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Share Name | Share Symbol | Market | Type |
---|---|---|---|
BioCryst Pharmaceuticals Inc | NASDAQ:BCRX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 4.16 | 4.16 | 4.24 | 4.26 | 4.11 | 4.21 | 2,310,948 | 01:00:00 |
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Per share
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Per pre-funded
warrant |
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Total
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Public offering price
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$
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$
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$
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Underwriting discounts and commissions(1)
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$
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$
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$
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Proceeds to BioCryst, before expenses
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$
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$
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$
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(1)
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We have agreed to reimburse the underwriters for certain FINRA-related expenses. See “Underwriting.”
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J.P. Morgan
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Piper Sandler
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the impact of the ongoing novel coronavirus (“COVID-19”) pandemic on all aspects of our business, including without limitation delays, stoppages, difficulties and increased expenses with respect to our and our partners’ development, regulatory and supply chain operations, or on our ability to access the capital or credit markets to finance our operations;
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the preclinical development, clinical development, commercialization, or post-marketing studies of our product candidates and products, including our hereditary angioedema (“HAE”) programs, BCX9930, BCX9250, peramivir, galidesivir, and early stage discovery programs;
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the potential funding from our contracts with the Biomedical Advanced Research and Development Authority (the “BARDA/HHS”) and the National Institute of Allergy and Infectious Diseases (“NIAID/HHS”) for the development of galidesivir;
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the potential for government stockpiling orders of peramivir and galidesivir, additional regulatory approvals of peramivir, or milestones, royalties or profit from sales of peramivir by us or our partners;
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the potential use of peramivir as a treatment for H1N1, H5N1, and H7N9 or other strains of influenza;
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the implementation of our business model, strategic plans for our business, products, product candidates and technology;
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our ability to establish and maintain collaborations or out-license rights to our product candidates;
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the outcome, cost and timing of any resolution of disputes and legal proceedings, including but not limited to the dispute with our partner Seqirus UK Limited (“SUL”);
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plans, programs, progress and potential success of our collaborations, including SUL for peramivir, Mundipharma International Holdings Limited (“Mundipharma”) for mundesine, Torii Pharmaceutical, Ltd. (“Torii”) for berotralstat (BCX7353) in Japan and Shionogi & Co. Ltd. (“Shionogi”) and Green Cross Corporation (“Green Cross”) for peramivir in their territories;
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our ability, and the ability of our consolidated subsidiary, MDCP, LLC, to satisfy obligations under our secured loan facility with MidCap Financial, a Delaware statutory trust, pursuant to the terms and conditions of the Second Amended and Restated Credit and Security Agreement dated as of February 5, 2019, as amended (the “Second Amended and Restated Senior Credit Facility”);
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the ability of our wholly owned subsidiary, JPR Royalty Sub LLC (“Royalty Sub”) to service its payment obligations in respect of its PhaRMA Senior Secured 14.0% Notes due 2020 (the “PhaRMA Notes”);
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the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
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our ability to operate our business without infringing the intellectual property rights of others;
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estimates of our expenses, revenues, capital requirements, annual cash utilization, and our needs for additional financing;
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our ability to continue as a going concern;
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the timing or likelihood of regulatory filings or regulatory agreements, deferrals, and approvals;
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the timing or likelihood of entering into additional U.S. government stockpile orders and our ability to execute any such order;
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our ability to raise additional capital to fund our operations or repay our recourse debt obligations;
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our ability to comply with the covenants as set forth in the agreements governing our debt obligations;
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our financial performance;
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the timing and success of our anticipated commercialization of berotralstat in the U.S. and elsewhere; and
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competitive companies, technologies and our industry.
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Drug/Drug
Candidate |
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Drug Class
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Therapeutic
Area(s) |
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Phase
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Rights
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Berotralstat
(BCX7353) |
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Oral Serine Protease Inhibitor Targeting Kallikrein (once-daily treatment)
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HAE
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NDA and MAA accepted for review. (PDUFA Date 12/3/2020; MAA approval anticipated March 2021)
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BioCryst (worldwide, except Japan)
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Oral Serine Protease Inhibitor Targeting Kallikrein (once-daily treatment)
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HAE
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JNDA accepted for review
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Torii Pharmaceutical Co., Ltd. (Japan)
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Distinct and different oral dose formulation for acute treatment
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HAE
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Phase 2 completed
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BioCryst (worldwide)
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BCX9930
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Oral Factor D Inhibitor
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Complement-
mediated diseases |
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Phase 1
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BioCryst (worldwide)
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Drug/Drug
Candidate |
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Drug Class
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Therapeutic
Area(s) |
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Phase
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Rights
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BCX9250
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Oral Activin Receptor-Like Kinase-2 Inhibitors
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Fibrodysplasia Ossificans Progressiva (“FOP”)
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Phase 1
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BioCryst (worldwide)
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RAPIVAB®
(peramivir injection) |
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Intravenous Neuraminidase Inhibitor
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Acute uncomplicated Influenza
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Approved (U.S., Australia & Canada)
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Seqirus UK Limited (worldwide, except Japan, Taiwan, Korea and Israel)*; BioCryst retains full U.S. Government stockpiling rights
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ALPIVABTM
(peramivir injection) |
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Intravenous Neuraminidase Inhibitor
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Acute uncomplicated Influenza
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Approved (European Union)
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Seqirus UK Limited (worldwide, except Japan, Taiwan, Korea and Israel)*
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RAPIACTA®
(peramivir injection) |
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Intravenous Neuraminidase Inhibitor
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Uncomplicated seasonal influenza
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Approved (Japan & Taiwan)
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Shionogi & Co., Ltd. (Japan & Taiwan)
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PERAMIFLU®
(peramivir injection) |
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Intravenous Neuraminidase Inhibitor
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Uncomplicated seasonal influenza
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Approved (Korea)
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Green Cross Corporation (Korea)
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Galidesivir
(BCX4430) |
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RNA dependent-RNA Polymerase Inhibitor
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Broad spectrum antiviral for 20 RNA viruses, COVID-19, Marburg, Yellow Fever, and Ebola
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Phase 1
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BioCryst (worldwide)
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Mundesine®
(forodesine) |
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Oral Purine Nucleoside Phosphorylase Inhibitor
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Oncology - PTCL
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Approved (Japan)
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Mundipharma International Corporation Limited (worldwide)
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*
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On March 4, 2020, the International Court of Arbitration of the International Chamber of Commerce (“ICC Tribunal”) delivered a Partial Arbitration Award in the arbitration matter between the Company and Seqirus UK Limited (“SUL”). The ICC Tribunal granted a declaratory judgment in favor of the Company terminating the agreement between the Company and SUL and restoring all rights to peramivir to the Company as of March 17, 2020 (or such other date as the parties agree). See our Current Report on Form 8-K filed on March 10, 2020.
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Focusing on High Value-Added Structure-Guided Drug Design Technologies. We utilize structure-guided drug design in order to most efficiently develop new therapeutic candidates. Structure-guided drug design is a process by which we design a product candidate through detailed analysis of the enzyme target, which the product candidate must inhibit in order to stop the progression of the disease or disorder. We believe that structure-guided drug design is a powerful tool for the efficient development of small-molecule product candidates that have the potential to be safe and effective. Our structure-guided drug design technologies typically allow us to design and synthesize multiple product candidates that inhibit the same enzyme target, with the goal of establishing broad intellectual property protection and formulating compounds with competitive advantages.
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Selecting Inhibitors that are Promising Product Candidates. We start by selecting disease targets with well-understood biology and characteristics that fit with our ability to utilize structure-guided drug design capabilities to build potent and specific enzyme inhibitors. Next, we narrow our selection of these product candidates based on product characteristics, such as initial indications of safety and biologic activity on the target.
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Developing our Product Candidates Efficiently. An important element of our business strategy is to efficiently progress our product candidates through the development process. In order to accomplish this, we typically strive for disease targets with a defined clinical and regulatory pathway for approval. In addition, we control fixed costs and overhead by outsourcing with strategic partners and contractors or entering into license agreements with third parties, including the U.S. Government. By contracting with the U.S. Government and outsourcing certain aspects of our operations, we are able to control overhead costs and focus financial resources directly where they provide the most benefit and reduce our business risk.
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Commercializing our Product Candidates Globally. A core part of our strategy is to commercialize our rare disease products globally. We are building the structure and expertise to commercialize our products in markets where we believe we can do this efficiently and effectively, such as the United States and Europe. We also will seek licensing or distribution partners in certain markets where we determine this to be the more effective approach.
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Advancing our Government-Funded Antiviral Programs to Address Public Health Needs. We continue to work with the federal government in the area of antiviral development and supply to address public health needs. Our government-funded antiviral programs include the development of candidates for potential use against a variety of viruses (including galidesivir for potential use against COVID-19, yellow fever, and other RNA viruses) and the stockpiling of antivirals for government use (including RAPIVABTM for the CDC’s Strategic National Stockpile).
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worldwide development, manufacturing, regulatory, pre-launch and commercial activities for the prophylactic berotralstat program in the US and EU;
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advancement of the worldwide development, manufacturing, regulatory and clinical activities for BCX9930 for complement-mediated diseases;
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post-approval commitments for RAPIVABTM/ALPIVABTM; and
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capital expenditures and other general working capital needs. See “Use of Proceeds.”
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19,295,174 shares of common stock issuable upon the exercise of stock options outstanding under our Stock Incentive Plan and 2,493,168 shares of common stock issuable upon the exercise of stock options outstanding under our Inducement Equity Incentive Plan as of May 26, 2020, at a weighted average exercise price of $5.86 per share and $3.32 per share, respectively; and
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10,546,020 additional shares of common stock reserved for issuance under our Stock Incentive Plan, 706,832 additional shares of common stock reserved for issuance under our Inducement Equity Incentive Plan, and 3,009,484 additional shares of common stock reserved for issuance under our Employee Stock Purchase Plan as of May 26, 2020.
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our or our partners’ ability to secure suitable clinical sites and investigators and to enroll and maintain an adequate number of patients on a timely basis or at all;
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patients that enroll in a clinical trial may not comply with the clinical trial protocol or maintain contact with investigators to provide complete data during and after treatment;
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our product candidates may not prove to be either safe or effective or may produce unfavorable or inconclusive results;
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we or our partners may decide, or be required by regulatory authorities, to suspend or terminate clinical research for various reasons, including a finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of the product candidate, noncompliance with regulatory requirements or their standards of conduct, or findings of undesirable effects caused by a chemically or mechanistically similar product or product candidate;
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regulatory authorities may disagree with our or our partners’ clinical trial protocols or our or their interpretation of data from preclinical studies and clinical trials;
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clinical protocols or study procedures may not be adequately designed or followed by the investigators;
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formulation improvements may not work as expected, which could negatively impact commercial demand for our product candidates;
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regulatory authorities may fail to approve or subsequently find fault with the manufacturing processes or facilities of third party manufactures with which we or our partners enter into agreements for clinical and commercial supplies;
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the supply or quantity of raw materials or manufactured product candidates or other materials necessary to conduct development activities may be insufficient, inadequate, or unavailable at an acceptable cost, and we or our partners may experience interruptions in supply;
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our or our partners’ development plans may be delayed or changed as a result of changes in development strategy, the impact of new or different regulations, requirements, and guidelines, or other unexpected events or conditions;
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the cost of pre-clinical studies and clinical trials may be greater than we anticipate;
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third-party contractors, including those manufacturing our product candidates or components or ingredients thereof, or conducting clinical trials or laboratory testing on our or our partners’ behalf, may fail to comply with regulatory requirements and industry standards or meet their contractual obligations in a timely manner or at all; and
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the impact of the COVID-19 pandemic on one or more of the foregoing factors.
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discovery of natural proteins that cause or enable biological reactions necessary for the progression of the disease or disorder, called enzyme targets;
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execution of certain pharmacology preclinical studies and late-stage development for our compounds and product candidates;
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management of our Phase 1, 2 and 3 clinical trials, including medical monitoring, laboratory testing, and data management;
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execution of toxicology studies that may be required to obtain approval for our product candidates;
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formulation improvement strategies and methods;
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manufacturing the starting materials and drug substance required to formulate our products and the product candidates to be used in our clinical trials, toxicology studies and any potential commercial product; and
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management of certain regulatory interactions outside of the United States.
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adverse drug experience reporting regulations;
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product promotion;
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product manufacturing, including good manufacturing practice requirements; and
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product changes or modifications.
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regulatory authorities may withdraw their approval of, or impose marketing or manufacturing restrictions on, the product, or require us or our partners to create a medication guide outlining the risks of unidentified side effects for distribution to patients;
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we or our partners may be required to recall the product, change the way the product is administered, conduct additional clinical trials, or be subject to civil or criminal penalties; and
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the product may become less competitive and our reputation may suffer.
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our partners may seek to renegotiate or terminate their relationships with us due to unsatisfactory commercial, regulatory or clinical results, including post approval clinical commitments, a change in business strategy, a change of control or other reasons;
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our contracts for collaborative arrangements may expire;
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our partners may choose to pursue alternative technologies, including those of our competitors;
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we may have disputes with a partner that could lead to litigation or arbitration, such as the recent arbitration proceeding between us and SUL, which could result in substantial costs and divert the attention of our management;
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we do not have day to day control over the activities of our partners and have limited control over their decisions;
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our ability to generate future event payments and royalties from our partners depends upon their abilities to establish the safety and efficacy of our product candidates, obtain regulatory approvals and achieve market acceptance of products developed from our product candidates;
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we or our partners may fail to properly initiate, maintain or defend our intellectual property rights, where applicable, or a party may utilize our proprietary information in such a way as to invite litigation that could jeopardize or potentially invalidate our proprietary information or expose us to potential liability;
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we or our partners may not devote sufficient capital or resources towards our product candidates; and
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we or our partners may not comply with applicable government regulatory requirements.
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we or our partners may fail to successfully complete clinical trials, or satisfy post-marketing commitments, sufficient to obtain and keep regulatory agency marketing approval;
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many competitors are more experienced and have significantly more resources, and their products could reach the market faster, be more cost effective or have a better efficacy or tolerability profile than our product candidates;
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we may fail to employ a comprehensive and effective intellectual property strategy, which could result in decreased commercial value of our Company and our products;
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we may fail to employ a comprehensive and effective regulatory strategy, which could result in a delay or failure in commercialization of our products;
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our ability to successfully commercialize our products is affected by the competitive landscape, which cannot be fully known at this time;
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reimbursement is constantly changing, which could greatly affect usage of our products;
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future revenue from product sales would depend on our ability to successfully complete clinical studies, obtain regulatory approvals, and manufacture, market and commercialize our approved drugs; and
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the impact of the COVID-19 pandemic on us or our partners.
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inconsistent production yields;
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product liability claims or recalls of commercial product;
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difficulties in scaling production to commercial and validation sizes;
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interruption of the delivery of materials required for the manufacturing process;
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scheduling of plant time with other vendors or unexpected equipment failure;
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potential catastrophes that could strike their facilities or have an effect on infrastructure;
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potential impurities in our drug substance or products that could affect availability of product for our clinical trials or future commercialization;
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poor quality control and assurance or inadequate process controls; and
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lack of compliance or cooperation with regulations and specifications or requests set forth by the FDA or other foreign regulatory agencies or local customs, particularly associated with berotralstat, BCX9930, BCX9250, galidesivir, peramivir and our early stage compounds.
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peramivir may not prove to be adequately safe and effective for market approval in markets other than the United States, Canada, Japan, Korea, Taiwan, Australia and the European Union (“EU”);
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necessary funding for post-marketing commitments and further development of peramivir may not be available timely, at all, or in sufficient amounts;
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flu prevention or pandemic treatment concerns may not materialize at all, or in the near future;
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advances in flu vaccines or other antivirals, including competitive i.v. antivirals, could substantially replace potential demand for peramivir;
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a limited number of governmental entities are expected to be the primary potential stockpiling customers for peramivir and if we are not successful at marketing peramivir to these entities for any reason, we will not receive substantial revenues from stockpiling orders;
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government and third party payors may not provide sufficient coverage or reimbursement which would negatively impact the demand for peramivir;
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we may not be able to supply commercial material to our partners and our partners may not be able to maintain or establish sufficient and acceptable commercial manufacturing, either directly or through third-party manufacturers;
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the commercial demand and acceptance for peramivir by healthcare providers and by patients may not be sufficient to result in substantial revenues of peramivir to our partners and may result in little to no milestones or royalties to us;
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effectiveness of marketing and commercialization efforts for peramivir by our partners;
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market satisfaction with existing alternative therapies;
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perceived efficacy relative to other available therapies;
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disease prevalence;
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cost of treatment;
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pricing and availability of alternative products;
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marketing and sales activities of competitors;
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shifts in the medical community to new treatment paradigms or standards of care; and
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relative convenience and ease of administration.
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other drug development technologies;
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methods of preventing or reducing the incidence of disease, including vaccines; and
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new small molecule or other classes of therapeutic agents.
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capital resources;
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research and development resources, including personnel and technology;
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regulatory experience;
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preclinical study and clinical testing experience;
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manufacturing and marketing experience; and
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production facilities.
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multiple, conflicting, and changing laws and regulations such as privacy and data regulations, transparency regulations, tax laws, export and import restrictions, employment laws, regulatory requirements, and other governmental approvals, permits, and licenses;
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introduction of new health authority requirements and/or changes in health authority expectations;
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failure by us or our partners to obtain and maintain regulatory approvals for the use of our products in various countries;
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complexities and difficulties in obtaining protection for, and enforcing, our intellectual property;
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difficulties in staffing and managing foreign operations;
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complexities associated with managing multiple payor reimbursement regimes, government payors, or patient self-pay systems;
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limits on our ability to penetrate international markets;
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financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products, and exposure to foreign currency exchange rate fluctuations;
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natural disasters and political and economic instability, including wars, terrorism, political unrest, results of certain elections and votes, actual or threatened public health emergencies and outbreak of disease (including for example, the recent coronavirus outbreak), boycotts, adoption or expansion of government trade restrictions, and other business restrictions;
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certain expenses including, among others, expenses for travel, translation, and insurance;
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regulatory and compliance risks that relate to maintaining accurate information and control over commercial operations and activities that may fall within the purview of the U.S. Foreign Corrupt Practices Act, or FCPA, including its books and records provisions or anti-bribery provisions, or the U.K. Bribery Act and similar foreign laws and regulations; and
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regulatory and compliance risks relating to doing business with any entity that is subject to sanctions administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury.
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the degree and range of protection any patents will afford against competitors with similar products;
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if and when patents will issue;
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if patents do issue we cannot be sure that we will be able to adequately defend such patents and whether or not we will be able to adequately enforce such patents; or
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whether or not others will obtain patents claiming aspects similar to those covered by our patent applications.
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obtain licenses or redesign our products or processes to avoid infringement;
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stop using the subject matter claimed in those patents; or
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pay damages.
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terminate or reduce the scope of our contract with or without cause;
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interpret relevant regulations (federal acquisition regulation clauses);
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require performance under circumstances which may not be favorable to us;
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require an in process review where the U.S. Government will review the project and its options under the contract;
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control the timing and amount of funding, which impacts the development progress of our programs; and
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audit and object to our contract-related costs and fees, including allocated indirect costs.
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liabilities that substantially exceed our product liability insurance, which we would then be required to pay from other sources, if available;
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an increase of our product liability insurance rates or the inability to maintain insurance coverage in the future on acceptable terms, or at all;
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withdrawal of clinical trial volunteers or patients;
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damage to our reputation and the reputation of our products, resulting in lower sales;
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regulatory investigations that could require costly recalls or product modifications;
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litigation costs; and
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the diversion of management’s attention from managing our business.
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convey, sell, lease, license, transfer or otherwise dispose of certain parts of our business or property;
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change the nature of our business;
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liquidate or dissolve;
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enter into certain change in control or acquisition transactions;
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incur or assume certain debt, including accessing additional tranches of debt under the Second Amended and Restated Senior Credit Facility;
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grant certain types of liens on our assets;
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modify, liquidate or transfer assets in certain collateral accounts;
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pay dividends or make certain distributions to our stockholders;
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make certain investments;
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enter into material transactions with affiliates; and
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modify existing debt or collaboration arrangements.
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announcements of technological innovations or new products by us or our competitors;
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developments or disputes concerning patents or proprietary rights;
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additional dilution through sales of our common stock or other derivative securities;
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status of new or existing licensing or collaborative agreements and government contracts;
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announcements relating to the status of our programs;
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developments and announcements regarding new and virulent strains of influenza;
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we or our partners achieving or failing to achieve development milestones;
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publicity regarding actual or potential medical results relating to products under development by us or our competitors;
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publicity regarding certain public health concerns for which we are or may be developing treatments;
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regulatory developments in both the United States and foreign countries;
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public concern as to the safety of pharmaceutical products;
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actual or anticipated fluctuations in our operating results;
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changes in financial estimates or recommendations by securities analysts;
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changes in the structure of healthcare payment systems, including developments in price control legislation;
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announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;
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additions or departures of key personnel or members of our board of directors;
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purchases or sales of substantial amounts of our stock by existing stockholders, including officers or directors;
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economic and other external factors or other disasters or crises; and
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period-to-period fluctuations in our financial results.
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worldwide development, manufacturing, regulatory, pre-launch and commercial activities for the prophylactic berotralstat program in the US and EU;
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advancement of the worldwide development, manufacturing, regulatory and clinical activities for BCX9930 for complement-mediated diseases;
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•
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post-approval commitments for RAPIVABTM/ALPIVABTM; and
|
•
|
capital expenditures and other general working capital needs.
|
Public offering price per share
|
| |
|
| |
$
|
Net tangible book value per share as of March 31, 2020
|
| |
$0.03
|
| |
|
Increase in net tangible book value per share attributable to investors purchasing our common stock and pre-funded warrants in this offering
|
| |
$
|
| |
|
Net tangible book value per share as of March 31, 2020 after giving effect to this offering offering
|
| |
|
| |
$
|
Dilution in net tangible book value per share to investors purchasing our common stock in this offering
|
| |
|
| |
$
|
•
|
19,227,583 shares of common stock issuable upon the exercise of stock options outstanding under our Stock Incentive Plan as of March 31, 2020, at a weighted average exercise price of $5.87 per share;
|
•
|
2,033,168 shares of common stock issuable upon the exercise of stock options outstanding under our Inducement Equity Incentive Plan as of March 31, 2020, at a weighted average exercise price of $3.15 per share; and
|
•
|
2,778,304 additional shares of common stock reserved for issuance under our Stock Incentive Plan, 1,166,832 additional shares of common stock reserved for issuance under our Inducement Equity Incentive Plan, and 9,484 additional shares of common stock reserved for issuance under our Employee Stock Purchase Plan as of March 31, 2020.
|
Name
|
| |
Number of
Shares |
| |
Number of
Pre-funded Warrants |
J.P. Morgan Securities LLC
|
| |
|
| |
|
Piper Sandler & Co.
|
| |
|
| |
|
Total
|
| |
|
| |
|
|
| |
Without exercise
of option to purchase additional shares |
| |
With full exercise
of option to purchase additional shares |
Per Share
|
| |
$
|
| |
$
|
Per Pre-funded Warrant
|
| |
$
|
| |
$
|
Total
|
| |
$
|
| |
$
|
A.
|
to any legal entity which is a qualified investor as defined in the Prospectus Directive;
|
B.
|
to fewer than 100 or, if the Relevant Member State has implemented the relevant provision of the 2010 PD Amending Directive, 150, natural or legal persons (other than qualified investors as defined in the Prospectus Directive), as permitted under the Prospectus Directive, subject to obtaining the prior consent of the representatives; or
|
C.
|
in any other circumstances falling within Article 3(2) of the Prospectus Directive, provided that no such offer of shares shall require the Company or the representatives to publish a prospectus pursuant to Article 3 of the Prospectus Directive or supplement a prospectus pursuant to Article 16 of the Prospectus Directive.
|
•
|
Our Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on March 13, 2020 (including the sections of our proxy statement relating to our May 12, 2020 annual meeting of stockholders that are incorporated by reference therein);
|
•
|
Our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 filed with the SEC on May 11, 2020;
|
•
|
Our Current Reports on Form 8-K filed with the SEC on January 13, 2020, January 15, 2020, February 3, 2020, February 18, 2020, February 25, 2020, March 5, 2020 (Form 8-K including Items 8.01 and 9.01 only), March 10, 2020, March 30, 2020, April 2, 2020, April 10, 2020 and May 13, 2020; and
|
•
|
The description of our common stock contained in our Registration Statement on Form 8-A (File No. 000-23186) filed with the SEC on January 8, 1994, including any amendment or reports filed for the purpose of updating such description.
|
|
| |
Page
|
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| | ||
| | ||
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| | ||
| | ||
| | ||
| | ||
| | ||
| | ||
| |
•
|
the type and amount of securities that we propose to sell;
|
•
|
the public offering price of the securities;
|
•
|
the names of any underwriters, agents or dealers through or to which the securities will be sold;
|
•
|
any compensation of those underwriters, agents or dealers;
|
•
|
information about any securities exchanges or automated quotation systems on which the securities will be listed or traded;
|
•
|
any risk factors applicable to the securities that we propose to sell; and
|
•
|
any other material information about the offering and sale of the securities.
|
•
|
the effect of the novel coronavirus (COVID-19) outbreak on our business and operations or the business and operations of third parties, including our suppliers, vendors, development partners, and regulatory agencies and government bodies with which we work;
|
•
|
the preclinical development, clinical development, commercialization, or post-marketing studies of our product candidates and products, including our acute and prophylactic hereditary angioedema (“HAE”) programs, BCX9930, BCX9250, peramivir, galidesivir, and early stage discovery programs;
|
•
|
the potential funding from our contracts with the Biomedical Advanced Research and Development Authority (the “BARDA/HHS”) and the National Institute of Allergy and Infectious Diseases (“NIAID/HHS”) for the development of galidesivir;
|
•
|
the potential for government stockpiling orders of peramivir and galidesivir, additional regulatory approvals of peramivir, or milestones, royalties or profit from sales of peramivir by us or our partners;
|
•
|
the potential use of peramivir as a treatment for H1N1, H5N1, and H7N9 or other strains of influenza;
|
•
|
the implementation of our business model, strategic plans for our business, products, product candidates and technology;
|
•
|
our ability to establish and maintain collaborations or out-license rights to our product candidates;
|
•
|
the outcome, cost and timing of any resolution of disputes and legal proceedings, including but not limited to the dispute with our partner Seqirus UK Limited (“SUL”);
|
•
|
plans, programs, progress and potential success of our collaborations, including SUL for peramivir, Mundipharma International Holdings Limited for mundesine, Torii Pharmaceutical, Ltd. for BCX7353 in Japan and Shionogi & Co. Ltd. and Green Cross Corporation for peramivir in their territories;
|
•
|
our ability, and the ability of our consolidated subsidiary, MDCP, LLC, to satisfy obligations under our secured loan facility with MidCap Financial, a Delaware statutory trust, pursuant to the terms and conditions of the Second Amended and Restated Credit and Security Agreement dated as of February 5, 2019, as amended;
|
•
|
the ability of our wholly owned subsidiary, JPR Royalty Sub LLC (“Royalty Sub”) to service its payment obligations in respect of its PhaRMA Senior Secured 14.0% Notes due 2020 (the “PhaRMA Notes”);
|
•
|
the foreign currency hedge agreement entered into by us in connection with the issuance by Royalty Sub of the PhaRMA Notes (the “Currency Hedge Agreement”);
|
•
|
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
|
•
|
our ability to operate our business without infringing the intellectual property rights of others;
|
•
|
estimates of our expenses, revenues, capital requirements, annual cash utilization, and our needs for additional financing;
|
•
|
our ability to continue as a going concern;
|
•
|
the timing or likelihood of regulatory filings or regulatory agreements, deferrals, and approvals;
|
•
|
the timing or likelihood of entering into additional U.S. government stockpile orders and our ability to execute any such order;
|
•
|
our ability to raise additional capital to fund our operations or repay our recourse debt obligations;
|
•
|
our ability to comply with the covenants as set forth in the agreements governing our debt obligations;
|
•
|
our financial performance;
|
•
|
the timing and success of our anticipated commercialization of BCX7353 in the U.S. and elsewhere; and
|
•
|
competitive companies, technologies and our industry.
|
•
|
funding commercialization, development, manufacturing and regulatory activities for BCX7353;
|
•
|
the advancement of development activities on other rare disease targets, including complement-mediated diseases and fibrodysplasia ossificans progressiva (FOP);
|
•
|
post-approval commitments for RAPIVAB™/ALPIVAB™;
|
•
|
funding our research and development efforts; and
|
•
|
capital expenditures and general working capital needs.
|
•
|
our Board of Directors is authorized to issue “blank check” preferred stock without stockholder approval;
|
•
|
our Board of Directors is classified, with members serving staggered three-year terms;
|
•
|
stockholders may not cumulate votes in the election of directors;
|
•
|
vacancies on the Board of Directors may be filled only by the board of directors;
|
•
|
stockholders may remove directors only for cause and only by the affirmative vote of the holders of at least 75 percent of the total number of votes entitled to be cast by the holders of all of the shares of our capital stock then entitled to vote generally in the election of directors (a “supermajority vote”);
|
•
|
stockholders may take action only at a duly called meeting of the stockholders, and stockholders are not permitted to act by written consent;
|
•
|
special meetings of stockholders may be called only by the Board of Directors; and
|
•
|
stockholders must satisfy advance notice procedures to submit proposals or nominate directors for consideration at a stockholders meeting.
|
•
|
whether the purchase contracts obligate the holder or us to purchase or sell, or both purchase and sell, the securities subject to purchase under the purchase contract, and the nature and amount of each of those securities, or the method of determining those amounts;
|
•
|
whether the purchase contracts are to be prepaid or not;
|
•
|
whether the purchase contracts will be issued as part of a unit and, if so, the other securities comprising the unit;
|
•
|
whether the purchase contracts are to be settled by delivery, or by reference or linkage to the value, performance, or level of the securities subject to purchase under the purchase contract;
|
•
|
any acceleration, cancellation, termination, or other provisions relating to the settlement of the purchase contracts; and
|
•
|
whether the purchase contracts will be issued in full registered or global form.
|
•
|
the title and the aggregate number of warrants;
|
•
|
the price or prices at which the warrants will be issued;
|
•
|
the currency or currencies in which the price of the warrants will be payable;
|
•
|
the securities or other rights, including rights to receive payment in cash or securities based on the value, rate or price of one or more specified commodities, currencies, securities or indices, or any combination of the foregoing, purchasable upon exercise of the warrants;
|
•
|
the price at which, and the currency or currencies in which, the securities or other rights purchasable upon exercise of such warrants may be purchased;
|
•
|
the periods during which, and places at which, the warrants are exercisable;
|
•
|
the date or dates on which the warrants shall commence and the date or dates on which the warrants will expire;
|
•
|
the terms of any mandatory or optional call provisions;
|
•
|
the price or prices, if any, at which the warrants may be redeemed at the option of the holder or will be redeemed upon expiration;
|
•
|
whether the warrants will be sold separately or with other securities as part of a unit;
|
•
|
if applicable, the designation and terms of the securities with which the warrants are issued and the number of warrants issued with each such security;
|
•
|
if applicable, the date on and after which the warrants and the related securities will be separately transferable;
|
•
|
any provisions for the adjustment of the number or amount of securities receivable upon exercise of warrants;
|
•
|
the identity of the warrant agent;
|
•
|
the exchanges, if any, on which the warrants may be listed;
|
•
|
the maximum or minimum number of warrants which may be exercised at any time;
|
•
|
if applicable, a discussion of any material United States federal income tax considerations;
|
•
|
whether the warrants shall be issued in book-entry form; and
|
•
|
any other terms of the warrants, including terms, procedures and limitations relating to the exchange and exercise of the warrants.
|
•
|
the title of the series of debt securities;
|
•
|
any limit upon the aggregate principal amount that may be issued;
|
•
|
the maturity date or dates;
|
•
|
the form of the debt securities of the series;
|
•
|
whether or not the debt securities will be secured or unsecured, and the terms of any secured debt;
|
•
|
whether the debt securities rank as senior debt, senior subordinated debt, subordinated debt or any combination thereof, and the terms of any subordination;
|
•
|
if the price (expressed as a percentage of the aggregate principal amount thereof) at which such debt securities will be issued is a price other than the principal amount thereof, the portion of the principal amount thereof payable upon declaration of acceleration of the maturity thereof, or if applicable, the portion of the principal amount of such debt securities that is convertible into another security or the method by which any such portion shall be determined;
|
•
|
the interest rate or rates, which may be fixed or variable, or the method for determining the rate and the date interest will begin to accrue, the dates interest will be payable and the regular record dates for interest payment dates or the method for determining such dates;
|
•
|
our right, if any, to defer payment of interest and the maximum length of any such deferral period;
|
•
|
if applicable, the date or dates after which, or the period or periods during which, and the price or prices at which, we may, at our option, redeem the series of debt securities pursuant to any optional or provisional redemption provisions and the terms of those redemption provisions;
|
•
|
the date or dates, if any, on which, and the price or prices at which we are obligated, pursuant to any mandatory sinking fund or analogous fund provisions or otherwise, to redeem, or at the holder’s option to purchase, the series of debt securities and the currency or currency unit in which the debt securities are payable;
|
•
|
the denominations in which we will issue the series of debt securities, if other than denominations of $2,000 and multiples of $1,000 in excess thereof;
|
•
|
any and all terms, if applicable, relating to any auction or remarketing of the debt securities of that series and any security for our obligations with respect to such debt securities and any other terms which may be advisable in connection with the marketing of debt securities of that series;
|
•
|
whether the debt securities of the series shall be issued in whole or in part in the form of a global security or securities; the terms and conditions, if any, upon which such global security or securities may be exchanged in whole or in part for other individual securities; and the depositary for such global security or securities;
|
•
|
if applicable, the provisions relating to conversion or exchange of any debt securities of the series and the terms and conditions upon which such debt securities will be so convertible or exchangeable, including the conversion or exchange price, as applicable, or how it will be calculated and may be adjusted, any mandatory or optional (at our option or the holders’ option) conversion or exchange features, the applicable conversion or exchange period and the manner of settlement for any conversion or exchange;
|
•
|
if other than the full principal amount thereof, the portion of the principal amount of debt securities of the series which shall be payable upon declaration of acceleration of the maturity thereof;
|
•
|
additions to or changes in the covenants applicable to the particular debt securities being issued, including, among others, the consolidation, merger or sale covenant;
|
•
|
additions to or changes in the events of default with respect to the securities and any change in the right of the trustee or the holders to declare the principal, premium, if any, and interest, if any, with respect to such securities to be due and payable;
|
•
|
additions to or changes in or deletions of the provisions relating to covenant defeasance and legal defeasance;
|
•
|
additions to or changes in the provisions relating to satisfaction and discharge of the indenture;
|
•
|
additions to or changes in the provisions relating to the modification of the indenture both with and without the consent of holders of debt securities issued under the indenture;
|
•
|
the currency of payment of debt securities if other than U.S. dollars and the manner of determining the equivalent amount in U.S. dollars;
|
•
|
whether interest will be payable in cash or additional debt securities at our or the holders’ option and the terms and conditions upon which the election may be made;
|
•
|
the terms and conditions, if any, upon which we will pay amounts in addition to the stated interest, premium, if any and principal amounts of the debt securities of the series to any holder that is not a “United States person” for federal tax purposes;
|
•
|
any restrictions on transfer, sale or assignment of the debt securities of the series; and
|
•
|
any other specific terms, preferences, rights or limitations of, or restrictions on, the debt securities, any other additions or changes in the provisions of the indenture, and any terms that may be required by us or advisable under applicable laws or regulations.
|
•
|
our failure to pay interest on any debt security of such series when the same becomes due and payable and the continuance of any such failure for a period of 30 days;
|
•
|
our failure to pay the principal or premium of any debt security of such series when the same becomes due and payable at maturity, upon acceleration, redemption or otherwise;
|
•
|
our failure or the failure of any restricted subsidiary to comply with any of its agreements or covenants in, or provisions of, the debt securities of such series or the indenture (as they relate thereto) and such failure continues for a period of 90 days after our receipt of notice of the default from the trustee or from the holders of at least 25% in aggregate principal amount of the then outstanding debt securities of that series (except in the case of a default with respect to the provisions of the indenture regarding the consolidation, merger, sale, lease, conveyance or other disposition of all or substantially all of our assets (or any other provision specified in the applicable supplemental indenture or authorizing resolution), which will constitute an event of default with notice but without passage of time); or
|
•
|
certain events of bankruptcy, insolvency or reorganization occur with respect to us.
|
•
|
depositing in trust with the trustee, under an irrevocable trust agreement, money or government obligations in an amount sufficient to pay principal of and interest, if any, on the debt securities of such series to their maturity or redemption; and
|
•
|
complying with other conditions, including delivery to the trustee of an opinion of counsel to the effect that holders will not recognize income, gain or loss for federal income tax purposes as a result of our exercise of such right and will be subject to federal income tax on the same amount and in the same manner and at the same times as would have been the case otherwise.
|
•
|
depositing in trust with the trustee, under an irrevocable trust agreement, money or government obligations in an amount sufficient to pay principal and interest, if any, on the debt securities of such series to their maturity or redemption; and
|
•
|
complying with other conditions, including delivery to the trustee of an opinion of counsel to the effect that (A) we have received from, or there has been published by, the Internal Revenue Service a ruling, or (B) since the date such series of debt securities were originally issued, there has been a change in the applicable federal income tax law, in either case to the effect that, and based thereon such opinion of counsel shall state that, holders will not recognize income, gain or loss for federal income tax purposes as a result of our exercise of such right and will be subject to federal income tax on the same amount and in the same manner and at the same times as would have been the case otherwise.
|
•
|
cure any ambiguity, omission, defect or inconsistency;
|
•
|
comply with the provisions of the indenture regarding the consolidation, merger, sale, lease, conveyance or other disposition of all or substantially all of our assets;
|
•
|
provide that specific provisions of the indenture shall not apply to a series of debt securities not previously issued or to make a change to specific provisions of the indenture that only applies to any series of debt securities not previously issued or to additional debt securities of a series not previously issued;
|
•
|
create a series and establish its terms;
|
•
|
provide for uncertificated debt securities in addition to or in place of certificated debt securities;
|
•
|
release a guarantor in respect of any series of debt securities which, in accordance with the terms of indenture applicable to the particular series, ceases to be liable in respect of its guarantee;
|
•
|
add a guarantor subsidiary in respect of any series of debt securities;
|
•
|
secure any series of debt securities;
|
•
|
comply with requirements of the SEC in order to effect or maintain the qualification of the indenture under the Trust Indenture Act;
|
•
|
make any change that does not adversely affect the rights of any holder; or
|
•
|
conform the provisions of the indenture to the final offering document in respect of any series of debt securities.
|
•
|
reduce the amount of debt securities of such series whose holders must consent to an amendment, supplement or waiver;
|
•
|
reduce the rate of or extend the time for payment of interest, including defaulted interest;
|
•
|
reduce the principal of or extend the fixed maturity of any debt security or alter the provisions with respect to redemptions or mandatory offers to repurchase debt securities;
|
•
|
make any change that adversely affects any right of a holder to convert or exchange any debt security into or for shares of our common shares or other securities, cash or other property in accordance with the terms of such security;
|
•
|
modify the ranking or priority of the debt securities;
|
•
|
make any change to any provision of the indenture relating to the waiver of existing defaults, the rights of holders to receive payment of principal and interest on the debt securities, or to the provisions regarding amending or supplementing the indenture or the debt securities of a particular series with the written consent of the holders of such series;
|
•
|
waive a continuing default or event of default in the payment of principal of or interest on the debt securities; or
|
•
|
make any debt security payable at a place or in money other than that stated in the debt security, or impair the right of any holder of a debt security to bring suit as permitted by the indenture.
|
•
|
the designation and the terms of the units and of the securities constituting the units, including whether and under what circumstances the securities comprising the units may be traded separately;
|
•
|
any additional terms of the governing unit agreement;
|
•
|
any additional provisions for the issuance, payment, settlement, transfer or exchange of the units or of the preferred stock, common stock, stock purchase contracts, depositary shares, warrants or debt securities constituting the units; and
|
•
|
any applicable United States federal income tax consequences.
|
•
|
directly to one or more purchasers;
|
•
|
through one or more underwriters on a firm commitment or best-efforts basis;
|
•
|
through broker-dealers, who may act as agents or principals, including a block trade in which a broker or dealer so engaged will attempt to sell as agent but may position and resell a portion of the block as principal to facilitate the transaction;
|
•
|
through agents;
|
•
|
through remarketing firms;
|
•
|
in privately negotiated transactions; or
|
•
|
in any combination of these methods of sale.
|
•
|
the name or names of any underwriters, dealers or agents;
|
•
|
the number of securities and purchase price of the securities being offered and the proceeds we will receive from the sale;
|
•
|
any underwriting discounts and commissions or agency fees and other items constituting underwriters’ or agents’ compensation;
|
•
|
any over-allotment options under which underwriters may purchase additional securities from us;
|
•
|
any delayed delivery arrangements;
|
•
|
any discounts or concessions allowed or re-allowed or paid to dealers; and
|
•
|
any securities exchange on which the securities may be listed.
|
•
|
Our Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on March 13, 2020 (including the sections of our definitive proxy statement relating to our May 12, 2020 annual meeting of stockholders that are incorporated by reference therein);
|
•
|
Our Current Reports on Form 8-K filed with the SEC on January 13, 2020, January 15, 2020, February 3, 2020, February 18, 2020, February 25, 2020, March 5, 2020 (filing containing Items 8.01 and 9.01 only), March 10, 2020, March 30, 2020, April 2, 2020 and April 10, 2020; and
|
•
|
The description of our common stock which is contained in our Registration Statement on Form 8-A (File No. 000-23186) filed with the SEC on January 7, 1994, together with the amendment thereto filed with the SEC on March 14, 1994, including any other amendment or reports filed for the purpose of updating such description.
|
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