Malinckrodt [MNK]

Transcript from Mallinckrodt Presentation at BMO 2019 Healthcare Conference. June, 16, 2019

Garry Nachman, an analyst with BMO Capital Markets interviewed Mark Trudeau, the CEO of Mallinckrodt and the CFO Bryan Reasons.

Summary:

  1. Expecting in the next three months MNK will have data readouts on two of our late stage development programs through TERLIPRESSIN and STRATAGRAFT.
  2. When asked if company will consider going private Mark Trudeau said he and board are assessing strategic options.
  3. Possible for Achtar to split into two brands
  4. Asked about outcome in CMS case, Mark Trudeau was adamant that  in arrears there’s unlikely to be an exposure.
  5. CMS hearing begins at the end of July
  6. CMS outcome will not affect Medicare sales.
  7. Spin Co on track – will have 2x leverage with 300MM revolver.
  8. MNK taking advantage of discounted bonds to aggressively deliver, FCF remains strong and company on track to take reduce debt by 1billion this year.
  9. Bryan Reasons mentions that current cap structure it’s a very covenant light structure and sees no risks of default in worse case Achtar scenario.
  10. Trudeau says STRATAGRA and TERLIPRESSIN have a very high likelihood of success.
  11. Foundation charity settlement expected to be under 50 MM.
  12. There may still be a pathway for VTS 270 approval, agency still engaged and seeking further data.
  13. Planning for growth in hospital business.

[00:00:01.700] – Garry Nachman [BMO]

We’re very excited to kick off the conference with Mallinckrodt. We have Mark Trudeau as CEO and Bryan Reasons the newly minted CFO coming over from Aamneal and Dan Speciale head of IRR. So great to have you guys here today. So Mark I will start with you of course with the stock having been under so much pressure and sentiment clearly very challenged largely due to all the noise with facts. How do you see the next six to 12 months playing out for the company and ways that you might be able to turn the tide.

[00:00:34.400] – Mark Trudeau [Mallinckrodt]

Yeah thanks Gary. So yes certainly the last couple of months have been particularly challenging from a share price perspective and it’s certainly not the result of operating performance because as you know starting in the year after the first quarter we’ve beaten raised and we continue to perform in the existing business very well. Certainly I think it’s the overlapping uncertainties that are around our business at the moment. And as we think about our next best steps from a strategic standpoint clearly removing those uncertainties or reducing those uncertainties is fairly important. We have a number of hours I’m sure we’ll talk about those but one of the things that’s clearly become more certain just in the last couple of weeks is the efficacy data around acts are obviously we’re very pleased to present that you are some very compelling data supporting actors used in refractory are patients. The data was very strong and very compelling can talk a little bit more detail in that regard. But certainly as we work over the next six months. And that was the focus of your question. We believe that we’re going to be able to reduce or eliminate a number of the uncertainty surrounding the business while we continue to remain focused on executing operationally in the same strongly that we have been really since the company has been public going back now six years okay.

[00:02:08.580] – Garry Nachman [BMO]

And I mean do you want to just highlight what you think some of the uncertainties are there out there in the marketplace maybe where perception is just not reality at a high level. And then we’ll take more into it after.

[00:02:22.440] – Mark Trudeau [Mallinckrodt]

Yes sir. I mean at the beginning of the year we outlined four strategic things that we thought were quite important to execute on. In 2019 we’ve been doing that consistently. One of those is obviously to separate the two businesses into the Specialty Generics business and the branded innovative business and we’re well on track to do that. There’s certainly uncertainty around that transaction. I think primarily because of the uncertainty around opioid litigation at the moment. But between now and the end of the year we will be separating these two businesses we’ve been quite clear about that and you know we just indicated very recently that not only have we formed a very solid board with well-known industry veterans but we’ve now set up the financing or in the process of setting up the financing for that separation. We’ve also form filed a Form 10. We’ve had a couple of iterations with the FCC will file another on a Form 10 with the reconstituted asset next year that we described very recently. But we believe we’re very much on track to separate that business potentially by the end of the third quarter and certainly by the end of the year. So we think that’s well on track and that element of uncertainty from our standpoint should be cleared up here within the next three to six months. There are a number of other uncertainties certainly around some of the CMS issues around acts are also the DOJ suit. That was just recently filed around legacy activities surrounding acts are beginning to see a masterpiece we believe is likely to be much more clarity certainly within the next three to six months. It was just documented publicly how that process will proceed culminating in a hearing at the end of July but we don’t anticipate actually that it’s likely to have any effect on the CMS side of Achtar in 2019. But we do believe that piece will be resolved by potentially by the end of the year perhaps in 2020. And then importantly I think there’s uncertainty around our pipeline and this is where I think we’re very excited and certainly within the next three months we’ll have data readouts on two of our late stage development programs through TERLIPRESSINand STRATAGRAFT. So we have a pretty good idea about the robustness of our pipeline. Again in a relatively short amount of time when I think about it as over the next three to six months a number of the uncertainties are kind of overlapping the stock today will certainly have a much more significant degree of clarity.

[00:05:16.490] – Garry Nachman Garry Nachman [BMO]

OK. So when you paint the picture it sounds like a lot of these uncertainties really could last. But let’s you know assume that they don’t. So what sort of conversations do you have with the board about considering more dramatic strategic alternatives for the company. What do you think would be the right time for that. And I know we’ve talked about this a lot in the past is going private a real possibility to get away from all the headline risk with Achtar if it’s just always going to be there to a certain extent.

[00:05:50.940] – Mark Trudeau [Mallinckrodt]

So as you might imagine nobody is particularly pleased with where our share price sits today. And we have consistent and ongoing conversations at the board level about a range of strategic options. I’ll also note that over the last year to two years we’ve made some significant additions to our board and if you look at the composition of our board today it’s really predominantly industry veterans from the drug development and commercial side of the pharmaceutical industry. So we’ve got a lot of expertise on our board. It’s quite clear though in our board discussions that the things that we need to do now regardless of where we take the company strategically are to reduce and eliminate as much uncertainty as possible and as I’ve just described we’re well on the process to doing that. So any additional bigger things that we might do and of course we consider a whole range of strategic options consistently would unlikely would be unlikely before we certainly separate these two businesses but our belief is that with the development of our pipeline with the clearing of many of these uncertainties with some of the very compelling acts are data that we’ve already presented in the market in a number of other additional studies yet to come. We think in the next six to 12 months certainly we’ll have a much clearer idea of what the brand and cultivated business is going to look like on a go forward basis.

[00:07:23.100] – Garry Nachman [BMO]

OK so let’s talk about the evolution of the Achtar franchise and you have you talked about some of the datasets that came out recently and you’re going to have some more in the near term. You have a pre filled syringe that’s coming out. So and you know understanding that given the recent decision by CMS HHS Medicaid that could hit Achtar by about 10 percent annually so how do you feel about the durability of the actor franchise with all those different moving pieces. Do you think it could hover in that sort of billion range. Obviously you want to return it to growth but understanding the pressures that you’re seeing that it’s just hard to overcome.

[00:08:17.210] – Mark Trudeau [Mallinckrodt]

Yes certainly there’s some near-term pressures and uncertainties and I think you know the CMS issue is one that as I said will resolve to relatively quickly you know regardless of where the CMS issue develops we’re working much more long term at Achtar and looking at an opportunity potentially to even create two different brands there. We have a prefab syringe in development as you mentioned. Much of the adult indications suspect all of the adult indications are really more suited for that particular formulation the multi dose vial was really for weight based indications and really the only indication there that requires a multi dose file would be the infantile spasms indication. So coupled with the emergence of clinical data as well as two different presentations over time we could potentially see two very different approaches to Achtar, the data and the pre filled syringe in combination. Really give us a lot of opportunity to think very differently about how we enable greater access for a variety of patients. For example when you have a pre filled syringe which is actually a unit dose as well as data like we just saw with the RA Data you can enter into some very interesting value based contracting with payers and we’ve already started to have those discussions as the RA data emerged. When you can take refractory RA patients who have tried and failed or on background therapy and they still have active disease and you can still convert two thirds of those into low disease activity that’s a pretty significant finding. Now we also have information that describes the appropriate dose and duration and what prep prescribers and payors can expect when treating for 90 days. And then what to expect whether they take the patients off drug or continue their main drug for another 90 days. That’s very valuable information that we can engage payers and prescribers on in a much different way than we have before. And when you have a unit dose available to you that can certainly give you additional flexibility and we expect studies like the M.S. study that’ll be out in the next couple of months here. The M.S. registry our lupus trial which should be reading out potentially in the fourth quarter early for the first quarter. You’ve got sarcoidosis you’ve got uveitis all primarily adult adopt indications that again we believe if they’re positive can provide significant long term growth opportunities for Acthar simply because we have relatively low patient penetration rates and this modern clinical data we think is crucial to that recognize. Now with the RA data that makes the third indication after I.S. and M.S. where we have controlled clinical data demonstrating strong emphasis efficacy with the drug in very difficult to treat patient populations and that’s the most important positioning of this product long term.

[00:11:34.270] – Garry Nachman [BMO]

Okay. And with the recent announcement about the Medicaid change in terms of calculating the rebates what is the realistic exposure to the company for those potential retroactive payments. The stock got hammered when that was announced so people are assuming a worst case scenario there. So maybe just throw the range out there and you know why you think you have a good case.

[00:11:59.660] – Mark Trudeau [Mallinckrodt]

Well certainly you know we’ve been very explicit about what we think the potential range of exposure is and you know it’s not for me to determine what the ultimate resolution will will be that’ll be something that the judge will determine. As you know the government what the government can and can’t do is certainly  to be interpreted by the judge. But what we do know is the government is required to follow a certain process. And so our suit is really fundamentally based on following that process. You know in the worst case if we were to lose everything the exposure could be up to six hundred million dollars in arrears. And that simply is going back to the original 2013 date. One of the reasons why we published our complaint and the letters that we got from CMS were that the previous owner got from CMS confirming the appropriate use of the NDA with the CMS based state AMP very important to establish that record. You know our view is that going forward you know there may be an exposure but certainly in arrears there’s unlikely to be an exposure. I mean we really can’t determine that at this point until we go through the whole process with the whole legal process but we actually think there’s quite a strong case frankly for the whole thing to to potentially not be valid simply from the standpoint that the government has really not followed procedure at this point. That was I believe clearly articulated in our complaint over the next couple of weeks. Now the government will have an opportunity to respond to our complaint. We’ll have an opportunity to respond culminate in a hearing at the end of July and then the other thing that translated through to the stock pressure was people were so concerned about a potential spill over to Medicare. So are you worried about that.

[00:14:05.350] – Garry Nachman [BMO]

Just talk about how much of the business is Medicare and if there’s been any rumblings from CMS about changing anything on the Medicare front because that could have been a misperception.

[00:14:17.000] – Mark Trudeau [Mallinckrodt]

I think there is a big misperception on that really CMS can certainly do things in Medicaid under their appropriate governance that don’t apply at all to Medicare. And we have a great degree of confidence that there’s unlikely to be any impact on Medicare. You know Achtar really is not on any Medicare formularies today. And so there’s not really an exposure there if you will any action in Medicare would really require an act of Congress literally to change the system and CMS to the best of our understanding. It doesn’t have the ability to make any any changes to the Medicare reimbursement for act or so our confidence there is quite high. Medicaid is a completely different situation. And again our position is simply the government needs to follow a standard process whatever decision is made. But that process to date has not been followed.

[00:15:17.460] – Garry Nachman [BMO]

Okay, All right let’s shift over to the generic spend which sounded very confident that that’s going to happen in the next three to six months or so. But do you still think that now is the right time to do that given all the concerns with generics and opioid exposure. Doesn’t sound like you think there are real hurdles to completing this spin so just explain that and then maybe for you Bryan how are you thinking about the expected leverage for both spin co and remain co now that you pull them tease out from spin co so that dynamics here have changed a little bit.

[00:15:57.150] – Mark Trudeau [Mallinckrodt]

Yes. So again we’re very confident that these businesses can and will separate in the timeframe that I just described certainly as early as the end of the third quarter. We believe again if you didn’t have this kind of opioid litigation that was ongoing the strategic rationale for separating these two businesses is quite clear. And we’ve been very public in the market for probably about two years that these are two businesses that are heading in dramatically different directions. And you know the Generics business has been really operating almost completely independently within Mallinckrodt for almost two years now and there’s really no synergy between the two product the two parts of the business. So the strategic rationale is sound. And each of these businesses now are pursuing dramatically different strategies going forward at this point. Again we’ve continued to systematically execute a plan for separation. I outlined a couple of those elements one of the big elements I think one of the big elements of uncertainty was our ability to put leverage on this business. And again as you saw we we declared publicly that we would be putting approximately three hundred million dollars of debt on this business with EBITDA number in excess of 150 million dollars and we would look again at a net that leverage ratio. Then obviously in the range of two times which would put us put that business in a very healthy position given the significant amount of cash flow that that business creates. We’ve also been very pleased with the performance of that business. The business continues to return to growth. We showed the first quarter that first quarter that in the first quarter and our confidence in that business continuing to grow now an entry a growth cycle continues to be high. We’ve also seen further development of that business this pipeline which will be a significant driver of growth in the future. And those elements really enabled us to put the empties the assets back into the branded business. Original thinking was that amitiza would help that business spin. Now with the strength of that business that we were seeing and the emergence of their pipeline there’s really no need for that asset which helps us on the branded side as well. So overall again our confidence in the ability to spin and the ability put leverage is quite high. We’re in advanced talks with with lenders to put the leverage on that business. Bryan can describe to you the details of how that’s going to work.

[00:18:44.690] – Bryan Reasons [Mallinckrodt]

Sure. Thanks to spin we’re most likely looking at a capital structure that’s going to be predominantly an ABL revolver and kind of where we’re land we’re landing on that just because it gives spin co’s management team a fairly low cost to capital and really more importantly gives them flexibility going forward. So we’re not going to saddled with a debt structure that they can’t change if they want to. The other part of your question is kind of how remain would like if we announced at the time of spin that we’d deliver over a billion dollars at the time and by the time we spend and you know we’re well on pace for that. I think at the end of the first quarter we announced that we’d delivered 460 million. We continue to be in the market. We do have an unusual situation where are most of our debt is trading at a pretty nice discount. And the company has incredibly strong cash flow. So we’re we’re certainly trying to take advantage of that. But we’re at the end q1 we’re at four point two times leverage and we’re continuing to aggressively deliver.

[00:20:02.570] – Garry Nachman [BMO]

OK to spin co you said the net leverage is going to be about?

[00:20:10.450] – Bryan Reasons [Mallinckrodt]

2x or less

[00:20:10.450] – Garry Nachman [BMO]

Okay

[00:20:10.870] – Bryan Reasons [Mallinckrodt]

So if you look at yeah if you look at compared to its generic peers haven’t really clean balance here compared to the peers.

[00:20:20.110] – Garry Nachman [BMO]

Okay. And then before we get into some of the other parts of the business I think it’s important to cover all this. You know your operational execution has been good. As you said at the outset delivering strong earnings and cash flow despite all the concerns out there but and is obviously very disappointing where the stock trades. It’s almost like there is a real risk of bankruptcy to just spend a couple of minutes about how you feel about your ability to service all that debt. Also in light of the spin and how you’ll be able to deliver after that.

[00:20:54.100] – Mark Trudeau [Mallinckrodt]

Sure. Yeah I mean we’re very confident about our ability to continue to operate this business very successfully. I think you know oddly enough are where our debt is trading it is helping us facilitate the separation it’s helping us deliver much more rapidly than we even had planned for just as as Bryan described our stated goal of reducing debt by greater than a billion dollars were well ahead of that going forward we’re a very profitable business. We generate a significant amount of cash. We talk all the time that you know it’s a interesting position to be in our market cap is about equivalent to our annual cash flow and our debt is trading at such distressed levels that it’s a great opportunity when you have as much cash as we do to take a tremendous amount of debt out of the market. We think about this primarily as a way to position ourselves for a longer term strategic moves are going to continue to enhance the growth prospects prospects of the business. The other piece of it obviously is that we’ve got a couple of new product launches that we’re anticipating could come in 2020 as well as enhancements to our apps our franchise our INOmax franchise with our evolved device as well as our long term commitment to the Therakos franchise. So all of these things we think positions us quite well for the future. Importantly we’re taking full advantage of the market conditions today to position our balance sheet even stronger going forward.

[00:22:32.950] – Bryan Reasons [Mallinckrodt]

I guess just to add a couple of things you know if you look at our current cap structure it’s a very covenant light structure. Our projected cash flows. We see no issue in servicing the debt and we do have quite a bit of secured secured capacity available to us as well.

[00:22:55.750] – Garry Nachman [BMO]

Okay. And then I guess one of the biggest concerns is just where Achtar is going to end and there’s a pretty wide range out there. If it doesn’t end up as favorable as you would like it this continued pressure just maybe spend a minute on the flexibility that you have behind that with the investments that you’ve been putting behind that business and how much of a leverage you would have there to manage in the event of a bad scenario with Acthar.

[00:23:28.140] – Bryan Reasons [Mallinckrodt]

Across our P&L we’ve got a lot of flexibility and I think one of the hallmarks of the company is that we’ve been very good stewards of the expenses and we can have continued I think to be quite thoughtful about how do you operate profitably. And we’ve got more room to do that in the event that everything went south which obviously where we don’t believe that that’s the case. But you know you do have to think through these things to ensure that you’re in a good position. We’ve done that exercise and you can all see it in the middle of our P&L. there’s plenty of room for us to continue to optimize particularly in the event that you had a bear case. Importantly though and I think you asked a very particular question Gary which is how do we think about Achtar and its durability for the future. And we’ve been quite clear for the last year or so that the future of Achtar will be highly dependent on the robustness of the clinical data. We are very pleased that the first one out of the box the Achtar RA data was so strong the data was very very compelling and it played out very much like we were hoping in that for those highly refractory patients where there’s a big patient population acts are clearly has a place and you can see how to get there. We also believe again as I described that pre filled syringe and the emergence of data really give us a lot of flexibility to think about driving the volume based growth over time given now that we have three indications that have modern controlled clinical data either placebo controlled or active controlled that demonstrate the efficacy of this product in three key indications infantile spasms acute exacerbations and multiple sclerosis and now refractory our patients with just a couple more in you might not even need maybe but one or two more out of the six or so that we have running you can see that the efficacy position in the utility position of this product should be clearly established. That then gives us the opportunity to think about creative ways to creating more access to more patients and we think that pretty filled syringe and value based contracting is really the way to think about that and all of this should play out in the next 12 no more than 18 months or so.

[00:25:54.970] – Garry Nachman [BMO]

OK let’s shift over to the hospital business which is a nice pillar of Europe that still remains so under appreciated so just any updates on potential item competition from Praxair when that when you think that might occur. And then just how the contracting has been for INOmax the last conference call you said it’s been pretty strong. So how much visibility you have for the next couple of years.

[00:26:20.070] – Mark Trudeau [Mallinckrodt]

Yes so the INOmax business and the hospital business as a whole continues to operate very well. You see that we’re posting in aggregate high single digit growth for that business and have been for quite some time. We would anticipate as we’ve said in our previous earnings calls for that to be the case in 2019 let’s also recognize that we do have an appeal for the INOmax intellectual property that’s pending that could happen at any time we would anticipate that to be resolved again by the end of the year or so. Another area of uncertainty but I want to be very clear we are fully assuming that that appeal could go negative. Appeals are difficult and even though we have a strong case appeals and overturning original rulings can be challenging regardless of the outcome of that appeal. While the near-term impact on INOmax could be a little choppy for a couple of quarters our long term view is that as a very robust business the evolved platform could dramatically change the way nitric oxide is delivered in the marketplace and we continue to invest in that portfolio going forward. So again that’s one that we feel quite good about over the long run regardless of the outcome of the appeal. Therakos as a business that consistently is delivering primarily volume based growth in the high single digit range it’s now approximately about a 250 million dollar or so based business and we would anticipate that business to continue to grow as well a firm as it’s well known that we’re facing a loss of exclusivity at the end of 2020. That business again has been growing in the low double digits and we would continue to foresee that certainly for a better time going forward. So overall the hospital business is very healthy. Importantly the two products that we have that are reading out in the next two months or so two to three months in terms of precedent and strategy graph are both hospital based businesses that would slide right into our hospital platform and we would anticipate over time that the peak year sales for the combination of through the press and strata gaffe are likely to exceed those of a firm of once it loses exclusivity. So we think the hospital business is very healthy today and has a very good future going forward with a very attractive pipeline. There are other products in our pipeline that are behind those first two that also would slide into that hospital based platform.

[00:29:00.150] – Garry Nachman [BMO]

Okay. So let’s continue on the pipeline and you know you sound very excited about both of those opportunities STRATAGRA and TERLIPRESSIN just how are you feeling about the Phase 3 data readouts the likelihood of success and why this is different than some of the other data readouts you had so far in your pipeline over the last year.

[00:29:22.620] – Mark Trudeau [Mallinckrodt]

Sure. So these two products are in phase 3. They’ve had development platforms that are a little bit more traditional if you will in the case of TERLIPRESSIN  and we have completed the largest trial ever done in hepatorenal  syndrome type 1300 patients it will have it’s essentially a response to a complete response letter and it’s operating under a spa. So if the data is positive and of course it’s a phase 3 trial and has a similar kind of likelihood of success to any traditional large scale Phase 3 trial but the data is positive. The road to approval and launch is relatively rapid because of the two components of CRL and and operating under a spot. Confidence. Again if the data is positive that we get two launches is quite high. Likewise on STARATAGRAFT again a traditional kind of phase two phase 3 development program we’re seeing at least initially in our Phase 3 information. What we can see in a blinded fashion that we’re replicating what we saw in Phase Two getting that trial has now been complete and we’re waiting for a last patient last visit and the final readout which will occur sometime late third quarter early fourth quarter. That’s one again that’s likely to have a very similar likelihood of success to any traditional Phase 3 program. The programs where we’ve had some initial challenges in stance support often and VTS 270 are both less traditional and higher risk programs. Sometimes you can’t pick when these things come certainly in the case of stand support and this was an asset that we brought on with not a lot of investment with the anticipation that there was the potential for the product get approved just on the basis of Phase 2 data that proved not to be the case and we’re evaluating next steps on that brand and  270 again very ultra rare disease condition. A curious finding in the Phase 2 to be Phase 3 program. A curious finding that in this traditionally neurodegenerative disease that you saw both placebo and active arms not regress unusual finding. We’re discussing now with the with the agency if there is a pathway to approval for VTS agency has been very clear that they want to evaluate all the information. The challenge here is that many of the patients in the market were really just no a couple of hundred have been on this product now for a quick extended period of time appear to be doing quite well and there are alternatives going forward appear to be pretty limited so remains to be seen where VTR 270 is going. But VTS 270 instance supports and completely different development platforms than STARATAGRAFT and TRELIPRESIN and again our confidence in those two programs STARATAGRAFT and TRELIPRESIN  are simply based on a traditional kind of phase 3 development and should have a similar likelihood of success to any other Phase 3 development program.

[00:32:47.310] – Garry Nachman [BMO]

OK. We have a couple minutes. Are there any questions in the audience. It’s early morning so I’m guessing probably not. Yes please go.

[00:32:58.190] – Audience Member

You mentioned June 15th a settlement with regarding DOJ. regarding the litigation but you didn’t settle on the foundation. So can you give us an update on that Mike. Mean that was 2010 and 2014 activity five years past. Why not the settlement there. You know what’s still going on. Why is it still hanging out there.

[00:33:25.740] – Mark Trudeau [Mallinckrodt]

Yes. So you know when we started with the DOJ on the sales and marketing piece of the complaint that dated back to legacy activities we did so because it was quite clear that that was the right thing to do to settle that piece of it in the context of you know non legal jargon. The governments showed us a little smoke no fire and so you know we wanted to dispose of that. In the case of the charitable foundations piece the government really didn’t present even any smoke. So there was no reason actually to settle anything because we don’t know that there’s anything there we haven’t seen anything. Clearly we would like to eliminate at a minimum reduce any uncertainty around all of these issues recognized as well there is also a case in Boston where we’re involved with 20 plus other companies looking at charitable foundations and sales and marketing activities from the period going forward from the 2014 timeframe until today. And so clearly you’ve got two cases going on both of which have similar elements and you’d likely you’d like to be able to dispose of all of those at once if you can. So rather than do this piecemeal and certainly when you’re not presented with any information the rationale for settling with it was was not there.

[00:34:58.430] – Bryan Reasons [Mallinckrodt]

I think it’s important if you look at it we think we have a great case but the last handful of foundations some contend for fairly diminished now what race for sub 50 million OK.

[00:35:15.380] – Garry Nachman [BMO]

Good job you took it down to the wire. So thank you guys. So thank your for participating Mark Brian and Dan Enjoy the rest of the conference everyone appreciate a great day. Thank you.

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