Fri, May 27, 6:20 AM| Fri, May 27, 6:20 AM
Thu, May 26, 6:02 PM
Tue, May 24, 7:05 AM
- The FDA approves Holly Springs, NC-based Seqirus' FLUCELVAX QUADRIVALENT, the firs four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people at least four year old. The vaccine helps protect individuals against two influenza A and two B viruses for the current flu season.
- The traditional flu vaccine is trivalent, consisting of two influenza A viruses and one influenza B strain, although Sanofi's (NYSE:SNY) quadrivalent flu vaccine was approved by the FDA in December 2014 for use in adults.
- Each year, about 200K Americans are hospitalized due to flu complications.
- Seqirus was created in July 2015 when bioCSL and Novartis' (NYSE:NVS) influenza vaccines business combined, creating the second largest influenza vaccine company in the world. Novartis sold the business to Australian blood products firm CSL Ltd. in October 2014 for $275M.
- Related tickers: (NYSE:GSK)(NASDAQ:NVAX)(NASDAQ:SVA)(NYSEMKT:HEB)
Tue, Apr. 5, 7:05 AM
- Sinovac Biotech (SVA) Q4 results: Revenues: $23M (+13.3%); R&D Expense: $2.9M (-17.1%); SG&A: $11.7M (+19.4%); Operating Income: $2.8M (+27.3%); Net Income: $1.3M (-45.8%); EPS: $0.01 (-66.7%); Non-GAAP EPS: $0.03 (unch).
- FY2015 results: Revenues: $67.4M (+7.2%); R&D Expense: $9.5M (-12.8%); SG&A: $37.4M (+9.4%); Operating Income: $3.7M (+76.2%); Net Income: $0.5M (-58.3%); Loss Per Share: ($0.01) (-200.0%); Non-GAAP EPS: $0.03 (unch); Quick Assets: $63.8M (-30.1%).
- No guidance given.
Tue, Apr. 5, 6:24 AM
Thu, Feb. 4, 9:19 AM
- Gainers: VHC +89%. GLUU +21%. OCLS +18%. WFT +12%. ATNY +11%. SEDG +11%. PETX +10%. SVA +9%. ING +9%. TTWO +8%. SBH +8%. GRUB +7%. VALE +7%. HMY +7%. CDNS +6%. CDE +6%. SBGL +6%. GSH +5%. AUY +5%. VIAB +5%. RIO 5%.
- Losers: PPP -16%. KSS -15%. GPRO -15%. IMPV -13%. CS -13%. PACB -13%. RL -9%. AZN -7%.
Thu, Feb. 4, 8:18 AM
- Sinovac (NASDAQ:SVA) received a preliminary non-binding proposal yesterday from a group of Chinese investors who seek to acquire the company for $7 per share in cash. The competing bid follows one received on January 30 from an investor group led by Chairman, President & CEO Weidong Yin for $6.18 per share.
- A special committee of the firm's independent directors will evaluate the offers.
- Shares are up 8% premarket on increased volume.
Mon, Feb. 1, 2:28 PM
- The China Food and Drug Administration issues a Good Manufacturing Practices (GMP) certificate to Sinovac Biotech (SVA +12.2%) for its Enterovirus 71 (EV71) vaccine, clearing the company to begin commercial production of up to 20M doses per year. It plans to deliver the vaccine to the market by the end of Q2.
- EV71 causes hand, foot and mouth disease (HFMD), a common and usually mild disease affecting small children. On occasion, though, EV71 infection is severe enough to cause neurological symptoms and death. According to the Chinese Ministry of Health, there were over 2.82M cases of HFMD in China with 508 fatalities. In the first 11 months of 2015, there were 1.61M infections and 118 deaths. No specific treatments or vaccines are currently available.
Tue, Jan. 5, 8:11 AM
- The China Food and Drug Administration clears Sinovac Biotech's (NASDAQ:SVA) application to begin human clinical studies of its Fast Track-tagged Sabin Inactivated Polio Vaccine (sIPV), slated to begin in H1 and be completed in 2018.
- The company intends to build a new manufacturing facility at its Changping site that will have the capacity to produce 10M doses per year. Construction should commence this year.
- Sinovac licensed sIPV from Netherlands-based Intravacc for development and commercialization in China and certain other countries.
- The Sabin IPV is safer to manufacture and more affordable than the currently available Salk IPV, making it more appropriate for developing countries.
Mon, Jan. 4, 1:14 PM
- The China Food and Drug Administration (CFDA) issues a new drug certificate and production license to Sinovac Biotch (SVA -3.1%) for its Enterovius 71 (EV71) vaccine. The company expects to receive its Good Manufacturing Practices (GMP) license in the coming weeks so production may commence. Commercial quantities will be available in four to five months.
- The company's Beijing-based manufacturing site will be able to produce up to 20M doses per year. The product will be targeted to the private pay market for children ages 6-35 months.
- EV71 causes Hand, Foot and Mouth Disease, a common viral infection that typically strikes children under five years old. It is spread through coughing, sneezing or contact with blister fluid or feces and is characterized by fever, mouth sores and skin rash.
Nov. 11, 2015, 6:06 PM
- Sinovac Biotech (NASDAQ:SVA): Q3 EPS of -$0.03
- Revenue of $16.8M (-2.0% Y/Y)
Aug. 12, 2015, 5:39 PM
Aug. 12, 2015, 4:31 PM
- Sinovac Biotech (NASDAQ:SVA): Q2 EPS of $0.04 beats by $0.05.
- Revenue of $18.5M (+53.0% Y/Y) beats by $2.8M.
May 15, 2015, 9:13 AM
May 15, 2015, 6:48 AM
- Sinovac Biotech (SVA +1.6%) Q1 results: Revenues: $9.3M (-31.1%); COGS: $2.4M (-27.3%); R&D Expense: $2.2M (+29.4%); SG&A: $6.9M (-11.5%); Operating Loss: ($2.2M) (-466.7%); Net Loss: ($2.3M); Loss Per Share: ($0.04); Quick Assets: $63.1M (-31.0%); CF Ops: ($8.2M) (-41.4%).
- No guidance given.
May 15, 2015, 12:23 AM
- Sinovac Biotech (NASDAQ:SVA): Q1 EPS of -$0.04 misses by $0.05.
- Revenue of $9.27M (-31.6% Y/Y) misses by $3.43M.
Sinovac Biotech Ltd. is biopharmaceutical company that focuses on research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases including hepatitis A and B, seasonal influenza, H5N1 pandemic influenza and mumps, as well as animal rabies... More
Other News & PR