Earnings Labs

Lantheus Holdings, Inc. (LNTH)

Q2 2016 Earnings Call· Sat, Aug 6, 2016

$80.44

-3.72%

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Transcript

Operator

Operator

Good afternoon, ladies and gentlemen. I would like to welcome everyone to the Lantheus Holdings’ Second Quarter 2016 Earnings Conference Call. This is your operator for today’s call. Please note that all lines have been placed on mute to prevent any background noise. This call is being recorded for replay purposes. A replay of this call will be available approximately three hours after conclusion of the live call through August 16. I would now like to turn the call over to your host for today, Mr. Meara Murphy.

Meara Murphy

Management

Thank you and good afternoon everyone. Welcome to the Lantheus Holdings Second Quarter 2016 earnings conference call. We appreciate you joining us. I’m Meara Murphy, Director of Investor Relations and Corporate Communications for Lantheus. With me on the call today are Mary Anne Heino, President and Chief Executive Officer; and Jack Crowley, Chief Financial Officer. Please note that earlier this afternoon, we issued a press release reporting second quarter 2016 results. We are also filing with the SEC our Form 10-Q for the quarter ended June 30th, 2016 later today. You will be able to find both of these documents in the Investor Relations section of the Lantheus website at lantheus.com. The agenda for this call will include an opening summary from Mary Anne, a review of our financial results and an update for our financial guidance from Jack, and then a review of our 2016 corporate priorities from Mary Anne before we move into our question-and-answer session. Before we begin, I would like to remind you that remarks during this call will include some forward-looking statements, including statements about our outlook for 2016 and other predictions or estimates regarding the future of our business. Matters addressed in these statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. The forward-looking statements made in today’s call speak only as of this original date and except to the extent required by law, we do not undertake any obligation to update any forward-looking statements. We caution you again for placing any undue reliance on any forward-looking statements. Additional information regarding forward-looking statements appears in the safe harbor section of today’s press release. Information about a specific risk and uncertainty is contained in our SEC filings including our annual report on Form 10-K filed with the SEC on March 02, 2016 and in our Quarterly Reports on Form 10-Q including that which we’re filing today with the SEC. Copies may be obtained at sec.gov and on our website at lantheus.com. On today’s call, we will also discuss certain non-GAAP financial measures with respect to our performance. We use these non-GAAP indicators for financial and operational decision-making and as a means to evaluate our performance. The definitions of EBITDA, adjusted EBITDA, operating income as adjusted and net income as adjusted along with the reconciliations to GAAP metrics are set forth in our earnings release which was filed today on Form 8-K. Copies may be obtained at sec.gov and on the company’s website at lantheus.com. Please note that unless indicated otherwise, all of our commentary on today’s call will make reference to as adjusted results. With that introduction, it is now my pleasure to turn the call over to our CEO, Mary Anne Heino. Mary Anne?

Mary Anne Heino

President

Thank you, Meara. And welcome to everyone joining us today on our conference call. I’ll begin our discussion today with a high level summary of our second quarter 2016 results before handing the call over to Jack for a more detailed review of our performance and guidance. Then I’ll return to provide an update of progress against our three corporate priorities for 2016. So let me start with a review of our second quarter 2016 performance. We posted strong second quarter results with $78 million in revenue, exceeding our second quarter guidance of $72 million to $74 million. Year-over-year, our second quarter 2016 revenue increased by 6% as reported and 7% on a constant currency basis. Additionally, our net income for the second quarter totaled $7.4 million versus a net loss of $24.4 million in second quarter of 2015, an improvement of $31.8 million year over year. We also well exceeded our second quarter adjusted EBITDA guidance posting $21.4 million versus our guidance of $14 million to $16 million. Sales of TechneLite to customers are higher than their contracted volumes with a key driver of our over performance in Q2. In addition, DEFINITY and certain of our other products also contributed to our strong performance. Overall, we are pleased with our second quarter results and the continued solid performance of our key products. I’ll expand further when I update you on our corporate priorities later in the call. Now, let me turn over the call to Jack for a detailed review of our second quarter 2016 financial results, and an update on our financial guidance. Jack?

Jack Crowley

Chief Financial Officer

Thanks, Mary Anne, and good afternoon everyone. The tables included in today’s press release as previously noted include reconciliation of our GAAP results to the as adjusted performance I will be covering with you today. A particular of note those tables include the reconciliation of our GAAP net income to adjusted EBITDA which is a metric we consider to be particularly relevant at this time due to the variability of our technology transfer activities and related costs. In total, second quarter 2016 delivered $78 million in revenue. As Mary Anne stated, we feel that our continued successful execution of our contracting strategy for our nuclear medicine products and our continued attention to driving DEFINITY revenue are the key drivers of this performance. Looking at our revenue results on a product line basis, DEFINITY outperformed delivering revenue of $33.5 million in the second quarter and growth totaling 18% and 7% on an as reported basis as compared to the year ago and prior quarter respectively. Our TechneLite business posted worldwide revenue of $25.3 million for the second quarter increasing by 45% and 2% as compared to the year ago and prior quarter respectively. This improvement versus prior year was the result of our contracting strategy. And in terms of the sequential quarter, similar to the first quarter, in the second quarter, we were able to capture incremental sales of TechneLite with customers who purchased at volumes in excess of the contracted commitments. Xenon revenues, which represented 9% of our total sales during the second quarter totaled $6.8 million, a decrease of 44% versus the prior year, and a decrease of 17% versus the prior quarter. This decrease versus the prior year was expected and driven by the execution of our contracting strategy. With respect to the results versus the prior quarter,…

Mary Anne Heino

President

Thank you, Jack. I would now like to share an update on progress against our 2016 priorities. To refresh, our 2016 priorities are, one, grow revenue and unit volumes of our commercial portfolio. Two, advance our pipeline assets and business development opportunities, and three, create efficiencies in our operations and optimize our capital structure. First, with respect to growing revenue and unit volumes of our commercial portfolio with an 18% increase of sales for the year over year quarter, DEFINITY delivered excellent growth with consistent unit performance in a competitive ultrasound contrast market. Both the echo market and contrast penetration delivered as anticipated in the second quarter. Our key U.S. nuclear products continue to deliver revenue and product volume reflecting strong execution and alignment with our contracting strategy. Impressively, TechneLite sales were up 45% year over year. While a portion of this is driven by opportunistic sales in Q2, the larger contributor here is the positive revenue from our nuclear products contracting strategy. The second quarter was the first full quarter of commercial availability of a competitive Xenon product. With Xenon’s highly contracted through our multi-year agreements we have in place with key radio pharmacy groups, we continue to be the leading supplier of this important agent. Internationally, we continue to advance worldwide expansion of DEFINITY. As I shared with you last quarter, we re-entered the EU with CS Diagnostics. We have now expanded our European footprint to renew distribution agreement with Lama Pro BD, executed in the second quarter which gives us access to the UK and the Netherlands. We are committed to continually expanding our DEFINITY footprint. Additionally in Canada, the divestiture of our radio pharmacy during the first quarter has produced the beneficial bottom line financial results we anticipated, and as evidenced in the second quarter result.…

Operator

Operator

[Operator Instructions] Our first question or comment comes from the line of Matt Keeler from Credit Suisse. Your line is open.

Matt Keeler

Analyst · Credit Suisse. Your line is open

Hey guys, thanks for taking the question. Can you hear me?

Mary Anne Heino

President

We can, Matt.

Matt Keeler

Analyst · Credit Suisse. Your line is open

Perfect. So I guess just to start, the 2Q performance is very strong vis-a-vis by $5 million versus the midpoint of guidance similar to last quarter, the full year guidance raised a little bit less than the beat. Is there anything in the second half that you’re more cautious on?

Mary Anne Heino

President

I’m going to start, Matt and I’ll turn it over to Jack. We are thrilled with the first half of the year, and I think you’ve heard us say on both of our calls now that in both of those quarters, we had higher than contracted volumes with some of our products. And that certainly contributed to our over-performance. Looking at the back half of the year and as we forecast, we do not forecast for that type of activity. And so that might look at the back half a little lower or a little lighter than the first half. Jack?

Jack Crowley

Chief Financial Officer

Yes. Thanks, Mary Anne. The only other thing that I’d add into that, Matt, is the second half of the year will reflect the full impact of some of the things that happened during the first half of the year. So if you think about the divestiture of the Canadian radio pharmacy during the first quarter, you think about the entrance of the Xenon competitor in the second quarter, that gets reflected fully in the back half of the year versus only partially in the first half of the year. And another thing that we tend to look at is a couple less selling days in the second half of the year than the first half of the year. So that probably covers the dynamics of what you’re saying.

Matt Keeler

Analyst · Credit Suisse. Your line is open

Okay, perfect. Thanks. And then could you give us any more color on the Xenon competition that you’re seeing, I don’t know if there’s an easy to do it, but maybe where you ended up in terms of market share at the end of the quarter versus start of the quarter, something like that.

Mary Anne Heino

President

So Matt, we don’t report market share for Xenon, and actually until the start of the second quarter, I guess you could say, with a 100% market share, but we were measuring it out there. What I can tell you is as we’ve shared, the second quarter was a full quarter of the presence of another Xenon offering in the marketplace. If you do the math on our sales quarter on quarter, I think what you’ll see is that our sales second quarter versus first quarter were down by 17%. I think that gives you a feel for the run rate.

Matt Keeler

Analyst · Credit Suisse. Your line is open

Perfect. That’s all, thanks.

Operator

Operator

Thank you. Our next question or comment comes from the line of Larry Biegelsen from Wells Fargo. Your line is open.

Larry Biegelsen

Analyst · Wells Fargo. Your line is open

Hey guys, thanks for taking the question. Congrats on another good quarter. Just a follow-up on Matt’s question. Should we assume that the competitor, your competitors no longer supply constrained on TechneLite given the guidance.

Mary Anne Heino

President

Larry, I don’t think we are trying to suggest that. When we talk about opportunistic sales, I think we all recognize that this is a supply chain that does have some kinks and cracks in it from time to time since we’re all sourcing from medical reactors that are located around the world and may find time to come into contact with either logistic issues or other types of issues. So I’m not trying to suggest on a forward-looking basis that we are aware of or we try to predict those types of occurrence.

Larry Biegelsen

Analyst · Wells Fargo. Your line is open

I guess I’m just wondering if you could give us a little more color on what led to the second quarter in a row over-performance there, and why we shouldn’t – certainly it doesn’t look like the guidance bakes that in. So maybe you can give us a little bit of color why it happened two quarters in a row and you don’t expect it to happen going forward?

Mary Anne Heino

President

So I’ll be clear, Larry. I don’t know what will happen going forward and we don’t get forward-looking guidance. But as you noted about baking into our forecast, I think what you’ll hear from Jack and I that we are willing to share is that you will not see us baking into our forecast for any future period, something that we see as opportunistic from a prior period. These are highly contracted volumes. And when we see opportunistic sales for certain of those products, it’s because we offer the temporary ability to provide at higher than contracted volume. I would not bake that in on a future basis.

Larry Biegelsen

Analyst · Wells Fargo. Your line is open

Okay, fair enough. I wanted to ask just two more questions, one, on 2017. Can you talk about – there’s a few different agreements. You have the Cardinal agreement, you have the Canadian sale. Can you talk about the time of the Cardinal agreement which was November, 2015, you said that your nuclear business sales and gross profit will be higher in 2017 versus 2016. Does that – and I think that was for the company based on my interpretation of the 8-K. Is that still the case given the strength in TechneLite in the first half of 2016? I did have one other question.

Mary Anne Heino

President

So again, Larry, I’m going to differentiate between contract, contracted sales and then the actual sales of experience in the quarter which may outperform a contract because we’re offered the ability to do so. You also referenced the Canadian business and that is also now highly contracted. We replaced what was direct ownership of our radio pharmacies with the long-term supply agreement. That’s a very stable outlook. But looking out to 2017, what I can share is what we’ve shared previously and that is as we look across the contracted position that we have with the nature of radio pharmacy team that’s applied to U.S. market. What we’ve shared previously is that with two of those customers are contracted position actually enlarges or increases in 2017 and therefore from a contracted basis, we would see higher revenue from those contracts.

Larry Biegelsen

Analyst · Wells Fargo. Your line is open

Fair enough. And then on the next generation DEFINITY, I think on the Q1 call, you said it was an active program with the new formulation and indications, I believe, being assessed. Can we get an update – when can we expect an update on that? And I guess the big question really is do you expect something to be approved before the patent expires on DEFINITY in 2019? Thanks for taking the questions, Mary Anne.

Mary Anne Heino

President

You’re welcome. Larry, from what we’ve shared previously, we have – I think offered that as a new formation. I have not spoken specifically to indication. We called it a next-generation program for our asset DEFINITY and that really does well describe it. I have also not shared an anticipated approval or launch date for that program and I’m not prepared to do that at this time. But it is an active program that we have underway.

Larry Biegelsen

Analyst · Wells Fargo. Your line is open

All right. Thanks for taking the questions, guys.

Mary Anne Heino

President

You’re welcome.

Operator

Operator

Thank you. Our next question or comment comes from the line of Jeff Johnson from Robert Baird. Your line is open.

Jeff Johnson

Analyst · Robert Baird. Your line is open

Thank you. Good afternoon. Can you hear me Okay?

Mary Anne Heino

President

I can, Jeff.

Jeff Johnson

Analyst · Robert Baird. Your line is open

Great, Mary Anne. Good afternoon. And my phone is cutting in and out here a little bit, so I apologize if that happens. But I just wanted to follow-up on Larry’s question, maybe just be a little more direct as far as the out of contract overages this quarter. On the TechneLite side, in looking at Mallinckrodt’s call, listening to their call this quarter, I don’t hear anything about whether they’re back in the market on the Mali [ph] side or on the generator side. Have you heard anything in the channel, are they still out of the market, are they back in the market, any updates there just – and if you could size maybe of the growth in TechneLite this quarter, revenue dollars, was it an extra $3 million, $5 million that was out of contract? Any size you could put on that would be helpful.

Mary Anne Heino

President

Yes, I will start. I apologize, whenever I can’t answer questions. I know you do ask them sincerely, but I will not now nor will you hear me in the future commenting on my competitors. I would very much suggest that you contact my peer with those questions. But I do think we do report TechneLite sales on a quarterly basis. And you can look at the sales volume there. We do not give forward-looking product level guidance, so I won’t comment there. I will say this, as I said before, it’s a complicated supply chain that we have with nuclear products. And we all anticipate and we very much plan for – because our common goal is to serve, seamlessly serve the U.S. medical market, and that’s the goal that we all stay true to. But we will anticipate that our own supply chains will have hiccups time to time, and then whenever that happens, whoever can supply the marketplace does so to again protect the integrity and the continuity of supply limitation.

Jeff Johnson

Analyst · Robert Baird. Your line is open

Okay. That’s helpful. When those volumes are out of contract – I know in the past when things have been out of contract, that’s allowed you to take better pricing on those products. Do out of contract volumes tend to come at higher prices and therefore, I would assume that would flow through a higher EBITDA contribution as well?

Mary Anne Heino

President

Yes, no, in general though, the contracted price remains in place and it’s offered for whatever incremental volume is offered intermittently.

Jack Crowley

Chief Financial Officer

Yes, Jeff, I may just add to that that from an adjusted EBITDA perspective, sometimes we’re able to spread some of our fixed manufacturing costs across a wider range of revenue, so we can see a little bit of bottom line pick up on them.

Jeff Johnson

Analyst · Robert Baird. Your line is open

Yes, that would make sense. And then any update on DEFINITY in China? And then my last question would just be, I think Bracco got liver indication in the last couple of months or so in the U.S. with Lumason. Does that at all change the landscape, I know you guys don’t have that indication and I don’t think even trying for that indication, although correct me if I’m wrong. But does that all change the landscape of Bracco being able to go in with a couple of different products where – a couple of different indications with the same product, they can negotiate more on volumes? Anything at all like that that we should be thinking about?

Mary Anne Heino

President

So let me take your question separately. China first, I’ll address. I didn’t not offer an update during this particular call because it would not have been unchanged from what I offered in the last call. That was a very positive news in that our CTA was approved by the Chinese FDA, and we remain in the process now of the final details and structure of the clinical trial for two small confirmatory trials that will take place. That is very much underway. What you’ll next hear me announce when I’m ready to do so will probably be the start of those clinical trials. So that closes out my China response. As I move on to Bracco, and as I think I shared last quarter, because we actually shared last quarter that Bracco had received approval of that indication. We did that as positive news. The more potential uses and appreciation for contrast and enhanced ultrasound, we think is a positive driver in the marketplace. It does not change our strategy as to how we are handling ourselves in echocardiography. And as I think you heard me allude to in my final comments, we remain the majority leader, market share leader in this marketplace in cardiac ultrasound. We are always looking ways to expand appropriate use, and included in that is I’m sure everyone can well imagine, we have a new product committee that is always testing the waters and testing the economic principles of additional indications and the effort that it would take to receive them.

Jeff Johnson

Analyst · Robert Baird. Your line is open

Understood. Thank you.

Mary Anne Heino

President

You’re welcome.

Operator

Operator

Thank you. Our next question or comment comes from the line of Anthony Petrone from Jefferies. Your line is open.

Anthony Petrone

Analyst · Jefferies. Your line is open

Thanks. Maybe just stay on DEFINITY for a moment, maybe to just get an update on the general level of penetration of ultrasound across sub-optimal ECGs broadly. And then you mentioned share in your prior comment. Maybe just an update on share between DEFINITY, among DEFINITY, GE, and of course Lumason.

Mary Anne Heino

President

Anthony, I’ll offer you what we do share publicly from a contrast penetration rate data points. Approximately two quarters ago, we stopped sharing specific contrast penetration numbers. And the reason I offer then which is true and remains valid is that because we are reliant on a single source for those data and because we’re well aware that it’s survey data, I was uncomfortable with sharing specific numbers rather than the sharing trends. And as I alluded to earlier in the call, perhaps I wasn’t specific enough, what we saw in the second quarter is that at two levels, which is the total volume of echocardiography exams being performed in the marketplace, as well as the penetration of contrast in that market. Second quarter is delivered as forecasted, which in both cases meant that we saw improvements or growth in those two indices. The other two drivers in the market are market share and price. We do not offer specific market share percentages, but as I also alluded to in my comments, we retain and remain market share leader in this marketplace which we’re very proud of and we think that a lot of our commercial efforts warrant [ph]. Price is not something that we speak to relative to our product.

Anthony Petrone

Analyst · Jefferies. Your line is open

Very helpful. Maybe to shift gears a bit to the imaging side of the business and specifically Xenon and TechneLite and you alluded to the NRU shutdown later this year in your comments. How do you see the pricing environment for those two imaging agents specifically going forward just considering that the market broadly will be supply constrained?

Mary Anne Heino

President

I’m not going to agree that the market will be supply constrained. In fact I think that we worked very diligently over the last several years to ensure that there’s a smooth transition to our inbound supply when NRU goes offline. And that coming date has been well-known to us for over two years now. So we’re well-prepared for that. Our contracting already exists for years past. So there will be no change in our pricing dynamic on an inbound perspective when NRU shuts down. On an outbound perspective, we’re also highly contracted already out through at least 2017 with our major radio pharmacy customers.

Anthony Petrone

Analyst · Jefferies. Your line is open

And then my last question will just be on flurpiridaz. You had some data out at ACC on obese patients and showed the benefit versus SPECT imaging. I believe there are other sub-analysis that are ongoing, so any update on other sub-analysis and anything you can share in terms of the search for a partner. Thanks.

Mary Anne Heino

President

So two separate questions I’m hearing there. On the sub-analysis that you’re absolutely right. At ACC, we presented data that looked at our 301 trial and looked specifically at the subgroups of females and patients who met the criteria for obesity. And what we demonstrated very convincingly is that the value principle is even more proven when you look at those subsets which by the way are two of the subsets, or two of the subgroups that are most challenging to image and therefore where the value really demonstrates itself. As I mentioned, we have advanced our discussion for a commercial partner for a commercial and development partner, having nothing else I can add to that at this time. So I will continue to say, patiently.

Anthony Petrone

Analyst · Jefferies. Your line is open

And just a follow-up there, I mean, is 2018 still realistic for a launch, or…

Mary Anne Heino

President

I have not offered a launched date, Anthony. And honestly, I’m not prepared to do so on this call either.

Anthony Petrone

Analyst · Jefferies. Your line is open

Thank you.

Operator

Operator

Thank you. [Operator Instructions] Our next question or comment comes from the line of Anthony Esposito from Ares. Your line is open.

Anthony Esposito

Analyst · Ares. Your line is open

Hi. Thanks for taking my question. So given the earnings and the leverage trajectory here, any comments can you make about the current capital structure and potential refi opportunities given kind of the cost of your current debt?

Jack Crowley

Chief Financial Officer

Yes, Anthony, it’s Jack. We are very well aware of the leveraging with us, and it is something that we constantly talk about and think about. And we are certainly really excited about the results and the buildup of cash and recognize the need to – eventually we get a lot of questions, are you going to de-lever, are you going to de-lever, but we want to be very thoughtful and mindful that we’re using the capital in the best way to drive shareholder value. So we’ll continue to aggressively evaluate those opportunities.

Anthony Esposito

Analyst · Ares. Your line is open

Okay, thank you. Congrats.

Jack Crowley

Chief Financial Officer

Sure. Thank you.

Operator

Operator

Thank you. I’m showing no additional questions in the queue at this time. I would like to turn the conference back over to management for any closing remarks.

Mary Anne Heino

President

I’ll just say thank you everyone for joining today and we look forward to speaking with you again next quarter.