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BioCryst Pharmaceuticals, Inc. (BCRX)

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14.38+1.54 (+11.99%)
At close: 4:00PM EDT

14.38 0.00 (0.00%)
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Previous close12.84
Open12.81
Bid0.00 x 2900
Ask0.00 x 3200
Day's range12.64 - 14.44
52-week range3.30 - 14.44
Volume7,473,598
Avg. volume5,461,211
Market cap2.555B
Beta (5Y monthly)2.66
PE ratio (TTM)N/A
EPS (TTM)-1.21
Earnings date04-Aug-2021 - 09-Aug-2021
Forward dividend & yieldN/A (N/A)
Ex-dividend dateN/A
1y target est16.56
  • BioCryst Receives UK Approval of ORLADEYO™ (berotralstat), First Oral, Once-daily Therapy to Prevent Attacks in Hereditary Angioedema Patients
    GlobeNewswire

    BioCryst Receives UK Approval of ORLADEYO™ (berotralstat), First Oral, Once-daily Therapy to Prevent Attacks in Hereditary Angioedema Patients

    RESEARCH TRIANGLE PARK, N.C., May 12, 2021 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for oral, once-daily ORLADEYO™ (berotralstat) for the routine prevention of recurrent hereditary angioedema (HAE) attacks in HAE patients 12 years and older. “HAE UK welcomes the decision from the MHRA to grant marketing authorization for berotralstat in the UK. Hereditary angioedema is an unpredictable and life-threatening condition which causes significant emotional and economic burdens on people with HAE and their families and careers. These burdens negatively impact their mental health and well-being, on top of the physical demands of living with a chronic condition. An oral therapy that shows effective control of HAE attacks will provide a different treatment choice for clinicians and patients and will assist in improving the quality of life of those living with the condition,” said Laura Szutowicz, chief executive officer of HAE UK. “This is a significant milestone in furthering our ability to meet the needs of more patients living with HAE. As the first oral, once-daily therapy proven to reduce the number of HAE attacks, today’s news has the potential to offer a convenient new treatment option to improve the lives and outcomes of patients with HAE,” said Dr. Sorena Kiani, consultant immunologist at Barts Health NHS Trust. A decision from the National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC) for use of ORLADEYO under the UK’s National Health Service (NHS) is anticipated in the fourth quarter of 2021. “With the approval of the first oral, once-daily treatment in the UK, BioCryst continues to bring ORLADEYO to HAE patients and their families around the world,” said Jon Stonehouse, president and chief executive officer of BioCryst. In the pivotal Phase 3 APeX-2 trial, ORLADEYO significantly reduced attacks at 24 weeks, and this reduction was sustained through 48 weeks. HAE patients who completed 48 weeks of treatment (150 mg) saw reductions in their HAE attack rates, from a mean of 2.9 attacks per month at baseline to a mean of 1.0 attacks per month after 48 weeks of therapy. In the long-term open label APeX-S trial, patients completing 48 weeks of therapy (150 mg) had a mean attack rate of 0.8 attacks per month. ORLADEYO was safe and well tolerated in both trials. The most frequently reported adverse reactions in patients receiving ORLADEYO compared with placebo were gastrointestinal reactions. These reactions generally occurred early after initiation of treatment with ORLADEYO, became less frequent with time and typically self-resolved. HAE patients note a significant treatment burden associated with existing prophylactic therapy. In addition to reducing HAE attack rate, data from APeX-2 show that patients reported meaningful improvements in both quality of life, overall patient-reported satisfaction, and significant reductions in their monthly use of standard of care on-demand medicine, while taking oral, once-daily ORLADEYO (150 mg). About ORLADEYO™ (berotralstat)ORLADEYO™ (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein. The UK Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL) for ORLADEYO will be available from the MHRA website at https://products.mhra.gov.uk/. About BioCryst Pharmaceuticals BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily ORLADEYO™ (berotralstat) is approved in the United States, European Union, Japan and the United Kingdom for the prevention of HAE attacks in adults and pediatric patients 12 years and older. BioCryst has several ongoing development programs including BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva, and galidesivir, a potential treatment for Marburg virus disease and Yellow Fever. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan and Korea. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the company’s website at www.biocryst.com. Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding BioCryst’s plans and expectations for ORLADEYO. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: the ongoing COVID-19 pandemic, which could create challenges in all aspects of BioCryst’s business, including without limitation delays, stoppages, difficulties and increased expenses with respect to BioCryst’s and its partners’ development, regulatory processes and supply chains, negatively impact BioCryst’s ability to access the capital or credit markets to finance its operations, or have the effect of heightening many of the risks described below or in the documents BioCryst periodically files with the Securities and Exchange Commission; BioCryst’s ability to successfully implement its commercialization plans for, and to commercialize, ORLADEYO, which could take longer or be more expensive than planned; risks relating to government actions, including that decisions and other actions relating to pricing and reimbursements may not be taken when expected or at all, or that the outcomes of such decisions and other actions may not be in line with BioCryst’s current expectations; the commercial viability of ORLADEYO, including its ability to achieve market acceptance; the FDA, EMA, MHRA, PMDA or other applicable regulatory agency may require additional studies beyond the studies planned for products and product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials, may impose certain restrictions, warnings, or other requirements on products and product candidates, may impose a clinical hold with respect to product candidates, or may withhold, delay, or withdraw market approval for products and product candidates; BioCryst’s ability to successfully manage its growth and compete effectively; risks related to the international expansion of BioCryst’s business; and actual financial results may not be consistent with expectations, including that operating expenses and cash usage may not be within management's expected ranges. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s forward-looking statements. BCRXW Contact:InvestorsJohn Bluth+1 919 859 7910jbluth@biocryst.com MediaCatherine Collier Kyroulis+1 917 886 5586ckyroulis@biocryst.com

  • BioCryst Reports First Quarter 2021 Financial Results and Upcoming Key Milestones
    GlobeNewswire

    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— 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 ORLADEYO™ (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 inadequate response (no prior treatment with C5 inhibitors) patients and 3.5 g/dL in treatment-naïve patients and reduced transfusions in an ongoing dose-ranging trial in PNH patients. BCX9930 was safe and generally well-tolerated in the trial.In the second half of 2021, the company plans to advance directly into PNH pivotal trials with oral BCX9930, at a dose of 500 mg bid, in patients naïve to C5 inhibitors, and patients with an inadequate response to C5 inhibitors. The goal of the pivotal trials is to achieve a broad indication for BCX9930 to treat PNH as oral monotherapy. Also in the second half of 2021, the company plans to initiate a proof of concept trial of oral BCX9930 (500 mg bid) in renal complement-mediated diseases. Additional Updates On February 3, 2021, the company announced that the FDA had approved a supplemental new drug application for RAPIVAB® (peramivir injection) expanding the patient population of RAPIVAB for the treatment of acute uncomplicated influenza to include patients six months and older who have been symptomatic for no more than two days. Prior to this approval, RAPIVAB had been indicated for patients two years and older.On March 19, 2021, the company announced the appointment of Helen Thackray, M.D., FAAP, to the newly created position of chief research and development officer. First Quarter 2021 Financial Results For the three months ended March 31, 2021, total revenues were $19.1 million, compared to $4.8 million in the first quarter of 2020. The increase was primarily due to $10.9 million in ORLADEYO net revenue in the first quarter of 2021. Research and development (R&D) expenses for the first quarter of 2021 increased to $42.4 million from $29.9 million in the first 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 (SG&A) expenses for the first quarter of 2021 increased to $22.1 million, compared to $15.9 million in the first quarter of 2020. The increase was primarily due to increased investment in to support the U.S. commercial launch of ORLADEYO and expanded international operations. Interest and other income in the first quarter of 2021 was $6.4 million lower than the first quarter of 2020, primarily due to the partial arbitration award in the first quarter of 2020 related to our Seqirus dispute. Interest expense was $12.9 million in the first quarter of 2021, compared to $3.0 million in the first quarter of 2020. The increase was due to service on the royalty and debt financings which were completed in December 2020. Net loss for the first quarter of 2021 was $64.3 million, or $0.36 per share, compared to a net loss of $37.6 million, or $0.24 per share, for the first quarter of 2020. Cash, cash equivalents, restricted cash and investments totaled $244.4 million at March 31, 2021, compared to $114.6 million at March 31, 2020. Operating cash use for the first quarter of 2021 was $60.0 million. Financial Outlook for 2021 In the launch period for ORLADEYO, the company is not providing specific revenue or operating expense guidance. Based on our expectations for revenue, operating expenses, and our option to access an additional $75 million from our existing credit facility, we believe our current cash runway takes us into 2023. Conference Call and Webcast BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 2660434. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 2660434. About BioCryst Pharmaceuticals BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily ORLADEYO™ (berotralstat) is approved in the United States, European Union, and Japan for the prevention of HAE attacks in adults and pediatric patients 12 years and older, and under regulatory review for approval in the United Kingdom. BioCryst has several ongoing development programs including BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva, and galidesivir, a potential treatment for Marburg virus disease and Yellow Fever. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan and Korea. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the company’s website at www.biocryst.com. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: the ongoing COVID-19 pandemic, which could create challenges in all aspects of BioCryst’s business, including without limitation delays, stoppages, difficulties and increased expenses with respect to BioCryst’s and its partners’ development, regulatory processes and supply chains, negatively impact BioCryst’s ability to access the capital or credit markets to finance its operations, or have the effect of heightening many of the risks described below or in the documents BioCryst files periodically with the Securities and Exchange Commission; BioCryst’s ability to successfully implement its commercialization plans for, and to commercialize ORLADEYO, which could take longer or be more expensive than planned; the results of BioCryst’s partnerships with third parties, including Torii, may not meet BioCryst’s current expectations; risks related to government actions, including that decisions and other actions, including as they relate to pricing, may not be taken when expected or at all, or that the outcomes of such decisions and other actions may not be in line with BioCryst’s current expectations; the commercial viability of ORLADEYO, including its ability to achieve market acceptance, which could also impact the amount of any related royalties BioCryst would be entitled to receive from Torii; ongoing and future preclinical and clinical development of BCX9930, BCX9250 and galidesivir may not have positive results; BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; BioCryst may not advance human clinical trials with product candidates as expected; the FDA, EMA, PMDA or other applicable regulatory agency may require additional studies beyond the studies planned for products and product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials, may impose certain restrictions, warnings, or other requirements on products and product candidates, may impose a clinical hold with respect to product candidates, or may withhold, delay or withdraw market approval for products and product candidates; product candidates, if approved, may not achieve market acceptance; BioCryst’s ability to successfully manage its growth and compete effectively; risks related to the international expansion of BioCryst’s business; and actual financial results may not be consistent with expectations, including that operating expenses and cash usage may not be within management's expected ranges. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s projections and forward-looking statements. BCRXW Investors:John Bluth+1 919 859 7910jbluth@biocryst.com Media:Catherine Collier Kyroulis+1 917 886 5586ckyroulis@biocryst.com BIOCRYST PHARMACEUTICALS, INC. CONSOLIDATED FINANCIAL SUMMARY (in thousands, except per share) Statements of Operations (Unaudited) Three Months Ended March 31, 2021 2020 Revenues: Product sales$17,871 $218 Royalty revenue (897) 1,945 Collaborative and other research and development 2,085 2,660 Total revenues 19,059 4,823 Expenses: Cost of product sales 5,923 - Research and development 42,435 29,867 Selling, general and administrative 22,114 15,865 Royalty (36) 69 Total operating expenses 70,436 45,801 Loss from operations (51,377) (40,978) Interest and other income 26 6,446 Interest expense (12,904) (3,047) Loss on foreign currency (29) (20) Net loss$(64,284) $(37,599) Basic and diluted net loss per common share$(0.36) $(0.24) Weighted average shares outstanding 177,343 154,156 Balance Sheet Data (in thousands) March 31, 2021 December 31, 2020 (Unaudited) (Note 1)Cash, cash equivalents and investments $ 240,356 $ 300,366 Restricted cash 4,008 2,221 Receivables 18,386 8,646 Total assets 284,431 334,715 Non-recourse notes payable 30,000 30,000 Secured term loan 123,039 119,735 Royalty financing obligation 131,296 124,717 Accumulated deficit (1,087,726) (1,023,442)Stockholders’ deficit (74,988) (19,262)Shares of common stock outstanding 177,670 176,883 Note 1: Derived from audited financial statements.

  • BioCryst to Present at Upcoming Investor Conferences
    GlobeNewswire

    BioCryst to Present at Upcoming Investor Conferences

    RESEARCH TRIANGLE PARK, N.C., May 05, 2021 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the company will present at the Bank of America 2021 Healthcare Conference on Wednesday, May 12, 2021 at 12:30 p.m. ET and the 2021 RBC Capital Markets Global Healthcare Conference on Wednesday, May 19, 2021 at 1:20 p.m. ET. Both are being conducted as virtual conferences. Links to a live audio webcast and replay of these presentations may be accessed in the Investors section of BioCryst’s website at http://www.biocryst.com. About BioCryst Pharmaceuticals BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily ORLADEYO™ (berotralstat) is approved in the United States, European Union, and Japan for the prevention of HAE attacks in adults and pediatric patients 12 years and older, and under regulatory review for approval in the United Kingdom. BioCryst has several ongoing development programs including BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva, and galidesivir, a potential treatment for Marburg virus disease and Yellow Fever. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan and Korea. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the company’s website at www.biocryst.com. BCRXW Investors:John Bluth+1 919 859 7910jbluth@biocryst.com Media:Catherine Collier Kyroulis+1 917 886 5586ckyroulis@biocryst.com