After the FDA shot down Mylan’s generic Advair for the second time in June, executives said they addressed the “minor deficiencies” and an approval should follow in mid-October. A week into November, the green light is nowhere to be seen—and the company had to again reassure investors.
Evaluation of its copy of GlaxoSmithKline’s asthma blockbuster is “in the final stage of labeling review,” said company president Rajiv Malik during the company's third-quarter earnings call. “We continue to believe that the FDA will be able to resolve any outstanding issues very soon.”
Back when the rejection was announced, analysts including Wells Fargo’s David Maris depicted the delay more as a sentiment blow than a financial one. But in a note to investors in late October, Maris changed his tone a bit.
“Given the lengthy delay for this product, deterioration of Advair sales and the likelihood of an authorized generic, we think this opportunity is also rapidly diminishing,” he wrote.
On GSK’s own third-quarter earnings call, CFO Simon Dingemans reiterated the company’s expectation of an overall 30% decline in Advair sales even before any generic entry. Besides, Teva has nonsubstitutable Advair drug-device copy AirDuo RespiClick and its authorized generic on the market, plus other would-be Advair copycats from Novartis’ Sandoz and a partnership between Hikma and Vectura could return from FDA exile.
It's no surprise, then, that Mylan tried Monay to divert attention away from the Advair copy, dubbed Wixela, to other products.
“Our ability to deliver long-term growth is not dependent upon the timing of any one approval, any one country's market dynamics or any one dosage form, but rather the broader, more complete context of Mylan’s global diversified business model,” said CEO Heather Bresch on the Monday call.
She probably has a point. As Evercore ISI analyst Umer Raffat noted on the third-quarter call, no more than 3% of Mylan’s revenues come from any single product. But trouble in the U.S. generics market has been a broader drag on sales, and investors have been looking for action there, too.
To overcome some of its problems amid that industrywide generic pricing pressure, Mylan announced in August a strategic review for its business but has yet to lay out a timeline. “I can assure you the board is busy looking at lots of things … but we've put no time frames around that,” said Bresch.
Meanwhile, Mylan has been looking to achieve growth from complex generics and biosimilars. Its three-times-a-week substitutable generic for Teva’ Copaxone had won about 26% of new prescription share as of early October, up from 20% at the end of June, Maris said, citing Iqvia data.
Fulphila, the first biosimilar to Amgen’s Neulasta, is on a steady launch with about 700 to 800 units added per week, according to CFO Ken Parks. But it will soon face an additional challenge from Coherus, which won an FDA nod on Friday and is hinting at some aggressive pricing moves.
Mylan also just launched a biosimilar to AbbVie’s megablockuster Humira in Europe, almost simultaneously with three other players.
With that, Mylan has confirmed its full-year 2018 guidance—with or without Wixela—that was already dialed down in August.
For the third quarter, Mylan’s revenue dropped 4% to $2.86 billion with the North American segment plummeted 14%, partially due to lower EpiPen sales and ongoing restructuring at its Morgantown, West Virginia, manufacturing facility. Its adjusted EPS beat analyst expectations to land at $1.25 during the quarter, representing a 14% year-over-year increase.