AbbVie's (NYSE:ABBV) presentation at the JP Morgan Healthcare Conference this week included some intriguing nuggets of information that investors ought to know about, including insight into the company's opportunity in hepatitis C, as well as drugs that are making their way through the pipeline.
A billion-dollar indication
AbbVie is best known for its autoimmune drug Humira, the planet's top-selling medicine. In 2013, it notched sales of more than $10.7 billion and accounted for more than 62% of AbbVie's sales during the first nine months of 2014. But AbbVie hopes to reduce its reliance on Humira ahead of patent expiration in 2016 by expanding into other indications, including hepatitis C.
In December, the FDA granted AbbVie's Viekira Pak the green light as a treatment for hepatitis C genotype 1, making Viekira Pak the most compelling challenger to Gilead Sciences' (NASDAQ:GILD) multibillion dollar hepatitis C twosome -- Sovaldi, which is approved for use across genotypes, and Harvoni, which won FDA approval for genotype 1 patients in October.
Although Viekira Pak's four pills daily regimine is more onerous than Harvoni's one pill daily, and Viekira Pak will be prescribed alongside side-effect-laden ribavirin in most cases (something that won't happen with Harvoni), AbbVie should still generate significant sales from Viekira Pak this year thanks to its exclusivity deal with Express Scripts (NASDAQ:ESRX), a pharmacy-benefit manager that manages drug programs for healthcare payers, including employers and insurers.
During the JP Morgan presentation, AbbVie didn't offer specific sales guidance for Viekira Pak, but did say that it will provide more insight into revenue projections during the fourth-quarter earnings conference call, which is scheduled for later this month. AbbVie indicated during its presentation that Viekira Pak's launch is officially underway, and that it expects a decision on European approval early this year.
In addition to its potential in hepatitis C, the company thinks it has multiple billion-dollar blockbuster opportunities in its pipeline, including therapies for the treatment of cancer.
One of those promising pipeline drugs is ABT-199, which is being studied as a treatment for blood cancers. ABT-199 is currently being evaluated in phase 3 trials in chronic lymphocytic leukemia, or CLL, and the company thinks that ABT-199 could transform CLL treatment by offering the potential for complete responses in some patients. Earlier this year, AbbVie reported that 23% of CLL patients treated with ABT-199 saw complete remission as part of a small, early-stage trial. If all goes as planned, AbbVie could be on track to submit an FDA application for the approval of ABT-199 later this year.
Another of AbbVie's late-stage drugs that was highlighted at the conference is Veliparib, a drug that has the potential to enhance the effectiveness of existing chemotherapy. The company has a range of ongoing late-stage studies evaluating it in solid tumors, including phase 3 trials evaluating it in breast cancer and non-small cell lung cancer.
Additionally, AbbVie's elotuzumab, which is being co-developed by Bristol-Myers Squibb as a treatment of multiple myeloma, could eventually have an opportunity to generate substantial revenue, too; the drug is being studied for use alongside Celgene Corp's Revlimid, a $5 billion a year second-line treatment for the indication.
Outside of oncology, AbbVie also has pipeline candidates across immunology and neurology.
The company has a slate of autoimmune drugs in mid-stage trials that could help solidify Humira's market share, including GLPG0634, ABT-494, BT-061, and ALX-0061. And in neuroscience, patients treated with AbbVie and Biogen Idec's daclizumab had a 45% reduction in MS relapses versus Biogen's Avonex, a top-selling drug that generates multiple billions of dollars in sales annually. The company hopes to file for daclizumab's approval this year.
Continuing to continue
AbbVie increased its dividend 17% for 2015 and announced a $5 billion buyback in December that will offer support to shares during the next couple of years. Whether or not the company can maintain its shareholder-friendly commitments once Humira loses patent protection remains to be seen, but it would appear, at least based on its comments at the JP Morgan conference, that it has multiple therapies that it believes may eventually blunt that risk.
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