Full Press Release Details
Sinovac Reports Unaudited First
Quarter 2013 Financial Results
-Conference call scheduled for Tuesday,
May 28, 2013 at 8:00 AM EDT -
BEIJING, May 28, 2013 /PRNewswire/
- Sinovac Biotech Ltd. (SVA), a leading provider of biopharmaceutical products in China, announced today its unaudited first
quarter financial results for the period ended March 31, 2013.
First Quarter 2013 Financial Highlights
(Year-over-year comparisons to first quarter 2012)
Total sales increased by 68% to $10.1 million.
Gross profit increased by 90% to $7.1 million and gross profit
margin percentage increased to 70% from 62%.
Net loss attributable to common stockholders was $2.0 million,
or $0.04 per basic and diluted share, compared to a net loss of $5.6 million, or $0.10 per basic and diluted share, for the first
Cash and cash equivalents totaled $91.6 million as of March 31,
2013, compared to $91.2 million as of December 31, 2012.
In January 2013, Sinovac completed a pre-clinical study for its
varicella vaccine candidate and submitted an application to the China Food and Drug Administration (CFDA) to commence clinical
In April, Sinovac Biotech Co., Ltd. or Sinovac Beijing, the main
operating subsidiary company of Sinovac, obtained a certificate of Good Manufacturing Practices for Pharmaceutical Products (GMP
certificate) from the China Food and Drug Administration (CFDA) for its proprietary vaccines, its Haidian bulk production plants,
and its Changping filing and packaging facility. The GMP certificate covers Sinovac Beijing's vaccines commercialized in China
and approved for stockpiling, inclusive of the inactivated hepatitis A vaccine (human diploid cell); Inactivated hepatitis
A and B combined vaccine; influenza vaccine (split virion), inactivated; H5N1 pandemic influenza vaccine (inactivated, adjuvanted);
pandemic influenza vaccine (split virion, adjuvanted); and H1N1 influenza A vaccine (split virion, inactivated). The GMP certificate
is valid for five years expiring on April 17, 2018.
Dr. Weidong Yin, Chairman, President
and CEO, commented, "I am very pleased with the sales performance of our hepatitis A vaccine in the first quarter 2013, which
is the primary driver to the total sales growth of 68% year-over-year. In the first quarter, the mumps vaccine manufactured
by our Dalian site was commercialized, which also contributed to the sales growth in the first quarter."
Dr. Yin continued, "As our commercialized
vaccines keep growing, our near-term pipeline product, the enterovirus 71 (EV71) vaccine, realized another significant milestone.
Enterovirus 71 (EV71) vaccine remains to be a significant unmet medical need across China and Asia because of the widespread outbreaks
of hand, foot and mouth disease (HFMD) caused by EV71 and significant pediatric mortality rates. In 2012, over 2 million cased
were reported and over 500 fatal cased published by China National Health and Family Planning Commission ( or "NHFPC",
previously named China Ministry of Health). We announced the approximately 95% efficacy rate of our proprietary EV71 vaccine from
the phase III clinical trial on this vaccine. Based on the study results, our EV71 vaccine candidate has a good safety, immunogenicity
and efficacy profile. The next step is to file the new drug application to Beijing Drug Administration in order to apply for the
new drug certificate and the production license. And it is expected to launch in 2014."
"We are also committed to advance
our other vaccine development pipeline. We have a few pipeline products, including varicella vaccine, pneumococcal vaccines and
rubella vaccine that are under the evaluation by CFDA for granting a clinical trial approval. We believe the advancement of these
product development programs will maintain our sustainable growth in long term."
Financial Review for First Quarter
Ended March 31, 2013
An analysis of sales and gross profit
| In USD'000 | 2013Q1 | % of Sales | 2012Q1 | % of Sales | Change % | |||||||||||||||
| Hepatitis A - Healive | 6,165 | 61.3 | % | 1,612 | 27.0 | % | 282.4 | % | ||||||||||||
| Hepatitis A&B - Bilive | 2,995 | 29.8 | % | 4,015 | 67.2 | % | -25.4 | % | ||||||||||||
| Hepatitis vaccines | 9,160 | 91.1 | % | 5,627 | 94.2 | % | 62.8 | % | ||||||||||||
| Influenza vaccines | 294 | 3.0 | % | 314 | 5.3 | % | -6.4 | % | ||||||||||||
| Core sales | 9,454 | 94.1 | % | 5,941 | 99.5 | % | 59.1 | % | ||||||||||||
| Animal vaccine | 13 | 0.1 | % | 32 | 0.5 | % | -59.4 | % | ||||||||||||
| Mumps vaccines | 585 | 5.8 | % | - | - | - | ||||||||||||||
| Total sales | 10,052 | 100 | % | 5,973 | 100 | % | 68.3 | % | ||||||||||||
| Cost of goods sold | 2,992 | 29.8 | % | 2,255 | 37.8 | % | 32.7 | % | ||||||||||||
| Gross profit | 7,060 | 70.2 | % | 3,718 | 62.2 | % | 89.9 | % |
Total sales for the first quarter 2013
increased by 68% to $10.1 million, from $6.0 million in first quarter of 2012. The total sales growth was primarily driven by sales
increase in Healive which was due to the favorable competitive landscape. The mumps vaccine manufactured by our Dalian site was
firstly commercialized in the current quarter that also contributed to the total sales growth. The total sales growth was partly
offset by the decrease of Bilive sales.
Gross profit of the first quarter 2013
increased by 90% to $7.1 million from $3.7 million in the same period of 2012. Gross profit margin percentage increased to 70%
from 62% in 2012 with Healive sales represented 61% of the current quarter sales compared to 27% in same period of 2012. The
main reasons for the increased gross profit margin in first quarter 2013 were the lower unit cost of Healive resulted from higher
production volume in response to increased sales and the higher sales mix of Healive vaccines in syringe sold at premium price.
Selling, general and administrative
expenses for the first quarter 2013 were $6.4 million, compared to $4.3 million in the same period of 2012. SG&A expenses as
a percentage of the sales in first quarter of 2013 were 63%, compared to 72% for the same quarter of prior year. The increase in
SG&A expenses was mainly due to increased selling activities and costs that resulted in sales increases in hepatitis A and
new mumps vaccines; Material and labor costs mainly for the ongoing validation activities to prepare for GMP certification for
the EV71 manufacturing facilities in the Changping site; And higher operating, amortization and utilities costs in current quarter
in Changping site, which was under renovation in same period of prior year.
R&D expenses in the first quarter
of 2013 were $1.8 million, a significant decrease from $7.3 million in the same period of 2012 as the EV71 vaccine Phase III clinical
trial was approaching to the end stage in current quarter where it just started in the same period of 2012. Also, since mumps was
commercialized, no research and development expenses in current quarter while it was being developed in the same period of 2012.
Depreciation of property, plant and
equipment and amortization of licenses and permits for the first quarter of 2013 was $0.8 million, compared to $0.3 million for
the same period of prior year. Depreciation increased because more assets were put into service at the Changping facility since
the last quarter of 2012.
Net loss attributable to stockholders
in the first quarter of 2013 was $2.0 million, or $0.04 per basic and diluted share, compared to a net loss of $5.6 million, or
$0.10 per basic and diluted share, for the same quarter of last year.
As of March 31, 2013, cash and cash
equivalents totaled $91.6 million, compared to $91.2 million as of December 31, 2012. Net cash used in operating activities was
$5.6 million in the first quarter of 2013. Net cash of $2.1 million was used in investing activities which was mainly used for
payment and prepayment for acquiring property, plant and equipment for Changping facility. Net cash provided by financing activities
was $8.0 million in the first quarter of 2013, including loan proceeds of $7.5 million drawn under credit facilities already in
place supporting EV71 vaccine commercialization and daily operations. When appropriate, the Company will seek new sources
of financing to commercialize other pipeline products.
Conference Call Details
The Company will host a conference
call on Tuesday, May 28, 2013 at 8:00 a.m. EDT (May 28, 2013 at 8:00 p.m. China Standard Time) to review the Company's financial
results and provide an update on recent corporate developments. To access the conference call, please dial 1-877-407-4018 (USA)
or 1-201-689-8471 (International). A replay of the call will be available from 11 a.m. EDT on May 28, 2012 to June 11, 2013 at
midnight. To access the replay, please dial 1-877-870-5176 (USA) or 1-858-384-5517 (International) and reference the replay pin
A live audio webcast of the call will
also be available from the investors section on the corporate web site at www.sinovac.com. A webcast replay can be accessed
on the corporate website beginning May 28, 2013 and the replay will remain available for 30 days.
Sinovac Biotech Ltd. is a China-based
biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect
against human infectious diseases including hepatitis A and B, seasonal influenza, H5N1 pandemic influenza (avian flu), H1N1 influenza
(swine flu) and mumps, as well as animal rabies vaccine for canines. The Company recently concluded the phase III clinical trial
for enterovirus 71 (against hand, foot and mouth disease). In 2009, Sinovac was the first company worldwide to receive approval
for its H1N1 influenza vaccine, Panflu.1, and has manufactured it for the Chinese Central Government, pursuant to the government-stockpiling
program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government-stockpiling program.
Sinovac is developing a number of new pipeline vaccines including vaccines for pneumococcal polysaccharides, pneumococcal conjugate,
varicella and rubella. Sinovac sells its vaccines mainly in China and exports selected vaccines to Mongolia, Nepal, and the Philippines.