Indevus Pharmaceuticals Inc. (IDEV) F2Q08 (Qtr End 3/31/08) Earnings Call April 30, 2008 9:00 AM ET
Brooke Wagner - VP of Corporate Communications
Michael Rogers - EVP and CFO
Glenn Cooper - Chairman and CEO
Gary Nachman - Leerink & Swann
Juan Sanchez - Punk Ziegel
Kevin DeGeeter - Oppenheimer
Gary Nachman - Leerink & Swann
Matt Renna - Soleil
Annabel Samimy - UBS
Good day ladies and gentlemen and welcome to the 2008 second quarter Indevus Pharmaceuticals Incorporated Earnings Call. My name is Cynthia, and I’ll be your Operator for today’s call. 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.
I would now like to turn the call to your host Brooke Wagner, Vice President of Corporate Communications. Please proceed.
Brooke D. Wagner, Vice President, Corporate Communications
Thank you, Cynthia, and good morning, everyone. Thank you for joining us on the call this morning to discuss our financial results for the second fiscal quarter of 2008. The order of the call today will be Michael Rogers, Executive Vice President and Chief Financial Officer followed by Dr. Glenn Cooper, Chairman and Chief Executive Officer.
Before Mike begins, I must inform you that today’s call is being recorded and a replay will be available on our website at www.indevus.com as well as by dialing 888-286-8010 in the U.S. and Canada or 617-801-6888 from international locations. The passcode for the replay is 23855950. The replay should be available by 11:00 AM Eastern Time this morning and will remain available until May 29th.
I must also remind everyone that today’s discussion contains forward-looking statements regarding events that involve risks and other uncertainties. The company’s actual results may differ materially from those anticipated by our forward-looking statements. The risks and uncertainties are set forth in the company’s securities filings and we encourage you to read them.
I will now turn things over to Mike.
Okay. Thank you, Brooke, and good morning, everyone. Today, I would like to review our second quarter and first half results and provide you with an update on our full year 2008 outlook. About an hour ago, we reported second quarter fiscal 2008 revenue of 17.6 million and a net loss of 17.9 million or $0.23 per share. This compares to revenue of 11.2 million and a net loss of 12.4 million or $0.22 per share in the second quarter of 2007.
For the full first half of fiscal 2008, revenue totaled 34 million compared to 24.4 million in the first half of fiscal 2007 and the first half fiscal 2008 net loss was 32.6 million or $0.43 per share compared to a first half fiscal 2007 net loss of 22.7 million or $0.41 per share.
Let me take you through the key components of the income statement and I will begin with revenue. In the second quarter, revenue from the SANCTURA franchise totaled 10.4 million. Product revenue from VANTAS totaled 3.6 million and SUPPRELIN LA sales totaled 3 million. Rounding up the revenue for the second quarter were DELATESTRYL sales of 400,000 and Sarafem royalties of 200,000.
For the first half, revenue from the SANCTURA franchise totaled 20 million. Product revenue from sales of VANTAS totaled 7.2 million, and SUPPRELIN LA sales totaled 5.2 million. Rounding up the first half revenues were DELATESTRYL sales of 1.1 million and Sarafem royalties of approximately $500,000.
On the expense side, cost of revenue for the quarter was approximately 6.4 million, consisting primarily of three items; one, the cost to produce SANCTURA XR that was passed through to Allergan upon the sale of product to them; two, royalty payments that are owed to Madaus, our licensor of SANCTURA which are also paid by Allergan; and three, the cost of product related to the sale of VANTAS, SUPPRELIN and DELATESTRYL. Cost of revenues for the first half of fiscal 2008 totaled 12.3 million.
Research and development expense was 6.3 million for the second quarter, a decrease of 3 million from the second quarter of last year. The reduction in R&D costs versus last year are driven primarily by the reduced spending associated with NEBIDO and SANCTURA XR, offset by development costs for the octreotide implant and VALSTAR. The reduction in expenses is even more notable as fiscal 2007 figures do not include the R&D expenses associated with the Valera products, particularly the octreotide implant and VALSTAR, and to a lesser extent, SUPPRELIN LA and VANTAS. Year-to-date, research and development expenses totaled 12.6 million, a reduction of 6.5 million from fiscal 2007.
Marketing, general and administrative expenses were 21.3 million in the second quarter, an increase of 8.6 million from the second quarter of last year. The increase is primarily related to our acquisition of Valera, as we expanded the sales force and began marketing VANTAS and SUPPRELIN, and in addition, we are incurring pre-marketing costs associated with NEBIDO. Year-to-date, marketing, general and administrative expenses totaled 39 million, an increase of 17.4 million from fiscal 2007.
On the balance sheet, our cash, cash equivalents and marketable securities balance at March 31st was 60.8 million, a decrease of approximately of 21.5 million from last quarter. This figure does not include the $7 million upfront payment we received from Orion for licensing the European rights for VANTAS.
Moving on to our P&L outlook for the remainder of fiscal 2008, starting with revenue. As I have mentioned before, our revenue stream from the SANCTURA franchise is fairly predictable in the near term. We believe quarterly revenues for the remainder of the fiscal year will be between 10.5 and 11 million per quarter. So we remain comfortable with our SANCTURA revenue expectations of approximately 41 million for fiscal 2008. This expectation continues to assume receipt of our guaranteed minimum royalty from Allergan, which is based on Allergan achieving sales of 65 million in calendar 2008. We are pleased with the launch performance to-date, and it appears that Allergan will exceed the guaranteed minimum sales levels prior to the end of our fiscal year in September; we will adjust our guidance accordingly.
Our guidance for VANTAS sales has been for relatively flat sales versus the 12.9 million we reported in fiscal 2007. With our first half revenues at 7.2 million and with the pending departure of Viadur from the market, there is some upside here. At this point though, without being able to gauge the near-term impact of the Viadur exit, we will continue to monitor the performance of VANTAS and revisit our guidance again next quarter.
In regard to SUPPRELIN, we’ve previously guided the sales in the mid-single digits in millions for fiscal 2008. The acceptance and initial trajectory of SUPPRELIN has been quite positive and in excess of our initial expectations. Although we are just over two quarters into the launch, we are comfortable increasing our guidance for SUPPRELIN to 10 million for the fiscal year. We also do expect to receive approval for VALSTAR this year and along with DELATESTRYL, this should provide a few million more in revenue. This brings our total revenue for fiscal 2008 excluding NEBIDO initial stocking and business development activities and partnerships to the mid $60 million range, up from the low 60s we guided to last quarter.
As I mentioned in our last call, we have several other potential sources for revenue in 2008. First, our expectation is that NEBIDO will be approved in June. And this sets us up for a launch in this fiscal year, and we hope to be able to record revenues for the initial sales of NEBIDO. In addition, we have a number of initiatives on the partnering side that may possibly contribute to the top line in fiscal 2008 including Pagoclone and SANCTURA XR for which we hold joint rights in Canada, Japan, China and Korea.
Prior to finalizing the terms of the business development transaction, it is challenging to forecast the ultimate accounting treatment of the deal. In the case of the outlicensing of VANTAS in Europe, we received a $7 million upfront payment from Orion. The revenue associated with the upfront payment, however, will be recognized over the term of the agreement.
On the cost side, our expectations remain unchanged from last quarter. On a year-over-year basis, the operating expenses will increase slightly overall as additional marketing expenses predominantly associated with NEBIDO, SUPPRELIN LA and VANTAS are largely, but not entirely offset by reductions in R&D spending. On the cash outlook, we continue to see the burn rate averaging in the high teens for the next several quarters not counting the impact of business development activity. And this provides an acceptable cash position to support the launch of NEBIDO. We expect the burn rate after this period to begin to be reduced significantly as we move towards profitability.
At this point, I will turn the call over to Glenn and I will address any questions you may have during the question-and-answer session following Glenn’s comments. Glenn?
Thank you, Mike, and good morning, everyone. Thanks for joining us. We are just past the halfway point of fiscal 2008, and I am very satisfied with the progress we are making on each of our key initiatives. Today, I am going to provide as much detail and insight into the status and plans for NEBIDO as I can. NEBIDO is obviously an extremely important product for Indevus, and our upcoming PDUFA date and post-Labor Day launch are big events for the company.
Before I discuss NEBIDO, there are several marketed products, development programs and business development opportunities that I want to provide an update on as they are also important components of our product portfolio and strategy. I’d like to start with SANCTURA XR. We are now just over three months into the launch of the product with our partner Allergan, and I am very pleased with the performance of the product in every respect. The SANCTURA family of products; SANCTURA XR and SANCTURA, now have approximately 4% in Rx market share in the OAB category. SANCTURA XR has an ideal efficacy and tolerability profile in the OAB space, an experienced sales force behind it, and a partner who is very committed, and has the resources to support the product effectively. I am confident that with Allergan the product will over time achieve its full potential in the growing OAB category and hit Allergan’s long-term sales forecast of 3 to $400 million per year.
As Mike stated, sales of SUPPRELIN LA have exceeded all of our initial expectations. As of launch in the late summer, over 450 implant procedures have been completed of this revolutionary 12-month therapy for central precocious puberty. Man has remained strong among patients and healthcare providers for this $14,000 implant. We are extremely pleased by the initial reception to this truly differentiated treatment. We’ve been tracking several metrics to evaluate acceptance of the product, including a number of physicians who have submitted an authorization request for an implant procedure, which we view as a measure of breadth of demand. We are also tracking the percentage of physicians who have made multiple requests which enable us to evaluate where the physicians are simply trying to park on one patient or are more broadly embracing the product.
To-date, a total of 251 physicians have submitted the authorization request for SUPPRELIN LA which represents about half of all potential physicians treating the disease and 61% of these physicians have submitted multiple requests. Eight months into the launch, these are highly favorable numbers. VANTAS, our 12-month implant for advanced prostate cancer achieved another on-target quarter generating $3.6 million in revenues. Our average selling price of $1,478 was again higher than the prior quarter representing a favorable trend over the last several quarters. The product continues to have a run rate of approximately $14 million per year. As I discussed last quarter, Bayer Schering Healthcare announced that they would discontinue marketing Viadur, the competitive 12-month implant and that their inventory would be fully depleted by the end of April.
We believe there is still a relatively small amount of Viadur inventory in the system. We are watching closely to see how and when they completely exit the market. In the meantime, our sales force has been actively communicating with physicians who currently utilize the Viadur implant. As we move through the next several quarters, as Viadur patients come up on their re-implantation cycles, we are emphasizing the distinct benefits of once-yearly treatments and encouraging physicians to utilize VANTAS as their treatment of choice rather than migrating its patients to shorter-acting injectables. Toward the end of 2008, we should have a clear picture of this transition and we will be providing updates.
Late last month, we completed an outstanding European partnership for VANTAS. Our partner, Orion, is well positioned to market VANTAS on a pan-European basis. VANTAS will be the only 12-month therapy available in Europe, and based on market research, we believe the market opportunity for the product in Europe is potentially larger on a unit basis than in the United States. With excellent economics from this agreement, we received a $7 million upfront payment. We are eligible for additional $14 million in approval at sales threshold milestones.
Importantly, we will manufacture and sell VANTAS to Orion at a negotiated transfer price with guaranteed minimum purchase requirements over a nine-year period beginning in 2009. The transfer price, although not disclosed, is meaningfully profitable and enables us to more fully utilize our Cranbury, New Jersey manufacturing facility.
Moving on to VALSTAR, our product for bladder cancer patients, who have failed primary therapy with BCG and are not candidates for cystectomy or surgical removal of the bladder. The only remaining hurdle to marketing approval is the re-inspection of our third-party manufacturer. We’ve submitted our request for re-inspection to the FDA according to our previously stated timeline. We are hopeful that we will receive our approval to reintroduce the product in the next couple of months. In anticipation of approval, we are actively planning for a summer launch. VALSTAR is the only approved product for these late-stage bladder cancer patients and is obviously an important treatment for the patients that it will serve. On Pagoclone, we continue to work with multiple parties on various forms of outlicensing transactions and we remain positive on our belief that we will successfully complete a transaction.
Timing of these types of outlicensing transactions is difficult to predict. These have obviously taken longer than we wanted, while on the other hand, our VANTAS agreements proceeded faster than we expected. Such is the nature of business development discussions. Although, I am not going to predict the specific timing, I remain confident we will complete a transaction.
On the clinical development front, we are planning for our Phase III program for our octreotide implant that’s progressing smoothly. As a six-month treatment, the octreotide implant has the potential to provide patients with acromegaly with a very compelling treatment option versus the daily or monthly injections available today. We are continuing our analysis of the opportunity to expand the development program beyond acromegaly to address the other indications where octreotide is currently utilized, especially carcinoid tumors. Today, the worldwide octreotide market for octreotide indications is approximately $1 billion. A six-month octreotide implant is proving to be effective to be a very attractive competitor in this market with a launch as early as 2010.
Now I’d like to discuss NEBIDO. We are two months away from our June 27th PDUFA date, and so far, everything is progressing normally. Our conversations with the FDA have been retained and the Urology Division seems to be operating in a way that would indicate that they can complete their review on a timely manner. Obviously, we are aware of all the discussions in the press over the last few months regarding the challenges of the FDA, the ever-increasing number of delayed decisions and action letter delays.
I certainly can’t provide any guarantees as to the outcome of our NDA, but I can say that we are satisfied internally that our application is being addressed by the FDA in a professional and timely matter, and from what we know today can be acted on by the PDUFA data. Our NDA package is robust, and our clinical data shows that we have an effective drug. The data from the Phase III regimen we submitted to the FDA met all the pre-specified pharmacokinetic endpoints, while patients succeeded testosterone concentrations of 1,800 nanograms per deciliter and fewer than 8% of patients succeeded 1,500 nanograms per deciliter and 94% of all patients at steady state had testosterone levels within the normal range throughout the dosing interval. These are really excellent numbers.
We believe that our regimen, initial 750 milligram injection of NEBIDO followed by 750 milligram injection four weeks later and 750 milligram injection every 10 weeks thereafter provides the optimal approach to replacing testosterone in hypogonadal men. All of our market research indicates that a regimen of only five injections per year will be very attractive compared to the 26 injections or so required from current injectable products or the daily application ritual of popular products.
We are now moving full speed towards preparing what we hope will be a NEBIDO launch before the end of our fiscal year September. So, our goal is according to plan. Our sales reps who are currently co-promoting SANCTURA XR will transition to NEBIDO. And we will expand the sales force appropriately. We are actively analyzing sales force sizing and evaluating several options in regard to maximizing reach and product profitability, which include head count increases and co-promotion opportunities.
When we have nailed down our sizing analysis, we’ll communicate our plan publicly. We’ve conducted additional managed care research and advisory board meetings and we continue to be comfortable with our pricing assumptions of approximate parity pricing with the leading topical gels. Our patient and physician market research continues to be very positive. We remain confident that NEBIDO can capture significant market share and lead the way to corporate profitability.
The last subject I’d like to address today is my retirement announcement in early March. I’ve been at Indevus for 15 years, and have had discussions with the Board over time regarding succession planning and the timing of my retirement. The decision to announce my retirement six months in advance of my actual date enables the company to openly and publicly conduct a search for my successor. The specific timing is appropriate. I view the approval of NEBIDO as a fitting capstone to my career at Indevus. At that time, Indevus will be truly a commercially-focused enterprise and it’s a perfect time for the company to recruit an experienced and commercially-focused CEO.
As far as the search process is concerned, it’s progressing very well, and to-date, the Board has seen several well-qualified candidates. I expect the remainder of the fiscal year to be very busy for the company. And as we move into fiscal 2009 with an approval for NEBIDO, we will be on a very exciting path for the future. Operator at this point, we can move over to questions and answers.
Thank you. (Operator Instructions). Your first question comes from the line of Annabel Samimy of UBS. Please proceed.
Annabel Samimy - UBS
Hi. Thanks for taking my question, good quarter. Let me ask you on your market research that you’ve been conducting, have you gotten any feedback on whether physicians are; number one, these are generally comfortable with depot formulations; and number two, whether physicians in general are comfortable with a drug that you can’t necessarily titrate that well?
Well, yes, physicians are very comfortable with depot formulations because the current shorter-acting testosterone therapies that are used by about 40% of all men with hypogonadism are in fact depot formulations. They just don’t have the same long-term pharmacokinetic payout that NEBIDO does. So, this is already a quite accepted therapy. And we’ve done extensive work around physician attitudes about using a ten-week depot injection and there is a high degree of comfort with all the standard and appropriate monitoring, that patients can be safely and effectively treated with intermittent depot injections.
Thank you. Your next question comes from the line of Matt Renna of Soleil. Please proceed.
Matt Renna - Soleil
Good morning, guys. Thanks for taking the questions. I was hoping you could give a little bit of color surrounding you pre-marketing activities for NEBIDO?
Certainly, well, we are doing everything right now that you would expect our company to do in preparing for a world-class launch. There is extensive work going on in terms of our medical education program, in terms of agency work for launch campaigns, in terms of third-party payer work to prepare for our managed care efforts in terms of internal sales force analysis, looking at physicians, targeting sales force sizing. We are also, as I mentioned, have been looking at the potential of co-promotions to increase the reach and frequency of our sales force effort in the most cost effective way possible. We have a very active publication plan that’s ongoing with excellent publications that will be arriving on the scene, at really – at perfect timing for launch and we will have a very aggressive presence at the AUA and other significant urology, endocrinology and primary care meetings.
So, we have a terrific team headed up by Kurt Lewis and on the marketing side by Nancy Bryan who was in charge of the men’s health marketing group at Bayer in the recent past, and launched Levitra quite effectively. So, we have a great team in place and a significant and I think effective effort for launch.
Your next question comes from the line of Gary Nachman of Leerink & Swann. Please proceed.
Gary Nachman - Leerink & Swann
Hi, good morning. Glenn, when do you think Allergan may start a DTC campaign for SANCTURA XR? Will that happen this year? And just in general, how optimistic you think they are on the launch so far?
Well, Allergan is in 100% control over all of the switches and levers of the launch and commercialization. So, you’d have to direct really all questions about DTC and marketing strategies and plans to them. We believe they are pleased with the launch trajectory as we are.
Your next question comes from the line of Kevin DeGeeter of Oppenheimer. Please proceed.
Kevin DeGeeter - Oppenheimer
Hi. Good morning, guys. In light of a number of your pretty attractively structured royalty monetization agreements signed by other biotech companies out there, can you just sort of give us your current thinking on the relative attractiveness of those deals, for SANCTURA I guess – for even NEBIDO, relative to equity at some point down the line?
Okay. Kevin, you are absolutely right. The credit markets have been a negative, but I think that the people that have played in this game have increased, and the market has certainly become more competitive and some deals have been done that look relatively attractive. So, I think we’ve said as it relates to financing that we will do – we will do everything that we can to avoid a dilutive event for investors, particularly with the stock price where it is today. And we have other options. We’ve got a very strong portfolio products and a very good business development group, and we have some things pending there that we think might be helpful. And then number two, that the second choice would be something like a royalty monetization which is non-dilutive.
So the market is – would be available to us. We know we’ve got a very nice product with a great partner. We’ve got the guaranteed minimum royalty stream, and we could do something there. So, I don’t think we’ve thought particularly hard about our other products, but we think we don’t want to be in a position where we give away a product, but we could monetize partially the SANCTURA royalty steam and could do a very attractive financing. So that at least is on the table, but we will continue to move forward with our first choice as well which is business development-related cash inflows.
(Operator Instructions). Your next question comes from line of Juan Sanchez from Punk Ziegel. Please proceed.
Juan Sanchez - Punk Ziegel
Good morning, guys. Could you share some more clarity on what happened with Alkermes and the COPD program? I mean what was in the contract that allowed them to take more ownership of this program? And the second question is whether or not the late-breaker presentation at AUA is going to be about the 1,000 milligram dose or the 750 milligram dose?
On the second question, Juan, it’s about the 750 milligram dose, which is again perfect timing for us for rolling that out to the urology opinion leader, and general urology community. In terms of Alkermes, in recent weeks and months, we’ve been having third-party negotiations for partnering of the product and negotiations with Alkermes on the development and commercialization of inhaled trospium chloride. And I would say we were unpleasantly surprised by Alkermes’ termination – purported termination as we believe the contract was not at a valid termination point, and we are going to be vigorously pursuing all legal remedies here. I think my view is that Alkermes’ action is a waste of resources that should be channeled into partnership efforts, but because this has now became a matter for litigation, that’s really all I can say about it, but we are very confident in our legal position here.
The next question is a follow-up question from Annabel Samimy of UBS. Please proceed.
Annabel Samimy - USB
Hi. I wanted to get a sense for the NEBIDO sales and marketing efforts. How many people are you going to have initially? How many do your competitors have? And how likely is it that you are going to have to increase the sales force to compete effectively? And also when you mention the co-promote, what exactly did you mean that – did you mean there, right? Are you very serious about considering a co-promotion of this product?
Sure. So currently as a kind of a benchmark, per se, Auxilium market Testim has about 150 reps. Solvay has a much larger effort. There are about 400 reps. We think as a general target, the size of the Auxilium effort has certainly been very effective and very appropriate. We are currently closer to about 80 or so available reps, who could role off of SANCTURA XR on to the program.
So, there’s a shortfall that, to really effectively address the marketplace, either at launch or eventually in the first few quarters, would need to be ramped up. And we are looking at several potential ways of doing that. The options really are to organically grow internally, and hire new reps. That’s certainly an option that’s very much on the table. We can employ a contract sales organization to bridge that kind of sales force that can always be incorporated into our existing sales force over time. It’s typical of these kinds of contracts. And the third option is a – is co-promotion with third-party companies, specialty pharmaceutical companies, major pharmaceutical companies that have spare capacity in the appropriate kind of allocation or some combination of those three maneuvers.
So, we were very actively looking at a sizing exercise right now, a targeting exercise in terms of the exact number of reps that we’d need to achieve various levels of penetration in the marketplace, certain share of voice targets, and then matching that with the co-promotion and internal resource options that we have available to us. We think the process should be sorted out in the next few months, and we’ll be making appropriate announcements. We think we have a timely action on our PDUFA dates with an anticipated launch in September, that there is ample time for some just-in-time hiring, so we wouldn’t be hiring at risk if that’s the way we decide to go.
Your next question is a follow-up question from the line of Gary Nachman of Leerink & Swann. Please proceed.
Gary Nachman - Leerink & Swann
Hi. Thanks for the follow up. First on the octreotide implant, when will we see Phase III data, Glenn? And I am assuming that’s in humans now. And what does the animal data look like in the biodegradable ureteral stent and what’s the status of that program? Thanks.
So, on octreotide, the Phase II was just completed. We’ll be rolling out appropriate academic meeting, presentation abstracts. We a lot of the data into the press release but there will be a scientific publication that will be in preparation soon. And the Phase III we hope to start in the summer with results about a year or so after that. The ureteral stent, we are moving toward a – our first human trial that we would expect to happen in the next few months and that will be sort of a gating decision point; looking at degradation rates, comfort levels, various efficacy and safety parameters surrounding these patients who’ve had lithotripsy.
Okay. Operator, I think we have time for one more question.
And your final question from the line of Matt Renna of Soleil. Please proceed. Mr. Renna, you may proceed with your follow-up question.
Matt Renna - Soleil
Hi. Thanks for taking the follow up. Mike, what’s the amortization schedule for the VANTAS payment? And if you guys do a deal for Pagoclone, can we expect that you’ll amortize the upfront payment as well or would you recognize it in the quarter that you do the deal?
Okay. Thanks, Matt. Let me address the second one first and that is that these are largely dependent on – in today’s world with the accounting rules, largely dependent on the obligations that we have on a continuing basis. The greater those obligations are the more clearly, the more likely it is that you’ll amortize any milestones over the period of those obligations. So, we don’t know, it’ll depend on the structure of any deals that we do, we will be – we will have that as a dependent factor.
As it relates to the VANTAS for Europe deal with Orion, that will be amortized over the life of the deal, but the way it’s done it’s sort of without getting too far into it, sort of a percentage of completion. They have minimum purchase orders that they have to submit, minimum requirements and will amortize the upfront over that period of time sort of on a pro rata basis and that goes for the life of the agreement, we will do it over. So, it will be amortized over starting in ‘09. There won’t be any revenue recognized in ‘08 because they don’t have required purchases in ‘08, but it will start in ‘09 and be recognized from that point forward. And I can get into more specific details with you, exactly how that flows.
And I would now like to pass the call back over to Dr. Glenn Cooper for closing remarks.
Okay. Thanks for joining us this morning everyone. Follow-up questions, Brooke Wagner will be at his desk in 3.5 minutes. So, thanks a lot. Talk to you soon. Bye.
And thank you for your participation in today’s conference. This concludes your presentation. And you may now disconnect. Good day.
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