Full Press Release Details
Reports Unaudited Second Quarter 2016 Financial Results
August 23, 2016 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products
in China, announced today its unaudited second quarter ended June 30, 2016.
Weidong Yin, Chairman, President and CEO of the Sinovac, commented, "As forecasted on our first quarter earnings call, we
experienced a continued decline to our financial results in the second quarter due to the incident involving the improper distribution
and sale of vaccines in Shandong province. This impacted nationwide sales of private-pay market vaccines as vaccine companies halted
vaccine delivery to wait for the interpretation of new regulation by the Chinese government."
mid-June, the China Food and Drug Administration ("CFDA") and China's Ministry of Health jointly issued an interpretation
of the new requirement and execution plan during the transition period before the infrastructure is set up to fully comply with
the new regulation. This allowed vaccine sales and delivery in the private-pay market to resume following the joint government
announcement. Since then, we have experienced a rebound in sales activity. When the private-pay vaccine market was reactivated,
our sales and marketing team launched marketing activities for promoting our newly approved EV71 vaccines. There have been vaccination
kick-off ceremonies, commercial launch activities at the provincial level, as well as educational seminars and marketing activities,
as planned. By now, we have delivered our EV71 vaccine to 16 provinces and three municipalities and we expect these numbers to
Yin also commended, "During the second quarter, we also made progress on our pipeline programs with the continuation of clinical
trials of our varicella vaccine and completed preparation for the trials of our sIPV vaccine. We expect that sales in our fiscal
second half of the year will be much stronger than the first half and look forward to updating our investors on our latest progress
and achievements in the months ahead."
Quarter 2016 Business Highlights
- Sinovac's EV71 was approved for commercialization early this year. After private pay market vaccine sales resumed, sales
and marketing of EV71 vaccine was initiated immediately and Sinovac's Public Tender market: Sinovac won the tender of supplying
Healive to Beijing over the course of 2016 to 2018. The total value of the tender is RMB 32 million ($4.8 million). Sinovac was
selected to be the sole supplier of Healive to Shanghai for 2016 and the value of the contract is RMB 3.2 million ($0.5 million).
- The vaccine candidate was approved to commence human clinical trials in 2015. The phase I clinical trial was initiated
in May 2016 in Henan Province. The phase I trial is designed as a single-center, randomized, double-blinded, and placebo controlled
study. 270 subjects were enrolled. The preliminary results show the vaccine has a good safety profile. We expect to initiate the
phase III trial in September 2016.
- The clinical trial license was received in December 2015.Sinovac has obtained the clinical site approval and ethics committee
approval for conducting the trial. Preparation for the trial is now complete and we expect to conduct clinical trial phase I in
the beginning of September 2016.
Results for Second Quarter 2016
| 2016Q2 | % of Sales | 2015Q2 | % of Sales | |||||||||||||
| (In $000 except percentage data) | ||||||||||||||||
| Hepatitis A - Healive | 877 | 63.7 | % | 8,462 | 45.8 | % | ||||||||||
| Hepatitis A&B - Bilive | (1,359 | ) | (98.7 | )% | 9,216 | 49.8 | % | |||||||||
| Hepatitis vaccines subtotal | (482 | ) | (35.0 | )% | 17,678 | 95.6 | % | |||||||||
| Influenza vaccine | 248 | 18.0 | % | 526 | 2.8 | % | ||||||||||
| Enterovirus 71 vaccine | 1,562 | 113.4 | % | - | - | |||||||||||
| Mumps vaccine | 49 | 3.6 | % | 287 | 1.6 | % | ||||||||||
| Regular sales | 1,377 | 100.0 | % | 18,491 | 100.0 | % | ||||||||||
| H5N1 | - | - | - | - | ||||||||||||
| Total sales | 1,377 | 100.0 | % | 18,491 | 100.0 | % | ||||||||||
| Cost of sales | 3,737 | 271.4 | % | 3,283 | 17.8 | % | ||||||||||
| Gross profit | (2,360 | ) | (171.4 | )% | 15,208 | 82.2 | % |
sales from continuing operations were $1.4 million compared to $18.5 million in the prior year period. The sales decrease was due
to lower sales to Centers for Disease Control and Prevention ("CDCs") and no sales to distributors combined with an
increase in sales returns as a result of the vaccine incident in Shandong province.
loss from continuing operations was $2.4 million, compared to gross profit of $15.2 million in the prior year period.
general and administrative expenses in the second quarter of 2016 were $8.3 million, compared to $9.0 million in the same period
of 2015. Generally, the Company's selling, general and administrative expenses declined with the lower level of sales activity,
but there were other significant factors that offset this trend, including a cost of $786 thousand relating to the proposed privatization
of Sinovac; and a recorded expense of $526 thousand resulting from the depreciation of the RMB against the United States dollar.
expenses in the second quarter of 2016 were $2.8 million, compared to $2.2 million in the same period of 2015. The increase was
mainly due to higher R&D expenses on the MMR vaccine project in the second quarter of 2016.
from continuing operations was $12.6 million compared to an income of $3.7 million in the prior year period. The second quarter
of 2015 includes a loss from discontinued operations of $244 thousand whereas no such income or loss was received in the second
loss attributable to common shareholders was $9.6 million, or ($0.17) per basic and diluted share, compared to net income attributable
to common shareholders of $2.3 million, or $0.04 per basic and diluted share in the prior year period.
EBITDA was negative $12.0 million in the second quarter of 2016, compared to $6.3 million in the prior year period. Non-GAAP net
loss from continuing operations in the second quarter of 2016 was $11.7 million, compared to net income of $3.9 million
in the prior year period. Non-GAAP diluted net loss per share from continuing operations in the second quarter of 2016 was $0.15,
compared to net income of $0.05 per share in the prior year period. Reconciliations of non-GAAP measures to the nearest comparable
GAAP measures are included at the end of this earnings announcement.
Unaudited Financial Results for First
| (In $000 except percentage data) | 2016H1 | % of Sales | 2015H1 | % of Sales | ||||||||||||
| Hepatitis A - Healive | 4,524 | 36.7 | % | 11,385 | 41.1 | % | ||||||||||
| Hepatitis A&B - Bilive | (1,143 | ) | (9.3 | )% | 14,271 | 51.5 | % | |||||||||
| Hepatitis vaccines subtotal | 3,381 | 27.4 | % | 25,656 | 92.6 | % | ||||||||||
| Influenza vaccine | 710 | 5.8 | % | 1,112 | 4.0 | % | ||||||||||
| Enterovirus 71 vaccine | 1,562 | 12.7 | % | - | - | |||||||||||
| Mumps vaccine | 286 | 2.3 | % | 930 | 3.4 | % | ||||||||||
| Regular sales | 5,939 | 48.2 | % | 27,698 | 100.0 | % | ||||||||||
| H5N1 | 6,392 | 51.8 | % | - | - | |||||||||||
| Total sales | 12,331 | 100.0 | % | 27,698 | 100.0 | % | ||||||||||
| Cost of sales | 8,363 | 67.8 | % | 5,591 | 20.2 | % | ||||||||||
| Gross profit | 3,968 | 32.2 | % | 22,107 | 79.8 | % |
from continuing operations were $12.3 million in the first half of 2016, a decrease of 55.5% from $27.7 million in the prior year
period. Excluding H5N1 revenue, sales from continuing operations were $5.9 million in the first half of 2016, a decrease of 78.6%
from $27.7 million in the prior year period.The sales decrease was due to lower sales to customers and additional sales return
provision provided as a result of the vaccine incident in Shandong province.
profit from continuing operations was $4.0 million, a decrease of 82.1% from $22.1 million in the prior year period. Gross margin
was 32.2%, compared to 79.8% in the prior year period. Excluding H5N1, the first half year gross margin was 3.7%, compared to 80.4%
in the prior year period. The decrease was mainly due to higher inventory provision provided for hepatitis A&B and mumps vaccines,
higher idle capacity costs charged to cost of sales, and a negative gross profit for the hepatitis A&B vaccine due to higher
sales returns provision provided in the first half of 2016.
general and administrative expenses in the first half of 2016 were $14.5 million, compared to $15.8 million in the same period
of 2015. The Company's selling, general and administrative expenses declined with the lower level of sales activity, but
there were other significant factors that offset this trend including a cost of $856 thousand relating to the proposed privatization
of Sinovac and a recorded expense of $403 thousand resulting from the depreciation of the RMB against the United States dollar.
expenses in the first half of 2016 were $4.9 million, compared to $4.4 million in the same period of 2015.
loss from continuing operations was $14.2 million, compared to a net income of $1.0 million in the prior year period. Net income
from discontinued operations was $2.3 million, compared to a net loss of $436 thousand in the prior year period.
loss attributable to common shareholders was $8.3 million or ($0.14) per basic and diluted share in the first half of 2016, compared
to net income attributable to common shareholders of $20 thousand, or $0.00 per basic and diluted share, in the first half year
Non-GAAP EBITDA was negative $11.9 million
loss in the first half of 2016, compared to $6.0 million in the prior year period. Non-GAAP net loss from continuing operations
in the first half of 2016 was $13.1 million, compared to a net income of $1.3 million in the prior year period. Non-GAAP diluted
net loss per share from continuing operations in the first half of 2016 was $0.17, compared to net income of $0.01 per share in
the prior year period. Reconciliations of Non-GAAP measures to the nearest comparable GAAP measures are included at the end of
this earnings announcement.
of June 30, 2016, cash and cash equivalents totaled $49.2 million, compared to $63.8 million as of December 31, 2015. In the first
half of 2016, net cash used in operating activities was $15.6 million. Net cash used in investing activities was $3.7 million,
which was for the purchase of equipment. Net cash provided by financing activities was $5.7 million, including loan proceeds of
$22.7 million and loan repayment of $17.8 million. As of June 30, 2016, the Company had $23.8 million of bank loans due within
one year. The Company expects that its current cash position will be able to support its operations for the next 12 months. The
Company will seek new commercial bank loans to finance the commercialization of its pipeline products and for other operational
purposes when appropriate.
will host a conference call on Tuesday, August 23, 2016, at 8:00 a.m. EDT (Tuesday, August 23, 2016 at 8:00 p.m. China Standard
Time) to review the Company's financial results and provide an update on recent corporate developments.
the conference call, please dial 1-877-407-9039 (USA) or 1-201-689-8470 (International). A replay of the call will be available
after the earnings call through September 6, 2016. To access the replay, please dial 1-877-870-5176 (USA) or 1-858-384-5517 (International)
and reference the replay pin number 13643261.
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. Sinovac's product portfolio includes vaccines against hepatitis A and
B, seasonal influenza, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), mumps and canine rabies. In 2009, Sinovac
was the first company worldwide to receive approval for its H1N1 influenza vaccine, which it has supplied to the Chinese Government's
vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the
government stockpiling program. Sinovac's newly developed innovative vaccine against HFMD caused by EV71 is ready for market launch.
The Company is currently developing a number of new products including a Sabin-strain inactivated polio vaccine, pneumococcal polysaccharides
vaccine, pneumococcal conjugate vaccine and varicella vaccine. Sinovac primarily sells its vaccines in China, while also exploring
growth opportunities in international markets. The Company has exported select vaccines to Mexico, Mongolia, Nepal, Tajikistan,
Bangladesh, Chile and the Philippines, and was recently granted a license to commercialize its influenza vaccine in Guatemala.
For more information, please visit the Company's website at www.sinovac.com.