Full Press Release Details
Reports Unaudited Fourth Quarter 2019 Financial Results and Files 2019 Annual Report on Form 20-F
China, April 30, 2020 /Business Wire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA) ("Sinovac" or the "Company"),
a leading provider of biopharmaceutical products in China, has filed its 2019 annual report on Form 20-F with the U.S. Securities
and Exchange Commission for the year ended December 31, 2019. The Company also reported its unaudited financial results for the
fourth quarter ended December 31, 2019.
Quarter and Full Year 2019 Financial Summary
Weidong Yin, Chairman, President, and CEO of Sinovac, commented, "Sinovac delivered strong performance in 2019 with growth
in sales and net earnings. We are pleased to report that during the fourth quarter of 2019, Anflu, the seasonal influenza vaccine,
was relaunched to the market after a one-year absence due to the manufacturing disruption orchestrated by the minority shareholder
of Sinovac Beijing in 2018. Furthermore, our varicella vaccine was granted market authorization in December 2019, and today the
batch release approval was obtained for our first batch varicella vaccines."
development team has had a busy year. In addition to our varicella vaccine being approved to market in China, we made good progress
on the development and regulatory advancement of our quadrivalent influenza vaccine (QIV), sabin inactivated polio vaccine (sIPV)
and 23-valent pneumococcal polysaccharide vaccine (PPV-23). We expect to obtain market authorization for QIV in 2020. As previously
announced, Sinovac is also at the forefront of the fight against COVID-19 through vaccine development. Our phase I human trial
is ongoing, and we expect to deliver results in the summer," Mr. Yin continued.
quarter of 2020, the COVID-19 outbreak has impacted the regular business of the Company. As disclosed previously, domestic sales
have ceased due to the suspension of vaccinations by the Chinese CDC since February, and exports are disrupted due to cancellations
of cargo flights and inflated freight costs. Any prolonged disruption of Sinovac's clinical trials could delay regulatory
approvals or the commercialization of any current or future products. Certain provinces and cities in China are starting to lift
some of the restrictive measures, and delivery of vaccines in China has slowly started to resume. The Company is closely monitoring
the situation in China as well as in the other countries in which it markets its vaccines," Mr. Yin concluded.
Pipeline Development
Sars-cov-2 (COVID-19)
vaccine - The Company initiated the development of a vaccine against COVID-19 at the end of January 2020. Preclinical
studies were conducted from then until early April, when the vaccine candidate was proved to be safe and can provide protection
on animals. The application for clinical studies was submitted to the National Medical Products Administration ("NMPA")
on March 13, 2020. Since then, 18 submissions have been made to the NMPA to complete the full submission for clinical application.
The NMPA implemented a concurrent review on the full submission and granted approval for human trials on April 13, 2020. The phase
I study commenced on April 16. The trial is ongoing.
Pneumococcal polysaccharide vaccine (PPV-23) - The Company submitted its application for a production license in 2017.
In 2018, the NMPA requested a supplementary submission. The technical review by the NMPA was commenced at the end of September,
and the site inspection was conducted in December 2019.
influenza vaccine (QIV) - The Company filed an application with the NMPA for a production license for the QIV vaccine
in March 2019. The NDA has been filed, and the site inspection was completed in March 2020. The Company expects the commercial
launch of QIV to occur in 2020.
Inactivated Polio vaccine (sIPV) - The production license application for the sIPV vaccine was accepted by the NMPA in
January 2019. In March 2019, given the high demand for effective polio vaccines, the application was granted fast track review.
Currently, the application is under review.
Financial Results for the Fourth Quarter of 2019
Summary of sales and gross profit
| (In $000 except percentage data) | 2019 Q4 | Percentage of Sales | 2018 Q4 | Percentage of Sales | ||||||||||||
| Hepatitis A vaccine - Healive | 18,862 | 23.3 | % | 16,528 | 31.1 | % | ||||||||||
| Hepatitis A&B vaccine - Bilive | - | 0.0 | % | (285 | ) | (0.5 | %) | |||||||||
| Hepatitis vaccines subtotal | 18,862 | 23.3 | % | 16,243 | 30.6 | % | ||||||||||
| Influenza vaccine | 6,179 | 7.6 | % | (50 | ) | (0.1 | %) | |||||||||
| EV71 vaccine - Inlive | 43,527 | 53.6 | % | 35,884 | 67.4 | % | ||||||||||
| Mumps vaccine | 12,543 | 15.5 | % | 1,134 | 2.1 | % | ||||||||||
| Total sales | 81,111 | 100.0 | % | 53,211 | 100.0 | % | ||||||||||
| Cost of sales | 12,251 | 15.1 | % | 6,732 | 12.7 | % | ||||||||||
| Gross profit | 68,860 | 84.9 | % | 46,479 | 87.3 | % |
for the fourth quarter of 2019 were $81.1 million, an increase of 52.4% from $53.2 million in the prior year period. The increase
was due to reintroduction of the Company's influenza vaccine and higher sales of the mumps vaccine due to a revamped sales
and marketing strategy and supply shortage on the market.
lack of Bilive sales remains attributed to its suspended production,
which was due to a lack of supply of the hepatitis B vaccine antigens from the Company's sole supplier.
profit in the fourth quarter of 2019 was $68.9 million compared to gross profit of $46.5 million in the prior year period. Gross
margin was 84.9% compared to 87.3% in the prior year period. The decrease of gross margin was due to a change of sales mix, primarily
caused by increased sales of the lower-margin influenza vaccine.
general and administrative expenses in the fourth quarter of 2019 were $33.3 million compared to $40.7 million in the prior year
period. The Company incurred lower legal and consulting fees associated with the Company's ongoing litigation matters in
expenses in the fourth quarter of 2019 were $7.8 million compared to $7.1 million in the prior year period, as the Company continued
to invest in the development of its pipeline product candidates, including sIPV and PPV.
income in the fourth quarter of 2019 was $32.8 million compared to $0.3 million in the prior year period. Net income increased
due to higher revenue and lower selling, general and administrative expenses.
income attributable to common shareholders was $21.6 million, or $0.22 per basic and $0.20 per diluted share, compared to net loss
attributable to common shareholders of $1.2 million, or $0.02 per basic and diluted share, in the prior year period.
the Company announced on February 22, 2019, the Company's Board of Directors determined that certain shareholders became
"Acquiring Persons," as defined in the Company's Rights Agreement ("Rights Agreement"), and a "Trigger
Event" occurred under the Rights Agreement. As a result, new common and preferred shares of the Company were issued. Without
the effect of the implementation of the Rights Agreement and the newly issued common and preferred shares, basic and diluted earnings
per share for the fourth quarter of 2019 would be $0.33.
adjusted EBITDA was $30.7 million in the fourth quarter of 2019 compared to $2.2 million in the prior year period. Non-GAAP net
income in the fourth quarter of 2019 was $34.0 million compared to $1.0 million in the prior year period. Non-GAAP diluted earnings
per share in the fourth quarter of 2019 were $0.21 per share compared to $0.02 losses per share in the prior year period. Non-GAAP
diluted earnings per share in the fourth quarter of 2019 excluding the implementation of the Rights Agreement and the newly issued
common and preferred shares would be $0.36 per share. Reconciliations of non-GAAP measures to the nearest comparable GAAP measures
are included at the end of this earnings announcement.
Company's fourth quarter 2019 financial statements are prepared and presented in accordance with U.S. GAAP. However, they
have not been audited or reviewed by the Company's independent registered accounting firm.
Results for the Twelve Months Ended December 31, 2019
Summary of sales and gross profit
| (In $000 except percentage data) | 2019 YTD | Percentage of Sales | 2018 YTD | Percentage of Sales | ||||||||||||
| Hepatitis A vaccine - Healive | 57,955 | 23.6 | % | 52,420 | 22.8 | % | ||||||||||
| Hepatitis A&B vaccine - Bilive | (2 | ) | 0.0 | % | 11,005 | 4.8 | % | |||||||||
| Hepatitis vaccines subtotal | 57,953 | 23.6 | % | 63,425 | 27.6 | % | ||||||||||
| Influenza vaccine | 19,145 | 7.8 | % | 2,028 | 0.9 | % | ||||||||||
| EV 71 vaccine - Inlive | 149,223 | 60.6 | % | 162,538 | 70.8 | % | ||||||||||
| Mumps vaccine | 19,732 | 8.0 | % | 1,659 | 0.7 | % | ||||||||||
| Total sales | 246,053 | 100.0 | % | 229,650 | 100.0 | % | ||||||||||
| Cost of sales | 32,469 | 13.2 | % | 24,723 | 10.8 | % | ||||||||||
| Gross profit | 213,584 | 86.8 | % | 204,927 | 89.2 | % |
in 2019 were $246.1 million, an increase of 7.1% from $229.7 million in the prior year. The increase was due to reintroduction
of the Company's influenza vaccine and higher sales of the mumps vaccine for the same reason mentioned in quarterly results.
profit in 2019 was $213.6 million compared to gross profit of $204.9 million in the prior year. Gross margin was 86.8% compared
to 89.2% in the prior year. The decrease of gross margin was due to a change in sales mix, with a higher proportion of sales of
the influenza vaccine, which has a lower profit margin.
general and administrative expenses in 2019 were $121.5 million compared to $137.0 million in the prior year. The Company incurred
lower legal and consulting fees associated with the Company's ongoing litigation matters in 2019.
expenses in 2019 were $24.3 million compared to $21.9 million in the prior year.
income in 2019 was $65.2 million compared to $36.1 million in the prior year. Net income increased primarily due to higher revenue
and lower selling, general and administrative expenses.
income attributable to common shareholders was $39.8 million, or $0.42 per basic and $0.41 per diluted share, compared to net income
attributable to common shareholders of $21.8 million, or $0.34 per basic and diluted share, in the prior year.
the implementation of the Rights Agreement, as described above, and the newly issued common and preferred shares, basic and diluted
earnings per share for 2019 would be $0.63.
adjusted EBITDA was $76.4 million in 2019 compared to $54.8 million in the prior year. Non-GAAP net income in 2019 was $68.5 million
compared to $39.9 million in the prior year. Non-GAAP diluted earnings per share in 2019 were $0.43 per share compared to $0.38
per share in the prior year. Non-GAAP diluted earnings per share in 2019, excluding the implementation of the Rights Agreement
and the newly issued common and preferred shares, would be $0.73 per share. Reconciliations of non-GAAP measures to the nearest
comparable GAAP measures are included at the end of this earnings announcement.
of December 31, 2019, cash and cash equivalents totaled $152.7 million compared to $158.2 million as of December 31, 2018. In 2019,
net cash provided by operating activities was $39.1 million, net cash used in investing activities was $42.5 million, and net cash
provided by financing activities was $1.7 million, including loan proceeds of $2.1 million and loan repayment of $3.3 million.
As of December 31, 2019, the Company had $5.9 million in bank loans due within one year. The Company expects that its current cash
position will be able to support its operations for at least the next 12 months.
previously disclosed by the Company, on March 13, 2018, 1Globe Capital LLC ("1Globe") filed a complaint against the
Company in the Antigua Court. The trial of the matter took place from December 3 to 5, 2018. On December 19, 2018, the Antigua