus Biosciences, Inc. (RCUS)|By: Douglas W. House, SA News Editor
Thinly traded cancer therapy developer Arcus Biosciences (RCUS +83.7%) is up big on almost a 7x surge in volume on reports that Gilead Sciences (GILD +2.0%) is mulling a "significant stake" in the company.

The company's pipeline includes anti-TIGIT antibody AB154, PD-1 inhibitor zimberelimab and dual A2a/A2b adenosine receptor antagonist AB928.

Alphabet's venture capital unit, GV, is also an investor.

Ralph01A 16 april 2020 22:29

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www.statnews.com/2020/04/16/early-pee...

The University of Chicago Medicine recruited 125 people with Covid-19 into Gilead’s two Phase 3 clinical trials. Of those people, 113 had severe disease. All the patients have been treated with daily infusions of remdesivir.

“The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” said Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital.

“It’s always hard,” she said, because the severe trial doesn’t include a placebo group for comparison. “But certainly when we start [the] drug, we see fever curves falling,” she said. “Fever is now not a requirement for people to go on trial, we do see when patients do come in with high fevers, they do [reduce] quite quickly. We have seen people come off ventilators a day after starting therapy. So, in that realm, overall our patients have done very well.”

She added: “Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn’t have to be 10 days. We have very few that went out to 10 days, maybe three,” she said.

Betreft slecht data van 1 clinical trial en vooralsnog anekdotisch, maar wat een positief nieuws!

Ralph01A 16 april 2020 22:38

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Ondertussen nabeurs al +5 %

Ralph01A 16 april 2020 22:46

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+ 6% en door de weerstand op 80. Lijkt erop dat de koers nu toch echt losgaat. Met anticipatie op goede resultaten trials, mogelijk fda approval en op 30 april cijfers die mogelijk een stuk stabieler zijn dan in veel andere sectoren mogelijk goede triggers voor verdere stijging.

Ralph01A 16 april 2020 22:54

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finance.yahoo.com/news/cancer-drug-ma...

Ralph01A 16 april 2020 22:54

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+10% ...

Ralph01A 16 april 2020 23:54

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www.businessinsider.com/stat-news-gil...

Endless 17 april 2020 00:01

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Na beurs 13% up
Gilead up 6% after hours on remdesivir buzz in COVID-19

Apr. 16, 2020 4:47 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor
STAT reports that preliminary results from a study in Chicago evaluating Gilead Sciences' (NASDAQ:GILD) remdesivir in severely ill COVID-19 patients are positive with rapid recoveries in fever and respiratory symptoms observed and almost all patients discharged in less than a week.

The news is lifting shares, up 6% after hours, a welcome bit of good news on the heels of two canceled studies in China due to low enrollment.

GILD, BCRX, APT and IFRX among after-hours movers

Apr. 16, 2020 5:48 PM ET|About: Silvergate Capital Corp... (SI)|By: Akanksha Bakshi, SA News Editor
Gainers: SI +30%. BCRX +25%. CEQP +19.7%. GILD +13%. SPR +8.5%.

Losers: CUTR -13.7%. APT -11%. IFRX -5.5%. CPSS -4%. RVP -1.4%.

Vertraagd	5 feb 2025 22:00
Koers	99,650
Verschil	0,000 (0,00%)
Hoog	0,000
Laag	0,000
Volume	343
Volume gemiddeld	7.154.819
Volume gisteren	9.419.694

06 nov	Gilead verhoogt outlook
aug '23	Gilead verlaagt outlook
apr '23	Gilead schiet tekort
feb '23	Hogere resultaten Gilead
aug '22	Hogere omzet Gilead
apr '22	Gilead verlaagt outlook
feb '22	Schikking drukt winst Gilead
okt '21	Gilead verhoogt outlook
apr '21	Gilead profiteert minder van remdesivir
apr '21	Biden wil medicijnkosten flink verlag...	14

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