First-quarter earnings reports have trickled in for the last week and a half, but will really kick into high gear on April 26 when six biotech and pharma heavy hitters all report on the same day.
So far, many executives have focused on reshaping portfolios and building out pipelines. Expect more of that going forward as much of big pharma continues to go through a transformation. But also look for commentary on how biosimilars are set to impact markets for some of the industry's top-selling biologic medicines.
Correction: A previous version of this article misidentified the disease for which Roche AG's drug Ocrevus is approved to treat. It also incorrectly stated what day AstraZeneca and Celgene will report first quarter earnings.
AbbVie Inc. (April 26)
Since its inception, the story for AbbVie has centered on its uber-blockbuster anti-inflammatory drug Humira (adalimumab). AbbVie is admired by its pharma peers for the layers of patent protection the company has amassed around the drug — making competitive inroads difficult. The company forecasts Humira revenues will exceed $20 billion annually by 2020.
So far, AbbVie has managed to reach settlement deals with several companies developing biosimilars of the drug, keeping competition at bay until 2023 in the U.S. Expect AbbVie to talk up the durability of Humira revenues, as well as potential price increases for the drug.
Beyond that, AbbVie has steadily built out its oncology portfolio in preparation for the day that Humira finally loses exclusivity. But a recent setback to its lung cancer drug rovalpituzumab tesirine, or Rova-T, has analysts and investors questioning this strategy. As a result, management will likely have to answer questions about the potential of AbbVie's position in oncology.
The Rova-T setback also raises doubts about AbbVie's M&A strategy — it paid $5.8 billion upfront to acquire Rova-T in a 2016 deal for Stemcentrx. Analysts will be looking for some clarity.
Bristol-Myers Squibb Co. (April 26)
In February, Bristol-Myers paid a staggering $1.85 billion upfront for 35% rights to an experimental drug developed by Nektar Therapeutics Inc. It was an audacious bet that the compound, known as NKTR-214, might prove an effective partner to checkpoint inhibitors like Bristol-Myers' Opdivo (nivolumab).
While the pricey pact may have raised eyebrows, standing still in immunotherapy could be an even greater risk. Even so, investors will likely press the company for further explanation of why Nektar's drug looks so promising — especially after the failure of Incyte Corp.'s partner hopeful epacadostat.
Elsewhere, recent success from CheckMate-227, a study combining Opdivo with Bristol-Myers’ older Yervoy (ipilimumab), could finally give the drugmaker the means to more fully compete with Merck in first-line lung cancer. Yet questions linger about the complexity and applicability of the CheckMate-227 results, which could dull the sheen off of the combo win.
Roche AG (April 26)
From a commercial perspective, drug launches don't go much better than that of Roche's new multiple sclerosis medicine Ocrevus (ocrelizumab).
In its first year on the market, the drug earned over $900 million and quickly cemented itself as a treatment for patients with a more severe type of the disease known as primary progressive MS. 2018 will be a major test, however, of how high Ocrevus' ceiling can reach.
Elsewhere, the Swiss pharma plans to file its hemophilia drug Hemlibra (emicizumab) for approval in patients without inhibitors — a much broader market and one still fiercely defended by rival drugmakers Shire plc and Novo Nordisk A/S.
Some concerns still linger about the drug's safety. In March, the company updated patient advocacy groups of two new deaths of patients who were receiving the drug, although investigators judged the deaths unrelated to treatment. For sicker inhibitor patients, treatment options are fewer and some risks more acceptable. Expanding into non-inhibitor patients will bring further scrutiny on safety.
Expect investors to poll executives on their expectations for Hemlibra and how the development path will unfold.
Also top of mind will be prospects for Roche's immunotherapy PD-L1 blocker Tecentriq (atezolizumab). Rivals continue to build momentum for their own checkpoint inhibitors, upping the pressure on Roche to make progress on the combination treatment front.
Vertex Pharmaceuticals Inc. (April 26)
Vertex has several highly-anticipated treatments coming down the pike. It's working on late-stage testing for two triple combination cystic fibrosis therapies that, if approved, could allow Vertex's portfolio to treat up to 90% of the people with the genetic disease, the company estimates.
Recently, Vertex also licensed its first drug from a partnership with CRISPR Therapeutics AG and plans to test it as a treatment for blood disorders. Those candidates are a ways from approval, though, and information on their progress may be scant.
Expect Vertex to talk more about its most recent portfolio addition, Symdeko (tezacaftor/ivacaftor). Another CF drug, Symdeko combines the active ingredient in Kalydeco with a next-generation corrector. It gained an FDA OK on Feb. 12, about two weeks ahead of schedule, and analysts will be looking to see how launch activities are going.
Vertex gave Symdeko a list price of $292,000, or $20,000 more than Orkambi (lumacaftor/ivacaftor). It's a smart price, according to Jefferies, which noted that Symdeco is most applicable to three CF subpopulations: those who have discontinued Orkambi, those who have never taken Orkambi, and those living outside the U.S. who have specific genetic mutations that Kalydeco monotherapy isn't cleared to treat.
"Symdeko's relatively high pricing means patients swapping from Orkambi to Smydeko would generate a slightly accretive benefit in revenues (modest). Since Symdeko adds efficacy and yields lesser side effects (chest tightness) compared to Orkambi, it is justifiable for Symdeko to have a slightly higher gross price," the investment bank said in a recent note.
Sanofi SA (April 27)
Sanofi is searching for a new identity as sales of the French drugmaker's once formidable Lantus (glargine) franchise weaken amid rising pressures in the diabetes market. This refocus has featured two significant acquisitions of Ablynx N.V. and Biogen Inc. spinoff Bioverativ Inc. as well as, more recently, the sale off its European generics business.
Look for management to talk at length about the strategy for re-energizing the business, with particular focus on how the hemophilia products from the Bioverativ acquisition fit into the portfolio.
Beyond that, expect some commentary on dealmaking; Sanofi has been one of the more active big pharmas on the M&A front this year and might not be finished yet.
The company has also overhauled its executive leadership. Most recently, Sanofi announced its head of R&D Elias Zerhouni will be retiring and will be replaced by John Reed, formerly Roche's head of Pharma Research & Early Development.