- An expanded U.S. approval for Roche's hemophilia medicine Hemlibra, granted late last year, spurred a near doubling in sales of the drug during the first quarter, reinforcing the Swiss pharma's lofty expectations for the product.
- Hemlibra is one of a dozen drugs launched since 2012 that Roche is counting on to sustain it through faltering growth for its trio of blockbuster cancer treatments. So far, that strategy is working: the drugmaker on Wednesday raised its sales forecasts for the year on strong pharmaceutical revenues.
- First quarter sales rose 8% overall for Roche, which also makes diagnostics. Almost all of that growth was due to the company's drug division, however, which jumped 10% year over year at constant exchange rates.
Roche has told this story before.
For much of recent memory, sales of Avastin (bevacizumab), Rituxan (rituximab) and Herceptin (trastuzumab) have fueled the pharma's growth. That won't be the case for much longer, as biosimilar competition revs up in Europe and looms in the U.S.
In preparation, Roche has repeatedly touted a pipeline of new drugs that will account for the company's future. First quarter results, disclosed Wednesday, make a convincing case for Roche's game plan.
All told, drugs launched since 2012 represented more than 25% of Roche's nearly $12 billion in sales from January to March, and nearly 75% of year-on-year pharma growth.
Much of that is thanks to the success of Ocrevus (ocrelizumab), a multiple sclerosis medicine launched in early 2017. The drug now holds a 16% share of the U.S. market, trailing only Biogen's Tecfidera (dimethyl fumarate).
And Hemlibra (emicizumab) is increasingly playing a role as well. First quarter sales of the drug totaled 219 million Swiss francs, or about $217 million, up nearly 100% from the preceding three-month period.
Nearly all of the sales growth since the third quarter stems from uptake among hemophilia A patients with no inhibitors to factor replacement therapy, an indication the Food and Drug Administration approved in October.
Since then, Hemlibra has captured almost a tenth of the non-inhibitor market in the U.S., according to Roche Pharmaceuticals chief Bill Anderson, speaking on an earnings call with analysts.
Cancer drugs Tecentriq (atezolizumab) and Alecensa (alectinib) also saw strong year-over-year growth.
With the first quarter in the books, Roche now expects group revenues to grow by mid-single digits, a rosier forecast than the low- to mid-single digit forecast the pharma previously gave.
However, much of Roche's business has yet to be tested by the competition that dragged down drug sales in Europe by 6% year over year. (U.S. sales rose 14% at constant exchange rates.)
Biosimilars are expected to arrive in the U.S. this year for all three of Roche's top drugs , although it's not clear when a launch may come.
"We do expect to see biosimilar competition for Rituxan and for Herceptin in the second half," said Roche's Anderson. "With Avastin, potential biosimilar competition would probably be not until Q4 at the earliest."
Copycat biologics have had a generally muted commercial impact in the U.S., so Roche may still be able to grow sales for some time.
Roche's succession planning has so far been a success. But new drug sales, while growing fast, are still well short of combined revenues from Avastin, Herceptin and Rituxan. If the story changes unexpectedly in the U.S., Roche may see a challenge to its streak of eight consecutive years of sales growth.