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BioCryst Reports First Quarter 2021 Financial Results and Upcoming Key Milestones —Q1 2021 ORLADEYO ™ ( berotralstat ) net revenue of $ 10.9 million -ORLADEYO now approved in U.S. , Japan and EU -BioCryst reaches agreement with FDA that change from baseline in hemoglobin is the primary endpoint for pivotal PNH trials of oral BCX9930 set to begin in second half of 2021 EXHIBIT 99.1 RESEARCH TRIANGLE PARK , N.C. , May 06 , 2021 ( GLOBE NEWSWIRE ) BioCryst Pharmaceuticals , Inc. ( Nasdaq : BCRX ) today announced financial results for the first quarter ended March 31 , 2021 , and provided a corporate update . -- " Our commercial team is off to an outstanding start with the U.S. launch of ORLADEYO . In this highly competitive market , we are demonstrating what we have known for some time now , HAE patients have been waiting to switch to an oral , once - daily therapy to reduce their attacks and burden of therapy , " said Jon Stonehouse , president and chief executive officer of BioCryst . " Our early launch performance is the latest piece of evidence that BioCryst's differentiated strategy to discover , develop and , now , successfully commercialize unique oral medicines for rare diseases has the potential to create greater and greater value . We are doing this first in HAE and will next apply what we have learned to patients suffering from complement - mediated diseases , " Stonehouse added . Program Updates and Key Milestones ORLADEYOTM ( berotralstat ) : Oral , Once - daily Treatment for Prevention of Hereditary Angioedema ( HAE ) Attacks • ORLADEYO net revenue in the first quarter of 2021 , the first full quarter of launch in the United States , was $ 10.9 million . ● • The majority of ORLADEYO revenue in the first quarter of 2021 came from new patients who switched to ORLADEYO from either injectable / infused prophylactic medications or from acute - only treatment . The remainder came from patients transitioning from clinical trials and the company's early access program . European Approvals and Launches • On April 30 , 2021 , the company announced that the European Commission ( EC ) had approved oral , once - daily ORLADEYO for the prevention of recurrent hereditary angioedema ( HAE ) attacks in HAE patients 12 years and older . The EC approval of ORLADEYO is applicable to all European Union member states plus Iceland , Norway and Liechtenstein . BioCryst has its European commercial team in place and expects to launch ORLADEYO in the second quarter in Germany , with launches in other European markets to follow . HAE patients in France currently have access to ORLADEYO through an Autorisation Temporaire d'Utilisation de cohorte ( cohort ATU ) . • On March 2 , 2021 , the company announced the submission of a marketing authorization application ( MAA ) to the United Kingdom's Medicines and Healthcare products Regulatory Agency ( MHRA ) seeking approval of ORLADEYO for the prevention of recurrent HAE attacks in HAE patients 12 years and older . The MAA was submitted under the MHRA's new European Commission Decision Reliance Procedure . If approved , ORLADEYO would be the first oral , once - daily therapy in the United Kingdom to treat patients with HAE . Japanese Approval and Launch • On January 22 , 2021 , the company announced that the Ministry of Health , Labor and Welfare ( MHLW ) in Japan had granted marketing and manufacturing approval for oral , once - daily ORLADEYO 150 mg for prophylactic treatment of HAE in adults and pediatric patients 12 years and older . • On April 14 , 2021 , the company announced that the Japanese National Health Insurance System ( NHI ) approved the addition of oral , once - daily ORLADEYO ™ ( berotralstat ) to the NHI drug price list on April 21 , 2021. This triggered a $ 15 million milestone payment to BioCryst from Torii Pharmaceutical Co. , Ltd. , the company's commercial partner in Japan . • ORLADEYO is the first and only prophylactic HAE medication approved in Japan . Torii launched ORLADEYO in Japan on April 23 , 2021. BioCryst will receive tiered royalties ranging from 20 percent to 40 percent of Japanese net sales . Complement Oral Factor D Inhibitor Program – BCX9930 • BioCryst has reached agreement with the U.S. Food and Drug Administration ( FDA ) that the primary endpoint for the upcoming pivotal trials in paroxysmal nocturnal hemoglobinuria ( PNH ) is change from baseline in hemoglobin . On March 22 , 2021 the company announced that BCX9930 increased hemoglobin from baseline by a mean of 3.3 g / dL in C5