NASDAQ OMX

Novavax Reports First Quarter 2017 Financial Results

8.5.2017 22:12 | NASDAQ OMX

Dela


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



Följ NASDAQ OMX

Skriv in din e-postadress så får du ett mejl när vi har något nytt att berätta.

Senaste nyheterna från NASDAQ OMX

TGS and PGS Announce Fourth 3D Seismic Project Offshore Eastern Canada26.5.2017 07:50

ASKER, Norway, May 26, 2017 (GLOBE NEWSWIRE) -- TGS and Petroleum Geo-Services ("PGS") announce the fourth 3D seismic project offshore Eastern Canada for 2017. Long Range 3D will comprise approximately 9,100 km2 of 3D GeoStreamer® data in the Eastern Newfoundland region. The survey covers open acreage which will be included in the November 2018 licensing round under Newfoundland and Labrador's Scheduled Land Tenure system. Following completion of these surveys, the jointly-owned library will have more than 175,000 km of 2D GeoStreamer data and 28,500 km2 of 3D GeoStreamer data. An expansive well log library is also available in the region, along with advanced multi-client interpretation products that will improve play, trend and prospect delineation. "With four 3D projects now committed for 2017 this will be our most active year ever in Newfoundland and Labrador. E&P companies are continuing to prioritize this region in their exploration strat

Mandalay Resources Corporation går ut med slutförande av reviderat Återköpserbjudande och begäran om medgivande gällande 5,875 % säkerställda utbytbara skuldebrev25.5.2017 13:46

TORONTO 24 maj 2017 (GLOBE NEWSWIRE) -- Mandalay Resources Corporation ("Mandalay" eller "Bolaget") (TSX:MND) meddelade idag att Gold Exchange Limited ("GEL"), ett självständigt företag för särskilda ändamål som är registrerat i Jersey, har ingått avtal gällande ett reviderat återköpserbjudande ("Återköpet") och en begäran om medgivande ("Begäran om medgivande") för sitt kapitalbelopp på 60 000 000 USD, 5,875 % säkerställda utbytbara skuldebrev som löper ut 2019 ("Skuldebreven"). GEL gav ut Skuldebreven 2014 och lånade ut inkomsterna till ett av Bolagets dotterbolag i enlighet med villkoren för låneavtalet och relaterad finansieringsöverenskommelse ("Lånet") som tillsammans speglar de huvudsakliga villkoren för Skuldebreven. Som angivet i Mandalays pressmeddelande från den 12 maj 2017, slutfördes inte det ursprungliga återköpserbjudandet och begäran om medgivande som GEL lanserade gällande Skuldebreven

Karolinska Development's Annual General Meeting 201724.5.2017 20:00

STOCKHOLM - May 24, 2017. At the Annual General Meeting of Karolinska Development AB held May 24, 2017, the following resolutions were passed: Profit and loss statement and the balance sheet: It was resolved to adopt the profit and loss statement and the balance sheet and the consolidated profit and loss statement and the consolidated balance sheet. Appropriation of the company's result: It was resolved to approve the allocation of the result, proposed by the board and the CEO, in total SEK -12 406 768 be allocated as follows: To be carried forward SEK -12 406 768. Discharge from liability of the directors and the CEO: It was resolved to grant the directors and the CEO discharge from liability for the financial year 2016. Resolution regarding the number of directors and auditors and deputy auditors to be appointed: It was resolved that the number of directors shall be seven without deputies and that the number

Karolinska Developments årsstämma 201724.5.2017 20:00

STOCKHOLM den 24 maj 2017. Vid Karolinska Developments årsstämma som hölls den 24 maj 2017 beslutade aktieägarna, följande: Redovisning: beslutades att fastställa av resultaträkning och balansräkning samt koncernresultaträkning och koncernbalansräkning. Resultatdisposition:  beslöts att godkänna styrelsens och verkställande direktörens förslag att till årsstämmans förfogande stående medel, sammanlagt SEK -12 406 768, disponeras enligt följande: SEK -12 406 768 balanseras i ny räkning. Ansvarsfrihet för styrelsens ledamöter och VD: beslöts att bevilja styrelsen och verkställande direktören ansvarsfrihet för verksamhetsåret 2016. Fastställande av antalet styrelseledamöter samt revisorer och revisorssuppleanter: Beslöts att antalet ledamöter i styrelsen skall vara sju utan suppleanter samt att antalet revisorer skall vara en utan suppleanter. Fastställande av arvoden till styrelsen och revisorerna: bes

Nasdaq to Deliver Post-Trade Technology to Depósito Central de Valores (DCV)24.5.2017 15:00

The Chilean central securities depository (CSD) will boost its infrastructure capabilities and increase efficiencies with fully-fledged CSD solution based on the Nasdaq Financial Framework NEW YORK and SANTIAGO, Chile, May 24, 2017 (GLOBE NEWSWIRE) -- Nasdaq, Inc. (Nasdaq:NDAQ) and Depósito Central de Valores (DCV)  today announced a new landmark agreement to bolster the technological infrastructure of Chile's central securities depository (CSD). "We are very satisfied with our thorough, year-long vendor partnership process in selecting the Nasdaq platform, which will replace the core system of the DCV," said Fernando Yáñez, CEO of DCV. "We believe with the implementation of this new system, we will have more opportunities for growth and diversification in our current services, as well as strengthening our day-to-day operations." Under the agreement with DCV, Nasdaq will deliver its CSD Solution, which will allow for:

Mandalay Resources Corporation Announces Completion of Revised Repurchase Offer and Consent Solicitation in Respect of 5.875% Secured Exchangeable Bonds24.5.2017 14:11

TORONTO, May 24, 2017 (GLOBE NEWSWIRE) -- Mandalay Resources Corporation ("Mandalay" or the "Company") (TSX:MND) announced today that Gold Exchange Limited ("GEL"), an unaffiliated special purpose vehicle incorporated in Jersey, has entered into agreements with respect to a revised repurchase offer (the "Repurchase") and consent solicitation (the "Consent Solicitation") in respect of its U.S.$60,000,000 principal amount 5.875% secured exchangeable bonds due 2019 (the "Bonds"). GEL issued the Bonds in 2014 and loaned the proceeds to a subsidiary of the Company pursuant to the terms of a loan agreement and related funding agreement (the "Loan") which together mirror the principal terms of the Bonds. As indicated in Mandalay's press release of May 12, 2017, the original repurchase offer and consent solicitation that GEL launched in respect of the Bonds on April 19, 2017 (the "Original Proposed

I vårt nyhetsrum kan du läsa de senaste nyheterna, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt nyhetsrum