Q4 2021 Ardelyx Inc Earnings Call
Good afternoon, and welcome to our delicate since fourth quarter and year end 2021 conference call.
At this time all participants are in a listen only mode. There will be a question and answer session. After the prepared remarks.
As a reminder, today's call is being recorded.
I would now like to turn the call over to Justin Renz, Chief Financial Officer Art Delek, Sir you may now begin.
Thank you good afternoon, everyone and welcome to our first financial results call. Our practice, we intend to implement going forward as we march towards becoming a commercial stage company.
During this call.
The press release issued earlier today, which is available in the investors section of the company's website at our Galaxy Dot com.
On the call with me today are Mike Raab, President and CEO .
Susan Rodriguez Chief commercial officer.
Dr. <unk> War Williams, Chief Medical Officer, Dr. David Rosenbaum, Chief Development Officer, and Rob Blanks, Chief Regulatory Affairs, and quality Assurance officer will join us for the question and answer period.
During this call we will be making forward looking statements that are subject to risks and uncertainties. Our actual results may differ materially from those described we.
We encourage you to review our risk factors in our annual report on Form 10-K , which we filed today.
Also can be found on our website at <unk> Dot com.
While we may elect to update these forward looking statements in the future, we specifically disclaim any obligation to do so even if our views change with that let me pass the call over to Mike.
Thank you Justin and good afternoon, everyone. It's exciting for me to kick off but will now be quarterly calls on the eve of launching our commercial product its rollout in the coming weeks.
It is so important to understand about its rollout is that it represents a significant advance in innovation, we're treating irritable bowel syndrome with constipation in adults with over 5 million prescriptions written annually. There remains a significant unmet need for many of those patients compared.
Compared to current treatment choices.
Well it provides a unique mechanism of action offering physicians and patients a different option to address the address the debilitating impact of Ibs C.
Today's dynamics around the Ibs C market, and particularly with its rollout make it a very compelling opportunity for patients the company and our shareholders.
This is a significant inflection point for our <unk> and we are excited to bring our innovative product to market as a commercially focused organization.
I would like to review a few key points number one we see a highly favorable dynamics as we prepare for launch.
The market has been cultivated and expanded over the past 10 years and is ripe for a differentiated product with a unique mechanism of action.
Two we establish prescription market includes over $1 6 million Ibs C patients treated with currently available therapies with at least 35 percentage.
And adequately managed and in need of effective treatment alternatives.
<unk>. This is a highly concentrated market with 9000 physicians responsible for approximately 50% there'll be over $5 million annual scripts for Ibs C.
This is a dynamic that is ideal for our focus.
Good specialized sales force all of whom have been hired trained and are preparing for launch.
For based on thoughtful well considered assumptions of mid to high single digit penetration in the Ibs C market, we expect to achieve peak annual net revenue of over $500 million.
With a clear path ahead of us to achieve breakeven and ultimately profitability for the product, which we believe will create significant shareholder value.
Susan will review, our Israeli launch plans in more detail later on the call, but before that I'd like to update you on the progress we were making at the FDA with our formal dispute resolution efforts for Hypervisor, but can happen around hypophosphatasia.
To remind you our initial appeal was filed with the Fda's office of Cardiology Hematology endocrinology nephrology on December 2nd of 2021.
Following an information request from the office on December 22nd we submitted additional analyses on January 7th of this year.
As we had anticipated on February 4th we received an appeal deny or denial letter from the office.
Also in February we then filed a second appeal to the center for drug evaluation and research office of new drugs.
If accepted for consideration we expect the decision on the second appeal in April of this year and we'll keep you updated as progress is made.
Meanwhile, Coyote kirin or <unk>, our partner for <unk> in Japan has now completed three of four planned phase III studies in adult patients on dialysis and although we're not yet able to disclose the results of their studies on February seven K Casey announced positive results from one of their phase III studies.
And there are plans to file for approval of <unk> in Japan in the second half of 'twenty, two with potential regulatory clearance in the second half of 2023.
Good afternoon continues to offer great promise as an importance and novel treatment.
For Hypophosphate team for adult patients with chronic kidney disease on dialysis.
The comprehensive clinical data generated <unk> <unk> in this indication are consistent and support the safety and efficacy as a twice daily oral therapy.
We will continue to push the FDA dispute resolution process on behalf of patients and their treating physicians, whom we know deserve better therapeutic alternatives to address the challenges of managing serum phosphorus.
In addition, we continue to advance our small molecule potassium secretive about program Rdx <unk> three as a potential treatment for hyperkalemia.
We are in the process of evaluating the efficacy safety and pharmacodynamics of Rdx 13 in adult patients with hyperkalemia from our phase II study with the next steps to be determined based on the final analysis of these results continued formulation development and sufficient financial resources.
We also continue to make progress with our Rdx O to O program, Oh bicarbonate exchange inhibitor to treat metabolic acidosis are highly prevalent comorbidity in <unk> patients.
That is strongly correlated with disease progression and adverse outcomes.
We have identified lead compounds that are potent selective and proprietary inhibitors of bicarbonate accretion. We continued to advance this program utilizing third party <unk>.
To summarize our Dallas is well positioned with an approved product launching in a large market with few competitors a strong pipeline of internally discovered drug candidates <unk>.
Our talented team that will drive our success and an anticipated revenue stream that has the potential to transform the company into a profitable entity.
To that end I believe that we are uniquely poised to weather projected near term market volatility with much higher probability for long term success now.
Now I'd like to pass the call to Susan to share details on the launch Susan.
Thanks, Mike our team is excited and ready to execute a successful launch in Australia. The market need is clear we can efficiently reach key prescribers and our research confirmed that the novel mechanism and strong efficacy data zarella will fuel market receptivity a.
Over the past decade, the introduction of GC C. Agonist has transformed the management of Ibs D with market building investment converting what was once an OTC market through an established prescription therapy Marco.
The market basket of Ibs D indicated products include Linzess sugar land, Amitiza and Dell norm with the market increasingly consolidated around two branded therapies that combined have 84% market share.
Despite active use of these therapies hcp's Chris.
Persistently report better.
Over a third of patients under their care continued to have some that are considered to be inadequately manage this relatively uncluttered market with a stated need for expanded therapeutic option is an ideal opportunity perhaps rolla.
<unk> mechanism and compelling and differentiated clinical profile.
All key commercial elements needed to drive a successful launch in Israel are in place.
We are ramping up our product supply and have mobilized our highly experienced specialty sales force and commercial team to engage with our targeted high writers introduce our derricks and inform them that Israel is coming soon.
Our go to market plan and strategy for its rollout is informed by comprehensive market research and analysis. Our commercialization. Okay is that physicians, who are high prescribers of the GCC agonist.
Getting the patients that are currently under their care.
Our research showed that 56% of high prescribers consider ibs C to be a difficult condition to treat and 83% reported a significant unmet need with more than one third of patients currently being treated with prescription therapy continuing to suffer from symptoms of Ibs C.
Is that a sanction centered on the efficacy parameters of abdominal pain and bloating.
75% of high prescribers reported a favorable response to the Israel our profile rating its novel mechanism and efficacy data as the most compelling attributes and projected use of <unk> in a meaningful subset of their patients.
Key elements to our commercialization strategy include one leveraging the market need for expanded therapeutic options to treat Ibs D. Our commercial efforts will be centered on high writing HCP for patients with a novel mechanism and clinical profile represented by umbrella would provide.
An attractive therapeutic alternative.
You enjoy will be positioned as a first in class <unk> three inhibitor with a triple action in treating Ibs C.
Three messaging will emphasize the zarella MLA as differentiated from existing therapies and the clinical data that demonstrate significant improvement in abdominal pain, bloating and constipation with a quick onset of action and sustained efficacy mess.
Messaging will also emphasize the demonstrated clinical results and improves patient quality of life versus placebo and patient reported treatment satisfaction.
This positioning and messaging focus will establish Israel up with its new mechanistic approach and triple acting effect as a meaningful new tool and the treatment tool kit for Hcp's, who treat patients with Ibs C.
For our sales force efforts targeted at the highest riders will be further amplified by omnichannel tactics, leveraging the rapidly advancing dynamics in the marketplace on how and where hcp's received their information.
Five we will have Brian based distribution, including retail and specialty channels to accommodate office and patient preferences, and where are they wish to pick up their prescription and to align to their existing processes for handling specialty product.
Six we have set the price spreads drama based on the value. It will provide patients and assist stablish therapeutic space with a limited number of option and a recognized unmet clinical need within the ibs market pricing landscape, which ranges from $450 a month to 2002.
Dollars a month, we have set the launch price spreads rollout to be $1500 per month.
As you think about the first few months and quarters of the lunch here's what to expect.
We will be stocking the channel early in Q2.
Throughout Q2 into Q4, our sales force will be focused on the highest riders with a key focus on the highest rate in Gi to build the foundation of use bribes are allowed to support continual expanded use.
Israel and will have a strong commercial and clinical data present at the largest GI conference digestive disease week that will take place Q2 in San Diego.
We will be working with payers to secure access for Israel as a novel product. Our access strategy is centered on the value proposition of addressing the existing clinical unmet need among actively treated patients and rebating not to match existing agents, but to minimize the step three requirements.
We will leverage the current processes in place and GI offices are well established to address access requirements for the agents, commonly prescribed in a Gi practice agents to treat Ibs C. Ibs D. Ulcerative colitis, crohn's disease, and H C. D are all therapeutic areas associated with payer restriction.
I'll take a Israel out over the first few quarters will be enabled by the pent up demand of Ibs D. Patients currently under the care of an HCP that are inadequately managed and good good candidates for treatment with Australia.
Counterbalanced by access ramp up challenges and the criticality of the HCP demand motivation to work through payer hurdles.
As Mike mentioned, our promotional focus will be centered on the 9000 high writing physicians, who account for approximately 50% of prescriptions written for drug indicated for Ibs C.
With a targeted specialty sales force full company engagement and innovative omnichannel peer to peer and digital in Michigan, We will bring its relative to patients being actively manage today, who are in need of additional treatment option.
From a payer landscape perspective, prior authorizations and step therapy protocol for novel entrants are standard for this market today with Hcp's, having to attest to the fact that patients are not adequately responding to preferred agent. We expect that payers will put in place step therapy requirements for its rollout we consider these payer channel.
Just to be addressable and the basis of four key considerations, one the patient need for Australia.
H C P demand spreads rolla, three HCP familiarity and experience in addressing the step hurdles implicit in the space and for the comprehensive customer service support we will have in place to support physician offices in parallel we will work to put in place contracts to secure access and minimize.
Step therapy requirements.
We are within weeks of launching Israeli law and are thrilled to bring this much needed highly differentiated therapy to market and most importantly to make a difference in the lives of patients who are suffering from Ibs D.
I will now turn the call over to Justin to review, our Q4 and year end 2021 financial.
<unk>.
Thank you Susan Thank you at the end of the fourth quarter 2021, we had total cash cash equivalents and short term investments of $116 $7 million as compared to total cash cash equivalents and investments of $188 6 million as of December 31, two.
1020.
As announced last week, we paid off our existing debt with solar capital limited and our life Sciences Group at Bridge Bank in fall and we have now entered into a new term loan with SLR capital limited for $27 $5 million with two years interest only as an option for an additional $22 $5 million in term loans.
That supposedly.
Once it receives approval and certain other conditions.
We generated $10 $1 million in revenue for the year ended December 31, 2021, an increase of $2 5 million or 33% compared to $7 6 million for the year ended December 31 2020.
The increase in our revenue was primarily attributable to a $5 billion development milestone, which we earned upon the initiation of phase III clinical studies in Japan by K Casey to evaluate tap nor hypophosphatasia.
Research and development expenses were $91 $1 million for the year ended December 31 2021.
An increase of $26 1 million or 40% compared to $65 1 million for the year ended December 31 2020.
The increase in our R&D expenses was primarily the result of to naphtha or manufacturing costs as we prepared for the launch of a trailer and should we be successful in our appeal the U S launch of exposure.
In late 2021, we eliminated our research group and so in 2022, we expect our research at all expenses to be significantly lower than in 2021.
R&D expenses for 2021 also included $2 $7 million in severance payments and other employee related restructuring costs.
Selling general and administrative expenses were $72 3 million for the year ended December 31, 2021, an increase of $39 2 million or 118% compared to $33 2 million for the year ended December 31 2020.
The increase in general and administrative expenses was primarily due to an increase in costs associated with building and staffing our commercial infrastructure as we prepare for the potential regulatory approval and U S launch of exposure.
General and administrative employee related expenses also included $3 5 million in severance payments and other employee related restructuring costs.
As Susan discussed we have a focused commercial launch plan and as a result, we expect our 2022 SG&A expenditures to be slightly less than in 2021.
Net loss for the year ended December 31, 2021 was $158 2 million compared to $94 $3 million for the year ended December 31 2020.
We will address our operating cash flow requirements with our current cash and investments revenue generated from sales of Goodfella.
Our potential receipt of anticipated milestone payments from our collaboration partners prudent cash management and the potential to access the capital markets in.
In addition to our debt refinancing we are actively pursuing other non equity solutions to extend our cash runway further into 2023 to support our planned operations support the <unk> launch and we have a lot of confidence in our ability to fund these operations.
Today, we received notice from NASDAQ that our bid prices closed below $1 for 30 consecutive trading days, we received the deficiency notice that advised us that we've been afforded a compliance period of 180 calendar days to regain compliance with the applicable NASDAQ listing requirements.
If we fail to regain compliance with NASDAQ continued listing requirements NASDAQ may take steps to list. Our common stock were to move us from the NASDAQ global market tier of companies from NASDAQ capital market tier.
We plan to take action to avoid Saturday listening to restore our compliance with nasdaq's listing requirements.
Additional disclosures are included in our Form 10-K , which we filed today.
I will now turn the call back over to Mike for some concluding comments before we open the call for questions Mike.
Thanks, Justin Despite some of these recent challenges. This is a monumental time for our dollar as we enter an important evolution to a commercial stage company.
We are enthusiastic to enter the marketplace and offer patients with Ibs C. A much needed novel mechanism therapy.
This transition differentiates us in the Biopharma industry now as a revenue generating company with a clear line of sight to breakeven for <unk> rollout and ultimately profitability for the product, which we believe will create significant shareholder value.
We will have a strong and capable commercial presence and we'll be poised from a position of strength, where additional commercial products could be leveraged including to support a potential launch of <unk> enterprise to foster team here upon a successful outcome of the formal dispute resolution process.
Given what many would characterize as a tumultuous 2021 for our Dallas, our pipeline diversification and visionary strategies have positioned us well for near term and future growth.
We believe that our focus on the patient and developing medicines to help them live longer and better lives will be successful for the patients and ultimately for our shareholders.
We look forward to keep you apprised of our progress and now with that I will open the call to questions Jessy.
Thank you speakers participants we will now begin the question and answer session.
Ask a question over the phone you May press the star key followed by the number one from your telephone keypads.
To withdraw your request you May press the pound key.
Again, Thats star one to ask a question or the county to dry request.
Speakers. Our first question is from the line of Chris Freeman of Piper Sandler. Your line is now open.
Hey, guys. Thanks for taking the question I guess.
I.
I need to ask.
You did a couple of weeks ago, you guys had an 8-K, where you highlighted.
The the outcome here and appeal to the office of new drugs, but I guess I was pretty intrigued by the language around.
You know potentially having a path to resubmit without running new trials.
I'm just kind of curious you there's no mention of that pathway here in this call.
Can you maybe.
<unk>.
Give a little bit of color is that path still open where does that stand I guess.
First and foremost.
Got it thanks for the question.
Purcell exist we pick.
But we've been consistent in saying that we believe any sort of positive outcome is going to come through cedar and OMD.
So rather than go through the process at Ocean. It made sense to then kick it upstairs as we've talked in the past and go through.
With them the process to hopefully be able to overturn the C. T. R L.
So.
Our assumption is that alter.
Alternative is still there it opened up the door, but I think strengthens the process, we're going through now through OND.
Which was the strategy.
That we had set at the beginning that we would pursue.
Okay. So just so I understand the sequence then so.
You go through the process with office the afternoon drugs.
Get your answer and in April and then depending on that answer or the decision pursue the.
The path of resubmitting based on some subset of the data that you already have alright.
So I'll ask Rob blanks to add a little bit more color, but.
The outcomes can be rejection, it can be overturning and remaining two cardio renal it could be additional information requests.
Or it could be.
Advisory Committee right. So those are kind of generally the outcome that could be there and in those could be additional analyses as we suggested in our filings.
Obviously, we don't have any way of predicting what it's going to be standing where we are now but the other nuances if its a two months versus six months submission because we don't have an active NDA. So we would have to submit resubmit in order to have discussions Rob anything to add.
No Mike I think you have it covered pretty well I mean, the paas still exists. We do obviously, we feel that you only have one chance to go up to a higher level and we felt that that was the the best way to go.
And certainly we did not think that.
The O C H N with Doctor job views are relatively new to that position would overturn them. So we still think we have a chance with the O N D.
Great. Okay. Thank you very much.
Thanks, Chris.
Next question is from taking bond sack of Cowen. Your line is now open.
Hi, guys.
Dissipating on for Joe.
So kind of following up on that how would you plan or with balancing additional investment in the Hyperpotassemia program with the potential inclusion in the dialysis bundle and if the 2025 timeframe for inclusion is still likely to span and then I've got a follow up as well.
Sure I mean, I think we're taking this a step wise fashion.
We believe wholeheartedly that patients deserve this drug first and foremost and.
As we were speaking over the past that the opportunity that exist even in a bundled scenario.
We think allows for a great opportunity commercially.
We believe there continues to be an opportunity to extend the exclusion.
That work is ongoing so lots of different obviously balls in the air but.
Additional investments and expose it would depend upon what that looked like I think we have been consistent in saying doing what was implied in the CRO.
Doing an outcome study is not on the table.
There is no other phosphorous lowering therapy that has ever been required to do that and that is a big part of the basis of our <unk>.
So we continue to be committed to seeing this through.
Anyone who knows me knows that I'm stubborn.
Quantify the path to get this product to the patients who need it.
Thank you that's really helpful. And then kind of a second question kind of more on its rollout in Europe .
The plans have there been any discussions of partnership or do you plan on potentially launching that yourself.
No I think we'll wait and see how we do here begin the conversations with folks that have reached out and will reach out to other folks as well I mean, we're a relatively small team doing.
A lot and want to focus on the U S launch before.
Distracting ourselves and trying to do those.
Thank you so much.
Sure. Thank you Dan.
Next question is from Laura Chico of Wedbush Securities. Your line is now open.
Okay.
So this is Sam on for Laura Chico.
Wondering.
At this point for the <unk> launch what are the key gating factors to launching in the second quarter and then I'm just wondering if your view on on market positioning.
In the few months that you've had to prepare has changed at all.
Yes, So let me just give a couple of comments then I'll pass it off to Susan we would've launched its rather sooner.
Had we had the material right we were focused on the exposed to launch making.
Those tablets, so we had to shift our efforts.
To make the 50 milligram tablets and Thats really been the gating issue for us in preparation for launch.
I will ask Susan to address your the second part of your question.
I would say that my conviction for what Susan has described the opportunity to be has only increased over the months.
<unk> decreased given the dynamics of that marketplace.
Susan.
Yeah. Thanks, Mike, Yes, we you know as a commercial team I mean, the commercial capability for our galleries have been ramping up over the last 18 months and part of building out a commercially facing company you know we've attracted.
Phenomenal talent very experienced talent in the industry with bringing new products to market and the first thing we did with very thoroughly evaluate our portfolio of assets and do the market research to understand the relative opportunity of each of those assets.
And how would you then direct our thinking around optimizing those assets, which implicit in that is it is the go to market strategy positioning and messaging for Israel and so we really were quite ready to be able to.
Little forward the launch for <unk>, given the timing on the FDA decision for <unk>. So we're moving that forward as Mike mentioned really what what's critical what we could we did.
Timely research in the first.
We ended last year and early this year to confirm our go to market approach very thorough quantitative and qualitative research Cerro work with our opinion leaders.
Testing out all of our positioning and messaging and so we really have everything ready to go.
And really quite confident in our go to market approach and readiness for this Q2 launch.
Okay. Thank you very much.
Next question.
As from Louise Chen Cantor Fitzgerald. Your line is now open.
Hi, Good afternoon, everyone. This is carvey on for Louise from Cantor.
Our questions. Our first question is what are some takeaways you guys have got her from Knight pharma and the commercialization of <unk> in Ibs C. In Canada that might be important in the states how should we view the initial uptick of a drug any feedback from provider community would also be helpful. Our second questions.
On peak annual revenue you have highlighted the potential peak.
To be at least 500 million, we wondering how long it would take to get to the peak. Thank you so much.
Susan that's where in your court.
Great Yes.
The first thing, Canada actually did COVID-19 restrictions in Canada have been quite significant so while they had.
The channel Brian Zarella, they really have not fully launched commercially in Canada. So it is too early to say exactly the early read in terms of the opinion leader response to provider research in Canada. The need for an alternative mechanism therapy for Ibs D. All the research findings are quite aligned with what we learned in the U.
So that's all I can tell you at this time.
And what's great is that we are very much aligned with the Canada commercial team for North America alignment on our go to market approach messaging positioning communication of the data and really leveraging the opinion leader community. So we will continue to keep you posted on that as they are really just starting to ramp up their full.
<unk> commercial launch.
In terms of your your next question on provider response here in the U S.
It's really.
Very interesting we conducted both quantitative and qualitative research, it's quite persistent that there.
There is a very established.
The pattern of how to manage these ibs D patients under their care. So the so keep in mind you know I think everybody is accustomed to thinking about this market is a market building market to bring patients into the physician's office to us that the prescription therapies that have been available and introduced over the last decade, but what we have to remember.
Now as we look forward to the launch of <unk>. What we're looking at is a very established market hubs market patients that are under a physician's care. They see the physician regularly they churn through a lot of therapies in managing these patients because the systems. The symptoms persist so that what we hear back from doctors is there is an unmet need.
Particularly along the pain and bloating there is.
Hum.
High level of interest and a novel mechanism therapy, and a strong intent to adopt the therapy and then in a very meaningful subset of patients.
And what's notable is that we see this not only across the high writing G is mixed across high riding Nanjing is we also see it across the opinion leader community on a national and regional level. So I'm. So everything you know all of the intelligence and insights are pointing toward.
So this opportunity and.
The extent to which a job can address this critical unmet need and with our sales team now deployed across the country. There's a high level of receptivity to meet with our team and eagerness for physicians to learn about novel mechanism in Israel.
Got it and just one final piece, how long should we should it take to get to the peak for for the drug.
Yes, sorry that was your last question.
Yeah. So we had projected that over a five year timeframe.
Got it okay. Thank you so much.
Thanks, a lot.
Again participants its star one to ask the question what does it count sheet withdrawn requests.
Speakers. Our next question is from the line of Matt Kaplan of Ladenburg Thalmann.
Now open.
Hi, Good afternoon, guys. Thanks for taking the question Matt.
Hi, So just wanted to I mean, maybe continuing with season a little bit.
She initially in our prepared remarks, you said the uptake of Israeli law is going to be driven by an unmet need in coverage.
Can you talk a little bit about.
Kind of how how long coverage will take to get in place and what you see kind of coverage levels exiting this year and kind of going into next and how we should think about that.
Yes, thanks for the question Matt.
We will you know we're working as we speak now in parallel educating payers on the clinical profile of Israeli law, we anticipate that Israel will ultimately would be carried.
Tier five specialty tier product.
That is you know really that needs to be our expectation because you have to look at the established nature of the Ibs D market and it's actually quite unusual to have branded products all have such a strong tier two and tier three position, which is what linzess in Chilean peso, we are not going head to head with that again, where we are.
We're going to market focused on addressing the clinical unmet need there is no alternative tubes rollout in the patients who have been managed and are continuing to show persistent symptoms. So that is the value proposition as you bring it forward to pairs our intention is to contract to secure access.
And to try to minimize that.
Prior off and step hurdle.
We do not intend to outmatched, the rebate levels of Linzess or Julien and we do not anticipate I'm holding formulary positions that are comparable to theirs. The crux of the opportunity is addressing the unmet need and novel mechanism drug and the clinical package. So we will be working with payors throughout 2022 to secure access for <unk>.
And I think as we go into 2023, we'll be able to give you a good read on how things are going with that access picture.
With in parallel keeping in mind that it is the introduction of any novel therapy, when there's an unmet need.
You can ask your prescriptions are filled.
Asked me writing physician is willing to go through the medical exception process. So obviously as part of demonstrating to payers. The demands for its rollout, which is what will help us security access positions. We see we'll be working very closely with them to give them all the support to really pursue approval of be Israel script, Miami exception process.
During lunch.
Okay. That's very helpful. Thank you and then I guess one more for you Susan in terms of.
What what commercial metrics do you plan to share with us on a quarterly basis beyond.
Yes, obviously, we're reporting revenues, but help as COO.
Gauge your success in Milwaukee.
Yeah. So yeah clearly reporting revenues. This is a primary metric that we will be sharing with you.
We I think we all need to be cognizant of the typical ramp up accuracy of data capture for IQ via script.
And that'll be very much determined by our the profile the mix of use may be retail versus specialty and reporting capture so over time as we get to a steady state brachia via capture them, we will be reporting on our script you know in our share penetration.
Okay.
And then just going back to the O N D. How does the process work now with one day until they arrived at the answer and in April is there significant interaction between you and and that part of the agency.
Rob.
Yes, we we've obviously we've.
Submitted the appeal and then we have it's a potential to have a meeting with them.
By the end of.
If they have 30 days to reduce them by the end of that process of potential that we have a meeting with them.
That mean likely not to be face to face.
Good to have a meeting with them and leaves it also get information requests from them asking for more information. So there is plenty of opportunity for interaction modality.
Okay. That's helpful. Thanks, and then.
A question just a quick question for Justin you.
He mentioned in his prepared remarks, the elimination of the R&D group late last year and that would have a significant impact on on R&D can you help quantify that for us.
I can't really give specifics out met yet other than it will be substantially reduced because as you know our clinical process, we've wrapped up.
Upon us for work with the phase four programs that David Rosenbaum and war led for Us and we aren't doing any novel New research in 2022, so it's going to be substantially less.
Then last year.
Okay. Okay.
Thank you thanks, thanks for that detail.
Thanks, Matt.
Okay.
Thank you participants I'll now turn the call back over to Michael Roth for final remarks.
Thank you all for joining our call. This is indeed, a transformational year for our <unk> with our launch of its rollout for patients with Ibs C. We look forward to keeping you apprised of our progress in the coming months and Jesse you May now and Nicole Thank you.
Thank you speakers. This concludes today's conference call. Thank you all for joining you may now disconnect.
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