Novavax Reports Third Quarter 2017 Financial Results
GAITHERSBURG, Md., Nov. 07, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) today announced its financial results for the third quarter and nine months ended September 30, 2017.
Third Quarter Achievements:
- Novavax initiated a Phase 1/2 clinical trial of its nanoparticle influenza vaccine candidate with its proprietary Matrix-M(TM) adjuvant (NanoFlu(TM)) in older adults. The trial is a randomized, observer-blinded, active comparator-controlled trial in approximately 330 healthy older adults. The primary objective of the trial is to assess the safety and immunogenicity of two antigen concentrations (15 µg or 60 µg) of NanoFlu compared to a licensed influenza vaccine, Fluzone® High-Dose (Fluzone HD).
- Novavax reported that NanoFlu demonstrated superior immunogenicity and protection compared to the market leader in a preclinical challenge study. In a head-to-head comparison study against Fluzone HD, NanoFlu demonstrated significantly stronger and broader immune responses against matched and unmatched influenza strains, including a series of "drifted" strains evolved over more than a decade of influenza seasons. NanoFlu was also protective in an established challenge model against both a matched and a ten-year old unmatched strain. Data from this study was published in the journal Vaccine.
- The Prepare(TM) clinical trial for infants via maternal immunization, supported by an $89 million grant from the Bill and Melinda Gates Foundation (BMGF), accelerated into the third global season of enrollment. Prepare's global footprint is expected to grow from 16 sites in five countries in its first season of enrollment to over 90 sites in 12 countries in 2018.
Anticipated 2017 Event:
- Announce topline data from a Phase 1/2 clinical trial of the NanoFlu vaccine candidate in a head-to-head comparison with Fluzone HD before the end of 2017.
"We were very pleased to initiate and fully enroll the Phase 1/2 clinical trial of our NanoFlu vaccine candidate in older adults, following impressive results in preclinical challenge models. Given this timing, we are well positioned to announce data from the ongoing trial before the end of the year," said Stanley C. Erck, President and CEO. "We also continue to make significant progress in our RSV F Vaccine program, highlighted by the continued execution of the Phase 3 Prepare trial for infants via maternal immunization. We are also evaluating plans to conduct a clinical trial for older adults in 2018."
Financial Results for the Three and Nine Months Ended September 30, 2017
Novavax reported a net loss of $44.6 million, or $0.15 per share, for the third quarter of 2017, compared to a net loss of $66.3 million, or $0.24 per share, for the third quarter of 2016. For the nine months ended September 30, 2017, the net loss was $132.9 million, or $0.47 per share, compared to a net loss of $222.9 million, or $0.82 per share, for the same period in 2016.
Novavax revenue in the third quarter of 2017 was $8.4 million, compared to $3.2 million in the same period in 2016. This 158% increase was driven by higher revenue recorded under the BMGF grant of $89 million.
Research and development expenses decreased 21% to $41.9 million in the third quarter of 2017, compared to $53.0 million for the same period in 2016. The decrease was primarily due to reduced activities related to the development of the RSV F Vaccine for older adults, other general R&D project-related expenses and lower employee-related costs.
General and administrative expenses decreased 40% to $8.1 million in the third quarter of 2017, compared to $13.6 million for the same period in 2016. The decrease was primarily due to lower professional fees for pre-commercialization activities and lower employee-related costs.
Interest income (expense), net for the third quarter of 2017 and 2016 was ($3.0) million.
As of September 30, 2017, the company had $172.6 million in cash, cash equivalents and marketable securities, compared to $235.5 million as of December 31, 2016. Net cash used in operating activities for the first nine months of 2017 was $106.6 million, compared to $194.2 million for the same period in 2016. The decrease in cash usage was primarily due to decreased costs relating to our RSV F Vaccine and lower overall employee-related costs.
Novavax management will host its quarterly conference call today at 4:30 p.m. ET. The dial-in number for the conference call is (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 2479419. A replay of the conference call will be available starting at 7:30 p.m. ET on November 7, 2017 until 7:30 pm ET on November 14, 2017. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 2479419.
A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the "Investor Info"/"Events" tab on the Novavax website. A replay of the webcast will be available through the "Investor Info"/"Events" tab on the Novavax website until February 7, 2018.
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and Matrix-M(TM) adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Additional information about Novavax is available on the Company's website, novavax.com.
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2016 and the Quarterly Report on Form 10-Q for the period ended September 30, 2017, both as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share information)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||41,862||52,983||118,779||186,839|
|General and administrative||8,118||13,556||25,911||38,183|
|Loss from operations||(41,628||)||(63,308||)||(123,926||)||(215,068||)|
|Interest income (expense), net||(2,989||)||(2,957||)||(9,021||)||(7,756||)|
|Other income (expense)||10||11||20||(33||)|
|Basic and diluted net loss per share||$||(0.15||)||$||(0.24||)||$||(0.47||)||$||(0.82||)|
|Basic and diluted weighted average number of common shares outstanding||296,435||271,064||284,767||270,669|
SELECTED CONSOLIDATED BALANCE SHEET DATA
|Cash and cash equivalents||$||104,245||$||144,353|
|Total current assets||225,995||287,830|
|Total notes payable and capital lease obligation||317,407||316,376|
|Total stockholders' deficit||(74,151||)||(5,546||)|
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novavax, Inc. via Globenewswire
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
Valero to Purchase SemLogistics Milford Haven Fuel Storage Facility23.2.2018 22:15 | Pressemelding
LONDON, Feb. 23, 2018 (GLOBE NEWSWIRE) -- Valero Logistics UK Ltd, a subsidiary of Valero Energy Corporation (NYSE:VLO), and SemGroup Europe Holding L.L.C., a SemGroup Corporation company, have today signed an agreement for the purchase of SemLogistics Milford Haven fuel storage facility on the west coast of Wales. Situated across the Haven from Valero's refinery at Pembroke, the facility is one of the largest petroleum products storage facility in the United Kingdom (UK) with 8.5 million barrels of capacity for storing gasoline, gasoline blendstocks, naphtha, jet fuel, gas oil, diesel, and crude oil. Over 67 percent of the storage capacity is multiproduct or dual purpose, giving Valero the flexibility to meet customers' demands in the UK and throughout Northwest Europe. Additionally, Milford Haven will continue to operate as a third-party storage facility, offering storage options for third party customers across the European petroleum markets. "This facility complements our Pembroke
Vricon launches Telco Suite at Mobile World Congress23.2.2018 19:20 | Pressemelding
Visit us at MWC Booth 6L8 to learn about our 3D geodata solution McLean, Virginia, Feb. 23, 2018 (GLOBE NEWSWIRE) -- Vricon is pleased to announce that it is launching its Telco Suite at this year's Mobile World Congress (MWC) in Barcelona. MWC participants can see a demonstration of the Telco Suite in Vricon's booth, located at #6L8. The Vricon Telco Suite is designed to help telecommunications companies navigate the rapid changes happening throughout the industry. With an increasing number of connected devices, high-definition content, and new services, the demands on networks are accelerating and growing exponentially. The Vricon Telco Suite is a cost-effective, next-generation solution that helps companies design networks for optimal performance, whether it's to densify existing 4G LTE networks, prep for 5G to empower smart homes and the Internet of Things, or work a more complex HetNet. "Mobile World Congress 2018 is the best place to see first-hand new technologies, to include Vr
Inspiration Provides Update23.2.2018 17:12 | Pressemelding
TORONTO, Feb. 23, 2018 (GLOBE NEWSWIRE) -- Inspiration Mining Corporation (CSE:ISM) - Pursuant to its previous news release Feb 14, 2018 Inspiration Mining Corp. is pleased to announce that the ongoing due diligence and negotiations with Compassion Cannabis is ahead of schedule and on track. Both parties are looking forward to positive conclusion. For further information, please contact Randy Miller, Chief Executive Officer of the Corporation, at tel: 416-842-9000, www.inspirationmining.com The CSE has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This press release contains forward-looking statements based on assumptions, uncertainties and management's best estimates of future events. Actual results may differ materially from those currently anticipated. Investors are cautioned that such forward-looking statements involve risks and uncertainties. Important factors that could cause actual results to differ materially from those expressed
Three Elemica Executives Named Supply Chain Pros to Know23.2.2018 15:22 | Pressemelding
Leading Clients on Their Digital Transformation Journey to Operational Excellence WAYNE, Pa., Feb. 23, 2018 (GLOBE NEWSWIRE) -- Elemica, the leading Digital Business Network for process manufacturing industries, announces that three company executives have been selected as 2018 Supply Chain Provider Pros to Know by Supply & Demand Chain Executive magazine. Armand Castro, Vice President, Application Engineering; Mark Walsh, Vice President, Global Customer Support; and Steve Troncelliti, Vice President, Global Professional Services and IT Security are this year's honored Pros to Know from Elemica. They were chosen for helping clients resolve their most significant supply chain challenges through innovative digital transformation solutions and a next-generation digital platform that lowers working capital costs, streamlines operations and drives efficiencies. "Supply chain executives want to increase their digital transformation efforts across their supply chains to gain intelligent visib
CP Kelco Appoints Jennifer Aspen Mason as Sr. Vice President, Global Innovation22.2.2018 20:00 | Pressemelding
ATLANTA, Feb. 22, 2018 (GLOBE NEWSWIRE) -- CP Kelco, a leading global producer of specialty hydrocolloid solutions, announced today that Jennifer Aspen Mason has joined its Executive Leadership Team as Senior Vice President, Global Innovation, reporting directly to CP Kelco President Didier Viala. A global executive with more than 20 years of industry experience, Mason has an extensive background leading science organizations with Fortune 100 companies. Most recently, she spent more than five years with Mars, Incorporated, where she served as Technology and Science Strategy Officer for all Mars segments. In her new role, Mason is responsible for leading CP Kelco's global research and development (R&D) function, including strategic innovation imperatives to drive the company's long-term growth, as well as oversight of technical teams focused on new product innovation, process R&D and research. "We are truly delighted to welcome Jennifer to our team, and will surely benefit from her glob
Leading the industry: Excel Dryer is the first hand dryer manufacturer to publish third-party, verified Environmental Product Declarations (EPDs)22.2.2018 16:00 | Pressemelding
High-speed, energy-efficient XLERATOR®, XLERATOReco® and ThinAir® Hand Dryers evaluated and proven to be sustainable EAST LONGMEADOW, Mass., Feb. 22, 2018 (GLOBE NEWSWIRE) -- Excel Dryer, Inc., today announced that three of their hand dryers, the original, patented, high-speed, energy-efficient XLERATOR® Hand Dryer, the XLERATOReco® Hand Dryer and the ThinAir® Hand Dryer, were evaluated, and their environmental claims, substantiated with the publication of the hand dryer industry's first Environmental Product Declarations (EPDs) by UL Environment, a business division of Underwriters' Laboratories. An Environmental Product Declaration is a standardized way of quantifying the environmental impact of a product by studying the raw materials and energy consumption during its production, use and disposal. For buyers and specifiers, the EPDs are a disclosure tool that helps purchasers better understand a product's sustainable qualities and environmental repercussions so they can make more inf
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom