07.14.15
Headquarters: Foster City, CA
twitter.com/gileadsciences
www.gilead.com
TOP SELLING DRUGS
In today’s sluggish R&D environment, Gilead is surpassing the odds—and its anti-viral competition—with burgeoning Solvaldi and Harvoni sales and flagship HIV franchise. Solvaldi alone nearly matched the company’s net revenues in 2013, with an astounding $10.3 billion in sales in 2014. No one is putting up numbers and results quite like this biotech behemoth, which jumped from 19 in last year’s ranking, to nine, joining the likes of Lilly and AstraZeneca.
Sovaldi, which was approved in the U.S. and EU in December 2013 and January 2014, respectively, proved a valuable advance for hepatitis C-related liver disease, providing the first cure for the virus. It’s now approved in more than 40 countries, and more than 170,000 HCV patients have been treated with a Sovaldi-containing regimen since the product was launched. However, more in-house—and to a lesser extent—external competition has sales cooling. Abbvie’s Viekira (approved December 2014) hasn’t made quite the financial impact as Sovaldi—at least not yet. It debuted with $48 million in sales in 2014, and jumped to $231 million in 1Q15.
More significantly, in Gilead’s efforts to further convenience and reduce treatment duration (and remain competitive), Harvoni was approved in the U.S., Canada, the EU and Switzerland in 2014, and debuted at $2.1 billion in sales for the year (and a whopping $3.6 billion in 1Q15). It’s the first once-daily single-tablet regimen (STR) to treat chronic HCV in genotype 1 patients–the most prevalent worldwide. Building on Sovaldi’s success, Harvoni eliminates the need for both interferon and ribavirin, and in clinical trials provided cure rates of 94–99% in as few as eight weeks. However, its introduction hit Sovaldi sales, which were down 57% to $972 million in 1Q15.
Sovaldi has made headlines this past year due to its price tag. In the U.S., the cost for the cure is $63,000 to $94,500, depending upon the drug and regimen, before any discounts. On an infamous note, Senator Bernie Sanders of VT is demanding the Government override Gilead’s patents in a rash effort to get meds to veterans. Perhaps there’s a better way?
In January, Gilead expanded its hep C generic manufacturing licensing agreements with India-based partners to include the investigational GS-5816, in Phase III studies as part of a single tablet regimen in combination with sofosbuvir for the treatment of all six genotypes of hepatitis C. This would allow the manufacture and distribution in 91 developing countries, which account for 54% of the total worldwide HCV population. If approved, the regimen would become the first pan-genotypic, all-oral single tablet regimen for HCV.
Gilead also picked up Phenex Pharmaceuticals’ Farnesoid X Receptor (FXR) program for $65 million, which includes small molecule FXR agonists being explored to treat of liver diseases, including nonalcoholic steatohepatitis (NASH), which is a common, serious chronic liver disease affecting 10 to 20% of people in the developed world, and for which there are currently no
approved therapies.
While the flagship HIV franchise faces several significant patent expiries, the company continues to develop new treatment regimens to thwart the impact of looming expiries. This common pharma practice may pay off in the short term, but Gilead will need to continue to address evolving needs and treatment options for the disease.
The company has made progress with regimens containing tenofovir alafenamide (TAF), demonstrating high antiviral efficacy and an improved safety profile. Results from two Phase III studies showed the compound known as E/C/F/TAF (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) had more favorable renal and bone safety profiles compared with Stribild.
Gilead also expanded its partnership with Janssen R&D Ireland, its distribution partner for Complera/Eviplera, to include the development and commercialization of R/F/TAF, which is F/TAF plus Janssen’s rilpivirine. Several Phase I and II studies of the new STR have been completed, and if approved, would be the first protease inhibitor-based STR.
Gilead’s oncology efforts don’t hold quite the same revel at its anti-viral successes. Fledgling, Zydelig, a PI3K delta inhibitor approved in the U.S. and EU in 2014 for several blood cancers, brought in a mere $23 million in sales. Zydelig is the company’s foremost foundation from which to develop new cancer therapies, including combination regimens to achieve better and more durable response rates and to expand the number of cancer indications. The drug has also shown potential benefit in a variety of lymphomas at various stages.
Gilead acquired EpiTherapeutics ApS, a privately-held Danish company, for $65 million. EpiTherapeutics has a library of first-in-class, selective small molecule inhibitors of epigenetic regulation of gene transcription, in particular histone demethylases. The company’s lead preclinical compounds are being studied for the treatment of certain cancers.
The company’s oncology pipeline includes GS-4059, a BTK inhibitor recently licensed from Ono Pharmaceutical, for the treatment of B-cell malignancies and other diseases. Gilead now has compounds targeting several signaling pathways associated with B-cell malignancies–PI3K delta, Syk, JAK and BTK. There’s also the recently acquired EpiTherapeutics portfolio of preclinical histone demethylases for certain cancers, which falls into the company’s combination strategy.
Several other focus areas include three clinical stage compounds for ulcerative colitis and Crohn’s disease, rare and potentially fatal heart conditions, respiratory syncytial virus (RSV), and idiopathic pulmonary fibrosis.
With impressive earnings growth and growth potential, this outperforming innovator doesn’t show any signs of weakness, and is expected to continue to dominate the HIV and hep C markets in the near-term.
twitter.com/gileadsciences
www.gilead.com
Headcount: | 7,000 | |
Year Established: | 1987 | |
Revenues: | $24,890 | (+127%) |
Net Income: | $12,059 | (+294%) |
R&D: | $2,854 | (+35%) |
TOP SELLING DRUGS
Drug | Indication | 2014 Sales | (+/-%) |
Sovaldi | chronic hepatitis C | $10,283 | N/A |
Atripla | HIV | $3,470 | -5% |
Truvada | HIV | $3,340 | 7% |
Harvoni | chronic hepatitis C | $2,127 | N/A |
Complera/Eviplera | HIV | $1,228 | 52% |
Stribild | HIV | $1,197 | 122% |
Viread | chronic hepatitis B | $1,058 | 10% |
In today’s sluggish R&D environment, Gilead is surpassing the odds—and its anti-viral competition—with burgeoning Solvaldi and Harvoni sales and flagship HIV franchise. Solvaldi alone nearly matched the company’s net revenues in 2013, with an astounding $10.3 billion in sales in 2014. No one is putting up numbers and results quite like this biotech behemoth, which jumped from 19 in last year’s ranking, to nine, joining the likes of Lilly and AstraZeneca.
Sovaldi, which was approved in the U.S. and EU in December 2013 and January 2014, respectively, proved a valuable advance for hepatitis C-related liver disease, providing the first cure for the virus. It’s now approved in more than 40 countries, and more than 170,000 HCV patients have been treated with a Sovaldi-containing regimen since the product was launched. However, more in-house—and to a lesser extent—external competition has sales cooling. Abbvie’s Viekira (approved December 2014) hasn’t made quite the financial impact as Sovaldi—at least not yet. It debuted with $48 million in sales in 2014, and jumped to $231 million in 1Q15.
More significantly, in Gilead’s efforts to further convenience and reduce treatment duration (and remain competitive), Harvoni was approved in the U.S., Canada, the EU and Switzerland in 2014, and debuted at $2.1 billion in sales for the year (and a whopping $3.6 billion in 1Q15). It’s the first once-daily single-tablet regimen (STR) to treat chronic HCV in genotype 1 patients–the most prevalent worldwide. Building on Sovaldi’s success, Harvoni eliminates the need for both interferon and ribavirin, and in clinical trials provided cure rates of 94–99% in as few as eight weeks. However, its introduction hit Sovaldi sales, which were down 57% to $972 million in 1Q15.
Sovaldi has made headlines this past year due to its price tag. In the U.S., the cost for the cure is $63,000 to $94,500, depending upon the drug and regimen, before any discounts. On an infamous note, Senator Bernie Sanders of VT is demanding the Government override Gilead’s patents in a rash effort to get meds to veterans. Perhaps there’s a better way?
In January, Gilead expanded its hep C generic manufacturing licensing agreements with India-based partners to include the investigational GS-5816, in Phase III studies as part of a single tablet regimen in combination with sofosbuvir for the treatment of all six genotypes of hepatitis C. This would allow the manufacture and distribution in 91 developing countries, which account for 54% of the total worldwide HCV population. If approved, the regimen would become the first pan-genotypic, all-oral single tablet regimen for HCV.
Gilead also picked up Phenex Pharmaceuticals’ Farnesoid X Receptor (FXR) program for $65 million, which includes small molecule FXR agonists being explored to treat of liver diseases, including nonalcoholic steatohepatitis (NASH), which is a common, serious chronic liver disease affecting 10 to 20% of people in the developed world, and for which there are currently no
approved therapies.
While the flagship HIV franchise faces several significant patent expiries, the company continues to develop new treatment regimens to thwart the impact of looming expiries. This common pharma practice may pay off in the short term, but Gilead will need to continue to address evolving needs and treatment options for the disease.
The company has made progress with regimens containing tenofovir alafenamide (TAF), demonstrating high antiviral efficacy and an improved safety profile. Results from two Phase III studies showed the compound known as E/C/F/TAF (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) had more favorable renal and bone safety profiles compared with Stribild.
Gilead also expanded its partnership with Janssen R&D Ireland, its distribution partner for Complera/Eviplera, to include the development and commercialization of R/F/TAF, which is F/TAF plus Janssen’s rilpivirine. Several Phase I and II studies of the new STR have been completed, and if approved, would be the first protease inhibitor-based STR.
Gilead’s oncology efforts don’t hold quite the same revel at its anti-viral successes. Fledgling, Zydelig, a PI3K delta inhibitor approved in the U.S. and EU in 2014 for several blood cancers, brought in a mere $23 million in sales. Zydelig is the company’s foremost foundation from which to develop new cancer therapies, including combination regimens to achieve better and more durable response rates and to expand the number of cancer indications. The drug has also shown potential benefit in a variety of lymphomas at various stages.
Gilead acquired EpiTherapeutics ApS, a privately-held Danish company, for $65 million. EpiTherapeutics has a library of first-in-class, selective small molecule inhibitors of epigenetic regulation of gene transcription, in particular histone demethylases. The company’s lead preclinical compounds are being studied for the treatment of certain cancers.
The company’s oncology pipeline includes GS-4059, a BTK inhibitor recently licensed from Ono Pharmaceutical, for the treatment of B-cell malignancies and other diseases. Gilead now has compounds targeting several signaling pathways associated with B-cell malignancies–PI3K delta, Syk, JAK and BTK. There’s also the recently acquired EpiTherapeutics portfolio of preclinical histone demethylases for certain cancers, which falls into the company’s combination strategy.
Several other focus areas include three clinical stage compounds for ulcerative colitis and Crohn’s disease, rare and potentially fatal heart conditions, respiratory syncytial virus (RSV), and idiopathic pulmonary fibrosis.
With impressive earnings growth and growth potential, this outperforming innovator doesn’t show any signs of weakness, and is expected to continue to dominate the HIV and hep C markets in the near-term.
Well, Gilead Sciences has definitely been the company that has galloped up the charts this year moving from 19th last year up into the Top 10 for 2015. The company, which has historically focused on HIV has been rocketed into the ether by souring sales of its latest hepatitis C drug, Harvoni (ledipasvir/sorosbuvir) accompanied by the very slightly older brother Solvadi. Solvadi was licensed by the FDA and in the EU in early 2014 followed by Harvoni in 4Q. While Solvadi is the less user friendly of the two drugs and has suffered at the appearance on the market of Harvoni, all of the company’s expectations have been surpassed, and as a result has increased its expected sales in 2015 by a billion dollars. Even though Gilead has competition hot on its heels from AbbVie and Merck, its drugs provide an effective cure for the disease. Even the somewhat hefty price tag of $1,000 a day makes it cost effective in the long term. Gilead is not resting on its laurels though. The drug pipeline for Gilead is strong with further regulatory submissions in place in the U.S. and EU in HIV therapy, and with late stage trials in liver disease and oncology, Gilead looks to be a strong player and a force to be reckoned with in the starry heights of the Global Top 10. Having realized strong sales results for the start of this year, it will be interesting to see how the coming months pan out and where it will send them in 2016. —Adele Graham-King |