Thank you for joining the Intercept Pharmaceuticals Fourth Quarter and Full Year 2012 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. Following the formal report Intercept management will open the lines for question-and-answer period. Please be advised that this call is being taped at the company’s request and the webcast of the call will be archived on the company’s website for two weeks from today’s date.
At this time, I would like to introduce Mr. Senthil Sundaram, Intercept Senior Director of Corporate Development. Please go ahead.
Good afternoon and thank you for joining us. Today we are reporting our financial results for the fourth quarter and year ended December 31, 2012, and providing an update on recent corporate developments for 2013. We plan to host this calls only on annual basis, however we may hold additional calls throughout the year to the extent at that time we believe such calls will be helpful to our investors.
Before we begin, please remember we will be making certain forward-looking statements on today’s call, including statements and forecasts regarding our future financial and operating performance, anticipated timelines for the potential approval and commercial launch of obeticholic acid in our regulatory, clinical and commercial plans, goals and estimates, as well as other statements which relate to future events.
These statements are based on the belief and expectations of management as of today. Our actual results may differ materially from our expectations. Investors should read carefully the risks and uncertainties described in our earnings release in our reports filed with the SEC, including the Risk Factors section of our most recent quarterly report on Form 10-Q and in our annual report on Form 10-K for fiscal 2012 when it is filed. We assume no obligation to revise or update forward-looking statements, whether as a result of new information, future events or otherwise.
The format for today’s call include opening remarks from Intercept management team and then we’ll open up the call to take your questions.
At this time, it’s my pleasure to turn the call over to Intercept CEO, Dr. Mark Pruzanski.
Thanks, Senthil. And thanks everyone for joining us on our year end 2012 conference call and webcast. I’m going to provide you with an update on the business activities and development of our lead product candidate obeticholic acid or OCA. Barbara Duncan, our Chief Financial Officer will then discuss our year end 2012 financial results. Dr. David Shapiro, our Chief Medical Officer is also here with me to answer any questions during the Q&A portion of the call.
We are very pleased with the significant progress that we made in 2012, which included the initiation and completion of enrollment for our POISE Phase 3 clinical trial of OCA in PBC, the successful completion of a private placement followed by our IPO, the advancement of OCA and additional indications beyond PBC, and the addition of a number of experienced and talented individuals to our team.
On the clinical front, we completed enrollment of POISE ahead of schedule in December by randomizing 217 patients about 20% more than our target of 180 patients. We believe that the speed and quantity of patient enrollment in POISE demonstrate enthusiasm from both clinical investigators and patients looking for an effective treatment for this disease.
The demographics and baseline disease characteristics of the patients enrolled in POISE are very similar to those observed in our Phase 2 combination trial of OCA in PBC patients.
Trial is progressing well. The first patients in the trial have completed 12-month double-blind phase and to this point after all patients have been on study for at least three months, a smaller proportion of patients have discontinued due to pruritus and in Phase 2 even if we assume that all such patients are in the OCA dosing groups.
We believe that this decrease reflect insight since the management of pruritus obtain from our Phase 2 clinical trials including the long-term extension portions of both these trials. We expect the final data for POISE will be available in the second quarter of 2014 just over a year from now.
On the regulatory front, further validation of the use of surrogate biochemical endpoints in PBC as predictive of clinical outcomes is forthcoming as the global PBC study group or what we've been calling the supergroup sponsored by Intercept will be presenting a poster with supporting data from over 2,100 patients at the 2013 EASL Annual Meeting next month in Amsterdam. While final data for the entire data set of more than 4,000 patients is expected to be available later this year.
Additionally, an independent academic consortium in the U.K. recently published data in gastroenterology from a large observational study of over 2,300 PBC patients obtained from every hospital in the U.K.
The results show that there is highly statistically significant correlation between alkaline phosphatase both alone and together with other biochemical parameters such as bilirubin and clinical outcomes.
Several different threshold values of alk phos were tested and it was demonstrated that reductions in alk phos levels down through to less than 1.5 times upper limit normal are strongly predictive of clinical benefit.
As we stated previously, we intend to file an NDA seeking accelerated approval of OCA in the U.S. based on the results of the POISE trial. Well ahead of such approval we expect to finalize the design of clinical outcomes trial in discussions with FDA over the coming months and initiated by the end of this year. Based on written scientific advice from EMA, we continue to believe that it will accept the POISE result as the basis for approval.
On the commercial front, we are excited to have announced the Dan Regan joined the Intercept team as Chief Commercial Officer earlier this month as we look ahead to the anticipated approval of OCA. Dan brings over 20 years of pharmaceutical and biotech industry experience to Intercept, including a 12-year tenure at Genzyme, where he was responsible for the commercial aspects of its rare disease franchise.
Dan’s experience in the global commercialization of novel drugs for rare and specialty indications will serve us very well as we design and execute our commercial strategy for OCA. Dan will be leading our pre-commercial activities in parallel with our continued development of OCA.
Moving on to other development activities, we continue to advance OCA for additional indications beyond PBC with ongoing Phase 2 trials in portal hypertension, NASH and bile acid diarrhea. We continue to be excited by the many potential therapeutic applications of OCA across the spectrum of liver diseases for which there is a compelling ethics or associated scientific rationale.
I’ll now turn over the call to Barbara Duncan, our CFO for a discussion of our 2012 financial results. Barbara?
Thank you, Mark. Good afternoon, everyone. Please refer to our press release issued earlier today for our summary of our financial results for three months and 12 months period ended December 31, 2012. I’ll focus my comments this morning on an overview of our financial position as of December 31, 2012.
We ended 2012 with $110 million of cash, cash equivalents and investment securities, which is on our balance sheet -- which is reflecting the $86 million initial public offering and the $30 million private placement in August.
Based upon our currently expected level of operating expenditures, we believe we will be able to fund our operations through mid 2015 which gets us comfortably past the NDA and MAA filings of OCA in PBC currently anticipated in late 2014.
While I won’t review all of the 2012 results that we shared in our press release today I will make a few remarks in the accounting treatment related to the periodic revaluation of our warrant.
In connection with our prior equity financings, we issued warrants that are classified as liabilities and are adjusted to their fair value on a quarterly basis with the change in that fair value being included in our net operating loss -- in our net loss. The amount included in net loss is a non-cash item as we are not required to expend any cash to settle the warrant liability.
The warrant liability is primarily affected by changes in Intercept stock price during each financial reporting period, which causes this liability to fluctuate as the market price of our stock will fluctuate, as well as remaining term on the warrant and underlying volatility utilized in the fair value calculation.
In general the warrant liability for the fourth quarter and the year ended December 31 increased significantly primarily due to the increase in our stock price after our IPO. For example for the full year 2012, the warrant revaluation expense was $24.6 million of which of an expense of $24.2 million was recorded in the fourth quarter of 2012.
Let me turn the call back over to Mark.
Thanks Barbara. In conclusion, for 2013 Intercept anticipate the availability of additional data and analysis which we believe will support the use of our biochemical endpoint in PBC and we’ll focus our efforts mainly around the continued execution of the POISE trial, the completion of other work necessary for robust NDA and MAA filing, and starting their preparation, the initiation of PBC clinical outcomes trial and of course, work towards a better understanding of the commercial opportunity in PBC.
I’ll now open up the call for questions, however, please note that we will not be taking questions on the supergroup data to be presented at EASL next month or the OBADIAH bile acid diarrhea data at -- to be presented at DDW in May since they are still under embargo.
Operator, please proceed with the Q&A portion of the call.
Thank you. (Operator Instructions) Our first question comes from Akiva Felt from Wedbush. Your line is open.
Akiva Felt - Wedbush
Hi. Good afternoon and thanks for taking the questions. Maybe without getting into details about the supergroup data in particular, but now that you have the first portion of the analysis in hand, has there been any change to your approach or timeline regarding the regulatory plan for PBC or future interactions with FDA?
Akiva, thanks for the question. I don’t think so. We are just keeping our heads down and executing on the Phase 3 program and we intend to keep to our plan, which is to file before the end of next year in the both the U.S. and Europe for approval. I think, clearly the fact that we hold together the Supergroup and that the data are so clearly supportive of our thesis is very helpful and as we have agreed with FDA, we are sharing the results on a real-time basis with them.
The fact that coincidentally, this U.K. PBC Group published in gastroenterology just this past month, further corroborating alkaline phosphatase on its own and with bilirubin just increases our confidence in the regulatory path that we are taking both in the U.S. and in Europe.
Akiva Felt - Wedbush
Okay. Thanks a lot. That’s helpful. I will jump back in the queue. I had to hit star one a few times. So there maybe other people lined up.
Thank you. Our next question comes from Alan Carr from Needham & Company. Your line is open.
Alan Carr - Needham & Company
Hi. Thanks for taking my questions. A couple of them. One of mine is can you outline where are the next steps? In the discussions with the FDA, it sounds like you are and you just mentioned that you are sharing the data from the Supergroup analysis on a real-time basis. But can you tell us more about the process going forward with the FDA, and how it might shape the ongoing POISE trial and the trial that you planned, the outcomes that which you plan to start by the end of this year? And then also, can you give us an update on the long-term experience with OCA? How many patients have been on it beyond a year? Has there been any changes in safety or tolerability profile? Thanks.
Sure, Alan. Thanks for your questions. I would say that and I will actually ask David to answer the second question. With respect to our interactions with FDA this year, our primary goal is to come to agreement with them on the -- an agreeable design for the second Phase 3 confirmatory trial and to get it started prior to end of the year.
As you know, FDA has expressed to a number of sponsors pursuing accelerated approval, a concern and a commensurate requirement that such confirmatory study should be well underway or substantially underway at the time that they approve, give you the first approval, the accelerated approval and we very much intend in good faith to be substantially underway, frankly, well before we even file the NDA.
As I’ve said before to you and say to our investors, we are not expecting necessarily anything further, clarifying from FDA in writing this year with respect to the acceptability of our specific surrogate endpoint or in general. We are simply executing on a plan that we believe maximizes the probability of success that we obtain accelerated approval based on the POISE trial data and the rest of the NDA package that we submit. And David, the question on long-term exposure and safety profile?
I don’t have the numbers right in front of me in terms of exposure, but we have -- we presented last year actually at EASL and the year before at AASLD data from longer-term therapy in PBC from the continuation phase of long-term safety extension of both our combination study and of our monotherapy study.
We had about 60 patients in the add-on study to us so and patients were treated for, at least a year and then we stopped that study or that extension. And we had approximately 20 patients continuing in the extension of the long-term safety extension who are all around the three-year mark, a few patients are above, some patients are longer than three years and some patients are coming up to them.
But in both of those phases or those extensions, we've seen a sort of a continued decrease in an improvement in alkaline phosphatase and other biochemistry levels. Pruritus is the most common symptom of the disease, as we had expected it, is the most common symptom.
And otherwise in general, most of the other symptoms were very much what you expect to get in a group old, middle-aged or somewhat more elderly patients who have followed for a three years sort of plethora of minor complaints as we presented. But no clear concerns or other signals and a number of patients have been in for hospitalization for pre-existing conditions and other issues and a few patients have dropped out. But essentially the affects are robust and the study continues.
Alan Carr - Needham & Company
Okay. Can I add in one more follow-up here? You mentioned that based on demographics being similar, I wonder if you could comment on percentage of, between the Phase 2 and the Phase 3. Does that apply to percentage on (inaudible), and age, the baseline that I think in Phase 2 was 2.5 times upper limit to normal for ALP, was just the average there? Are all those factors similar for this one?
I don’t think it’s appropriate to comment and give specific information on our ongoing clinical trials. We don’t usually do that. But I think you’ve hit all of key issues for the demographics. The sex, the age of the patients, the concomitant use (inaudible) which is pretty high and we have those blocked out into two studies. But I can say that yeah, the population is very similar to that seen in Phase 3.
And as you indicate in Phase 2, sorry, and as you indicate, obviously the minimum level to enter the Phase 3 trial is they have to have at least 1.67 times the upper limit to go normal whereas it was only 1.5 times the upper limit to normal in the Phase 2 trials and it would be highly surprising if the mean baseline levels were not higher.
But I think there is nothing surprising. I think that's fair to say that I don’t think it’s appropriate to give out specific numbers for any of our ongoing clinical trials until we present that in the public -- in a public scientific forum.
Alan Carr - Needham & Company
That’s fine. Thanks very much.
The next question comes from Rachel McMinn from Bank of America. Your line is open
Rachel McMinn - Bank of America
Hi there. Hopefully, you can hear me. Can you hear me, okay. I’m on my cellphone right now.
I’m, perfectly, Rachel.
Rachel McMinn - Bank of America
Okay. Great. So, I apologize if I missed out a little bit of the beginning of the call, but I was hoping you could give us a little bit more of an update on just new indications for OCA and I guess in particular, we are going to get some data at DDW for bile acid diarrhea and I know you guys have talked about doing another, say in portal hypertension. Can you talk a little bit about, what is about you are looking for in the bile acid diarrhea study and give us a sense of what your development outlook in these other indications would be gated by? Thank you.
Sure. I’ll begin the answer and ask David to fill in any additional detail. So let me just review the other indications that we are in right now behind PBC. Bile acid diarrhea, you mentioned portal hypertension and NASH. I will speak briefly to each one of those. In bile acid diarrhea, we will have interim data available and presented in an oral presentation at TDW and we expect the entire study to be completed later this year.
This is an open-label study. There are cohorts of 10 patients each. The first is patients with primary bile acid diarrhea, are a population of interest. The second is Crohn's patients with the ileal resections who have, what’s called secondary bile acid diarrhea and the third is a group of idiopathic IBS-D patients who have normal FGF19 levels.
And remember that patients with primary bile acid diarrhea have this condition and very severe diarrhea, because they had deficient FGF19 release in the gut postprandially. And therefore produce far too much bile that then causes this chronic diarrhea.
This signal we are hoping to exploit here is one that we’ve demonstrated and reproduced in all three of our Phase 2 trials where we showed a very significant dose-dependent induction in patients of FGF19 which was expected based on the pre-clinical data. And of course, remember FGF19 is directly regulated by FXR and it is the rate limiting that continue to break on the novel bile acid production.
This actually of course, this is a biomarker of FXR activation that proves that we are hitting FXR dose dependently in these patients. And we’re now looking to exploit that mechanism in these patients. So the scientific rationale is very clear and we’re hopefully looking for -- in -- so called PBAD primary bile acid diarrhea patients. A very nice FGF19 signal with symptomatic improvements and we hope to show ideally more of the signal in these patients than the two other control cohorts.
In terms of a next step there, that’s something that we are currently discussing as I don’t have any further information on that. In terms of portal hypertension, as you know we presented interim data on the first 10 milligram dose cohort at AASLD this past November, showing positive response in about six of eight patients evaluated for efficacy, sure to reduce portal pressure, five of the six met at least one of the two co-primary endpoints. And the six just missed and these eights and a further four evaluated just for safety, tolerated, associated very well with that dose.
We are currently testing a 25 milligram dose at the same center, UCL in London and have initiated a second corroborating 10 milligram dose cohort in -- at a site in Belgium. And I think that what we are looking for there, Rachel, would be additional co-operating data from another site, in a certain minimum number of patients that would give us the confidence to commit to doing a placebo control, longer term, let’s say three-month Phase 2 trial with the idea that we might look at patients both on beta blockers, as add-on therapy and potentially monotherapy.
So that’s currently what we are thinking. But we obviously need to make for additional data. We do expect to complete both of the ongoing cohorts by the end of this year. Finally in NASH -- sorry, go ahead.
Rachel McMinn - Bank of America
Well, I guess, before you get to NASH, I guess, one of the things that maybe I should ask a question this way. That was a super, super helpful review of the data. But I’m just wondering, as you look at these opportunities, maybe you can give us some insights into how you’re thinking about it. PBC is relatively rare indication.
And as you think about your -- why you’re thinking about pricing, how elastic is that pricing model for some of these indications that you’re considering and what it makes more sense, you know, in one market versus other to come up with second molecules that would be distinct that you could price it differently. Would you feel like all of these indications are sort of rare enough that it would support that pricing that you’re thinking about to keep it safe?
Yeah. I know, great question. And again, I’ll answer with the caveat that we just brought Dan on board as our CCO. And we’ll be doing a lot more detailed work to analyze this. But the good news is, we’re not a one-trick pony. Behind OCA, we have other compounds in the pipeline as you know, including INT-767 and others.
And so we have the luxury, I think in establishing a proof-of concept, let’s say, an indication that might not necessarily be commercially synergistic with the kind of orphan focused of OCA to then move to a follow-on or backup compound and take it in that direction.
One indication that obviously comes to mind here would be the primary bile acid diarrhea indication, which if as the investigator in this study claims, he’s published this. It’s true that these patients could represent up to one-third of all IBS-D patients out there, which could in theory mean up to 1% of entire general population. That’s obviously not an orphan indication. And this might be one, where if we do establish proof-of-concept, we might look to follow-on compound to address.
I think with respect to portal hypertension, that is if not an orphan but it’s an orphan like indication and as much as there is nothing available, nothing approved to treats these patients. And there is a very clear high unmet need and they’re in the care of hepatologists.
So we feel that that indication is quite synergistic with PBC and getting a label for it -- expanding the label for it but not necessarily be pricing eroding for the compound. And even in NASH, I know Rachel that you’ve commented on this, in your initiation note.
I think we need to do a lot more work on NASH and clearly its thought of now is the most prevalent liver diseases in developed countries. But I think that there would a rationale there to go initially after to treat patients with a confirmed disease and advanced disease.
Patients i.e. who are being seen by hepatologists and patients who are likely going to run into problems, morbidity, mortality issues due to their NASH rather than just having the disease and running into problems first because of diabetes or atherosclerosis. And again, I caveat this saying that we need to do a lot more work instead of understanding how to target NASH.
But I don’t necessarily believe that NASH would be in accessible to us or that would -- would -- by the time, we get there and get the approval too for the indications would not be synergetic with the other indications that we’ve launched for OCA.
Rachel McMinn - Bank of America
Thank you so much. Really appreciate the insights and the detail.
(Operator Instructions) Our next question comes from Jim Molloy from Janney. Your line is open.
Jim Molloy - Janney
Hey guys. Thanks for taking my questions. And I don’t have certainly about the super group. I know that you’re going to have the EASL. In EASL, you have some interim look at the super group. And how kind of predictive of how the whole trial might look?
Should we expect that how informative should that data, that interim look. So I’ll hand that to David.
So I mean, we have sponsored this. So the collection of data from a number of centers based upon our interactions with a number of groups, who look to our Phase 3 and other points to be placed initially on some publications from Toronto. And all of those large groups who got an interest in this field that data and their results were remarkably similar.
So I think our perspective without obviously having seen what we will get finally over what is being presented next month in Amsterdam at EASL will be that the numbers get larger. I hope and expect the data will get stronger.
The effect of any particular one center is more diluted. And I think that overall, our thesis has been all along and all of the published data is highly supportive of the more normal biochemistry without alkaline phosphatase and billirubin, the better off you are and that has been our thesis going into it.
So we’ll have the first set of data then and I think that if that’s well received. I think, we -- I'm not seeing no reason to be particularly worried if that datasets gets larger. In fact, over contrary, I think as it gets larger, I think it will get better.
Jim Molloy - Janney
No, gentlemen, I would only add that one thing we can talk about publicly now and we just have to wait a month or so for EASL. But we think it’s been enormously helpful that this U.K. group published in gastroenterology. And if you look at -- in that paper, if you look at their supplementary figures and supplementary figure three to be exact, you can see the Kaplan-Meier survival curves on outcomes PBC evaluated against four previously published biochemical end points. Two of those endpoints were on alkaline phosphatase on its own and two others were on alk phos plus billirubin and in the case of Paris criteria, AST as well.
And you can see there that across the continuum of increased or elevated values of alk phos three times upper limit, normal down to less than 1.5 times upper limit, normal, keeping in mind our endpoint, it’s 1.67.
This is a very, very strong correlation. I mean, we’re talking about p values and down to the 10 to minus 16 for one of those endpoints is very, very strong correlation with clinical -- benefit clinical outcomes. So, we expect to see that duplicated with the Supergroup data set. So I hope that addresses the question as best we can at this point.
Jim Molloy - Janney
It does. We like it very much and how -- and I know that Europe is on board with this -- have interactions with the FDA. Obviously, we’re moving in that direction as well and getting better. Do you think this gets over the top or we really ever know?
Well, you could say one to be cynical. One never knows with FDA until you get that approval letter. But we -- look we are very confident. With Europe, we’ve said this before. We have it in writing from them, our specific endpoint trial are good enough for them. With respect to FDA, the option that we have right now with the surrogate endpoint is guided under Subpart H guidelines at the accelerate approval pathway.
And we’re very confident and we’ve talked about this before that frankly the pendulum swung back in favor of sponsors like us especially in the context of pursuing rare and life-threatening diseases under the -- under PDUFA 5, the enhance accelerated approval mandate that requires FDA now to get more creative and expecting surrogate endpoints for approval.
And we feel that the reason that FDA and specifically in our case with GI Division has gotten pretty excited about what we’re doing. I use that word deliberately, is because I think we really trying -- what we’re trying to do is follow-up best practice here in pulling together the best possible evidence in support of our surrogate endpoint being reasonably likely to predict clinical benefit in PBC. And that course is the test, the surrogacy test for accelerate approval.
Jim Molloy - Janney
Excellent. Thank you very much for that. And David, last question is should -- would you have opportunity -- will you have an opportunity -- excuse me -- to accelerate one or two of your trials, which would be though the one or two you’d say and that’s the one we want to move forward next faster?
Do you mean indication -- that’s a good question. That’s difficult to comment on, Jim, I’d say. All of them -- one thing we’re doing here is we’ve been very carefully selecting. There are really a number of different therapeutic -- potential therapeutic applications of an FXR agonist that we could address with OCA and our other compounds.
And I think we’ve been very careful to try to prioritizing indications where the patients with true unmet medical need and it’s hard to prioritize one over the other. So that’s all I think I consider right now but obviously if you could find this way to accelerate, getting trial results or closer to approval in anyone, please let me know.
Jim Molloy - Janney
And that said, it sounds that might be great. But thank you guys for taking the question.
One more question guys.
Our next question comes from Jim Birchenough from BMO Capital Markets. Your line is open.
Nick Abbott - BMO Capital Markets
Oh! Hi. This is Nick standing in for Jim Birchenough. Thanks taking our questions. I know you can’t really comment on baseline demographic for the Phase 3 POISE trial. But can you provide a little bit more information with regards to whether the baseline demographics are key criteria such as the alkaline phosphatase or bilirubin book end around Phase 2 where they tend to be skewed one way or another to the higher low side of the Phase 2? And then from blinded data, can you tell whether pruritus is similar magnitude to that observed in Phase 2? Thank you.
Sure. Thanks Nick. As David commented before and as I also committed in my initial remarks. The baseline demographic characteristics of the PBC population in our POISE trial really is very similar to that of our Phase 2 trial, the combination trials specifically that it’s modeled on, and as David also mentioned, just to remind you, the entry criteria for POISE differ from the Phase 2 in one meaningful way of being the increase floor for baseline alkaline phosphatase at 1.67, obviously our endpoint is that -- to find is that threshold as compared to the Phase 2 which was 1.5.
So proportionately speaking there is an increase in baseline al phos. But I think that’s the best we can do, I think that the spread of patients across the spectrum of elevated values is very similar. So, and I don’t thing it’s appropriate to comment further.
Interesting in my opening remarks that, of course, we’re blinded, but -- even if we assume that all of the patients who have discontinued to this point due to pruritus are in one of the two OCA dose groups i.e. no placebo only from the OCA groups. We are doing significantly better in term of discontinuation rate.
And I think we won’t know until we unblind, but we knew at this time to expect it and there is some tried-and-true ways to manage pruritus that the investigators are implementing successfully we feel.
Nick Abbott - BMO Capital Market
Excellent. Thank you. Perhaps just one final quick question, have you requested breakthrough designation therapy for OCA in PBC?
We have not. It’s funny. We are getting a flood of questions on breakthrough. And I think breakthrough is interesting, it is designation but with respect to PBC, given that we are already well underway in a pivotal randomized Phase 3 trial, we are not necessarily clear that that it would help accelerate or improve the probability in getting approval.
However, we like any other company with breakthrough we believe, of course, we have OCA is probably is essentially a breakthrough therapeutic. We can certainly look into it and it might help with other indications.
Nick Abbott - BMO Capital Market
Yeah. Okay. Thank you very much.
Thanks everybody. I’d like to thank everyone on the phone for your interest in listening in today and the questions that you post. We very much appreciate your support of Intercept as we move this exciting story along and we look forward to interacting with you, those of you are at EASL next month and otherwise over the course of this year. Thanks very much.
Ladies and gentlemen, thanks for participating in today’s program. This concludes the program. You may all disconnect.
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