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Cardica, Inc. (NASDAQ:CRDC)

F2Q 2014 Earnings Conference Call

February 04, 2014 4:30 PM ET

Executives

Robert Y. Newell – Chief Financial Officer and Vice President-Finance

Bernard A. Hausen – President, Chief Executive Officer and Co-Founder

Analysts

Tao L. Levy – Wedbush Securities, Inc.

Todd D. Mitchell – UBS Securities LLC

Operator

Good afternoon, ladies and gentlemen. Welcome to the Cardica Fiscal 2014 Second Quarter Financial Results Conference Call. My name is Shaun, and I will be your operator for today. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session. (Operator instructions)

I would now like to turn the conference over to your host for today, Mr. Bob Newell, Chief Financial Officer of Cardica. Please proceed.

Robert Y. Newell

Good afternoon. And thank you for participating in our financial results conference call. Earlier today we issued a press release, including our financial results, so please refer to the release for complete details.

This conference call will include forward-looking statements, including all statements regarding the continued clinical and other developments, future product features, future regulatory approval and commercial launch and use of products in our planned MicroCutter product line, including our MicroCutter XCHANGE 30 and XCHANGE 45, including the timing thereof and our expectations regarding future support for and sales of our automated anastomosis products. The words expect, believe, plan, continue, intend and similar words are intended to identify these forward-looking statements. Any statements contained in this conference call that relate to future events, results or predictions are forward-looking statements.

There are a number of important factors that could cause our results to differ materially from those indicated by these forward-looking statements, including those set forth in our press release of today, as well as other risks detailed from time-to-time in our reports filed with the U.S. Securities and Exchange Commission, including our quarterly report or Form 10-Q for the quarter-ended September 30, 2013 under the caption Risk Factors.

We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements. You are encouraged to read our reports filed with the SEC, available at www.sec.gov. This call is a property of Cardica and any rebroadcasting of this call without the expressed written permission of Cardica is prohibited.

At this time I would like to turn the call over to Bernard Hausen, Cardica’s President and CEO for a corporate update.

Bernard A. Hausen

Thank you, Bob. Good afternoon and thank you for participating in our call today. Over the course of the last three months we had made tremendous strides in accomplishing our corporate, commercial, and product objectives. And I’m pleased to be able to share our achievements with you today.

On the call we will talk about our ongoing commercial operations in Europe, the recent market clearance of the MicroCutter XCHANGE 30 in the United States and other near term corporate plans. The MicroCutter XCHANGE 30 is the world’s smallest cutting and stapling device with the shaft diameter of only five-millimeters compared to most conventional staplers with the 12 millimeter diameter. The XCHANGE 30 provides a range of articulation of 80 degrees in each direction.

This significantly reduced end effective diameter and the almost double degree of articulation over existing stapling product is of significant advantage to current and future uses of this product. As you know, we have made continued improvements based on surgeon feedback in Europe. Intentionally producing small batches of product as each change requires testing and validation.

While this process disrupts the supply line for a short period we have improved product performance and reliability substantially, and we have received positive feedback from customers that are; emphasis on quality over quantity is the correct approach to the introduction of a novel surgical device used for stapling during the variety of procedures including laparoscopic to endoscopic and open.

Today we believe, we have a commercial product that fires consistently in a variety of surgical procedures. Of note each step alone the way we have clearly communicated our business approach our customers and distributors in Europe. As a result of the small batch production and product improvement strategy, we ended the fiscal second quarter of 2014 in back order for both the device and the white cartridge, but have since cleared the back order.

In January we see more revenue from MicroCutter sales than we booked in the fiscal second quarter and more consistent re-order pattern since the introduction of the white cartridge in these markets. Importantly, while further improvements are forthcoming, we do expect to be in a position to build inventory and supply both the yield and U.S. markets consistently sooner.

In addition to the device and cartridge improvements we plan to make some operational changes in Europe. We continue to work with our key distributors and this strategy is working very well in most areas. The distributors have relationships with surgeons and a level of technical ability that suited to our product. In Germany, however we plan to change our operational approach and plan to begin selling directly to surgeons beginning in the April.

Of note Germany is the largest potential market for the MicroCutter in the European Union. We are taking this action because the German market is so important and it seems to be more price sensitive than other European markets. The size of this market in our opinion warrants the investment in a small direct sales force.

We have been selling our cardiac products primarily the PAS-Port direct into hospitals in Germany for several years, and believe this experience will benefit our efforts with the MicroCutter. The MicroCutter continues to facilitate both open, laparoscopic and endoscopic cases in Europe and we believe that during the current quarter we expect the sales to begin to grow on the market system basis in the European Union.

Turning to the U.S. We received market clearance from the FDA in January 2014 for our MicroCutter XCHANGE 30 device and blue staple cartridge. The invitation for use in the U.S market is aligned with the clinical trial experience specifically covering the use of the MicroCutter in multiple open or minimally invasive surgical procedures for the transection, resection or creation of anastomoses in small and large intestine, as well as transection of the appendix.

We work closely with the FDA to answer these questions to clear this product for marketing in the U.S. with a review time from the August 2013 submission to the clearance from January 2014 consistent with the FDA guidelines. This is the significant milestone for any medical device company and I’m exceptionally proud of our – each of our employees for their hard work, persistence, perseverance they have put into see this objective become a reality. For the last several months, we’ve been working towards this clearance putting together our plans in the infrastructure for successful market release and subsequent commercial launch in the United States.

As an integral part of our strategy we hired Liam Burns, who has worked as an Executive Marketing Consultant for the MicroCutter over the last several year and knows our business in particular in the stapling market in general very well. Over this time Liam has been integral in developing our launch strategy and establishing relationships with many surgeons from the United States.

To provide you with Liam’s background, most recently he served as president of a strategic marketing and sales consulting practice he founded to help healthcare and life science companies accelerate product sales and market growth. Earlier in his career, he served as Vice President of Marketing at Power Medical Interventions, leading a global team responsible for all aspects of marketing, sales, clinical affairs and physician education.

Previously, he served in escalating sales and marketing roles at Ethicon, most recently as group marketing director for biosurgicals. Liam heads up our sales and marketing worldwide and I’m extremely pleased to welcome him to the Board at this exciting time in Cardica’s history.

While we are in early days of our commercial presence with the MicroCutter in the United States, we are encouraged by the feedback and interest we received to-date. We have fielded inquiries from surgeons across the country acknowledged that the MicroCutter 30 fills an important need with its small size and large degree of articulation. We are now focused on the selected target group of approximately 30 surgeons each of who is a key opinion leader in their specialty. These surgeons have a network of influence across the United States and based on our longer term interactions are excited about new technology in general and our product in particular.

For the selected market release, we identified a group of surgeons with a desire to use the MicroCutter with the blue cartridge only. Based on the indications for use of this product in the U.S. this includes all procedures that require resection or anastomoses of intestinal tissue as well as all appendectomy.

In the U.S. alone this could theoretically be applied to over 1 million surgical procedures. Our initial potential customers are eager to use the MicroCutter XCHANGE 30 as it should allow them to advance their less invasive surgical practice something U.S. hospitals are placing an increased focus to gain a competitive advantage.

Importantly, we have filed the documentation with the FDA to obtain market clearance for the white cartridge for the same indications as our blue cartridge. The submission is based on extensive chronic animal trials and very elaborate bench testing data.

Turning to operations, we are in the process of hiring two additional sales representatives with long-term stapling experience to work directly with Liam on the focused list of leading surgeons and cities with a concentration of KOLs awaiting the MicroCutter product.

Our initial territory include New York, the Mid-Atlantic and the Southeast and in addition to the Bay Area. We plan to extend our reach with our current cardiac sales representatives who will also offer the MicroCutter in hospitals within their current sales regions. We believe this will allow us to steadily build a base of business to drive initial revenue growth and establish strong clinical reference centers.

Our initial 510(k) submission for the XCHANGE 30 were based on the product materials implemented at the time of filing in August of 2013. Towards the end of last year we replaced the particular plastic which required an additional filing with the FDA. We believe this will fall under the 30 day review period. Pending FDA clearance of the new material we expect to begin shipping initial products to U.S. customers this quarter. We believe we have a solid foundation from our experience in Europe, but we also feel that we’ll learn a lot in the next few months specific to the U.S market and appropriately adjust our approach to meet customer expectation and market needs.

Surgeons have been very receptive to the product, each work with it in their hospitals. We are working to the process of approval with the appropriation committees at several hospitals, always supported by local surgeon champions to help guide us through this process. As we gain success in the U.S. and see revenue growth we intend to add three to four sales representatives per quarter, focused on cities with large concentration of both patients and key surgeons.

In Japan, our partner Century Medical continues to work with the Ministry of Health to enable potential market clearance of the XCHANGE 30 in this significant market and Century anticipates market clearance within this calendar year.

Turning to our Cardiac business. The PAS-Port system continues to generate consistent sales particularly in Japan and Germany. During the quarter, we saw an increase in C-Port system purchases. December, Dr. Carlo Bassano of Vergata University in Italy, published a long-term clinical outcome study validating the use of the PAS-Port system during Cardiac bypass procedures.

The study results were published on line in the Journal of Cardiac Surgery. The publication detailed, detailed observational single center study which was designed to evaluate long-term clinical performance and patency of the PAS-Port system forming connector coronary artery bypass also know as C-CAB. The study included 152 patients several of which were followed out to five years. It suggests that the utilization of the PAS-Port system results in a true clinical benefit both in terms of improved graft patency and reduce neurological complications.

This is a very important study for the PAS-Port system has further validated the link between the elimination of the aortic manipulation of positive patient neurological outcome. We are pleased to have it available today.

At this time I’d like to turn the call over to Bob for a discussion of our financial results. Bob?

Robert Y. Newell

Thanks Bernard. For the fiscal 2014 second quarter total revenue was approximately $851,000 compared to approximately $874,000 in the same period of fiscal 2013. Total product sales for fiscal 2014 second quarter were approximately $836,000 compared with approximately $773,000 for the same period of fiscal 2013.

We shipped 46 commercial MicroCutter devices and 252 cartridges in the quarter bringing cumulative commercial device shipments to over 300 and cumulative commercial cartridge shipments to more than 1,250. During the fiscal 2014 second quarter we shipped 1,163 PAS-Port systems, bringing cumulative worldwide shipments of our PAS-Port systems to almost 35,000 units.

We are experiencing increase in C-Port shipments during the quarter with a 150 units shipped in cumulative worldwide shipments of C-Port systems now over 14,000 units. Cost of product sales was approximately $1.1 million for the fiscal 2014 second quarter compared to approximately $1 million for the same period of 2013.

R&D expenses for fiscal 2014 second quarter were $1.7 million compared to approximately $2.3 million in the fiscal 2013 second quarter. The decrease in R&D expenses is due primarily to the completion of the XCHANGE 30 European clinical study and the reduction in purchase of prototype materials used in R&D activities.

Selling, general and administrative expenses for the fiscal 2014 second quarter were approximately $2.2 million compared to $1.7 million in the same period of fiscal 2013. The increase in SG&A expense was primarily due to an increase in MicroCutter demo and sample expenses as part of our training efforts. Increased marketing efforts for the MicroCutter and stock compensation expense related to the amortization of the fair value of options.

Total operating costs and expenses for the fiscal 2014 second quarter were approximately $4.9 million compared to approximately $5 million in the same period of fiscal 2013. For the fiscal 2014 second quarter, our net loss was approximately $4.2 million or $0.08 per share, compared to approximately $4.2 million or $0.11 per share for the same period last year.

Cash and short term investments at December 31, 2013, were approximately $6.5 million compared with $9.4 million at September 30, 2013.

At this time I would like to turn the call back to Bernard.

Bernard A. Hausen

Thank you, Bob. Looking ahead we expect to continue to book revenue from commercial sales of XCHANGE 30 in Europe and begin booking revenue in the United States this quarter. We expect to further refine, improve expand the MicroCutter product line in the months to come. We expect market clearance of the MicroCutter XCHANGE 30 in Japan in the second half of calendar 2014.

Look forward to keeping you apprised of our progress in the months ahead. It is an exciting time for Cardica. This time we would like to open the call for questions.

Unidentified Company Representative

Operator?

Question-and-Answer Session

Operator

Yes, ma’am. (Operator Instructions) Your first question comes from the line of Tao Levy, Wedbush. Please proceed.

Tao L. Levy – Wedbush Securities, Inc.

Hi, good afternoon.

Bernard A. Hausen

Hi, Tao.

Tao L. Levy – Wedbush Securities, Inc.

Hi, so maybe we can start with – did may be I missed it, the timing of when you expect the white staple to be approved?

Bernard A. Hausen

The white staple, we filed the 510(k) for to get that approved to the FDA, and at this time I can’t really tell you what time it will be approved as you know. It’s in the review process as we speak.

Tao L. Levy – Wedbush Securities, Inc.

And sorry I just maybe I’m trying to get a better sense, is it going to – does it have to grow through the same process as the blue cartridge or in your discussions, you can kind of piggyback on what they have learned on the blue cartridge, so it’s potentially a shortened amount of time obviously, you never know but just any thoughts around that.

Bernard A. Hausen

We believe that clinical data itself should be a very strong basis for the approval of the white cartridge because the staple shape and design that’s really not changed, the only difference between a white staple and the blue is a 0.43 millimeter longer times, we have animal data that we have submitted and we have bench data that showed it and the same indication for a slightly thinner issue, these white skin obtain – you can obtain the same good results white as you can with blue. So in that regards the submission for the white has less data but we think it’s in a very good position to get approved based on what we have submitted.

Tao L. Levy – Wedbush Securities, Inc.

Okay, great.

Robert Y. Newell

It’s a benefit of using our own device as a predicate.

Tao L. Levy – Wedbush Securities, Inc.

Okay. And then in terms of the U.S. introduction and you’ve already sort of identified and discussed with those compared to you U.S. KOLs, that you said the MicroCutter?

Bernard A. Hausen

Yes, we have. We have identified them with many of them were already in the process of getting through their committees to be able to sell into those accounts.

Tao L. Levy – Wedbush Securities, Inc.

And when will they start performing procedures you think.

Bernard A. Hausen

Number one we need to get the special 510(k) cleared on the plastic change, which compared to the other submission is almost a formality of all, I don’t want to be little that it is a submission. Once we get that cleared then we need to be cleared though the appropriations committees of each hospital and the processes may vary. And with all that cleared then we can start shipping product to those customers.

Tao L. Levy – Wedbush Securities, Inc.

So it’s towards the end of the quarter or this quarter.

Bernard A. Hausen

Correct.

Tao L. Levy – Wedbush Securities, Inc.

Okay. And when did you file that supplement for plastic piece.

Bernard A. Hausen

Right on the heels of the clearance.

Tao L. Levy – Wedbush Securities, Inc.

Okay, can you give, and so now on the manufacturing front, it sounds like you’re still doing a somewhat in small batches, is that correct and so, you guys we think longer-term what do you need to see to start moving to sort of more of larger batch large scale manufacturing process maybe even outsourcing some of the…

Bernard A. Hausen

Well, first of all, recently we made smaller a lot not because we couldn’t build large, because we purposely chose to do so that we could quickly implement changes and improvements that we thought would be beneficial for both patients surgeon. We are almost out of that phase, we still think there is some left, some work to do but definitely much further along that we where half a year already especially a year ago. Once we get to that point, once we have identified what the ideal processes are to get into hospitals so that we know there is real volume need, we will ramp up the sales accordingly to reach demand.

Tao L. Levy – Wedbush Securities, Inc.

And then just sort of the last question, so just based on that and based on your earlier comments that doing a prepared remarks around January haven’t been a very good months compared to the fiscal second quarter until the shipments of products. Is that the limiting factors here over the next several months in terms of how much product you’re going to able to ship, you’re still making in these small batches. So…

Bernard A. Hausen

Probably for this quarter that will be limiting guess. I think in the next quarter we will be in a much better position it always takes a while every change requires validation additional testing of changes, changes some of the supply chain. Supply chain demand so – so then that has to become stabilize and then we can build a lot more product yes.

Tao L. Levy – Wedbush Securities, Inc.

Great. And this is actually the last question upcoming medical meetings SAGES, this is actually – in the U.S you know the bigger conference coming up in early April, marketing plans, podium presentations that were we going to potentially see, you have the study. Thanks.

Bernard A. Hausen

The study is being submitted to the ACS so that’s in October. We have other submissions some of our researchers have submitted to the SAGES meeting and I don’t know what has been accepted or hasn’t been accepted we will definitely be there we are not going to have huge presence. We are not challenged by leads at the moment we are trying to stay focus on those 30 key opinion leaders so there is no point in the expenditure of the blues at this point.

Tao L. Levy – Wedbush Securities, Inc.

Okay, great thank you.

Bernard A. Hausen

Thanks a lot.

Robert Y. Newell

Thanks

Operator

(Operator Instructions) Your next question comes from the line of George Stainer, a Private Investor. Please proceed.

Unidentified Analyst

Yes, I listen to the conference call and do it is pretty encouraging, but I miss the earnings results. I know you worked that a lot, but I want to know what the loss was compared to the last quarter. I own 25,000 shares U.S stock by the way, it may not seem like a lot but that for me it is?

Bernard A. Hausen

It was comfortable, the cash burn was about $3 million for the quarter and the loss was comparable for the last quarter.

Unidentified Analyst

What do you mean by comparable for the figure at?

Robert Y. Newell

It’s about $4 million?

George Stainer

A loss

Robert Y. Newell

Yes.

George Stainer

Well, the projection was pretty good, and I can stay – well I listen to the entire conference call and I got the 0.08 as a loss or I wasn’t – I got a little ecstatic in the phone.

Robert Y. Newell

It is $0.08 per share.

George Stainer

Versus what? For the last quarter.

Robert Y. Newell

Versus the similar number and it was $0.08 last quarter as well.

George Stainer

So you are at the same thing basically and the whole thing is you’re getting this approved and I think if you are going to have a lot more success in the European market and the largely in the United States for the simple reason I think they are little bit liberal than the FDA it was right over here? What is your thoughts on that?

Robert Y. Newell

Well we now have the clearance right from the FDA so the market is definitely much bigger in the U.S than it is in Europe, if anything or just a little bit behind, right we already have distribution in Europe and that’s how in the U.S that’s what we were just building and starting but I think in the few quarters from now the U.S. will be our primary source of revenue. Did I answer your question?

Operator

Your next question comes from the line of Todd Mitchell with UBS. Please proceed.

Todd D. Mitchell – UBS Securities LLC

Bernard and Bob congratulations on the clearance of the MicroCutter and I know it’s been a long track in a process but if you could and also hiring Liam Burns, it’s a great hire. So I can enjoy speaking with him over the years. So if you could provide a little bit better understanding I think Bernard you used a couple of words from the last conference call regarding Europe about the white staple being a gating factor, and that you would see this quarter a meaningful pickup in sale and it sounds like may have insert words and phrases which you use there. Always seen a meaningful pickup in sales in Europe and sounds like you are changing the model in Europe a little bit going from the indirect to the direct and what type of sales force do you have in Europe to support that?

Bernard A. Hausen

Well Todd, we ended the quarter in December in some back order and we aren’t sold more in January by dealing with that background and we sold all of the previous quarter.

Todd D. Mitchell – UBS Securities LLC

Okay.

Bernard A. Hausen

And our model in Europe is still primarily distributor model and we are actually pleased with the number of the reps that we are working with over there would become very enamored with MicroCutter and very in depth at training and using and are being in the all with surgeons over there with some of our distributors. So we are going to keep going for the distributor model however as Bernard mentioned, we think it makes a lot of sense to try to go direct in Germany, so that’s what we are planning to do that beginning in April quarter.

Todd D. Mitchell – UBS Securities LLC

Okay and my next question deals with the capital needs of the Company, you presently have a what’s called an after-market offering out there through MLV, is the company presently using that if so what still outstanding on that?

Robert Y. Newell

Most of it still outstanding and stop the perspectives we follow I think in September we showed about $5 million available under that facility. We almost since that filing we only used it in the second quarter we only used a little over a couple of hundred thousand shares so most of it is still available.

Todd D. Mitchell – UBS Securities LLC

Okay. And just curious why wouldn’t the company use more of that, the liquidity has been in the stock and the opportunity first and say, an offering out there it can be a very expensive on all fronts for shareholders in the dilution side plus the discount side.

Bernard A. Hausen

That was really a balancing act in terms of the pricing and there are various other rule regarding the use of that facility self. We’ve tried to be judicious in how we use it and we’re glad it’s still there.

Todd D. Mitchell – UBS Securities LLC

Okay, two other question, you’ve talked about the update, could you just the XPRESS 30 where does that stand and as far as – is that still we just I don’t hear about that anymore but is that still out there, the XPRESS 30 and the XCHANGE 45 the timing?

Bernard A. Hausen

Yes, good question. Those are two products that we still plan to develop most of our resources are still on the XCHANGE 30 to how net product into the market need but there is a lot of ongoing work for primarily XCHANGE 45 unless so on XPRESS 30 is just a matter of resources and capacity and funding for all these very, very good and interesting projects.

Todd D. Mitchell – UBS Securities LLC

Okay. And one last thing here back on this I’m just trying to understand this a little better it sounds like you guys made some changes to the XCHANGE 30 that required a supplemental filing to the FDA regarding the plastic piece?

Bernard A. Hausen

Yes.

Todd D. Mitchell – UBS Securities LLC

Is that correct?

Bernard A. Hausen

That’s correct we just changed the source or the material itself and based on FDA guidelines that require a special submission and they need to approve that.

Todd D. Mitchell – UBS Securities LLC

Okay and timing on something like that high branded you don’t know exactly how the FDA work, but…

Bernard A. Hausen

Yes.

Todd D. Mitchell – UBS Securities LLC

I mean is that would restrict when you can sell the product?

Bernard A. Hausen

It does yes, unless we wanted to sell with the older plastic which we do not want to do we change that for a good reason. So it’s a 30 day submission.

Todd D. Mitchell – UBS Securities LLC

Okay.

Bernard A. Hausen

We submitted on the heels of the clearance so it’s been out there we are hopeful we are going to get clearance fairly soon so that we can keep, keep within announcements we just made during the call as we could generate some revenue this quarter.

Robert Y. Newell

In the U.S.

Bernard A. Hausen

In the U.S.

Todd D. Mitchell – UBS Securities LLC

Okay. Okay thank you and congrats on the progress guys.

Bernard A. Hausen

Thank you.

Robert Y. Newell

Thanks Todd.

Todd D. Mitchell – UBS Securities LLC

Thanks.

Bernard A. Hausen

Thank Todd, appreciate it very much.

Operator

Your next question comes from the line of [indiscernible]. Please proceed.

Unidentified Analyst

Hi, thank you for taking my call. Wondering what has been the feedback regarding the blue staple cartridge from different position with different users?

Bernard A. Hausen

That’s the kind of the first cartridge we launched, it was basically the only cartridge we evaluated in the clinical trial. It’s the medium tissue range. It covers probably 80% of tissue thickness that stapling products used on. The feedback has been good. It’s getting better and better and the challenge with all staples not just ours is out of speck tissue use, so using the product and tissue thickness instead is really not designed for and what all manufacturers try to do is get the biggest the buffer around what their products are capable of, were somewhat limited by the size of our stapler that’s the kind of the downside of having something so small as that you can only make it so robust that we made grade strides and I think it’s a very reliable product.

I just got back from Europe where we did a nine year old kid that had ulcerative colitis and inflammatory bowel disease and required the entire colon to be removed. And this procedure was done completely laparoscopic with the use of our stapler in a child where really there was no alternative that would have required an open laparotomy approach which would have been a lot more traumatic for the poor kid and this way we were able to do it laparoscopicly and with a beautiful result just as an example.

Unidentified Analyst

Okay, okay. Yes and regarding the regulatory documents to the FDA have you got any feedback from the FDA or…

Robert Y. Newell

They’ve acknowledged the mission, they have acknowledged the mission.

Unidentified Analyst

Okay

Robert Y. Newell

And that’s kind of as a policy we tried to not comment on any of the interactions because it’s just not helpful to the process. And

Unidentified Analyst

All right thank you.

Bernard A. Hausen

Thank you

Robert Y. Newell

Thank you, nice talking to you. Thank you.

Operator

Ladies and gentlemen, this will conclude the question-and-answer portion of today’s conference. I would now like to turn the call over to Mr. Bernard Hausen for closing remarks. Please proceed.

Bernard A. Hausen

Thank you for joining us on our call today. We hope to see some of you in Salt Lake City at the SAGES meeting in April.

Operator

Ladies and gentlemen, this will conclude today’s conference. Thank you for your participation. You may now disconnect. Have a great day.

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