Earnings Labs

Lantheus Holdings, Inc. (LNTH)

Q4 2016 Earnings Call· Tue, Feb 21, 2017

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Transcript

Operator

Operator

Good afternoon, ladies and gentlemen. I would like to welcome everyone to the Lantheus Holdings' Fourth Quarter and Full Year 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 the audio webcast will be available in Investors section of the Company's website approximately two hours after the completion of the call and will be archived for thirty days. I would now like to turn the call over to your host for today, Gary Santo, Head of Capital Markets and Investor Relations. You may begin.

Gary Santo

Management

Thank you, Catherine. Good afternoon, everyone, and thank you for joining us for Lantheus Holdings' fourth quarter and full year 2016 earnings conference call. With me on the call today are Mary Anne Heino, Lantheus' President and Chief Executive Officer; and Jack Crowley, our Chief Financial Officer. Please note that earlier this afternoon, we issued a press release also filed with the Securities and Exchange Commission under Form 8-K reporting our fourth quarter and full year 2016 results. Within the next week, we anticipate filing our Form 10-K with the SEC for the year ended December 31, 2016. You can find these documents as well as a replay of this call in the Investor section of our website at www.lantheus.com. Remarks that we make today regarding future expectations, plans and prospects for the Company constitute forward-looking statements for purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors which we disclosed in more detail in the risk factor section of our Form 10-K. We remind you that any forward-looking statements represents our views as of today and should not be relied upon as representing our views as of any subsequent date. While we may update any such forward-looking statements in the future, we specifically disclaim any obligation to do so. Finally, on today's call, we may reference 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, adjusted operating income, adjusted net income, adjusted net income for diluted common share and free cash flow along with reconciliations to GAAP metrics are set forth in our earnings press release. On particular note, these tables include the reconciliation of our GAAP net income to adjusted EBITDA, a metric we consider to be particularly relevant at this time due to the variability of our technology transfer activities and related cost. Mary Anne will begin her comments today with a high level review of 2016, including progress made against our three corporate priorities. Jack will then offer a more detailed review of our 2016 financial performance as well as financial guidance for 2017, followed by Mary Annes corporate outlook for the year. With that, I will now turn the call over to Mary Anne

Mary Anne Heino

Management

Thank you, Gary. And welcome to everyone joining us today on our conference call. 2016 was a successful year for Lantheus as we delivered significant value to shareholders on a number of levels. A principal contributor to that success was stabilizing the base of business represented by our nuclear product portfolio. We successfully accomplished this through disciplined execution of our nuclear product contrasting strategy, which we started in the latter half of 2015 and had fully in place by the start of 2016. Additionally, the resource of approach to supply chain logistic coupled with our agile operational infrastructure provided a foundation by which Lantheus profited from unanticipated opportunities in the marketplace. Finally, our fiscal discipline drove improved free cash flow and continued reduction of our leverage and interest expense. We ended 2016 with an improved financial profile as compared to prior year, positioning us well to capitalize on the opportunities ahead of us. Before turning the call over to Jack, for more detail review of the numbers behind our 2016 performance, I'd like to summarize achievements against our 2016 priority. As you may remember they were; one, grow revenue and unit volume of our commercial portfolio; two, advance our pipeline asset and business development opportunities; and three, create efficiencies in operations and optimize our capital structure. With respect to growing revenue and unit, as expected, DEFINITY remains a key growth driver in 2016. From a marketplace perspective, we saw continued growth in the number of echocardiography studies performed, and more importantly the percentage of those procedures utilizing a contrast agent. We believe our industry leading sales force drove this to with their consultative approach. As a result, awareness and usage amongst industry participants continue to increase. In the same time frame, Lantheus maintained our leading share of the U.S. echo…

Jack Crowley

Management

Thanks, Mary Anne, and good afternoon everyone. The tables included in today’s press release, as previously noted include a reconciliation of our GAAP results to the as adjusted non-GAAP performance I will be covering with you today. I’d like to start by focusing first on fourth quarter results followed by our full year results and then 2017 guidance. In the fourth quarter of 2016, we delivered 74.4 million in revenue. As Mary Anne comments indicated, our continued focused towards driving DEFINITY revenue, as well as successful implementation of our nuclear products strategy were keys to our performance. Looking at our revenue results on a product line basis, DEFINITY once again delivered posting revenue of 34.1 million in the fourth quarter, a 5% increase compared to the prior quarter, and an 18% increased on a year-over-year basis. Our TechneLite business posted worldwide revenue of 24.6 million for the fourth quarter consistent with the prior quarter and a 44% improvement on a year-over-year basis. Opportunistic sales were contributed to our strong performance in 2016 accounting for approximately 8 million in revenues for the full year. Xenon revenues totaled 7.5 million in the fourth quarter, an increase of 12% compared to the prior quarter driven by customers buying are higher than contracted volumes. As expected, Xenon revenues were down 32% as compared to a year-over-year basis. Revenue from our other products category which represents approximately 11% of total revenue with 8.2 million during the fourth quarter of 2016, down 6.1 million compared to last year. This decrease was driven primarily by the divestiture of our Canadian and Australian radiopharmacy businesses in the first and third quarters of 2016, respectively. As we have previously discussed, these transactions were accretive to adjusted EBITDA. Moving below the revenue line, our fourth quarter 2016 gross margin excluding…

Mary Anne Heino

Management

Thank you, Jack. At this point, I would like to move on from 2016 and share our outlook for 2017. Jack and I both believe that Lantheus is well positioned for the future, while 2016 was a story about stabilization, 2017 will be the start of the story about growth. That growth will come from both organic and business development activity. Our capital structure now allows us to participate opportunistically across that spectrum. Today, we've heard as 18 announcements is one such example. We are excited about the prospects of GE Healthcare being our global partner to bring this next generation PET cardiac imaging agent to market, as GE Healthcare touches every level of the PET diagnostics delivery continuum and shares our commitment to serving the nuclear medicine community. The collaboration would enable us to participate in the long-term economic success as compared as '18. Lantheus will also continue to advance other pipeline assets, deploy additional resources towards the next generation programs for DEFINITY and pursue additional near-term business development opportunities to drive growth. Under the proposed transaction, GE Healthcare would completely fund the agents second phase preclinical study as well as worldwide regulatory approvals and worldwide launch and commercialization. Lantheus would collaborate in both development and commercialization through a joint steering committee and would also maintain the options to co-promote the agents in the U.S. GE Healthcare’s development plan would focus on obtaining regulatory approval in the U.S., Japan, Europe and Canada. Under the proposed transaction, we would receive a $5 million upfront cash payment, and if successful, up to $60 million in regulatory and sales milestone payments plus tiered double digit royalties on U.S. sales and mid-single digit growth on sale outside of U.S. Both parties anticipate entering into a definitive agreement for the proposed transaction in the…

Operator

Operator

[Operator Instructions] And our first question comes from Erin Wright with Credit Suisse. Your line is open.

Erin Wright

Analyst

What is your guidance assume in terms of growth rate across your core commercialized products and any normalizes or one-time factors we should be thinking about, as we think about quarter-to-quarter re-progression throughout 2017? Thank you.

Jack Crowley

Management

Hi, Erin, it's Jack. I'll take that. So, the way that we've guided, I want to impact your question a little bit. Most of the one-time items in any, we would capture to the adjusted EBITDA guidance, so you kind look at our revenue, revenue is pure, and then when you kind look at our FX between net income and adjusted EBITDA. I think we capture most of the one-time items through that adjusted EBITDA calculation. So when you look to that, you will see anything of our recurring nature. One thing I would think about is kind of the campus consolidation cost, which you can see broken out in our in the detailed reconciliations in our press release. So, I think that guidance that we give does contemplate, but again it adds it back to the adjusted EBITDA. You asked about co-commercialization and I don’t know, if you were referring to the agreement that we're talking about with GE. And at this point, if you think about the timeline ahead of us, there would be none of that that would be contemplated in the 2017 at this point. As part of guarantee that answered your question?

Erin Wright

Analyst

Yes, I guess I was thinking about the different growth rate assumed through the underline product lines, the commercialized products that you have?

Mary Anne Heino

Management

Erin, this is Mary Anne, and I will answer that for you. We do not offer guidance on a product side, product basis. We do talk about it respectively. I think what is fair to take away from the comments that we offer today is that DEFINITY continues to be a growth driver for our company and the growth rate that we see with that product exceeds that we see for our nuclear business. In 2016 and latter half of 2015, we work very hard and very successfully to ensure that we had a stable source of revenue and volumes for our nuclear business. And the contract that we signed that now come into play in ’17 actually call for greater volume in 2017 for some of the key nuclear products compared to the compliance commitment that had been in ’15. So that will be a source of growth rate when that's already predicted by the contract that we sign.

Erin Wright

Analyst

And then just on the GE relationship and collaboration there. When will that start to materialize financial refer you? How should we think about the development timeline? And then you alluded to potential other longer term opportunities with this collaborations. Could you potentially elaborate on that? And how could this potentially evolve beyond F 18? Thanks.

Mary Anne Heino

Management

Yes. So, the mechanics of the GE deal, once fully signed and as we shared, we anticipate that deal will be fully consummated in Q2 of 2017. The first economic factor that you’ll see will be the $5 million upfront cash payment that we will receive, and you will see the accounting treatment for that money getting through our ledger. The rest of 2017 will quite frankly be quiet because as I noted in my comments and as I think it’s also played in the press release. What happens next is GE undertakes all responsibility for the conduct of the second Phase 3 clinical trial, as well as the rest of the activities that relate to the March towards what will be regulatory approval and ultimately commercialization. So, we would not anticipate having any other financial events that occurring 2017. I’ll respond also to the final question that you post, which had to do with the future relationships with GE. It is common in this marketplace, GE as both a partner and a customer of ours, and they're very longstanding customer on receipt of our nuclear product portfolio that they deployed through their radiopharmacy in the United States. We absolutely accept that relationship to continue, it's one been in place for very long time, and one that is very healthy and enabled to both parties. So, you may hear us talking about that relationship as we go forward.

Operator

Operator

Thank you. And our next question comes with Anthony Petrone with Jefferies. Your line is open.

Anthony Petrone

Analyst

Just as it relates to GE, I’m wondering if you can maybe recap the market opportunity for F 18 both in the U.S. and non-U.S.? And then how the clinical sort of past two U.S. market clearance may change with the partnership? And then I have a follow-up on DEFINITY.

Mary Anne Heino

Management

Sure. Anthony, let me speak first to market opportunity in the U.S., quite frankly that's just quite large. And it’s one that we and GE are already very familiar with because we both operate in it. Currently, this market is mostly satisfied using the PET modality to conduct MPI or myocardial perfusion imaging studies using PET modality. The advantages use of PET modality and then agent flurpiridaz are quite dramatic in the clarity and the diagnostic surgency that it had to exam. So, we would anticipate in the future when the product is available that it will successfully compete and what it's firmly called MPI marketplace. I can tell you that on an annual basis currently there are approximately 6.1 studies, MPI studies conducted annually in the U.S. I’m not prepared as me to speak to the relevant size of all U.S. markets. I don't compete there right now and therefore I don't -- I wouldn't feel comfortable giving you what I would consider to be relevant to our up-to- date data. I think you had another question?

Anthony Petrone

Analyst

This is related to the clinical pathway now. How that may or may not changed with the partnership in place?

Mary Anne Heino

Management

The clinical pathway is dictated by the FDA and not by an individual company. As a refresher where we are, as a point in that clinical pathway is one Phase III study has been completed. The FDA has approved an SPA, which is a protocol for conduct of second study by then just how the FDA drives its own regulatory approval progress to require to conduct, two Phase III trials, which they are used to populate an NDA or new drug approval application, which is then offered to the FDA. And based on the assumption of paying a user fee, the FDA has approximately a 10-month window during which to consider the contents of your application and opinion back to the company as well as the applications complete and approval as is or whether there were questions that they would like to answer. As I mentioned while we, Lantheus, will fully involved with joint steering committee, GE will head that process as we go forward. And we anticipate given their longstanding presence in the United States medical marketplace, they have a well established relationship with the FDA that they will use as a value for that for the movement of that program.

Anthony Petrone

Analyst

Very helpful, and then the last one for me just on the DIFINITY would be on the label update that you announced in early February. Is that product specific to DIFINITY or was it category specific to just all contrast agents? And if it's sort of the former it seems that DIFINITY would have competitive advantage as it relates to label claims, but an update that would be helpful?

Mary Anne Heino

Management

It's a very fair question, Anthony. Now, I can answer very directly to you. While the label change was individually awarded to each of the three products that currently compete in the U.S. marketplace in the echo contrast. The net result to the labels for those three products is the same. Each of the products prior to their label change carries in the contraindication section, a contraindication against use in the patient population I mentioned. And as a result of each of the three companies for their products submitting for the change the FDA each of the label has been updated. Therefore, I think what a fair answer to your question is, the product, the three products are a par with reference to how that particular patient population is referenced in their package insert. And of course I would refer you to the package insert for the other products to confirm that. The effect maybe positive to the kind of larger issue of safe use of contract, and therefore may evidence itself of an increased contrast penetration rate, but it's probably too early to say that and we'll continue to monitor market.

Operator

Operator

Thank you. [Operator Instructions] And our next question comes from Lei Huang with Wells Fargo. Your line is open.

Lei Huang

Analyst · Wells Fargo. Your line is open.

I want to start with just a couple of financial ones. So, it looks like your adjusted EBITDA margin in the Q4 was 26% to 27%, but your guidance for 2017 suggests that margin is going to decline during the year. And just want to understand what accounts for that difference?

Jack Crowley

Management

Yes, it's Jack. I think the way that we look at it, just to take you back to, one of the things we have talked about during the year, the opportunistic sales we have with our nuclear products. May as you recall, I did a give a quantification of the year of about 8 million for this year 2016 and those opportunistic sales because they were really incremental to us. We have a greater margin on those and we do our baseline business. So, when we forecast to our baseline business we don’t capture that margin improvement that we gave at the opportunistic sales. So, if you were to kind of strip those out from the 2016 results and look at the margin our baseline business, I think we are pleased with the margin improvement that we predict in '17. But again those opportunistic sales are something we don’t forecast, but they do give us grater margins because we're spreading over a fixed cost base manufacturing, so all really picking up for those just the incremental raw material cost.

Lei Huang

Analyst · Wells Fargo. Your line is open.

And then as far as the top line guidance that your Q1 revenue guidance seems to imply somewhere around 4% to 7% sequential growth versus Q4, I just wanted to say what's going to be driving that sequential revenue growth. Because if I look back to '16, it seems like the sequential revenue trend been flattish to maybe low single digit growth. What's going to drive that bigger step out?

Jack Crowley

Management

Yes, one of the things that we talked about in the past, it's been '17 we do get incremental volume under our contracts with our four largest radiopharmacies in '17 versus '16. So, I think that would one of the drivers to the sequential improvement in Q1 '17 over Q4 '16.

Mary Anne Heino

Management

And also, Lei, this is Mary Anne Hello. Also have a little bit lumpiness in some of our quarters with the number of selling days and Q4 is our typically lower in selling days versus other quarters. And in fact if we look at Q4'16 had six -- when we would consider 62 seven days; while Q1 of '17 we are noting that there are 64 seven days in that quarter.

Lei Huang

Analyst · Wells Fargo. Your line is open.

And then on the call you mentioned something I thought I heard something about you're distributing a couple of product to non-medical customers. And I don’t know if that’s something talked about before I just want to understand in the context of your business and the revenue you generated in 2016?

Mary Anne Heino

Management

So, let me first press it by saying that well we have added these products to our manufacturing mix. I would be demystified if I did not qualify that day or as compared to the rest of our products, they're low revenue opportunities. But what's exciting about then really two things. One, it moves us into the non-medical community for sale of these products; and as you can imagine, we are very-very strongly over sighted for our manufacturing capabilities, not only because the nuclear product but because they're also used in human in medical diagnostics. So having met that hurdle, we certainly need the hurdle for selling products into non-medical usage. And we are very -- the second piece that it really tends to is the expertise that we have in cyclotron technology and the manufacturing of different isotopes using our cyclotron. So, they are two different isotopes, I won't say specifically which they're because I don't want to draw competition. But suffice to say its two different isotopes that have used the non-medical applications perhaps for some types of testing of machinery equipment, and we can produce them on cyclotron and sell them to the public and capabilities that we already have. The sales started in 2016. They were very right -- it was late in 2016. 2017 will truly be the first full year of sales. Right now, it's two products we hope to continually add more.

Lei Huang

Analyst · Wells Fargo. Your line is open.

And then if I can just squeeze in two more. One from the GE deal with F 18, that initial 5 million, is that a onetime revenue reorganization will that be amortized over some period of time in terms of how it shows up by your P&L? And then second just any update on DEFINITY China? Thanks very much.

Jack Crowley

Management

Lei, this is Jack. I can take the first part of that question, which is the revenue recognition on the upfront 5 million. We're still in the process of evaluating that. I think it's safe to assume, we will see that presuming a second quarter signing throughout 2017, that wouldn’t get spread over a long, long-term, but I would like to have finalized on that and give guidance once we -- when and if we announced that deal as final.

Mary Anne Heino

Management

And I'll take the second part of the question, which is regarding DEFINITY China. I think we're satisfied with where I left us, when I commented. And that is that our partner in China, which is Double-Crane, now has responsibility for conducting the small clinical trials which will use as a basis of approval. One piece of added information that we count is that the Chinese FDA did ask us to include an additional small study like a pharmacokinetic study for DEFINITY as well. It will occur and be conducted simultaneously with the other study. So, it will not add time to it. Have been said that, as I mentioned kind of ball is now in Double-Crane's court, if thereby nature of our partnership and our contracts, it's their responsibility to conduct the trial to accumulate the, if the data from those trials and then submit it to the Chinese FDA.

Operator

Operator

Thank you ladies and gentlemen, this concludes today's conference. Thank you for participating. You may now all disconnect. Everyone have a great day.