Novavax (NASDAQ:NVAX) has climbed 66% since announcing Q117 results at the beginning of May.
NVAX has been on the road to recovery since its stock took a major hit in September 2016 when it’s price dropped 84% overnight on news of a failed Phase 3 drug trial.
The stock suffered a further setback in April on significant selling volume that saw a price drop of another 30%.
Now, since the beginning of May, NVAX has been on a tear climbing up the charts over 66% running from $0.73 to $1.21.
NVAX appears to be regaining investor confidence as the stock is now trading over its 50 Day Moving Average. The 200 Day Moving Average is on the horizon and could be a possibility as NVAX continues through it Phase 2 trials.
On May 8th, NVAX announced Q117 earnings results and here are the highlights:
- Enrollment continued during the second global season in the RSV Phase 3 Prepare™ 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
- 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)
- 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 $0.29per share, for the first quarter of 2016.
- 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.
Novavax (NASDAQ:NVAX) Company Overview
Novavax (NASDAQ:NVAX) is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases.
Using innovative proprietary recombinant nanoparticle vaccine technology, they produce vaccine candidates to efficiently and effectively respond to both known and emerging disease threats.
Their vaccine candidates are genetically engineered three-dimensional nanostructures that incorporate recombinant proteins critical to disease pathogenesis.
The NVAX product pipeline targets a variety of infectious diseases, with clinical vaccine candidates for respiratory syncytial virus (RSV) and Ebola virus (EBOV), and preclinical programs for Zika virus (ZIKV), seasonal influenza and a combination respiratory vaccine candidate, as well as other infectious disease vaccine candidates.
Recent NVAX Milestones
NVAX has been moving its products through various research and development stages including FDA Phase 2 trials:
- June 2017 – Announced RSV F vaccine phase 2 clinical trial data in women of child bearing age published in vaccine (see news release)
- May 2017 – Announced promotion of Dr. James F. Cummings to Vice President, Clinical Development and Translational Medicine (see news release)
- May 2017 – Reports first quarter 2017 financial results(see news release)
- February 2017 – Reports fourth quarter and year-end 2016 financial results (see news release)
- January 2017 – Initiates phase 2 safety and immunogenicity trial of the RSV F vaccine in older adults (see news release)
NVAX Management Team
NVAX is led by a seasoned management team experienced in leading pharmaceutical research and development and bringing new products to market.
Stanley C. Erck
President and Chief Executive Officer
Mr.Erck was named President and Chief Executive Officer of Novavax in April 2011. He became a Novavax Director in June 2009 and beginning in February 2010, served as its Executive Chairman of the Board. From 2000 to 2008, Mr. Erck was President and Chief Executive Officer of IOMAI Corporation, leading the company through an initial public offering and a merger with Intercell, an Austrian vaccine company, and through the development of a late-stage infectious disease product candidate.
Senior Vice President, Corporate Development
Mr. Andréasson joined Novavax in June 2014 as Senior Vice President, Corporate Development. He’s responsible for identifying, prioritizing and evaluating new strategic opportunities that leverage the company’s core strengths and growth initiatives.
Amy B. Fix, M.S., M.B.A., R.A.C.
Senior Vice President, Regulatory Affairs
Ms. Fix joined Novavax in April 2013 as Vice President, Regulatory Affairs with responsibility for regulatory strategy and our interactions with international regulatory agencies, including the U.S. Food and Drug Administration and the European Medicines Agency, which oversee the development and commercialization of our vaccine product candidates.
Louis F. Fries III, M.D.
Senior Vice President, Chief Medical Officer
Dr. Fries, who joined the Novavax team in 2011, has 22 years of experience in the clinical testing and development of human vaccines in academic, small biotech, and major biopharmaceutical environments. While a major career focus has been influenza, he has also had extensive involvement with bacterial and parasitic vaccines and therapeutic and prophylactic immunoglobulins.Keith Schmid
Gregory M. Glenn, M.D.
President, Research and Development
Dr. Glenn is the President of Research and Development and is responsible for leading Novavax’ recombinant nanoparticle RSV F vaccine program. Dr. Glenn joined Novavax following the acquisition of the publicly-traded biotechnology company IOMAI by Intercell. As a founder of IOMAI, Dr. Glenn conducted pioneering work in vaccine antigen delivery via skin patch technology and succeeded in bringing several products from early concept into late-stage clinical development, evaluated in 35 clinical trials.
Barclay A. “Buck” Phillips
Senior Vice President, Chief Financial Officer and Treasurer
Mr. Phillips joined Novavax in June 2013 as Senior Vice President and Chief Financial Officer, with responsibility for managing all of Novavax’ financial strategy, treasury and communications functions. He was most recently Senior Vice President and Chief Financial Officer of Micromet, Inc. which was acquired by Amgen in 2012.
John A. Herrmann III, J.D.
Senior Vice President, General Counsel & Corporate Secretary
Mr. Herrmann joined Novavax in 2010 and is responsible for managing all of Novavax’ legal affairs, including its patent portfolio, transactional and contractual matters, public securities filings, and attending to all the duties of Corporate Secretary. Mr. Herrmann also works with the senior management team at Novavax to define and develop corporate policies and procedures.
NVAX’s chart is showing strength after several setbacks in Q416 and early 2017.
The stock may be potentially undervalued and investors will be paying close attention to the results of current FDA trials as NVAX looks to move its product pipeline closer to commercial readiness.
Keep watching NVAX as it continues to work to bring its vaccination products to market.
Disclosure: We have no position in NVAX and have not been compensated for this article.