Welcome to the first quarter 2019 Lantheus Holdings earnings conference call. At this time, all participants are on a listen-only mode. Later, we'll conduct a question-and-answer session, and instructions will be given at that time. If anyone should require assistance during the call, please press star then zero on your touch-tone telephone. As a reminder, this conference call is being recorded. I would now like to introduce your host for today's call, Mr. Mark Kinarney, Director of Investor Relations. You may begin.
Thank you, and good morning. Welcome to Lantheus Holdings' first quarter 2019 earnings conference call. Joining me today is our President and CEO, Mary Anne Heino, and our CFO, Bob Marshall. This morning, we issued a press release, which was furnished to the Securities and Exchange Commission under Form 8-K, reporting our first quarter 2019 results. You can find the release in the Investors section of our website at lantheus.com. Before we get started, I'd like to remind you that our comments during this call will include forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements due to a variety of risks and uncertainties. Please note that we assume no obligation to update these forward-looking statements, except as required by applicable law, even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties.
Discussions during this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is also included in the Investors section of our website. With that, I'd like to now turn the call over to Mary Anne. Mary Anne?
Thank you, Mark, and good morning, everyone. We delivered strong first quarter results, driven by double-digit sales growth for both DEFINITY and TechneLite. In addition to posting these results, we advanced efforts on our internal projects and business development. Earlier this month, we announced a strategic collaboration with Cerevast Medical for the treatment of retinal vein occlusion, or RVO, one of the most common causes of vision loss worldwide. Under this agreement, Lantheus' microbubble will be used in combination with Cerevast's ocular ultrasound device to address blood flow in occluded retinal veins in the eye. By treating the underlying cause of this disease, as opposed to the symptoms, this therapy has the potential to reduce or eliminate the need for chronic maintenance therapy and improve the quality of life for those patients afflicted with RVO.
Cerevast's RVO technology is expected to enter a phase II-B clinical trial in the second half of 2019. If approved, the RVO technology could be commercialized as early as 2023. This collaboration fits squarely into Lantheus' growth strategy of identifying new applications for its microbubble franchise. A number of additional scientific collaborations and research initiatives are underway that include expanded uses of microbubbles for diagnostic and therapeutic applications. One such example was recently presented at the American College of Cardiology by Dr. Wilson Mathias of São Paulo, Brazil. In his research, Dr. Mathias is utilizing ultrasound-induced cavitation and DEFINITY in the treatment of acute myocardial infarction, or MI.
This application has the potential to be useful in the developing world, as well as rural areas with little or no access to endovascular therapy, as it allows emergency technicians the ability to initiate mitigating treatment to MI patients while en route to treatment centers. Our belief in the potential application of microbubbles remains strong. We will continue to support valid efforts to evaluate additional applications of DEFINITY. In a moment, I'll speak more about our performance and highlights from the first quarter. I'll turn the call over to Bob, who will review our financial results. Bob?
Thank you, Mary Anne. Good morning, everyone. I will provide highlights of the first quarter financials, focusing on adjusted results, unless otherwise noted. Then provide second quarter and full year 2019 revenue and earnings guidance. Net revenue for the first quarter totaled $86.5 million, an increase of 4.7% over the prior year. As a reminder, we had one fewer shipping day this year's first quarter as compared to the same quarter last year. Foreign currency was a negative headwind of approximately $250,000, or a negative impact of 30 basis points on year-over-year growth. DEFINITY continued to post solid growth with recorded sales of $51.1 million or 14.5% higher as compared to the prior year quarter. TechneLite revenue was $24.1 million, an increase of 12.9% over the prior year quarter, despite another production outage at NTP late in the quarter, a situation we are monitoring closely.
Other nuclear revenue, which exclude TechneLite, include, due principally to Xenon, decreased 22.4% to $15.1 million. Revenue was offset by rebates and allowances of $3.9 million. Adjusted gross profit margin was 52% of net revenue, a decrease of 30 basis points from the first quarter of 2018 on a similar basis. This quarter's results are in line with our forecasts and include, among other items, planned expenses in support of the construction of our new manufacturing facility. Operating expenses were 60 basis points favorable to the prior year at 29.6% of net revenue as adjusted. Driven primarily by lower G&A and sales and marketing expenditures. While our LVEF clinical studies remain on track for completion in 2019, anticipated expenses now skew more to the second and third quarters, creating first quarter favorability relative to initial expectations.
That said, the increased investment in R&D led to higher expenses by approximately 100 basis points versus the prior year at 5.4% of net revenue. Total adjustments in the quarter were $3.2 million before taxes. Of this amount, $2.8 million is associated with non-cash stock and incentive plans, with the balance attributable to intangible amortization expense. Adjusted operating profit for the quarter was $19.4 million, an increase of 6.1% over the same period prior year. Net interest expense and other income amounted to $3.4 million. Underlying net interest expense was slightly higher over the prior year, due mainly to a higher interest rate environment. The reported effective tax rate for the quarter was 22.1%. The rate, adjusting for certain prior period non-recurring tax benefits booked in the period, was 29.7%. The resulting net income for the first quarter was $9.9 million, or an increase of 21.2%.
Adjusted net income was $11.2 million, or an increase of 9.1%. Reported GAAP fully diluted earnings per share were $0.25, an increase of 20.3% from the same quarter last year. Adjusted fully diluted earnings per share were $0.28, an increase of 8.2% over the same period prior year. Lastly, first quarter operating cash flow totaled a source of $10.5 million as compared to a use of $700,000 in the first quarter of 2018. Capital expenditures totaled $10.6 million, which increased over the prior year, mainly due to planned strategic investment in our manufacturing facility on our Billerica campus. A significant portion of the expected flows from the quarter were for construction equipment installation in the new facility, which remains on time and on budget. Free cash flow, which we define as operating cash flow less capital expenditures, was essentially flat for the quarter.
Cash and cash equivalents totaled $112.1 million at quarter's end. For modeling purposes, depreciation and amortization expense amounted to approximately $3.3 million for the quarter. Turning now to our guidance for the second quarter of 2019. Net revenue is expected to be in a range of $86 million-$90 million. Shipping days are equivalent quarter-over-quarter last year's same quarter. Adjusted fully diluted earnings per share are expected to be in a range of $0.23-$0.28. For reference, the equivalent adjusted EPS for the second quarter of 2018 was $0.30. For the full year, we are affirming our prior revenue guidance range of $358 million-$363 million. We are also affirming our adjusted fully diluted earnings per share range of $1.14-$1.17. With that, let me turn the call back over to Mary Anne.
Thank you, Bob. Now let me provide some additional color on our business performance and progress on our strategic programs. Turning back to our microbubble franchise, we delivered double-digit DEFINITY sales growth while continuing to make progress on key pipeline and infrastructure initiatives. We believe these investments support the sustained growth and profitability of our microbubble franchise. The first of these initiatives is our investment in our DEFINITY left ventricular ejection fraction, or LVEF, clinical program. We remain on track with our two parallel phase III studies, BENEFIT 1 and 2, with patient enrollment now over 50% complete for BENEFIT 1, and total enrollment on track to be completed this year. With the data from these completed studies, we plan to file a supplemental NDA that, if approved, would enable us to commercialize soon thereafter.
We are excited about the prospects of an LVEF indication and continue to evaluate the associated market opportunity. Additional research completed recently supports the view that clinicians see value in improved LVEF measurement accuracy, particularly for heart failure, valve disease, and chemotherapy patients. The inclusion of these patient types, for whom LVEF is an important measurement, approximately doubles the addressable market for DEFINITY enhanced echocardiography. We also continue to make progress with our DEFINITY RT program. Having completed the critical phase of producing qualification batches with our partner, Samsung Biologics, we are now gathering stability data critical to the submission of our regulatory application. Regarding the status of a potential generic filer, to date, we have not received notice of an ANDA application. We remain confident in DEFINITY's future and will continue to invest in our expanding microbubble franchise.
I'd now like to provide an update on our ongoing initiative to build a specialized manufacturing facility for DEFINITY and potentially other sterile vial products at our North Billerica headquarters. As Bob noted, the project remains on schedule. We expect to receive final delivery of equipment and to substantially complete construction in the first half of 2019. These steps should position us for product qualification in 2020 and keep us on track to produce commercial product by early 2021. I'd like to now turn to China and our ongoing program with Double-Crane to introduce DEFINITY into that market. During the first quarter, our partner informed us that they anticipate a delay as they work through certain issues related to Chinese regulatory approval of our packaging components, as well as the completion of clinical data assessment from our liver and kidney clinical trials.
We will continue to work closely with Double-Crane on these matters. We are not providing a specific timeframe for our regulatory filing, our ultimate goal remains the same, to introduce DEFINITY into China through Double-Crane in cardiac, kidney, and liver imaging. In our nuclear business, we continue to focus on meeting the needs of our patients and customers. As Bob mentioned, we are managing a temporary loss of moly supply from NTP. NTP has again experienced an outage, another critical partner, ANSTO, recently received regulatory approval from the Australian nuclear regulatory authority to begin initial production in its new moly processing facility, ANSTO Nuclear Medicine, or ANM. In recent days, we received notice that the FDA completed its audit of ANM and approved our use of moly supplies from this new facility.
At full ramp-up capacity, ANM will be able to provide incremental supply to our globally diversified moly supply chain. Turning now to flurpiridaz F 18, our novel PET cardiac imaging agent. The second phase III trial is underway and will eventually enroll up to 650 participants, with a target completion date in the second half of 2020. Our partner, GE HealthCare, has informed us that enrollment in the program is going well. For LMI 1195, our PET-based molecular imaging agent targeting the norepinephrine transporter, we have not yet finalized a special protocol assessment or SPA, we continue active negotiations for our phase III heart failure program in patients under consideration for ICD implantation.
In addition to pursuing this indication, we are also defining two phase III clinical trials for the use of LMI 1195 in the diagnosis and treatment follow-up of neuroendocrine tumors in pediatric and adult populations respectively, which may qualify for an orphan drug regulatory filing and could allow for a streamlined regulatory process. Overall, our first quarter financial results and operational achievements reflect progress in yet another year of growth and strategic investment for Lantheus. As we look ahead, we remain focused on enhancing the sales growth and profitability of our core microbubble franchise, investing in our pipeline with an emphasis on emerging technologies, and continuously screening external development opportunities to deliver long-term sustainable growth. With that, Bob and I are now ready to take your questions. Operator, please go ahead.
Thank you. Ladies and gentlemen, if you have a question at this time, please press star one on your touch tone telephone. If your question has been answered and you wish to remove yourself from the queue, please press the pound key. One moment, please. First question comes from Raj Denhoy from Jefferies. Your line is open.
Hi, good morning. Maybe I could start on the moly supply issue. You mentioned NTP has gone down again. You're expecting additional supply perhaps from ANSTO over the course of the year. Maybe you could just flesh out for us how that dynamic's going to play out as it relates to your revenue over the course of this year.
Sure. Good morning, Raj. It's Mary Anne.
Morning.
Happy to. First let me say, NTP is down again, but I hope everyone appreciates when we look at our revenue forecast and when we look at our business model, and we've been in this nuclear business for more than 30 years, there's lots of moving parts, and our end game is always to mitigate and make use of what moly we need where we need it. That is our plan going forward. You saw us do something similar last year where in dealing with the outage, we were able to shift supply sources from different suppliers. Ideally, they'd all be up and always running, but practically, we are always managing supply. At the end of the day, our target always remains the same, keep patients whole and then keep our customers whole. From that perspective, that really is our first effort.
We will keep you updated if there is any news that becomes public about NTP, but at this point, we're thrilled with our approval from ANSTO. As I mentioned, when they get to full ramp-up capacity, which is certainly this year, and perhaps by mid to early late this year, they will have a significant amount more of moly available to us.
Okay. If we think about last year for 2018, I don't know if you ever gave us an exact number in terms of the impact to your revenue last year, but it was offset by the additional ANSTO sales. This year, it sounds like you're not expecting as sizable an impact on the business given all the dynamics. Would that be a fair conclusion?
I think the more fair conclusion is that last year, if you're just purely looking at the TechneLite line, then yes, you can say that certainly what we were mitigating in loss from NTP out to our U.S. customers was offset by what we sold directly to ANSTO and generated for their market. Again, there's so many different pieces to our forecast, we look for the total revenue forecast to kind of offset each other, from not only a revenue top line, but from a margin bottom line, which is important to us as well.
Okay. Maybe just two other quick ones. You mentioned LVEF. It doesn't sound like you're still ready to give as much in terms of your expectation for the potential of that. By mid-2020, it sounds like that could be on the market. Do you have any, just even broad thoughts in terms of how much of a contributor that could be to DEFINITY growth as we start thinking about late 2020 and beyond?
Yeah. I can give you some color on that. Again, we're constantly looking at that market, and it's very appropriate at this timeframe before market. Every month or every quarter that we get closer, we will continue to firm up our commercial launch plans for it. One of the pieces that's so attractive to us is this is going right back into the market we're already in. This is squarely in the echocardiography suite. It's just a whole different section or segment of patients. We're well-known there. We're obviously, if you look at the share of DEFINITY, we're well-liked there. We're trusted.
Our educational efforts, which were so successful in addressing suboptimal images, we will have similar programs which will educationally address the benefit of accurate LVEF measurement in the patient types, especially those patient types that I mentioned, which are valve disease and chemotherapy patients especially. We're hoping our educational efforts there, in conjunction with the medical practitioners we work with, open up this product for good use in what we see as a market that is similar in size to the market we're addressing with suboptimal. That's why I mentioned that it approximately doubles the addressable market population for the product.
Great. Maybe just one last one for Bob. The guidance for the second quarter, the revenue guidance of $86 million-$90 million, the 0.5%-5.2% is relatively wide range relative to what you've given in the past. I'm curious if there's some uncertainty baked into that, maybe from the TechneLite line or what's really behind perhaps that wider range than you've normally given for quarterly guidance.
Hey, good morning, Raj. From a guidance range perspective, we did think through it, there are a lot of moving parts, like Mary Anne mentioned. As we think through the performance across the entire portfolio, yes, of course, we've taken into consideration the impact of NTP in the quarter or at least the potential and have given ourselves a thoughtful analysis around what the potential outcomes can be. We feel comfortable with where we've guided and had wanted to provide you with our best insight into where things can go.
Okay, great. Thank you, guys.
Thank you, Raj.
Our next question comes from Larry Biegelsen from Wells Fargo. Your line is open.
Hey, good morning. Thanks for taking the question. Just one housekeeping, Bob, the one less selling day in Q1 2019, did that take off about 1.5% growth? You did more like 6.5% in Q1, when do we lose that day in 2019?
Yeah, we've not done that specifically in terms of the math, Larry, I think that that's a very fair assessment. We give back in the third quarter.
Okay. Then to follow up on Raj's question, Q2, the 0.5%-5.2%, Q2 is an easy comp. What are you assuming gets worse in Q2 versus Q1? Then Bob, the second half growth, if I'm doing the math right, it implies 5%-8% on tougher comps. What's going on here, are you assuming DEFINITY is pretty constant at mid-teens?
Yeah. One of the big assumptions, honestly, is that DEFINITY has outperformed our expectations as we go through the year. I think coming in, we had said sort of low to mid-teens, we're seeing that mid-teen type growth, what we're seeing is positive on volume. We're also seeing decent price from our expectations perspective as that carries forward through the balance of the year. In terms of the dollar, yes, the percent range in the second quarter is wider, again, on a smaller dollar base, those percentages can get widened a bit. The absolute dollars are fairly consistent with what we've done historically. What has the potential obviously could be TechneLite, at the same time, these are some of the unknowns, at the same time, we have confidence in the base as we build up the overall guidance range for the quarter.
Yes, if you look at the second half of the year, those numbers, as I looked at them, were more than achievable just based on the sum of the parts. As Mary Anne noted, that we'll come into the back half of the year with a more diversified moly supply, which we believe that will continue to support the ongoing efforts to sort of drive the TechneLite sales. I guess just to even just further that in terms of the comps, they're varied in the third and fourth quarters, to be honest. I think I had mentioned that those growth rates would be a little lumpy in the back half of the year, but would expect to see some decent growth rates based on comps of the certain different product lines.
Then just two more from me, and I'll drop. EPS guidance, Bob, down sequentially in Q2. We don't typically see EPS down in Q2 versus Q1 if I look back historically. Just so why is that? Then just Mary Anne, lastly, what are the next steps on the next generation DEFINITY with Samsung? What's next before the filing, and are you still on track for 2020 launch? Thanks for taking the questions, guys.
Two things there, Larry. One, as I noted, the clinical studies from LVEF, we had originally sort of forecasted that would be a little heavier in the first quarter. That has shifted a little bit, because there's multiple reasons why it's not just based on numbers of patients that are going through, but different aspects of the way that those expenses roll out. We see it a little heavier now as we move towards conclusion in Q2, t hat sort of weighing. The other thing too is as you think through, as we go through the balance of the year, this is also where we will see heavier investment in our manufacturing facility, which is part of our adjusted results.
If you were to take the first quarter and the second quarter together, in terms of taking our outperformance, you'll note that when you look at half one, it's more or less in line with overall expectations as we set them out at the beginning of the year, and I think also your own. I think it was just really more of a phasing issue between Q1 and Q2, more so than a sequential movement in overall performance.
Larry, I'll speak to the DEFINITY RT program. As I mentioned during my comments, the period we're in now is a period, I don't want to call it a wait period, but what happens is once you complete your qualification batches, you then literally put your product up on stability and you let your product sit, because you gather time-based stability data that is part of your application. In many different programs, that can be anywhere from 3- 24 months, depending on what the product is. We are in that phase, and once we reach our date for what we're gathering that stability data, that's the last component of data that goes into the actual application, which will then be submitted, where the rest of the components of the application are already in process and being completed. Again, we're waiting for that stability data.
Once that gets to the FDA, in the entire application, then we do see an expedited review period because this is an sNDA and not an NDA application. With that in mind, we see ourselves on track to keep to the timelines that we've talked about.
Which are 2020, Mary Anne?
Oh, I think we've mentioned late 2020 or sometime 2020 for our commercial implementation period. We haven't identified a quarter.
Okay. Thanks for taking the questions, guys.
You're welcome.
Thanks, Larry.
Our next question comes from Larry Solow from CJS Securities. Your line is open.
Great. Good morning. Some of my questions were answered, just a few follow-ups. On the DEFINITY specifically, obviously you mentioned a little better growth than you expected, at least for the full year, and it was up against a pretty difficult comp. Does your guidance sort of imply a little bit of a slowdown? I assume it does in the back half.
No, I think that it just sort of continues to grow. The commercial team has done a very good job from an execution perspective. The products, as we've noted in past calls, it has a lot of runway, a lot of availability for sustainable growth. As we look at that market and we continue to execute, and we do believe that we're able to continue to grow it, at these levels that we've indicated.
Right. I think you had guided sort of towards a low -double. The 15% in Q1 is probably a little bit outside, and hopefully that's maintained, but a little bit higher than sort of your full-year guidance.
I don't think, Larry, that we intended to specifically guide to low -double.
Okay.
I think we said mid-teen growth. This is a product, as Bob said, that continues to perform. Right behind that is because the market continues to perform. It's a market that continues to grow.
Absolutely.
That's when we talk about the market here, we talk about the total number of echocardiography exams being executed in this case, the U.S. market as referring to. Then we look at within those exams, the percent of those exams that are being done using a contrast agent. Then below that, what percent of those are done using a DEFINITY agent, the DEFINITY agent, we continue to see very good dynamics there. That has us confident about continuing to have DEFINITY produce what it needs for us.
Great. You mentioned pricing was actually maybe, I don't think the big driver, but even a little better than your expectations. Can you just remind us , is pricing sort of flattish? Is it a little bit north of that, south of that?
I don't speak to pricing. I haven't, I won't start now. What I will say, what I've said in the past is, for me, price is an investment, as is any other investment in the market, such as education or the like, we use it where appropriate.
Okay. Just a follow-up on the RT, the room temperature program. Is that something that will more or less cannibalize some of your sales and I guess maybe help you take some share in some areas? Can you sort of speak to where that incremental benefit would come from?
Sure. I think when we look at the RT program, first and foremost, we see it delivering choice into the marketplace. We have historically been very successful with our formulation, which does require cold temperature storage. There is a room temperature storage choice out there for contrast agent. Our goal here is to ensure that whichever the market prefers, they have that choice and they have it from Lantheus' microbubble. More importantly, the RT program takes us places that our current formulation can't, because the restraint, I'll say, or the constraint of requiring refrigeration does make it a hindrance to use DEFINITY in some situations where a room temperature formulation really is more ideal. The program I spoke to that we have with Cerevast is a terrific example of that.
The Cerevast kits, which will be ultimately commercially produced and be available to clinicians, will include other components. For including DEFINITY or Lantheus' microbubble, it would be inelegant if that whole kit then required refrigeration or cold temperature storage. Allowing for a room temperature storage variation puts our product into more situations where it's currently not right now.
Okay, great. Excellent. Thank you very much. Appreciate it.
We sure have no further questions at this time. Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may disconnect and have a wonderful day.