Gilead Science Inc. (GILD)

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Gilead Science Inc. (GILD)

Hallo Community,

Bin seit geraumer Zeit in Gilead Sc. (GILD) investiert. Per Jahresanfang haben diverse Banken eine Hochstufung vorgenommen. Beispiel UBS:

06.01.14 : 12-month rating: BUY - $ 102.00  

Kürzliche News zu Pipeline beinhaltenden Produkten: U.S. FDA Accepts New Drug Application (NDA) for Gilead's Idelalisib for the Treatment of Refractory Indolent Non-Hodgkin's Lymphoma (iNHL).

 

Denke auch diese Firma hat enormes Potenzial. Firma ist gut positioniert und zeigt solide Struktur auf. Spezialisiert sich vorallem in den Bereichen HIV/AIDS. Mal sehen was an der J.P. Morgan Healthcare Conference herauskommt.

watch: www.gilead.com

Gibt es sonst noch jemand, der auf die Aktie aufmerksam wurde?

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UBS research:

"We continue to view Gilead as our top large cap stock and believe that the HCV pipeline, anchored by Sovaldi (sofosbuvir), along with tenofovir alafenamide fumarate (TAF) in HIV, and idelalisib in oncology will continue to drive shares even higher over the next 12 months as investors reflect the implications of better-than-expected pricing, higher market size estimates from Gilead, and geographic expansion, among others."

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Gilead

hallo hublot BB

Besten dank für die eröffnung des threads!

bin seit ca. letzten märz in gilead investiert! Noch sind sie vorallem im bereich hiv, doch durch die zulassuung von sovaldi (hepatitis c) und der bevorstehende fda entschied über idelalisib werden sie in zukunft viel breiter abgestützt sein!

bin sehr zuversichtlich!!

Gruss

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Gilead Science Inc. (GILD)

UBS CIO Research View Headline of Gilead Sc.:

- Matthew Roden (Analyst), Andrew Peters (Analyst), Jeffrey Hung (Analyst):

Thoughts on the stock: Growth Story Robust; Reiterate Buy

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Takeaways from meeting with management

Takeaways on Commercial: All systems go.

[1] On HCV, Gilead reiterated it can file on 12-week ION-1 data, which

implies to us that FDA approval could come in 3Q14, suggesting upside

to 2014 estimates. [2] Sovaldi use has been principally in GT2 and GT1

treatment-experienced patients (including with JNJ's SMV, which is getting

reimbursed) with GT1 use expected to increase after Jan-1, all consistent

with our checks at HEP DART. [3] Japan HCV can launch by 1Q15e in GT2

and GT1 by mid-year. [4] On HIV, EU is going well with Eviplera #1 in EU,

and Stribild doing 2x what Eviplera did in EU at this point of launch. In

the US, the ADAP program should be steady in 1Q14; there is uncertainty

into the FY15 although the program is in place provisionally. There has

been very limited switching from ADAP into exchanges. [5] Mgmt doesn’t

believe the HCV market will fade after an initial bolus, and downplayed the

potential for an epic price war. These views are consistent with our wellabove

consensus HCV model (updated last week).

Takeaways from R&D: "There is life after HCV"

[1] Gilead is moving into the clinic with 2 new (non-boosted) HIV integrase

inhibitors that will be paired with TAF, which in our view should best position

the franchise vs. competition. [2] Mgmt seeks a cure to HBV, which

"won't be easy" although there is a low bar for improving the current

treatment options even without a cure. [3] Based on its proprietary examination

of the Ranexa mechanism, mgmt is advancing GS-6615 into ph2 in

2 cardiovascular indications. [4] Mgmt is upbeat on lesser-known pipeline

programs, including in solid tumors and RSV. [5] Mgmt is spending time on

business development opportunities (as expected).

Implications: GILD our favorite large cap biotech

What we think isn’t in the stock is [1] upside to HCV numbers with a strong

SOF and SOF/LDV launch, [2] corporate development / deployment of cash,

[3] further pipeline data in HIV (TAF), HCV (GS-5816), cancer (idelalisib and

others), and other programs.

Valuation: Buy with $102 PT based on 15x our 2015 EPS

We expect Sovaldi will drive EPS inflection 2015-17, where GILD is cheap

vs. peers.

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European Commission Grants Marketing Authorization for Gilead's Sovaldi(R) (Sofosbuvir) for the Treatment of Chronic Hepatitis C Infection

-- Sovaldi Approved For Use in Genotypes 1-6 --

-- High Cure Rates and Shortened, 12-Week Course of Therapy for Treatment-Naïve Patients --

-- First All-Oral Treatment Option for Patients Who Cannot Take Interferon --

-- First Regimen for Patients Awaiting Liver Transplantation to Prevent HCV Recurrence --

FOSTER CITY, Calif.--(BUSINESS WIRE)--January 17, 2014-- 

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for Sovaldi(R) (sofosbuvir) 400 mg tablets, a once-daily oral nucleotide analogue polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection in adults, in combination with other antiviral agents (ribavirin (RBV) and pegylated interferon alpha (peg-IFN)). Today's marketing authorization follows an accelerated assessment by the European Medicines Agency, a designation that is granted to new medicines of major public health interest, and allows for the marketing of Sovaldi in all 28 countries of the European Union (EU).

"Unlike many chronic diseases, hepatitis C can be cured. However, for a number of reasons, many HCV patients have not currently achieved a cure and often progress to end-stage liver disease or liver cancer," said Graham Foster, MD, Professor of Hepatology, Queen Mary University of London. "With high cure rates across a broad range of patients and a short duration of therapy, Sovaldi is a very welcome therapeutic advance that will increase the number of patients who can be treated and ultimately cured."

Approximately nine million people in Europe are infected with HCV, a major cause of liver cancer and liver transplantation. The societal, clinical and economic burden of untreated HCV is substantial, with HCV-related healthcare costs directly related to disease severity. The current standard of care for HCV involves up to 48 weeks of therapy with a peg-IFN/RBV-containing regimen, which may not be suitable for certain types of patients.

"The marketing authorization of Sovaldi is an important step forward in the management of hepatitis C in Europe, enabling many more patients the opportunity of cure," said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. "We are committed to working with local governments and health systems to make Sovaldi available in Europe as quickly as possible."

The European Commission marketing authorization for Sovaldi is supported primarily by data from four Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION in which 12 or 16 weeks of Sovaldi-based therapy was found to be superior or non-inferior compared with the currently available treatment options RBV/peg-IFN or historical controls, based on the proportion of patients who had a sustained virologic response (where HCV becomes undetectable) 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV. Trial participants taking Sovaldi-based therapy achieved SVR12 rates of 50-90 percent. For full study details, see the Summary of Product Characteristics at www.ema.europa.eu.

During the regulatory review, data from two additional Phase 3 studies, VALENCE and PHOTON-1 were added to the marketing authorization application. In the VALENCE study, patients with genotype 3 HCV infection were treated with Sovaldi and RBV for 24 weeks. The PHOTON-1 study evaluated Sovaldi and RBV for 12 weeks in patients with genotype 2 or 3 HCV infection co-infected with HIV-1 and for 24 weeks in patients with genotype 1 HCV co-infected with HIV-1. In all Phase 3 studies of Sovaldi, no viral resistance to the drug was detected among patients who relapsed following completion of therapy.

To date, nearly 3,000 patients have received at least one dose of Sovaldi in Phase 2 or 3 studies. Sovaldi was well tolerated in clinical studies. Adverse events were generally mild and there were few treatment discontinuations due to adverse events. The most common adverse events occurring in at least 10 percent of patients were consistent with the safety profiles of peg-IFN and RBV and included fatigue, headache, nausea, insomnia, dizziness, pruritis (severe itching) and anemia.

Sovaldi was approved in the United States on December 6, 2013 and in Canada on December 13, 2013. Applications are pending in Australia and New Zealand, Switzerland and Turkey.

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Barron's Blog:

Gilead Sc. (GILD) in spotlight of the issued Off-Topic "Where to find Yield".

 

--> Momentan wieder +3% Smile

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"Long ago Amanda Alix from Motley Fool wrote: There's no Stopping Gilead Sciences! Today we know better, the sky is the limit!", a US analyst said in the yesterday interview.

Gilead Sc. (GILD) gained in the early market about 2.5 pc. -> Barron's Blog

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Statement of changes in beneficial ownership of securities (Form 4)

AnhangGröße
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auch noch ein spannender Bericht. Auf jedenfall lesenswert:

Gilead kann mehr als viele andere seiner Branche: nämlich Produkte auf den Markt bringen. Analysten sehen rosigen Zeiten entgegen.

Foster City/Wien. Kennern der Biotech-Branche ist das Unternehmen schon lange ein Begriff: Gilead Sciences. Hepatitis, HIV oder schwere Lungenerkrankungen sind das Spezialgebiet des Unternehmens, deren Heilung oder Linderung sich der US-Konzern auf die Fahnen geschrieben hat.

Doch Biotech lässt bei vielen Investoren die Alarmglocken schrillen. Denn in dem Bereich sind nicht selten Firmen aktiv, deren Aktienkursentwicklung am Prinzip Hoffnung hängt. Biotech-Firmen forschen in erster Linie, mit Glück bringen manche irgendwann ein Produkt auf den Markt.

Bei Gilead ist das anders. Erst kürzlich konnte sich das Unternehmen erneut über die Zulassung eines weiteren Medikaments freuen. Die Aufsichtsbehörden gaben dem US-Konzern, der 2012 einen Umsatz von 9,7 Mrd. Dollar machte, grünes Licht für ein Mittel gegen Hepatitis C. In mehreren Studien habe sich gezeigt, dass die Tabletten nicht nur deutlich mehr Patienten helfen, sondern zugleich auch weniger Nebenwirkungen haben, wie es heißt. Experten trauen dem Medikament im kommenden Jahr ein Umsatzvolumen von 1,9 Mrd. Dollar zu.

 

Die Aktie hat noch Potenzial

Auch sonst lief es für den Biotech-Konzern rund. Die Ergebnisse zum dritten Quartal verbesserten sich merklich. So legte der Nettogewinn im Vergleich zum Vorjahreszeitraum um 17 Prozent auf 789 Mio. Dollar zu.

Die Produktverkäufe erhöhten sich ebenso. Und zwar um satte 15 Prozent auf 2,7 Mrd. Dollar. Zahlreiche Analysten setzen schon seit einigen Jahren auf das Unternehmen. Derzeit empfehlen 26 von ihnen das Papier zum Kauf, wie Daten von Bloomberg zeigen. Vier raten, die Aktie zu halten. Für den Verkauf des Papiers spricht sich niemand aus.

 

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Gilead Announces Executive Promotions

-- Robin Washington, Paul Carter and John McHutchison, MD Named Executive Vice Presidents --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 27, 2014-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced several promotions within the company's senior management team. Robin Washington, Chief Financial Officer (CFO), has been promoted to Executive Vice President; Paul Carter, formerly Senior Vice President, International Commercial Operations, has been promoted to Executive Vice President with responsibility for Gilead's worldwide commercial organization; and John McHutchison, MD, formerly Senior Vice President, Liver Disease Therapeutics, has been promoted to Executive Vice President and will assume additional responsibility for clinical development programs in the areas of oncology, respiratory diseases and inflammation. <?xml:namespace prefix = o />

"Robin, Paul and John have made significant contributions to Gilead, each demonstrating a commitment to improving systems and processes and advancing programs that will allow us to meet the needs of patients as quickly as possible," commented John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. "They have each built strong, capable teams and have helped Gilead navigate an increasingly complex environment as we expand geographically and into new therapeutic categories. Their leadership and vision will help ensure Gilead is able to achieve our goals and reach more patients in need around the world."

Ms. Washington joined Gilead in 2008 as Senior Vice President and CFO. She oversees the company's finance, information technology and investor relations functions, reporting to John Milligan, PhD, Gilead's President and Chief Operating Officer. Prior to joining Gilead, Ms. Washington was Chief Financial Officer of Hyperion Solutions, which was acquired by Oracle Corporation in March 2007. She previously served in a number of executive positions with PeopleSoft, most recently in the role of Senior Vice President and Corporate Controller. Ms. Washington is a member of the Board of Directors of Honeywell International, the Board of Directors of Salesforce.com and the Board of Visitors, Graziadio School of Business and Management, Pepperdine University. She is a certified public accountant and holds a bachelor's degree in business administration from the University of Michigan and an MBA from Pepperdine University.

Mr. Carter joined Gilead Sciences in April 2006 to head its European commercial organization. Later that year he assumed additional responsibility for Gilead's growing operations outside of Europe and North America. He has helped to establish the company's regional Asian headquarters in Hong Kong and numerous new affiliate offices, most recently including operations in the Czech Republic, Poland, Russia and South Korea. In his new role, Mr. Carter will oversee worldwide commercial operations, reporting to Dr. Milligan. Prior to joining Gilead, Mr. Carter spent 15 years in the pharmaceutical industry with GlaxoSmithKline and its legacy companies. During his time with GSK, Mr. Carter gained increasing levels of senior experience as General Manager in Europe and later as a Regional Head of the International business in Asia. In this latter role he was also a member of GSK's International Management Committee. Mr. Carter's early experience includes several years with Arthur Andersen at its London office. He has a degree in Business Studies from the Ealing School of Business and Management (now merged into University of West London) and is a Fellow of the United Kingdom's Chartered Institute of Management Accountants.

Dr. McHutchison joined Gilead in 2010 as Senior Vice President, Liver Disease Therapeutics. In his newly expanded role, he will be responsible for Gilead's development programs in oncology, respiratory diseases and inflammation. Dr. McHutchison will continue to report to Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer. Prior to joining Gilead, Dr. McHutchison worked at Duke University Medical Center, where he served as Associate Director of the Duke Clinical Research Institute. He also held the positions of Professor of Medicine in the Division of Gastroenterology at Duke University Medical Center and Co-Director of the Duke Clinical and Translational Science Award. Prior to his positions at Duke, Dr. McHutchison spent nearly 10 years at Scripps Clinic, most recently as Medical Director, Liver Transplantation. He also previously held an Assistant Professorship in Medicine at the University of Southern California. Dr. McHutchison received bachelor of medicine and bachelor of surgery degrees from the University of Melbourne, Australia, and completed his residency in internal medicine and a fellowship in gastroenterology at the Royal Melbourne Hospital. He is also a member of the Royal Australasian College of Physicians.

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NEUES KURSZIEL

DEUTSCHE BANK ERHÖHT KURSZIEL FÜR GILEAD SC. (GILD) MASSIV:

We view large-cap biotech as fundamentally stable yet providing attractive growth. Our thesis is based on: 1) more diversified businesses, 2) pipeline, 3) new product launches, 4) strong balance sheets, and 5) strong free cash flow/potential cash...

We think generalists will continue to favor biotech due to above average rev & EPS growth...Based on consensus numbers, we estimate biotech top-line & bottomline CAGRs from '13-17 of 20% and 32% respectively. This compares to average 13-17 CAGRs for other healthcare sectors of 5% and 10% respectively. On a broader basis, we estimate that S&P EPS '13-17 is 6%. We view large cap biotech consensus as conservative

Karnauskas and Young raised their Gilead target to $132 from $95.

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bin eh erstaunt, dass wir hier nicht einige Stufen höher sind.

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2brix hat am 29.01.2014 - 17:16 folgendes geschrieben:

bin eh erstaunt, dass wir hier nicht einige Stufen höher sind.

Ja das bestimmt, aber die Turbulenzen der letzten Tage und das wirtschaftliche Umfeld in den USA hatten die Aktie einige Male gebremst. Geben wir ihr Zeit Smile

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Idenix Pharmaceuticals Announces Decision by the United States Patent and Trademark Office Patent Trial and Appeal Board in the First Patent Interference

Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the United States Patent and Trademark Office Patent Trial and Appeal Board (USPTO) issued a decision in the first patent interference proceeding (No. 105,871) concerning one of the Company's patent applications (U.S. Patent Application 12/131,868) and an issued patent (U.S. Patent 7,429,572) owned by Gilead Pharmasset LLC ("Gilead") that covers certain 2'-methyl-2'-fluoro nucleoside compounds useful in the treatment of the hepatitis C virus (HCV). The USPTO determined that Idenix is not entitled to priority of invention and judgment was entered in favor of Gilead.

"We intend to challenge this decision in proceedings outside the USPTO. We are confident in our patent portfolio and will continue to defend it vigorously, and this specific matter before the USPTO represents just one part of our overall effort," said Ronald Renaud, President and Chief Executive Officer at Idenix. "Idenix has several patent families that provide coverage for 2'-methyl nucleoside compounds and 2'-methyl, 2'-fluoro nucleoside compounds specifically."

Idenix does not believe that the patent application at issue in the interference is relevant to any of the compounds currently under clinical development, including samatasvir, its NS5A inhibitor which is in two ongoing 12-week phase II all-oral HCV combination studies, or IDX21437, its lead uridine nucleotide prodrug which is in an ongoing phase I/II clinical trial.

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Mylan Named as Gilead's Exclusive Branded Medicines Business Partner for India

PR Newswire

PITTSBURGH and MUMBAI, India, Jan. 31, 2014

Mylan Inc. (Nasdaq: MYL) today announced that its India-based subsidiary Mylan Pharmaceuticals Private Limited has been named Gilead Sciences, Inc.'s (Nasdaq: GILD) exclusive branded medicines business partner for India.

Under the agreement, Mylan will market and distribute in India Gilead's:

   -- HIV therapies Viread(R) (tenofovir disoproxil fumarate), Truvada(R) 
      (emtricitabine/tenofovir disoproxil fumarate) and the newer single tablet 
      regimen Stribild(R) (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 
      200 mg/tenofovir disoproxil fumarate 300 mg) 
 
   -- AmBisome(R) (amphotericin B liposome for injection), a treatment for 
      life-threatening, systemic fungal infections, which is also used to treat 
      the parasitic disease visceral leishmaniasis 
 
   -- Viread(R) for its indication as a treatment for chronic hepatitis B virus 
      (HBV) infection. 

Gilead has partnered with Mylan since 2006, granting the company rights to manufacture and sell their own generic versions of licensed Gilead HIV therapies in India and up to 111 developing world countries where the HIV epidemic affects millions of individuals. Mylan will continue to maintain these rights, in addition to those in this new agreement.

Mylan CEO Heather Bresch commented, "This further extension of our collaboration with Gilead builds off of our existing successful partnership manufacturing and supplying high-quality, cost-effective generic antiretroviral therapy for those in resource challenged countries, delivering on our mission of providing access to high quality medicine to the world's seven billion people."

Gilead's executive vice president of Corporate and Medical Affairs, Gregg H. Alton said, "The appointment of Mylan as our branded medicine business partner in India is a result of their strong knowledge of the Indian healthcare system and demonstrated capabilities of supporting and distributing antiretroviral therapies. We have established an excellent working relationship with Mylan over the past few years, and believe that their operations in India will allow the company to best serve the needs of patients in that country."

In addition to distributing branded Gilead medicines, Mylan will manage regulatory and pharmacovigilance activity, such as adverse event reporting, as well as broader medical education initiatives.

Mylan and HIV in India

Mylan has one of the largest field forces exclusively specializing in HIV/AIDS in India. In September 2012, Mylan was selected as a leading supplier of antiretroviral medicine to India's National AIDS Control Organization (NACO). NACO is a division of India's Ministry of Health and Family Welfare and is responsible for overseeing HIV/AIDS control programs in India. India is home to the world's third largest population of people with HIV/AIDS, with approximately 2.4 million people living with the disease.

Gilead Medicines

Stribild(R) (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) is a complete once-daily single tablet regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naive. (U.S. approval, 2012)

Truvada(R) (emtricitabine/tenofovir disoproxil fumarate) is a fixed-dose once-daily combination pill containing Viread and Emtriva. It is used in combination with other antiretroviral agents for the treatment of HIV infection in adults and pediatric patients 12 years of age and older (U.S. approval, 2004; EU approval, 2005). Once-daily Truvada is also approved for use in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk. (U.S. approval, 2012)

Viread(R) (tenofovir disoproxil fumarate) is a once-daily oral nucleotide reverse transcriptase inhibitor (NtRTI) for the treatment of HIV infection in patients 2 years of age and older in combination with other antiretroviral agents. (First U.S. approval, 2001; EU approval, 2002.) Viread is also approved as a treatment for chronic hepatitis B in adults and pediatric patients 12 years of age and older. (U.S. and EU approval, 2008)

Viread(R) is also indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated and decompensated liver disease and pediatric patients 12 years of age and older. (U.S. and EU approval, 2008)

AmBisome(R) (amphotericin B liposome for injection) is a treatment for life-threatening, systemic fungal infections in adults. (EU approval, 1990; U.S. approval, 1997). Astellas Pharma US, Inc. commercializes the product in the U.S. and Canada.

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Investing in Funds & ETFs

A Healthy Prognosis -- Investing In Funds & ETFs

One thing investors should be aware of is which biotech stocks, if any, a fund holds: Do they include mature biotech assets like Gilead Sciences Inc. and Amgen Inc., or experimental startups?

(FROM THE WALL STREET JOURNAL 2/4/14)
   By Jane Hodges

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Jahreszahlen 2013

Im Anhang findet ihr die Jahreszahlen 2013 von Gilead Sc. und die dazugehörende Analystenmeinung der UBS:

Key takeaways from 4Q13 results: Upside Sovaldi launch helps 4Q beat

[1] Gilead posted a nice 4Q13 beat on revenues and EPS (see Fig. 1) and delivered '14 guidance that was generally in line with Sovaldi-adj ests, vs. prior years when guidance has been more conservative. [2] Of the $139m in 4Q Sovaldi sales (consensus: $75m), patient demand accounted for ~ $50m, in line with Rx data. This adds confidence that the Rx data for 1Q14 imply that Sovaldi is already in enough patients to beat the 1Q14 consensus $393m (UBSe: $600m) even if no new patients were added after Jan-24 Rx data. [3] Gilead provided a new estimate of the number of HCV patients in treater care in the US (385k of the 1.7m diagnosed), which is lower than we thought, but reinforces the notion that it will likely take several years to penetrate the market, in part through the company's patient identification efforts. [4] The PDUFA date established for idelalisib in CLL is Aug-6 and narrows the gap on Imbruvica. [5] The filing for TAF is expected 1Q15, implying potential market entry by YE15 and ample time to switch HIV patients from TDF-containing regimens before late 2017 patent expiry.

Sovaldi launch datapoints

[1] Sovaldi has been prescribed by multiple types of physicians specialists. [2] The distribution of genotypes has been in line with the US HCV population, with ~70% of Sovaldi usage coming from GT1. [3] Mgt is not aware of any secondary warehousing of patients for an all-oral regimen. [4] The price is ~$57,000 in UK and ~$66,000 in Germany, with the company noting that the UK price is a good proxy for most of EU. [5] During 2014, GILD plans to expand HCV awareness through advertisements on HCV treatment options, encouraging patients to seek information from their physicians.

Impact on our model, and thesis: All systems go for 2014

We modestly lower EPS on various moving parts, but remain significantly above consensus 2014E-17E. Our Buy thesis on GILD shares is unchanged. We see significant upside to consensus and increasing pipeline visibility as the drivers in 2014.

Valuation: Buy with $102 PT based on 17x our 2015E EPS

We expect Sovaldi will drive an EPS inflection 2014E-2017E. GILD looks cheap vs peers on P/E.

AnhangGröße
PDF icon Jahreszahlen 201348.75 KB
PDF icon Analystenmeinung UBS343.45 KB
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GILD upgraded to Outperform from Neutral at RW Baird

Gute Neuigkeiten aus der Vermögensverwalter-Ecke:

Baird upgraded Gilead based on strong Sovaldi prescription trends and expectations that U.S. 2014 sales could exceed $5B. Price target raised to $103 from $65.

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Why Gilead drops

So ein Schwachsinn!

 

ISI Group's Mark Schoenebaum explains why Gilead's decision to forgo Sovaldi forecasts has spooked investors:

I had written in our preview note that [Gilead] is extraordinarily conservative and that this was a possibility. However, Street is clearly worried that this was a "signal" by mgmt that sell side numbers are getting out of hand. Personally, I disagree as this company has a history of extreme conservatism..

The critical point with stock is, in my opinion, that [Gilead] is virtually assured of earning at least $8, and probably closer to $10 by 2016. Thus, at around $80, the implied PE on that number is not high and downside seems pretty limited. And, if they crush Street numbers and investors can get incremental comfort that there is "tail value" here (this is the BIGGEST INVESTOR DEBATE RIGHT NOW!!), a PE of around 12x 2016 (i.e. $95-$100) seems doable when we are standing in January of 2015.

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GILD

Gilead ist bei BB Biotech bei den Hauptinvestments.

/ http://www.bbbiotech.ch/de/bb-biotech/strategie-portfolio/portfolio-ueberblick/

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ja da will woll noch jemand rein, dass versucht wird den Kurs zu drücken. Erinnert mich irgendwie an die Geschichte bei Osiris

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2brix hat am 07.02.2014 - 10:30 folgendes geschrieben:

ja da will woll noch jemand rein, dass versucht wird den Kurs zu drücken. Erinnert mich irgendwie an die Geschichte bei Osiris

Ich kenne die Geschichte bei Osiris leider nicht, aber trotzdem schade, denn die Zahlen sprechen für sich...

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Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir

Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C

-- If Approved, Fixed-Dose Combination Would be First Oral Treatment Regimen for Patients with Genotype 1 HCV Infection, Eliminating Need for Both Interferon and Ribavirin --

FOSTER CITY, Calif.--(BUSINESS WIRE)--February 10, 2014-- 

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults. The data submitted in the NDA support the use of LDV/SOF in patients with genotype 1 hepatitis C virus (HCV) infection, with a treatment duration of eight or 12 weeks depending on prior treatment history and whether they have cirrhosis. Approximately 75 percent of people infected with HCV in the United States have the genotype 1 strain of the virus.

"Today's filing brings us one step closer to our goal of offering all patients with hepatitis C a simple, safe and highly effective all-oral treatment regimen," said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer. "Based on the data from the Phase 3 ION studies, the LDV/SOF combination may have the potential to cure HCV in genotype 1 patients in as little as eight weeks and without the need for interferon injections or ribavirin."

The FDA has assigned LDV/SOF a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. The NDA for LDV/SOF is supported by three Phase 3 studies, ION-1, ION-2 and ION-3, in which nearly 2,000 genotype 1 HCV patients were randomized to receive the fixed-dose combination, with or without RBV, for treatment durations of eight, 12 or 24 weeks. Trial participants included patients who were treatment-naïve or who had failed previous treatment, including protease inhibitor-based regimens, and also included patients with compensated cirrhosis.

Gilead plans to file for regulatory approval of LDV/SOF in other geographies, including the European Union, in the first quarter of 2014. Gilead has submitted an application to the European Medicines Agency (EMA) for accelerated assessment of LDV/SOF, a designation that is granted to new therapies and medicines of major public health interest. If accepted, accelerated assessment could shorten the EMA's review time of LDV/SOF by two months, although it does not guarantee a positive opinion from the Committee for Medicinal Products for Human Use or approval by the European Commission.

LDV/SOF is an investigational product and its safety and efficacy has not yet been established.

SOF as a single agent was approved by the FDA under the tradename Sovaldi(R) on December 6, 2013 and by the European Commission on January 17, 2014.

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UBS Research 11.02.14

So, die UBS hat auch nochmals eine neue Analystenmeinung abgegeben.

AnhangGröße
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Sovaldi Exclusion No Big Deal

Last week, investors freaked out when biotech giant Gilead ( GILD) announced its 2014 outlook and didn't include Sovaldi in its calculations.

"Argus"- analyst David Toung explains why Sovaldi would make the Gilead's numbers look even better:

In issuing guidance for 2014, Gilead notably excluded any sales from Sovaldi, even though it has been approved in the U.S., Canada and Europe. It expects 2014 sales from core products, excluding Sovaldi, of $11.3-$11.5 billion, an increase of 6%- 8% from 2013. It also projects a product gross margin of 75%-77%. It did not provide specific EPS guidance. Management expects to increase sales and marketing spending to support the launch of Idelalisib, its first oncology drug. It also expects to increase R&D spending to develop its product pipeline. As for Sovaldi, Gilead noted that every $1 billion of incremental Sovaldi sales would increase the gross margin by 75- 100 basis points and reduce the tax rate by 75-100 basis point.

We are raising our 2014 EPS estimate to $3.35 from $3.25, and establishing a 2015 estimate of $5.10. Our revised earnings model includes contributions from Sovaldi and Idelalisib as well as ongoing growth from core pharmaceutical products. We also note the favorable impact from Sovaldi sales on Gilead's gross margin and tax rate.

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Just How Good are Sovaldi's Sales?

Just How Good are Sovaldi's Sales?

Very, very good, says Citigroup's Yaron Werber and team, who expect Gilead Sciences ( GILD) sales of Sovaldi to blow away expectations. They explain:

 
 

[Gilead's] Sovaldi is tracking at $484M for the first nine weeks of launch and will post $5.74B in sales for 2014 and $1.21B for Q1:14 vs. Citi $516M and Consensus $368M, if Sovaldi scrips continue at same level as the recent week without any growth. We anticipate that Sovaldi will materially exceed our and consensus ests and believe that posting >$4B-$5B in total sales in FY14 is possible. In the ninth week of launch, Sovaldi's weekly TRx and NRx were 4,051 and 2,848 respectively. While this is only the ninth week, it is still much ahead of protease inhibitor Incivek' launch which had 1,365 TRx in the ninth week of launch.

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One Reason the Biotech Boom Won't Turn to Bust

Das dürfte sich auch der Cash-Insider zu Gemüte führen...

 

Biotech stocks like Biogen Idec ( BIIB) and Regeneron Pharmaceuticals ( REGN) have come so far, so fast that some analysts now contemplate what could make the biotech boom turn to bust. Cowen's Phil Nadeau offers a reason not to worry: pricing power.

Consider: Biogen Idec and Regeneron Pharmaceuticals have risen 24% this year, Gilead Sciences ( GILD) has gained 12% and Amgen ( AMGN) is up 10%. The SPDR S&P Biotech ETF ( XBI) has risen 31% so far in 2014.

Nadeu explains why pricing power is such a big deal for Amgen and its ilk:

Many investors worry that the biopharmaceutical industry will soon lose its pricing power, and some look on the potential for pricing restrictions as a reason to be wary of the sector. Investors worry that any signs of diminished pricing power will make the biotech industry uninvestable.

We found no signs of diminished pricing power. Quite the contrary - the frequency and magnitude of price hikes for these products has increased in recent years. Price is not pressured as products mature or face new competition. Higher-priced entrants often provide an umbrella under which the established players can raise their price...

We think pricing power is a unique and important, though often underappreciated, strength of the biopharmaceutical industry. Prices of branded drugs can be raised to maintain growth (or at least stability) of franchises despite decelerating volumes or new competition. This is one of the reasons that biopharmaceutical companies with established franchises have growth and earnings visibility better than many other industries.

To demonstrate, Nadeau offers up the examples of Amgen's Epogen, Gilead's Viread and Biogen's Avonex, all which have higher dollar sales now than in 2007.

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Gilead Prices $4 Billion of Senior Unsecured Notes

Gilead Prices $4 Billion of Senior Unsecured Notes

FOSTER CITY, Calif.--(BUSINESS WIRE)--March 04, 2014-- 

Gilead Sciences, Inc. (NASDAQ: GILD) today announced the pricing of senior unsecured notes in an aggregate principal amount of $4 billion in an underwritten, registered public offering, consisting of three tranches:

   -- $500 million of 2.050% senior notes maturing in April 2019 
 
   -- $1,750 million of 3.700% senior notes maturing in April 2024 
 
   -- $1,750 million of 4.800% senior notes maturing in April 2044 

The senior notes are rated A- by Standard & Poor's and Baa1 by Moody's. The offering is expected to close March 7, 2014, subject to customary closing conditions.

Gilead intends to use the net proceeds from this offering for general corporate purposes, which may include the repayment of certain of our indebtedness, debt-related payments, working capital and the repurchase of our outstanding common stock pursuant to our authorized share repurchase program.

Merrill Lynch, Pierce, Fenner & Smith Incorporated, J.P. Morgan Securities LLC, Goldman, Sachs & Co. and Wells Fargo Securities, LLC acted as joint book-running managers in the offering. The offering of the securities is being made only by means of a prospectus supplement and the accompanying base prospectus, which is filed as part of Gilead's effective shelf registration statement on Form S-3 (File No. 194298) copies of which may be obtained from:

 
 
Merrill Lynch, Pierce, Fenner & Smith 
Incorporated                             J.P. Morgan Securities LLC 
222 Broadway, 11th Floor                 383 Madison Ave, 
New York, NY 10038                       New York, NY 10179 
Attention: Prospectus Department         Attn: Investment Grade Syndicate Desk 
(800) 294-1322                           (212) 834-4533 
 
 

An electronic copy of the prospectus supplement and the accompanying base prospectus may also be obtained at no charge at the Securities and Exchange Commission's website at http://www.sec.gov/.

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Ein neuer Research Bericht. Ich finde es gibt im Moment einfach keine "sicherere" Firma mit demselben Potenzial. Für mich eindeutig ein Kauf!

AnhangGröße
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What the Heck happened?

The trading day started out like any other for Gilead Sciences ( GILD).

Deutsche Bank's Robyn Karnauskas and Alethia Young released a report yesterday reiterating Gilead's Buy rating and noting that the market didn't seem to be giving it credit "for success on their future pipeline." Gilead also announced last night that it would sell $ billion in debt, an offering that Maxim's Jason Kolbert called "very positive and accretive to Gilead." Even Bernstein's Geoffrey Porges and team offered positive comments on Gilead, suggesting that Gilead has "a number of viable options in development to sustain revenue, cash flow and growth, underscored by their commitment to building the "third leg of the stool" with their oncology franchise, and their early stage pipeline and potential strategic bolt-on acquisitions." Just after the open it was up 0.7%.

Then the selling started, slowly at first. By noon it was down 0.5%; by 1 p.m. it was off 2.3%. By 2:34 p.m., Gilead was off 4.1% at $79.49, and the iShares NASDAQ Biotechnology Index ( IBB) had dropped 2.5% to $261.60, despite Biogen Idec ( BIIB) getting upgraded by BMO Capital Markets and Barclays touting Alexion Pharmaceuticals ( ALXN). This chart shows the damage over the course of the day.

So what caused the plunge? No one really knows. This piece from Bespoke Investment Group, which speculates about the potential for a biotech bubble, could be at fault. Or it could be something happened to Gilead that hasn't made it's way into view yet. Or it could be nothing at all. ISI Group's Mark Schoenebaum explains:

 

I've been asked dozens of times in past hour why biotech is selling off. The honest answer is I really have no explanation.

 
 

In general, my thoughts on the biotech sector have been that a massive sell-off is unlikely, but that a more modest correction is, in theory possible, since all the stocks now trade above conservative DCF analyses. However, PE multiples are still undemanding and suggest that if a sustained sell off (not just a single day move) were to occur, it's unlikely to be dramatic or sustained.What

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