BeiGene is squaring off against industry bigwigs with its new BTK inhibitor Brukinsa, and early sales figures show just how difficult it will be for the Chinese biotech to steal share in the U.S. market.
Approved by the FDA in November as a new BTK option besides Johnson & Johnson’s blockbuster Imbruvica and AstraZeneca’s Calquence in previously treated mantle cell lymphoma (MCL), Brukinsa only sold $720,000 in its first full quarter on the market, way below industry watchers’ expectations of around $7 million.
But it's too soon to pass judgment, BeiGene said. "Early launch indicators including new patient starts, reimbursement coverage, and physician perception have been encouraging," its first-quarter announcement stated.
Brukinsa's inaugural sales number is more in line with the $1 million SVB Leerink analyst Andrew Berens had expected. In a note to investors on Tuesday, Berens suggested the lackluster performance probably stemmed from low off-label use in chronic lymphocytic leukemia (CLL).
At last year’s American Society of Hematology annual meeting, BeiGene rolled out data showing Brukinsa had triggered a response in 91% of relapsed or refractory CLL patients in a phase 1/2 trial at a median follow-up of 29.5 months.
Berens pointed out that Calquence’s sales of $3 million, $8 million and $12 million in its first three quarters after nabbing an FDA go-ahead in MCL in October 2017 included significant contributions from CLL, which is a much larger market than MCL.
BeiGene is trying to prove that Brukinsa is a better option than market leader Imbruvica. But its first swing at that goal recently suffered a setback as it failed to significantly outdo the J&J drug in a phase 3 head-to-head trial in Waldenstrom macroglobulinemia.
However, as Berens noted, Brukinsa demonstrated a better side effects profile in that trial, and the Imbruvica control arm appeared to have outperformed compared with historical data. BeiGene is slated to present the full data from that Aspen trial at the upcoming American Society of Clinical Oncology virtual event and will talk to U.S. and EU regulators this year about a potential approval.
Berens’ team has dialed down its 2020 sales estimates for Brukinsa to $14.6 million but still maintains that the drug could reach blockbuster status in 2024.
Brukinsa isn’t the only disappointment for BeiGene, though. Near the end of the first quarter, Chinese regulators halted importation, sales and use of chemotherapy Abraxane in China after spotting manufacturing problems at contractor Fresenius Kabi’s sterile injectables site in Illinois. BeiGene licenses Abraxane—along with Revlimid and Vidaza—from Bristol Myers Squibb’s Celgene.
As a result, Bristol initiated a voluntary recall of Abraxane in mainland China, and BeiGene is seeking clearance to source the drug from another facility. But in a move more damaging to the company for at least the following two years, Chinese authorities have kicked BeiGene’s originator drug off a bulk procurement program, handing its share to generic rivals Hengrui Medicine and CSPC. That leaves only 30% of the market for BeiGene to fight for, provided it's able to resume supply—and it will have to duke it out against three copycat makers, with no guaranteed purchase.
In the first quarter, BeiGene reported sales from the three Celgene drugs at $30.82 million, a little more than half of their $57.42 million haul during the same period last year. Besides the Abraxane fiasco, BeiGene attributed the decline to the COVID-19 pandemic and increased generic competition.
But PD-1 inhibitor tislelizumab represented a bright spot in BeiGene’s first quarter. Launched in China in March for classical Hodgkin lymphoma (cHL), the drug already racked up revenue of $20.53 million, significantly ahead of the Street’s consensus of $5.2 million. And it did that even though Eli Lilly partner Innovent Biologics and Hengrui are fielding their own PD-1 drugs in the cHL market.
Recently, Innovent’s Tyvyt became the first checkpoint inhibitor to land on China’s National Reimbursement List. Both Tyvyt and tislelizumab have posted trial wins in all-important newly diagnosed non-small cell lung cancer. Approved in China toward the end of 2018 and launched in March 2019, Tyvyt raked in CNY1 billion ($143 million) in 2019 sales.
Thanks to that tislelizumab showing, BeiGene’s first-quarter haul of $52.1 million still beat consensus expectations of $47.1 million.