Analyst Sees Attractive Entry Opportunity After BioCryst's Pipeline Setback

  • Tucked in its Q4 earnings press releaseBioCryst Pharmaceuticals Inc BCRX reported a setback on the early-stage BCX10013 study.
  • The company noted recent dose-related observations in an ongoing BCX10013 nonclinical study would delay the clinical program.
  • BioCryst planned to advance BCX10013 into patient studies in mid-2023, including in patients with paroxysmal nocturnal hemoglobinuria (PNH), to evaluate once-daily dosing.
  • In January, the company announced initial data from ongoing phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trials in healthy volunteers.
  • It showed rapid, sustained, and >97 percent suppression of the complement system's alternative pathway (AP) 24 hours following a single 110 mg dose and that BCX10013 has been safe and generally well-tolerated at all doses studied to date.
  • Needham writes that they believe the sell-off was overdone and that BCRX's 25% YTD decline brought its shares to the level that fails to adequately capture Orladeyo's sales (2023 sales guidance of ≥$320 million, +27%Y/Y) and growth trajectory.
  • The analyst upgraded the stock to Buy from Hold with a price target of $14.
  • The analyst expects Orladeyo can attain peak sales of $700 million, given that competition from another oral HAE prophylactic is unlikely for at least 5-7 years. 
  • BCRX's OpEx spending is high, but the company is well-funded, with a cash balance of $443.9 million. The BCX10013 setback may prompt R&D spending cuts that accelerate the progression to break even, potentially as early as 2024. 
  • Price Action: BCRX shares are up 12.33% at $9.70 on the last check Wednesday.
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