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Sinovac Biotech Ltd. (NASDAQ:SVA)

F4Q2012 Results Earnings Call

April 18, 2013 08:00 ET

Executives

Stephanie Carrington - The Ruth Group

Weidong Yin - Chief Executive Officer

Helen Yang - Investor Relations Manager

Danny Chung - Chief Financial Officer

Analysts

Yi Chen - Aegis Capital

Operator

Greetings, and welcome to the Sinovac Biotech Ltd. Fourth Quarter and Full Year 2012 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. [Operator Instructions]. As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Stephanie Carrington, of The Ruth Group. Thank you Ms. Carrington, you may begin.

Stephanie Carrington

Thank you, operator. Good day everyone. Before we begin, we would like to remind everyone that this conference call contains forward-looking statements. These statements are made under the Safe Harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words or phrases such as will, expects, anticipates, future, intends, plans, believes, estimates and similar statements. These statements that are not historical facts, including statements about Sinovac's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of important factors can cause actual results to differ materially from those contained in any forward-looking statement. Sinovac does not undertake any obligation to update any forward-looking statements, except as required under applicable laws.

On the call today from management we have Dr. Weidong Yin, CEO; Mr. Danny Chung, Sinovac's Chief Financial Officer; Ms. Helen Yang, Investor Relations Director; and Mr. Rui Chung, Investor Relation Specialist. In addition, we would like to apologize for the delay of the start of the conference call, as you may have seen the quarterly release has now crossed the wires.

As such, I will now turn over the line to Helen Yang. Go ahead Helen.

Helen Yang

Thank you, Stephanie, and hello everyone. Thank you for joining us on this conference call. I will provide an update on the business on behalf of our CEO, Mr. Yin, and our CFO, Mr. Danny Chung will then provide a financial overview.

Let me firstly highlight that 2012 was a transformative year for Sinovac, as we made significant advances across our entire business; both on the clinical development pipelines and also for the commercial lines of vaccine. We believe that we are well positioned for medium and long term growth on multiple fronts. As such, we will start by providing a recent update on the vaccine development pipeline, and our most advanced candidate. Our Phase III clinical studies for our proprietary inactivated vaccine against human enterovirus 71 or EV71.

As many of you know, in March, we announced the preliminary top line data for our Phase III clinical trials, on our EV71 vaccine candidates against hand, foot and mouth disease, caused by EV71 virus. The primary objective of the study was to evaluate the efficacy of the vaccine candidate; and this trial was conducted among infants from six to 35 months old, and we were very pleased to report that the preliminary data shows that Sinovac EV71 vaccine was 95% effective against hand, foot and mouth disease caused by EV71.

In addition, yesterday, Dr. Zhu Fengcai, Deputy Director of the Jiangsu Provincial Center for Disease Control and who is the co-principal investigator of our Phase III trial, presented additional efficacy and safety data from the trial that was conducted in Jiangsu Province. On the 13th Annual World Vaccine Congress and Expo held in Washington DC, of the United States. And this data shows that EV71 vaccine has 95% efficacy, when compared to the placebo group, and safety was comparable, between the vaccine group and placebo group, and injection site and general adverse reaction was similar across both groups.

We are working with the PR team to drop an article about this vaccine for a (inaudible) journal and we will make an announcement on the publish of this article, once it's completed.

Our clinical research and regulatory team are right now working on the summary reports of the clinical studies and also to prepare the new drug application dossier, and we expect to submit the application for the new drug license to China's FDA by the end of May.

Regarding to EV71 vaccine production facility at our Changping site; we have completed the construction and installation of the equipment, and a validation was carried out in the last year, and right now, the facilities are ready for GMP inspection. Therefore, once the new drug license is granted, we can make [anticipation] for our production license and the GMP certification, before we can commercialize our vaccine to the market. And we would expect that the vaccine could be commercialized in the year of 2014.

With respect to our vaccine development pipeline, we also have several other candidates in various phases of development, and earlier this year, we filed an IND for the varicella vaccine developed by our Dalian site, and also, we previously filed a clinical application for our pneumococcal polysaccharide vaccine; and we would expect to start a trial, once we obtain the license granted by the government, in China.

Also you may have seen, that recently the news about the new avian flu strain, H7 and H9, that is beginning to be found in China. With our flu vaccine platform, we believe we are capable of developing and manufacturing vaccines, which are flu related, and we are experienced in developing avian flu vaccines for humans, including vaccines against newly emerged flu viruses, such as the H5N1 and H1N1 flu strain; and we intend to begin preliminary research on H7 and H9 strain, after we obtain the virus [leads].

In December of 2012, the China FDA conducted an on-site inspection on our Changping site and Shangdi site at Beijing, to evaluate the compliance under China's new GMP standards, which is according to the 2010 version, which is the latest one. (Inaudible) public comment, [theory] was conducted from March 19 to April 1st, and we are currently awaiting the GMP certification for these two sites.

Now I would like to turn over to our commercial lines of vaccine business. We saw a 38.6% increase in our regular vaccine sales in 2012, including our core products like Healive, Bilive, and Anflu, and also our recently launched mumps vaccine and RabEnd, which is a animal rabies vaccine; and we have actually achieved growth across all our core products, and in every market segment, including private pay market, public market, and overseas market, and specially for the private market that we supplied our Bilive and Healive, that actually contribute the growth in both the growth rate and magnitude of the sales.

Our financial results was benefitted from a successful price increase for both of these products, as well as higher sales volumes, and that we believe that our current sales team is [very] successfully to execute their sales strategy to drive up the growth; and we also believe that the capability of our sales team can be utilized, when we are commercializing our EV71 vaccine in China.

In addition to that, in order to have a successful commercialization, we are actually supplying the vaccine to the targeted population in China, under five years old, with our EV71 vaccine, which actually is about approximately 80 million of population, and as it was reported last year, a total of about 2.63 million cases of hand, foot and mouth disease was reported, of among which 560 cases are fatal (inaudible).

However that opportunity right now, is no matter in China or around -- in the rest of the world, there is no any EV71 treatment method, therefore that providing the vaccines is the most effective solution to help our population, to prevent the disease and to control the disease epidemic. That's why we believe, with our sales team's experience and also our good vaccines, we are helping our population to prevent the outbreak of the hand, foot and mouth disease, caused by EV71.

Also yesterday, we received a very good news from our overseas market. As actually, Sinovac has spent over two years for -- in order to get our license, to commercialize our vaccine in Mexico. Yesterday, we were informed that the license of commercializing flu vaccines in Mexico was granted to us; and if you remember, that in year of 2011, Sinovac flu vaccine [quant] and the Hepatitis A [quant] passed the onsite inspection by Mexican authority. So now, we are in a good position to be planning of our commercialization funds of our flu vaccines in Mexican market.

We also want to take this opportunity to mention that, we were -- besides human vaccines, we were also making efforts to develop our animal vaccine market. However but, we believe this market is completely new for Sinovac and that we will need sometime for the market and sales to be up, and therefore that management takes a conservative approach for the year end 2012, to provide accounting treatment to do an impairment of (inaudible), which are related to the production of animal vaccines, on our P&L.

For now I think I complete the statement for the business, I would now like to turn over the call to Danny, to review the financial results for the fourth quarter and full year 2012. Danny?

Danny Chung

Thank you, Helen. Good day everyone, I am going to walk you through briefly on the financial highlights for the fourth quarter and the total year. Total revenue for the fourth quarter of 2012 was $19 million, a decrease of 10.4% from $21.1 million in the same period of 2011. Fourth quarter 2012 sales of our regular products, Healive and Anflu, mumps vaccine and animal vaccine, increased by 166.9% to $19 million from $7.1 million in the same period of 2011.

The significant increase in sales of core products in the fourth quarter was driven by one, expansion of Healive to a new territory, Jiangsu Province in the fourth quarter. Second, successful implementation of the new sales strategy, that could achieve high volume, and also average selling prices increases for Healive vaccines. Third, high input sales in the fourth quarter, compared to other regular year, due to a later start of Anflu sales season in 2012.

2011 sales included recognition of approximately $14 million revenue from Panflu and Panflu.1 vaccines, stockpiled by the Chinese government in 2010. These two products are not for regular sales, since they were produced upon government order and subject to the government decision of using the vaccines within its shelf life, if there was any flu pandemic caused by H1N1 and/or H5N1. The company's revenue recognition requirements were not met until the fourth quarter of 2011; and in 2012, there was no revenue recognized for either Panflu or Panflu.1.

Compared with the fourth quarter of 2011, the gross profit margin for the fourth quarter of 2012 decreased from 62% to 54.1%. The high gross margin in the fourth quarter of 2011 was due to the recognition of $14 million in revenue from H1N1 vaccine stockpiling, which has higher gross margin than the other vaccines.

Selling, general and administrative expenses for the fourth quarter of 2012 were $12.8 million, compared to $5.9 million in the same period of 2011. The increase in SG&A was largely due to an increase in G&A, although both selling expenses and G&A also increased. The increase of G&A expenses was a result from increased expenses incurred for validation, commissioning, and trial production for the dedicated production facility for our EV71 vaccine at the Changping site, and the preparation for GMP inspection by the government authorities of our existing manufacturing facilities in both the Changping and Shangdi sites in Beijing for compliance with China's 2010 GMP guidelines.

The R&D expenses for the fourth quarter of 2012 was $1.3 million, a $1 million decrease from $2.3 million for the same period in 2011, due to lower EV71 clinical trial expenses, as the trial is approaching its end. Depreciation of property, plant and equipment and amortization of licenses and permits for the fourth quarter of 2012, was consummated, compared to 40,000 for the same period in 2011.

For the fourth quarter of 2012, an impairment charge of $1.5 million on the long-lived assets, including plant, building, machinery and equipments related to the animal vaccine production was made. Overall, net loss attributable to stockholders for the fourth quarter of 2012, was $5.4 million or $0.10 per basic and diluted share, compared to a net income of $2.8 million or $0.05 per basic and diluted share for the same period in 2011.

So now we turn to the full year results; total revenue for the fiscal year ended December 31, 2012, was $48.6 million, a decrease of 14.5% from $56.8 million reported in 2011. Excluding the revenue recognized on the government stockpiling of Panflu and Panflu.1 in 2012, sales of our regular product, Healive, Bilive and Anflu, mumps vaccine and RabEnd increased by 38.6% to $48.6 million in 2012, from $35.1 million in 2011.

Gross profit margin for the year was 60.7% in 2012, a decline from 62.8% in 2011. When excluding the impact of the sales and cost of sales in both years, by the Panflu and Panflu.1 government stockpiling products, gross margin of regular vaccine product actually increased to 63.7% in 2012, from 57.7% in 2011.

SG&A expenses in 2012 were $31.7 million, compared to $22.4 million in 2011. The increase in SG&A was largely due to an increase in G&A, both in selling expenses and general admin expenses. The increase of G&A was due to the increased cost incurred on the validation of facility in Changping site and preparation for the new GMP compliance for the existing facility in Changping and the Shangdi sites.

Research and development expenses for the year 2012 increased to $17 million from $9 million in 2011. The increase was mainly due to the expenses incurred in 2012 in connection with the EV71 Phase III clinical trial.

Depreciation and amortization expenses in 2012 was $1.6 million, compared to $1.4 million in 2011. The higher depreciation in 2012 was mainly due to the additional depreciation on the property, plant and equipment at the Changping site.

The company recorded loss on disposal and impairment of $2.2 million for the year, in the operating expenses, in which $1.5 million was for animal vaccine production related assets and $0.5 million was for human vaccine production related assets.

For the total year, net loss attributable to stockholders in 2012 was $15.7 million, or $0.29 per basic and diluted share, compared to a net loss of $800,000 or $0.02 per basic and diluted share in 2011.

Now we come to the cash position; as of December end 2012, our cash balances totaled $90.9 million, compared to $104.3 million as of last year, December 31, 2011. Net cash used in operation activities was $16.6 million in 2012, primarily resulted from payment made for our EV71 clinical trial and validation cost of its manufacturing sites and GMP preparation costs.

Net cash used in investing activities was $16.2 million, primarily because we made payment for the purchase of property, plant and equipment to be installed at the Changping site. Net cash provided by financing activities was $17.3 million in 2012. At the end of the day, the company maintained a strong cash balances, $90.9 million by the end of December 31, 2012, despite the significant expenditure on the Phase III clinical trial, EV71, and the investment in our production facilities. In order to commercialize other pipeline products, the company may continue to explore new sources of financing when appropriate.

In closing, we want to point out that we included a set of an audited financial tables in today's press release, to correct prior unaudited quarterly results in Q2 and Q3 in 2012. The correction of the latest two government grants, related to the purchase of equipment that should have been (inaudible) doubling grants.

The above concludes management highlights on the financials. So operator, we would now take questions. Thank you.

Question-and-Answer Session

Operator

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions]. Thank you. Our first question comes from the line of Ben Lee with Morgan Stanley. Please proceed with your question.

Unidentified Analyst

Hi everyone. It's [Bella] calling in behalf of Ben Lee from Morgan Stanley. I have two questions. The first question is, can management give us a little bit color for the 2013 outlook in terms of the revenue growth and net income, and what kind of growth rate we will be seeing, and also, what kind of growth driver we will be seeing, in terms of the products (inaudible)? And the second question is regarding for the EV71, we are now pleased to see the positive progress of Sinovac's EV71 clinical trials, but could management give us a little overview of the competitive landscape, and would the company develop the same vaccine and what kind of competitive advantages Sinovac has in terms of launch of this EV71 in terms of the timeline? Thank you.

Helen Yang

I will translate your question first, then I will invite Mr. Yin to answer your question.

[Foreign Language].

Weidong Yin

[Foreign Language].

Helen Yang

So to answer your first question, because we don't expect any new product to be commercialized in 2013, therefore our sales team will keep -- to execute a similar strategy as they executed in last year, in terms of selling our existing vaccines in the market, and therefore for the management we would expect to maintain the sales, and to try to achieve the growth from the existing vaccines in 2013. And also after we conceded clinical studies on EV71, we would expect the R&D expenses in 2013 to be lower than the levels that we reported for last year, and therefore that we think from the loss position should be improved, compared to last year.

Weidong Yin

[Foreign Language].

Helen Yang

Regarding to the EV71 results, and we believe that with the 95% efficacy rate, which shows the vaccine has a very good efficacy profile, and also we indirectly understood that the other two companies who were also developing EV71 vaccines, also obtained a similar level of efficacy from their results. However that none of us published the results yet, but we think generally speaking, all these three companies are at a similar stage of the development, and we would expect everyone could be aligned in order to speed up the progress, in terms of regulatory approval for these vaccines, and then we could expect the vaccines can be commercialized as soon as we can.

Unidentified Analyst

Okay. Thank you. Can I ask the other question, the question is regarding for the commercialization of the anti-flu in Mexico and what kind of sales contribution you expect, and what time in --

[Foreign Language].

Weidong Yin

[Foreign Language].

Helen Yang

Great. Actually for Mexican market, we have spent a long time to pursue the regulatory approval for commercializing the vaccine, and recently, we just obtained license, and regarding to the Mexico market, actually the tender for 2013 has been completed and granted in 2012, and that actually is the majority of Mexican market. But there are still some (inaudible) market opportunities, therefore we don't expect any significant contribution to our total revenue from Mexico market this year.

Unidentified Analyst

Okay. Thank you. That's all of my questions.

Operator

Our next question comes from the line of Yi Chen with Aegis Capital. Please proceed with your question.

Yi Chen - Aegis Capital

Hi. Thank you for taking my questions. My first question is, what is Chinese government's current opinion on whether it is necessary to develop that same for H7 and H9?

Weidong Yin

[Foreign Language].

Helen Yang

To translate Mr. Yin's answer to that question, actually Sinovac was engaged in developing vaccines against the potential pandemic of flu kind of viruses, starting from 2004, at the time, we were developing H5N1 vaccine. But after that many years, we actually -- we didn't obtain too much profit or revenues from these products, but we think we actually gathered the platforms, and people were trained to do that. By the year of 2009 and 2010, H1N1 caused a very serious pandemic, and Sinovac also led a research to develop a vaccine, and that actually gave the company a good opportunity, in terms of selling the vaccine and also to provide a vaccine stockpile by the government, and now, there is new viruses, also within the flu family, the H7 and H9 epidemic, that actually provides the possibility for Sinovac to do the research on another kinds of avian flu vaccines for humans.

Weidong Yin

[Foreign Language].

Helen Yang

As you remember that, actually in last year, we have completed our GMP certification for our new -- brand new filling and packaging line on our new site, and also our flu (inaudible) certification, GMP certification was completed as well, and we believe that Sinovac has the capability technically to develop a new type of avian flu vaccine for humans. However, there are big uncertainties of the epidemic situation, and whether this virus will come up through human-to-human transmission, and maybe some of you have seen that the company has explained to the media that once we obtain overseas from either the (inaudible), we will immediately start to do the development of the vaccine, and this partly is that we want to be a responsible company for the social society and also we think that even though there are some uncertainties, but we would like to be ready, once there is any good opportunities for us, and we would expect that our shareholders and our friends could be closely monitoring the situation with us, on how this epidemic would be developed in the next few months.

Yi Chen - Aegis Capital

Okay. My second question is, what is your expectation for -- R&D expenses in 2013?

Weidong Yin

[Foreign Language].

Helen Yang

Mr. Yin just roughly answered your question, that because it is related to the information that we actually previously didn't disclose in public, and we would expect that the R&D expenses comparing to last year should be lower, because we don't have to set amount of money on EV71 kind of clinical studies. But, there are some other uncertainties, like if we (inaudible) to develop the H7 and H9 vaccines, that part was not been included in our consideration, when we are doing a budget for the company, yet. So generally speaking, the H7 and H9 number should be lower, significantly lower.

Yi Chen - Aegis Capital

So do you also expect the -- so you expect the SG&A expenses to be much lower in 2013, compared to 2012? Is that correct?

Helen Yang

SG&A, you said?

Yi Chen - Aegis Capital

Yes, G&A?

Weidong Yin

[Foreign Language].

Helen Yang

We didn't see any indicator to show that the SG&A could be significantly lower than last year. So we expect SG&A should be similar to last year.

Yi Chen - Aegis Capital

Okay. Thank you for the answers.

Helen Yang

You're welcome.

Operator

[Operator Instructions]. Our next question comes from the line of [James Song], a private investor. Please proceed with your question.

Unidentified Analyst

(Inaudible) to the progress in Mexico. My first question would be, [at any potential] for Mexico come into announce any public procurement for 2014 for Anflu to sell to Mexico?

Helen Yang

[Foreign Language].

Weidong Yin

[Foreign Language].

Helen Yang

This actually is the objective that we want to pursue, one, because we spend quite a long time obtaining the license, and as we explained earlier, normally the tender for next year will be granted in the prior year, so we are currently working with our partner, to make (inaudible), in order to participate, and if we can successfully win the tender, and the sales could potentially be reported on 2014.

Weidong Yin

[Foreign Language].

Helen Yang

Actually, Mr. Yin added to his answer that, for overseas market, especially for flu vaccines, this is kind of a medium to long term strategy. Because, right now, we are primarily selling flu vaccines in China, and we are starting to expand -- to utilize our facilities to manufacture other type of flu vaccines, like H5 or H1N1, and to adding up other potential from overseas market, actually provide another opportunity for us to fully utilize our facilities to manufacturing flu vaccines.

Unidentified Analyst

Got you. My second question would be, what's the quality control improvement for EV71 vaccine. We had done lot of large scale projects for Healive, for H5N9 also H5N1 and H1N1. So this time, where we'd do better in quality control for EV71?

Helen Yang

Sorry, are you asking site of quality improvements?

Unidentified Analyst

For safety (inaudible) thus we can -- still in better marketing position?

Helen Yang

Great. Well actually, even though we believe that as vaccine manufacturers, Sinovac always took the quality assurance and quality control as the most important task, we need to follow that -- are you asking how has the QC and QA improved for different products?

Unidentified Analyst

To change the question in another way, compared to competitors, quality control for Sinovac?

Helen Yang

Understood.

[Foreign Language].

Weidong Yin

[Foreign Language].

Helen Yang

Actually Mr. Yin provided an example with our EV71 vaccine, and when we were doing the clinical studies, the standard from different aspect of these clinical studies are in line with the international norm, and we actually spent quite a lot of efforts on different aspects to evaluating the vaccine, and also Sinovac invested a lot in the pilot production site, to do a big amount of validation, to prove the stability of the process. Also I add on that is that one quality -- quality control is from (inaudible), [but on other hand], and also in order to maintain good quality, the GMP capability also will be very important, and once we start to design the new facilities, we are looking at a high percent of credit available in the international society, and we think that this also provides another kind of assurance for manufacturing a vaccine with good quality.

Unidentified Analyst

Good. Can I ask a couple more questions?

Helen Yang

Sure. Please.

Unidentified Analyst

For EV71 introduction in [Finland], Cambodia and other countries like Egypt, the announcement this year for treating (inaudible), I believe all those countries are praying for help from companies like us. But do we have any plan to push to neighborhood countries first in 2014, after the Chinese commercialization?

Helen Yang

[Foreign Language].

Weidong Yin

[Foreign Language].

Helen Yang

We were also aware of the epidemic situation in other neighboring countries. However that, for vaccine sales in every other country, we need to go through a very complicated regulatory approval process, sometimes they may also require to do the local clinical studies, and these can only be done after our vaccine is being commercialized in China; and also our primary market in China, and reaching the potential is very big at the moment, and actually if we compare the potential market in terms of population, maybe any one province population will be even bigger than some other countries very close to us. Therefore we think that our most important task is to commercialize EV71 in China, which we are supplying the vaccine to the total market, which potentially could be 80 million population in China, for the children under five years old.

Unidentified Analyst

My last question will be finance related, current rate of deflation of amortization is only $0.5 million per quarter. Do you have any estimation for 2013 after the Changping facility getting to production for packaging facility, etcetera?

Danny Chung

I think that's a good question. As what you said, we came up with the production, installing more equipment. In the future, we expect this number will be more than the number this year; because the way the company is developing and enlarging the [size] on the Changping facilities.

Unidentified Analyst

Thanks and have a good day. Bye.

Helen Yang

Thank you.

Danny Chung

Thank you.

Operator

[Operator Instructions]. One moment please while we re-poll for any additional questions. It appears we have no further questions at this time. I would now like to turn the floor back over to management, for closing comments.

Helen Yang

Great. Thank you, operator. And we are really appreciative that everyone of you to joining us today, and we actually expect to share Sinovac excitement of our new development in the near future, with all of you, and thank you very much.

Danny Chung

Thank you.

Operator

Ladies and gentlemen, this does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a wonderful day.

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