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Gilead kondigt de nieuwste gegevens aan in het lopende onderzoeksprogramma voor HIV-genezing
- Nieuwe studies evalueren agenten met mogelijke rol bij het elimineren van HIV viraal reservoir -

FOSTER CITY, Californië - (BUSINESS WIRE) - jul. 23, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD) presenteerde vandaag de resultaten van twee studies van onderzoeks-toll-like receptor 7 (TLR7) agonisten als onderdeel van een onderzoeksprogramma voor genezing van HIV. De resultaten van fase 1 en preklinische studie tonen aan dat de TLR7-agonisten vesatolimod (GS-9620) en GS-986 immuunactivatie kunnen induceren en eerder preklinisch onderzoek volgen dat suggereert dat TLR7-agonisten mogelijk kunnen leiden tot virale remissie, als onderdeel van combinatieregimes. Het hiv-virusreservoir is zelfs aanwezig bij personen die virologisch onderdrukt zijn en de eliminatie ervan wordt beschouwd als een belangrijk obstakel voor het bereiken van een remedie. De gegevens werden gepresenteerd tijdens de 10e International AIDS Society Conference on HIV Science (IAS 2019) in Mexico City.

“Hoewel behandelingen drastisch zijn verbeterd, worden mensen met hiv nog steeds geconfronteerd met een levenslange therapie en mogelijke complicaties. Die realiteit drijft ons voortdurende streven naar een remedie voor HIV, ”zei Diana Brainard, MD, Senior Vice President, HIV and Emerging Viruses, Gilead Sciences. "Deze bevindingen tonen aan dat TLR7-agonisten een potentiële rol kunnen spelen in schaalbare strategieën voor het bereiken van duurzame virale remissie bij mensen, en we zullen deze middelen blijven evalueren als onderdeel van curatieve onderzoeksregimes."

Studies over TLR7-agonisten gepresenteerd op IAS omvatten:

Mondelinge presentatie WEAA0304: Vesatolimod (GS-9620) is veilig en farmacodynamisch actief bij met hiv geïnfecteerde personen

Aan deze dubbelblinde, placebo-gecontroleerde klinische fase 1-studie namen 48 mensen met hiv deel aan antiretrovirale therapie. De mediane leeftijd van de deelnemers aan deze studie was 47 jaar (43 waren mannen), met een mediaan van 8,1 jaar therapie. In het onderzoek ontvingen 36 deelnemers escalerende doses vesatolimod (1-12 mg) en 12 kregen om de week een placebo. Vesatolimod stimuleerde bij hogere doses een reeks immuunresponsen. Vesatolimod werd goed verdragen bij alle doses, zonder geneesmiddelgerelateerde bijwerkingen van graad 3 of 4, geen gerelateerde ernstige bijwerkingen en geen bijwerkingen die leidden tot stopzetting van het onderzoeksgeneesmiddel. Geneesmiddelengerelateerde bijwerkingen, waaronder milde, voorbijgaande griepachtige symptomen, werden waargenomen bij 9 van de 36 deelnemers bij doses van 2 mg en hoger, consistent met eerdere onderzoeken. Deze symptomen verdwenen binnen één dag en traden niet bij elke dosis op.

“Deze studie toont aan dat vesatolimod kan worden toegediend aan mensen die met HIV leven in doses die een immuuneffect kunnen hebben en goed worden verdragen. De resultaten ondersteunen studies naar de mogelijke rol van vesatolimod als onderdeel van combinatieregimes gericht op het bereiken van ART-vrije controle van HIV, ”zei Sharon A. Riddler, MD, directeur van Clinical Research in de Infectious Diseases Division, University of Pittsburgh School of Medicine , een van de hoofdonderzoekers van de studie.

Mondelinge presentatie WEAA0105: orale toediening van TLR7-agonisten induceert een immunostimulerende reactie bij met SIV geïnfecteerde ART-onderdrukte resuskaken van zuigelingen

Deze preklinische studie evalueerde de orale toediening van GS-986 in twee simian immunodeficiency virus (SIV) geïnfecteerde, virologisch onderdrukte resusapen. Op de leeftijd van zeven maanden kregen beide makaken 0,1 mg GS-986 oraal toegediend. Vier weken later werd een tweede dosis van 0,3 mg toegediend en in beide gevallen werden bloedtelling, virale ladingen, cytokineconcentraties en immuunrespons gevolgd. Bij zowel de dosisniveaus van 0,1 mg als 0,3 mg induceerde GS-986 de activering van het immuunsysteem met waargenomen toename van perifere plasma-cytokines / chemokines en activering van immuuncellen. GS-986 werd goed verdragen met normaal volledig bloedbeeld en behoud van virale onderdrukking.

Deze resultaten voegen nieuwe informatie toe aan de bestaande preklinische gegevens over GS-986 voor de mogelijke toekomstige toepassing van een orale TLR7-agonist bij mensen met HIV.

Vesatolimod en GS-986 zijn onderzoeksverbindingen en zijn niet goedgekeurd door de Amerikaanse Food and Drug Administration of enige andere regelgevende instantie. Hun veiligheid en werkzaamheid zijn niet vastgesteld.

Er is geen remedie voor HIV-infectie of AIDS.

Over Gilead Sciences

Gilead Sciences, Inc. is een op onderzoek gebaseerd biofarmaceutisch bedrijf dat innovatieve geneesmiddelen ontdekt, ontwikkelt en commercialiseert op gebieden waar medische behoeften nog niet zijn vervuld. Het bedrijf streeft ernaar de zorg voor mensen met levensbedreigende ziekten over de hele wereld te transformeren en te vereenvoudigen. Gilead is actief in meer dan 35 landen wereldwijd, met hoofdkantoor in Foster City, Californië.
 
Poelifinario
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Mooi instapniveau. 1/3 van de beurswaarde is cash
Deal met GLPG belooft veel goeds.
Dividend en pay out ratio ogen mooi.
PT van 99 dollar
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Poelifinario schreef op 26 jul 2019 om 10:08:


Mooi instapniveau. 1/3 van de beurswaarde is cash
Deal met GLPG belooft veel goeds.
Dividend en pay out ratio ogen mooi.
PT van 99 dollar

O day heeft vanaf maart al 6 innovatieve bedrijven overgenomen cq samenwerking gekocht. Waarvan onze galapagos de grootste en uitgebreidste is. De deal is super voor galapagos maar in mijn optiek nog lucratiever voor Gilead. O day heeft in een nieuwsshow aangegeven iets extra voor zijn aandelers te willen doen. Ik ben pas weer ingestapt nu voor de LT. Want dividend is momenteel 2,64 $ per jaar verwacht zelf verhoging komende jaren ,wordt per kwartaal uitgekeerd Op 31 juli cijfers en vooral outlook.
Poelifinario
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Endless schreef op 26 jul 2019 om 11:25:


[...]
O day heeft vanaf maart al 6 innovatieve bedrijven overgenomen cq samenwerking gekocht. Waarvan onze galapagos de grootste en uitgebreidste is. De deal is super voor galapagos maar in mijn optiek nog lucratiever voor Gilead. O day heeft in een nieuwsshow aangegeven iets extra voor zijn aandelers te willen doen. Ik ben pas weer ingestapt nu voor de LT. Want dividend is momenteel 2,64 $ per jaar verwacht zelf verhoging komende jaren ,wordt per kwartaal uitgekeerd Op 31 juli cijfers en vooral outlook.

Gisteren de tijd genomen om hun eigen productenverkoop meer in detail te bekijken. Biktvary is een blockbuster in wording.
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Babbelaar schreef op 30 jul 2019 om 01:41:


Komt Gilead woensdag met hun cijfers van het tweede kwartaal ?

31 juli inderdaad.
alexnr75
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Nee, vandaag 30 juli!!

Upcoming Events
Jul 30, 2019 at 4:30 PM EDT
Second Quarter 2019 Gilead Sciences Earnings Conference Call

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 16, 2019-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its second quarter 2019 financial results will be released on Tuesday, July 30, after the market closes. At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s financial results for the second quarter 2019 and provide a business update.
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Gilead At An Inflection Point: Examining The HIV Market
6:46 pm, Wed, Jul. 31, 2019, by Denis Buivolov
Read now »

Conclusion

Given the above points, GILD may be a good investment due to the promising launch of Biktarvy, the hopeful pipeline, and a lack of strong competitors. However, in order to make an excellent investment decision, it is not right to take into account only one part of Gilead’s business. This investment requires additional due diligence of other GILD's segments.

Thanks for the reading and sharing any comments you wish to contribute!
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Top Stock Trades for Tomorrow #2: Gilead Sciences
top stock trades for GILD
Click to Enlarge

Gilead Sciences (NASDAQ: GILD ) reported strong earnings results and raised its outlook. That didn't stop sellers from pushing it lower, though.

Shares held right on channel support, but are stalling near the 200-day moving average. This chart is a little too sloppy at the moment needs some clarity. Specifically, a move over $67 would help the bulls quite a bit.

That would put GILD stock over all three major moving averages, as well as channel resistance and a key level. Below and Gilead may continue to chop around.
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Gilead Sciences: A Very Core Holding

Aug. 2, 2019 6:11 AM ET | About: Gilead Sciences, Inc. (GILD)
The Value Investor
The Value Investor
Value In Corporate Events
Finding value that gets unlocked in M&A, IPOs and other corporate events

(13,406 followers)
Summary
Gilead reports relatively resilient second-quarter sales.

Revenues are up on an annual basis again, as are earnings.

Strength in HCV, Yescarta and pipeline boost is encouraging.

A strong balance sheet, compelling value and green shoots make me a happy holder with a near 4% dividend yield to compensate for.

Looking for more? I update all of my investing ideas and strategies to members of Value In Corporate Events. Get started today »

Gilead Sciences (GILD) has been making some moves which create some enthusiasm, although that still has to be reflected in a higher share price. The company of course recently closed a high-profile deal with Galapagos (NASDAQ:GLPG), as Yescarta sees a steady increase in sales, and revenue declines have come to a halt.

Reasons enough to update the constructive thesis, which I have long held on Gilead after reviewing the recent events, as I still like the prospects at current levels amidst emerging green shoots.

About The Galapagos Deal

Halfway July, Gilead announced a transformative deal with Galapagos in a multi-billion-dollar deal. Deal terms for the 10-year R&D collaboration are quite complicated and lengthy. Key details include that Gilead will make a $3.95 billion upfront payment and furthermore invest another $1.1 billion in the shares of Galapagos.

In exchange, Gilead will receive product licenses for all current and future programs outside of Europe, with the rights of Galapagos being limited to Europe. The closer scientific partnership and cash infusion should accelerate the discovery process as Galapagos has stressed its desire to remain independent. The deal is full of additional milestone payments as well as relative fat royalties for Galapagos on non-European sales, ranging up to 20-24% of sales.

The $1.1 billion investment in the shares boosts Gilead's stake in Galapagos from 12.3% to 22.0%, as the company has the option to further expand the stake to 29.9% over time. Yet here is a 10-year standstill agreement in this deal under which Gilead is not allowed to increase its stake beyond this percentage. The $1.1 billion investment made around EUR 140 and change per share is already paying off; currently valued at EUR 156. This makes the entire stake of Gilead in Galapagos worth about $2.8 billion.

About The Second Quarter

Gilead reported relatively resilient second-quarter results with total revenues up 0.7% on the year to $5.68 billion, even as royalty streams were down a bit. This solid result came after first-quarter results which were up a little bit as well, marking a true halt to the steep revenue declines witnessed in recent years.

Growth is driven by the HIV product line, which saw revenues increase from $3.7 to $4.0 billion, which shows that after years of reliance on HCV sales, Gilead is now becoming reliant on HIV. Talking about HCV, sales fell from a billion to $842 million amidst competitive dynamics (read prices) and lower patient starts.

The company furthermore reports sales of "other" drugs, a category which includes quite a few individual names. Sales of these drugs as a group fell from $807 million to $604 million on the back of two patent expirations: Ranexa and Letairis.

Yescarta, the drug acquired with the purchase of Kite, contributed $120 million in sales in the second quarter. This number compares to sales of $68 million in Q2 of last year. Sequential revenue growth remains solid enough as first-quarter sales came in at $96 million. At this rate, the company is already on track to do half a billion in sales, more than 2% of total revenues.

The Earnings

On the back of the modest increase in sales, or better said the sales stabilisation, Gilead managed to grow reported operating earnings from $2.28 billion to $2.43 billion. The company managed to grow net earnings from $1.82 billion to $1.88 billion as a small reduction in the share count resulted in earnings per share increasing $0.08 to $1.47 per share. Adjusted earnings totalled $1.82 per share, although a sizeable part of the discrepancy results from amortisation charges.

On the back of the improved operating performance, the company is hiking its full-year sales guidance by $300 million to $21.6-22.1 billion. Based on the GAAP earnings performance in the first half of the year, the company could earn about $6 per share. Realistic earnings might come in even a bit higher as a result of the fact that some adjustments to the GAAP earnings seem fair.

Ending the quarter with $30.2 billion in cash and equivalents, the company operates with a very modest net debt load of little over a billion. While this will increase a bit following the Galapagos deal, leverage is anything except a big worry for investors in Gilead.

Some Encouraging Signs

After years of revenue declines, it is evident that Gilead has now stabilised the franchise. While growth in the HIV franchises is encouraging, it creates a new reliance/dependency problem as well, although this franchise looks steadier than HCV. While Yescarta is moving ahead a bit slower than originally expected, I think that progress in the second quarter was good, as the drug could start to contribute meaningfully in the coming quarters if this pace of improvements could be maintained.

While HCV is no longer seeing huge declines, it is disappointing to see declines at the other drugs, as some progress in the pipeline (or that of Galapagos) is very much welcomed in the near term.

With GAAP earnings running at $6 per share already and realistic earnings even a bit higher, needless to say that valuations are non-demanding at $66, or 11 times earnings while the balance sheet remains very strong by all means. During the whole downturn, Gilead has now been able to stabilise the sales and thus earnings, as it of course made a huge move with the $12 billion deal for Kite and a multi-billion-dollar deal with Galapagos, while preserving the integrity of the balance sheet. With HIV being very strong and the company making progress with the pipeline, there are many things to like at this point in time.

Hence the company remains a core holding for me given the value argument amidst green shoots and a near 4% dividend yield.
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FDA adviescommissie steunt Gilead's Descovy voor PrEP

7 augustus 2019 15:51 PM ET | Over: Gilead Sciences, Inc. (GILD) | Door: Douglas W. House, SA Nieuwsredacteur
Een FDA-adviescomité stemde 16-2 en beval goedkeuring aan van Gilead Sciences '(GILD -0,2%) Descovy (emtricitabine en tenofovir) voor profylaxe vóór blootstelling (PrEP) om het risico op seksueel verworven HIV-1-infectie bij mannen en transgendervrouwen te verminderen die seks hebben met mannen.

De actiedatum van de FDA is in oktober.

Lees nu: Paratek Pharmaceuticals, Inc. 2019 Q2 - Resultaten - Resultaten Oproepdia's »

FDA advisory committee backs Gilead's Descovy for PrEP

Aug. 7, 2019 3:51 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor
An FDA advisory committee voted 16-2 recommending approval of Gilead Sciences' (GILD -0.2%) Descovy (emtricitabine and tenofovir) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in men and transgender women who have sex with men.

The FDA's action date is in October.

Now read: Paratek Pharmaceuticals, Inc. 2019 Q2 - Results - Earnings Call Slides »
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Agenus up 8% on AGEN2373 IND, milestone payment

Aug. 8, 2019 9:51 AM ET|About: Agenus Inc. (AGEN)|By: Douglas W. House, SA News Editor
Agenus (AGEN +8%) is up on light volume in early trade on the heels of its announcement that the FDA has accepted its IND filing for immuno-oncology (I-O) candidate AGEN2373, triggering a $7.5M milestone payment from collaboration partner Gilead Sciences (GILD).

AGEN2373 is a fully human monoclonal antibody that inhibits (binds to) an immune checkpoint protein called CD137.

The companies established their partnership in December 2018 to develop five I-O therapies.
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Goed nieuws.
China National Medical Products Administration approves Gilead single tablet regimen for the treatment of HIV: bit.ly/2ONMh1R.
Endless
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GILD grew Q2 2019 revenue 8% Q/Q. Is it sustainable?

HIV continues to be the stalwart, but HCV and LOE could weigh.

GILD chugs along. Until it can generate consistent revenue growth the stock remains a sell.

Looking for a portfolio of ideas like this one? Members of Shocking The Street get exclusive access to our model portfolio. Start your free trial today »

Source: BarronSource: Barron's

Gilead (GILD) has been delivering uneven revenue growth over the last few quarters. Q2 2019 results showed promise, yet they followed an 8% sequential revenue decline in Q1. Gilead is chugging along, but I consider the stock a sell until it can deliver consistent top line growth. Heading into Q2 earnings the company was facing falling revenue within its core HIV franchise. Gilead had to cut costs to preserve margins. Management chalked up the Q1 decline to seasonality and a change in payer mix that moved more toward public payers. Its revenue growth in Q2 was more robust, however. Total Q2 total product sales of $5.6 billion rose 8% sequentially.

Q2 2019 product sales

HIV sales were $4.0 billion, up 12% Q/Q on higher prescription demand. Biktarvy was the star again this quarter with $1.1 billion in product sales, up over 40% Q/Q. It surpassed the $1 billion mark for the first time and is now Gilead's top selling product.

Biktarvy's U.S. prescriptions have traditionally been driven by switches from Genvoya and dolutegravir-based regimens. This likely explains why sales from Genvoya fell 3% this quarter. Nonetheless, Biktarvy is helping Gilead grow its HIV franchise, which is a good thing. It could be the company's most-important product in the near term.

HCV revenue of $842 million grew 7% Q/Q. HCV product sales from Europe grew 36% Q/Q. Europe benefited from an $80 million adjustment for revenue claw back reserves pursuant to sales in prior periods. Sans this claw back reserve, total HCV revenue would have fallen. Long term, HCV revenue will likely decline due to competition from AbbVie's (ABBV) Mavyret and new generic drugs introduced by Gilead.

Gilead still has enough scale to drive higher margins, in my opinion. Gross margin was flat, in the 82% range. SG&A and R&D costs were a combined 39% of revenue, versus 40% in Q1. As a result, EBITDA of $2.7 billion was up 7% Q/Q. EBITDA margin was 49%, the same as Q1. However, I get the impression management can adjust SG&A or R&D costs as needed in order to maintain margins.

LOE Kicks In

Heading into the quarter Gilead faced a loss of exclusivity ("LOE") for heart drugs, Letairis and Ranexa. They generated a combined $352 million in Q1 2019. In Q2 they generated a combined $223 million, off 37% Q/Q. Sales from Letairis actually grew as inventory was favorable in comparison to a draw down in Q1. Management indicated Letairis prescriptions were eroding due to generic competition. Its revenue is expected to decline going forward.

Teva's (TEVA) generic version of Truvada could arrive in 2020. Atripla could face generic competition by 2021. Truvada, Atripla, Letairis and Ranexa generated combined product sales of $1.1 billion, or about 19% of total product sales. LOE for these products could become a point of contention over the next few quarters.

Gilead Pulls The Trigger

Last month Gilead made a $1.1 billion equity investment in Galapagos (GLPG), (OTC:GLPGF) and a $3.95 billion upfront payment to access Galapagos's current and future drug pipeline. On the Q2 earnings call management talked up the ability of Galapagos to discover new drugs:

As you know, Galapagos is a highly productive R&D engine. They have seven medicines now in clinical development including filgotinib, which has a very comprehensive of life cycle program. And they have more than 20 medicines now in preclinical and their model has been very productive at producing new candidates for the clinic every year. And of course with our increased investments we would expect that to even increase in the future.

This is a really unique collaboration because it combines complementary strengths between Gilead and Galapagos and very importantly and, as you know, we structured this to allow Galapagos to remain independent ... They can invest and innovate to accelerate the progress based upon our investments. And in return we have an exclusive access right to their proven drug discovery platform.
Gilead has a core competency in (1) acquiring companies with drugs in late stage clinical trials and (2) helping target companies develop and market those drugs. The Galapagos arrangement is a departure from previous blockbuster deals, yet it is a good thing the company is putting capital to work. Gilead has $30 billion in cash on hand. In my opinion, the Galapagos deal seems more financially attractive than buying back its own stock.

Gilead will help Galapagos develop filgotinib, a drug to treat rheumatoid arthritis and other inflammatory diseases. The treatment is in the latter stage of clinical trials. The rheumatoid arthritis market was estimated at around $22.6 billion in 2018. The market expected to grow in the low single digit range over the next five years. Prospects for filgotinib sound promising. However, Cantor Fitzgerald analyst Alethia Young believes many of Galapagos's programs beyond filgotinib are less-developed. In my opinion, Galapagos was a headline-grabbing deal, yet meaningful financial returns may not be realized for several years.

Conclusion

GILD is down 15% Y/Y. Until the company generates consistent top line growth I rate the stock a sell.

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