Earnings release
Page 1
EXHIBIT 99.1 BioCryst Reports Third Quarter 2021 Financial Results and Upcoming Key Milestones -3Q 2021 revenue of $ 41.0 million ORLADEYOⓇ ( berotralstat ) net revenue of $ 37.0 million -Full year 2021 ORLADEYO net revenue expected to be $ 115- $ 120 million RESEARCH TRIANGLE PARK , N.C. , Nov. 03 , 2021 ( GLOBE NEWSWIRE ) BioCryst Pharmaceuticals , Inc. ( Nasdaq : BCRX ) today announced financial results for the third quarter ended September 30 , 2021 , and provided a corporate update . " With the significant revenue of $ 115 million to $ 120 million we expect to generate with ORLADEYO in its first year of launch , and an even larger fast - following pipeline that includes four separate indications currently in pivotal or proof of concept trials in the complement space with BCX9930 , BioCryst plans to repeat our clinical and commercial success with ORLADEYO again and again as we bring these much - needed oral medicines to the patients who are waiting for them , ” said Jon Stonehouse , president and chief executive officer of BioCryst . Program Updates and Key Milestones ORLADEYOⓇ ( berotralstat ) : Oral , Once - daily Treatment for Prevention of Hereditary Angioedema ( HAE ) Attacks U.S. Launch " Almost a year into the launch of ORLADEYO , we continue to see strong , consistent demand from new patients switching to ORLADEYO from their existing injectable prophylactic and acute therapies , and it is exciting to see the positive impact ORLADEYO is having on their lives . With the excellent start to the launch , and the excitement we hear from physicians and patients , ORLADEYO is now on a trajectory to become the market leader in HAE prophylaxis , ” said Charlie Gayer , chief commercial officer of BioCryst . • ORLADEYO net revenue in the third quarter of 2021 was $ 37.0 million . • New patient demand for ORLADEYO remains strong and consistent with as many new patients added in Q3 as in Q2 . • Patient switches continue to drive the launch with more than half of patients who were new to ORLADEYO in the third quarter switching from other prophylactic medicine to ORLADEYO and the remainder from acute - only treatment . • The number of new physicians prescribing ORLADEYO grew by another 25 percent in the third quarter and the ORLADEYO prescriber base has now increased to include nearly half of the top 500 hereditary angioedema ( HAE ) treating physicians in the United States . • ORLADEYO has been very well received by payors and is now covered by nearly all national and regional pharmacy benefit managers . • Most patients continue to have an excellent experience on ORLADEYO and remain on therapy . Through the launch thus far , patient retention on therapy remains consistent with the one - year patient retention rate observed in the APEX - 2 clinical trial . ORLADEYO : Global Updates • ORLADEYO has received reimbursement approval in Norway and is expected to launch in Norway in early December . • On September 15 , 2021 , the company announced that the United Kingdom's National Institute for Health and Care Excellence had recommended ORLADEYO for preventing recurrent attacks of HAE in eligible patients 12 years and older if they have at least two attacks per month . • On September 9 , 2021 , the company announced that the Ministry of Health and Prevention in the United Arab Emirates ( UAE ) had granted marketing authorization for ORLADEYO for the prevention of recurrent attacks in patients with HAE 12 years and older . To support commercialization efforts in the UAE , BioCryst has entered into a supply and distribution agreement with NewBridge Pharmaceuticals , which also covers the Gulf Cooperation Council and Iraq . • On August 25 , 2021 , the company announced that the new drug submission for ORLADEYO had been accepted for review by Health Canada for the prevention of recurrent attacks in patients with HAE 12 years and older . The company also announced that Swissmedic has accepted BioCryst's marketing authorization application for ORLADEYO for review . Complement Oral Factor D Inhibitor Program - BCX9930