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Myriad Genetics, Inc. (MYGN)

Q2 2015 Earnings Call· Tue, Feb 3, 2015

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Myriad Genetics Second Quarter 2015 Financial Earnings Conference Call. During the presentation, all participants will be in a listen-only mode. Afterwards, we will conduct a question-and-answer session. [Operator Instructions] As a reminder, this conference call is being recorded Tuesday, February 3, 2015. I would now like to turn the conference over to Scott Gleason, VP of Investor Relations. Please go ahead, sir.

Scott Gleason

Analyst

Thanks, George. Good afternoon, everyone, and welcome to the Myriad Genetics' second quarter earnings call. My name is Scott Gleason. I am VP of Investor Relations. During the call, we will review the financial results we've released today. After which, we'll host a question-and-answer session. If you have had not a chance to review the earnings release, it can be found on the Investor Relations section of our website at Myriad.com. Presenting for Myriad today will be Pete Meldrum, President and Chief Executive Officer; Mark Capone, President, Myriad Genetics Laboratories; and Bryan Riggsbee, our newly appointed Chief Financial Officer. This call can be heard live via webcast at myriad.com. The call is being recorded and will be archived in the Investor section of our website. Please note that some of the information presented today may contain projections or other forward-looking statements regarding future events or the future financial performance of the Company. These statements are based on management's current expectations and the actual events or results may differ materially and adversely from these expectations for a variety of reasons. We refer you to the documents the Company files from time-to-time with the Securities and Exchange Commission, specifically the Company's annual report on Form 10-K, and its quarterly reports on Form 10-Q and its current reports on Form 8-K. These documents identify important risk factors that could cause the actual results to differ materially from those contained in our projections or forward-looking statements. With that, I'll now turn the call over to Pete.

Pete D. Meldrum

Analyst

Thank you, Scott. As was announced earlier today after 24 wonderful years at Myriad, I have decided to retire at the end of the fiscal year. This was a very difficult decision for me since Myriad has been an important part of my life for nearly a quarter of a century. I have enjoyed being part of Myriad's pioneering work in personalized and predictive medicine. I feel extremely fortunate to have been a part of the team that played a central role in building this new industry of molecular diagnostics which has such an enormous potential to save lives and improve the quality of life of patients. However, I'm also looking forward to spending more time with my family and friends and focusing on the charitable work of the Meldrum Foundation. Myriad has always placed a high priority on management succession, and I am very fortunate to have been surrounded by an exceptionally talented and dedicated team of executive officers with whom I have had the privilege to work. Among my executive officers, one stands out as an ideal successor to me as Chief Executive Officer. Mark Capone has the experience, the skill set, industry knowledge, business acumen, and leadership style to guide Myriad into the future. Having worked alongside Mark for 13 years, I can think of no one I would trust more with the Company I co-founded 24 years ago. I want to thank Myriad's Board of Directors for their wisdom and guidance over the years. And, in particular, I have enjoyed my partnership with our Chairman, John Henderson. On a more personal note, I will genuinely miss each one of the exceptional Myriad employees who make this Company such a unique and special place to work. I appreciate everything our employees do each and every day to…

Mark C. Capone

Analyst

Thanks, Pete. I'm pleased to provide a more in-depth look at our operational performance in the second quarter. First, I would like to provide you with an overview of our segment performance followed by an update on our myRisk conversion progress and finally provide some additional detail around our newer product launches. Overall, the Hereditary Cancer business generated a $165 million in revenue which represented a significant sequential increase of 9.5%. The oncology revenues were $83.7 million in the second quarter and preventive care revenues were $84.6 million. We achieved a major milestone this quarter where for the first time our preventive care business exceeded the size of our oncology segment. The promise of hereditary cancer always has been to prevent cancers from occurring in generations of family members. This milestone is a significant accomplishment and that it shows the physicians are increasingly identifying patients with red flags early. So they can take affirmative steps to prevent those cancers. As a reminder, we are less than 5% penetrated in the preventive care market and continue to expect this to be a the fastest growing segment of our hereditary cancer business. We continue to make excellent progress on the conversion of the Hereditary Cancer business from single syndrome testing to the myRisk hereditary cancer test. We ended the quarter with 53% of hereditary cancer revenue attributable to myRisk. As a reminder we decided not to add any additional physicians to the myRisk conversion program in the second quarter while we were increasing the laboratory capacity to meet current demand. I am pleased to say that we have exceeded that goal and now have sufficient equipment, personnel, and informatics hardware to support the complete transition of the market. In the third quarter, we will be installing additional priority software applications that will…

R. Bryan Riggsbee

Analyst

Thanks, Mark. I'm pleased to provide an overview of our financial results for the second quarter followed by a detailed look at our updated fiscal year 2015 financial guidance. Second quarter total revenue was $184.4 million compared to $204.1 million in the same period of the prior year. The 9.6% decline in revenue this quarter was primarily a result of the significant benefit we received from celebrity publicity in last years fiscal second quarter. The timing of certain pharmaceutical and clinical services contracts. The reduction in Medicare reimbursement for our Hereditary Cancer test partially offset by the Crescendo acquisition. Moving on to our operating expenses, our consolidated gross profit margins this quarter was 79.5%. We saw some improvement in the gross margin associated with our Hereditary Cancer franchise this quarter as we work to make the testing process more efficient and we expect to make further progress throughout the reminder of the fiscal year as we continue to enhance the efficiency of our testing process. Some of these efficiency gains were offset as we saw significant increases in Prolaris and myPath Melanoma sample volumes during the second quarter. Since these tests have not yet received reimbursement, we bear the full cost of performing the test without the offsetting revenue. As we begin to garner revenue for these products, we will experience a significant improvement in our overall gross margin. Additionally, Vectra DA has not yet received significant private insurance reimbursement and its margins remained in the mid 40s this quarter and continue to negatively impact our overall gross margin. We continue to work on expanded payer coverage that will improve the Vectra DA gross margin and believe that as we obtain broad-scale reimbursement, we can achieve a Vectra DA margin in the 75% range. Research and development expenses were $17.5…

Scott Gleason

Analyst

Thanks Bryan. As a reminder, during today's conference call we use certain non-GAAP financial measures, a reconciliation of the GAAP financial results to the non-GAAP financial results and a reconciliation of GAAP to non-GAAP financial guidance can be found on the Investor Relations section of our website. Now we are ready to begin our Q&A Session. In order to ensure broad participation in today's Q&A session, we're asking participants to please ask only one question and one follow-up. Operator, we are now ready for the Q&A portion of the call.

Operator

Operator

[Operator Instructions] Our first question comes from Amanda Murphy she is with William Blair. Please go ahead.

Amanda L. Murphy

Analyst

Hi, good afternoon guys. So Just a question on the guidance, obviously that's going to be a key topic here given the magnitude of the production. And, if you do the math on what you've highlighted in the commentary, it is hard to get there without assuming some deterioration in the hereditary cancer business both sequentially and then going forward. Maybe you can help us get more comfortable, obviously people are concerned about market share loss, [versant] pressure, et cetera. Get us more comfortable with what is going on in the hereditary cancer business, even considering the changes in Crescendo guidance, Prolaris, et cetera.?

Pete D. Meldrum

Analyst

Thank you, Amanda. Let me address the question initially and I will ask Mark to add any color as well. We lowered the guidance by about $70 million and a large part of that was due to slower reimbursement on the private insurance sector for Crescendo. If you’re a member, Amanda, the original guidance for Crescendo was about $65 million and if you can look and just do the math from the first half of the year that’s about $20 million of the $70 million lower guidance. The second is Bryan indicated, we had a delay in a large contract on the pharmaceutical services and clinical services sector original our guidance was about $35 million in that sector and again if you do the math on the first half of the year that would contribute about $15 million and those combined or half of the guidance change. The other changes as we mentioned were Prolaris with the delay which was really outside of our control of Medicare reimbursement into late fourth quarter. We are also experiencing some delay in revenues for tumor BRCA CDx. AstraZeneca had originally applied to the cancer drugs fund for earlier reimbursement for its test. They have recently risk drawn that waiting for a nice recommendation to NIH. So that's certainly have to an impact on both our international revenues and our guidance. And then we did see some additional with impact, but beyond that we feel the hereditary cancer market is growing. We feel that we have retained the vast majority of that market and have not seen serial additional market share loss in that segment.

Mark C. Capone

Analyst

Yes, just maybe to talk specifically about hereditary cancer Amanda. The guidance does assume that we are going to see growth in the second half of the year relative to the first half of the year, obviously we saw some nice sequential growth going from Q1 to Q2 as Bryan mentioned we have historically seen the third quarter as a headwind from the reset of deductibles and as the percentage of patients in high deductible plans has increased year-over-year we have seen the impact of that. Yet, despite that, our guidance does assume that there will be hereditary cancer growth second half versus the first half of the year. So those patterns are actually pretty consistent with the historical patterns that we have seen in the hereditary cancer business. As Pete mentioned we didn’t any additional, or as I mentioned we didn't see any additional with in the second quarter and so what we saw was truly reflective of the underlying business. The guidance does assume there will be some additional we have build through the second half of the year, unlike previous guidance. And that’s only because we are not anticipating that the reductions and turnaround time will now fully offset the additional WIP associated with their additional conversion through the back of the year, so I think that was the last piece to that. And the last comment I will make in the second quarter, your question about shares, we did, we really weren’t able to identify any discernable changes in market share in the second quarter. As you can appreciate as other laboratories don’t actually provide any details on their BRCA testing volumes. Its becoming increasingly difficult to determine precise market shares but the analytics that we do looking at all of our physicians all of their behaviors, all of our segment performance. We were unable to discern any material changes in market share in the second quarter.

Amanda L. Murphy

Analyst

And then Just a follow-up on the WIP commentary. I think there is some level of confusion around exactly how this impacts your financial statement both from a P&L perspective and a balance sheet. Maybe you could just review that. Obviously, there is still quite a lot of – you still have about $30 of guidance reduction to make [it] up there between all of the things you quantified. Maybe you can help us figure out what that -- what the WIP effect in the back half might be from a dollar perspective?

Mark C. Capone

Analyst

Yes, we haven’t, we aren’t really planning to provide anymore granularity other than what Pete already has. Obviously, the rest of that $30 million between Prolaris tumor, tumor BRACAnalysis CDx, some additional width build, those in total get you the rest of that change in guidance. So I think that’s where that comes from. As to how the WIP appears on the balance sheet, it doesn’t get not a balance sheet transaction at all. So the impact of WIP is just demand that comes and ultimately does not translate into revenue, because that’s all revenue if you will that’s left as work-in-process. So it impacts the income statement, but it does not impact the balance sheet. And what especially happening is that reductions and turnaround time can reduce that WIP, but as we convert to myRisk, which has a 14-day longer turnaround time. So as more the business goes from single syndrome testing to myRisk, you are going to see an increase in WIP associated with that longer turnaround time. So those two factors offset each other to some extent, but we are guiding to now is that we don’t expect turnaround time reductions in the back half of the year to fully offset any of additional WIP associated with higher conversion, previously we’re expecting those two to offset.

Amanda L. Murphy

Analyst

Okay, thanks very much.

Operator

Operator

Our next question comes from the line of Jack Meehan with Barclays. Please go ahead.

Jack Meehan

Analyst · Barclays. Please go ahead.

Hi, thanks and congrats, Mark, and congrats to Pete as well. I just want to start with the BRACAnalysis for CDx. Can you just talk maybe anecdotally to start the year? What you're seeing in terms of sample volumes? And then, what is it -- what are the marks that you need to hit in order to get the reimbursement there?

Mark C. Capone

Analyst · Barclays. Please go ahead.

Yes, so I’ll start with reimbursement first. I think the good news with BRACAnalysis CDx is we actually have reimbursement already with the current codes that are available, we are able to obtain reimbursement and so that’s in this particular case unlike some of our other new test what we actually have to establish codes in reimbursement that’s not necessarily the case with BRACAnalysis CDx. We will discuss with payers the fact that this is an FDA approved version and therefore should have some premium associated with that, those are discussions we’ll have with payers as time goes forward, but at least currently we can pursue billing as we have with the BRACAnalysis. As I mentioned in my commentary we have seen a noticeable uptick in the number of ovarian cancer patients that coming into the laboratory and those all look to be incremental with the BRACAnalysis CDx test and so this is a significant change in what we’ve seen as the historical pattern not ovarian cancer. As a reminder that market will start with 40,000 patients that are survivors that have been diagnosed with ovarian cancer and those previously only 25% of those patients have been previously tested. So 75% of that 40,000 patient group would be appropriate for testing so that we can discern whether or not they might be eligible for Lynparza. So in addition to that prevalent pool there is also the incident pool of newly diagnosed ovarian cancer patients where our physicians will want to know their BRCA status, so that when they eventually become eligible for Lynparza they can immediately receive that drug. So that’s the opportunity for BRACAnalysis CDx.

Pete D. Meldrum

Analyst · Barclays. Please go ahead.

And on the international front I would like to add that we're also fortunate and that we have reimbursement for our tumor BRACAnalysis CDx as well and so that wont delay revenues from that standpoint, but as I mentioned in the call where our original guidance did assume in many of the major market countries in Europe we do not or AstraZeneca does not have reimbursement yet for Lynparza and that’s usually a six month to maybe nine month process. We did anticipate under the ability in the UK to get new breakthrough reimbursed before formal reimbursement under NHS to the cancer drugs fund, AstraZeneca initially submitted an application and has decided to withdraw that application and go directly for NHS guidance. So it’s the Lynparza reimbursement that is impacting the delay in tumor BRACAnalysis revenues, not the reimbursement of tumor BRACAnalysis itself.

Jack Meehan

Analyst · Barclays. Please go ahead.

Got it. That makes sense. That is helpful. Mark, I just want to get your thoughts on the balance sheet now that you are in the seat. I know Bryan touched on it a little bit -- just the run rate for 2016 revenues. Obviously, the new pipeline is ramping in the next year. So, I guess, what is your opinion on capital deployment? And then, maybe also on leverage as a way to improve your cost of capital?

Mark C. Capone

Analyst · Barclays. Please go ahead.

Thanks for the question, I think we are actually all of the same mind on this – on the use of cash, on the balance sheet, I think our same priorities hold first is internal research and development which I think you can see from a work over the last five years that team has been extraordinarily productive and is now potentially fueling our long-term growth and so that will continue to be our first use of cash. The second is to look at M&A activities that fit into our strategy of the six different business unit that we’ve identified you’ve seen examples of that with rules-based medicine and Crescendo Bioscience and we will continue to look at those tuck-in opportunities that fit within that strategy. We have consistently believe that those will not use all the cash and so our third-party has been a robust here repurchase that is something that we continue to believe there opportunities for share repurchase and we’ll continue do so. As a reminder, we have over $60 million left on our previous authorization and in this part quarter we were – we also had repurchased over 50 million of shares in the second quarter. So we will continue to look at a share repurchase as a vehicle to return cash. As it relates to leverage, these are things that we are not opposed to. I think we will look at those opportunities as they present themselves and where there opportunity to take on leverage either for M&A activities or if we wanted to be more aggressive on share repurchase. Those are things that we are not opposed to and recognize there’s opportunities to take on leverage given the type of cash flow that we generated.

Jack Meehan

Analyst · Barclays. Please go ahead.

Got it, that’s great thanks again.

Operator

Operator

Our next question comes from the line of William Quirk with Piper Jaffray. Please go ahead.

William R. Quirk

Analyst · Piper Jaffray. Please go ahead.

Great thanks and good afternoon, everybody. First question is a follow-up to Amanda's. I wanted to clarify here that 100% of the guidance reduction has nothing to do with the myRisk/BRACAnalysis transition? And then, just specifically on myRisk, where are we on lab automation right now? And then, the turnaround time? Mark, you signaled that there is an extra 14 days. I'm curious where we are today? Thank you.

Mark C. Capone

Analyst · Piper Jaffray. Please go ahead.

Yes, so let me take those one at a time. So from a lab turnaround time standpoint, we have been successful in maintaining the turnaround time, we’ve always promise their customer if they would have under 21 day turnaround time with myRisk and we’ve been able to maintain that even in first quarter, but in the second quarter as well. So as I mentioned there was no change in WIP in the second quarter. So that 9.5% sequentially increased that – none of that was impacted by any change in WIP. And so at least as it relates to lab turnaround time. For a transition standpoint I think we continue beyond track with what we have said historically. The we decided to make sure in the second quarter that we scaled up the lab process sufficient to give the full transition as a oppose to just meeting current demand. And so in that way we were actually head of the schedule in the second quarter. So we’ve installed all the equipment we need, we hired the people that are going to necessary for full transition and we installed all of the hardware informatics hardware that was necessary. The last remaining piece for full transition is being installed this quarter, which are all the propriety pieces of software that we need in order to make all those, that hardware work together and achieve under 21 day turnaround times, that software is going in this quarter. And so as a result we are planning on only modest increases in the conversion this quarter, but then not should position us for full conversion, beginning in the fourth quarter and then moving over into the first quarter of next year. The last part is in our guidance where we are now contemplating at some increase in WIP associated with the myRisk conversation in the second half of the year that’s not due to increased turnaround times. We will maintain turnaround times under our stated promise of 21 days that’s associated with the fact that we now no longer expect turnaround time reductions to fully offset the conversion that will happen in the third and fourth quarter.

William R. Quirk

Analyst · Piper Jaffray. Please go ahead.

Okay, got it. And then, I guess as a follow-up, another multi-part question here. One is obviously glad to hear that the OUS business is doing well. Can you just remind us specifically how large that is today? And then, secondly, Mark, help us think a little bit about the ordering patterns within myRisk. You mentioned that you didn't open it up to any additional physicians. But obviously, it was up nicely sequentially in terms of the overall hereditary cancer. Should we read this that the physicians are getting more comfortable expanding it to all of their patients within colon, breast, and ovarian? Or, are you starting to see some tests coming in for some of the other solid tumors as well? Thank you.

Pete D. Meldrum

Analyst · Piper Jaffray. Please go ahead.

Yes, let me start off, as I mentioned in the call today, we are excited about the opportunity outside the US, we saw 118% year-over-year revenue growth this particular quarter and see a real bright spot as Lynparza gets reimbursement with our Tumor BRACAnalysis CDx, our new EndoPredict product, again which was up sequentially, dramatically and even myRisk has seen over a 50% increase sequentially in Europe. So we are very excited about Europe. We still think we are on track to meet our original guidance of $50 million in revenue by fiscal 2016. And we will at some point in the future, be breaking out revenues as they rise to a more meaningful level. So you’ll be able to track the international ex-US revenues as well. And then to your second question Bill, if you remember at the end of first quarter we had talked about the fact that we were exiting the quarter with about 50% of income in samples being ordered as myRisk. And so in the second quarter you saw 53% of revenue that recorded as myRisk. So what we essentially saw is that those physicians that were ordering at the end of the first quarter continue to order all of their business as myRisk in the second quarter which is why you see that 53% number in the quarter and that’s essentially what our exit rate was coming out of the first quarter. The pattern is really unchanged from what we’ve seen historically when a physician has offered the myRisk test and virtually every physician wants to order the test and in fact they convert their business fully over to myRisk. As I mentioned, there is even more impressive data that was released at San Antonio whereby a 105% increase in a number of patients identified with mutations with myRisk. And so when the physician has presented that type of data that says you can more than double the number of mutation carriers you identify by using myRisk as opposed to single syndrome tests, those physicians want to covert their business completely to that more sensitive test and that’s a pattern that we’ve seen continue.

Operator

Operator

Our next question comes from Drew Jones, he is with Stephens Inc. Please go ahead.

Andrew L. Jones

Analyst

Thanks. On Crescendo, understanding commercial reimbursement has been a little slow to come on. But, it seems like there is still a pretty significant opportunity with CMS patients, and penetration looks like it seems to have stalled a little bit. Can you walk us through what is happening there? And, maybe give us some physician penetration and reordering metrics as far as Vectra is concerned?

Mark C. Capone

Analyst

Thank you Drew. You are correct that the Medicare markets where we already have reimbursement for Vectra DA is large, it represents a $600 million opportunity and we with the transition from Bill Hagstrom to Bernard Tobin have refocused our strategy on not only continuing to strive to obtain private insurance reimbursement but really focus on our existing customers that are in the test and making sure that they ordered for all of their Medicare patients where it is fully reimbursed. We’ve also focused part of our strategy on Medicare advantage plans, which will have to cover Vectra DA because Medicare covers Vectra DA. So I think you will see with the addition Bern into our team and his experience in managed care and obtaining reimbursement probably with Amgen a very strong strategy both on the Medicare and private pay front that will return Vectra DA to its stronger growth trajectory.

Andrew L. Jones

Analyst

Okay. And then, as far as Prolaris is concerned, do you have visibility into what percentage of the volumes would fall into the low-risk reimbursable group?

Mark C. Capone

Analyst

Yes, so the 50% of the incoming samples would be – would qualify for that low or very low risk category, so it’s what we see for sample ordering is pretty consistent with what you would expect based on the prevalence out there in the general population. So if you were to translate the coverage, the draft LCD coverage decision to the entire population of prostate cancer patients, you are looking at about a $300 million market. So we think that’s a good opportunity to start with, we believe we continue to have very strong data that would suggest its appropriate for all risk categories and in fact the NCCN was commenced of that as well and so we’ll continue to pursues broader indication, but at least that initial indication where that adopted by every payers its still a $300 million market that provides a good opportunity to start with.

Andrew L. Jones

Analyst

Thanks guys and congrats Pete and Mark.

Mark C. Capone

Analyst

Thanks Drew.

Pete D. Meldrum

Analyst

Thank you.

Operator

Operator

Our next question comes from Derik De Bruin; he is with Bank of America Merrill Lynch. Please go ahead.

Derik De Bruin

Analyst

Hi good afternoon. You mentioned that 75% of your hereditary testing now is under long-term contracts. I am curious, could you elaborate that on a little more detail on the ASP and the duration? I am asking this question as we gear up next year for the PAMA legislation and the implementation of that as CMS goes to market-based pricing? And, I'm just wondering is the current -- where you are currently getting reimbursed by commercials above or below where you're at with CMS right now?

Mark C. Capone

Analyst

Yes, thanks Derik, just to clarify my comments so that we have continued to make progress and signed additional long-term contracts in the second quarter as you will remember our strategy was to sign a three year contracts with fixed prices, so that it would provide visibility to both Myriad and the payers on their hereditary cancer business. We don’t have 75% of commercial lives under contract. We will if we are successful in getting all of the BlueCross BlueShield affiliates to sign on to the Association contract that we have already put in place. And that’s what our managed care team is working is signing up the reminder, so that we can get to that 75% number, obviously we are continuing to approach other payers as well. Those contracts prevent us from talking about any of the pricing that is included in those. That is commentary that we won’t provide in the future other than what we said previously is that our goal with myRisk after we have been through full conversion and put some of the efficiencies in places that we anticipate 87% gross margin on myRisk once all of those contracts are in place and once we’ve got conversion fully under our belt. That's, I think, the commentary we can make on that. As to the PAMA regulations, I think what is important about those are that those are dependant, those are a weighted average of the pricing that is available. And so, its highly dependant on what the market shares are of each of the various laboratories because it is a weighted median price. And so I think obviously our market share will factor heavily into the final pricing that will come from that PAMA regulation.

Derik De Bruin

Analyst

Great. And I guess Mark, a philosophical questions. What are you - is there anything significantly you're going to do under the management of the Company that is going to be a departure from what has been done in the past? What are you doing to bring new to the role?

R. Bryan Riggsbee

Analyst

Well, I think in this case obviously Pete and I have worked very closely for a number of years as have the entire management team. I think we made a very critical strategic shift five years ago when we spun off the pharmaceutical business and became a pure play diagnostic business and launched our four and six strategy. I think what we’re seeing now is on the cost of the realization of those efforts with 10 product launches over the last few years with market potentials in excess of $15 billion. So I think a lot of our focus is going to be continuing to execute on the strategy that we laid out five years ago, because we’ve really haven’t seen all of the benefits from that strategy and the expansion to global footprint. So I think you are going to continue to see us execute on that. I think as we laid out we are going to exit into fiscal year 2016 with revenue run rates approaching $800 million, our earnings per share approaching $2 a share. I think those are great launching point as we move into fiscal 2016, we see all these investments kind of fruition and exert some significant leverage on the income statement. So I think you are going to see us continuing to execute on that strategy as we move forward.

Derik De Bruin

Analyst

Thank you. End of Q&A

Operator

Operator

Mr. Gleason, I’ll turn the call back over to you.

Scott Gleason

Analyst

Thank you. This concludes our earnings call. A replay will be available via webcast on our website for one week. Thank you again for joining us this afternoon.