Novavax, Inc. (NASDAQ:NVAX) 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™ 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™ 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.
Shares of Novavax popped nearly 8% to $1.05 in after-hours trading Tuesday. NVAX has a 1-year high of $8.49 and a 1-year low of $0.73. The stock’s 50-day moving average is $1.16 and its 200-day moving average is $1.16.
On the ratings front, NVAX has been the subject of a number of recent research reports. In a report issued on July 25, Cantor analyst William Tanner reiterated a Hold rating on NVAX, with a price target of $2.00, which represents a potential upside of 104% from where the stock is currently trading. On July 24, Piper Jaffray’s Edward Tenthoff reiterated a Hold rating on the stock and has a price target of $1.50.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, William Tanner and Edward Tenthoff have a yearly average return of 11.7% and 3.9% respectively. Tanner has a success rate of 57% and is ranked #624 out of 4628 analysts, while Tenthoff has a success rate of 43% and is ranked #1313.
Novavax, Inc. operates as a clinical-stage biopharmaceutical company, which engages in the provision of development of recombinant nanoparticle vaccines and adjuvants. Its product pipeline targets infectious diseases with vaccine candidates in clinical development for respiratory syncytial virus, seasonal influenza, pandemic influenza, and Ebola virus.