NASDAQ OMX

Novavax Reports First Quarter 2017 Financial Results

8.5.2017 22:12 | NASDAQ OMX

Del


GAITHERSBURG, Md., May 08, 2017 (GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) today announced its financial results for the first quarter ended March 31, 2017.

First Quarter Achievements:

  • Enrollment continued during the second global season in the RSV Phase 3 Prepare(TM) clinical trial for infants via maternal immunization. Enrollment in the first quarter of 2017 transitioned from the northern hemisphere to southern hemisphere sites in Argentina, Australia, Chile, New Zealand and South Africa. The second season of enrollment has benefitted greatly from the establishment of the operational infrastructure and experience from the first global season, resulting in material increases in enrollment and enhanced momentum as we move towards the third global season of enrollment.
  • Initiation of a randomized, observer-blinded, multi-arm, dose-ranging Phase 2 clinical trial, in one and two dose formulations, both with and without adjuvants, of its RSV F Vaccine in older adults (60 years of age and older). The trial will evaluate safety and immunogenicity of these formulations in older adults as measured by serum microneutralization titers against RSV/A and RSV/B, palivizumab competing antibodies ("PCA") and anti-F IgG.

Anticipated 2017 Events:

  • Announce top-line data from the Phase 2 safety and immunogenicity clinical trial of the RSV F vaccine in older adults in the next 90 days.
  • File revised study documents and conduct an informational analysis of the Prepare trial that would provide an indication of the RSV F Vaccine's potential efficacy against the trial's primary endpoint before the end of the year.
  • Initiate a Phase 1 clinical trial of the Company's recombinant seasonal influenza vaccine candidate before the end of the year.
  • Initiate a Phase 1 clinical trial of the Company's Zika vaccine candidate before the end of the year.

Summary

"We continued to make significant progress in the execution of our two key clinical trials of our RSV F vaccine for both infant via maternal immunization and in older adults. We look forward to reporting important clinical data from our older adult trial in the next 90 days. We've also been in discussion with the FDA about conducting an informational analysis of the Prepare trial that would provide an indication of our vaccine's potential efficacy. From these discussions, we believe we can conduct this analysis in late 2017," said Stanley C. Erck, President and CEO. "In addition, we are seeing the continued adoption and use of our proprietary adjuvant, Matrix-M, in a number of internal and partnered programs."

Financial Results for the Three Months Ended March 31, 2017

Novavax reported a net loss of $43.9 million, or $0.16 per share, for the first quarter of 2017, compared to a net loss of $77.3 million, or $0.29 per share, for the first quarter of 2016.

Novavax revenue in the first quarter of 2017 increased 35% to $5.7 million, compared to $4.2 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 45% to $37.7 million in the first quarter of 2017, compared to $69.0 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 16% to $8.9 million in the first quarter of 2017, compared to $10.5 million for the same period in 2016. The decrease was primarily due to lower professional fees for pre-commercialization activities.

Interest income (expense), net for the first quarter of 2017 was ($3.0) million, compared to ($1.9) million for the same period in 2016.

As of March 31, 2017, the company had $211.2 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 quarter of 2017 was $38.6 million, compared to $69.8 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 employee-related costs.

Conference Call

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 15607801. A replay of the conference call will be available starting at 7:30 p.m. ET on May 8, 2017 until 7:30 pm ET on May 15, 2017. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 15607801.

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 July 3, 2017.

About Novavax

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.

About RSV

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide, with estimated annual infection and mortality rates of 64 million and 160,000, respectively.1 In the U.S., RSV is the leading cause of hospitalization of infants, and globally, is second only to malaria as a cause of death in children under 1 year of age. 3 Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common. Currently, there is no approved RSV vaccine available. 5

Forward-Looking Statements

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 Report on Form 10-Q for the period ended March 31, 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.

1 Nair, H. et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet, 2010; 375: 1545-1555.

2 Hall, C.B. et al. Respiratory Syncytial Virus-Associated hospitalizations Among Children Less Than 24 Months of Age. Pediatrics, 2013; 132(2): E341-348.

3 Oxford Vaccine Group: http://www.ovg.ox.ac.uk/rsv

4 Glezen, W.P. et al. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child, 1986; 140:543-546. 

5 Glenn GM, et al. Modeling maternal fetal RSV F vaccine induced antibody transfer in guinea pigs. Vaccine, 2015; In press. http://dx.doi.org/10.1016/j.vaccine.2015.08.039.

 
NOVAVAX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
(unaudited)
             
      Three Months Ended  
      March 31,  
        2017       2016    
             
Revenue $      5,680     $   4,218    
             
Expenses:        
  Research and development   37,654       68,952    
  General and administrative   8,852       10,528    
    Total expenses   46,506       79,480    
Loss from operations   (40,826 )     (75,262 )  
Interest income (expense), net   (3,039 )     (1,957 )  
Other income (expense)   11       (33 )  
Net loss $      (43,854 )   $   (77,252 )  
             
Basic and diluted net loss per share $      (0.16 )   $   (0.29 )  
Basic and diluted weighted average        
  number of common shares outstanding       274,178       270,179    

 

 
SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
 
  March 31,  
2017
  December 
31, 2016
  (unaudited)    
Cash and cash equivalents $   95,847     $   144,353  
Marketable securities     115,331         91,126  
Total current assets     258,449         287,830  
Working capital     201,951         221,424  
Total assets     361,504         394,301  
Total notes payable and capital lease obligation       316,714         316,376  
Total stockholders' deficit     (29,099 )       (5,546 )
               

 

Contact:  

Investor Relations
Novavax, Inc.
Andrea N. Flynn, Ph.D.
Associate Director, Investor Relations
ir@novavax.com  
240-268-2000
 
Westwicke Partners
John Woolford
john.woolford@westwicke.com
443-213-0506

Media
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull@russopartnersllc.com 
212-845-4271



This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
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 OMX

NASDAQ OMX
NASDAQ OMX
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ OMX (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra NASDAQ OMX

Registrer deg med din epostadresse under for å få de nyeste sakene fra NASDAQ OMX på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra NASDAQ OMX

Promethean Opens New Global Headquarters in Seattle18.8.2017 18:38Pressemelding

Seattle, Wash., Aug. 18, 2017 (GLOBE NEWSWIRE) -- PrometheanTM, a global education technology company, announced today the opening of its new global headquarters in Seattle, Wash. Promethean's office in Atlanta, Ga. will continue to serve as the hub for the Americas markets, and the Blackburn, U.K. office will continue to carry on as the hub for the EMEA markets and parts of Asia.  Promethean is one of the leading brands in the international education technology market with more than 20 years of experience in the K-12 classroom. Its solutions are in more than 50,000 schools and institutions in 154 countries. "As traditional pedagogy continues to move towards immersive learning, it's important for Promethean to lead innovation in education with the latest technology," said Vin Riera, CEO of Promethean. "Seattle is a global technology hub, and establishing Promethean's global headquarters there increases opportunities for new business models, concepts

Hminers Disrupts the Cryptocurrency Market with Powerful, Multi-Algorithm Mining Rigs18.8.2017 11:00Pressemelding

Hminers continues to hit the headlines in the rapidly expanding global market for cryptocurrency. The Miami-based company has recently introduced three extremely powerful, multi-algorithm mining rigs that have been designed to provide maximum hash rate with minimum power consumption. MIAMI, Aug. 18, 2017 (GLOBE NEWSWIRE) -- In their relentless efforts to deliver state-of-the-art products related to cryptocurrency, Hminers has recently launched three brilliantly designed bitcoin mining rigs. The unique features and capabilities of the company's new H2U Miner, H4U Miner, and Rack Equipped with 5 x H4U have already grabbed the attention of the cryptocurrency enthusiasts and experts around the world. An organization with a rich tradition, Hminers (www.hminers.com) is recognized in the industry as the creator of the first ever 10 nm ASIC Chip in the world. Cryptocurrency mining is the process of generating new cryptocurrency that requires a pot

Nasdaq Welcomes I-AM Capital Acquisition Company (Nasdaq: IAMXU) to The Nasdaq Stock Market17.8.2017 18:50Pressemelding

NEW YORK, Aug. 17, 2017 (GLOBE NEWSWIRE) -- I-AM Capital Acquisition Company (Nasdaq:IAMXU), a blank check company formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses, celebrated its initial public offering (IPO) on The Nasdaq Stock Market.  I-AM Capital's founders, Chief Executive Officer F. Jacob Cherian and Chief Financial Officer Suhel Kanuga, have been focused on investing into India over the last decade, with the distinction of completing the first listed-SPAC investment in India. "Through our keen focus and unique accomplishments in India over the last decade, we have seen our investment thesis bear fruit: India's prominence and rise on the world stage, its distinction as being one of the fastest growing major economies of the world, and its strong vibrant consumer demographics. We believe these factors are aligning well now,

Tetraphase Pharmaceuticals Announces Submission and Validation of IV Eravacycline Marketing Authorization Application by European Medicines Agency17.8.2017 14:30Pressemelding

WATERTOWN, Mass., Aug. 17, 2017 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical-stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug- resistant (MDR) infections, today announced that the Marketing Authorization Application (MAA) for IV eravacycline for the treatment of complicated intra-abdominal infections (cIAI) has been submitted and was validated by the European Medicines Agency (EMA). Eravacycline is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of serious infections, including those caused by multidrug-resistant (MDR) pathogens. The MAA filing is based on data from the phase 3 IGNITE1 clinical trial in which eravacycline was well tolerated and demonstrated statistical non-inferiority to ertapenem using the primary endpoint of clinical response at the test-of-cure (TOC) visit. "The MAA filing represents a significant milestone for Tetraphase as it is our

RedHill Biopharma Announces U.S. Commercialization Agreement for FDA-Approved GI Product Esomeprazole Strontium Delayed-Release Capsules17.8.2017 13:00Pressemelding

RedHill was granted the exclusive rights to promote Esomeprazole Strontium Delayed-Release (DR) Capsules to gastroenterologists in certain U.S. territories Esomeprazole Strontium DR Capsules 49.3 mg is an FDA-approved, proprietary, prescription proton pump inhibitor (PPI), indicated for adults for the treatment of gastroesophageal reflux disease (GERD) and other gastrointestinal (GI) conditions   RedHill expects to initiate the U.S. promotion of Esomeprazole Strontium  DR Capsules 49.3 mg  in the coming weeks   Esomeprazole Strontium  DR Capsules 49.3 mg  will be the third commercial GI product to be promoted by RedHill in the U.S.    RedHill's GI-focused sales force currently promotes two GI s

Brand Industrial Services Announces Agreement to Acquire Venko Groep BV16.8.2017 19:40Pressemelding

Complementary core strengths provide broader range of services for customers KENNESAW, GA, Aug. 16, 2017 (GLOBE NEWSWIRE) -- Brand Industrial Services, known as BrandSafway, has signed an agreement to acquire Venko Groep BV, a portfolio company of Mentha Capital. Venko will become a part of the Brand Energy & Infrastructure Services (Brand) group. "We are very pleased to announce the agreement with Venko," said Bill Hayes, President and CEO of BrandSafway. "Our combined customers in Europe will benefit from a broader range of solutions and greater depth of expertise in access, insulation and coatings. Bringing Venko's highly specialized knowledge in coatings to BrandSafway will provide the expertise we need to expand our services in the offshore market worldwide." Based in the Netherlands, with a focus on operations in the North Sea area, Venko is a leading offshore and onshore coatings maintenance provid

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom