From other sites
at Benzinga.com (Sat, 2:08PM)
at Investor's Business Daily (Sat, 8:02AM)
at CNBC.com (Fri, 5:15PM)
at CNBC.com (Fri, 2:34PM)
at CNBC.com (Fri, 12:27PM)
at MarketWatch.com (Fri, 11:27AM)
at Nasdaq.com (Fri, 11:08AM)
at Nasdaq.com (Fri, 11:06AM)
at Zacks.com (Fri, 10:10AM)
at Benzinga.com (Fri, 9:57AM)
A Reason To Be Bearish On Gilead - Everyone Seems Bullish
- In the wake of Express Scripts' decision to stop covering Harvoni in 2015, several well-written articles were published on Seeking Alpha, suggesting that the shares of Gilead Sciences remain attractive.
- In addition, 23 out of 27 industry analysts currently have a positive rating on the stock.
- Trading at only 9 times projected 2016 earnings, either Gilead is the stock pick of the decade, or risks to its future earnings are substantial.
- The lack of bearish articles and opinions makes me concerned that overall sentiment for Gilead remains too bullish, causing me to be fearful.
- As expected, AbbVie has received approval for its Viekira Pak hepatitis C combination.
- AbbVie surprised the market by undercutting rival Gilead on price.
- As a result, Express Scripts is dropping Gilead's Harvoni from its National Preferred Formulary.
- After minimizing my risk in the healthcare space, I am buying what many now consider to be a high risk stock in GILD.
- Despite GILD's big stock decline on Monday, there are reasons to believe the stock reaction did not warrant the news.
- Investors often overlook GILD's valuation, its HIV and oncology pipelines.
- Shares in Gilead Sciences dropped more than 14% on Monday.
- The drop can be attributed to a deal between pharmacy benefit manager Express Scripts and primary Gilead competitor AbbVie.
- Gilead's Harvoni is a superior drug to AbbVie's Viekira Pak and should become a blockbuster despite the deal.
- I rate Gilead Sciences a Strong Buy on the drop.
Who Is The Devil? Will Gilead Fall Or Soar In 2015?
- On Friday, AbbVie's Viekira Pak received US approval for HCV GT1 patients with or without ribavirin. Today, Express Scripts said they will exclusively cover AbbVie's regimen and drop Sovaldi-based regimens.
- The real loser today is not Gilead, but the patients that cannot get access to Gilead's safer HCV cure, Harvoni. Despite what you think, AbbVie loses as well.
- Payers may find that treating advanced HCV patients using Viekira Pak and ribavirin for 12-24 weeks is cost prohibitive based on healthcare costs to treat side effects from ribavirin.
- The only winner today is Express Scripts. Even insurance companies that use Express Scripts may lose based on increased healthcare costs to treat patients with hemolytic anemia and lawsuits.
- Despite the decline, Gilead looks solid with a great product portfolio and pipeline. Combined with stock buybacks and a regimen that will maintain majority market share, Gilead is a buy.
- Gilead Sciences is selling off on the announcement of an exclusive deal excluding them from Express Scripts formulary.
- The stock has sold off more than twelve percent which I view as overdone.
- The article below will detail my thoughts on the recent sell-off.
- AbbVie’s hepatitis C treatment was approved by the FDA last Friday.
- AbbVie and pharmacy benefit manager Express Scripts have reached an agreement under which AbbVie’s hepatitis C treatment has been given exclusive status in return for significant discount.
- Gilead shares have tumbled on the news, however, the impact of the agreement could be minimal on Harvoni sales.
- AbbVie has received approval of its widely-anticipated hepatitis C combination, called Viekira Pak.
- This regimen has a high cure rate but certain issues when given with a number of other drugs, and has less convenient dosing than Gilead's Harvoni.
- Express Scripts is dropping Gilead's Harvoni from its National Preferred Formulary as of January 1, 2015.
- Biotech juggernaut Gilead Sciences has provided its shareholders with better than a 30% gain in 2014 so far as we head into the end of the year.
- Although the stock has spent the last three months consolidating those gains in a relatively narrow trading range, the direction for 2015 remains up.
- Gilead has several major positive catalysts on the horizon in 2015. Why I believe the stock will head much higher in the twelve months ahead is detailed below.
While Gilead's Profits Soar, Uncertainty Reigns Supreme At AbbVie
- This article analyzes AbbVie using the DRAG framework and compares the company's fundamental attributes with those of Gilead Sciences.
- While AbbVie's dividend yield and dividend growth profile are impressive, its balance sheet is highly levered and analysts offer only modest earnings growth projections.
- Furthermore, Gilead generates a higher return on invested capital and trades at a lower forward earnings multiple than AbbVie.
- While much uncertainty exists surrounding the future of hepatitis C treatment, AbbVie shares appear slightly overvalued at the current time, making Gilead the more compelling opportunity.
The 2015 Calendar Of NASH Trial Catalysts IV: GENFIT And Gilead
- Non-alcoholic steatohepatitis (NASH) became a buzzword when Intercept Pharmaceuticals shares nearly tripled with positive results from the FLINT trial in January. There are several companies presenting NASH data next year.
- With a minimum 6 million Americans at risk for NASH, each company's product has blockbuster potential, given that an already approved product being re-purposed for NASH has an $18,000/month price tag.
- GENFIT and Gilead are two of the companies with the best-designed ongoing NASH trials.
Update: News On Gilead From The California Technology Assessment Forum
- I attended the CTAF session today on treatments for Hepatitis C, Genotype 1.
- Unlike the prior CTAF meeting, I felt the panels were more positive regarding the clinical benefits of the newer therapies.
- Hepatitis C pharmacotherapy pricing remains an issue, though evidence suggested a favorable QALY cost for Harvoni versus an Interferon/Ribavirin regimen.
Ho Ho Harvoni: Gilead Sciences Is A Gift That Should Be Under Every Investor's Tree.
- Whether you're a value or a growth investor, GILD belongs in your portfolio.
- Gilead Sciences is at the forefront of worldwide HCV eradication with its combination tablet: Harvoni.
- Regardless of anticipated competition, Gilead is a rapidly growing, highly profitable and cash-gushing machine.
- GILD is one of my top picks to significantly outperform the S&P 500 in 2015.
- A relatively straightforward screen meant to help me find attractive growth stocks located only one result: Gilead Sciences.
- Although I have had mixed feelings about Gilead in the past, it compares favorably to wide variety of similar companies, including Biogen Idec, using several criteria.
- Based on Gilead's return on invested capital, estimated future earnings growth and forward price to earnings ratio, it should be included in nearly every growth portfolio.
- The drug pipeline is the lifeblood of all research-based companies.
- A thorough understanding of the potential embedded in a company's pipeline offers a glimpse into potential for future revenue and profits.
- Gilead Sciences currently has a real gem in development which I will detail below.
- GILD's forward P/E ratio (10) is well below its competitors (~19-35) and this is an anomaly as Gilead’s Free Cash Flow will continue to grow at >20% each year.
- EBIT margins are growing and this shows that Gilead has control over its cost base. These alone should ensure above average forward P/E and PEG ratios when compared to S&P.
- Gilead is on track to achieve US HCV revenue consensus of $2.75B in Q4 and $12B in 2015.
- The 2014 revenue consensus assumes a 25% market share for Abbvie’s HCV drug. This is a worst case scenario that assumes that all GT1b patients will switch to Abbvie.
- Recent results clearly show that Abbvie’s cure rates are 10% less than Gilead’s for GT1a patients but are very similar (99% vs 100%) for GT1b patients.
How To Beat The Market - My Best Large-Cap Stock Portfolio: Gilead Sciences
- I have developed a large-cap stock selection strategy that can beat the market by a large margin with lower risk.
- A 16-year simulation of the strategy has given an annualized return of 11.51%, while the S&P 500 index has increased only 3.07% during that period.
- I also focus in this article on the first ranked stock by that strategy, Gilead Sciences.
- Gilead has surged more than 40% this year, driven by the tremendous success of its hepatitis C treatment.
- Despite the significant surge in Gilead shares, the stock has further upside.
- The risk to Gilead’s hepatitis C treatment market share is minimal.
Gilead Sciences' Stock Forecast: Algorithmic And Fundamental Analysis
- Gilead Sciences has had one of its most successful years, with growth in Q3 2014 exceeding 100% growth over last year's Q3.
- Sovaldi currently profits on being the first to market; the single product is currently responsible for almost 50% of the company's revenues.
- The current product portfolio poses a high risk, and is dependent on competitors' failures/successes in the upcoming months.
- I Know First algorithmic forecast suggest the stock will increase in the next 3-7 days, but is no longer the optimal long-term investment.
Thu, Nov. 6, 9:34 AM
- Gilead Sciences (GILD +1.8%) submits its NDA for a once-daily single tablet HIV-1 regimen containing elitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide (TAF) 10 mg.
- TAF is an investigational prodrug of tenofovir, the active ingredient in Viread (tenofovir disoproxil). It has demonstrated high antiviral efficacy at a 10x lower dose with an improved renal and bone safety profile.
- The company expects to submit an MAA to the EMA for the product candidate by the end of 2014.
Mon, Nov. 3, 3:23 PM
- According to the Wall Street Journal, Bristol-Myers Squibb (BMY -1.1%) has begun talks with health authorities in 90 countries and generic drug makers regarding licensing deals and tiered pricing for Daklinza (daclatasvir). The European Commission approved the drug in late August for the treatment adults with HCV infection (in combination with Sovaldi, ribavirin or peginterferon alfa, depending on the genotype). The company's actions are intended to make the drug available in most markets.
- The company's actions are facing criticism, however. Doctors Without Borders Director of Policy and Analysis, Rohit Malpani says 70% of HCV-infected people live in countries where the lower priced version of Daklinza will not be available. He declares, "Unfortunately, history seems to be repeating itself with BMS, who hasn't learned from the company's poor track record responding to the HIV epidemic."
- Health agencies around the world are straining over the cost of HCV treatments. The full regimen tab for Sovaldi is $84,000 and $95,000 for Harvoni. In September, Sovaldi maker Gilead Sciences (GILD -1.9%) negotiated deals with seven Indian generic firms that allows them to manufacture the product and set pricing in local markets. Earlier, it announced that it would sell full-regimen Sovaldi in India and Egypt for $900.
Fri, Oct. 31, 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.
Wed, Oct. 29, 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 $0.21 toll on Q3 EPS.
- Q3 results, guidance/details
Tue, Oct. 28, 4:32 PM
- Gilead Sciences (GILD +0.8%) Q3 results ($M): Total Revenues: 6,041.8 (+117.1%); Sovaldi Sales: 2,796,1; Total Antiviral Sales: 5,544.5 (+138.3%); Other Product Sales: 423.7 (+10.6%).
- COGS: 987.3 (+44.8%); R&D Expense: 630.5 (+29.1%); SG&A Expense: 944.8 (+150.7%); Net Income: 2,724.3 (+245.5%); EPS: 1.67 (+255.3%).
- Gross Profit: 5,054.5 (+140.6%); COGS: 16.3% (-33.3%); Gross Margin: 83.7% (+10.8%); Operating Profit: 3,479.2 (+181.6%); Operating Earnings Yield: 57.6% (+29.7%); Net Earnings Yield: 45.1% (+59.1%); Quick Assets: 7,691.7 (+179.1%).
- 2014 Guidance: Net product sales: $22B - 23B from $21B - 23B; non-GAAP gross margin: 86 - 88% from 85 - 88%; R&D expense: $2.3B - 2.4B (unch); SG&A expense: $2.7B - 2.8B from $2.3B - 2.4B; effective tax rate: 17.5 - 19.5% from 17.5 - 20.5%.
Tue, Oct. 28, 4:07 PM
Mon, Oct. 27, 5:35 PM
- AEC, AFG, AFL, AJG, AMCC, AMP, APC, ARI, AZPN, BGFV, BLDP, BOOM, BXP, CAP, CBT, CEB, CHMT, CHRW, CINF, CRAY, DLR, DNB, DYAX, EA, EIX, EPR, EQR, ESRX, EXP, EXTR, FARO, FB, FEIC, FISV, GFIG, GILD, GPRE, HIW, HLIT, HTA, HTS, HURN, INAP, INVN, IPHI, KEYW, KIM, KONA, MAC, MAR, MCK, MRCY, MWA, NANO, NFX, OI, PEI, PLT, PNRA, PSMT, RJET, ROG, RPXC, SKT, SM, SWI, TQNT, TRN, TSS, UDR, ULTI, USNA, VRSK, VRTX, WDC, WES, WGP, WNC, WSH, WTS, WYNN, X, XCO, XOOM, ZLTQ
Wed, Oct. 22, 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.
Tue, Oct. 21, 9:08 AM
- Privately-held Boehringer Ingelheim commences patient enrollment in a Phase 3 clinical trial evaluating the safety and efficacy of nintedanib in patients with colorectal cancer refractory to standard treatments. The double-blind randomized, placebo-controlled study will enroll more that 750 patients at 150 sites worldwide.
- Nintedanib (trade name Ofev) is a small molecule tyrosine kinase inhibitor that was recently approved by the FDA for idiopathic pulmonary fibrosis.
- CRC-related tickers: (NASDAQ:GILD) (NYSE:LLY) (NASDAQ:MGNX) (OTCPK:BAYRY) (OTCPK:BAYZF) (NASDAQ:AMGN) (OTC:MKGAF) (NYSE:BMY) (NASDAQ:ONXX) (NASDAQ:IMMU) (NASDAQ:ONCY) (NASDAQ:ARQL) (NYSE:SNY) (OTCQB:SNYNF) (NASDAQ:REGN)
Mon, Oct. 20, 10:40 AM
- Laboratory Corporation of America (LH -0.2%) launches its HIV GenoSure Archive, the first laboratory test that helps clinicians optimize antiretroviral (ARV) drug regimens for virally suppressed HIV patients. The test was developed using the Next Generation Sequencing Platform (NGS).
- Previous lab testing to guide ARV drug selection required higher viral loads than many HIV patients have. GenoSure Archive is performed by amplifying cell-associated HIV-1 DNA from infected cells in whole blood samples and then analyzing the polymerase region using NGS methods. The assay is analytically validated to identify mutations associated with resistance to all members of the most widely used ARV drug classes.
- HIV-related tickers: (ABBV +1.2%)(GILD +1.6%)(BMY +0.1%)(PFE -0.2%)(GSK -0.3%)(ABT +0.2%)(JNJ +0.1%)(PGNX +3%)(MRK +0.1%)(OTCQX:RHHBY +0.6%)
Sun, Oct. 19, 5:39 PM
Tue, Oct. 14, 3:31 PM
- Global growth, foreign-exchange, oil, and small caps are the subject of every client inquiry, says David Kostin. His team's recommendation: Buy "American exceptionalism."
- In Kostin's view, U.S. economy and corporate fundamentals are still strong, with economic growth expected by Goldman economists to be 3.2% next year, the fastest expansion since 2005. Europe is expected to grow just 1%.
- What his team likes are those stocks of companies which have a high proportion of domestic sales, plus sectors like Consumer Staples (XLP -0.1%) and Discretionary (XLY +0.7%) which stand to benefit from lower oil prices (plunging again today).
- As for small caps (IWM +0.9%), Kostin is wary, noting downward earnings revisions have boosted small cap P/E ratios even as prices have declined.
- The list of S&P 500 names capturing two or more of Kostin's themes: GT, GM, PCLN, AMZN, CMCSA, LOW, DG, TSN, ADM, CVS, AVP, WAG, PXD, HAL, JPM, BAC, SCHW, PNC, MS, C, GNW, LNC, MET, THC, AET, UNH, ESRX, HUM, WLP, BIIB, GILD, DAL, CMI, FLR, CRM, JBL, MA, FB, MU, FSLR, VMC, MON, T.
Fri, Oct. 10, 1:43 PM
- The FDA approves Gilead Sciences' (GILD -0.3%) Harvoni for the treatment of chronic hepatitis C genotype 1 infection.
- Harvoni is a combination of ledipasvir and sofosbuvir. It is the first approved regimen that does not require administration with interferon or ribavirin.
- This is the third HCV drug approved in the last 12 months. The agency cleared Janssen's (JNJ +0.3%) Oysio (simeprevir) in November 2013 and Sovaldi in December 2013.
- Price: $94,500/12 weeks, $63,000/8 weeks.
Tue, Oct. 7, 1:28 PM
- The FDA's PDUFA date for its review of Gilead Sciences' (GILD -0.1%) NDA for the combination of ledipasvir and sofosbuvir for the treatment of hepatitis C genotype 1 infection in adults is October 10.
- The European Medicines Agency's CHMP adopted a positive opinion recommending approval for the combination therapy on September 26. A final decision by the EC usually takes ~60 days.
Tue, Sep. 30, 10:23 AM
- France intends to implement a "progressive contribution scheme" that will levy taxes on selected hepatitis C drug makers if the cost to the government exceeds a certain amount each year.
- If social security spending on hep C drugs exceeds €450M in 2014, the drug makers will be taxed based on the revenue that exceeds the cap. The cap in 2015 will be €700M.
- Specific details of the cap will be presented to lawmakers in October and a vote on the budget should happen by year end.
- Gilead Sciences (GILD -0.9%) is still negotiating Sovaldi's (sofosbuvir) official price there.
Fri, Sep. 26, 10:20 AM
- The EMA's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending marketing approval for Gilead Sciences' (GILD +0.5%) Harvoni, an investigational once-daily tablet combining the NS5A inhibitor ledipasvir 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir 400 mg for the treatment of adult patients with hepatitis C infection.
- CHMP's opinion follows an accelerated review process similar to the FDA's Fast Track.
- A final decision by the European Commission usually takes ~60 days.
GILD vs. ETF Alternatives
Other News & PR