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Dyax Corporation (NASDAQ:DYAX)

Q2 2012 Earnings Call

July 19, 2012, 5:00 p.m. ET

Executives

Gustav Christiansen – President, CEO

Rick Berard – VP Commercial

Burt Adelman – Chief Medical Officer

Ivana Magovčević-Liebisch - EVP, Corporate Development and General Counsel

George Miguasky - EVP, CFO.

Analysts

Joseph Schwartz – Leerink Swann LLC

Phil Nadeau - Cowen and Company

Serge Boulanger – Needham and Company

Operator

Good afternoon, and welcome ladies and gentlemen to the Dyax Corporation Second Quarter 2012 financial earnings call. At this time, I would like to inform you that this conference call is being recorded, and that the participants are in a listen-only mode. (operator instructions).

Before turning this call over to Gustav Christiansen, President and Chief Executive Officer of Dyax, the company will now read their Safe Harbor Statement.

Unidentified Company Representative

This afternoon, Dyax issued a press release concerning second quarter 2012 financial results. Dyax would like to remind everyone that statements made today reflect current expectations, estimates and projections about products, programs, collaborations, strategies and financial performance, and are forward-looking statements. These statements, including those related to Dyax’s FDA-approved product KALBITOR, are subject to risks and uncertainties that could cause actual events and results to differ materially. Important information concerning these risks and uncertainties is contained in Dyax’s press release today, and described or referred to in its most recent form 10-K and other periodic reports filed with the SEC, and are also available on the company’s website at www.dyax.com. I will now turn the call over to Gustav Christiansen, President and CEO of Dyax. Gustav?

Gustav Christiansen

Thank you, Jen. Good evening everyone and welcome to Dyax Corp.’s second quarter 2012 earnings call. My remarks today will provide you with highlights on the second quarter, and a review of our key value drivers, KALBITOR angioedema franchise, as well as the Licensing and Funding Research Program.

We are pleased to report another strong quarter for our KALBITOR business, marking the ninth quarter in a row of steady, consistent revenue growth. This is based on solid execution of our strategy to provide patients with premiere services and support.

We will go into more detailed account of the KALBITOR business momentarily, but I want to mention a few key metrics and achievements we had this past quarter. First, KALBITOR sales for the second quarter were $9.2 million, up 14% from the first quarter of 2012. Second, patients treated with KALBITOR increased to 518, up 12% from the first quarter of 2012. This continued positive momentum is a result of delivering first class services and support to the entire HAE community, including patients, advocates and healthcare professionals.

We have launched several new programs in the last quarter, designed to identify and attract new patients, which together with our entire suite of offerings positions Dyax for continued growth in the KALBITOR business. Along with the developing the HAE market, we are also leveraging our knowledge of the plasma kallikrein pathway to ultimately diagnose and treat other angioedema states. Our second pillar, the LFRP, continues to be a near- and long-term value driver for Dyax. It already provides us with approximately $15 million in revenues annually, and has significant potential, through its broad and maturing pipeline of clinical candidates, addressing large therapeutic markets.

For more detail on these key business areas, I’ll now turn the call over to our executive management team. First, Rick Berard, Vice President, Commercial, will discuss our ongoing marketing efforts for KALBITOR in the U.S. Dr. Burt Adelman, Chief Medical Officer, will discuss our resurging initiatives in the angioedema franchise. Dr. Ivana Magovčević-Liebisch, Chief Business Officer, will discuss our global expansion efforts for KALBITOR, as well as the LFRP. And finally, George Miguasky, Chief Financial Officer, will present our financial highlights and financial guidance. Following these updates, I will provide concluding remarks, then open the lines for Q&A. At this time, I will turn the call over to Rick, who will review the progress of KALBITOR in the U.S.

Rick Berard

Thank you, Gustav. Good evening. We built on the momentum from the first quarter by focusing on three key objectives: patient identification, patient treatment and patient re-treatment. We remain dedicated to providing patients and healthcare providers with unparalleled resources to build awareness, treat and manage acute attacks of HAE. The results of these efforts have been meaningful. In the second quarter, KALBITOR net sales were 9.2 million, an increase of 14% quarter-over-quarter, reflecting steady increases across multiple patient metrics.

As of June 30th, 518 patients were treated with KALBITOR, an increase of 12% from the first quarter; 59% of patients with drug are now treating. The vast majority of these patients have already re-treated with KALBITOR, and the KALBITOR treatment rate remains between six to nine attacks on a forecasted, annualized basis, and KALBITOR patients receiving patient-supplied drug, or PSD, are showing treatment rates at the top or above this range. This strong, consistent growth is a result of our focused marketing plan, an expanding suite of support and service programs which continues to distinguish Dyax as a leader in the treatment of HAE.

One program that clearly differentiates Dyax in the HAE marketplace is the KALBITOR home infusion services. This program provides patients with a convenient, monitored treatment option in the comfort of their home by a qualified and knowledgeable home infusion nurse, available 24 hours a day, seven days a week. Both patients and physicians increasingly recognize the value of this service, with most new patients electing this option.

The feedback from this program has been very positive. In the majority of cases, nurses arrive on site within an hour after being contacted by the patient. Patients have been highly satisfied with the treatment they receive through this program, which is translating to higher re-treatment rates among home infusion patients, compared to other patients. Most importantly, this service is cultivating a loyal patient base. Additionally, physician support and enthusiasm for this service continues to drive adoption.

Physicians not only appreciate the timely feedback from the KALBITOR home infusion nurses, which is invaluable in managing patients’ overall HAE treatment, but they can be confident that the patients are receiving highly-trained care, rather than having to make decisions on their own during the stress of an acute attack. This individualized, high-touch program is what truly sets KALBITOR service and support programs apart from the other HAE treatment options.

To provide the best possible care to HAE patients, we continue to evolve and adapt our programs to meet their needs. During the quarter, we launched a free genetic counseling program, a new iPhone application, the HAE Attack Tracker, and a diagnostic test reimbursement program. Early feedback on these programs has been very positive, and together with our entire suite of service and support offerings, these patient-focused initiatives provide us additional opportunities to build our KALBITOR business. It is our belief that by offering patients innovative and comprehensive disease management options, we will continue to make substantial inroads in the HAE market, which remains underpenetrated with approximately 70% of identified patients still not taking advantage of novel therapies.

We are finding patients, building strong relationships with the HAE community and providing a platform to help diagnose and treat acute attacks of HAE. By offering patients a truly unique service package and level of support, the number of patients treated with KALBITOR continues to increase at a steady rate. We are encouraged by this, and expect this trend to continue in the coming months and quarters, as awareness of our suite of programs grows and as more patients evaluate their treatment choices.

I will now turn the call over to Burt to provide updates on the rest of the angioedema franchise.

Burt Adelman

Thank you, Rick. I’d like to begin by reiterating what Rick and Gustav have already said. We at Dyax, first and foremost, are fully committed to providing the best therapeutic solutions for patients with hereditary angioedema. We believe that KALBITOR is an important therapeutic option for patients with HAE, and their treating physicians. We also recognize how complex the decision-making process can be once a patient is diagnosed with HAE and has to choose a therapeutic plan.

To help patients and physicians best understand the value of KALBITOR, we are committed to the rapid publication of all clinical trial data generated in KALBITOR studies. In just the past twelve months, five papers have been published in peer-reviewed journals, and eighteen abstracts have been presented in various major medical meetings. We know that the best therapeutic decisions are made when both patient and physician are well-informed.

Hereditary angioedema is a clinically heterogeneous disorder. Some patients have rare attacks and others have frequent episodes of swelling. At Dyax, we believe that multiple therapeutic options will enhance patient management. The development and approval of KALBITOR has validated plasma kallikrein as an important drug target in HAE. In fact, long-term plasma kallikrein blockade may provide effective preventive therapy for many patients with hereditary angioedema.

We believe that patients with very frequent or very severe attacks would want to have the option of a convenient and highly-effective prophylactic agent. A likely candidate molecule for this purpose is a fully human monoclonal antibody that blocks plasma kallikrein with high affinity and has a long plasma half-life.

Monoclonal antibody products are the backbone of biotechnology. They’re readily manufactured, amenable to convenient dosage formulation and generally well-tolerated. Using our own proprietary phage display platform, we’ve been able to select a unique fully human monoclonal antibody, which we call DX-2930, that has excellent pharmaceutical properties. Preclinical studies have demonstrated that DX-2930 is a potent inhibitor of plasma kallikrein, is bioavailable following subcutaneous injection and has a long half-life that will allow infrequent dosing. We are currently in scale-up of GMP manufacturing of DX-29 and plan to file an IND by mid-2013.

Not all forms of angioedema are hereditary, and it is likely that plasma kallikrein generation may play a role in other forms of chronic, recurrent angioedema. To explore this possibility, we are developing diagnostic tests that will identify non-HAE patients who have plasma kallikrein-driven edema. This testing capability will enable us to identify patients in whom we can evaluate KALBITOR and DX-2930. Dyax is the only biotechnology company committed to expanding our basic understand of all forms of plasma kallikrein-driven angioedema. We are excited to think that Dyax will be able to offer a suite of product options to patients with HAE and related disorders. Thanks for your attention, and I will now pass the call over to Ivana.

Ivana Magovčević-Liebisch

Thank you, Burt. We continue to make progress in expanding the angioedema franchise, to bring KALBITOR to HAE patients around the world. We recently signed a new agreement with Taiba to distribute KALBITOR in select areas in the Middle East. We feel that the breadth and knowledge of the open disease market will help deliver KALBITOR to patients searching for another option to treat their acute HAE attacks. Taiba expects to make KALBITOR available in their territories this year.

Moving on to Japan. Our partner CMIC is moving forward according to their planned timeline, and [inaudible] to commence a small, open-labeled study in the second half of 2012. As soon as successful completion of the open-labeled study, CMIC will begin marketing KALBITOR as early as 2014.

Our partner, Sigma-Tau, is making strides on the regulatory front, in both Australia and Switzerland, with expected approval by year-end. We’re moving ahead in our expansion efforts and are focused on partnering territories in Latin America and Southeast Asia, including China. We look forward to updating you on our progress in the upcoming quarter.

Let me now turn to our Licensing and Funded Research Program, or LFRP, which is based upon a gold standard phage display technology, and is one of the most successful licensing programs in the industry today. The strength and success of this program is centered on establishing new licensing agreements and having multiple [inaudible] with a number of compounds entering and advancing to the clinics in various high-value indications. The value of the LFRP continues to build, as we sign new license agreements and candidates in the portfolio continue to mature. The LFRP has 18 clinical stage products in the pipeline, including four programs in phase three, five in phase two and nine in phase one. This robust, diverse pipeline provides us both near- and long-term growth.

This quarter, we were pleased to announce an extension of our contract with Bayer to license antibody phage display technology. This agreement provides further validation of the strength and breadth of our technology platform, and the value it provides to pharmaceutical and healthcare providers.

The maturing LFRP continues to generate value for Dyax in the near-term. Recently, Dyax received a $1.5 million milestone payment from Baxter for undisclosed compounds, which was yet another compound generated by our phage display technology to enter the clinic. We also received news that our licensee, Biogen, has advanced their multiple sclerosis compound, LINGO-1, from phase one to phase two. Lastly, [inaudible], one of the most advanced candidates for [inaudible], a fully human antibody targeting the VEGFR-2 receptor, Eli Lilly. The [inaudible] lab is currently in six phase three trials for five different oncology indications, and is approaching data readout for multiple trials beginning in the first half of 2013. Eli Lilly recently accelerated the final completion date of one of their gastric cancer trials by six months, to July 2012. Additionally, we still expect primary completion in the breast cancer trial at the end of this year. Enrollment in the trial for other indications, [inaudible] carcinoma, colorectal cancer and non-small cell lung, is ongoing and are scheduled to be completed throughout the next year and a half.

These four examples, Bayer, Baxter, Biogen and Eli Lilly, highlight the pedigree of our licensees, the diversity of indications in the pipeline and the significant market potential that distinguishes the LFRP from other technology platforms in the industry. With patent protection through 2024 and royalty agreements extending 10 years beyond product’s first commercial sale, the LFRP has a long runway. We see this franchise as important near- and long-term growth drivers, with the potential for significant revenue as the portfolio continues to grow and mature.

At this time, I will hand the call over to George, who will walk you through our financial highlights. George?

George Miguasky

Thanks, Ivana. By now, I hope that you’ve all been able to review our press release, which we issued after the market closed today. First, I’ll take you through our second quarter 2012 financial results, and then review our 2012 and longer-term financial guidance.

As reported this afternoon, our revenue for the second quarter 2012 was $14 million, compared to $21.9 million in the same quarter in 2011. Included in the 2012 revenues are $9.2 million in KALBITOR net sales, as compared to 5.2 million for 2011. The sales in Q2 of ’12 are net of discounts, rebates and other charges of approximately 7.7% of the gross sales. Please note that in 2011, second quarter revenues included a $10.7 million revenue associated with an expanded partnership with Sigma-Tau. For the six-month period, total revenue was $25.5 million in 2012, versus 30.1 million in 2011.

Operating expenses for the second quarter of both 2012 and 2011 were unchanged, at $19.4 million. Within our operating costs, our research and development expenses, which include KALBITOR post-marketing requirements, development of a single injection formulation of KALBITOR, the clinical study of the use of ecallantide for the treatment of ACE inhibitor-induced angioedema, including costs related to the discontinuation and closeout of the phase two study in this indication, the development costs associated with DX-2930 and pass-through license fees paid by Dyax licensees under the LFRP.

R&D costs for the second quarter of 2012 decreased to $8.7 million, as compared to 10.1 million for the same period last year, and for the six-month period, R&D costs were 16.5 million, versus 17.6 million in 2011. The second quarter decline is primarily due to lower personnel costs after the realignment around the angioedema and LFRP franchises, and a reduction in the pass-through license fees paid by Dyax licensees under the LFRP.

Selling, general and administrative costs, which include commercial costs for KALBITOR, were $10.4 million in the second quarter of 2012, as compared to 9.1 million for the same period last year, and for the six-month period ending June 30th, 2012, SG&A costs were 20.8 million, compared to 18.3 million in 2011.

For the second quarter of 2012, Dyax reported a net loss of $7.9 million, which calculates to $.08 on a per-share basis. This compares to a net loss of $76,000, or zero income or loss on a per-share basis, for the same quarter in 2011. For the six-month period, Dyax net loss was 19.2 million, or $.19 per share, as compared to a net loss of 11.3 million or $.11 per share for the comparable 2011 period.

With respect to our cash resources, as of June 30th, 2012, Dyax had cash, cash equivalents and short-term investments totaling $38.6 million, exclusive of restricted cash.

Now, turning to our financial guidance, we are reiterating our 2012 guidance of topline total revenue of $50 to 54 million. This range reflects KALBITOR sales of 36 to 40 million and other license and development fee revenues of $14 million. This guidance excludes any potential revenue from new KALBITOR license arrangements or from any ex-U.S. KALBITOR sales. We are also reiterating our guidance to reach cash flow break-even during 2013. Let me review the way that we get there.

First, aligning the company around the angioedema franchise and the LFRP, which was implemented in the first quarter. Second, KALBITOR sales growth. As we’ve guided, KALBITOR sales are expected to grow by more than 60% in 2012, to $36 to 40 million, and as a result we expect that product line to be profitable and generate positive cash flow before year-end 2012. And thirdly, controlled operating costs, both R&D and SG&A, with an increase of less than 5% in 2012.

We continued toward cash flow break-even in the second quarter, when our operating cash burden declined to approximately 7 million, down from 8.5 million in Q1. With costs carefully planned, with achievable sales growth through the year, the cash burden is expected to continue to decline both quarterly and annually. So now, I’ll turn it back to Gustav for his closing remarks.

Gustav Christiansen

Thank you, George. Before I open the call to questions, I want to reiterate today’s key takeaway messages. Our key value drivers, KALBITOR and the angioedema franchise and the LFRP continue to deliver solid results for Dyax. We had a strong quarter across multiple metrics in the KALBITOR business, and are on track to meet our financial guidance for 2012. The robust and maturing LFRP portfolio and continued strength in this technology create opportunities for additional near- and long-term goals. To that end, we are focused on several key initiatives, including delivering consistent revenue growth by establishing KALBITOR as the treatment of choice for acute HAE attacks in the U.S. and abroad, expanding our suite of products and programs to better diagnose and treat a broader range of angioedema patients; building the LFRP by adding new licensees, so that your already robust pipeline continues to grow, assuring multiple shots on goal, and reaching our financial goals to become cash flow break-even during 2013. With a well-defined strategy, levering our knowhow and expertise, we are driving our key businesses forward. We will continue to build on this progress and look forward to updating you in future calls.

Question-and-Answer Session

Operator

(Operator instructions). Our first question is from Joseph Schwartz of Leerink Swann, your line is open.

Joseph Schwartz – Leerink Swann LLC

Hi. Thank you, and congratulations on an excellent quarter and execution. I just wanted to ask a couple housekeeping questions first. In terms of the current gross to net, can you give us that figure and how that’s been trending?

Gustav Christansen

Thank you Joe. Certainly we will. George, do you want to lead off?

George Miguasky

Sure, the elements that are in there, of course, includes the discounts to our distributors, government rebates, allowances for potential sales returns and things of that nature. As I had mentioned on the call, it was about 7.7% on a gross-to-net basis this quarter, it was about 7% in Q1, and that’s the relative rate that we expect to be at during the course of this year.

Joseph Schwartz – Leerink Swann LLC

And then how many patients are receiving KALBITOR versus treating with KALBITOR? I think you’ve given us that in the past.

Gustav Christansen

So that number, Joe, you know at 59% of patients with KALBITOR placed that are treating patients. That has steadily increased over the last twelve months.

Joseph Schwartz – Leerink Swann LLC

Have you noticed anything about the patients going on drug today that’s different, or evolving, are there more newly-diagnosed patients? Are there more patients that have received other therapies but broken through? Anything there that you can share with us?

Gustav Christansen

Ivana, would you like to pull up?

Ivana Magovčević-Liebisch

Sure George. I think we see efficacy. As you know that the Asian population is not fully penetrated at all. As you know there’re about 6,500 identifications and about only 2,500 are on novel therapies. So we’re really seeing everything. We’re seeing, in our newly diagnosed patients, as well as patients who might be choosing, you know, an acute therapy or prophylactic therapy, or patients who are choosing an another acute therapy. So we’re certainly seeing it all at this point.

Joseph Schwartz – Leerink Swann LLC

Okay great, and then lastly if I can sink one more in there, I would love to hear some more about the diagnostic that you’re developing and what is the path to get that into physician’s hands. Does that need FDA approval? Is it something that they can already use off-the-shelf components for. And then what is the opportunity, if something like that is available to identify more than just HAE patients that could benefit from your therapies?

Gustav Christansen

This is a strategic program we have initiated and where we are in fact looking to help doctors easier diagnose patients who have swelling attack stemming from the same plasma kallikrein (bradykinin) pathway. And maybe Burt wants to give some general comments.

Burt Adelman

Well I don’t actually think there’s a problem diagnosing HAE once you suspect that the patient has HAE, it’s pretty straightforward. I think what we’re interested in is the possibility that other recurrent attacks of angioedema may, at least a portion of those individuals, may have a kallikrein driven abnormality. So we are obviously looking for a diagnostic test that would tell us whether kallikrein is being activated in those patients. And you know there are a number of points in the biologic pathway that leads to kallikrein activation (bradykinin) release that are potentially useful as diagnostic strategies. And we are looking at all of them at this time, and we would hope to have a format that could be easily developed into a FDA-approved standard diagnostic. But that’s pretty early at this point to speculate. Right now we’re looking at the spectrum of detectable agents that might form a reasonably sensitive and specific assay.

Joseph Schwartz – Leerink Swann LLC

Thank you for taking all my questions.

Gusav Christiansen

Thanks Bert.

Operator

Thank you. Our next question if from Phil Nadeau of Cowen. Your line is open.

Phil Nadeau - Cowen and Company

Good afternoon. Thanks for taking my questions. Just first to follow up to Joe’s question. So 518 is 59% of 878. So is 878 the right number of patients which are placed, or am I missing something in doing that calculation?

Ivana Magovčević-Liebisch

No, you are not missing anything.

Phil Nadeau - Cowen and Company

Okay, good. Second, on the number of attacks treated month or this quarter. It seemed like the increase in attacks treated was somewhat less than we saw over the prior couple of quarters. Or the increase in number of patient who had attacks treated was a little bit less than what we’ve seen in prior quarters numerically. Was there anything going on in this quarter that caused disruption, or is there just a little bit of fluctuation from quarter to quarter in those ads?

Gustav Christiansen

Thank you Phil, that’s a very good question. Ivana would you like to talk.

Ivana Magovčević-Liebisch

Yes. Phil thanks for that question, it’s actually an excellent question. You are right on. HAE is a chronic disease eposodic medicine patients would have fluctuations from patient to patient, but even within the patient. So you know, we are still within our six-to nine range of attacks treated on an annualize bases, but there are definitely fluctuations within that, and we’ve seen that in the past. I don’t think there’s anything else going on there, than that. Obviously if we had more patients of treatment, this will even out. So therefore more patients equals more growth, and ultimately you know what’s really important is that our patient adds continued to be very strong.

Phil Nadeau - Cowen and Company

Okay. And is there any seasonality to HAE attacks? Do they happen more in the summer months or winter months or appreciating that they’re episodic for each patient throughout the year. Are they relatively consistent across the different seasons?

Ivana Magovčević-Liebisch

Phil, you know, what we hear from patients is that cold can bring on attacks. But beyond that, we really haven’t any real seasonality. You know, it really fluctuates across the board.

Phil Nadeau - Cowen and Company

Okay. I guess my last question is for George. You mentioned that the expenses were down this quarter because of the alignment around [inaudible]. Was that a significant portion of Q2 of the expenses or should we expect another step-down in Q3 now that that trial’s over?

George Miguasky

So the cost that we’re quoted or accrued in Q2 would be part of closing out the study, which will actually occur during the Q3 period is roughly three-quarters of a million dollars. So that is a, in that sense, a one-time element that will go away now that the study is wrapped up.

Phil Nadeau - Cowen and Company

So no charges in Q3 for that program or that trial?

George Miguasky

That’s correct.

Phil Nadeau - Cowen and Company

That is very helpful, thanks for taking my questions.

Gustav Christiansen

Thank you, Phil.

Operator

(Operator Instructions). Next question is from Serge Boulanger of Needham and Company. Your line is open.

Serge Boulanger – Needham and Company

Good afternoon. I have a couple of questions. First, one of your competitors has reported some supplies issues with their prophylactic treatment. Just wanted to know if that has resulted in any change in the patient profile that you’ve enrolled in KALBITOR or in the retreatment rate. I think in the past you’ve reported that one third of you enrolled patients were on prophylactic treatment?

Gustav Christiansen

Ivana, you want to comment?

Ivana Magovčević-Liebisch

Yes. So we’re really not seeing any significant change from that, because remember that’s a prophylactic treatment. So they have another choice of profile prophylaxis if that’s what they want. And we’re not seeing really, as you said, we’re still in that six to nine stage for the forecasted annual number of attacks, and we haven’t seen a significant change, except at outpatient who have patient supply drug, and are using home infusion services are definitely treating at the top or about that range.

Serge Boulanger – Needham and Company

Okay. I recently noticed on ClinicalTrials.gov, your pediatric trial was updated to withdrawing from not recruiting. I just wanted to know if this is just standard procedure, or if you were planning new trials for the pediatric expansion?

Burt Adelman

Hi, this is Burt. Yes, that’s a standard procedure. We are looking at ways to expand potentially expand the age range for approved treatment. I’m not sure we need to do a clinical trial to get there, so we did withdraw that.

Serge Boulanger – Needham and Company

So, it can be done without a full trial, or?

Burt Adelman

We’re exploring that.

Serge Boulanger – Needham and Company

Okay, got it. And one last question for George. Now that the ACE inhibitor induced angioedema trial was halted, how does that affect the cogsI think I previously mentioned that the initial supply of KALBITOR was expected to last through 2012, is that now extended beyond that date?

George Miguasky

Just to clarify on the supply lasting through 2012, that supply was the original drug manufactured before KALBITOR was approved by the FDA?

Serge Boulanger – Needham and Company

Yes.

George Miguasky

And is that already segregated out any clinical trial drug or used for other than commercial uses? And so, it doesn’t really change the 2012 timeline for the original drug. And of course from a supply perspective we have additional supply that has been manufactured subsequent to FDA approval. And that will kick in and be represented in the fall structure commencing in 2013.

Serge Boulanger – Needham and Company

Got it, thank you.

Operator

Thank you there are no further questions at this time. I would like to turn the call over to Mr. Christiansen for any closing remarks.

Gustav christiansen

Well thank you very much. I want to thank you all for listening and I wish you well. Thank you.

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