BioCryst Pharmaceuticals Stock (BCRX): Why The Price Surged Today

By Amit Chowdhry ● Jan 10, 2022
  • The stock price of BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) increased by 27.85% today. This is why it happened.

The stock price of BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) increased by 27.85% today. Investors are responding positively to BioCryst Pharmaceuticals announcing preliminary unaudited ORLADEYO (berotralstat) revenue for the fourth quarter and full-year 2021 and provided new guidance for full-year 2022 ORLADEYO net revenue and expected peak ORLADEYO sales.

Q4 2021 ORLADEYO Launch Dynamics

— Preliminary, unaudited ORLADEYO net revenue in Q4 2021 was $45.6 million. Preliminary, unaudited ORLADEYO net revenue for full-year 2021 (FY 2021) was $122 million.
— New patient demand for ORLADEYO remains strong and consistent, with a similar number of new patients added in Q4 2021 as in each of the previous three quarters of the year. And patients switching from other prophylactic therapies and acute-only therapy continue to drive the launch. Over half of patients new to ORLADEYO since launch had a previous prophylactic medicine prior to ORLADEYO and most of the remainder were from acute-only treatment.

— Most patients are well-controlled on ORLADEYO and remain on therapy. And about 70% of patients starting ORLADEYO, including those switching from injectable prophylaxis, remain on ORLADEYO in the first year.

— ORLADEYO is now covered by all major payors and national and regional pharmacy benefit managers, which will lead to more patients being reimbursed quickly.

— The ORLADEYO prescriber base continues to grow significantly. And the number of new physicians prescribing ORLADEYO in Q4 2021 was similar to the number added in Q3 2021. And in market research, 60 U.S. physicians — who treat an average of 7 HAE patients each — reported that they expect to double their use of ORLADEYO and that ORLADEYO will become their most prescribed prophylactic treatment in the next 12 months.

Pipeline Update: BCX9930 Pivotal Trials in PNH Now Enrolling

BioCryst is now enrolling patients in 2 global pivotal trials, REDEEM-1 and REDEEM-2, with the company’s oral Factor D inhibitor, BCX9930 (500 mg bid), in patients with paroxysmal nocturnal hemoglobinuria (PNH). And the company also has begun screening patients in a proof of concept (PoC) basket trial of BCX9930 (500 mg bid) in patients with C3 glomerulopathy (C3G), IgA nephropathy (IgAN), and primary membranous nephropathy (PMN).

BioCryst is planning to further advance and expand its Factor D program over the next 2 years by achieving the following:

— Complete and report data from REDEEM-1 and REDEEM-2

— Prepare to submit regulatory approval filings in PNH

— Complete the renal PoC basket trial and advance to pivotal trials in C3G, IgAN and PMN

— Commence PoC trials in other complement-mediated diseases

KEY QUOTES:

“Following 12 months of a successful launch through a global pandemic, we have a clear picture of the continued commercial trajectory for ORLADEYO based on a very attractive product profile, leading to strong patient demand to switch from injectable therapies to our oral, once-daily medicine, with 70 percent patient retention through the first year. Building on our substantial 2021 patient base, we are confident that ORLADEYO will achieve no less than $250 million of net revenue in 2022 and that ORLADEYO will become the market leader as the most prescribed prophylactic therapy with peak sales of $1 billion.”

— Jon Stonehouse, president and chief executive officer of BioCryst

“We expect ORLADEYO revenues in 2022 to more than double in our second year of launch as we benefit from a full year of reimbursement and continued strong demand from patients and physicians. ORLADEYO is transforming the lives of HAE patients, which is why ORLADEYO is on a trajectory to become the market leader in HAE prophylaxis.”

— Charlie Gayer, chief commercial officer of BioCryst

“Following the discovery, development and commercialization of ORLADEYO, the BioCryst team plans to repeat this success as we leverage our platform to bring new oral medicines to patients suffering from other rare diseases. BCX9930 is especially exciting because the clinical data we have reported so far provides confidence that we can help patients in PNH, and across many complement-mediated diseases, with this pipeline in a molecule.”

— Dr. Helen Thackray, chief research and development officer of BioCryst

Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.