Meara Murphy - Director, IR and Corporate Communications Mary Anne Heino - President and CEO John Bakewell - Chief Financial Officer.

Matt Keller - Credit Suisse George Santo - RBC Capital Markets Raj Denhoy - Jefferies Lei Huang - Well Fargo.

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..

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?.

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?.

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 selling prices attributable to our customer specific changes that occurred earlier this year.

Our other product category, which represents 21% of our total revenue, totaled $15.3 million during the third quarter, decreasing by 10% in constant currency as compared to the third quarter of 2014.

Similar to our Q2 performance, the year-over-year decrease is attributable to certain license fee revenues that ended in December 2014 as well as lower sales of certain other nuclear medicine products impacted by our previously noted customer specific changes.

Moving below the revenue line, our third quarter 2015 gross margin totaled 45.5%, a 370 basis-point improvement over gross margin of 41.8% for our third quarter of 2014.

Similar to the year-over-year comparisons we reported for Q2, the main drivers of this significant Q3 improvement are increased sales of DEFINITY, our highest margin product; and lower volumes with increased selling prices for certain nuclear products associated with the previously noted customer specific changes.

As we’ve noted during previous earnings calls, our reported cost of goods sold includes technology transfer costs, which are the period expenses associated with our various contract manufacturing initiatives.

These costs totaled approximately $1 million during Q3 and were lighter than previously anticipated due to changes in the timing of underlying activity. Going forward, we expect a considerably higher level during the fourth quarter of 2015 as our CMO related activities intensify.

Technology transfer costs are included in our reported cost of sales while those increased costs will dampen our reported gross profit and gross margin results. As we’ve noted previously, they do not impact adjusted EBITDA since they’re included as an add back to that calculation.

Note that our tech transfer cots have historically demonstrated and we believe will continue to demonstrate for the next one to two years, considerable variability from period-to-period, depending on the timing and cost of our various transfer related projects.

Moving now to operating expenses, third quarter 2015 operating expenses totaled $20.3 million and were $2.1 million lower than last year, primarily due to the inclusion of offering costs in the prior year results that were charged off following our mid-2014 financing efforts.

Third quarter 2015 expense levels reflect the benefit of our ongoing operational efficiency initiatives as well as the deferral of certain sales and marketing R&D spending, totaling approximately $700,000 into the fourth quarter.

We delivered operating income of $13.4 million for the third quarter of 2015, an increase of 45% over last year with operating margin expanding by 590 basis points to 18.1% for the third quarter.

Moving below operating income, third quarter interest expense totaled $7.1 million, which improve by $3.5 million dollars in comparison with the third quarter 2014 and is consistent with our expected go forward quarterly expense level, following our June refinancing activities. Pretax earnings for the quarter totaled $6.1 million.

Third quarter income tax provision totaled $700,000, consisting exclusively of taxes on foreign income and discreet items unrelated to our U.S. pretax earnings. As I noted during last quarter’s call, U.S. pretax earnings are currently being offset, both for GAAP and cash tax purposes by the utilization of our significant NOL carry forwards and credits.

Finally, per share count, our Q3 per share results are based on an average of 30.8 million diluted shares for Q3 of this year and 18.1 million for Q3 2014.

If our share count and value were to remain unchanged through the end of this year, our Q4 weighted average diluted shares would total 30.4 million and our full year share count would total 24.7 million. Moving on to our balance sheet, cash flow and liquidity, at September 30, 2015, we had cash and equivalents totaling $21.9 million.

Our ABL facility, with an outstanding loan balance of zero and an outstanding letter of credit totaling $8.8 million, provided us with net availability of $37.3 million at September 30th. Our total liquidity including cash on hand is $59.2 million at September 30, providing ample liquidity to support our operating needs.

Our third quarter 2015 operating cash flow totaled a positive $5.4 million.

Within operating cash flow, we had working capital uses of cash totaling $6.3 million in the aggregate during the quarter, the main consumers being receivables expansion related to sales growth and timing which used approximately $3.5 million of cash during the quarter and additions to our DEFINITY inventory stock which used approximately $2 million.

This was a particularly working capital intensive quarter for us, the good portion of the use is being timing related. As a result, we expect the much more favorable working capital profile for the rest of the year, anticipating a positive working capital performance that provides a source of cash in the aggregate during the fourth quarter.

As for other key components of our cash flow, capital expenditures during the third quarter of 2015 were $2.3 million compared with one $1.8 million in the third quarter of 2014 and $2.6 million in the second quarter of 2015.

Within the financing activities, we used $900,000 of cash during the third quarter of 2015 in payment of our quarterly term loan principal commitment and an additional $2 million to pay the remainder of costs associated with our second quarter IPO and refinancing activities. My final topic is our guidance for the remainder of 2015.

Please note that our guidance ranges and assumptions for 2015 exclude the effect of possible future acquisitions or divestitures, other anticipated material, future business developments and the adjustments of earnings as reported to earnings as adjusted that are set forth in the reconciliations provided in today’s press release.

As stated in today’s press release, we anticipate total revenue for full year 2015 in the range of $292 million to $294 million, representing constant currency year-over-year change of minus 1% to 0% compared to previous guidance of $293 million to $297 million.

Considering there is only one quarter left in the year, it would imply a Q4 revenue outlook of approximately $69.7 million to $71.7 million.

This effectively reduces the midpoint of our full year revenue outlook by $2 million, approximately half of which is the result of continued foreign currency rate declines and the other half being a result of reduced expectations for some of our lower margin products in certain international markets.

Note that our guidance range includes the negative impact from currency of approximately $7 million for the full year or 2% as compared to 2014. Our currency assumptions are based on prevailing rates.

Also as stated in today’s press release, we continue to anticipate adjusted EBITDA for full year 2015 in the range of $72 million to $75 million, representing approximately 25% to 26% of reported revenue.

This implies a Q4 adjusted EBITDA performance that is lower than our Q3 results, reflecting the previously noted shift in certain operating expenses from Q3 to Q4 along with the impact of stronger currency headwind and lower international revenue expectations.

With respect to a couple of the more significant components to our adjusted EBITDA calculation, first going forward, our quarterly interest expense is expected to remain consistent with the $7.1 million reported for third quarter of 2015.

Additionally, regarding our technology transfer costs, our 2015 program plan for activities now totals approximately $6 million for the full year. Therefore, we anticipate finishing the year with fourth quarter spending of approximately $3.5 million. With that, I will conclude our third quarter 2015 financial review.

And now I’ll turn the call back over to Mary Anne..

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 our strong share position.

As you know, to gauge the quarterly growth of the use of contrast in the U.S., we track contrast penetration rate. This is a percentage of all cardiac echos performed with an imaging agent of any kind. I am pleased to share that the market demonstrated growth for the third quarter three-month rolling average U.S. contrast penetration rate of 4.9%.

This represents a 110 basis-point increase over the year ago quarter. In fact, we have seen steady growth of a contrast penetration rates for the past 11 quarters.

We also continued to advance international opportunities for the DEFINITY including regulatory progress with our partner in China and the planned reintroduction of LUMINITY into targeted European counties. LUMINITY is the trade name for DEFINITY in Europe.

I am pleased to share with you today the achievement of the significant milestone in our DEFINITY China program. We recently revived confirmation that our clinical trial application or CTA is now under active review by the Chinese FDA.

We believe the current healthcare environment in China as well as the large underserved contrast market presents a significant opportunity, not only in echocardiography but also in abdominal ultrasound [Technical Difficulty].

Finally timing of approval of DEFINITY will be dependent upon favorable completion of the review of the CTA, the successful conduct of the confirmatory clinical trials and the granting of the import drug license. The timing for completion of the program could be as early as late 2017.

We will update you on the future calls about this important opportunity as we move through the regulatory and clinical process. In addition, we are advancing our next generation development program for DEFINITY. This program introduces changes to the current DEFINITY offerings which we believe augment value for our users.

We expect to be awarded extended patent runway with the changes. On a nuclear medicine side, we continue to deliver value and reliability to our customers. We believe we have the most diversified moly supply chain in the industry with surface levels recognized by our stakeholders.

I shared with your last quarter, we successfully negotiated a multiyear agreement with Triad Isotopes that initiated in second quarter and expands in 2016. We continue to accept and fill product orders in Cardinal at our noncontract prices, predominantly for Xenon and Quadramet.

We remain open to exploring an agreement with Cardinal that we feel would benefit our Company, the nuclear medicine industry and most importantly, the patients we both serve.

With respect to the competitive landscape in the nuclear space, we recently become aware that another radiopharmaceutical manufacturer is now seeking regulatory approval from the FDA to sell Xenon.

We cannot currently judge that manufacturer’s likelihood of regulatory success, the timing of any regulatory approval for the pricing, availability or possible market penetration of a new Xenon offering. If a competitor does receive regulatory approval, we intend to compete vigorously in the market for this important agent.

We continue to monitor this situation closely. Now I would like to turn to our pipeline. We remain excited about our PET imaging agent flurpiridaz F-18, which we believe has a potential to become a next generation myocardial perfusion imaging or MPI agent.

This is a market we are very familiar with as our product Cardiolite, the most successful branded radiopharmaceuticals stage serves the same patient population. On Sunday November 8th, Dr. Gary Heller will present data from a sub analysis of our first Phase 3 study of flurpiridaz F-18 at the American Heart Association 2015 Scientific Sessions.

The sub analysis compares diagnostic finding of coronary artery disease in women. You can compare that F-18 versus PET MPI. In temporary news [ph] with our presentation, we will issue a press release for to closing the data Dr. Heller presents.

As shared on the last quarter’s call, our first of two Phase 3 trials completed and our FDA approved the second trial, we are prepared to initiate our second Phase 3 trial.

We are advancing discussions with prospective partners for the development and commercialization of this promising candidate and we’ll keep you apprised of all future developments.

Finally, as part of our growth strategy, we continue to evaluate a range of strategic opportunities to further strengthen and diversify our business while leveraging our established core competencies and in-house manufacturing capabilities. We’ll update you with information about that in the future. That concludes my remarks for this quarter.

And with that we would now like to open the call and take your questions..

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

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

Thanks Matt..

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.?.

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..

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..

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?.

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..

Thank you. And our next question comes from the line of 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?.

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..

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..

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..

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..

Thank you. [Operator Instructions] And our next question comes from the line of 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?.

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. .

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?.

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..

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..

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..

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?.

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..

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..

Thank you. And our next question comes from the line of 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?.

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..

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?.

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..

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..

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..

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