Cytomedix, Inc. (CMXI) Q1 2014 Results Earnings Conference Call May 16, 2014 8:00 AM ET
Paul Arndt - Managing Director of LifeSci Advisors
Martin Rosendale - Chief Executive Officer
Steve Shallcross - Chief Financial Officer
Dean Tozer - Chief Commercial Officer
Jason Napodano - Zacks
Good day, ladies and gentlemen. And welcome to the Q1, 2014 Cytomedix Earnings Conference Call. My name is [Frieda] and I will be your operator for today.
At this time all participants are in a listen-only mode. We will conduct a question-and-answer session towards the end of the conference. (Operator Instructions). As a reminder this call is being recorded for replay purposes.
I’d like to turn the call over to Paul Arndt, Managing Director of [Life Science] Advisors. Please proceed, sir.
Thank you, [Frieda] and good morning, everyone. This is Paul Arndt with LifeSci Advisors. Joining me on today’s first quarter 2014 financial results conference call for Cytomedix are Chief Executive Officer, Martin Rosendale; Chief Financial Officer, Steve Shallcross; and Chief Commercial Officer, Dean Tozer.
By now you should have received the press release that was disseminated yesterday afternoon announcing Cytomedix’s financial results for the first quarter of 2014. If you have not yet received this news release or if you like to be added of the company’s distribution list, please call LifeSci Advisors in New York at area code 646-597-6992 and ask for me, Paul Arndt.
Before we begin today’s call I would like to remind you that comments made during this conference call will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Cytomedix. Actual results could differ materially from those projected. Please review the company’s filings with the Securities and Exchange Commission, including without limitation the company’s Forms 10-K and 10-Q, which identify specific risk factors that may cause actual results or events to differ materially from those described in the forward-looking statements.
Furthermore the content of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast, Friday, May 16, 2014. Cytomedix undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.
I will now turn the call over to Martin Rosendale. Martin?
Thank you, Paul. Good morning everyone and thank you for joining us today. First this morning, I will provide an update on where we stand on the commercial launch of our wound care product AutoloGel. Then I will briefly discuss the recent announcement we made regarding the Phase II RECOVER-Stroke clinical trial and our R&D reorganization. Steve Shallcross our CFO, will provide a review of the financial results for the quarter and then our new Chief Commercial Officer Dean Tozer will join the call to give you some additional details on the AutoloGel commercialization process. Finally, we'll open the call for questions.
Our primary focus for Cytomedix today is to commercialize AutoloGel and build a successful business in wound care. On with compelling clinical data and significant unmet medical need, FDA clearance are now adequately reimbursement from CMS, AutoloGel positions for a successful launch in the U.S. chronic wound market, which is estimated to be worth approximately $3.4 billion.
AutoloGel's reimbursed under a national coverage decision from CMS for Coverage with Evidence Development. This is a mechanism through which CMS agrees to provide reimbursement for certain products and services, while at the same time requiring the continued collection of clinical data demonstrating the impact on health outcomes.
The hospital outpatient division of CMS issued its final payment decision on reimbursement in late 2013. And the payment became effective on January 1st of this year. The payment decision significantly expands the coverage for AutoloGel and allows providers in the outpatient setting to treat a broad patient population with a variety of wounds.
This outcome provides Cytomedix with substantial and economically viable business opportunity and we are now in a position to effectively sell AutoloGel into this market. A clinical part of our strategic launch initiative is to
A critical part of our strategic launch initiative is to have the right leadership team in a place to drive our commercialization activities. We’ve made a lot of progress here. And I have to say we've been very happy with the caliber of people we've been able to recruit.
We were pleased to announce during the first quarter the appointment of Dean Tozer as our Chief Commercial Officer. Dean is a very experienced healthcare executive with particular expertise in wound healing losing and a proven track record of launching products in to that space. We feel very fortunate to have him joined our team. Dean is recognized as one of the top executives nationwide in wound care and we see him playing a pivotal role in building our AutoloGel business and establishing the brand.
We also announced the addition of Jennifer Linsky, as our Senior Director of National Accounts. And just a few weeks ago Andrew Cohen joined us as the Vice President of Marketing. Andrew is also very experienced in the wound care sector. He and Dean worked together at Advanced BioHealing with a focus primarily on launching and building market share for Dermagraft.
Later in the call today, Dean will discuss some of the specifics around the AutoloGel launch. However, first I'd like to frame the market dynamics and launch process for you.
Physician interest in the product concept is high. We continue to believe that the greatest opportunity is in the hospital outpatient setting. In wound care, the AutoloGel CED initiative is a first of its kind program and a land market opportunity to establish AutoloGel and [Cytomedix as] industry leaders. CMS was thoughtful in coming to the decision to issue the national coverage decision and see it as an opportunity to establish a new threshold for reimbursement wound care.
With this opportunity come certain challenges. For instance, there is no precedent to follow. In addition to establishing our strong commercial team, we have retained top consulting talent and we are fortunate to have forged a good relationship with CMS built on trust and integrity. The establishment of this relationship was confirmed for me recently in a conversation with a former division director of CMS.
While initial progress may seem slow, our recent financing is allowing us to execute our plan and establish the team and resources needed to execute properly and effectively. As I’ve mentioned, our commercial team is coming together and they hit the ground running.
Our clinical team led by Dr. Pete Clausen is facilitating the protocols under CED and our commercial partners are establishing the data collection and management tools. We expect the impact to be apparent in the second half of this year with aggressive expansion in 2015. For a company at our stage, a critical element in preparing and executing on our business plan is the financing.
On March 31st, we announced that we had entered into an agreement with the Deerfield Management Company to provide us with up to $35 million in funding under a convertible credit facility. And concurrent with the Deerfield financing, the Anson Group has provided an additional $2 million in equity funding. We’re very encouraged by the support and commitment shown by both Deerfield and Anson and by the recognition of the potential AutoloGel and the compelling opportunities that exist in chronic wound care.
Regarding the Bright Cell technology, as we announced last week, we’re discontinuing further funding of the ALDH Bright Cell development program. And unfortunately this means we’re closing our R&D facility in Durham, North Carolina. We made this decision in light of the results from the RECOVER-Stroke Phase 2 trial which showed no significant clinical benefit with ALD-401 in patients with ischemic stroke. Our R&D staff, clinical partners and investigators have all been exemplary throughout the study.
A second Phase 2 trial with our Bright Cell product candidate ALD-301 is ongoing and fully funded by the NIH. Manufacturing has been transferred to a facility designated by the NIH along with the closer our R&D facility. We retained the commercial rights to this program but because of NIH’s involvement, there is no further development expenditure required from Cytomedix at this time.
The PACE study in patients with peripheral artery disease or PAD is approximately 30% enrolled and is continuing at a good rate PAD is a serious medical problem affecting approximately 8 million in the U.S. and can lead to chronic wounds amputation and death.
Steve Shallcross will give you more information in his financial report on the status of our R&D reorganization and its impact on our finances including the cost savings. We continued to evaluate other opportunities for maximizing the value of this program.
So now I will turn the call over to Steve for an overview of our financial results. Steve?
Thanks, Martin. First I will cover our latest financial developments and then I will provide the detail of our first quarter financial results. Last week we announced plans discontinuing further finding of the ALDH Bright Cell development program that closed our R&D facility in Durham North Carolina. This decision is consistent with the ongoing realignment of commercial operations to focus on the wound care market and is expected to result in the annual savings of approximately $4 million. As a result of these actions we expect to incur total pre-tax exit and its total cost in a range $500,000 to $600,000. In addition we expect to incur a non-cash impairment charges related to intangibles and fixed assets such as facilities and equipment or amortizing and non-amortizing intangible assets and possible lease termination charges related to Durham facility.
We expect to record the majority of these charges in the second quarter ended June 30, 2014 and will provide additional details when they are available. On March 31st, we entered into a financing agreement with Deerfield Management Company. Under the terms of this agreement Deerfield agreed to provide the company with up to $35 million for a senior secured convertible debt facility. The commitment will be funded in two separate projects. Deerfield has initially provided $9 million at the closing of the transaction on March 31, and will invest an additional $26 million after shareholder approval to authorize the additional shares of the company's common stock required for the potential conversion of the note, warrants, fees and interest under the agreement. The special shareholder meeting is scheduled for June 9. Please refer to the company’s form 10-K filed with the SEC for the complete disclosures related to our recent financing transactions.
Now turning to the financial results for the quarter. Total revenues were $1.8 million in the quarter ended March 31, 2014 compared to $2.3 million recognized in the same period last year. The decrease was primarily due to lower product sales of $0.8 million offset by an increase in royalty revenue of $0.3 million and licensing revenue of $0.1 million. The decrease in product sales was primarily due to a reduction in the average selling price of Angel products under the terms of the Arthrex Agreement.
AutoloGel sales for the quarter were $0.2 million. Overall gross margin decreased to 21% in the first quarter of 2014 from 45% in the first quarter of 2013. The decrease is primarily due to the sale of Angle products under the Arthrex agreement signed last year this was offset by the gross margin realized from Angel related license fee and royalty revenue. Although the cost of the company's products has remained constant, the contractual selling price of Angel disposable products to Arthrex is significantly lower than the historical average. Furthermore a negative impact on gross margin is primarily the result of the generally accepted accounting principal requirement to report revenues and cost of goods related Angle product sales on a pass through basis.
In the future, we expect to realize the economic benefit from the Arthrex license agreement in the form of growing quarterly royalty revenues. We also expect future reported gross margins to recover as the launch of AutoloGel in the wound care market gathers momentum and these related sales begin to account for a more significant portion of our overall revenues. Current and future Arthrex royalty revenue will have no associated cost.
Total operating expenses in the first quarter were $5 million, compared to $6 million reported in the same period last year. The change in total operating expenses is primarily the result of a non-cash charge of approximately $1 million recognized in 2013 due to the effect of the amendment to the contingent consideration associated with the Aldagen acquisition.
Net loss to common stockholders in the first quarter of 2014 was $5.6 million or $0.05 per share compared to the net loss of $5.3 million, or $0.05 per share in the same period last year. As of March 31, 2014, cash and cash equivalents totaled $7.7 million.
Now I'd like to turn over the call to Dean.
Thanks Steve. As Marty and Steve outlined, much has transpired since I joined the company on April 1 of this year. With adequate capital now in place, we have made tremendous progress in just six weeks on building out our commercials.
We've added a number of experienced commercial leaders and also added two key team members in the area of reimbursement. These team members add many years of wound care experience from a broader ray of products and companies. The commercial team is now laser focused on getting all the necessary systems and process in place to launch a full scale commercial effort into a hospital outpatient market in the next few months.
As has been mentioned in previous calls, the CMS decision to cover AutoloGel through coverage with Evidence Development process is an exciting opportunity for us to market our product for the Medicare beneficiary population. We're also collecting [real world] clinical data and our patient outcomes on the product.
However, this is a first set of a CED protocols approved in wound care market and as such requires a little more commercial preparation and might typically be the case with traditional product launch. I continue to believe that market opportunity for AutoloGel is substantial and in the long-term not reduced due to CED.
Getting the CED data collection in place simply represents a near-term commercial scale and the element. In the long-term, I absolutely believe the data we collect will provide a tremendous body of clinical evidence that will only enhance the profile and adoption of the product. With the data collection we have agreed with CMS withstands to generate one of if not the largest body of clinical data related to specialized wound care.
Our initial approach to the hospital outpatient market will be through a partnership with a company called IntelliCure. This Houston based company specializes in electronic health record systems for the wound care market. We are currently working with IntelliCure and a number of their wound care customers to operationalize the collection, the necessary clinical data to satisfy the CED requirements, while also ensuring the various Medicare reimbursement processes that are in place to allow for both facility and physician reimbursement.
Access to the IntelliCure electronic health record expertise provides a much more seamless first effort in collection in the necessary clinical information. Our plan is to work initially with the IntelliCure system providers in and then expand outside that network as we refine our systems and processes.
We are very pleased that we’ve begun treating patients with AutoloGel in the hospital outpatient setting. In concert with patients being treated, our reimbursement team is hard at work implementing the necessary processes with Medicare Administrative Contractors or MACs to enable reimbursement for AutoloGel, as I said to both facility and healthcare provider.
I envision the rest of 2014 to be focused on building our team and processes with a more aggressive commercial expansion in 2015. We’re actively working on other points of care, channels and cares as well but continue to believe Medicare beneficiaries in the hospital outpatient setting represents the largest and most promising segment for near-term revenue growth.
As Marty mentioned, interest in AutoloGel and specialized wound care market continues to be very high. Many healthcare providers that we educate about the CED process are intrigued about the potential of being involved in collecting a large body of clinical evidence with a real world approach. This interest in our CED process as well as the price point of the product combined with the broad range of wounds that are indicated for treatment give me continued confidence in the market potential of this product.
Thanks for your time and attention today, and Marty back to you.
Thanks Dean. So, just briefly before we go to the questions and answer session of the call this morning, I’ve asked Dr. Jim Hinson to be on the line. Jim is on the line to take any detailed questions that may arise with respect to the stroke study, the Bright Cell technology and where we are with that technology and that product.
So, with that operator, I’d like to open the call up to questions please.
Thank you. (Operator Instructions). Your first question comes from Jason Napodano from Zacks. Please proceed.
Good morning Jason.
Jason Napodano - Zacks
Good morning, Martin. So, let me start off with Angel, because I am confused about the lower sales price. I had thought that you discussed or you guys have discussed that Arthrex would be raising the sales price on Angel and even bundling Angel within some kits and with some higher priced products. So can you just explain what happened here in the first quarter with respect to them selling the product at lower sales price than you guys had historically done?
So Jason, what you are seeing in the financials is not the sales price that they are selling it at. What you are seeing that’s essentially our transfer price. So our transfer price to Arthrex is slightly above our cost, right because our margin is made only on the royalty after they sell it. So, and I will let Steve address why in the accounting practices we are required to report it that way.
So essentially Jason, what you are seeing is the sale of products to Arthrex for their inventory. So as Marty said, the sales that you are seeing in the financial statements are essentially offset by related cost of goods number. The royalty for the period little over 300,000, about 260,000 of that was specifically related to royalty we received on the results of Arthrex passing product or selling product through to their customers. And what we expect to see happen as we go forward into second, third, fourth quarters throughout the year, we expect those royalty numbers to continue to improve and get larger.
And then to the point Jason that the sales price to customer will be going up, Arthrex essentially prepared for the Arthrex launch of the product that essentially took place last month. They have been developing new kits and new components and followed through on that commitment to create new kit with higher selling prices. So that’s all coming.
Jason Napodano - Zacks
Okay. So the royalty number in the first quarter looks pretty comparable to the royalty number in the fourth quarter. If I am looking at my model correctly, it actually looks like it may have just been down a tiny bit, but is that because Arthrex really wasn’t out actively in the first quarter selling the product or promoting the product, I mean you mentioned that they launched at last month?
That is correct. So up until last month, what they have essentially been doing is maintaining sales while they have been preparing. And so it’s a correct observation that the royalty in the first quarter is very comparable to the royalty in fourth quarter and both are comparable to what would have been our sales prior to the agreement.
Jason Napodano - Zacks
Okay, and then you are expecting now that they are out in the field promoting the product will see that royalty number accelerate here in the next couple of quarters?
Yes, that’s our expectation.
Jason Napodano - Zacks
Okay. Just moving onto to the PACE study. Can you give us a sense, you are 30% enrolled, can you give us a sense of the enrollment of the PACE study and when you think we will see a 100% enrollment and then when we will actually see that data readout?
So the number that I am going to go put out there is about 12 months and now I am going to qualify that a little bit. So I mentioned we transferred the manufacturing of the technology to a facility designated by the NIH, that transfer has gone very well, that facility is producing the product affectively within specification, everything is going smoothly, it’s a slightly smaller operation and as a result the number of therapies that they can produce over a week or a month, is likely to be a few less than what we would have been capable of producing.
So my [qualification] is it would have been about 10 months to 12 months, I believe under full manufacturing and it maybe a little bit slower than that given this transfer, but I'm not sure at this point and I don't want to speak specifically for the NIH.
Jason Napodano - Zacks
Okay. So, what happens if this trial is successful? Do you ramp back up with manufacturing or production or do you outlicense it. Give us a sense of what would happen if the PACE study came back and you've got positive data there?
So, we're going to continue to look for partners for ways to monetize the value of the technology, while the study is ongoing. When given the philosophy of short time frame to get to the completion of that study, at this point I would say most likely we're still going to be effectively book I think all of our time and attention and resources on AutoloGel and the wound care market.
So, the most likely outcome, if we have a successful Phase II study and remember in the case of peripheral arterial disease, we did have a Phase I study in critical limb ischemia and we did show a therapeutic effect, not statistically significant of course because of the small Phase I study. But nonetheless this is not the first in-human studies for PAD with the Bright Cell technology.
So, assuming that this study is successful going forward and most likely outcome is that it would be partnered to take beyond that.
Jason Napodano - Zacks
Okay. And you guys own a 100% of that?
Jason Napodano - Zacks
Okay. Just moving on to AutoloGel [Technical Difficulty].
Jason, did we lose you?
I will just open his line again, okay, one second.
Okay. Go ahead Jason.
Jason Napodano - Zacks
Hi, thank you. So Martin last time we saw each other was at SAWC and I was shocked by the amount of products is there in the wound care market, the number of companies, the lack of differentiation between so many of these just regular dressings, it just seems like such an incredibly fragmented market. I'm wondering given that there is a lot of and I'm going to use a word generic, because it just seem like again a lot of these simple bandages were basically all the same thing with different names on them. Given how much let's call generic competition there is and then the skin substitute products and that seems to be a lot of them as well. How do you pickup market share in such a highly fragmented market. And then when you think about market share, what is a fair market share for a leading product in this space. I mean again because the market seems so fragmented. It doesn't seem like anyone is going to get 30%, 40%, 50% of this market. But what is a target in your mind for a reasonable market share?
So Jason, I'm going to start to response that question and then I'm going to pass it to Dean, because I think Dean is back then and perspective as unique and particularly suited to address the question that you just asked. A couple of things, one we are very uniquely positioned. In that, we have a product with good clinical data. We’ve got nine peer reviewed publication supporting AutoloGel. And we have a product that is cost effective and now was covered with reimbursement, it’s cost effective for the clinicians and the clinics themselves as well.
So we can differentiate ourselves in the marketplaces both by being an effective and cost effective product and that’s what we will set out to do and I think it will be effective. You’re absolutely right. There is a lot of noise in this marketplace and the marketplace itself is somewhat disjointed. I also believe that we have an ally here in CMS. We have had many conversations with CMS over some of their concerns about the marketplace becoming even more disjointed and more unclear as to what appropriate treatments are. And I think CMS is going to continue to attempt to hold this marketplace together through their reimbursement policies and in the end that will be effective for us with the CED program as we go forward because we will be able to establish ourselves again as an effective and cost effective technology.
Dean, maybe you want to get a little bit deeper into the market to answer Jason’s question.
Sure. So Jason yes, you’re absolutely correct. When you look at this market particularly going to somewhere like SAWC you do see a tremendous amount of undifferentiated technologies and in fact that’s just a fact of this market. The other fact of this market is there is if you look at the three wound types that AutoloGel is going to be -- is cleared for which is diabetic foot, venous leg and pressure ulcer there is in excess of 6 million of those every year in the United States. And so it’s a huge market. And so I think when we look at -- when I look at this market, I start to carve out pieces of it. So, there are -- a segment of this market that is going to be just a standard, what we refer to as a wet dry approach which is a lot of the -- what you refer to as bandages. There is going to be a segment of the market that’s going to use that, people are going to get healed, and everybody is going to be fine. That’s not an area we’re really going to go after. We’re going after more into the specialized wound care centers that are dealing with more complicated patients who have chronic wounds. And it’s not uncommon in our space that chronic wounds can have lasted years. We tend to in the medical community tend to look at chronic wound as something that somebody has had for more than 30 days.
When you look at that market, it’s still very large. And that’s an area where we see with as Marty said our clinical data, our specialized sales team and reimbursement teams that will build. We go into those specialized wound care centers which in the United States there is about 2,000 of those and then we will find those ones where we believe we have the highest opportunity to pull market share and to treat patients.
So you are absolutely correct and that it is a very fragmented market but it is also a very large market. And so carving out pieces of it where we think AutoloGel will be really effective for these patients, it’s still a very substantial market opportunity for us.
Jason Napodano - Zacks
So, Dean just to build off that, Marty mentioned 3.4 billion in sales for the wound care market and then I’ve heard that 6 million wound number often, and I have got the breakdown of that between DFU and VLU and pressure ulcers. But give me a sense of those let’s call it 6 million wounds, how many are being treated in the specialized wound care centers or how many -- what percent are since advantages wet to dry not an affective product, so that they would need in advance byproduct like AutoloGel?
Jason, it’s a great question. I don’t have the exact numbers to carve out. That’s one of the challenges because this market is so fragmented. The data accuracy and times for the total market is challenging to find. I think what we do know is when you look at a couple of 1,000 wound care centers in the United States, when you look at VA system for example which is another area that will go look for business as well in the future, those are dealing with a very large portion of those wounds. And that’s one of the things as you look at the way that this market is changing as far as some of the changes in the U.S. healthcare system, I think what you are going to see in the future is that more of these when they go past 30 days are going to get moved into these specialized areas, because we are going to see changes where the healthcare system is going to be much more aggressive about trying to treat these in an aggressive manner early on, because these patients are very costly to the healthcare system.
So I can’t give you specifics because I know that in these wound care centers, they have very large volumes, they have seen patients multiple days five plus days a week and they are very full of patients. And I will come back to you, I can get back to you with numbers in the future, I don’t have those with me right at this moment
Jason Napodano - Zacks
And I appreciate that, Dean. I think from an investor standpoint and certainly from my standpoint as an analyst, I am sitting here looking at excel file and I am trying to build revenues and costs and expenses, and I'm trying to get a sense of when you guys are going to be profitable. And I like to start with the patient population and then throwing things like cost and penetration and market share and come up with sales numbers. And it's very difficult to do that when the market seems like I said so fragmented and so difficult to try to understand, who is being treated where and what is the motivation for physicians, and within these centers, is it economic, is it pharmacoeconomic to use different products?
I think the last question and then I'll jump out. As you guys build new models, I guess the same kind of models that I'm building, when do you see the ramp in AutoloGel to the point where we’ll see some profitability from this business? And I'm looking at your -- the 10-Q right now. I see the break out that you have done for the AutoloGel P&L and I really appreciate that disclosure. But from a companywide standpoint, you had roughly $5 million or so in operating expenses in the first quarter. It sounds like that will come down a little bit from closing all Aldagen. But $0.2 million in AutoloGel certainly isn't going to get the market very excited. But when does that ramp take place to the point where AutoloGel is now driving the top-line and we are starting to see the positive operating income and positive EPS?
So, Jason as you know, we haven't given a lot of direct financial guidance in the past. But let me try to help you here.
Over the remainder of 2014, we expect to continue to establish these relationships and we're doing a lot of market education around CED and AutoloGel and we'll -- that will be the focus in 2014. So as I mentioned earlier, we expect that you'll be able to see impact of that in the second half of 2014. In 2015, we expect there will be significant growth throughout 2015. And then it's conceivable that in first half of 2016 is when we could start expect to be at that point where certainly AutoloGel is driving the top-line for the company, but also the possibility of being at profitability.
Jason Napodano - Zacks
Okay. I appreciate that Marty. I think obviously this is a very large market. I mean the 3.4 billion number that we've heard and that you've mentioned, it doesn't take a very large market share to get to the point where you've got a very large product, but I think it will be very interesting to follow this over the next couple of quarters. So as we look forward to hearing more just from you guys on that. And I'll jump out now. Thank you.
Thank you, Jason.
Thank you for your question, Jason. That's all the time we have for the call. I would now like to turn the call over to Martin Rosendale for closing remarks.
Thank you, operator. In closing, this past year and a half has been a period of significant change in the chronic wound care market. And it looks like that change is going to continue throughout the end of this year and well into 2015.
Looking at our future, we anticipate benefiting from the growing demand for chronic wound treatment due to the prevalence of diabetes and obesity in the U.S. We believe AutoloGel is well suited to meet the needs of patients, care givers and payers in this dynamic marketplace.
With [clarity] on government reimbursement rates, a highly competent commercial team in place and the support from our financial partners, we believe we’re well positioned to not only provide a therapeutic and cost effective alternative for patients suffering with chronic wounds but to execute our commercial business plans that will enhance shareholder value.
Thank you everybody, I appreciate your time this morning. And operator, we can close the call now.
Thank you. Thank you for your participation ladies and gentlemen in today’s conference call. This concludes the presentation. You may now disconnect and have a good day.
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