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Gilead Sciences, Inc. (GILD)

  • Wed, May 27, 8:30 AM
    • A Phase 2 clinical trial evaluating GlobeImmune's (NASDAQ:GBIM) GS-4774, a therapeutic vaccine candidate for hepatitis B infection, failed to achieve its primary efficacy endpoint of demonstrating a reduction in hepatitis B surface antigen (HBsAg) at week 24 in patients treated with the highest dose of GS-4774 plus ongoing antiviral therapy (OAV) compared to OAV alone. There was a slight increase in viral knockdown in the test group at week 48 but the difference was not statistically significant.
    • The 178-subject, randomized, open-label study was designed to assess three different doses of GS-4774 in combination with ongoing oral antiviral therapy in patients with chronic HBV infection whose disease was under control with OAV. The analysis of the data and characterization of the T cell response to GS-4774 and its relationship to HbsAg changes are ongoing.
    • GS-4774 is exclusively licensed to Gilead Sciences (NASDAQ:GILD).
    • The data will be presented at a future medical conference and will be submitted for publication.
    • GBIM shares are down 62% premarket on light volume. GILD is up a fraction premarket also on light volume.
  • Mon, Feb. 9, 7:34 AM
    • All of the patients in a 12-subject Phase 2 trial evaluating Achillion Pharmaceuticals' (NASDAQ:ACHN) ACH-3102 (50 mg) plus Gilead's (NASDAQ:GILD) Sovaldi (sofosbuvir) (400 mg) in treatment-naive HCV-1 patients achieved sustained viral response for 12 weeks (SVR12) after the completion of six weeks of therapy. The results included patients with high baseline viral load.
    • Mean baseline viral load was 10M (7 log10) IU/ml, range 2M (6.23 log10) - 97M (7.99 log10) IU/ml, including seven patients with baseline HCV RNA viral load exceeding 6M (6.78 log10) IU/ml. Seven patients were genotype 1a and 5 were genotype 1b.
    • 100% of patients (12/12) also achieved SVR24.
    • Achillion CMO Dr. David Apelian says, "The achievement of 100% SVR12 after six weeks of treatment with a dual NS5A-nucleotide regimen, even in patients with high baseline viral load who would otherwise require extended duration treatments, supports out belief that ACH-3102 can unleash the potential of this combination to drive down treatment duration. We are currently preparing to initiate our SPARTA Phase 2 program which evaluates short treatment durations with our proprietary once-daily regimens of ACH-3102 and ACH-3422, with or without sofosbuvir, for treatment-naive genotype 1 HCV patients. In parallel, we plan on exploring sofosbuvir-sparing regimens that will leverage shorter durations of sofosbuvir in combination with ACH-3102 and sovaprevir as part of our global development program."
    • ACHN is up 12% premarket on higher-than-normal volume.
  • Wed, Feb. 4, 9:13 AM
  • Tue, Feb. 3, 4:26 PM
    • Gilead Sciences (NASDAQ:GILD) Q4 results ($M): Total Revenues: 7,314 (+134.4%); COGS: 1,063 (+24.0%); R&D Expense: 1,045 (+104.3%); SG&A Expense: 876 (+86.0%); Net Income: 3,462 (+337.5%); EPS: 2.18 (+363.8%).
    • Gross Profit: 6,251 (+176.3%); COGS: 14.5% (-33.3%); Gross Margin: 85.5% (+17.9%); Operating Earnings: 4,330 (+238.3%); Operating Earnings Yield: 59.2% (+44.3%); Net Earnings Yield: 47.3% (+86.6%).
    • Sales by product: Harvoni: 2,107; Sovaldi: 1,732 (+999%); Atripla: 925 (-0.9%); Truvada: 897 (+10.2%); Compera/Eviplera: 348 (+32.9%); Stribild: 385 (+88.9%); Viread: 311 (+16.5%); Letairis: 181 (+30.7%); Ranexa: 144 (+10.9%).
    • 2015 Guidance: Net Product Sales: $26B - 27B; Non-GAAP Gross Margin: 87 - 90%; R&D Expense: $3.0B - 3.3B; SG&A Expense: $3.0B - 3.3B; Effective Tax Rate: 18 - 20%; Diluted impact of certain items: $0.82 - 0.87.
  • Tue, Feb. 3, 4:07 PM
    • Gilead Sciences (NASDAQ:GILD): Q4 EPS of $2.43 beats by $0.21.
    • Revenue of $7.3B (+134.0% Y/Y) beats by $580M.
    • Shares +1.4%.
    • Press Release
  • Wed, Jan. 7, 8:50 AM
    • Thinly-traded nano cap Galectin Therapeutics (NASDAQ:GALT) is up 49% premarket on robust volume in response to its report of results from a 30-patient Phase 1 study of GR-MD-02 in patients with nonalcoholic steatohepatitis (NASH).
    • The principal objective of the trial was to assess the safety, tolerability and pharmacokinetics of GR-MD-02 but investigators also noted a potential therapeutic effect on fibrosis as measured by a serum biomarker (FibroTest) and liver stiffness (FibroScan). Patients in cohort 3 who received 8 mg/kg GR-MD-02 showed a statistically significant reduction in FibroTest score versus placebo in one of the cohorts.
    • Fibrotest is a composite score of six blood tests that correlate to the extent of liver fibrosis.
    • NASH represents the next big potential payoff for drug firms after HCV.
    • Previously: Galectin NASH treatment meets primary endpoint in Phase 1 (Nov. 10, 2014)
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  • Mon, Jan. 5, 12:57 PM
    • CVS Health (CVS -1.3%) bestows Preferred Status to Gilead Sciences' (GILD +2.3%) Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir) for the treatment of HCV infection. The pills will be the exclusive treatment option for beneficiaries on CVS's Medicare, Medicaid and other drug benefit plans. AbbVie's (ABBV -2.9%) Viekira Pak will be available only via a medical exception or prior authorization. Recently, AbbVie announced a similar deal with Express Scripts.
    • Previously: AbbVie's new hepatitis C drug gets boost (Dec. 22, 2014)
  • Dec. 30, 2014, 12:26 PM
    • Small cap Arrowhead Research (ARWR +17.5%) is up on 50% higher volume on rumors that Gilead Sciences (GILD -0.9%) may be eyeing the company for its RNA interference-based drugs.
    • Arrowhead has yet to recover from the plunge in October after it reported Phase 2a results for its hepatitis B candidate, ARC-520, that fell short of investors' expectations.
    • Gilead has three drugs in development for the treatment of chronic HBV infection: tenofovir alafanamide, a nucleotide reverse transcriptase inhibitor, GS-4774, a Tarmogen T cell immunity stimulator and GS-9620, a TLR-7 agonist in addition to the commercially available Viread (tenofovir disoproxil fumarate) and Hepsera (adefovir dipivoxil).
    • Previously: Arrowhead explains the ARC-520 data (Oct. 9)
  • Dec. 23, 2014, 10:49 AM
  • Dec. 23, 2014, 10:40 AM
  • Dec. 22, 2014, 9:17 AM
  • Dec. 22, 2014, 7:53 AM
    • AbbVie (NYSE:ABBV) is up 4% on moderately-higher volume and Enanta Pharmaceuticals (NASDAQ:ENTA) is up 11% on light volume in response to AbbVie's deal with Express Scripts (NASDAQ:ESRX).
    • Gilead Sciences (NASDAQ:GILD) is off 7% on high volume.
    • Previously: AbbVie's new hepatitis C drug gets boost (Dec. 22, 2014)
  • Nov. 14, 2014, 12:00 PM
    • The money continues to flow out of biotech. The iShares NASDAQ Biotech Index (NASDAQ:IBB) is down 2%. The index is down almost 5% since the peak of 302.98 on October 31.
    • A sampling of moves today: (BIIB -4.3%)(CELG -3.4%)(AMGN -1.6%)(GILD -1.6%)(REGN -1.6%)(ALXN -2.3%)(VRTX -0.1%)
  • Oct. 31, 2014, 2:42 PM
    • AbbVie (ABBV +3.7%) surges to a new 52-week high after posting better than expected results in its first earnings report since its mega-merger with Shire fell apart.
    • ABBV also raised its EPS outlook for the year to $3.25-$3.27, up from its prior view for $3.06-$3.16, not including any potential sales from its hepatitis C virus treatment, which is expected to receive approval from U.S. regulators before year's end.
    • While declining to provide details of its marketing and pricing strategy for the treatment, ABBV execs said in today's earnings conference call that the hepatitis C market is bigger and more attractive than it had thought, and expressed confidence the treatment would be able to compete with Gilead's (GILD -2.2%) Sovaldi.
    • Global sales of Humira, the world's top-selling drug, jumped 18% Y/Y to $3.26B; in the U.S., sales surged 25% to $1.74B; the arthritis drug accounted for 65% of total company sales.
    • CEO Richard Gonzalez said ABBV's underlying growth prospects preclude another big merger attempt, but added the company was keen on smaller acquisitions.
  • Oct. 29, 2014, 1:41 PM
    • With doctors and patients waiting for the launch of Gilead's (NASDAQ:GILD) Harvoni hepatitis drug, Q3 Sovaldi sales ($2.8B) fell short of a FactSet consensus of $2.93B.
    • Piper: "GILD reported a somewhat sloppy 3Q, with strong beats for the HIV franchise, particularly products that are facing generic entry over the next 5-7 years, while the HCV franchise that is also being replaced by the new HCV franchise came in weak."
    • The firm was also disappointed with European hepatitis drug sales, but ultimately thinks Q3 "isn’t that important for GILD as its shares are primarily dependent on the new wave of HCV products, its next-gen HIV franchise, and ability to sustain some type of EPS growth through various financial strategies." Its target has been hiked by $2 to $120.
    • Likewise, Leerink Partners calls the Q3 Sovaldi weakness "relatively unimportant," and is pleased with positive early trends for Harvoni. It also notes Q3 non-Sovaldi product sales were up 8% Q/Q.
    • A non-tax deductible Branded Prescription Drug fee attached to the Affordable Care Act took a $0.21 toll on Q3 EPS.
    • Q3 results, guidance/details
  • Oct. 22, 2014, 9:21 AM
    • Thinly-traded micro cap Regulus Therapeutics (NASDAQ:RGLS) is up a whopping 127% premarket on robust volume in response to its announcement that its experimental microRNA therapeutic, RG-101, demonstrated a mean 4 log reduction in viral load in 14 HCV patients after a single subcutaneous dose of 2 mg/kg as a monotherapy.
    • Treatment with RG-101 resulted in significant and sustained reductions in HCV RNA in a variety of patients, including difficult-to-treat genotypes and some who experienced viral relapse after a prior IFN-containing regimen.
    • Six of 14 patients had HCV RNA levels below the limit of quantification at day 29 and three reached day 57 below the limit.
    • The study protocol has been amended to follow patients for up to six months after dosing to evaluate the possibility for certain patients to achieve viral cure after a single dose of RG-101.
    • A full regimen of Gilead's (NASDAQ:GILD) HCV drug Sovaldi (sofosbuvir) involves taking a once-daily pill for almost three months.
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Company Description
Gilead Sciences Inc is a research-based biopharmaceutical company that discovers, develops and commercializes new medicines for different medical sectors.
Sector: Healthcare
Industry: Biotechnology
Country: United States