Nuwellis Inc (NUWE) 2015 Q3 法說會逐字稿

Thank you. Before we get started, I would like to remark briefly about forward-looking statements. Except for historical information mentioned during the conference call, statements made by the management of Sunshine Heart are forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.

Forward-looking statements involve known and unknown risks and uncertainties that are based on management's beliefs, assumptions, expectation, and information currently available to management. Those risks include, but are not limited to, risks associated with the possibility that the Company's clinical studies do not meet their enrollment goals, meet their endpoints or otherwise fail; that regulatory authorities do not accept the Company's application or approve the marketing of the C-Pulse System; the possibility that the Company may be unable to raise the funds necessary for the development and commercialization of its products; that the Company may not be able to commercialize its products successfully in the EU; and other risk factors described under the caption risk factors and elsewhere in the Company's filings with the Securities and Exchange Commission.

By providing this information, the Company undertakes no obligation to update or revise any projections or forward-looking statements, whether as a result of new information, new developments, or otherwise. You should review the cautionary statements and discussion of risk factors included in the Company's press release issued today; the Company's latest 10-K; subsequent reports, as well as its other filings with the Securities and Exchange Commission under the titles risk factors or cautionary statements related to forward-looking statements.

For additional discussion of risk factors that could cause actual results to differ materially from management's current expectations, and those discussions regarding risk factors, as well as the discussion of forward-looking statements and such sections, are incorporated by reference in this call and are readily available on the Company's website at www.sunshineheart.com.

During this call, management will also discuss non-GAAP financial measures as defined by the SEC Regulation G. Reconciliations of these non-GAAP financial measures to the comparable GAAP financial measures are included in the Company's earnings press release and supplemental information. In addition, a replay of the call is provided through a link on the Investor Relations section of the Company's website.

With that said, I would now like to turn the call over to Dave Rosa, Sunshine Heart's President and Chief Executive Officer. Sir, you may proceed.

Thanks, operator. Good morning, everyone, and thank you for attending Sunshine Heart's third-quarter 2015 results teleconference. With me today are Claudia Drayton, Sunshine Heart's Chief Financial Officer; Molly Wade, Vice President of Worldwide Patient Recruitment and Marketing; Jim Georgakopoulos, Chief Scientific Officer; and Debra Kridner, Executive VP of Regulatory and Quality Affairs.

Additionally, I'm also pleased to have Dr. Leslie Miller and Dr. Alan Gass join the call. Dr. Miller, of the University of South Florida Heart Institute, and Dr. Gass, of Westchester Medical Center, will address questions relating to the COUNTER HF study, our future protocol regarding patient weaning, the new data regarding potential neuromodulation signals, and impact on patient recovery. Both centers were recently activated in the COUNTER HF study. Dr. Miller is very well-known for his work with patient recovery and LVADs, and can offer his perspective on our recent data collected with respect to the neurohormonal response. Both Dr. Gass and Dr. Miller are also on Sunshine Heart's Advisory Board.

The third quarter was an important period for the Company on multiple fronts, as we advanced the C-Pulse technology, continue to activate COUNTER HF study sites, and make progress with our fully implantable system. I am particularly pleased with having a patient also reach the five-year mark on the C-Pulse therapy, and the progress made during the quarter to maximize the potential of the C-Pulse platform.

During the quarter, we collected pre-clinical animal data for pulmonary hypertension, recorded initial echocardiographic and neurohormonal clinical data pointing to neuromodulation as a potential mechanism for myocardial recovery. In addition, we continued the development of the next-generation fully implantable system.

Before proceeding with an update on our overall progress, I would like to remind everyone that on August 31 we announced that the FDA approved an amendment to our US COUNTER HF study protocol that changes the stopping rule criteria from all cause deaths to mortality associated with the device, procedure, or therapy. We view this as a very positive step, and I believe the amendment will greatly reduce the risk of a future stoppage in the study.

With respect to COUNTER HF status, we communicated in our last call that we expected to have the majority of our sites activated by the end of August. Due to site-related delays, however, we finished August with 15 activated centers, approximately a little more than half of the sites we originally expected to activate. That said, we had a very strong September, finishing with 23 activated centers, with eight coming in the last two weeks of the month. In October we have added another four, and currently have 27 activated centers with 13 additional centers now moving through the activation process.

There were seven patients enrolled in the quarter, due to the limited number of centers. And at September 30, 2015, we had an aggregate of 55 patients enrolled, of which 30 are currently randomized in the COUNTER HF study. We are pleased to report that we have already enrolled another five patients in October, and have a robust pipeline of 117 patients waiting for evaluation between both currently activated sites, and sites going through the activation process. This is more than we have ever identified in a given quarter. We are obviously pleased with the progress we are seeing so far in the fourth quarter of this year.

A recent Advisory Board meeting in October confirmed the genuine enthusiasm for the COUNTER HF study. Furthermore, there was unanimous agreement among the advisors that the clinical pause, which covered roughly a three-month period from March through May, hampered the study's momentum. But everyone expects meaningful traction, with study enrollments start occurring now that many of the sites have been reactivated. There was a great deal of enthusiasm for the technology, as well, especially after learning more about the fully implantable system and reviewing the new data regarding a new potential mechanism of action with the C-Pulse device.

As I mentioned at the beginning of the call, having a patient reach the five-year mark on C-Pulse therapy represents a significant milestone for the Company. In addition, during the quarter, we collected clinical data which may point to a neuromodulation effect that could explain why physicians have been able to wean patients from the therapy. To date, six patients have been successfully weaned off the therapy.

This research has been led by Dr. Jim Georgakopoulos, our Chief Scientific Officer, who over the past few quarters has been collecting echo and neurohormonal data from the OPTIONS HF European post-market study, and optimization data from the COUNTER HF study. The results so far appear to indicate a neuromodulation mechanism of action in addition to what we always believed was a mechanical mechanism of action. This would be extremely significant for the therapy, as this neuromodulation effect has been identified as being critical for myocardial recovery to occur. Most importantly, this mechanism of action has not been demonstrated in left ventricular assist devices, such as LVADs; and, therefore, it positions the C-Pulse therapy as the only current mechanical assist therapy that offers mechanical unloading and neuromodulation effects.

Based on this new data, which was just presented at the TCT meeting in San Francisco on October 14, we initiated protocol development for a modified European post-market study that incorporates many of the OPTIONS HF endpoints, but also includes patient recovery and weaning endpoints. The study is expected to start in early 2016, and replaces the OPTIONS HF study.

With respect to German reimbursement, we also again filed with the German reimbursement authority in October, and expect a decision the first week of February 2016.

Another exciting milestone for the quarter was the initiation of acute pre-clinical studies to evaluate the effects of C-Pulse for pulmonary artery hypertension that were conducted under the guidance of Dr. Mark Slaughter at the University of Louisville. Initial data confirmed that counterpulsation of the pulmonary artery reduced pulmonary artery hypertension. Based on this outcome, we are planning to conduct additional evaluation studies expected to start in the first quarter of 2016. Advancing the development of our fully implantable system is a top priority, as this opportunity represents a transformational therapeutic solution. To this end, chronic animal trials were initiated in September and October at Texas Heart under the guidance of Dr. Billy Cohn, and they are progressing very well.

We have contact with the FDA to explore an expedited access pathway, or EAP, to market. If granted, an EAP designation could potentially expedite the process for obtaining US approval and could have significant implications to our overall corporate growth strategy. Most importantly, the FDA has responded they are willing to discuss this pathway with us. The Company is currently preparing requested information for the FDA to review early in the first quarter of 2016.

Finally, before turning the call over to Claudia, I just want to emphasize our ongoing commitment to presenting data at medical conferences. During the quarter, we submitted a number of important presentations and papers, including two abstracts that were accepted for presentation at the upcoming AHA meeting in Orlando.

The first abstract submitted to AHA is titled Reduced Heart Failure Readmission Rates: Clinical Experience with the C-Pulse Extra-Aortic Counterpulsation System. This will be presented by Dr. Sanjeev Aggarwal of Mid-America Heart and Vascular in Kansas City, Missouri.

The second abstract is titled Arterial and Cardiac Hemodynamics in Advanced Heart Failure Patients Implanted with a Para-Aortic Counterpulsation Device Assessed by Pulse Wave Analysis. This will be presented by Dr. Eduardo Rame, at the Hospital of University of Pennsylvania in Philadelphia, Pennsylvania.

And, most recently, we just conducted oral and poster presentations at the TCT conference held in San Francisco, California, on October 11 through 15.

I will now turn the call over to Claudia Drayton, who will provide an update on the third-quarter financials.

Thanks, Dave. Good morning, everyone. This morning we released our interim unaudited financial results for the third quarter of 2015. Next I will walk you through a few of the financial highlights. As we have reported before, our revenue to date has been generated by sales of the C-Pulse System to hospitals and clinics in conjunction with our US clinical study. The Company did not record any revenue during the third quarter of 2015, as there were no implants performed during this period that qualified for reimbursement. The Company recognized $59,000 in revenue during the third quarter of 2014.

Results for the nine months ended September 30, 2015 and 2014 include revenue of $59,000 and $118,000, respectively. As we have stated before, we have obtained reimbursement for some but not all of our implant procedures, because some private insurance companies and certain governmental institutions have a non-coverage policy for experimental or investigational procedures. Since all activities are conducted under clinical studies in both the United states and Europe, we record all costs associated with our devices directly to research and development expense, as incurred. We expect to continue to do so until such time as we begin producing devices for commercial sales in either Europe or the US.

Operating, expenses on a GAAP basis, in the third quarter of 2015 totaled $6.3 million compared to $6.2 million in third quarter of 2014. Equity compensation expense included in operating expenses totaled $0.5 million for the third quarter of 2015 and $0.7 million for the comparable period in 2014. Excluding equity compensation expense, non-GAAP operating expenses totaled $5.7 million and $5.5 million for the three months ended September 30, 2015 and 2014, respectively. Operating expenses for the quarter reflect lower spending resulting from the consolidation of certain management positions, offset by increased investments in clinical infrastructure.

Operating expenses, on a GAAP basis, for the nine months ended September 30, 2015 were $19.7 million compared to $19.2 million in the same period of 2014. Equity compensation expense included in operating expenses during the first nine months of 2015 totaled $2.1 million compared to $2.2 million during the same period of 2014. Excluding equity compensation expense, non-GAAP operating expenses totaled $17.6 million and $17.1 million for the nine months ended September 30, 2015 and 2014, respectively. The slight increase over the prior year is primarily attributable to increased investments in clinical infrastructure, along with increased development expenses associated with our fully implantable system, offset by lower spending resulting from the consolidation of management positions.

Any fluctuation in equity compensation expense is attributed to the timing and structure of equity awards granted during the period, as well as the fluctuations in our stock price. We expect equity compensation expense to continue to fluctuate based upon these factors.

Net loss in the third quarter of 2015 was $6.6 million or $0.36 per share compared to $6.1 million or $0.36 per share in the third quarter of 2014. Excluding equity compensation expense, third-quarter 2015 and 2014 net non-GAAP losses totaled $6 million or $0.33 per share and $5.4 million or $0.32 per share, respectively. Net loss in the nine months ended September 30, 2015, was $20 million or $1.11 per share compared to $18.8 million or $1.12 per share in the nine months ended September 30, 2014. Excluding equity compensation expense, net non-GAAP losses for the nine months ended September 30, 2015 and 2014 totaled $17.9 million or $0.99 per share and $16.7 million or $0.99 per share, respectively.

Cash used in operating activities totaled $18.2 million for the nine months ended September 30, 2015, compared to $17.4 million for the same period of 2014, with the increased driven primarily by higher research and development expenses, as well as interest expense on outstanding debt. During the first nine months of 2015, the Company received net proceeds from financing activities of $15.1 million, as follows: $7.1 million from the sale of common shares under the Company's existing at-the-market facility, and $8 million from borrowings on our $10 million facility from Silicon Valley Bank. The Company had $27.9 million in cash and cash equivalents on September 30, 2015, compared to $31.3 million at December 31, 2014.

Going forward, during the fourth quarter of 2015, and into 2016, we expect to see modest albeit growing revenues in the US as we continue to grow patient enrollment into the trial. As we have previously stated, we have not modeled any revenue from implants in Europe in 2015 or 2016 at this point. We submitted for reimbursement in Germany again, but we have not modeled any reimbursement in 2016, or in any future projections at this point. We expect our quarterly operating expenses and cash burn will be at the same or higher levels to comparable periods last year, as we continue to support our studies in the US and Europe and continue to invest in our fully implantable system.

With regards to the Company's loan facility and the required equity raise by March of 2016, we are exploring alternative structures with a goal of achieving increased financing flexibility. We cannot comment on the specifics of these alternatives, or assess the likelihood of success, as these discussions are ongoing. In addition, during the remainder of 2015, and into 2016, we may selectively use our equity ATM facility when and if we deem appropriate.

I will now turn the call back over to Dave.

Thanks, Claudia. This concludes our prepared remarks. Before we turn the call over to the Q&A portion, I would ask that the questions for Dr. Gass and Dr. Miller be asked first, just with all due respect to their time. And Dr. Miller was at attendance at our October Advisory Board meeting. Unfortunately, Dr. Gass, at the 11th hour, had something come up that prevented him from coming. So some of the questions relating to maybe the advisory-board meeting, and the data that we presented at that regarding this neuromodulation effect, Dr. Gass has not had the luxury to see, but Dr. Miller has.

So, with that, we can open up the questions for the physicians.

(Operator Instructions). Suraj Kalia, Northland Securities.

So, Dave, let me start out with the obvious. How many patients are there in the funnel right now for COUNTER HF?

So there is a total of 117, Suraj. 62 of them are from currently activated centers, and the other 55 are from centers that are looking to come on.

And would I (multiple speakers)?

We are now at maximum, by the way. If all these 13 additional centers are activated, we would be at the maximum number of allowed centers that the FDA has given us, which would be 40.

And would I be close enough in saying that between one in three and one in five patients would get enrolled in the COUNTER HF study, if I used that metric?

Yes, that would be approximately correct.

And I know you guys don't give guidance, per se, in terms of patient enrollment. But even if I do, let's say, one in five, to use the worst-case scenario, you are talking roughly around 24 patients, give or take, that will end up. Are we talking about, now that most of the sites are activated, is this a one-quarter phenomenon? Or you think this will bleed out into Q1? The reason I ask is because last quarter, you all talked about optimizing the presentation of therapy. I just want to tie both of them together and get some directional color from you guys.

Yes. So, good question. Regarding optimizing the therapy, one of the things that has come up -- and I'll say it was really brought to our attention by Dr. Miller -- was that it would be very helpful in doing that -- was to produce a patient consent video. So today what happens is a patient will meet with the doctor or clinical coordinator; will receive the patient consent form, which I think is probably close to 30 pages long; will take that home, come back; and then make a decision as to whether or not they are going to enroll in the study.

And sometimes, if the physician is not able to meet with the patient to discuss this, then the patient is left to having to go through the documentation, speak to the clinical coordinator. And we feel -- and again, Dr. Miller brought this up -- we feel that there is a more efficient way of doing that. And that is to have a video that actually has, in essence, a condensed version of the patient consent form. And it would highlight, obviously, the therapy, the clinical data, and obviously the risks.

So that's something that we are working on now. I don't expect that that's going to have -- that that's going to be introduced this quarter. It's more likely that it will be done early next year.

So is it a one-quarter phenomenon? I sure hope not. We don't have -- we have all the centers pretty much activated from the study that were initially activated. But we still have 13 more that we have to get through. So there is still -- with another 13 sites, we get to 40. Now we've got a good number of sites, and I would expect this to carry forward.

Fair enough, Dave. One for you, and one for Claudia -- Dave, on the fully implantable, the expedited access path, obviously a lot of companies are making hay with this new pathway that the FDA has presented. Should we triangulate that you are looking at, in some way, weaving this into COUNTER HF? Are we talking about a stand-alone, should I say, program, clinical effort on its own?

Yes. So, Suraj, I'll address that. Right now, I'm not going to speculate how this plays into COUNTER HF. I think we need to get at least a better understanding of what the FDA's thoughts are on this. And when we contacted them earlier and said, look, we really feel this therapy would apply to it, their response was, hey, we are excited to sit down and review this; but here is what we need to see from you before we are able to give you any feedback.

So I would say, yes, this could have some pretty big implications, all in a positive way, for the Company. But I'd rather refrain from saying, gosh, this is what we are going to do. Because I'd like to at least first hear from the FDA as to what their thoughts are on this.

Fair enough. And final one, Claudia, and I'll hop back in queue -- what is the expected R&D burn on the implantable and the PH program, let's say, over the next 3, 6 months?

Suraj, We don't comment on those programs in particular at this point. So, sorry.

(Operator Instructions) Thom Gunderson, Piper Jaffray.

Dave, I'm going to ask the doctors -- you said in the interest of time -- I'm going to ask the doctors some questions, and then I'll get back in queue. Gentlemen, just as a general question, you are both, I believe, in the clinical trial in COUNTER HF. And on the Wall Street side, we have been watching this impatiently, probably the same as the Company has. And I'm just curious: on your side, you've both done clinical trials before. Do you see any unusual speed bumps in this trial? Anything about the product or the patient selection that would keep it from accelerating, now that some of the pauses and other things have been gotten out of the way?

This is Les Miller. I guess I'll take the first response. We are a new center. And I think that this trial was brought here because I think it fills an important niche that we see in the whole spectrum of advanced heart failure patients. It has many advantages that we think patients, at least the few we've already contacted, have seen as a preference over -- are they really ready to consider a full ventricular assist device? And the advantages that I highlight that I think patients have responded to quickly is particularly the ability to electively stop this. You are certainly well apprised as a field that if an LVAD stops, you have a couple minutes until you are in really a crisis. And so I think that ability -- not intravascular, no anticoagulation, and this encouraging information about potentially improving and recovering ventricular function -- we've had really a very encouraging response thus far. The first person is ready to go, and we've got two more this week.

So I would think that as centers see this and begin to be -- all of the clinical trials at an individual site starts at a little bit of a bend in the curve, and then I think it will accelerate. So I'm anticipating, certainly from our side, is perhaps representative of what new information has come forward that will really begin to bolster the recruitment.

This is Dr. Gass. I fully agree. I think the space is completely unmet, the functional Class III, ambulatory IV. And I think the problem, especially talking about bridge to recovery: the VADs are being put in, in INTERMACS 1 and 2; patients are way too late to appreciably reverse, remodel, or recover. And I think this is the perfect device to achieve that goal. And I think that that will be communicated to the patients and their current physicians.

The other important thing is quality of life. And if you look at all the quality-of-life data from implantable VADs, there is only a 20% chance of not having complication in the first year. This is much, much better as far as complications. The patient could come off the device -- I mean, an ambulatory quality of life. And now that the Company is putting the science behind the bridge to recovery, I think that is really going to drive this study forward, because there really is no LVAD that has achieved even the science of reverse remodeling. And bridge to recovery in an LVAD worldwide is about 5%. So I think this device meets a lot of unmet needs.

Thank you. And then again for both of you, on the neurohormonal side, Dr. Miller, you'd mentioned the gap in treatment that the Sunshine product could fill, possibly, here, and that that's a good thing. I know it's early. I know not all the information is out there. But on this neurohormonal reverse remodeling hypothesis, do you think that maybe it would open the market a little bit more, that you would go earlier upstream, that it could have a metabolic effect more emphasized before some of the heart is destroyed? Or, on the other hand, do you think you would get a bigger impact, later stage? Just curious where you see the remodeling maybe adding to or taking away from the overall market.

It's a great question, and we always are trying to understand where to position new devices. But I think that the LVAD community tried to roll back into less sick. And I think the complexity and complications of that technology have clearly stopped that movement. So I think, again, if you look at people that are symptomatic, so-called IIIBs and ambulatory IV, that's a huge population. We have done several projections of 150,000 to 200,000 people. So even if we stayed within that target range, there's an enormous population.

But if you just go back to mechanism, one of the most astounding pieces of data that I've seen is the neurohormonal change in the end terminal pro-BNP. You guys have been around, and seeing a lot of trial data. And in statistics, if you have a fall of 50 to 100 milligrams, you may reach statistical significance. This was almost 3,000 milligrams, from over 5,000 to around 2,000. And there's nothing out there, I don't think, including the big LVADs, that have shown that kind of power in turning off neurohormonal stimulation.

So that -- and I think the other piece that I look at mechanistically is this change in heart rate variability which is a really profound look at chronic overstimulation of the sympathetic nervous system, and a loss of that variability, and the restoration with this kind of stimulation and its proximity in the ascending aorta, I think, really lends it, anatomically and mechanistically, to really taking advantage of stimulating the bare receptors and having this very positive effect on myocardial function. So long answer, perhaps, but I think there's a bigger population. And as we get more experience, we may well bend it back in both directions to define its optimal location.

Thanks, Dr. Miller.

Dr. Gass?

I just want to -- there's really nothing that meets that need in the ambulatory IIIB or IV. And if you look at the medical therapy that exists, all the cornerstone therapies do not really achieve this long-term. Once the patient gets to this point, clearly the medical therapy is not achieving the goal of reverse remodeling. So I think that the traditional trajectory is that on that medical therapy, these patients are going to progress. And this is really going to stop that progression. And I think there's really, again, an unmet need to reverse remodel. There's nothing out there, certainly not being medically -- and in the LVADs up front, with not only big surgery, a lot of complications, life-threatening complications -- this will meet that need.

Thanks. That's it for me, Dave. I'll let somebody else ask the doctors some questions.

Jan Wald, The Benchmark Company.

Doctors, just in terms of maybe carrying on with what Thom just asked, on the neurohormonal modulation, it sounds like there's a pretty strong signal that has been seen to date. How do you translate that into a clinical study? What do you see having to be done to prove the point in order to make it palatable for other folks?

This is Dr. Miller again. I think that that's a little bit challenging to really look at biochemical markers other than, as we said, you've got two things that physiologically we can look at -- heart rate durability: most of these people have devices in that we can track that and show that restoration. And secondly, BNP -- I think that has become the surrogate of all neurohormonal stimulation in the heart. And I think that's in the protocol as an endpoint. So I think we'll have a good look at it, getting more defined. And pre-tracking bare receptor activity and so forth, I think, is really extrapolating from the animal experience into what we see in the clinic.

But I think if you look at the data, one of the most compelling parts to me is the concordance of the data in terms of all of the changes are going in a really consistent manner in terms of wedge, cardiac output, ejection fraction. And not a small part in this is the left ventricular and systolic volume. I think that maybe you have seen the data from the large meta-analysis that looks at what a 30-milliliter reduction in systolic volume -- and the meta-analysis suggest that you have an 80% chance of achieving a mortality benefit.

So all of these things, and reducing wall stress, are measured and consistent with the mechanisms that have been suggested. And all of those are, again, really critical in the concept of recovery. And I think that all this really sets the stage to move, as I think Dave suggested, into really trying to study recovery in this technology. Because the data and the signals, so far, are so encouraging, and the mechanism underlying why it's different than a distal intra-aortic balloon pump or other technologies is really pretty astounding and, I think, very encouraging.

And I just want everyone to -- the issue, the latest issue about reducing pulmonary vascular resistance and pulmonary hypertension, I think one of the biggest unmet needs is RV failure. And I think, speaking to moving upstream, if you could put this device in at the right time and prevent pulmonary hypertension and RV failure, I think that's another unmet need.

And the other thing is that biomark is they seem to be coming out every day. We use galectin-3 in our institutions. I think, going forward, there will be more markers available to confirm the benefit of this device for reverse remodeling.

And this is an impression I have, and it may be wrong. But if I looked at pulmonary hypertension and things like that, bioreceptors are certainly involved. And it's been very hard to prove that there's a benefit from a particular therapy. And I'm thinking in particular of renal denervation. And I don't know if there's an analogy here or not, but do you think the signal is strong enough, and it will be maintained well enough that it will be demonstratable in the clinic?

With right-sided support or left-sided support?

Both, I guess. Either.

I think they both would seem to be suggestive. It's a little earlier in the experience with the pulmonary vascular support. But I think that the left-sided support really looks -- as I said, if you look at the whole aggregate of data, it all suggests that this is all moving in the right direction; and likely in response, at least in part, to not just corner perfusion and reduced resistance that we've thought about in this technology, but now really getting into a much more fundamental understanding of why this could be different, and why that mechanism will be so important in achieving a goal of recovering and removing devices.

Okay, thank you very much. I appreciate the answers.

Thank you. And I'm showing no further questions from our phone lines.

I would now like to turn the conference back over to Dave Rosa for any closing remarks.

I want to thank both Dr. Gass and Dr. Miller for being present, and for all you guys as well, for participating on the call. Thanks, and have a good rest of the day.

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Everyone have a wonderful day.

Thank you.