Amgen, Novartis, BMS map future

BMS has upped its Opdivo sales game
BMS has upped its Opdivo sales game

Earnings season brought mixed news Amgen, Novartis and Bristol-Myers Squibb Tuesday as well as insight about how they see 2015 shaping up.

Amgen's earnings news included $5.3 billion in fourth-quarter sales, a 6% uptick compared to the same period in 2013. Annual sales pushed the company past the $20-billion mark for the first time, a lift that represented a 7% increase compared to 2013.

Drivers included anti-inflammatory Enbrel (etanercept), which balanced out falling sales with higher prices. This combination gave the injectable an 11% boost for the quarter, to $1.3 billion, compared to $1.2 billion for the the year-ago period. Year-end sales were $4.7 billion, a 3% increase over 2013's $4.6 billion.

Commercial operations lead Tony Hooper noted that although the drug's market has grown, Enbrel has been losing out when it comes to dermatology and rheumatology. He added that this does not mean the 15-year-old drug lacks a future. “When you're treating psoriasis, it's a long-term chronic disease . . . and patients do switch backwards and forwards. So we continue to see a clear place for Enbrel in the marketplace,” he explained.

The drugmaker, which has pipeline biosimilars for Roche's Avastin (bevacizumab) and AbbVie's Humira (adalimumab) is also weathering competition to its biologic Neupogen (filgrastim). Neupogen sales fell 11% during the quarter — to $274 million, compared to $309 million for the same period the year before — and slid 17%, to $1.2 billion for the year, compared to $1.4 billion in 2013.

R&D head Sean Harper said the company's filing for broadlumab — its Humira biosimilar — will include data from its head-to-head comparison with Johnson's Stelara (ustekinumab), a competitor that Novartis is using as a pricing benchmark for category newcomer Cosentyx (secukinumab).

Novartis logged $14.6 billion in quarterly sales, a 2% drop compared to the same 2013 period. Year-end totals rose 1% to $58 billion, compared to $57 billion in 2013.

Key products included MS drug Gilenya (fingolimod), which garnered $2.5 billion in 2014 sales, a 30% jump over 2013; renal cell carcinoma and breast-cancer drug Afinitor (everolimus) which rang up $1.6 billion in sales, up 22% from 2013; and chronic myeloma leukemia drug Tasigna (nilotinib), which enjoyed $1.5 billion in 2014 sales, a 24% lift over 2013.

Eye drug Lucentis (ranibizumab) raked in $2.4 billion for the year, 5% more than 2013. Pharma division head David Epstein told investors that competition in the diabetic macular edema space and off-label use of Avastin slowed the drug's quarterly growth, which was up 1% compared to the same period last year.

Despite reports that its new psoriasis medication Cosentyx could roil the market, the company was enthusiastic about the treatment, but cautious. Epstein said the plan is to price the new drug on par with J&J's Stelara to accelerate market access. Although drugs like Stelara and Humira tend to have overlapping and expanding indications, Novartis indicated that rheumatoid arthritis is probably not going to be on Cosentyx's roster. “There is a lot of competition in rheumatoid arthritis and the profile was not compelling enough for us to invest further,” CFO Harry Kirsch said during Tuesday's call.

Bristol-Myers Squibb saw fourth-quarter sales fall 4% to $4.3 billion, compared to $4.4 billion for the same 2013 period. Year-end sales slipped 3%, to $15.9 billion compared to $16.3 billion in 2013.

Despite the drop, BMS said the 2014 approval of its immuno-oncology drug Opdivo (nivolumab) for melanoma was proof that its strategy was working. The company noted that it is leveraging the melanoma marketing force it uses for Yervoy (ipilimumab) to introduce specialists to Opdivo.

The company is also pursuing a lung-cancer indication. Although BMS would not disclose what the melamoma Yervoy/Opdivo force consists of — for example, whether the firm is using sales reps, medical science liaisons or a combination of both — a spokesman told MM&M that that the company has “increased the size of our field teams, both sales and medical to ensure we have the right resources if we receive approval for a lung cancer indication.”

COO Giovanni Caforio told investors during Tuesday's call that Yervoy's 2011 professional launch will act as a template for a lung-cancer rollout. He noted that melanoma doctors and lung cancer doctors are two distinct groups, which means lung doctors “are probably at the beginning of their learning curve with respect to immuno-oncology . . . it would be important for us to do the same education we did four years ago when we launched in melanoma.”

BMS also indicated it expects continued high performance from its blood-thinner Eliquis, and attributed its 20% jump in fourth-quarter sales — to $281 million — to an expanded indication.