LL schreef op 5 augustus 2021 15:15:
BioCryst Reports Second Quarter 2021 HAE highlights—2Q 2021 revenue of $50.0 million—
—ORLADEYO® (berotralstat) net revenue of $28.5 million—RESEARCH TRIANGLE PARK, N.C., Aug. 05, 2021 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced financial results for the second quarter ended June 30, 2021, and provided a corporate update.
“BioCryst is in an outstanding position, both near-term and long-term, with growing revenue from a strong ORLADEYO launch in the U.S., more approvals and launches of ORLADEYO around the globe and a pipeline in a molecule with our oral Factor D inhibitor, BCX9930, entering pivotal trials this year in the first of many indications,” said Jon Stonehouse, president and chief executive officer of BioCryst.
Program Updates and Key MilestonesORLADEYO® (berotralstat): Oral, Once-daily Treatment for Prevention of Hereditary Angioedema (HAE) Attacks
U.S. Launch
“The ORLADEYO launch is off to an excellent start because HAE patients want a safe and effective oral medicine to control their attacks and reduce their burden of therapy, and switching to ORLADEYO meets these needs for them,” said Charlie Gayer, chief commercial officer of BioCryst.
ORLADEYO net revenue in the second quarter of 2021 was $28.5 million.
Patient switches continue to drive the launch with 60 percent of patients who were new to ORLADEYO in the second quarter switching from other prophylactic medicine to ORLADEYO and the remainder from acute-only treatment. The number of physicians prescribing ORLADEYO grew by approximately 50 percent in second quarter.
The majority (approximately 70 percent) of HAE patients in the U.S. now have access to ORLADEYO through insurance policies.
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 On July 10, 2021, the company announced data presented at the European Academy of Allergy and Clinical Immunology Hybrid Congress 2021. HAE patients who were randomized to receive 150 mg of oral, once-daily ORLADEYO at the start of the APeX-2 trial had an 80 percent average reduction in their mean attack rate per month during weeks 25-96 of the trial, compared to baseline. Median attack rates also decreased from 2.7 attacks/month at baseline to 0.0 attacks per month in 16 of 17 months through the same period. ORLADEYO was generally well-tolerated during the treatment period with fewer drug-related adverse events reported in part 3 (weeks 49-96) as compared to part 1 (weeks 0-24) and part 2 (weeks 25-48). Eighty-one percent of the patients who entered part 3 completed the trial.
On June 16, 2021, the company announced that the Israeli Ministry of Health has accepted the regulatory submission of ORLADEYO for the prevention of recurrent attacks in patients with hereditary angioedema (HAE) 12 years and older. In addition, BioCryst entered into a distribution and supply agreement granting Neopharm Ltd., the exclusive rights to commercialize ORLADEYO in Israel.
On June 3, 2021, the company announced the launch of ORLADEYO in Germany.
On May 12, 2021, the company announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency has granted marketing authorization for ORLADEYO for the routine prevention of HAE attacks in HAE patients 12 years and older.
On April 30, 2021, the company announced that the European Commission (EC) has approved ORLADEYO for the prevention of recurrent 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.
On April 14, 2021, the company announced that the Japanese National Health Insurance System (NHI) approved the addition of ORLADEYO 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, which BioCryst received and recognized in the second quarter.
Additional Updates On July 28, 2021, the company announced the appointment of Vincent Milano to the BioCryst board of directors.
Second Quarter 2021 Financial ResultsFor the three months ended June 30, 2021, total revenues were $50.0 million, compared to $2.9 million in the second quarter of 2020. The increase was primarily due to $28.5 million in ORLADEYO net revenue in the second quarter of 2021, the recognition of a $15 million milestone payment to BioCryst from Torii Pharmaceutical Co., Ltd., the company’s commercial partner in Japan, following approval and successful pricing negotiations in Japan, and $4.6 million for RAPIVAB® (peramivir injection) stockpile sales to the government, all realized in the second quarter of 2021.
Research and development expenses for the second quarter of 2021 increased to $52.9 million from $27.5 million in the second quarter of 2020, primarily due to increased investment in the development of BCX9930 as well as other research, preclinical and development costs, offset by a reduction in spend on the ORLADEYO program following our commercial launch in December 2020.
Selling, general and administrative expenses for the second quarter of 2021 increased to $26.3 million, compared to $13.9 million in the second quarter of 2020. The increase was primarily due to increased investment to support the U.S. commercial launch of ORLADEYO and expanded international operations.
Interest expense was $13.5 million in the second quarter of 2021, compared to $2.9 million in the second quarter of 2020. The increase was due to service on the royalty and debt financings which were completed in December 2020. The interest payment-in-kind (PIK) option on the Athyrium term loan has been exercised and $3.9 million has been added to the $125 million principal in the second quarter of 2021, and $7.5M since issuance.
Net loss for the second quarter of 2021 was $43.2 million, or $0.24 per share, compared to a net loss of $38.6 million, or $0.24 per share, for the second quarter of 2020.
Cash, cash equivalents, restricted cash and investments totaled $222.8 million at June 30, 2021, compared to $191.6 million at June 30, 2020. Operating cash use for the second quarter of 2021 was $22.0 million.
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