Novavax Reports Second Quarter 2017 Financial Results
GAITHERSBURG, Md., Aug. 08, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced its financial results for the second quarter and six months ended June 30, 2017.
Second Quarter and Subsequent Achievements:
- Novavax' nanoparticle flu vaccine demonstrates superior immunogenicity and protection compared to market leader in preclinical challenge studies. In head-to-head comparison studies against Fluzone® High-Dose, Novavax' nanoparticle influenza vaccine with our proprietary Matrix-M(TM) adjuvant (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. Further details will be published in the near future in a peer-reviewed journal and presented at scientific conferences.
- Topline data from Phase 2 older adult safety and immunogenicity trial (E-205) demonstrated the benefit of adjuvanted formulations and two-dose regimens. Immunogenicity outcomes indicate both Matrix-M and aluminum phosphate adjuvants significantly increased the magnitude, duration and quality of the immune response relative to the RSV F antigen alone. All formulations and regimens were safe and well-tolerated.
- The Company announced the path forward for an adjuvanted RSV F protein recombinant nanoparticle vaccine (RSV F Vaccine) in older adults with plans to initiate a Phase 2 efficacy trial in 2018. This approach is driven by an observed 61% reduction in hospitalizations due to COPD exacerbations.
- 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 has grown from 16 sites in five countries in its first season of enrollment to 80 sites in 11 countries.
- Data from the second of two Phase 2 trials of its RSV F Vaccine candidate confirmed an overall reduction of infection of >50% in women of childbearing age, published in the journal Vaccine.
Anticipated 2017 Event:
- Initiation of a Phase 1/2 clinical trial of the Company's NanoFlu vaccine candidate in a head-to-head comparison to Fluzone High-Dose. Data from this trial should be available in the fourth quarter of 2017.
"Novavax has demonstrated considerable progress in our RSV F Vaccine program, highlighted by the continued strong execution of the Prepare trial, and the data from our recent trial in older adults, which confirmed the ability of the vaccine to generate robust immune responses and provided us with a development path forward," said Stanley C. Erck, President and CEO. "We are also excited by the recent preclinical results of our nanoparticle influenza vaccine and look forward to Phase 1/2 clinical data in the fourth quarter of this year."
Financial Results for the Three and Six Months Ended June 30, 2017
Novavax reported a net loss of $44.5 million, or $0.16 per share, for the second quarter of 2017, compared to a net loss of $79.4 million, or $0.29 per share, for the second quarter of 2016. For the six months ended June 30, 2017, the net loss was $88.3 million, or $0.32 per share, compared to a net loss of $156.6 million, or $0.58 per share, for the same period in 2016.
Novavax revenue in the second quarter of 2017 increased 169% to $6.7 million, compared to $2.5 million for the same period in 2016, primarily due to increased revenue recorded under the BMGF grant relating to our ongoing Prepare clinical trial.
Research and development expenses decreased 40% to $39.3 million in the second quarter of 2017, compared to $64.9 million for the same period in 2016. The decrease was primarily due to reduced costs associated with the clinical trials and development activities of our RSV F Vaccine and lower employee-related costs.
General and administrative expenses decreased 37% to $8.9 million in the second quarter of 2017, compared to $14.1 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 second quarter of 2017 was ($3.0) million, compared to ($2.8) million for the same period in 2016.
As of June 30, 2017, the company had $187.3 million in cash and cash equivalents and marketable securities compared to $235.5 million as of December 31, 2016. Net cash used in operating activities for the first six months of 2017 was $69.4 million, compared to $131.9 million for 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 15614203. A replay of the conference call will be available starting at 7:30 p.m. ET on August 8, 2017 until 7:30 pm ET on August 15, 2017. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 15614203.
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 November 8, 2017.
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 June 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||Six Months Ended|
|June 30,||June 30,|
|Research and development||39,263||64,904||76,916||133,856|
|General and administrative||8,940||14,099||17,793||24,627|
|Loss from operations||(41,471||)||(76,498||)||(82,297||)||(151,760||)|
|Interest income (expense), net||(2,993||)||(2,842||)||(6,032||)||(4,799||)|
|Other income (expense)||(1||)||(11||)||10||(44||)|
|Basic and diluted net loss per share||$||(0.16||)||$||(0.29||)||$||(0.32||)||$||(0.58||)|
|Basic and diluted weighted average|
|number of common shares outstanding||283,444||270,760||278,836||270,469|
SELECTED CONSOLIDATED BALANCE SHEET DATA
|Cash and cash equivalents||$||75,793||$||144,353|
|Total current assets||236,683||287,830|
|Total notes payable and capital lease obligation||317,051||316,376|
|Total stockholders' deficit||(59,062||)||(5,546||)|
Andrea N. Flynn, Ph.D.
Director, Investor Relations
Russo Partners, LLC
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
Fura Completes Acquisition of Colombian Emerald Mine, Coscuez22.1.2018 13:00 | Pressemelding
TORONTO, Jan. 22, 2018 (GLOBE NEWSWIRE) -- Fura Gems Inc. (TSXV:FURA) is pleased to announce that it has completed its acquisition of 76% of the issued and outstanding shares of Esmeracol S.A. ("Esmeracol"), which owns a 100% interest in mining licence no. 122 - 95M (the "Coscuez Licence"). Dev Shetty, President & CEO of Fura, commented: "Fura has achieved one more important milestone by adding the iconic Colombian emerald mine, Coscuez, to its portfolio. With this acquisition, Fura now has two important silos in its portfolio, Colombian emeralds and Mozambican rubies. Fura will now work towards modernisation of the Coscuez emerald mine and deployment of the best health and safety standards for its employees while keeping the environmental impact minimal. Fura will also closely work with the local community and relevant authorities to promote the social-economic development in the region. We would like to thank our local partner and also the entire team on the ground in the Colombia fo
Agency for the Cooperation of Energy Regulators (ACER) continues to use Nasdaq's SMARTS for Pan-European Market Monitoring of EU Wholesale Energy Markets22.1.2018 12:30 | Pressemelding
NEW YORK, Jan. 22, 2018 (GLOBE NEWSWIRE) -- The Agency for the Cooperation of Energy Regulators (ACER) has officially extended its contract with Nasdaq (Nasdaq:NDAQ) to continue to leverage Nasdaq's SMARTS Market Surveillance technology to detect insider trading and market manipulation across the European Union's wholesale energy markets by digesting and analyzing massive volumes of data from hundreds of power producers, exchanges, operators, and brokers across 28 member states. The new agreement contract extension will continue to allow national regulatory authorities to share data, technology, and expertise, with the aim of creating a cooperative regulatory infrastructure. Under the contract, SMARTS technology will continue being leveraged to monitor the European wholesale gas and electricity markets, covering both spot trading and derivative markets across Europe in accordance with the obligations under the REMIT legislation. Further, the surveillance technology will support ACER's
Bell Canada Reaches Milestone in Network 3.0 Vision with Open Network Automation Platform (ONAP) and Strategic Partnership with Amdocs22.1.2018 12:00 | Pressemelding
Bell's leadership in bringing open source ONAP into production enables innovative new offerings to customers faster and at lower cost ST. LOUIS, Jan. 22, 2018 (GLOBE NEWSWIRE) -- Amdocs (NASDAQ:DOX), a leading provider of software and services to communications and media companies, today announced that Bell, Canada's largest communications company, has successfully implemented the first network automation use case in production leveraging the Linux Foundation's Open Network Automation Platform (ONAP). As Bell's strategic partner, Amdocs brings unparalleled ONAP expertise and DevOps scrum team agility and delivery capabilities with the goal of driving innovation faster and reducing the cost of building and operating the data center of the future. With clear benefits such as a more elastic network and increased business agility to be gained from taking advantage of network functions virtualization (NFV), Bell is driving its network transformation by leveraging the ONAP-based network serv
Alvogen CEO Robert Wessman speaks exclusively to World Finance about new opportunities in generic pharmaceuticals22.1.2018 11:51 | Pressemelding
LONDON, Jan. 22, 2018 (GLOBE NEWSWIRE) -- Industry disruptor Robert Wessman, the CEO of rapidly growing generic pharmaceuticals company Alvogen, shares his thoughts on the latest market trends in the new edition of World Finance magazine. Only different in name and price, generic pharmaceuticals in the US are a whopping 50 to 70 percent less expensive than their branded equivalents. Unsurprisingly, in an era of ever-rising medical costs, a growing number of governmental entities and corporations are now choosing generics over branded pharmaceuticals. For some time, just a handful of big-name organisations dominated this nascent market. But, following its peak in 2015, over-valuations have prompted vulnerability, opening the door for new, more nimble competitors to join and disrupt the market. Among this innovative group of 'next generation' pharmaceutical companies is Reykjavik-based Alvogen. Though it was only established in 2009, this global-facing organisation now boasts an annual t
SD-WAN Market Leader Aryaka Names Claudio Perugini Senior Vice President of Global Channels22.1.2018 06:00 | Pressemelding
SAN MATEO, Calif., Jan. 22, 2018 (GLOBE NEWSWIRE) -- Aryaka®, the leading global SD-WAN provider, announced today that networking industry veteran Claudio Perugini has joined the company's leadership team as Senior Vice President of Global Channels. In his new role, Perugini will lead and further scale Aryaka's global partner program as the company continues to grow rapidly and expand its market footprint in 2018. "Aryaka's channel partners have played an essential role in establishing the company as the market leader in the global SD-WAN space," said Perugini. "Our technology is a game-changer for the channel community as we offer global enterprises a next-generation alternative to legacy network technologies. As the Senior Vice President of Global Channels, my key focus areas will be recruitment, further scaling the channel organization, enhancing the structure of the Aryaka Global Partner Program, and improving partner enablement." Perugini has more than 30 years of channel and sale
Ant Financial Hosts Technology Conference in Silicon Valley20.1.2018 06:39 | Pressemelding
Conference featured global fintech leaders and showcased Ant Financial's capabilities across blockchain, AI, security, IoT and computing SANTA CLARA, Calif., Jan. 20, 2018 (GLOBE NEWSWIRE) -- Ant Financial today hosted the Ant Technology Exploration Conference (ATEC) in Silicon Valley, bringing together global partners and technology leaders to explore new innovations and technologies that further Ant Financial's mission of bringing the world equal opportunities. This was the first ATEC held outside of China, following the inaugural ATEC held in Hangzhou in October 2017. The conference featured a diverse range of speakers from academia and industry to better explore the future of fintech, including Turing Award winner and MIT Professor Silvio Micali; Partner and Director of blockchain-based global payment platform Ripple, Emi Yoshikawa; founder of prediction market Bodhi, Xiahong Lin; and Director of JPMorgan Chase's digital channels, Umar Farooq, among others. Ant Financial's Vice Pre
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom