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
Följ NASDAQ OMX
Abonnera på våra pressmeddelanden.
Senaste pressmeddelandena från NASDAQ OMX
Raven Indusries Releases CR12(TM) Field Computer18.6.2018 16:49 | Pressmeddelande
12-Inch Display With Field Planning Features Helps Farmers Save Time and Increase Efficiencies MIDDENMEER, The Netherlands, June 18, 2018 (GLOBE NEWSWIRE) -- Raven Industries (NASDAQ:RAVN) announced today the release of a new, larger field computer: the CR12(TM). Utilizing the same powerful functionality as the CR7(TM) field computer, the CR12 offers an extensive field planning feature for increased efficiencies. Built with a durable magnesium waterproof housing and a full glass capacitive touchscreen with high brightness, the CR12 also boasts a wider, 12.1-inch display. The CR12 joins the CR7 as the latest field computer in the CRX display family. This powerful operating system features easy job set-up, fewer touches and greater efficiencies - empowering the user with extraordinary data management capabilities. A simple widget concept, easily accessible settings, and ISO Universal Terminal and Task Controller capabilities make this mighty unit an affordable, plug-and-play system. Like
FPGA programming solution goes live at AEE 2018 in latest version of SLX18.6.2018 15:00 | Pressmeddelande
Silexica / FPGA programming solution goes live at AEE 2018 in latest version of SLX . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. Industry-first solution fully explores the design space to optimize hardware/software partitioning SLX automatically inserts pragmas and rewrites code to make it High-Level Synthesis (HLS) ready Solution designed in collaboration with customers including Ricoh SAN JOSE, Calif. and COLOGNE, Germany, June 18, 2018 (GLOBE NEWSWIRE) -- Silexica will launch a new solution within SLX to support the increasing use of FPGAs for embedded computing tasks such as sensor fusion and deep learning. It has been developed in partnership with Ricoh and other customers who will use the solution for industrial automation and defense projects. The technology will be presented at Silexica's first appearance one of the world's biggest avionics exhibitions - AEE held in Munich from June 19-20. The
Immunicum AB (publ) meddelar publicering av en översiktsartikel kring ilixadencel-konceptet i Pharmaceutical Research18.6.2018 14:00 | Pressmeddelande
Pressmeddelande 18 juni 2018 Immunicum AB (publ) meddelar publicering av en översiktsartikel kring ilixadencel-konceptet i Pharmaceutical Research Immunicum AB (publ; IMMU.ST) offentliggjorde i dag online-publiceringen av en översiktsartikel av den senaste tidens utveckling inom immunonkologiforskning, med särskilt fokus på tidigare publicerade data som stöder värdet av bolagets ledande program, ilixadencel. Artikeln, med titeln "Ilixadencel - An Allogeneic Cell-Based Anticancer Immune Primer for Intratumoral Administration" publicerades on-line i Pharmaceutical Research , American Association of Pharmaceutical Scientists officiella tidskrift. Artikeln finns via följande länk https://link.springer.com/article/10.1007/s11095-018-2438-x - Det är en ära för vårt forsknings- och utvecklingsteam på Immunicum att bli erbjudna att skriva denna omfattande översikt som tar upp ilixadencels verkningsmekanism mot bakrund av de senaste upptäckterna gällande immunaktivering mot cancer. Våra preklin
Goldman Sachs and Cisco to Host Tech Talk on Data Center Networking18.6.2018 14:00 | Pressmeddelande
SAN JOSE, Calif., June 18, 2018 (GLOBE NEWSWIRE) -- Cisco will host a conference call with Goldman Sachs and Cisco's Ish Limkakeng, SVP, Product Management, Data Center Networking Group. The discussion will focus on Cisco's data center networking strategy, comprehensive portfolio, and its competitive advantage as customers seek highly secure and differentiated offerings. Interested parties can find more information on Cisco's Investor Relations website at https://investor.cisco.com. No new financial information will be discussed on this conference call. Date: Thursday, June 21, 2018 Time: 8:30 am PT / 11:30 am ET Speaker: Ish Limkakeng, SVP, Product Management, Data Center Networking Group Moderator: Goldman Sachs' Rod Hall, Managing Director Participant Dial in: Toll Free: 877-208-2954 International Number: 973-528-0056 Passcode: 201872 Replay Information (available until July 5, 2018): Toll Free: 800-332-6854 International Number: 973-528-0005 Passcode: 201872 This event will be webc
Immunicum AB (publ) Announces Publication of Scientific Review of Ilixadencel Approach in Pharmaceutical Research18.6.2018 14:00 | Pressmeddelande
Press Release 18 June 2018 Immunicum AB (publ) Announces Publication of Scientific Review of Ilixadencel Approach in Pharmaceutical Research Immunicum AB (publ; IMMU.ST) announced today the online publication of a review article providing an overview of recent developments in immuno-oncology research, specifically focusing on previously published data supporting the value of its lead program, ilixadencel. The article, titled "Ilixadencel - An Allogeneic Cell-Based Anticancer Immune Primer for Intratumoral Administration", was published in Pharmaceutical Research , the official journal of the American Association of Pharmaceutical Scientists. The article can be accessed via the following link https://link.springer.com/article/10.1007/s11095-018-2438-x "It is an honor for our research and development team at Immunicum to be invited to write this in-depth review article covering ilixadencel's mode of action in context of the most recent discoveries in anti-cancer immune activation," comme
DSM Sinochem Pharmaceuticals launches Atorvastatin film-coated tablets, expanding its finished dosage statins portfolio18.6.2018 11:23 | Pressmeddelande
Rijswijk, 18 June 2018, June 18, 2018 (GLOBE NEWSWIRE) -- Building upon its first generic finished dosage statin launch (Rosuvastatin) in January of this year, DSM Sinochem Pharmaceuticals (DSP) has this month released its fully backward-integrated, generic Atorvastatin drug product within the EU. Additional markets are scheduled to follow later in the year.Atorvastatin is used primarily in the prevention of cardiovascular disease and hyperlipidemia, commonly known as high cholesterol, the number one cause of death worldwide. Currently, statins are the most prescribed drug family globally in the fight against these potentially life-threatening conditions. Expanding statins portfolio With the launch now of Atorvastatin finished dosage formulation, coming on the heels of the successful launch of Rosuvastatin in January of 2018, DSP is actively expanding its statins drug product portfolio, realizing its aspiration of becoming a full-service generics pharmaceutical company. What sets DSP a
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum