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Lantheus Holdings, Inc. (LNTH)

Q3 2015 Earnings Call· Wed, Nov 4, 2015

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Transcript

Operator

Operator

Good afternoon, ladies and gentlemen. I would like to welcome everyone to the Lantheus Holdings Third Quarter 2015 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 November 18th. I would now like to turn the call over to your host for today, Ms. Meara Murphy.

Meara Murphy

Management

Thank you. And good afternoon, everyone. Welcome to Lantheus Holdings third quarter 2015 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 John Bakewell, Chief Financial Officer. Please note that earlier this afternoon we issued a Press Release reporting third quarter 2015 results. We are also filing with the SEC our Form 10-Q for the quarter ended September 30, 2015. You can 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 from John, and then business update from Mary Anne, before moving into our question-and-answer session. Before we begin, I would like to remind you that remarks during this call may include some forward looking statements, including statements about our outlook for 2015 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 expectation. 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 against placing 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 our specific risks and uncertainties is contained in our SEC filings including our prospectus dated June 24, 2015 and filed with the SEC on June 26, 2015 and in our subsequent quarterly report on Form 10-Q, including that which we are 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 third quarter 2015 earnings conference call. Before we cover the business of the quarter considering this is my first time talking to you as CEO, let me take a moment for those of you have not yet personally met and also give a brief overview of my background. I’ve been in life sciences for almost 30 years, a large chunk of that was at J&J in the pharmaceutical sector in a variety of roles across several therapeutic and functional areas. I held President roles for the U.S. subsidiary of a Canadian pharmaceutical company and for a life sciences joint vision. I was recruited to Lantheus in 2013 to first serve as Chief Commercial Officer and held the role of Chief Operating Officer before moving into the CEO role in late August with Jeff Bailey’s retirement. I am thrilled to be here and thrilled with what we plan to accomplish with this business. So, let’s talk about the business. As those of you have been following us know, we have been actively transforming our business since 2013. We’ve been successful to-date and are pleased to provide you today with an update of that progress. As today’s press release highlights, during the third quarter, we again delivered strong performance with DEFINITY posting growth of 20% annually in constant currency and achieving the 13th consecutive quarter of sequential growth. We are also pleased with both the performance of our nuclear medicine portfolio and the diversification of the customer mix that comprises that performance. Third quarter 2015 revenue totaled $74.1 million, increasing by 1% on a constant currency basis over year-over-year while adjusted EBITDA increase to $19.4 million or 26.2% of recorded revenue. All together, we’re quite pleased with our third quarter performance and a sustained demonstration of our business strategy. DEFINITY’s growing contribution in tandem with gross margin improvement and operating expense management has significantly expanded our operating and adjusted EBITDA margins versus last year. At the same time, we have continued to make strides in our plan to diversify our commercial footprint and advance our key strategic initiatives. I will expand further on that during my business review later in the call. First so, let me turn the call over to John Bakewell, our CFO for a detailed review of our third quarter results. So with that, John?

John Bakewell

CFO

Thanks Mary Anne and good afternoon everyone. As we get started, let me reiterate than unless otherwise stated, all of today’s discussions regarding our sales growth rates refer to our constant currency growth rates and our results of operations refer to our as adjusted results as referenced by Meara, during the introduction to our call. The tables have included in today’s press release as previously noted include the reconciliations of our GAAP results to the as adjusted performance I’ll be covering with you today. Of particular 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 and which we will be referencing in our guidance outlooks, going forward. As Mary Anne noted, third quarter 2015 revenue totaled $74.1 million, increasing by 1% on a constant currency basis. Looking at our revenue results on a product line basis, DEFINITY again posted a strong performance with revenue growth totaling 19% as reported and 20% on a constant currency basis. Our third quarter sales results for the balance of our product portfolio are quite consistent sequentially with those of our second quarter. As we discussed during last quarter’s call, changes in our nuclear medicine business were driven by a shift in status of a large customer to non-contract pricing, earlier this year. At the product level, our TechneLite business posted worldwide revenue of $17.2 million for the third quarter of 2015, decreasing by 25% on a constant currency basis, compared to the year ago quarter. Xenon revenues which represent 17% of our total sales during the third quarter of 2015, totaled $12.7 million, increasing by 43% versus prior year, primarily reflecting increased per unit…

Mary Anne Heino

President

Thank you, John. As I start my business update today, let me state at the outset that our business strategy remains unchanged. As we focused on, one, continuing to grow U.S. sales of our existing commercial products diversified across the range of imaging modalities; two, enhancing the position of our portfolio of commercial products in international markets, obtaining additional regulatory approvals where necessary; three, creating a strategic partnership to further advance our agents in development to maximize their value in potentially large domestic and international markets; and four, pursuing select strategic transactions to further strengthen and diversify our portfolio of commercial products, improve our margins and leverage our core competency. One of our key drivers and the market leading echocardiography contrast agents DEFINITY has continued to perform strongly during our third quarter, increasing19% as reported and 20% in constant currency. DEFINITY currently accounts for approximately 39% of our total revenue. We remain committed to growing the appropriate use of contrast in echocardiography studies or cardiac echo. As we have referenced in prior calls, medical literature suggests approximately 20% of these studies may benefit diagnostically from the addition of a contrast agent. We believe there remains a significant opportunity for growing the contrast cardiac echo market in the U.S. in which DEFINITY remains the clear leader. Our dedicated sales team is focused on educational efforts within the cardiac echo community to recognize patients and doing the use of contrast and enhance image quality and improve interpretability of the study. We believe the additional voice in the market afforded by a new competitor may further drive appreciation of the value of using a contrast agent where appropriate in the 31 plus million cardiac echo studies currently performed annually in the U.S. We believe growth in the segment will benefit us disproportionally given…

Operator

Operator

Thank you. [Operator Instructions] And our first question comes from the line of Matt Keller with Credit Suisse. Your line is now open.

Matt Keller

Analyst · Credit Suisse. Your line is now open

Hey guys, thanks for taking the question. And Mary Anne, congrats on taking over the CEO role.

Mary Anne Heino

President

Thanks Matt.

Matt Keller

Analyst · Credit Suisse. Your line is now open

Sure. I guess just to start can you give us a little more color on what you are seeing in the U.S. from DEFINITY competition growth? Obviously it was pretty strong, did make any inroads in the quarter in terms of volume that you saw? And then anything different on the pricing front in the U.S.?

Mary Anne Heino

President

Sure. Matt, I’ll speak to the first part of your question, which is what we are we seeing in the U.S. marketplace. As I noted we’re very pleased with DEFINITY’s performance in Q3, 20% growth in constant currency. We’re also pleased with what we see as the underlying factor for that, which is the strong growth in CPR. [Ph] From a market perspective, if we interact on a daily basis with physicians and sonographers, because our sales force is out there all the time. We do also monitor the marketplace from a third-party perspective with data that gives us information about total number of Cardiac echo studies and the market share for different products. We did note first in August and then again in September a small and then slightly increasing market share of presence of Lumason. At the end of the day, we welcome the competition, because the added void in the market we feel helps drive further awareness around appropriate use of contrast in echocardiogram and that is kind of a rising tide that benefit will shift and since we hold leading market share, we think we’ll benefit disproportionately from that. From a pricing impact, I think you -- that question as well. We’ll use pricing as a strategic alternative where we see fit. It’s a tool we use likely any other investments where we are trying to either preserve or gain volume with customer. I would say in general our pricing has been stable and that is not a strategic tool that we’ve use to-date for Lumason.

John Bakewell

CFO

Matt, let me add to that. DEFINITY ASP is -- nothing has occurred that wasn’t already anticipated. If you look on a year-over-year basis, as we were expecting, our DEFINITY ASP is down about 7% year-over-year. And that’s consistent with what we saw in Q1 and Q2 and it reflects mainly the pricing actions that were taken back in 2015 in response to competitive activities at the time by GE. So, we’re now annualizing through that. And as we move into Q4, we should actually see that year-over-year decline moderate just a bit, because the prior year comps are going to ease as we move into the fourth quarter.

Matt Keller

Analyst · Credit Suisse. Your line is now open

And if I could, just one more on the guidance change; $1 million from lower sales from lower margin products in international markets. What’s sort of driving that?

Mary Anne Heino

President

So Matt, a large portion of that actually comes out of Puerto Rico. We include Puerto Rico in roll up under our international sales. And some of the larger economic factors that are impacting the general economy on that island kind of slowdown and have an impacting some of the healthcare business as well.

Operator

Operator

Thank you. And our next question comes from the line of Glenn Novarro with RBC Capital Markets. Your line is now open.

George Santo

Analyst · Glenn Novarro with RBC Capital Markets. Your line is now open

Hi, this is George Santo on for Glenn. Thanks for taking my questions. I just had a quick question and then a follow up. Regarding the Cardinal contract, I wonder if you can elaborate a little bit more on the ongoing discussions that maybe going on with Cardinal to review that contract? And to the extent that you can provide it, can you give us a sense of how much the new supply contract with Triad can offset those loss volumes from Cardinal?

Mary Anne Heino

President

George, my first short answer about revealing my discussions with Cardinal is no. I don’t think it would be good for anyone to offer details of that other than just say we remain in active discussions and we are open to finding a mutual place where both companies exist and bring value to the marketplace and we’ll continue those discussions. From a Triad perspective, what I can share with you is that contract initiated a second quarter of 2015 and the initial portion of the contract is for three of our nuclear products. The contract extends in 2016 with the addition of generator sales to Triad.

John Bakewell

CFO

And just to remind everyone that the effect of that has been in the guidance that we’ve offered up really since the beginning of our IPO process.

George Santo

Analyst · Glenn Novarro with RBC Capital Markets. Your line is now open

And then last one is related to your leverage ratios. As you think about the coming years in the current cash generation profile of your business, can you comment on specific leverage targets that you may have and on approximate period of time you think you like to get there? And broadly speaking, how do you prioritize reinvesting cash into the business going forward versus paying down debt? Thank you.

John Bakewell

CFO

Well, George, we aren’t going to offer up any specific cash flow guidance today but certainly we will say that deleveraging is our priority and we would aim to seek leverage below four times as fast as we can get there with cash flow or any other means. So, we will be opportunistic including a consideration of other further capital market events if conditions are attractive but at the end of the day, we remain focused on that also with an eye obviously towards ensuring that we have adequate liquidity for the business.

Operator

Operator

Thank you. [Operator Instructions] And our next question comes from the line of Raj Denhoy with Jefferies. Your line is now open.

Raj Denhoy

Analyst · Raj Denhoy with Jefferies. Your line is now open

I just like you to follow the bid on that competitive question. Bracco received a new technology add on payment for Lumason. I’m curious if you could maybe just offer your opinion on how important it is if they are going to be getting incremental reimbursement for that product?

Mary Anne Heino

President

The reimbursement is -- actually reimbursement is standard as part of the CMS procedure of approving new product. I would say from a CMS perspective, they just recently published their reimbursement rates of 2016. Based on the review, those reimbursement levels for contrast use in echocardiogram remain only slight change to the positive versus 2015. And our sense is that use of contrast agent in the cardiac echo procedure remains sufficiently reimbursed. Bracco will have additional payments for a period of time but again that is standard practice for CMS with the approval of a new agent.

Raj Denhoy

Analyst · Raj Denhoy with Jefferies. Your line is now open

But competitively with that product in the market and hospital potentially receiving additional payments to use their product relative to yours, I’m really just kind of asking if you view that as more of a competitive risk or how do you think hospitals will look at that additional payment in terms of the competitive landscape of the two products?

Mary Anne Heino

President

That’s a fair question. We don’t expect that the temporary difference of reimbursement will significantly change ordering patterns because contrast agents in general are already well reimbursed and much of our business is already contrasted and driven by protocol in hospital.

Raj Denhoy

Analyst · Raj Denhoy with Jefferies. Your line is now open

Maybe if I could just about Xenon and it continues to be -- continues to get nice pricing around that and we just saw contract. And I guess I’m curious as how long you think that’s sustainable. And then also you mentioned that there is another company that has potentially filed here for approval as well, perhaps you could just address that as well in terms of what the timing might look like around that product and anything else would be helpful.

Mary Anne Heino

President

So, let me say first, it’s not going to be my stand on these calls to talk about the strategic or developmental activities of my competitors. And I hope in return that they have special courtesy with me. Having said that we have recently become aware that another radiopharmaceutical manufacturer is seeking approval from the FDA for Xenon. I can’t and as a company, we can’t currently judge that manufacturer’s likelihood of regulatory success, the timing if any of a regulatory approval or even given that the pricing, extend of availability or market penetration of another Xenon offering. What I will say is if another company does receive regulatory approval for Xenon product, we intend to compete very vigorously in the market for this important agent. It’s a situation that we’re watching very closely.

Raj Denhoy

Analyst · Raj Denhoy with Jefferies. Your line is now open

And then just the first question about the pricing, you continue to get benefit from kind of off contract pricing around Xenon. How long should we expect that to continue?

Mary Anne Heino

President

Raj, I am going to clarify just what I answered. Your comment was too general to me to answer -- continue to benefit from what contract pricing that is not true across our entire customer base. And in fact, most of our Xenon business is contracted. We mentioned specifically that Cardinal is currently paying off contract pricing for that product because we don’t have contract with them. As I also mentioned, we continue to engage with Cardinal to look for what would be a mutually acceptable contracted space. So, I hope that answers your question. I am happy to take a follow-up if it doesn’t.

Raj Denhoy

Analyst · Raj Denhoy with Jefferies. Your line is now open

It does. So, I guess it’s something you’re working on. I guess that’s a fair answer. So, I’ll just leave it there. Thank you.

Operator

Operator

Thank you. And our next question comes from the line of Lei Huang with Well Fargo. Your line is now open.

Lei Huang

Analyst · Lei Huang with Well Fargo. Your line is now open

I know you’ve talked about gross margin into Q4, but you have incremental $2.5 million or so of new manufacturing cost, so lower to gross margin, if we exclude that, what other factors should we consider in terms of where margins could go in Q4 from Q3 level?

John Bakewell

CFO

Outside of the technology transfer cost which as we mentioned previously, can really vary from quarter-to-quarter. There is nothing that we would expect that would affect the gross margin number on -- excluding tech transfer. So, I think if you compare expectations for Q4 excluding tech transfer to what we reported here for Q3, I think you would see a relatively consistent gross profit percentage.

Lei Huang

Analyst · Lei Huang with Well Fargo. Your line is now open

And if I can just have one quick follow-up on DEFINITY China. I know Mary Anne there is some update with that CTA is under active review. Can you just remind us what was happening prior to that? I thought that CTA was submitted some time ago, was it just waiting in the queue to be reviewed?

Mary Anne Heino

President

Yes, you’re right. In the past, we have referred to the CTA having already been submitted. There are actually four stages in the Chinese total regulatory process and the first one is CTA submission. The second form of stage is CTA review and that is the gate that we passed through. It’s the submission queue given the number of products and filings before the Chinese FDA is a very long run for us. We see it as a significant milestone to move into that queue of active review. Just as a further explanation of what we will happen going forward, once that review is completed, then Double-Crane will be approved to conduct their clinical trial into two small confirmatory trial one in each of the two therapeutic areas. When those are completed, the Chinese FDA again takes over and their final review is when they culminate the approval of the import drug license or the IDL.

Operator

Operator

Thank you. [Operator Instructions] And I am showing no further questions at this time. I would like to turn the conference back over to Ms. Mary Anne Heino for any final remarks.

Mary Anne Heino

President

Thank you, operator, and thank you all for joining today’s call. As I mentioned, we’re pleased with our progress during the third quarter and we will remain focused on driving forward with those strategic initiatives that are important to our company to further grow and strengthen our business. I look forward to updating you on our continued progress on our next quarterly earnings call. We appreciate your interest and support. Have a great day.

Operator

Operator

Thank you, ladies and gentlemen. This concludes today’s conference. Thank you for participating. You may now disconnect.