Thanks to billions of dollars in new revenue from recently launched hepatitis C drugs, Gilead Sciences (GILD +0.62%) sales surged 117% year over year during the third quarter. That's impressive growth by any measure, but investors might be surprised to learn that Pharmacyclics (NASDAQ: PCYC) and Medivation (MDVN +0.00%) sales grew even more quickly over the past year.
GILD Revenue (Quarterly YoY Growth) data by YCharts
Winning away global market share
Medivation's sales have soared 234% in the past year thanks to growing global use of Xtandi, its prostate cancer treatment, co-developed by Japan's Astellas. The FDA approved Xtandi for use in post-chemotherapy prostate cancer patients in 2012 and the drug has become the market share leading therapy used in that indication. In the past year, Astellas has secured approval for Xtandi in overseas markets, which has significant increased Xtandi revenue. In the third quarter, U.S. sales of Xtandi totaled $181 million and ex-U.S. sales reached $119.6 million.
Medivation's success in winning market share in the post-chemotherapy patients suggests that Xtandi sales could head even higher during 2015. That's because the FDA approved Xtandi for use in pre-chemotherapy patients in September.
Approval for pre-chemotherapy patients was based on phase 3 trials showing that Xtandi patients saw a statistically significant improvement in both progression free survival and overall survival versus placebo and hormone therapy. In that trial, Xtandi reduced the risk of disease progression by 83% and the risk of death by 29%.
A similar pre-chemotherapy approval at the end of 2012 for Johnson & Johnson's (JNJ 1.16%) Zytiga helped its sales jump from $961 million in 2012 to $1.7 billion in 2013. If Xtandi follows a similar path to Zytiga, then its sales could soon be closing in on $2 billion, too.
Source: Pharmacyclics
Battling blood cancer
Pharmacyclics sales jumped 162% year over year during the third quarter thanks to rising use of Imbruvica, a treatment for blood cancers that was developed by Pharmacyclics and J&J.
Last November, the FDA granted approval for Imbruvica's use in mantle cell lymphoma and earlier this year the FDA expanded Imbruvica's label to include its use in treating chronic lymphocytic leukemia, or CLL, too. Those two cancers aren't very common, but both have significant unmet need for new therapies. According to the National Cancer Institute, 15,720 people will be diagnosed and 4,600 people will die from CLL this year.
As a result, the FDA has approved a slate of treatments in the past year that address CLL, including Gilead Sciences Zydelig, which won approval in the indication this past summer. So far, it's Imbruvica, however, that is capturing the bulk of prescriptions.
Imbruvica's approval in CLL patients was based on a late stage study of Imbruvica in 391 patients that showed that patients enjoyed a 78% reduction in risk of disease progression or death and a 57% improvement in overall survival. Since Imbruvica performed so well during clinical trials, sales of the drug have steadily climbed since its launch. In the third quarter, Imbruvica net sales totaled $142 million, up from $109 million in the second quarter.
Pharmacyclics and J&J think that Imbruvica has plenty more room to grow too. The two companies are conducting 53 studies of the drug, including a range of trials that are evaluating its use alongside other cancer treatments from drugmakers including Bristol-Myers Squibb and AstraZeneca.
Staying ahead
Thanks to catalysts at each of these companies, sales growth at Medivation and Pharmacyclics is likely to continue to outpace that of Gilead Sciences next year. After all, Gilead Sciences is likely to see revenue growth slow as year-over-year comparisons get tougher in 2015. Of course, Medivation and Pharmacyclics could stumble, but each is already enjoying impressive sales growth for their existing products and each offers a solid balance sheet. As a result, both may be good options for biotech investors to buy.
