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China Biologic Products, Inc. (NASDAQ:CBPO)

Q4 2013 Earnings Conference Call

March 13, 2014, 08:00 AM ET

Executives

William Zima - Investor Relations, ICR

Xiaoying Gao - Chairman, Chief Executive Officer and President

Ming Yin - Vice President, Investor Relations

Ming Yang - Chief Financial Officer, Vice President, Finance and Compliance and Treasurer

Analysts

Yi Chen - Aegis Capital

Li Yu - Goldman Sachs

Operator

Good day and welcome to the China Biologic Products' fourth quarter fiscal 2013 earnings conference call. (Operator Instructions) And I would now like to turn the conference over to Bill Zima of ICR. Please go ahead.

Bill Zima

Thank you, operator. Hello, everyone, and thank you for joining us on today's call. China Biologic's announced it's quarterly and full year financial results on March 12, after the market closed and earnings release is now available on the company's website.

Today you will hear from China Biologic's Chairman and CEO, Mr. David Gao, who will start off the call with a review of recent company developments, strategies, basic operating results; followed by the company's Vice President, Mr. Ming Yin, who will address financial results in more details; company's CFO, Mr. Ming Yang is also on the call and will be available during the Q&A session that follows the prepared remarks.

Before we proceed, I would like to remind you of our Safe Harbor statement. Our conference call may include forward-looking statements made under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.

Although, we believe that the expectations reflected in our forward-looking statements are reasonable as of today, those statements are subject to risks and uncertainties that could cause actual results to differ dramatically from those projected. There could be no assurance that those expectations will prove to be correct.

Information about the risks associated with investing in China Biologic is included in our filings with the Securities and Exchange Commission, which we encourage you to review before making an investment decision. The company does not assume any obligation to update any forward-looking statements as a result of the new information, future events, changes in market conditions or otherwise except as required by law.

The company will also discuss non-GAAP measures, which are more completely explained and reconciled to the most comparable measures reported under Generally Accepted Accounting Principles in the company's earnings release and filings with the SEC. You are reminded that such non-GAAP measures should not be viewed in isolation or as an alternative to the equivalent GAAP measure and that non-GAAP measures are not uniformly defined by all companies including those in the biopharma industry.

With that said, I'm pleased to present Mr. David Gao, Chairman and CEO of the company. David, please go ahead.

Xiaoying Gao

Thank you, Bill. Hello, everyone. And welcome to China Biologic's fourth quarter and the fiscal year 2013 conference call. We are very proud to maintain steady growth and solid profitability in 2013, regardless of our production suspension for GMP renewal at our Guizhou facility midways through the year and from a challenging comparison to the strong growth in 2012.

Our total sales increased by 10%, reaching $203.4 million for the full year. Operating margin continues to improve, increasing 240 basis points to 42.7%. Non-GAAP adjusted net income attributable to the company increased 22.9% to $59 million for the year.

Such growth was supported by raising market demand; favorable product pricing; reduction of sales expenses, as a result of stringent cost control measures; and most importantly, the expansion of our product portfolio and the transition to a more profitable product mix.

In the first half of 2013, we added one new plasma collection center in Cao County and commenced full operating in July. As you know, the China plasma market is a highly regulated and underserved. With a total of 15 plasma collection centers in three provinces, we are well-positioned to increase our plasma supply base.

For the full year, we had a 16% increase in our plasma collection volume, mostly through organic growth on our established centers. As we ramp up our new center in the coming years and seek to add additional centers, we believe we have adequate raw material supply to support our capacity expansion efforts.

During the year, we made progress with our R&D efforts to improve production yields in the plasma utilization efficiency, following the launch of our Factor VIII products. We are particularly pleased to have amassed a market share of 19% in China's Factor VIII market during the first year of its launch.

In 2013, we achieved our primary corporate goal to ensure full compliance with new Good Manufacturing Practice, GMP standards. As of today, we have obtained the GMP certification for plasma production in Shandong and the GMP certification for the Placenta Polypeptide production line in Guizhou.

In addition, we expect to receive GMP certification this April for our plasma production line in Guizhou. With these offerings, we are confident we can increase our production and enhance operating efficiency to meet growing market demand moving forward.

Human albumin and IVIG products remained our largest two sales contributors in 2013. And we expect these products to remain significant contributors to our portfolio in 2014.

At the beginning of 2013, we had concerns over increased albumin import volumes and its impact on product pricing. However, during the course of the year, the main domestic albumin producers maintained their respective market positions and favorable pricing, mainly due to strong overall market demand outpacing domestic production and the import growth.

Looking at the albumin landscape for 2014, as global market demand continues to evolve. We believe there will be greater demand for albumin products in Europe and in the U.S., prompting a change in focus for international producers.

At the same time, a number of domestic manufactures will likely resume production after securing their renewed GMP certificates. Consequently, we expect the competitive environment to tilt to domestic producers in 2014, where you're close to the monitor, the situation and the respond to market dynamics.

In 2013, the company engaged new distributors to promote IVIG sales in certain Tier-1 cities and saw encouraging sales volume growth. We believe the market potential for IVIG is huge and may intent to penetrate deeper in those markets through greater marketing efforts.

Our Placenta Polypeptide products contributed $12.2 million for the full year, accounting for 6% of total sales. We believe these products have great potential and may plan to capitalize on our recently upgraded Guizhou production line with increased production capacity to increase production and sales of this product in 2014.

With our increased plasma supply, CFDA manufacturing approval in the new production facilities, we see great potential to further penetrate sales of IVIG and other hyper-immune products in certain markets and to enhance our production and sales of Placenta Polypeptide products.

We also expect to strengthen our market leadership in human coagulation factor VIII sector, and commence commercial production for Human Prothrombin Complex Concentrate, PCC, first at Guizhou, in the second quarter of 2014, followed by our Shandong facility in the fourth quarter of the year. These expansion efforts to our product portfolio can enhance our sales performance and profitability and further reinforce our industry leadership.

At the non-operational level, we continued to enhance our shareholding structure and increase shareholders value. In the past three quarters, we have closed two share repurchase transactions, where we repurchased in aggregate 3.98 million shares of common stock for our total consideration of $99.6 million. The repurchase of the share represent approximately 14.76% of the total common stock outstanding in earlier August prior to the first share repurchase.

We are also pleased that the two individual selling shareholders in this repurchase transaction have both reached settlement with a certain plaintiff group for the title dispute in the planned growth initiatives. We are confident that 2014 will be another productive year for China Biologic Products. We intent to further capitalize on growing demand for our products and aim to achieve double-digit growth in revenue and profit over 2013.

We expect higher growth in the second half of 2014, as there will be more products available for sale from our newly certified plasma production line at Guizhou facilitating. We intent to strengthen our market leadership by further expanding our sales opportunities with existing products and further develop new plasma based products to serve the growing market.

I will now turn the call over to Ming Yin, our Vice President, to who review the full year financial results. Ming, please go ahead.

Ming Yin

Thank you, David, and hello, everyone. Before discussing our financial performance for the full year of 2013, I would like to address a few P&L items for the fourth quarter.

Total sales increased by 25.3% year-over-year to $42.6 million in the fourth quarter of 2013. Income from operations decreased 10.4% year-over-year to $12.5 million from $13.9 million in the same period of 2012. Net income attributable to company increased by 52% to $8.8 million, while non-GAAP adjusted net income attributable to the company was $9.6 million, representing a 32.2% increase from the same period in 2012.

Now, let's move on to the full year 2013. Total sales increased 10% to $203.4 million. During 2013, human albumin products and IVIG products remained the largest two sales contributors. As a percentage of total sales, human albumin products revenue accounted for 44.1%, while IVIG revenue accounted for 38%.

During the full year, Placenta Polypeptide products contribute $12.2 million, accounting for 6% of total sales. The sales increase of other products was mainly attributable to the newly-launched human coagulation factor VIII in Shandong Taibang, which accounted for 2.1% of total sales in 2013.

Gross profit was up by 9.4%, reaching $137.9 million. Gross margin remained relatively stable at 67.8% and 68.2% in 2013 and 2012, respectively. As compensation paid to plasma donors gradually increase, we intend to drive future gross margin improvement increase in the product pricing and in volumes, product mix, use and manufacturing efficiency.

While it can be challenging to further increase the selling price of our products based on NDRC pricing guidelines, we believe our gross margin will remain close to current level through sales volume expansion and our transition to a higher margin product mix, assuming there are no unforeseeable adverse impacts on product pricing.

For the full year of 2013, selling expenses decreased by 26.2% to $10.6 million or to 5.2% of total sales. The decrease was primarily due to stringent control of selling expenses since second half of 2012.

G&A expenses increased by 6% to $36.1 million in 2013, mainly due to higher payroll expenses and employee benefits, as well as increasing non-recurrent legal expenses. G&A expenses as a percentage of total sales declined slightly to 17.7% from 18.4% in 2012.

R&D expenses were $4.2 million in 2013, representing an increase of 39.3% year-over-year. The increase was primarily due to certain R&D investment that resulted in improved production yields on certain hyper-immune products during the year.

In addition, we started a clinical trial program on human fibrinogen in 2013. As a percentage of total sales, R&D expenses stood at 2.1% compared to 1.6% in 2012.

Operating income was $86.9 million, representing an increase of 16.7% over the past year. Operating margin increased to 42.7% from 40.3%.

Net income attributable to company in 2013 was $54.6 million, resulting in net margin of 26.9%. Fully diluted net income per share was $1.96.

Non-GAAP adjusted net income attributable to the company was $59 million or $2.12 per diluted share. Non-GAAP adjusted net income and diluted earnings per share excluded $4.4 million of non-cash employee share-based compensation expenses.

Now, I would like to address select balance sheet and cash flow items. We ended 2013 with approximately $144.1 million in cash and cash equivalents, primarily in the form of demand deposits. The increase in accounts receivable was $6.1 million in line with our sales expansion efforts in 2013. Accounts receivable turnover days decreased slightly from 28 days in 2012 to 26 days in 2013.

Inventory for years ended December 31, 2013, and 2012, were $88.6 million and $25.7 million, respectively. The inventory increase was mainly due to increase in raw materials from continued delivery of plasma at Guizhou Taibang, during its production suspension for GMP renewal.

For the year ended December 31, 2013, net cash provided by operating activities was $74.3 million. Net cash using investing activities was $25.6 million, primarily due to the construction of new Factor VIII production facility and to manage our office in Shandong Taibang and the production facility upgrade of Placenta Polypeptide product and plasma-based products at Guizhou Taibang.

Net cash used in financing activity was $38.5 million mainly for share repurchase compared to $5.1 million for 2012. Our working capital on December 31, 2013, was $200.9 million and our current ratio was 4.2. Total shareholders equity was $304 million as of December 31, 2013, compared with $257.4 million as of December 31, 2012.

We believe that the company has sufficient cash on hand and can continue positive cash inflow from continuous operation. We also plan to maintain a solid balance sheet going forward.

Guidance and business outlook for 2014. Turning to our 2014 guidance, we expect total sales to be in the range of $230 million to $240 million. We estimate full year non-GAAP adjustment net income to be in the range of $67 million to $69 million. This estimate assumes only organic growth and reflects company's current and preliminary views, which are subject to change.

That concludes our prepared remarks. We will now take questions. Operator, we're now ready to take some questions.

Question-and-Answer Session

Operator

(Operator Instructions) And our first question comes from Yi Chen of Aegis Capital.

Yi Chen - Aegis Capital

Could you provide us with some color on the pricing trend of human albumin going forward for this year and 2015?

Ming Yin

Let me try it. For the albumin, we notice that the demand for albumin has substantially increased in the past few years. The imported albumin quantity grow over 50% year-over-year in 2013, although the domestic produced albumin quantity remains flat weight year-over-year in 2013. With such substantial growth in albumin supply in 2013, in the prior quarters we were concerned of the pricing pressure, and what surprised us is albumin pricing today is very solid.

We're trying to find some reasons behind. The recent study actually give us some color. Number one is, actually, more aging population and greater occurrence levels of cancer and liver disease in China. And number two is, the people with better affordability for albumin and because of a benefit with the economic reform. And [indiscernible] there is a recent Chinese local newspaper published an article about albumin shortage and indicate that the Chinese doctor are very conservative to prescribe albumin due to the shortage of products in hospitals in Tier-2 and Tier-3 cities.

And looking to 2014, and we just recently learned that the oversea illness projection for the 2014 European albumin demand probably will go over 10% due to banned use of the hetastarch due to findings of higher kidney renal risk. And recently, CFDA just follow a suit, issued the similar warning latter for use of hetastarch as well.

And besides that, according to recent research and survey, the major global players might have some supply constraint to keep up with the momentum in albumin import patient to China or exported patient China, as they did in the 2013. And just like David said earlier, there are few local class manufacturer, probably will resume production this or the next quarter. So we might expect some local produced albumin to gradually come to market starting from 2Q this year, due to the few months in production and the batch release, the lab effect.

So therefore, the short-term market condition should be favorable. The mid-to-long term albumin pricing will be again decided by the mixed factors among global albumin pricing situation, import patient growth rate and a local produced albumin growth rate as well. So we will continue to monitor market trends related to albumin volume and adjust our pricing and product shipments according to the market change. Hopefully, I answer your question, Yi.

Yi Chen - Aegis Capital

My second question is previously you reported that Guizhou Taibang received CFDA manufacturing approval for Human Prothrombin Complex Concentrate. So is that products production related to the upgrade facility process that you after receiving the GMP approval, you will be able to start producing that in the second or third quarter this year?

Ming Yin

Actually, the PCC, the production line is partial. It's within the same manufacturing facility of the Guizhou that just completed a new the manufacturing line. So once we have the GMP license received in next maybe months. So we will expect to commence the commercial operation for the PCC.

Yi Chen - Aegis Capital

And how much revenue do you expect to receive from that product roughly?

Ming Yin

Just like you mentioned, this is from our experience from the Factor VIII. So I think the first year the PCC, because we only have a partial year production, so we don't expect a meaningful sales contribution from PCC at Guizhou alone.

Yi Chen - Aegis Capital

My final question is could you tell us something about Phase 3 clinical trial for Human fibrinogen and when do we expect to see some results from that? And when do you expect to -- in terms of timeframe, when do you expect to receive final approval to start production?

Ming Yin

As we indicated in the 10-K filed yesterday, the commercialization timeline probably will be in 2015, because reasonably we down with CFDA, which they have a very slow proving pace on all the biological products. During the last eight months, we don't see any of the new products being proved. So we just learned they have some new team that will be in place in the CFDA to expedite the process.

So last like eight months delay, so we probably expect the fibrinogen approval will be in 2015. So we're as to actually being at final stage in the stage of the clinical trial in the Phase 3. So hopefully we'll complete the clinical trial by end of the year and submit to the CFDA for review

Yi Chen - Aegis Capital

Additionally, what is the likelihood for China Biologic to acquire additional or establish additional plasma collection stations for 2014 and 2015?

Ming Yin

To establish the plasma station is always our priority. So we're always looking to that opportunity to select a proper area for ideal plasma centers. The most potential donors pay with a potential donor base. As you might be aware, the China, the regulation for the plasma center's approval is very different compared with U.S.

In the U.S., the manufacture, like us, if we were in U.S., operating in U.S., we can just set up the centers anywhere we want and we don't need actually local government to give us a pre-clearance. And before we run the center, we're going to have the FDA or the PPTA to audit the center for the operating procedures, and after that we can run a center.

But in China this is totally completely different. Before we have the center established, we need actually go through a County municipal and provincial government to approve the site, and there is a lot of uncertain. So always we think it's pretty immature to disclose any definitive plan for any new plasma station. But we will actually make announcement accordingly, if there is a positive development.

Operator

Our next question is from Li Yu of Goldman Sachs.

Li Yu - Goldman Sachs

My question is concerning the whole industry picture. Can you update us on the latest overall national demand for plasma, how many tons, is there any update and the total supply? And then also as you know, just give us a current shortfall for the plasma? And also what's our the current plasma capacity at the moment up to past years, in terms of openings and closings? And also as the state is trying to double the plasma supply in the next two to three years, so can you update us on what is the progress of all the players in the plasma area?

Ming Yin

For the albumin it's like 40% of revenue contributor. So I think it's worthwhile to mention the albumin's competitive dynamics. And the last year, of course, the company's internal estimate from the government, the batch release, the system for albumin last year, just like I said earlier, oversea imported albumin grow 50% and the domestic players only like grow 2% from the batch release data.

And last year our internal calculated, the albumin tonnage last year, the total supply in China is about close to 260 tons. So we understand the global albumin, probably that account 50% of global albumin supply. It's a very meaningful amount. And for the demand, I guess just like I mentioned earlier, there is no industry consensus on what is actual China demand. But according to most recent MRB report from 2012 to 2015, next three years, albumin probably will grow at 15% every year. So hopefully that answer your question.

Li Yu - Goldman Sachs

I mean the plasma capacity that we have some dated numbers that China will grow is around 4,000 tons and that the demand could be like 3,000, there is some shortfall?

Ming Yin

Yes. I mean just like I mentioned from albumin, the calculation last year, the overall, the China plasma throughput is due actually 44,000 metric tons overall in China. So there is always difference between plasma collection and the plasma fractionation throughput, because there is like nine months in quarantine. So based on the release products, the local supply in albumins, the release data is local supply albumin in last year or the equivalent, the plasma collections throughput, is close to 4,500 metric tons. And from 2012 the number is actually only 2% increased.

Li Yu - Goldman Sachs

So do you actually see any trend of opening up new plasma collection centers in the provinces or do you see like any openings in the less development regions? And do you see any new openings in the developed region, what was the recent trend that we are observing?

Ming Yin

Well, on the market we saw there is a local plasma manufacture actually make announcement that they have new plasma centers open, but that's very, it's not actually -- we don't see a trend. There is a countrywide plasma station. There more centers will be open. It seems to isolate it just like it happened to one manufacture, open one center in certain region. There is no guarantee when they can open the next center. And I guess during the last couple of years, maybe three, four years, there is only less than dozens new centers being open. Being like only manufactures open.

Li Yu - Goldman Sachs

You mean less than a dozen?

Ming Yin

Yes.

Li Yu - Goldman Sachs

That's within past three years?

Ming Yin

No, two year. Two to three years, actually, the timeframe.

Li Yu - Goldman Sachs

I just want to ask regarding the 4Q. You mention some higher than usual plasma cost and for some higher selling expenses for your Placenta Polypeptide. Can you just elaborate on that?

Ming Yin

As we indicated in the script, the high cost, the plasma cost is non-recurring. So for the full year of 2014, we will expect the gross margin rate will be close to our 2013. The full year average is like a 68%, 67%, in that range. And the selling expenses is because we have more shipments of our Placenta Polypeptide products, which results in the higher agent commissioning expenses, which we have a full disclosure in the 10-K, in the 10-Q, I mean in the full note, because that product we have agents in contract.

Li Yu - Goldman Sachs

With the plasma cost like what is it, like I mean you always say that it's higher than usual?

Ming Yin

It's just a number of recurring costs. So actually it's very simple, its marketing and expenses for the new donor's promotion, which is back to 2011. It's a one-time charge associated with all plasma. So that's how we happen to sell the products in the 4Q 2013. That product was from that batch of plasma, which have higher cost.

Li Yu - Goldman Sachs

What's your average share compensation now for the plasma donors?

Ming Yin

China's average, the compensation right now is close to $50, it's between $40 to $50.

Li Yu - Goldman Sachs

No, because you mentioned I think it's getting higher, right, slightly higher?

Ming Yin

It is getting higher, but we don't actually adjust every year.

Li Yu - Goldman Sachs

And anything you guys can comment, regarding your dividend policy?

Ming Yin

Actually, we have a full disclosure in our 10-K. We did not actually declared dividend.

Li Yu - Goldman Sachs

Because I mean, as you guys are getting comfortable and I mean you're sitting on decent amount of cash. I mean is there a reason for that like just -- I mean it's just building up I think?

Ming Yin

Not really. We recently just did a share repurchase. For 1Q we see our cash was decreased by $70 million. So we are actually finding the good alternative to utilize the cash. And we will reserve that for there further, if there is acquisition opportunities.

Li Yu - Goldman Sachs

And one last question, you mentioned in the recent press release or the notes that you are sort of promoting IVIG in the Tier-1 cities, is that correct?

Ming Yin

Yes.

Li Yu - Goldman Sachs

But I thought you could only sell in provinces that you collect?

Ming Yin

Well, where did you see that?

Li Yu - Goldman Sachs

I thought if you're collecting gradual, well, you can only sell in gradual province. I mean that's what I was told.

Ming Yin

No, that was not true. We can sell anywhere in China.

Operator

And our next question comes from [indiscernible].

Unidentified Analyst

I got a couple of questions. First is regarding your 2014 outlook. You have mentioned the total sale to be in the range of $230 million to $214 million that's around 15% to 20% increase from the 2013. Can you elaborate what's the drive, is that a volume growth, it's a price growth? So that's the one. Two is, your guidance for net profit for year 2014 that's a net of $67 million to $69 million versus last year '13 of $59 million. So the percent increase on profit of growth seems to be slightly lower than profit of growth. Can you elaborate why is that the case?

And I guess the third question is also regarding cash deployment. You just mentioned, in first quarter you used the cash to buyback some shares. Can you give us a guidance, what's the cash position now is projected at the end of the fourth quarter? And do you have any plans to further use that cash? So that's three of my questions.

The second question is why, in terms of profit growth, profit is on $67 million to $69 million, which is an increase about 15% and you are not there as close to $60 million, so the profit growth is lower than your sales growth, and why, if that's the case?

Ming Yin

So first of all, I think based on the 2014 guidance, so the $230 million to $240 million the range which is 13% to 18% growth, right. It's not even close to 20% yet. So it's 13% to 18%. So just want to clarify with that. So let me try to answer your question one by one.

For the growth driver for 2014, as David mentioned earlier, that we go for 30%, resume production in early part of second quarter. So we probably have like -- we expect to normalize our production and increase shipment to the hospital clients from the second half maybe in the third quarter of 2014, right.

And as we indicated in the 10-K, we acquired the technical support services to improve the production yields on certain hyper-immune products. And today, we have already seen meaningful yield improvement for certain product and we're looking to having more revenue and profits and generate from the hyper-immune products in 2014.

And we will be able to commercially launch the new PCC product in the mid-2014, hopefully. This will be the first year, as we'll be focused on the fine tuning our manufacturing process, but the new products will improve our margin. And also David mentioned, we will increase the Factor VIII production volume. And the calculation of Factor VIII processing facility in Shandong is substantially completed and we expect to utilize in the second half of 2014.

And lastly, we will be benefited from the increased production capacity for the newly certified plan at Guizhou for the product, the Placenta Polypeptide products. So hopefully that answer your first question. I was trying to go to second question, if you don't have any comments.

Unidentified Analyst

That's fine. And let's move on to the second question.

Ming Yin

So I mentioned earlier, you said that the bottomline growth will be actually lower than the topline. The reason why we give the range is because we think the CFDA, the GMP certificate, hopefully we can actually receive in the early April. So we can actually have a full scale operation in April, which will give us more products available to sell in third quarter.

But according to the CFDA reason, the GMP certification process and practice, there might be one to two months lag. So if that happens, so where our topline, the growth rate will be subject to when we'll receive the GMP license. So actually that's why we give the wide range to ensure we have a flexibility, right. So from that respect, the bottomline should be in line with the topline growth, because I mentioned earlier, we have the margin improvements like new product PCC Factor VIII, so a whole new can improve the margin, so which will increase the bottomline.

And for the third question, for the cash, we recently just completed our repurchase transaction. It was a usage for the cash deployment of $70 million. So if you ask us what's the next plan for the cash and we indicated in the prior filing or this 10-K, in order to meet our plasma growth in 2018, we are planning to build our new plasma production facility in Shandong, in the same city, where Shandong facility operates in.

So in 2014 we will use a portion of the cash to build some R&D and sales and marketing function for the new facility, and also we have some plan for our reserve for the plasma station investments. And in connection with new plasma facility in Shandong, we hopefully can launch in 2018. We need actually some cash to buy the land use right. So I guess we have applied the alternative for the cash the deployment. Hopefully, that answer your question.

Unidentified Analyst

What's your cash position now after $70 million share repurchasement?

Ming Yin

The last year's, the ending balance for cash and cash equivalents is $144 million. So you can simply do the math, the cash for the repurchase $70 million. So we should now believe there is $74 million, without considering the first quarter's operation cash inflow.

Operator

And this concludes the question-and-answer session. I'd like to turn the conference back over to management for any closing remarks.

Xiaoying Gao

Thank you for your participation and ongoing support for China Biologic. Have a good day.

Operator

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

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