Roche is set to announce its full-year results and expectations for 2018 on Feb. 1, and investors are understandably jittery. Biosimilar versions of its blockbuster cancer drugs Herceptin and Rituxan are hitting the market, and Avastin is set to face off against cheaper rivals soon.
That triad makes up a hefty chunk of the Swiss drugmaker's sales, bringing in more than $20 billion per year before the biosimilar onslaught.
Roche CEO Severin Schwan is well aware of the challenges, conceding in an interview with the Financial Times that the three cancer drugs are “highly, highly profitable medicines coming off patent.” Roche has also chalked up a couple of key regulatory approvals, which normally would be good news for any drugmaker, but the need to pour marketing resources into those launches “puts a lot of pressure on the profitability,” Schwan said.
The pressure is so great that Jefferies analyst Jeffrey Holford said investors need to “brace for impact.” Holford expects strong takeoffs from four newer Roche entries—Ocrevus for multiple sclerosis, Perjeta plus Herceptin in the adjuvant setting for breast cancer, Hemlibra for hemophilia A and Gazyva in first-line follicular lymphoma. But in an investor note earlier this month, he also predicted “conservative 2018 guidance from Roche, as management assumes harsh erosion curves for Rituxan and Herceptin.” At best, he added, the company will only be able to pull off “flat margins in 2018” because of the high cost of the new launches.
Schwan told the FT that the company is deep into budget discussions as the earnings announcement looms, and that executives are considering some key questions. “How can we [organize] ourselves in a more efficient way? How can we increase productivity?” he said. “And how can we compensate for this portfolio mix effect which is obviously negative on the bottom line?”
The only assurance Schwan was willing to offer is that Roche will increase its dividend this year, as promised to investors. Beyond this year, however, dividend decisions “will all depend on how the business develops.”
No doubt all of Roche’s new medicines will face challenges as they enter their respective markets. Hemlibra, approved by the FDA in November and now up for review in Europe, faces competition from Shire, not to mention concerns about nonresponders in Roche’s pivotal trial and a blood-clot risk that prompted the agency to slap a boxed warning on the product.
On the same day the FDA green-lighted Hemlibra, it also granted a label expansion to Gazyva. Holford of Jefferies predicts the new use as a first-line treatment for follicular lymphoma could help Gazyva reach $3.5 billion in peak sales, though the consensus estimate is a much more conservative $1.2 billion. The marketing task won’t be easy, however: Gazyva outperformed Rituxan in its pivotal trial in follicular lymphoma, but it missed the mark in diffuse large B-cell lymphoma, and with Rituxan off patent, persuading providers to switch to the pricier drug will likely be a high hurdle.
Still, there are some important milestones for Roche coming this year. It has been testing its immuno-oncology drug Tecentriq in chemo cocktails to treat squamous and nonsquamous lung cancer, with key data expected this year. “The market continues to ignore the wave of pivotal data coming for Tecentriq,” wrote Holford. Positive data from those trials could set up a “sustained period of ‘Under-Promise, and Over-Deliver’” from the company, he predicted.
At least one other analyst has Roche on its list of under-appreciated pharma companies: Morningstar. The combination of Roche’s portfolio of targeted cancer drugs and its diagnostics product line creates “sustainable competitive advantages,” the firm said in a recent note to investors. What’s more, Morningstar analysts noted, biosimilar developers have faced their own development challenges, raising the prospect that “Roche's innovative pipeline could make these products less relevant by their launch.”