Q2 2021 Theravance Biopharma Inc Earnings Call
Yeah.
Okay.
Ladies and gentlemen, thank you for standing by.
Good afternoon, I'd like to welcome everyone to their parents Biopharma second quarter 2021 conference call. During the presentation. All participants are in a listen only mode. A question and answer session will follow the company's formal remarks. The question. Please press star followed by the digit 1 on your telephone again Thats star 1 to ask a question.
Listening via webcast. Please mute the audio.
On your webcast device before asking your question over the phone I will repeat the instructions after management completes their prepared remarks also today's conference call is being recorded and now I'd like to turn the call over to Gail Cohen, The Vice President Corporate Communications. Please go ahead.
Good afternoon. Thank you for joining the thorough than I am pharma second quarter 2021 conference call to discuss our business.
As always 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 and anticipated timing of clinical trials regulatory filings and expected financial results.
Information concerning factors that could cause results to differ materially from our forward looking statements are described further in our filings with the FTC.
Now I would direct your attention to slide 3 joining us are Rick Winningham, Chief Executive Officer, followed by Rick Brown Senior Vice President development Brink, Pos Kumar Chief Business Officer, and Andrew Hindman, Chief Financial Officer, now I will hand, the call Rick Winningham for opening remarks.
Yeah.
Thanks Gale force.
21 of its been about progress progress of our clinical pipeline of our commercial outset, you'd call rate and progress since we as the company adapt to the ever changing pandemic and define what our business will look like for the future I'm grateful to the team of terror events, Biopharma and continue to show resilience and perseverance, while continuing to ensure our advance.
Splitting commitments of developing medicines that make a difference.
Starting on slide 5 in the second quarter, we made strong progress delivering the date of 1 of our for pipeline tablets phase 2 data for dental suddenly of more investigational inhaled <unk> lung selective pan JAK inhibitor for acute and chronic lung injury.
We continue to drive forward, our clinical programs preparing for 2 critical data readouts I sort of setting the phase <unk> data in the ulcerative colitis, which will report top line results. Just ahead of an for walks the team phase III data for symptomatic neurogenic orthostatic hypotension, and the third quarter on the respiratory front.
Moving to slide 6 you Pelerine trilogy of continue to make strides showing signs of rebounding from the pandemic headwinds for 2020 with continued market share of net sales growth Frank will expand on the metrics from the second quarter and trends that we are continuing to see in July of 'twenty 'twenty 1.
We're also planning for a future of your power as we along with a partner of Beatrice are initiating phase for clinical study. The study will compare improvements of lung function and the adults with severe very severe COPD and suboptimal Innsbruck Tory flow rate following once daily treatment with the.
Either your Perl Rea delivered via standard jet Nebulizer of Tia Tropaeum delivered via dry powder inhaler findings from this study are intended to provide day to support of possible label update and help better inform physicians as they are working with their patients. The design COPD treatment plans, we expect the study to kick off later this year.
Now ill turn the call over to Rick, Brian who will discuss the upcoming pipeline catalysts Rick.
Thanks, Rick.
It's an exciting quarter for thorough vans biopharma as we approach topline data readouts for 2 of our key clinical programs. The phase <unk> study of IV sitting there had been ulcerative colitis will read out first followed by the first of 2 ongoing pivotal studies for them for walks of team and symptomatic and of which.
I'll start with is in certain of our oral gut selective pan JAK inhibitor to treat inflammatory bowel diseases, which is partnered with Janssen.
On slide 8 we outlined details for the EIS and sit in the phase <unk> study.
In addition to reporting the primary end point, we plan to share key secondary end points and standard of disease surrogate IBD Biomarkers. We will also provide the safety analysis and systemic drug concentrations low drug concentration in the systemic circulation is an important differentiator for EIS and sitting them given the JAK class.
The concerns.
We will report the adverse event profile and highlight adverse events of special interest.
As a reminder, the goal for EIS and sitting them is to maximize therapeutic benefits of patients while minimizing side effects. We believe the gut selective JAK inhibitor like eyes, and fitness has the potential to be a game changer for the treatment of IBD and that it has the potential to become a once daily oral treatment amenable to earlier lines of therapy.
As well as combination approaches.
On slide 10 of the details for the ample ochs of team Phase III, Sequoia study, which will read out this quarter. Shortly after is in Sydney.
The Korea is the first of 2 ongoing pivotal studies will share of timeline for reporting on the second study of Redwood in the near future.
As a reminder, ample ochs of teen is a once daily norepinephrine reuptake inhibitor for the treatment of symptomatic and away.
We're working to break new ground in this disease area as there is of significant unmet medical need for the treatment of patients with symptomatic end of wage a condition that profoundly impacts the quality of life and occurs in people suffering from Parkinson's disease multiple system atrophy and pure autonomic failure.
We plan to share the primary the key secondary endpoints and we will also report the adverse event profile, including supine hypertension Wheeler.
We look forward to sharing results for both of these important pipeline catalysts soon.
Next Frank will speak to our commercial team's progress with your calorie Frank.
Thanks, Rick.
Turning to slide 12, you power is indicated for the maintenance treatment of patients with COPD is the first and only once daily nebulizer long acting muscarinic antagonist that provides a full 24 hours of control for patients.
Last year, despite the headwinds created as a result of the global pandemic <unk> recorded solid sales growth through.
Through the second quarter of 2021, the trend continues and we remain optimistic given the significant patient opportunity for you Corey.
As a reminder, there Vance biopharma and via true co promote in the U S with our combined sales infrastructure targeting health care professionals, who treat COPD patients suitable for Ya <unk>.
The advanced Biopharma commercial and medical field teams cover the hospitals segment of health care providers and Beatrice covers community health care professionals.
Also remember the V interest there bands Biopharma commercial partnership is the 65.35 profit share split.
Slide 13 shows their advanced Biopharma is implied 35% share of net sales for Ya calorie during quarter 2 of 2021 of $14.6 million.
Importantly, we saw you calorie sales pick up momentum throughout the quarter quarter..2 of 2021 net sales were up 13% from quarter, 1 of 2021 and up 38% compared to quarter 2 of last year.
Turning to slide 14, you can see that our share continues to grow both in the hospital and the community setting.
As we've noted previously many patients with COPD experienced an acute respiratory episodes of serious enough to require a trip to the hospital for immediate care.
The hospital, then becomes the key point to assess the person with COPD and converter switch them from their current medicine to empowering.
Data shows that many patients who received <unk> in the hospital are discharged with the prescription to continue treatment, allowing for continuity of your calorie therapy post discharge the Beatrice and their advanced Biopharma teams continue to work effectively using several tools tactics and coordination to convert.
Appropriate patients from competitive products to your calorie during the hospitals to outpatient experience.
As evidenced by the share gains since launch the strategy is effectively being executed by both companies teams.
Demand doses increased 13% second quarter over first quarter, 2021, and 34% over second quarter of 2020.
The impact of Covid on commercial efforts may be easing somewhat as states local governments and institutions and some parts of the country are beginning to allow in person meetings. However in person access to customers as well as patient visits to Hcp's remained below pre pandemic levels.
Approximately 62% of all COPD targeted hospital accounts are physically accessible to our field colleagues.
However, the T V. P. H sales team continues to leverage customer engagement opportunities via virtual meetings and phone interactions.
In the second quarter total HCP interactions grew by 16% over quarter, 1 of 2021 with live face to face interactions, reaching 39% of total interactions the highest quarterly average since the pandemic began.
We've also been encouraged with prescription activity through June.
The new to brand our axes in total our actions have continued the upward growth that was reignited in late first quarter.
In addition hospitals continue to add new Pal read the formularies and new accounts are being added weekly.
Looking specifically at the third advanced field sales deployment efforts in quarter, 2.2021 doses sold exclusively in the hospital setting represented a 25% increase from the previous quarter.
June hospital volume hit of new launch to date high and we saw 127% year over year growth from June 2020.
Quarter 2 of 2021 incremental volume growth was 47% from April to June representing the highest in quarter growth launch to date.
You can see this upward growth on slide 15 progressing through the end of the second quarter.
We also continue to track the key performance metrics since launch and the following are the quarter to 2021 metrics of total of 815 hospital accounts have ordered <unk> calorie and 69% of these accounts have ordered the power at least twice.
Quarter, 2.2021 formulary wins totaled 5 which equates to 446 formulary accounts launch to date with the formulary win rate of 91%.
85% of these formulary accounts purchased to date, owing to a lag between formulary approval and ordering commencing.
The medical science liaisons formulary support for presentations in quarter..2 2021 was the highest since quarter 1 of 2019 when the brand was launched.
In person interactions by the MSL team were 3 times higher Inc quarter, 2 versus quarter, 1 but remain markedly below pre pandemic levels at the end of quarter 2 <unk> commercial coverage was 75%.
So looking ahead, it's important to understand that according to the gold guidelines of Lama is foundational to COPD maintenance care.
The execution of our tactical plan will continue to leverage the guidelines in appropriate patient types, while we continue to optimize the marketing mix through rigorous and continued measurement of tactics.
As Rick Winningham mentioned, we'll be initiating of base for Pipper clinical study, which is aimed at helping to better informed decisions. When physicians are designing of personalized COPD treatment plan with patients.
<unk> has demonstrated resilience to many of the external factors and we remain committed to continuing to bring this medicine to appropriate patients in the second half of this year and beyond so now I'll turn the call over to Andrew to review the financials.
Thanks Frank.
And before moving to the events Biopharma of quarterly financial highlights, let's start with an update on Gsk's trilogy on slide 17.
As a reminder, trilogy is the first and only once daily single Inhaler Triple combination therapy approved for the treatment of COPD and asthma.
<unk> biopharma is entitled to receive upward tearing royalties on global net sales of trilogy.
At present, 75% of the income from our economic interest is pledged to the service principal and interest payments on our outstanding 2035, Nonrecourse notes and the remaining 25% of income is retained by us.
We've received $46.3 million from Trc LLC during the first 7 months of 'twenty 'twenty 1.
And during Gsk's recent earnings call. They noted the trilogy continued to lead the market as the single inhaler Triple therapy with Q2.2021 sales growth of over 68% over Q2, 2020 generating global net sales of $405 million.
Moving to slide 18 here, we provide our second quarter 2021 financial highlights compared to the second quarter 2020.
R&D expenses for the second quarter were $51.1 million compared to $62.4 million in the second quarter of 2020.
SG&A expenses for the second quarter were 50.
$25.9 million compared to $24.8 million in the second quarter of 2020.
And as a reminder, all of these figures exclude share based compensation.
In addition to those end of quarter financial highlights for second quarter highlights during June we closed a public offering of ordinary shares at a price to the public of $15 per share with gross proceeds of $115.6 million before deducting expenses and we ended the second quarter with.
$265 million in cash and cash equivalents.
Regarding financial guidance for the full year 2021.
We are reiterating previously issued guidance and that was for R&D, we expect to invest between $195 million to $225 million relative to actual R&D investment of $230 million in 2020.
For SG&A, we provided a range of 80 million to $90 million relative to an actual SG&A expense of $77 million in 2020.
And again all of those figures exclude share based compensation.
With that I'll turn the call back to Rick for closing remarks.
Thanks, Andrew on.
On slide 19, we summarize what makes their events biopharma valuable for a unique entity for a company our size with value drivers include a mix of differentiated wholly owned compounds, coupled with strategic collaborations and partnerships.
This concludes our commercial partnership with via Trust co promote your power in the second quarter for the.
The second full year since its launch <unk> continue the experienced solid net sales growth on an annual basis in 2020, which is the trend we're continuing to see in 2021 true.
<unk> for which we're entitled to receive upward <unk> royalties on global net sales of <unk>.
The pipeline with the answer the license suddenly oven 50, TV for 5200 to the potential of up to 1 billion of milestone payments. The TV ph plus profit sharing and the U S and double digit royalties ex U S. And then finally, our wholly owned assets several of the later.
Stage development <unk> seen in phase III and knows the suddenly the face to several other key programs to address large patient populations. When you add the store in house research and development capability plus the U S commercial infrastructures that leverages.
Leverages analytics, driven deployment and has demonstrated success. We believe there's a strong case for value creation of thereabouts Biopharma as we deliver key clinical data in your Perl rate commercial performance for the future.
In closing on slide 22, this quarter is critical to us as we look to deliver the data for EIS and certain of the ulcerative colitis and <unk> in symptomatic get away. These programs for value drivers of potential not only to be transformational to their events biopharma, but also the patients impacted by these diseases. Our mission of continue to develop.
Since that make a difference for the progress of our clinical pipeline all with your power and trilogy demonstrate we're working to make that a reality I'll now hand, the call back over to the operator for questions operator.
You Sir once again, if you would like to ask a question you may do so by pressing the star key followed by the digit 1 on your Touchtone phone.
Listening via webcast. Please mute audio on your webcast device before asking a question over the phone if you're using a speaker phone for todays call. Please make sure. Your mute function is turned off to allow your signal to reach our equipment again that strong wondering if you'd like to ask a question and we'll pause for a moment to assemble our roster.
Our first question comes from the line of Geoff Porges from SBB Leerink. Your question. Please.
And the ban on for Jeff.
The question first can you remind us of the.
Hurdle for statistically and clinically significant results from the for lots of teams pivotal trial results coming up and for.
On cash we ended the quarter.
$5 million in cash and then put up the net loss of about 50 million, which presumably approximate the cash burn he ran the numbers out of less than 6 quarters of cash runway do you expect expenses to come down significantly at the end of the year and could R&D the car, let's say in half once the.
The current trials for <unk> and into net of our completed thank you.
Tim.
Yeah, Rick do you want to take the <unk> question Andrew.
We will take the.
For the ask questions at all close Rick.
Sure sounds good thanks for the question Anna for the you mentioned the hurdle with regard to statistical and clinical significance for him for walks the team with regard to the Sequoia study that we'll be reading out this quarter 3 the.
The primary endpoint is a change in OE HSA, 1 from baseline and what we have agreed to with regard to the endpoint with the FDA is a clinically meaningful change.
You know HSA 1 of 1 point.
So its a 10 point scale and Thats the primary endpoint for the Sequoia study.
Yes, Andrew.
Sure with respect of the question on the from my initial profit profile of their Anna I guess, there's 2 components that I would focus in on.
Yes, the math, if you simply straight line $265 million divided by about $50 million of cash utilization of our investment during Q2 that gets you to about 6 months of quote unquote runway.
I've heard that that is an overly simplistic view of our business number 1.
We've been talking to investors and the sell side for quite some time.
The changing financial profile of our of.
P&L and.
This relates predominantly to an increased revenue growth and cash flow from both <unk> and trilogy that are becoming increasingly material contributors to our balance sheet.
And we've.
Mentioned previously and it is still true today that the on.
On a brand basis, you Pal re is generating cash flow into their events Biopharma when we factor in our 35% profit split.
And all in costs associated with commercialization of the brand of shared costs with the interest and then the non shared commercial costs that we.
More of a 100% at sort of events Biopharma.
So the the source of cash flow generation from both <unk> and trilogy, even the 25% stake is not used to pay down the 2035 nodes is becoming increasingly meaningful contributors to our balance sheet and then secondly.
And by the way that that would trend is true today. It was true last year and it will become increasingly true that <unk> calorie and trilogy, our net cash contributors to our balance sheet in 2022 and beyond so.
Cynthia 6.6 quarters out 5 quarters out 4 quarters out that the.
Changing financial complexion is increasingly cash flow generation from non financing sources.
The other component that's very important to keep in mind is that while the Janssen is our collaboration partner on island sitting them. They currently will have to make a decision once we generate the data packages, both for UC and Crohn's and deliver those data packages. After the receipt of the second data package for Crohn's They will have.
The 90 days to decide if they want to enter into an exclusive global collaboration agreement and if they choose to do so they will pay us $200 million for an option payment.
And that is going to be a significant source of additional capital that will extend our runway beyond 2023. So hope that helps answer it with the a bit of detail, but Rick winningham, if I missed anything please chime in.
Oh, I think I think you've covered everything adequately we continue to have.
The robust.
Research organization and translational Science group debt.
<unk> continues to deliver.
Political out of assets into the clinic and in some of those instances those SaaS that's well.
We will enter into partnerships in certain regions of the world with those assets, So I think and total debt.
It's a pretty complete complexion of the.
Both the financial picture as well as our expectations of <unk>.
The <unk> team from the $1.6 line study.
Very helpful. Thank you.
Thank you. Our next question comes from the line of Martin from from Cowen and Company. Your question. Please.
Thanks for taking my questions.
Maybe just on <unk> can you remind us kind of.
What you would expect on the safety analysis, just kind of on background rate of the end of the key safety events like infections in thromboembolic event for.
There are pockets of study population like Ria and considering the limited follow up Thats in the phase II portion.
Yes, that's of Great. That's a great point, Mark Rick do you want take debt.
Yes sure Mark.
So the race study and maybe I'll step back for a minute and just remind everybody that the program here is the seamless phase <unk> 3 design. So the race study of the to be portion and that's of dose dose finding portion where we have 3 different dose levels relative to placebo patients the complete ray for the phase II.
The study roll into a 44 week maintenance study. So that's the phase III portion and then after we select the dose or more than 1 dose we would initiate a second confirmatory induction study. So I think what you were alluding to with regard to some of these adverse events of special interest where the small sample size of 240 <unk>.
We're probably not going to be able to prove definitively.
As in certain of is not causing any.
On the warrants at the safety effects, but what we're gonna be focusing on is the adverse events of special interest like multi dermatome zoster opportunistic infections malignancy and thrombolytic events. So these are certainly JAK class events.
But again they have a relatively low adverse of that rate, we're going to be focused on those and we'll report on those as we read out the trial.
Some of the things that are more sensitive, though that we do have confidence with the sample size of 240 to really hone in on the gut selective nature of adviser sit in our lab parameters like cholesterol and see PK. So these are things that will also be focused on to understand whether there was a gut selective.
Our gut selective effect or not with regard dies and sitting up on safety.
And I think just to close off the Mark obviously, the the driver of the toxicity of the systemic jacks it's the.
As the concentration.
All of the strain of the drug at the in the <unk>.
To the street been aware of that bloodstream carries the drug throughout.
Throughout the body and obviously our expectation in the phase <unk> study for the island's set that was to see extremely low concentrations of the <unk>.
Drug in the bloodstream in contrast to the systemic JAK inhibitors.
Okay, Great. That's helpful. And then maybe just follow up on the last question on cash.
Cash burn.
Can you just.
Kind of what the spend level is on kind of the early stage pipeline that.
Obviously doesn't get talked about a lot.
And then kind of what the expectation would be assuming <unk>.
While it's positive in terms of.
Meaning the build out the commercial organization to kind of support that the filing and approval and hopefully approval.
Yes, mark either the standard the.
The quick answer is.
Everything that is what I would characterize as early development or research is not very much of our R&D spend you could probably use corrado assumptions to get to.
What I mean by that.
And with respect for the commercial build out of all.
Take a stab out of and frame as Glen can certainly correct me, if I'm wrong, but.
We're looking in as we've talked about with investors for quite some time, we're looking with an prolongs the team given that it's focused on of rare disease population to build out our commercial infrastructure to right size the launch.
And of course that that will be based on finalizing the development timelines with the regulators. Once we have the study 169 results and we will invest in the in the launch of appropriately well in advance to ensure its success, but we will be leveraging existing investments that we're already making.
To support <unk> in the home office and in other areas of management and medical Affairs. So.
The incremental investment to adequately support the launch of Amp locks of team will not be.
Material addition to our SG&A in total but the franc.
Yeah, no. Thanks, Andrew I don't know if I have much to add to that we will take a very targeted approach.
We are doing the work now to understand exactly where these patients are are headed when they need help in and what are those physicians that treat those patients and we're going to focus.
Very heavily on.
On those as the start and I'll just reiterate what what Andrew said, we do plan to leverage the investment that we have in the commercial organization now.
[noise] excuse me where.
In some ways, we're a little bit inefficient with 1 product will be able to leverage those investments much much better going forward with the with 2 products of the bag.
And just to conclude the.
The.
As some.
Of the rare disease companies have done obviously well the.
The medical clinical team that is our clinical liaisons that are in the field of those clinical liaisons will will move over to augment the medical groups that we currently have in the field. So that really gets at some of the points that are making about incremental investment.
Okay, great. Thank you.
Thank you. Our next question comes from the line of lease of Baker from Evercore ISI. Your question. Please.
Hi, Thanks for taking the question can you, maybe just elaborate a little bit more on.
You've kind of had mentioned in your last comment that they are looking at various lab parameters.
I'm, sorry, I'll, let Ben I think you said parameters the CFO.
If I just.
Net net there's indeed, a gut selective can you may be expand on a little bit more on that we should be looking for exactly.
Yes, Rick.
Yeah sure Hi, Lisa So what I was meaning is that for the systemic JAK inhibitors across the board. It's been reported that there are changes in a relatively short amount of time in cholesterol, whether thats HDL LDL and then the other 1 is crap and the possible kinase. So those are those of parameters that with the gut selective.
JAK inhibitor of other guys and certainly we don't expect to be targeting or modulating. So we will take a close look at those because with a relatively small sample size, we should be able to discern whether or not there's the signal there.
Okay. So we would expect the thing no changes are more modest changes or what's the.
Paul.
Yes, we would expect to see no changes in those parameters again that of relatively sensitive to systemic JAK, because we're not expecting to see high levels of Iceland sitting there had been the liver where these enzymes are synthesized.
In the case of see PK in the muscle.
Okay.
Can you give us any more color on year of kind of like timing in the quarter for the different studies of which 1 we should expect first should we read anything from like kind of the the order in which you are discussing them just curious.
No I think the nothing nothing with any more granularity I think Iceland setting the.
We will read out first to be shortly followed by <unk> and that's the.
That's the sequence that.
We'll rollout of the data.
Okay.
Great and then can you talk about next steps for <unk>.
For your.
I can't lung injury program.
Sure I mean, I'll start and then Rick can chime in and we've.
<unk> begun to meet with regulators.
In Europe.
The well meet with regulators in the U S really focused on COVID-19 as a part of acute lung injury in defining the.
The fine of sample size that would be made for studies in the.
<unk> learning entering various types of the acute lung injury going forward Rick.
Yeah, the only thing I would add there in addition to interactions with health authorities, which has been very helpful. We've been talking to a number of different.
Groups that have platform trials and sort of we're getting feedback and considering our options there as well.
Can you is acute lung injury of how does that differ from.
He already asked or is that sort of the same thing.
No. It's not the thought the same thing usually you see the acute lung injury proceed of <unk>.
Yes.
The.
That's the general.
The clinical paths that day or the us takes and we would expect to be able to modulate.
Acute lung injury, that's related to the unplanned of Torrey Cascade.
That like what we like what we saw in the.
And the C.
CRP subset with.
It doesn't set the.
And I think that was a fairly important finding and certainly as.
As we've shared the data with others.
<unk> agreed with us that CRE.
See our GP is the Saar.
Alright.
The biomarker that we used was the very important point to cut off.
Terms of the rates of inflammation of the lungs Rick.
Yeah. So I don't Lisa if you remember we had actually reported that we saw a meaningful reduction in 28 day all cause mortality in time to recovery in patients with Covid, who were treated with nasal sitting and knows the had a baseline C reactive protein level of less of the 150 milligram per liter. So.
That.
Despite the fact that we didn't hit the primary endpoint on the ordinal scale, which is a tricky 1 of the head and that's been true for other molecules in the space. We do believe that this change in mortality was meaningful.
Okay.
Great and then just final question for me for Amber lots of the team can.
Can you describe any conversations you've had with regulators that may indicate no flexibility and how they are willing to consider the day. It I. Just you know you look back at some of the approvals in the space and kind of scratching. Your head. So I'm just wondering kind of what the bar is for you guys and NIH and that's my last question. Thank you.
Yeah, that's a great point I think we've got a great relationship with the FDA on this application overall since we began began the work.
And the N of wage.
And it's because of the more or less paucity of data that exists for the existing agents and in fact, the the risk benefit.
There are for the existing agents at brickyard provide even more color.
Yeah, it's important to step back again and think about the design of this body of work. So there's 2 pivotal trials..1 is the Sequoia study, which will read out very shortly and that's a 4 week efficacy study randomized 1 to 1 active drug ample ox team to placebo patients with <unk>.
<unk> The Korea can then roll into the study that is called Redwood. This was a 16 week open label study. So everybody gets active drug and at the end of 2016 weeks. The randomized 1 to 1 again active to placebo and Theyre looking we're looking then for a worsening of effect in that randomized withdrawal period over 6 weeks.
So between the first study in the second this is a very robust body of work to demonstrate the benefit and risk profile of AMT blocks of team again as Rick said, Lisa we worked closely with the FDA on the design of this body of work.
And we do expect that both studies are going to be required for a full approval. However, we will have a conversation with the FDA at the end of the Sequoia study with the data in hand, and have an opportunity to have a conversation about the data.
In particular, we would focus on breakthrough therapy designation request, which is an opportunity for an expedited review of an NDA based on therapies that meet an unmet medical need.
Okay, great. Thank you.
Thank you. Our next question comes from the line of Douglas Tsao from H C. Wainwright Your question. Please.
Hi, good afternoon. Thanks for taking the questions just maybe as a starting point on your calorie I'm just curious.
You indicated that you had.
The second quarter south of the most of them for.
The presentation since launch and was that just sort of improved access post COVID-19 and how long should it take before we start to see those translate into wins and ultimately revenue.
The Franklin Okay. Yeah. Thanks. Thanks for the question we are on the MSL.
The metric that we recorded related to the M. S cells they were.
We're really had many many requests from the field for formulary support presentations and as I mentioned in the script. It was the highest.
Quarterly amount since we launched the drug we launched the drug in quarter..1 of 2019. So we were very pleased that that's an indicator that the the level of awareness and interest that the teams the.
Field teams are generating is paying off for us.
And we do measure the the amount of time it takes from those those first formulary presentations 2 of win and then also ordering now I will tell you that the length of time has been lengthening since the pandemic began because obviously these pulmonologists have a lot on their plate.
And typically even if you have everybody else shaking their head affirmatively for formulary review a.
The Pulmonologists has to pass the way in a very heavily and supported the drug so the the.
The attempt.
The typical average time is somewhere between somewhere approaching 3 months.
<unk> been as high as 90 days, it's been as low as 60 days.
So I hope that answers your question, but it's just the tough metric to key in on right now because of the pandemic lengthening that cycle time for us.
No. That's very helpful. Thank you and just the level of fitness.
Terms of it sounds like you're looking at sort of some of these bigger trials that are of value of multiple products that are at the different time.
I know the mortality of benefit was quite compelling.
Are you looking at that as potentially an endpoint versus 1 that is sort of more based on on respiratory function. Thank you.
Yes, Rick.
Yeah. Thanks, Doug the general of the General interest as Rick has said not just from their vans Biopharma book from the stakeholders externally that we've shared the data with has really been around the mortality benefit. So certainly as you have said with each of these platform trials they have different objectives and work.
Keeping our options open with regard to what makes sense for the next steps with Nestle sitting there.
Okay, great. Thank you.
Thank you. Our next question comes from the line of of Anoop them ramp from Jpmorgan. Your question. Please.
Hi, guys. Thanks, so much for taking the question.
As an update on sort of the latest that's ongoing with the arbitration with the N of Veeva I think most recently you've kind of made of response back from the courts and I think he may be in the waiting phase for a response back maybe you can just give us an update there. Thanks so much.
Yes, well I think.
We've concluded the obviously concluded the second arbitration period, where.
Our perspective is that the there were certain guidelines relative to the usage of the royalties that became.
Slightly slightly more clear with the with the arbitrators ruling there are some just.
Some of.
Particular parts of that ruling we are in the middle of seeking clarity.
Of those of those.
Particular sections of that don't have anything to update 1 on it at this point in time with regards of that but we continue to to.
To watch the.
Much of the end of Veeva of management of the Trc royalty company quite closely such that the actions of the.
Then of Veeva as manager of consistent with maximizing the.
The value of the of the royalty stream for.
For the <unk>.
The ship as well the limited partnership as well as the.
As well as their advanced Biopharma. So that's about it on the arbitration.
Thanks, so much.
Thank you. Our next question comes from the line of the Chrome program from Morgan Stanley. Your question. Please.
The current you might have for your phone on mute.
Hi can you hear me now.
Yes.
Yeah the area.
Great. Thanks for taking my question.
So I had 1 on.
The Ray program.
It seems that the highest dose you're evaluating in the phase <unk> portion here is.
Debt lower than the the dose that was the value of into the phase 1 portion. So I was wondering if you could just talk us through the thinking behind dose selection.
For the Phase III study.
Rick.
Yeah, sure Hi, Vikram. So the phase <unk> study that we conducted in patients with moderately to severely active ulcerative colitis, we published in the journal of Crohn's and colitis recently that study used doses of 2080, and 270 milligram, but that study was done with the powder in <unk>.
Capsule formulation. It was literally just the active pharmaceutical ingredient put in a capsule.
When we moved on to later stages of development.
We wanted to move into a tablet formulation to start getting close to a commercial formulation.
And this was just the practical matter. This wasn't with regard to a difference between 270 versus 200 milligram, which is our highest dose from the to be it was just that that was the capsule size that we chose that could accommodate that load load of 200 milligram. So we don't consider those to the markedly different.
Okay understood and I had a follow on question on <unk>. So I know that you've mentioned that.
1 point of difference of something you would consider clinically meaningful but.
Just on any conversations you've had with clinicians.
What's your sense on durability and how much.
The duration of response would be clinically meaningful over.
Some of the options that are currently on the market.
Yes, well, obviously if we.
We saw a change of that magnitude of for weeks versus placebo and that would be that would be a meaningful difference for for clinicians.
And I think that showing it at 4 weeks that duration is greater.
And then what's been shown by by drops of Delta and as Rick said, we're really shooting for to 2 different objectives here 1 of the mills.
Efficacy, both the fact and duration of effect and the second is.
The safety.
With regard to supine hypertension.
And that's.
Both objectives, we expect to be able to.
We expect to be able to.
To meet with the study 106, 9 and then complement with the 170 study.
Rick.
Yeah, not really much to add other than for Ya. Unfortunately for these patients there isn't really anything that.
It's good for their durability as it stands currently so while they have some options I think if you look at the package insert for trucks. The dope of for example, there was the.
1 point change approximately from placebo at 1 week after treatment and the pivotal study, but that that went away after 1 week.
The the other point about durability of though is in the second study, which will we will report on later.
After we report on the Sequoia study, but the second study really gets a bit at durability, which is the 16 week open label followed by that 6 week randomized withdrawal. So in totality. The data between both of these studies is really going to get at fault before week efficacy and then the longer term durability.
In that randomized withdrawal study. It's also of 1 point change in the HSA, 1 coupled with an endpoint on what's called Pgi, which is the patient global impression score. So those 2 together make up the endpoint for 174 of the Redwood study.
Yes, I think it's important to understand that.
The $1.6 starting of the 170 they represent the largest.
Datasets Thats been studied for symptomatic the other wage.
And the in a randomized randomized settings so were.
As we've said before we're very excited about.
About completing 106.9 and taking a look at what the 1.6 type of data.
Sales with regard to efficacy and safety.
Yeah.
Okay understood. Thank you.
Thank you. Our next question comes from the line of Devine Aman from Bank of America. Your question. Please.
Good afternoon, and thanks for taking my questions.
Some of them have already been answered, but as it relates to the I think the net you know youre going to have data in Q3.
And now I'll turn of colitis, and then more towards the end of the year and potentially early next year data in Crohn's. So my question is just based on whatever we thought at the show for them all through the Florida.
Should we.
Try to extrapolate based on that result, what the data the book like for ground. That's my first question.
And then for you probably as it relates to the let's say for studying and I'm sorry, if I missed this in your prepared remarks, but.
Could it increase your addressable patient population from successfully and if so by how much. Thank you.
Sure.
Both very good questions.
I think the.
The EIS and setting up data for for ulcerative colitis will provide some guidance.
Carlin's disease, but there are 2 different disease crohns being more more trans mural in Boston volume.
<unk> permit sort of <unk>.
Geographic perspective.
More of the more of the intestinal track potentially.
The required us so we do believe that there is.
There is some information obviously it will be good for <unk>.
From the ulcerative colitis study to view Crohn's, but it is the different disease.
Well given.
Given that we're getting very close to the end of the Crohn's program, we will complete the Crohn's program and see what the see what the data are as we unplugged.
The <unk>.
Second question on your call right.
That's a great point to bring up because there is some estimates that the spending is.
1 in 5 Seo.
COPD patients have low peak inspiratory flow.
And I think this is the this has been an area of significant interest from for thorough events for quite some time.
In addressing that particular population with nebulizer therapy now there are many reasons why patients use of NAV.
<unk> of dexterity issues.
Just certain is the involvement of a caregiver.
Cetera, the inability to because of dexterity to work of course, the metered dose inhaler or in fact, the dry powder inhaler, but certainly what what we do see is we see some patients use utilized net realization because they do have peak sales per flow.
Low peak inspiratory flow and we're hopeful that the space for program that we're running.
We'll be able to complement an earlier phase 2 dataset where.
Where we showed in patients with low to very low peak inspiratory flow. There was there was the.
Vantage of.
Of your power again, those patients that was the small data set so hence the need to do to do the phase 4 confirmatory trial and look to potentially expand the overall population that is addressable by.
Nebulize once a day medicine, the IQ Pell rate frankly, I think Dan.
I think you hit most of the key points. There are a lot of patients that are on head handheld agents that have dexterity issues separate from dexterity. They have coordination issues, where you have to manipulate the handheld device.
Half the breathing deeply at just the right time as well as cognitive issues excuse me the.
The other thing is we're testing pardon me.
We're testing of a bit of a hypothesis because previous nebulize agents may be were not optimal in this patient population.
Salaries of the first once a day agent that provides a full 24 hours of of control and it takes about 8 minutes in the morning, and then you're good for the rest of the day until the following morning.
And with the Nebulize agent you only have to execute title breathing as opposed to a deep inhalation with a handheld device. So we look at this as a as an opportunity well worth investing in not only for the brand, but particularly for the patients that potentially will be treated with <unk>.
Calorie with with low Cooper.
Okay. Thanks for the color and I know, it's probably difficult to answer numerical question, but you know just.
I don't know could it increase the patient population by 50% more than that less than that.
Well it's about.
9 of 10% of patients that you use nebulizer is for maintenance therapy and again, it's been.
Some indication that 1 of the 5 patients out of.
Low peak inspiratory flow.
So you're looking at a fairly significant increase of <unk> 900000 patients for something that use nebulizer is for.
For maintenance therapy with COPD. So the sales this is of significant additional.
Segment of the market. However, I think the that's.
So it's exciting for us what the Pell rate is the progress that you power he is making and the.
With our existing marketing strategy with Beatrice.
And really targeting those patients who are who are underserved.
By either existing handheld therapy or in fact, using short acting agents and just not getting the benefit of the short acting agents for the entire 24 hour period like what is possible with you Paul range. So again I do think the the way Youre looking out of this right. This is the.
This is really targeting to expand the size of the pie, what's your Perl rate, but we are we have a significant amount of work to do and I think we can do that work successfully and positioning of <unk> and increasing its share of continuing to increase the share and the.
In the existing market cycle.
Frankly, I think there.
No no I think that's the I think that's it.
I can't I don't have anything to add Rick.
Okay, great. Thank you Rick.
Thank you our final question for today comes from the line of Joseph Stringer from Needham <unk> Company. Your question. Please.
Hi, everyone. Thanks for taking my question the 2 from us quite a sort of on for lots of clean and in a way it's kind of.
Related to the questions that have been asked earlier just curious.
In your discussions with clinicians.
With the available options and therapies out there.
Really the main sort of.
For both.
The drawback that you can point to I know there are several of us.
Is it really efficacy based sort of durability of effect for us.
Is it.
Safety related in terms of supine.
Hypertension, well guess what.
I'm going off of it if you had an efficacy results for <unk>.
The team that that's clinically relevant but.
Okay.
Yeah.
That's a hell of a spike.
Thank you.
Could you.
Do you think that was frankly too.
The ability of cash the majority of market share.
Sort of the current.
Furtive dynamics and then second question is just beyond NIH and UC Crohn's.
What is the.
Top program that we can look for in terms of.
Advancing in the clinic, we could see clinical data from thanks for taking my questions.
Yeah.
Sure I'll just start with him for walks of teen I think.
When you look at the look at the market researches that physicians for.
Are looking for a therapy, where the they can be they can be there can be a level of confidence with the patient that they're gonna achieved durability of response and durability of response without the titration of potential titration with unknown consequences and certainly in some instances with that titration increase.
The risk of supine hypertension.
This is.
And when you look at the program of 106.9 in the 170 <unk>. This is the most significant body of evidence that's been developed for symptomatic N of wage.
There is not another compound that she use either on the label or off label that has the than it has it will have a dataset.
<unk> for walks of team so the of Bill I think overall, it's simply the ability to lever.
On the promise of a product of delivering efficacy without the without significantly increasing the risk of supine hypertension.
Just tie it back to another product that where we're seeing success. The lesson you Paul right.
If you look at the success of your Perl rate.
With the clinicians and the feedback loops that they get from patients. The the root of your powers success as it delivers all of its promise.
As of product and that's what we're seeking to achieve with with ample occitane. So.
On the next the next significant clinical.
Program, well I think the significance obviously of.
Of the <unk> 169, and 170 study ulcerative colitis and Crohn's for ice and setting them. These are very very significant programs for us.
Now, we've just announced another program the phase 4 study.
The new calorie with the with low low pipher patients versus T of tropaeum, So that'll that's likely to be the next but we remain quite excited about the inhaled JAK program both of the inhaled from of dry powder inhaler as.
As well as for a certain segment of the population.
As well as the acute use of the JAK inhibitor for acute lung injury acute lung injury caused by viral illnesses as well as promised that we might have.
Both acute and chronic lung allograft dysfunction of a transplant so the.
These all of these programs are moving forward, but obviously our focus is on right now in the near term, which is the data on the <unk> and the data in ulcerative colitis.
Great. Thank you.
Thank you. This does conclude the question and answer session of today's program I'd like to hand, the program back to Mr. Winningham for any further remarks.
Thank you operator in the I'd like to thank everyone for joining us today, obviously, we're on the on the Eve of some very important data readouts for us at all.
Rick Fleitas as well as symptomatic neurogenic orthostatic hypotension.
And we continue to we're very excited by the continued strength of your power you're showing EBIT in the face of the continuing pandemic and we look forward to updating you on these programs as the remainder of the year unfolds. So thank you very much for your time.
Thank you, ladies and gentlemen for your participation in today's conference. This does conclude the program you may now disconnect good day.
Yes.
[music].