Q4 2021 Theravance Biopharma Inc Earnings Call
Ladies and gentlemen, thank you depending by your conference also begin momentarily again, thank you for standing by your conference call should begin momentarily. Thank you.
[music].
Ladies and gentlemen, good afternoon, I'd like to welcome everyone to get their advanced Biopharma fourth quarter and full year 2021 conference call.
During the presentation, all participants will be in a listen only mode.
A question and answer session will follow the Companys formal remarks.
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Now I'd like to turn the call over to Gail Cohen, Vice President Corporate Communications. Please go ahead.
Good afternoon, and thank you for joining the <unk> Biopharma fourth quarter and full year 2021 conference call to discuss our business outlook.
I remind you that this call will contain forward looking statements that involve risks and uncertainties, including statements about our development pipeline expected benefits of our products.
For me the timing of clinical trials regulatory filings and expected financial results.
Information concerning factors that could cause results to differ materially in our forward looking statements.
Describe further in our filings with the SEC.
Now I would direct your attention to slide three joining us are Rick Winningham, Chief Executive Officer, followed by Rhonda <unk> Senior Vice President commercial and Medical Affairs, Rick Graham Senior Vice President Research and development and Andrew Hindman, Chief Financial Officer, now I will hand, the call to Rick Wayne.
Ham for opening remarks.
Thanks Gail.
Turning to slide four last September we announced a restructuring of the company to optimize our business model.
We immediately initiated a significant cost reduction program and has taken actions to reduce the company's head count by approximately 75%.
The estimated 270 positions we completed most of these reductions by the end of November with the remainder remainder expected to be completed by the end of this month.
Since then we've rapidly transition to a streamlined focus there against Biopharma, we plan to leverage our expertise in developing and commercializing respiratory therapeutics and we will continue to explore strategic partnerships for our pipeline assets to unlock additional value.
All of these actions drive towards our goal of maximizing shareholder value.
There are three pillars of value creation highlighted on slide five for the go forward plan to build on our proven track record of respiratory innovation supporting several approved medicines for COPD and asthma.
These pillars include number one <unk>, which was discovered and developed my fair events Biopharma commercialized currently in partnership with via Trust you.
<unk> demonstrated market share growth quarter after quarter, despite the respiratory pandemic.
Sell side analysts covering through advanced Biopharma estimate your power against potential to generate U S peak sales of approximately $400 million annually.
We announced in early January .
Enrollment of the first patient in the calorie phase four <unk> study.
This study is successful we could potentially increase the addressable U S market from one in 10 patients to one five patients.
This increase in the total addressable market. Obviously isn't included in current analyst peak sales estimates Rhonda will speak to this.
In summary.
Summary of quarterly successes.
Number two.
Our respiratory pipeline, our second pillar value creation includes our most advanced candidate wasn't suddenly our dry powder inhaled JAK inhibitor program that we indicated would move into the clinic after securing a partnership.
Graham will walk through our development update.
And the third pillar is our economic interest in trilogy respiratory medicine developed my Glaxosmithkline.
Also known as GSK in collaboration with the company's predecessor.
Zap Viva <unk>.
<unk> is the first and only once daily single Inhaler Triple combination therapy approved for the treatment of COPD and asthma and its own controlled and marketed globally by GSK.
Given the strength of the clinical data underlying trilogy indicated uses coupled with Gsk's commercial excellence trilogy continues to experience exceptional revenue revenue growth trends, even in the face of a global respiratory pandemic.
At present GSK sell side analysts project trilogy could generate global peak sales of $3 6 billion annually.
Andrew will review <unk> fourth quarter performance and full year 2021 performance as well as review <unk> financials.
We believe the strong and growing cash flows your tolerant trilogy, and the expected future robust revenue for both coupled with several sources of upside potential in our development pipeline to generate significant value creation opportunities for our shareholders and now I will turn the call over to Roger to review your Perl right Ronda.
Thanks, Rick.
I am pleased to have the opportunity to share our latest performance update on <unk>, which is the first and only once daily nebulizer long acting muscarinic antagonist that provides a full 24 hours of control for patients and is indicated for the maintenance treatment of patients with COPD.
Despite the continued headwinds created because of the global pandemic. We are encouraged by the growth of <unk> performance in 2021.
As a reminder, there events biopharma and the interest co promote in the U S with our combined sales infrastructure targeting healthcare professionals, who treat COPD.
Suitable for heat tolerant.
They are against Biopharma commercial and medical teams cover the hospital segment and the interest covers outpatient based community health care professional.
From a financial perspective, we share profits on <unk> in the U S, 65% going to the interest and 35% or thereabouts biopharma.
Slide eight shows they are advanced Biopharma implied 35% share of net sales <unk> during the fourth quarter 2021.
$15 $3 million, which is the brand's strongest quarter to date.
However year over year net sales are up 13% Q4, 2021 versus Q4 2020.
The implied 35% share of <unk> net sales for the full year 2021.
With $56 7 million.
Which represents a 13% increase from 2020.
Demand doses for <unk> increased 8% in the fourth quarter over third quarter, 2021, and 17% year over year.
Total product demand for the full year of 2021 was up 25% versus 2020.
And was the case last quarter, while institutions in some parts of the country are allowing more in person access.
In person engagements remained below pre pandemic levels for our team.
It is also important to note that although the total prescription volumes continue to demonstrate growth.
Across most therapeutic specialties with volumes heading towards parity with 2020.
Prescription volumes within the Pulmonology specialty remain below pre pandemic levels.
This lagging growth is associated with the challenging the pulmonary community has experienced throughout the respiratory pandemic when trading COPD patients.
This included competing time demands of Covid patients a decrease in in patient COPD patient visit volume and a limited ability for HCP to diagnose and reassess their patients without pulmonary function tests or spirometry, which cannot be performed via telemedicine. These factors contributed.
<unk> two a reduction in prescriber confidence and ultimately fewer prescriptions.
Despite these challenges we have been encouraged with growth in total scripts for empowering which were up Q4 versus the prior quarter Q3 by 7% and increased by 32% year over year.
New to brand prescriptions also increased 11% in Q4 of 2021 versus Q3, and 31% year over year Q4, 2021 versus Q4 2020.
As a reminder, the script data represent the retail setting and they serve as a proxy for overall growth, but are not inclusive of the dnb or durable medical equipment fulfillment channel, which represents the majority of the volume of <unk> sales.
Turning to slide nine you can see that <unk> share continues to grow in both the hospital and the community settings.
<unk> share of the long acting Nebulize COPD market.
<unk> to 'twenty three 2% through October of 2021, which is our latest data point and up from 18, 2% in October of 2020.
As we have noted previously many patients with COPD experienced an acute respiratory episodes serious enough to require a trip to the hospital and therefore, the hospital becomes a key point to assess a person with COPD and convert a switch them from their current medicine <unk> calorie.
Data shows that many patients who received <unk> in the hospital are discharged with a prescription to continue treatment.
Allowing for continuity of you tolerate therapy post discharge.
The interest in <unk> Biopharma teams continue to work effectively and collaboratively using multiple tools and tactics and coordination to convert appropriate patients to new calorie during their hospital visits supporting them through their discharge and enabling them to be maintained on <unk>. After.
Their return home.
Looking specifically at the <unk> event.
Fuel sales deployment efforts in Q4 of 2021 doses sold exclusively in the hospital setting represented an 18, 5% increase from the previous quarter, demonstrating the highest quarter volume launch to date.
Slide 10, visually illustrates <unk> growth trajectory in the hospital segment since launch.
You can see how the unprecedented demands on pulmonologists in 2020 due to the pandemic changed the growth trajectory.
The new Palo Verde Hospital volume has returned to growth and during the fourth quarter of 2021, we achieved new key hospital account formulary placements and new purchasing accounts are being added regularly.
We believe these wins will yield significant growth in 2022, and <unk> will be the first Lama choice and many hospital systems.
Moving to slide 11, the outlook for 2022 and beyond for new tolerance is favorable.
Our medical liaisons have surveyed healthcare professionals, who have shared their observations on their role and use of <unk> and even with the COVID-19 surge as we saw in the fourth quarter <unk> was reinstated.
You can tolerate once daily dosing is proving critically important to alleviate system overwhelmed by COVID-19 cases and healthcare provider shortages.
It is important to understand that according to the evidence based gold guidelines for COPD management Lama or long acting muscarinic antagonist is foundational to COPD maintenance cure.
The execution of our tactical plan will continue to leverage these guidelines and the important role our once a day nebulizer therapy like <unk> can offer inappropriate patient types.
Looking beyond 2022, as we announced in early January fair events Biopharma enrolled the first patient in the FERC two study.
The phase four trial evaluating the performance of your salary compared to Spiriva in patients with low peak inspiratory flow.
Successful the <unk> study will allow us to capture more of <unk> addressable market and further strengthen its competitive advantage.
Lastly, the interest continues to develop <unk> for registration in China.
<unk> is marketed in China their advanced Biopharma will receive double digit royalties and milestones from sales in the China market.
I will now turn the call over to Rick Graham.
Thanks Rhonda.
As highlighted on slide 12, we're focused on the highest value core respiratory opportunities as Rhonda mentioned the paper to study the <unk> phase <unk> study in partnership with Beatrice, which is being conducted by <unk> biopharma.
Study will compare improvements in lung function and adults with severe to very severe COPD and suboptimal inventory flow rates. Following once daily treatment with either <unk> delivered via standard jet Nebulizer <unk> appropriate I am delivered via dry powder inhaler.
<unk> will be responsible for 35% of the cost of this study, which is currently enrolling and with topline results expected in the first quarter of 2023.
That will fit in there thats, our nebulize lung selective JAK inhibitor in development for the treatment of acute and chronic lung diseases and is our most advanced respiratory clinical candidate.
The UK COVID-19, therapeutic Therapeutics advisory panel, our UK CPAP has recommended evaluation of medical sitting at the remap cap trial, citing the unique inhaled formulation to black lung inflammation tissue damage directly and Malone, while reducing potential side effects caused by systemic administration.
Externally funded platform studies are an efficient way for us to generate additional clinical data with meso fitting there have been patients with COVID-19 that may be applicable to its continued development and related indications.
We're finalizing details of the planned platform study with remap cap and intend to share more information on when enrollment begins.
Our pipeline slide Slide 13 has been updated to reflect our respiratory focus on Repowering medical fitness and our inhaled JAK inhibitor program for asthma.
We have economic interest in <unk> and our skin selective JAK inhibitor that is licensed to Pfizer for the treatment of dermal dermatologic diseases.
Our other pipeline assets are now considered noncore and we're on track to complete study closeout, Verizon fitness and ample oxygen trials by the end of the first quarter and we aim to leverage partnerships to unlock value of the noncore assets I will now turn the call over to Andrew for the financials.
Thanks, Rick.
Turning to slide 14, we look at the performance of trilogy, the third pillar of our respiratory focused value creation plan as a reminder, <unk> zoned and marketed globally by GSK.
Through our 85% ownership interest in <unk> respiratory company LLC.
Or Trc LLC.
We are entitled to receive upward tiered royalties on global net sales of trilogy.
At present, 75% of income received from our economic interest is pledged to service principal and interest payments on our outstanding 2035, Nonrecourse notes and the remaining 25% of income is retained by us.
On slide 15, we've captured the most recent information GSK shared during their earnings call on February nine GSK.
GSK noted that trilogy continued to lead the market as a single inhaler triple therapy with year over year global sales growth of 52% generating global net sales of $479 million during the fourth quarter of 2021 and $1 $7 billion for the full year.
This growth is primarily driven by the continued adoption of trilogy, and the asthma indication and strong global commercial performance by GSK is team.
Moving to our consolidated financials on slide 16 here, we summarize our fourth quarter and full year financial highlights for 2021 compared to 2020.
R&D expenses for the fourth quarter of 2021 were $28 million compared to $58 million in the fourth quarter of 2020.
And for the full year 2020, 'twenty, one they were $168 million compared to $230 million in 2020.
SG&A expenses for the fourth quarter of 2021 were $16 million compared to $22 million for the fourth quarter of 2020, and the full year 2021, they were $71 million compared to $77 million in 2020.
These quarterly and annual figures exclude share based compensation and the onetime restructuring expenses.
We ended 2021 with $173 $5 million in cash and cash equivalents.
Turning to slide 17, with respect to 2022 financial guidance.
For R&D expenses, we expect to invest between 45 and $55 million relative to actuals of $168 million in 2021.
Of this expense range of approximately $10 million as non recurring spending that will be incurred in Q1 2022 to support the completion of ice <unk> fitness and air products team programs that Rick just mentioned.
R&D spending in Q2 and beyond will then normalize and reflect recurring investments in the respiratory focus.
Portfolio.
For SG&A expenses, we expect to invest between $35 million to $45 million relative to actuals of about $71 million in 2021.
Again, these operating expense guidance figures exclude share based compensation and the onetime restructuring expenses.
As a result of our reduced spending and improved cash flow generation from <unk> and trilogy, we reiterate our expectation to become sustainably cash flow positive on a corporate basis in the second half of 2022.
With that I'll turn the call back to Rick Winningham for closing remarks.
Thanks, Andrew.
2022 on slide 18 is effectively launch the new focus their advanced Biopharma as we've reviewed we've got three pillars of our value creation plan, returning <unk> commercial performance to pre pandemic launch mode growth trajectory, realizing the potential of our highest value R&D.
Clinical programs led by the Pepper to program on <unk> in the third key pillars, our economic interest in trilogy, which is experiencing strong revenue growth based on Gsk's commercial performance.
New focus their events Biopharma is moving toward our goal to become sustainably cash flow positive beginning in the second half of 'twenty two.
And to maximize shareholder value in closing I'd like to thank our internal team for their perseverance. During this period of time.
I'm at the company I am grateful for their commitment to our mission of continuing to develop medicines that make a difference in the respiratory area. The progress of our clinical pipeline and <unk> as well as the communities, we serve and I'll now hand, the call back to the operator for questions.
Thank you Sir once again, if he would like to ask a question you may do so by pressing the star key followed by the did you want on your Touchtone telephone if listening via webcast. Please need audio on the webcast device before asking a question over the phone.
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Again, Thats star one if you'd like to ask a question.
And we will pause for a moment to assemble our roster.
We will have our first question from Marc Frahm of Cowen Your line is open.
Hi, Thanks for taking my question congrats on the growth with <unk>.
Maybe looking to that pivot to trial, that's starting up now.
What do you view as the clinically meaningful difference that you need to show there and then assuming the trial's successful and you're able to show at least that benefit.
How quickly would you expect that to translate into kind of an inflection in use how resales as data.
Data released the inflection point.
Or should we be looking more towards maybe a label update that might come.
Nine months a year later.
Rick you want to take that or.
Yes, sure. So now Mark we have we have now put some of the details of the trial on clinical trials Dot Gov and <unk>.
Remember it is a few hundred patients then have head to head you tolerate with Spiriva. So we would be looking for a statistically significant difference in the trough that could be one at day 85. So that's what we'd be looking for in terms of the second question, Rick I'll hand, it back to you.
I think the.
The publication of the results is obviously one step forward.
It's worth noting that in the Registrational program, we have low peak inspiratory flow patients and the rep.
Phase III program and that data is.
Within the within the clinical trials a section mixed in with high power per patient so low pepper patients exist as part of our part of our label I would see the data rolling out to <unk>.
Early rapid publication, and then followed by that interaction with the agency on.
On the effects on the label so.
Without a doubt given that we are targeting <unk> versus the market leader increases as Rick said the F&B. One at trough is very is as important as this overall overall response rates in response differences in patient so.
We're pretty encouraged by what we saw overall with the low pepper patients in the phase III and then the pilot study that we did and we think that.
We can we can make significant headway with positive data in the pepper two study because as I've as I've mentioned in other.
<unk>.
We're just scratching the surface with the Bel Ray.
The opportunity out there for the nebulizer.
Once daily product with 24 hours of control is quite significant given approximately one in 10 patients use a nebulizer for maintenance many of them are using short acting nebulizer therapy that is not indicated for maintenance so.
I'm pretty excited about what we might be able to deliver with pepper too.
Okay, Great. That's very helpful. And then maybe just on the cash flow positivity guidance can you just remind us what kind of major variables that.
We are going into that.
Maybe what what do you assume on the visa side are you assuming theres more.
Investment activities from them are you assuming in the royalty flow of cash or maybe that you are able to start monetizing some of the investments that have been made.
The Mark the main driver of cash flow positivity is the performance of <unk> in our 35% profit split of those increasingly positive cash flows based.
Based on the U S performance. So it was.
It's been profitable since October 2020.
And we are happy that it's continued to maintain that profitability and is the key driver. In addition to focused cost management, both on R&D and SG&A expenses.
As I mentioned in my prepared remarks, 75% of the cash flows coming out of Trc LLC are pledged against the principal and interest.
Notes that we have outstanding for that.
The $400 million facility so.
The remaining 25% of any cash dispersed from Trc LLC does come to our balance sheet and income statement and cash flow statement, but it's a small driver relative to <unk> performance and cash flow management.
Alright, thank you.
Thank you. Our next question comes from <unk> Rama of Jpmorgan. Your line is open.
Hey, guys. Thanks.
Thanks, so much for taking the question on <unk> are there any seasonal <unk> dynamics, we should be considering just when we think about sort of quarter over quarter growth that you would point to.
Are there any second question, maybe some timeline so better understanding the missile setting the development program more broadly thanks, so much.
The one that you want to touch on the seasonality of <unk>.
Under the umbrella of it as far as we're concerned really you're probably still in the launch mode. But go ahead, yes, I was going.
To lead off from that 2019 being a launch year.
Our best baseline for looking at trying to establish.
Any seasonality that could be associated with the product beyond what you would expect with COPD in general honestly 2020, having the disruption with Covid.
I saw on that ability.
Looking at 2021 I think.
Can start to mimic what we would anticipate with the seasonality with COPD. However, looking at our trajectory of return to growth. It's still hard to demonstrate that there is explicit different seasonality associated with the product.
The Ric.
Yes, sure so and upon them on level setting.
With regard to what we've discussed previously our focus is on acute lung injury.
Chronic lung injury and fibrotic diseases, along with medical fitness. So at the current time. The team is really and this was a very focused team given our restructuring.
Really focused on the preclinical work so trying to understand.
The acute and the chronic indications, which makes the most sense scientifically from a priority standpoint, and so theres a lot of preclinical work that's going on so.
More to come in the future, but right now our focus is on following the science for nasal sitting at pre clinically.
Thanks, so much for taking our questions.
Thank you our next one.
Next question comes from Douglas Tsao of H C. Wainwright Your line is open.
Hi, good afternoon, thanks for taking the questions.
Turning to the pipeline.
You talked about the JAK programs that are in house.
In additional to the fitting out.
Obviously.
There was the Allergan study with 80, 236, which I know isn't a perfect proxy there've been drugs that have been approved that have not succeeded in that.
<unk> seen some very promising data earlier, so just where are you with that program or is that really on pause pending finding a potential partner.
And.
How far along are other sort of assets and potential development and how far along are you willing to take those without a partner or before finally, finding a partner.
Yeah.
Yes, so <unk>.
<unk>, which is the nebulizer JAK inhibitor, which.
Showed.
Proof of concept in.
Acute lung injury due to due to COVID-19 .
It is lined up to go as Rick mentioned into the Remap cap program, that's that's where a significant amount of focus is for us in pushing those forward, obviously as Rick said.
Preclinical work going on really to to understand the effect dose and duration of doesn't set in the chronic in fibrotic.
Chronic or the other other diseases like fibrosis is underway and the dry powder program I think what.
We've learned quite a bit from where we were with $82 36 on the necessary characteristics, we think to bring bring forward a stronger dry powder inhaled JAK inhibitor, we said before.
That program will proceed into the clinic with a partner Rick anything to add no nothing to add.
Okay, great. Thank you.
Thank you. Our next question comes from Lisa Baker of Evercore. Your line is open.
Hi, there I know you had indicated that maybe.
Maybe.
The outlook for trilogy.
Was.
It should be higher than current estimates.
<unk> indicated 4 billion versus 3 billion, which is more along lines. The consensus can you maybe just walk us through your assumptions there and how do you think about the timing of that I know a lot of it was driven by asthma.
Maybe being underappreciated, but perhaps you could pass a little more detail just mathematically how we get there.
Andrew you want to talk about the move over time with consensus.
We're not going to go through AD revenue build here on this call happy to do that offline with you but.
The commentary we've made our general observation about the fact that the street initially at the time of launch in 2017 valued peak sales in the COPD indication alone at $2 billion.
And as of as a quarterly print that GSK just put out for February 9th this month.
The Street has moved to $3 6 billion.
Over the passage, obviously over the last five years with a lot of strong commercial performance and the label indication globally and when most regions for the asthma indication so.
It's really based on the back of the sell side analyst community that cover GSK that were making those comments we of course have our own internal estimates that range around that the street sales estimates.
<unk>.
Could could exceed $4 billion, but we're really making reference in our prepared remarks today to the sell side analysts covering GSK, which of course.
Models are generally public and at the end of the day.
As we remarked GSK is team globally has been doing a great job and the data set supporting its use both in COPD and in asthma as the only once daily Triple combination therapy.
In a dry powder inhaler is really a unique offering for patients.
Relative to the other therapies available so we see it continuing to capture share across the board.
Yes, I think if you.
At least as you look at what's happening in the United States.
With a waning of the.
The pandemic you are seeing more COPD prescribing Ronda referenced this in our comments this is likely to affect trilogy in COPD.
Pulmonologists, we're seeing more patients so that I think are a true growth driver of this was from third party.
Market research for <unk>, obviously, as Andrew said is the asthma.
Indications are in fact getting.
Getting use and prescribing from primary care.
The asthma patient population with trilogy as has been the real driver through the pandemic and given the effectiveness of the drug overall.
Moderate to severe asthma patients I don't think that there is.
At least from the efficacy and safety perspective, it doesn't seem to be.
Any sort of cap.
We should continue to see growth.
Out of both primary care and the asthma, probably pulmonology to asthma, and then obviously pulmonology and COPD. Those are the kind of three legs of the stool at least as we've seen them for trilogy in the U S.
Okay, Great and then I guess for last year, where are we with <unk>.
With the payments royalty payments from <unk> for you guys like how much is outstanding and how much are you in receipt of on I guess on a percentage basis there.
Yes, I think we'll provide an update when we filed the 10-K here shortly statutorily required at the end of this month, so there'll be a exhaustive footnotes that we will answer those questions. We did get $60 million in cash out of Trc LLC through October of last year as we've previously noted.
Okay, and then I think you said.
We would expect we would expect the cash.
Cash payments to be.
Somewhat.
Characterized it was lumpy coming out of the.
Out of the LLC, but we do.
Do continue to expect to get all the all the cash due to us out of the LLC overtime.
Yeah, Okay and then just final question for me can you talk about the trial design for <unk> and Covid and maybe timing.
Rick you want to take that yeah, we haven't disclosed the design yet we're still working through the details with the remap organization, but with regard to timing.
We do expect in the very near future to be able to announce.
Enrollment so still more to come I can't comment very much on that today Lisa.
Okay, great. Thanks for answering my questions.
Thank you. Our next question comes from Joseph Stringer of Needham <unk> Company. Your line is open.
Hi, everyone. Thanks for taking our questions. A question on your salary mentioned HCP and in person interactions remain below pre COVID-19 pandemic levels. Just wondering if you could sort of quantify this a little bit more in terms of a relative percentage to pre pandemic levels how is that.
Increased our progressed over the last couple of quarters and do you expect.
It's a reach let's say, 100% of pre pandemic levels by the end of this year. Thank you.
Rhonda will take that sure.
Well looking at the back half of last year. They certainly increased over the immediate kind of pairing phase thinking about Q2 of last year and I think in Q2 of 2020.
We are still below pre pandemic levels. However, seeing the continued kind of variability across various regions continue to open up access.
With <unk>.
In person as well as the allowance of continued virtual engagement for promotional activities that continuing to grow over time I would like to say by the end of the year. It could be closer on all of that is dependent upon what next phase we are of the pandemic arent truly entering the endemic phase.
<unk>.
As Kelvin.
Yes, I mean so.
It's bounced around from this is just general.
General numbers too.
30%, 40% pandemic to 80, 90% given where were you are regionally in the United States.
I think on average our expectation is around the status of that goes into the endemic stage.
As the bottom to move up and obviously get back hopefully to close to pre pandemic levels.
A levels by by the end of the year now Fortunately, we've been able to expand.
The number of.
Tactical considerations that we used to get in front of customers and I think those those expanded.
Tactics are likely to continue to represent part of the calls and in addition to face to face interactions with health care professionals.
Great. Thanks for taking our question.
Thank you again, if you'd like to ask a question. Please press Star then one on your touch tone telephone against the ask a question. Please press Star then one.
Our next question comes from Vikram.
<unk> of Morgan Stanley Your line is open.
Great. Thanks for taking my question.
Two from my side, both focused on pipeline. So first on <unk> could you clarify what level of regulatory interaction that you win.
The interest May have had with the FDA regarding this program and then based on these interactions what amount of data do you think you would need to be able to file.
And what would be in the final bill package for a label update.
And then second question your pipeline page notes the skin selective JAK inhibitor for dermatology, that's partnered with Pfizer. So I just wanted to see if you could provide us with an update on where this program stands and what the next steps here could be.
Yeah sure on the Pfizer.
Pfizer program, that's listed 11 Clinton trials Dot Gov.
<unk> is preparing to go into phase one so I think you can pick it up pick it up off of off of there.
And followed the progress both with our updates as well as as well as progress on <unk> trials.
I think the.
But we've had level of interaction with the FDA on on peffer to and where it would go.
Where it would go in the label obviously.
It depends.
Any regulatory interaction.
Pins on the data, but I think clearly we see a we see a path forward for inclusion of the pepper to data in the label depending on the strength of evidence that we demonstrate so.
We wouldn't have we wouldn't have gone forward without it so.
Thank you. Our next question comes from Douglas Tsao of H C. Wainwright. Your line is open.
Alright, thanks for taking the follow ups, just maybe Rhonda just in terms of <unk>. Just curious if you could provide some color on some of the competitive dynamics you've continued to gain some share.
I think earlier in the year make your provided one had some generics.
Just maybe where you are gaining traction and how you might see that playing out in the coming months.
Thanks.
So certainly seeing traction related to.
Increased awareness in the appreciation of the role <unk> can offer as of Wednesday long back.
Backing back to the comments that Rick made earlier, we're still in launch mode. So the ability to get the message out there.
And see that experience take place that's.
Certainly driving the utilization there is utilization in combination with <unk>.
With other long acting products like provider.
<unk> performance, although we do not promote that and.
<unk> also seen.
We're watching very closely how the market is playing out with the generic entries for both providers and performance.
We're still watching that over time to better understand those dynamics.
Yes, I think.
Doug the benefit here with <unk> and one to hit all of our comments is that the Lama is really considered foundational therapy for COPD and for patients that.
For patients.
That have COPD and need a debbie lives, where they haven't been able to access that foundational therapy product before really at scale before you Perl rate and so we talked about being in launch mode. Thats really true I think we're continuing to get out there drive awareness of <unk> and then the.
The generic <unk> of the two.
Two twice a day law, because we really haven't seen kind of anything but probably a net positive effect on <unk> from that.
Thank you.
Okay, great. Thank you.
Thank you. It appears we have no further questions on the phone I will turn the conference back over to Mr. Winningham. Please go ahead Sir.
Yes, just thank you for your thank you for your attendance and your interest in the company, we look forward to.
<unk> 2020.
<unk> and we'll be updating you on our progress throughout the year have a great day.
Thank you ladies and gentlemen, this does conclude today's conference. Thank you all for participating you may now disconnect have a great day.
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