Gilead Coronavirus Drug Remdesivir Positive Recovery Results

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    Gilead Sciences’ antiviral medicine remdesivir is showing positive…



    Analysts at RBC Capital Positive but Cautious:

    “Anecdotal data reported this afternoon from one of the sites in GILD’s ongoing ph.III Remdesivir program looks promising on the surface and continues to support some potential for the drug to be active in certain COVID-19 pts (unlike for HCQ, where emerging data continue to worsen).”


    BMO Capital Markets downgraded Gilead Sciences GILD Monday to market perform from outperform.

    Analysts there believe that despite [l: investor excitement about remdesivir, an experimental drug being tested as a treatment for COVID-19 patients, they “no longer see favorable risk/reward in shares given continued uncertainty around the remdesivir commercial opportunity.”

    They wrote that progression of vaccines in development, which would prevent infection with the virus, raise questions about the durability of a post-infection treatment, noting that Roche AG’s ROG, +2.66% Tamiflu flu treatment generated more than $3 billion in revenue in 2009 during the H1N1 pandemic but sales of that drug brought in an average of $670 million annually after that.

    Year-to-date, Gilead’s stock is up 29.6%, while the S&P 500 SPX, +2.29% is down 11.0%.


    [b][size=5][color=green]Market Summary > Gilead Sciences, Inc.
    81.31 USD +2.78 (3.54%)


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    US Stock Futures Sharp Move Down as Gilead Sciences Announces Remdesivir Disappointing Trial Results
    $GILD 76.28 5.03 (-6.19%) [color=red][size=5]
    A potential antiviral drug for the coronavirus has flopped in its first randomised clinical trial, disappointing scientists and investors who had high hopes for remdesivir, according to draft documents published accidentally by the World Health Organization and seen by the Financial Times.


    Baird Analyst Brian Skorney negative on Gilead

    “Results should be very sobering: no effect on clinical improvement or mortality and maybe even more concerning, no effect on PCR. If remdesivir, as an antiviral, can’t even get an antiviral effect, it’s highly unlikely there will be any role, even in earlier stage patients.”

    “It is unfortunate that this program did not work out, because it is obviously what is most readily available, but this was an obvious hail mary pass attempt that didn’t work out.””This is pretty close to a worst case scenario as not only did the clinical effect not manifest, but there wasn’t even an antiviral effect to explore” with apparent side effect imbalance showing potential safety risk.”

    “This is pretty close to a worst case scenario as not only did the clinical effect not manifest, but there wasn’t even an antiviral effect to explore” with apparent side effect imbalance showing potential safety risk.

    Super Harley

    Gilead Remdesivir trial for Covid-19 has met primary endpoint

    Study to provide info on 5-day duration of therapy
    will share added Remdesivir data from phase 3 shortly
    Seees data from 2nd simple study at the end of May
    5 day and 10 day Remdisivir treatment see similar results

    Super Harley

    Dr Fauci on Gilead results today talks positively about Coronavirus recovery

    data shows Gilead drug Benefit in reducing the time to recover from coronavirus
    data needs to be further analyzed but has proven that a drug can target novel coronavirus
    Data showed Gilead drug had benefit in reducing time of recovery in patients
    FDA working with Gilead on drug availability
    FDA working with Gilead on approval for a drug that would be used for hospitalized patients,
    Has no timeline on FDA approval


    Gilead Sciences Gains Remdesivir Approval in Japan

    Gilead Sciences. (NASDAQ: GILD) took another big step forward in its treatment for COVID-19 on Friday when a Japanese regulatory body approved that treatment.

    Japanese Ministry of Health, Labour and Welfare has granted regulatory approval of Veklury (remdesivir) as a treatment for infection by SARS-CoV-2, the virus that causes COVID-19, under an exceptional approval pathway.

    This exceptional approval was granted due to the COVID-19 pandemic and references the Emergency Use Authorization (EUA) of remdesivir in the United States. Due to the current public health emergency, the U.S. Food and Drug Administration (FDA) issued the EUA for remdesivir for the treatment of COVID-19.

    The Japanese approval was based on clinical data from the U.S. National Institute of Allergy and Infectious Diseases’ global Phase 3 trial, Gilead’s Phase 3 Simple trial in patients with severe manifestations of COVID-19, and available data from Gilead’s compassionate use program, including patients in Japan.

    Merdad Parsey, MD, Ph.D., chief medical officer of Gilead Sciences, commented:

    The Japanese approval of remdesivir is in recognition of the urgent need to treat critically ill patients in Japan. It is a reflection of the exceptional circumstances of this pandemic. We thank the Japanese Ministry of Health, Labour and Welfare for their leadership and collaboration, as we together work to respond to this public health emergency.


    Gilead licensing agreement to make remdesivir coronavirus treatment with five generic drugmakers n 127 countries

    deal is to make antiviral drug remdesivir in 127 countries
    deal is “royalty-free” until WHO says the Covid-19 outbreak is no longer a global health crisis or “until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent Covid-19.”

    Drugmakers Mylan, Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences will manufacture remdesivir for distribution in “low-income and lower-middle-income countries, as well as several upper-middle- and high-income countries” that face health-care obstacles amid the coronavirus pandemic, the company said.



    South Korea begins using remdesivir for COVID-19 treatment

    South Korea began providing remdesivir, an experimental drug conventionally used for Ebola, as a treatment drug for the novel coronavirus, health authorities said
    South Korea Centers for Disease Control and Prevention (KCDC) said it will be used for COVID-19 patients with severe symptoms.

    Via Yonhap

    Super Harley

    Gilead treatment associated with 62% cut in mortality

    Gilead data on remdesivir

    Remdesivir associated with improvement in clinical recovery
    74.4% of patients recovered by Day 14 vs 59% of patients receiving standard of care
    Data includes trial analysis and retrospective cohort of patients
    Mortality rate was 7.6% at Day 14 vs 12.5% not taking it

    Super Harley

    Credit Suisse upgraded Gilead Sciences (GILD) to Neutral from Underperform

    Bullish view of the remdesivir opportunity but still concerned with need to build a broader pipeline; however the RDV opportunity somewhat addresses their EPS/revenue growth concerns.


    Pfizer agrees to manufacture Gilead’s coronavirus drug remdesivir

    Pfizer has agreed to manufacture and supply Gilead Sciences’ antiviral drug remdesivir, the pharmaceutical giant announced Friday.

    The multi-year agreement will support efforts to scale up the supply of the intravenous drug, which has shown to help shorten the recovery time of some hospitalized coronavirus patients, the company said.

    “From the beginning it was clear that no one company or innovation would be able to bring an end to the COVID-19 crisis. Pfizer’s agreement with Gilead is an excellent example of members of the innovation ecosystem working together to deliver medical solutions,” Pfizer CEO Albert Bourla said in a statement. “Together, we are more powerful than alone.”

    Doctors have been using the remdesivir, which was developed to treat HIV, on Covid-19 patients in recent months. In May, the FDA granted remdesivir an emergency use authorization, allowing hospitals and doctors to use the drug on hospitalized Covid-19 patients even though the drug has not been formally approved by the agency.


    Gilead $GILD reports after close

    Analysts expect EPS of $1.95 on $6.39 billion revenue.

    Remdesivir questions
    Drug GLPG’s R&D pipeline
    $IMMU deal

    While COVID-19 has helped boost sales of remdesivir, it has also hurt the company in other areas. Biktarvy, previously a stalwart for the company, experienced a 5% revenue decline Q/Q. Gilead experienced a reversal of the pandemic-related stocking that occurred in Q1, which may have made Q1 results appear more robust than normal:

    The quarter overall was down year-on-year, 1% and quarter-over-quarter by 3%. The impact on our HIV revenue, including Biktarvy was primarily driven by inventory dynamics. In Q2, we saw a reversal of the pandemic related stocking that happened in March during the onset of COVID across U.S. and Europe. Also on the treatment side as expected, we’re seeing reduced switches due to the decline in patient visits and physicians not wanting to initiate new therapies during the pandemic. We’re also seeing unfavorable shift in payer mix from commercial to government segments. Despite this, our overall demand remained robust with both the overall Gilead’s portfolio and Biktarvy gaining share quarter-over-quarter and year-on-year.

    Doctors’ offices may not become fully reopened until early 2021. Several healthcare companies have had to readjust earnings projections or delay product launches while offices have been closed. This issue could create headwinds for Biktarvy for the rest of 2020.

    Descovy revenue fell 9% Q/Q as PrEP experienced a decline in initiations and therapy discontinuations. Fewer people are visiting their healthcare providers amid the pandemic. The weak consumer has reared its ugly head, and it may not subside even after the economy fully reopens. For now, double-digit revenue gains for Descovy could be a thing of the past. Descovy and Biktarvy still represent over 50% of total HIV sales, and they will likely drive the narrative going forward.

    HCV revenue was $448 million, down 39% Q/Q. The HCV runway remains in decline, so any quarter Gilead can keep this segment from free falling could be considered a win. Yescarta revenue was $156 million, up 11% Q/Q. At 3% of total revenue, the treatment may not be the shot in the arm GILD bulls previously expected.

    Gilead’s gross margin declined to 79% from 82% in Q2. The decline in scale and decline in higher margin HIV revenue weighed. R&D costs were $1.3 billion, up 18% sequentially. The increase was driving by Gilead’s investment in remdesivir, and costs related to clinical trials and additional manufacturing costs. After receiving FDA approval, remdesivir’s sales could spike over the next few quarters.

    SG&A costs rose in the double-digit percentage range to $1.2 billion; a $97 million accrual related to a Department of Justice investigation that may not be recurring. The fallout was that EBITDA of $1.9 billion fell over 30% Q/Q to $1.9 billion. EBITDA margin was 37%, down from 50% in Q1. EBITDA should improve once additional sales from remdesivir pick up or the ramp-up to support remdesivir subsides. At the end of the day, Gilead has $2.5 billion of combined R&D and SG&A costs it can cut into if it wanted to drive EBITDA higher.

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