Q2 2020 Endo International PLC Earnings Call
Ladies and gentlemen, please stand by your Q2 2020 Indoor International P.L.C. earnings Conference call will begin momentarily.
And your conference will begin in one minute. Thank you.
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And instructions will follow with that time.
If anyone should require assistance during the conference. Please press Star then zero on your Touchtone telephone as a reminder, this conference call is being recorded I would now like to turn the conference over to your host Ms. Lori Apart senior Vice President.
Investor Relations and corporate affairs.
Thank you Crystal good morning, and thank you for joining us to discuss our second quarter 2020 financial results. Joining me on today's call or Blaise Coleman, President and CEO that do Mark Bradley Executive Vice President and Chief Financial Officer, and Patrick Barry President Global commercial operations, we've prepared a slide.
Presentation to accompany today's webcast and that presentation as well as other materials are posted online in the investor section at Endo Dot com.
I would like to remind you that any forward looking statements made by management are covered under the U.S. Private Securities Litigation Reform Act of 1995, and the applicable Canadian Securities laws and are subject to the changes risks and uncertainties described in the press release, and our U.S. and Canadian Securities filings.
In addition, during the course of this call we may refer to non-GAAP financial measures that are not prepared in accordance with accounting principles generally accepted in United States and that may be different from non-GAAP financial measures used by other companies.
Investors are encouraged to review Endos current report on form 8-K furnished with the FCC for Endos reasons for including those non-GAAP financial measures in our earnings release and presentation. The reconciliation of non-GAAP financial measures. The most directly comparable GAAP financial measures is contained in our earnings press release issued last night unless.
Otherwise noted there in I'd now like to turn the call over to please please.
Good morning, everyone and thank you for joining us for this early morning call. Let me start by saying and what are truly challenging times for everyone I'm proud of what our entire endo team delivered in second quarter.
I want to thank the team for their tireless efforts and prioritizing the safety of our people in communities, ensuring the resiliency of our supply chain and supporting our customers.
If we moved the agenda on slide two I'll start with a discussion over second quarter business performance, followed by an update on our evolve strategic priorities.
Also provide an update on our pipeline then mark will address our second quarter financial results and provide financial expectations for the third quarter and full year 2020.
Slide three is a snapshot of our segment and consolidated revenues and our adjusted EBITDA for the quarter.
Second quarter revenues of $688 million decreased 2% compare to prior year, primarily due to decreased branded segment revenues, resulting from a reduction in physician office activity in patient office visits related to the killed it 19 pandemic.
This was largely offset by an increase in sterile Injectables segment revenues due to significant channel inventory stocking of these district in anticipation of treating certain patients infected with cobot 19.
Second quarter consolidated revenues exceeded our previously communicated expectations, mainly due to the performance of our branded and generic segments.
<unk> adjusted EBITDA in the quarter of $336 million increase compared to prior year due to favorable changes in product mix as well as lower adjusted operating expenses.
Turning to slide four in the second quarter branded segment revenues decreased by 30% compared to the same period in 2019.
The specialty products portfolio in XIAFLEX is second quarter revenues declined by 45% and 55% respectively compared to the prior year.
The decrease in revenue was due to the impact of Cobot 19.
In terms of the specialty portfolio demand volumes were greater than previously communicated expectations due to a faster pace of physician office, reopenings and a higher level of patient visits.
This in combination with our effective commercial execution, including our combined virtual and in person approach to physician engagement.
Resulted in a much stronger recovery in the second quarter.
We're very encouraged by the level of underlying demand recovery, we seem to date and the continued strong interest of patients willing to seek treatment.
Our established products portfolio declined by 20% compared to the same period in the prior year, primarily due to competitive pressures in a temporary product supply disruption.
Which has since been resolved.
Our sterile Injectables segment revenues grew by 31% compared to the second quarter of 2019, driven by strong growth a visa strict which resulted primarily from increased sales volume due to significant channel inventory stocking during the quarter in anticipation of potential treatment needs for certain patients.
In fact, it with cobot 19.
Sterile injectable segment revenues were lower than our previously communicated expectations due to lower days of strict hospital utilization in the quarter.
Moving to slide size.
Our generics segment revenues decreased by 1% during the second quarter compared to second quarter 2019.
The underlying performance in the quarter reflects the impact of competitive events, partially offset by the impact of certain recent product launches.
Second quarter revenues were better than our previously communicated expectations due to stronger second quarter prescription fulfillment trends following accelerated first quarter 2020 prescription for films.
The decrease in international segment revenues for the second quarter was primarily due to competitive pressures in certain international markets as well as the impact of certain product discontinuations.
Turning to slide six we want to spend a few minutes, providing an update in our company strategic priorities going forward.
As you know Endo has a long history of evolving as a company in order to develop and deliver different types of high quality products in its constant pursuit to address the many needs of patients.
With the recent FDA approval quo in aren't pending entry into U.S. instead its market, we probably continue our evolution as a company.
As we are now preparing for this next cycle of evolution, it's only natural our strategic priorities of off too.
Our strategic priorities served guide every decision we make in request to create long term sustainable value for our stakeholders.
Let's take a moment to walk through our about strategic priorities.
Our first priority is to expand and enhance our portfolio.
We are investing to build a more differentiated adorable portfolio the benefits our customers and create sustainable long term value.
This shift to a more differentiated endurable portfolio is not new given our investments to date in the development in approval of quell our investments in our sterile injectables pipeline and our investments in our <unk> XIAFLEX logistical management opportunities.
What is new is our increased focus on identifying ways to accelerate this portfolio transformation through a combination of internal and external investments.
We look forward to fully capitalizing on our current portfolio opportunities and adding additional opportunities aligned with the strategic priority.
Our second priority is to reinvent how we work we are embracing the future bikes are accelerating new ways of working to better serve our customers promote innovation and further improve our productivity.
This is the strategic priority because the rate of change in the world is accelerating everyday and we need to change with it.
Whether it be how we engage with our customers how we conduct our clinical development studies, how we manufacture our products. How are we moved from a physical some more virtual work environment reinventing, how we work will be critical to our future success.
This drives us to increase our effectiveness and all we do an open some exciting opportunities for us to create meaningful value for all of our stakeholders.
Our third strategic priority is before through good.
In driving our ambitions around our first two priorities, we will deliver on those priorities in a way that benefits all of our stakeholders.
From our customers to our into team members to the communities, we work and living.
We deeply believe operating this priority place is essential to our goal to create long term sustainable value for all of our stakeholders.
We're excited to continue our evolution as a company and believe our successful execution against these strategic priorities will drive our future success.
Turning to slide seven.
As we work to expand and enhance our portfolio. We're excited by the recent ft approval of quell and aren't pending entry into the medical aesthetics.
[noise] quote was the first and only injectable approved for the treatment of cellulite and provides a non invasive option that addresses the underlying cost cellulite.
We're very encouraged by the medical aesthetics and beauty industry response, the approval of quo to date and look forward to bring this innovative treatment option the market.
If we turn to slide eight we see a sizable U.S. market opportunity weeding quote.
As we enter the widely accepted in growing injectable market.
Well also has the potential to addressing unmet need in the growing body contouring market.
We believe the potential target population for treatment with quo, it's exceeds 6 million women, aged 25 to 54 and could reach as high as 11 million each 21 to 59.
We continue to actively prepare for our spring 2021 launch and the long term success of quell.
We've already begun or salesforce recruitment with the hiring of our sales management team.
As we move into the fall, we'll be launching consumer activation plans inclusive of social media channels in an unbranded condition awareness campaign.
We are finalizing a physician early experienced program and preparing for robust physician injector training, which will begin in early 2021.
Product pricing is still being finalized and will be announced closer to cause launch date.
Moving to slide nine and discussing or ongoing clinical studies and pipeline.
Starting with quell our data generation plant and development remains focused on dosing injection technique and responses and target patient populations as well as rollovers studies on durability.
Results in analysis from these studies are key to our publication and presentation strategies.
We're currently running a phase one label expansion PK study on plasma clearance evasive pressing in healthy volunteers, which we believe me further advance our clinical understanding of these are strict and how physicians.
Studies progressing and final results are expected in the fourth quarter of this year.
We continue to make progress on XIAFLEX development programs for the treatment of plantar Fibromatosis and adhesive capsulitis with the first patient dose milestones achieved for both indications over the last month.
Turning to slide 10.
As we invest to build a more differentiating durable portfolio. We believe both plantar fibromatosis adhesive capsulitis represent an opportunity to bring innovative treatment option to address the potential large unmet need for patients who are seeking a non surgical approaches treatment.
Plantar fibromatosis presenters nodules on the plantar fasciitis in feet and in the majority of cases patients have pain associated with condition.
You. This patient claims data suggest or over 400000 surgeries for plantar performed annually.
From a patient population standpoint, the majority of symptomatic and nearly all have pain and currently the only treatment option is a potential complication prone surgery.
In the case of frozen shoulder right he says capsulitis.
Sickening in fibrosis of the shoulder capsule results in shoulder motion restriction and can be painful.
With a 2% to 5% prevalence rate in the U.S. and over 200000 surgeries performed annually.
Adhesive Capsulitis also rep represents an attractive market opportunity.
We're proud to advance our clinical studies in these indications with the ultimate goal of improving patient care.
Turning to slide 11.
As we said before you can see that our pipeline is increasingly reflective of our sterile injectables growth strategy.
We believe are sterile injectables opportunities have a higher level of differentiation and a more durable revenue profile.
We are pursuing opportunities that we believe can help to meet evolving needs for customers and potentially improve patient care.
Almost 60% of R&D pipeline is in differentiated sterile injectable products and for 2020, we estimate 50% or more of our new product regulatory filings will be for sterile injectable products.
Our pipeline is supplemented by strategic relationships with third party partners, such as never car, which we potentially provide five differentiated five or five be to hospital in critical care based products.
We anticipate launching the first never car product in late 2020.
We plan to launch approximately 15 products in 2020.
During the second quarter, we received a major complete response letter from the FDA on our generic Supertex Andy application.
We are currently developing our response to the FDA.
Now, let me turn the call over to Mark to further discuss the Companys financial results and provide an update on our financial guidance Mark.
Thank you placed and good morning, everyone first on Slide 12, you will see a snapshot of our second quarter GAAP non-GAAP financial results leased covered company in segment revenues earlier, So I will not review that again.
On a GAAP basis income from continuing operations was approximately 18 million or eight cents per share on a diluted basis in the second quarter compared to a loss from continuing operations of approximately 98 million.
Were 43 cents per share on a diluted basis in the second quarter of 2019.
This increase was primarily attributable to asset impairment charges that were taken in the second quarter 2019, but not in the second quarter 2020.
On an adjusted basis income from continuing operations was 152 million 65 cents per share on a diluted basis in the second quarter compared to income from continuing operations of 139 million were 60 cents per share on a diluted basis in second quarter 2019.
This increase was primarily due to a favorable change in product mix in the second quarter compared to the second quarter 2019, as well as lower adjusted operating expenses.
Slide 13 provides a summary of our third quarter and 2024 year financial guidance.
We are providing both full year and third quarter guidance due to the significant impact from channel Destocking is expected in the third quarter.
Also while these estimates contemplate a number of different scenarios. They do not assume a significant impact from resurgence of could 19 in the second half of the year.
Having said that we expect 2020 total revenues to be between 2.6 billion and 2.7 billion.
Adjusted EBITDA to be between 1.19 billion and 1.23 billion.
And adjusted diluted net income per share from continuing operations to be between $2 and $2.15.
With respect to total 2020 revenue the midpoint of our guidance range implies a high single digit percentage decline compared to 2019 revenue.
This implied decline reflects the expected decline in our branded pharmaceutical segment, primarily driven by cooked 19, as well as declines in our generic and international segment, driven by competitive events and the timing of new product launches.
These declines are expected to be partially offset by expected growth in the sterile injectable segment.
Our full year 2020 guidance assumes an adjusted gross margin of approximately 66.5% to 67%.
The midpoint of our adjusted gross margin assumption is slightly higher than 2019, primarily due to a shift in sales mix.
We also assume adjusted operating expenses as a percentage of revenue will be approximately 25%.
20, 25.5%, which reflects continued investments in our core areas of growth, including XIAFLEX in club.
Additionally, we assume adjusted interest interest expense will be approximately 530 to 535 million inclusive of the impact of recently completed debt exchange.
Finally, we expect or 2020, adjusted effective tax rate to be in the 14% to 15% range.
As for the third quarter 2020, we expect total revenue to be between 515 million and 559.
Adjusted EBITDA to be between 175 million 200 million.
And adjusted diluted net income per share from continuing operations to be between eight and 13 cents.
With respect to third quarter 2020 revenue.
The midpoint of our guidance range implies a low to mid 20% decline compared to the second quarter 2020.
This imply decline reflects a decline in our sterile injectable segment, which is expected to be driven by significant channel inventory destocking in the quarter.
Declines are also expected in our generic and international segment driven by competitive event.
One product Discontinuations.
These declines are expected to be partially offset by an increase in our branded segment driven by the expected continued increase in demand for our physician administered products as physician and patient activities continue returning port pre cobot 19 levels.
Our third quarter guidance assumes an adjusted gross margin in the 64% to 65% range.
Adjusted operating expenses as a percentage of revenue of approximately 34%.
Adjusted interest expense of approximately 140 million.
And the adjusted effective tax rate in 7.5% to 8.5% range.
These assumptions reflect the expected phasing of result in the second half of the year.
Switching to slide 14. This is a summary of third quarter and full year segment in total enterprise revenue guidance previously discussed.
Advancing to slide 15, wrapping up the financial discussion unrestricted cash flow prior to debt payment was $390 million for the first six months of 2020.
We ended the second quarter of 2020 with approximately $1.8 billion of unrestricted cash and a net debt to adjusted EBITDA leverage ratio of approximately 4.5 times.
For the full year 2020, we expect unrestricted cash flow part of debt payments to be in the range of approximately $60 million to $100 million.
We expect to make approximately $260 million in payment into the mesh qualified settlement fund information legal expenses and assume this will be fully funded by the end of the year.
We also expect to incur approximately $80 million in opioid related legal expenses and previously announced opioid settlement.
Now, let me turn the call back over to Laurie to manage our question and answer period Laurie. Thank you Mark in the interest of time, if you could limit your initial questions to allow us to get in as many as possible. We would appreciate it Chris. So can we have first question. Please.
Your first question comes from Greg Gilbert with Truest.
Hi, ask a two parter upfront.
Good morning, first Blaze, how are you thinking about the durability of visa strict exclusivity. Obviously you have a lot of facts that we don't have in terms of settlement. So we'd like to understand sort of the best case, and worst case, and maybe how the new form fits in and secondly, given that the opioid risk around the company is still somewhat of an elephant in the room, what can you tell.
All investors to make them comfortable and your ability to sort of see this mission through and pivot the company towards a more branded future in light of what is many people's eyes, an existential risk that's out there. Thank you.
Hey, good morning, Greg. Thanks for the question, let's start with days district.
Theres not a lot going to be able to say here I mean, the owned it.
Status of the work we're doing against the the on the P. For litigation right now we continue to work through that we have had a couple settlements which.
We have been.
Everyone's aware of and.
From a trial standpoint, right now we don't have a trial set with a with equal at this point and the the first trial date is in January so that's where that stands and we're going to continue to work that and we hope that we can find a constructive settlement, but if not we'll be ready to fend that IP in terms of the lifecycle management. All these district, we've talked about this before.
We.
We've had two different things happening one is on the we recently had the earlier in second quarter, the Premixed bottle approved.
So that's an opportunity for us and as we think about launch timing around that will launch that strategically.
And then also as I mentioned before we have the district PK safety study going on which we hope to get the read out on that by the end of the year. So those two things will be important as we move forward with phase of strict in terms of opioids listen.
We continue to work that.
And continue to have constructive conversations.
Around that matter.
We are we're optimistic that we will be able to find a constructive settlement. We think that isn't the best interest of all parties that are involved but again, we're not able to do that we will continue to defend ourselves going forward, if we need to and we'll be ready to do that just as a follow up surveys district is it conceivable that you could have a up a large profitable the district franchise for us.
Several more years or is that not a possibility all things considered.
Oh, that's a possibility okay. Thanks.
Next question please.
Your next question comes on line of Randall Stanicky with RBC capital markets.
Great. Thanks, Hey, please can you help better understand as we look at the back half Ebitdas step down how much.
How should we be thinking about that is that or a new run rate for the business going forward.
And then if you could quantify the spend on flow that you're.
Planning for the back half year that would be helpful. As well and then just maybe the overall strategy is this a one product to Fedex franchise are you looking to add additional products. How are you thinking strategically about.
Growing your aesthetics platform. Thank you.
Sure Mark Warner you comment on the back half EBITDA and how we're thinking about in terms of what that represents from an applied standpoint.
In terms of the question on medical aesthetics, I'll take that one and then.
The other question on CWO was the back half spend so on that one let's start with Zelman first we ran to we haven't commented on that.
What we can tell you is that as I mentioned in the.
The prepared remarks that we have started our investment in terms of the the launch of that and have hard the Salesforce management team and then we'll continue to progress.
Recruiting for the sales team.
More towards the latter part of third quarter into fourth quarter since the wouldn't think about it from a phasing standpoint in terms of the question on.
What we're doing with our U.S. admitted medical aesthetics, and what's our strategy there listen our focus is to have the absolute best launch of qual, when the U.S. and that is our focus right now because we're incredibly excited about the opportunity that weights us with that with that product.
We'll make sense as we move forward to add complimentary products. So that part of our business and we'll do that through through business development, but thats not something that we're doing today our focus today is on an absolute.
Great launch of quell in the spring of 2021, Mark you want to comment on the up the EBITDA sure. Yes site. We don't think that fourth quarter. We think the fourth quarter is a reasonable estimate for fourth quarter, but we don't believe that is a reasonable basis for establishing any sort of run rate for a couple of reasons first fourth.
It really doesn't reflect a full rebound in our branded specialty business.
Because physician offices and visits are not really expected to be back to 100% by then.
Second.
The fourth quarter doesn't also.
Considered the launch of CLO next year or any other new product launches in 2021, now offsetting that of course.
Fourth quarter doesn't consider generic competition.
Additional generic competition that it might be expected in the future and it also doesn't consider any increase investment in CLO.
Or investments in our pipeline that we may be expecting in the future.
Thanks Randall next question please.
Your next question comes from the line of David insulin with Piper Sandler.
Thanks, I wanted to focus on flex and wanted to get your thoughts on.
The pace of potential normalization, obviously, there's some disruption into the second half of the here, but can you comment.
And your thoughts.
Regarding normalization procedure normalization in 2021 then.
Are you planning for disruptions bleeding into 21, and then secondly, you mentioned additional spend on XIAFLEX expansion opportunities.
Can you talk about how aggressive that spend is going to be.
Longer term.
And.
Beyond what you've talked about are there other opportunities for XIAFLEX that.
You plan to explore thanks.
Great. Thanks, David Let me turn over to to Patrick to talk about XIAFLEX as we mentioned in the prepared remarks, we were pleased with what we saw in the second quarter, but Patrick can talk about how we think about going forward. Thanks for the question David XIAFLEX, obviously was impacted earlier in the quarter, we saw a cross.
The industry, we saw what the shelter in place.
Patient activity really being reduced significantly we saw electric procedures being amp impacted and frankly office closures earlier in the quarter.
Urology procedures were down between 60, and 70% early in the quarter, but but as states began to reopen.
And as patient activity began to to accelerate XIAFLEX did in fact did show nice nice improvement and so I would say this I would say XIAFLEX showed a little bit better resiliency than maybe some of the other specialty administered analogs that we've been looking at I can be a data and as a as plays.
I mentioned in his prepared comments, we've been very pleased with the recovery and its traveling very well and as as we talked about earlier in the call. We do anticipate that we would return to normal as the office procedures and patient activity continues to recover levels and so right now we're tracking in about.
80% to preapproved levels, we would anticipate that that would continue to show that type of recovery and resiliency and as was mentioned I think either by marker blaze in his prepared comments, we are not currently preparing for a.
Another surge of coded that would would impact that that's not contemplated here. So we would anticipate a steady recovery as we close the year and then going into 2021, having that continue on.
Yeah, and then David on your second part of your questions around XIAFLEX.
XIAFLEX by far is an absolutely fantastic asset we have we're trying to continue to fully invest against that from a selling and marketing standpoint for our on market indications.
From a development standpoint, we talked earlier about our two opportunities. We're pursuing right now that are in development, which is plantar fibromatosis and adhesive capsulitis and we're going to invest against those.
Fully as those continue through the clinical development plan and then there are potential other opportunities that we're looking at in XIAFLEX.
And we'll continue to evaluate those but we're going to fully maximize that asset and and fully invest in that two to really get all the value out of that that we possibly can.
Next question please.
Your next question comes from the line of Amy video with the.
There Nick.
Hi, This is Ethan on cromie. Thank you for taking my questions on two if I may.
Maybe first on CLO.
It would love to know what you define as a successful launch.
How much you plan to invest for the launch and then when do you think you could break even and then maybe second question on margin.
The guidance implies a pretty big step down in Q3 for returning to what looks like more normalized levels. In Q4. Just curious if this is reflective of product mix or is there. Some additional things that we should think about it this quarter. Thank you.
Great. Thanks for those questions on the gross margin one we'll turn it over the market before we go there.
We'll have Patrick talk about what success looks like around quo, we're not going to comment on when we believe it's going to be breakeven, but let me turn over to Patrick talk about how we're setting the launch of for success. Thanks place. We're we're planning still planning on our spring 21 launch in so given that that's a 21 milestone we're not we're not going to guide on top.
Appliance sales, but we certainly are excited by the opportunity that well represents for us it's a transformative opportunity as as place mentioned in his in his prepared comments.
Success for US is a successful launch where we we do see a wide scale adoption amongst consumers and physicians, we plan to launch in such a way, where we're activating those medical aesthetic focus physicians.
And.
Again I think.
For us this is an opportunity to really launch a new category.
You've got a burgeoning in growing injectable market, you've got a growing body contouring market and with quo, we have the opportunity to create our own category as the first and only injectable to treat cellulite. So for us it's about adoption amongst consumers and HCP isn't more prepared to invest in execute in a way to establish.
Well as a cornerstone treatment for cellulite.
Yeah with respect to the margin step down in the third quarter, that's primarily due to mix if you indicated.
And that's really around our.
Sterile injectables business and the Destocking that we expect to see in the third quarter.
Next question please.
Your next question comes from the line of Gary Nachman with BMO capital markets.
Hi, Good morning, first could you provide more detail in the various impacts to adrenalin and the second quarter and how you think that will persist going forward and then with generic how much that new launches contribute into Q and you mentioned a major CRL for Supertex just explain what the issue was there.
Thanks.
Sure. Thanks, David.
So with regards to try to Lynn.
Step down we saw year over year was really related to two things one was destocking because we had a significant amount of stocking in Q1 at the related to kill that 19, but also we did see a little bit of.
An impact from a contract mix standpoint, which impacts price and then the third pieces that we did we did see competition come into the market in Q2. So the piece that it will be ongoing is there is some knock on effect there from a competitive standpoint.
In terms of Supertex I'm, not really going to comment on that we did get a major CRL, we're working through that and are preparing our response to the FDA.
Your last question.
Was on.
How much revenue on generic.
Thanks, and then maybe Mark you can you can comment on that.
Yes, so the impact of.
Launches with probably order magnitude like $70 million.
Sure.
Okay.
Please.
Your next question comes from the line of Annabel I Shimmy, what's stifle.
Hi, Thanks for taking my question had a couple just on the additional clinical trials for.
Hello could you layout some of the data that we can be the data releases that we can be expecting us in the trials that are going on right now specifically the real world trial and also for the additional.
Programs for XIAFLEX I'm wondering if you can sort of frame for us.
What kind of programs that what that might make sense, how extensive the programs might look obviously is an improved product. So.
Backing.
Movement strain from phase two inch phase three one phase three what is how extensive is the program can be for each of those indication. Thanks.
Great. Thanks, Annabel, maybe on on quo alternate over to Patrick and I can take the XIAFLEX one yes, let me start by just maybe giving everyone. A brief outline as to what the data generation that we haven't works because we're quite proud of.
The work that we're doing and I think it's going to be important work.
We've got our two or nine trial, which looked at different injection techniques, which validated the bucket injection technique and also gave us additional insights into that I injection technique, which we then consequently taken into into clinic, particularly in the 305 trial and so the three or five trial.
It's both up on us in size and non obese aesthetically experienced patients and so we're not going to comment specifically on the timing because we've got up we've got publications and podium presentations in the works, but you can anticipate that our data generation plan in.
General will culminate as we get closer to launch and as we get into the early part of of next year in latter part of this year, you'll start to see an emergence of some our data until nine.
And thrill five mainly going into next year and so all the data generation is coincided in and pretty much running in parallel with our commercial launch so as we enter into the marketplace commercially. We obviously have released one and release two which are landmark trials largest cellulite trial ever and we will be.
Complementing that with additional data specifically around three or five as we get closer to launch.
Annabel and on the XIAFLEX development programs, what I would say is that this studies that were currently on do.
Just got the first patient dose on for both plants are in for adhesive will really inform our development plan as we move forward and we have multiple scenarios in terms of what that path to approval looks like under all path.
This is a very promising opportunity for us, but there is the option potentially in some cases to do it.
And get to approval quicker than than other centers, but under all scenarios, we really up we really like these two opportunities.
Next question please.
Your next question comes from the line of Nathan Rich with Goldman Sachs.
Good morning, thanks to the questions.
Please move to start can you just talked about your marketing.
And kind of education plans are qual in the back half of the year in and kind of how we should think about.
That setting you up for the launch of quote once the product becomes available in early 21.
And then I think you also mentioned on the never car partnership.
We expect first launch.
Later this year could you maybe just talk about the high love opportunity with partnership.
The market.
Sure Thanks needs and let me turn over to Patrick to talk about.
The quote question and then I'll take the NASCAR.
Thanks place now that we have of the approval behind us for quell I mean, there was a lot of media pickup on the successful approval of close the first and only injectable available in the first injectable treatment for sale at approved by the FDA. So we obviously will be continued to work up PR channels to make sure that among.
The trade publications as well as mainstream media that its top of mind.
Our Harris poll survey is is a good example, if some of the things will continue to.
Try to do to keep that top of mind fresher mined in the mines of our consumers as we finish up this year will start to transition more actively around condition awareness and so that will be both digital and social strategy to create more awareness around the condition of cellulite, obviously as we get into the new.
A year and we're really ramping up commercially we will transition to more of an aggressive branded consumer activation strategy and so we're committed to really building out the market. We're committed to building a category and you would see us.
Really a step up our level of investment activities around consumer activation as we get into the new year, and we are tracking towards a product availability in the early spring.
Great sense, Patrick and anything on your question around the sterile injectables.
We as we said upfront our sterile injectables strategy is really focused on providing differentiated opportunities and some of those opportunities include ready to use products and the never car capabilities in that space around ready to use our really strong and so the five potential opportunities we have there which are five ish.
The two opportunities.
We are really excited about I'm not going to say a lot about the one we have coming up at the end year other than to say it fits the profile just described and we're going to be really excited about launching that.
Crystal next question please.
Im showing no further questions at this time I would now like to turn the conference back to Blaise Coleman, President and CEO of Endo.
Great. We appreciate your continued interest and support of the company and we look forward to providing updates as we move forward.
Thank you for joining us. This morning, you. Please have the fantastic debt.
Ladies and gentlemen. This concludes today's conference. Thank you for your participation and have a wonderful day you may all disconnect.
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