Dive Brief:
- New drug launches helped drive a 3% increase in Roche's pharmaceutical sales in 2016, as revenues began to add up for the Swiss giant's cancer immunotherapy Tecentriq (atezolizumab) and for its three other recently launched drugs.
- Roche said it expected low- to mid-single digit sales growth and hopes to win approval in the U.S. for two more drugs: the closely watched multiple sclerosis treatment Ocrevus (ocrelizumab) and its hemophilia A treatment emicizumab.
- Breast cancer drugs Perjeta (pertuzumab) and Kadycla (ado trastuzumab emtansine) also fueled 2016 sales growth, building out Roche's HER2 franchise.
Dive Insight:
Roche has seen more launches recently than at any other time in its history, executives trumpeted in an earnings conference call, and these new launches are feeding into the pharmaceuticals unit's coffers.
While sales of the mainstay cancer drug Avastin (bevacizumab) have fallen in the U.S., Roche is optimistic its new crop of cancer meds — headlined by Tecentriq — will propel revenues, explained Daniel O'Day, head of the pharmaceutical division.
Roche faces other threats as some of its drugs reach the end of their patent life. Schwan expects to see a decline in Tamiflu (oseltamivir) sales in 2017 due to generic competition, while major drugs like Herceptin (trastuzumab) could soon have to face off biosimilars.
"This is a very important phase for Roche, with some products reaching the end of their lifecycle, offset by others reaching the market," Schwan said on the call via an interpreter. "It is difficult to estimate the impact of biosimilars, as it will depend on price and market penetration. We expect that the decline will be more than offset by new launches," says Schwan.
Roche is hopeful for further launches in 2017, particularly for Ocrevus (ocrelizumab). The Food and Drug Administration pushed back the target action date for this drug, which is now scheduled for March 28. A decision on emicizumab, another key pipeline drug, is expected to follow in either late 2017 or early 2018.
While approvals for both drugs would be a major boost for the Swiss pharma, Roche's bread and butter remains in oncology. And Tecentriq appears to be gaining ground quickly in the immuno-oncology market. Sales in the fourth quarter — after the FDA approved Tecentriq in non-small cell lung cancer (NSCLC) — hit 80 million Swiss francs, surpassing revenues earned through the first three quarters.
Bristol-Myers Squibb acknowledged on its earnings call last week that it has seen Tecentriq begin to eat into market share in the second-line NSCLC market.
As with other I/O leaders, Roche is studying Tecentriq in combination with other drugs. Late-stage studies include combinations of Tecentriq with chemotherapy, Avastin and Cotellic (cobimetinib).
And Roche expects to read out results from a study testing Tecentriq in non-squamous NSCLC, which would be a significant catalyst for sales growth in the future is positive.
"Overall, we have 50 trials ongoing in oncology, forty of which are combinations," said O'Day.
Expectedly, analysts questions also focused on the impact of President Trump's policies on the pharmaceutical industry.
"We have created a lot of new jobs, including in the U.S., and we will continue to invest in the U.S., which is an attractive market for us," said Schwan. "Decisions on future sites will depend on the attractiveness of the site and the market at the time." He added that the company will remain in dialogue with the current administration, and would be happy to meet with President Trump.