Q2 2021 Omeros Corp Earnings Call
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Good afternoon, and welcome to todays earnings call for a marriage Corp. At this time all of it.
The kids are in a listen only mode. After the company's remarks, we will conduct a question and answer session.
And the advice that this call each of being recorded at the company's request and.
The replay will be available on todays company's website for 1 week from today.
I'll turn the call over to Jennifer Williams Investor Relations for <unk>.
Good afternoon, and thank you for joining the call today I'd like to remind you that some of the statements that will be made on the call today will be forward looking.
<unk> are based on management's beliefs and expectations as of today and only and are subject to change.
All forward looking statements involve risks and uncertainties that could cause the company's actual results to differ materially. Please refer to the special note regarding forward looking statements and the risk factors section and the Companys quarterly report on form 10-Q, which was filed today with the SEC and the risk factors section of the Companys 2020 annual report.
And on form 10-K for a discussion of these risks and uncertainties now I would like to turn the call over to Dr. Greg Demopoulos of merits of as chairman and CEO.
Thank you Jennifer and good afternoon, everyone and we.
We appreciate you joining us for today's call.
We'll go through of corporate update and our second quarter financial results.
And we'll be joined by both non <unk>, our chief commercial officer, and Mike Jacobsen, Our Chief Accounting Officer.
Following the prepared comments, we have some time reserved for questions.
And we'll begin today with an update on our supplement of our fully human monoclonal antibody targeting mask too.
Masks 2 is the effector enzyme of the lectin pathway of complement.
Our biologics license application or BLA for the treatment of hematopoietic stem cell transplant associated thrombotic microangiopathy or Ta TMA.
And is under priority review by FDA.
Our <unk> date for the BLA as of October 17th following FDA is extension of the review period.
We continue working closely with the FDA and look forward to the agency completing its review.
We continue to share of the data from the Ta TMA of pivotal trial publicly across a variety of scientific and medical venues. Most recently and June during a podium presentation at the 2021 annual Congress of the European Hematology Association.
In addition to manuscript authored by international leaders and both the stem cell transplantation, and and complement science have been submitted for publication to peer reviewed journals.
The first detailing the findings from the pivotal trial and the second elucidating the role of the lectin pathway and masks to specifically.
Ta TMA.
And our supplement of it is also being evaluated and 3 other indications and immunoglobulin, a or Iga nephropathy, atypical hemolytic uremic syndrome, or a H U S and COVID-19.
Our phase III Artemis <unk> trial has approximately 130 sites activated worldwide.
And given the prevalence of Iga nephropathy and China.
And are adding a number of Chinese investigational sites.
Our presentation focused on the pharmacology and pharmacokinetics and pharmacodynamics of lectin pathway inhibition by and our supplemental will be part of the 16th International Symposium on Iga Nephropathy next month and Prague.
Our U S phase III trial is also ongoing.
With the recent resurgence in COVID-19 cases, due primarily to the Delta variant and additional variance being identified it appears that the COVID-19 pandemic will be with us all throughout the foreseeable future.
And might well become endemic.
The most recent data show about 100000, new Covid cases daily and the U S.
With infections, rising and both unvaccinated and vaccinated individuals the need for an effective therapeutic, particularly 1 that can prevent death and speed of recovery and the sickest of COVID-19 patients is beyond dispute.
And our supplemental continues to be evaluated as part of the nationwide ice by COVID-19 trial that is sponsored by quantum leap healthcare of collaborative and funded in part by BARDA.
And our supplement is the only complement inhibitor selected for inclusion in the trial and dosing in patients with severe COVID-19 began in March.
The trial is run by quantum and other than providing drug <unk> has no involvement and the trial.
We are told that enrollment is progressing and we await the trials results.
No previously studied drug has demonstrated sufficient efficacy to graduate from the trial and we are optimistic that and our thoughtful of map will be the first.
And May we announced results from the second cohort of COVID-19 patients treated and Bergamo, Italy the.
The 10 patients and this cohort were even sicker than those in the initial cohort of COVID-19 patients.
The patients and the first cohort of.
All had comorbidities and or risk factors for poor outcomes and all were on mechanical ventilation and in fact 9 of the 10 were intubated prior to initiation of and our supplement of treatment.
All of that failed other treatments, including steroids.
Despite these patients being so severely ill 8 of the 10 recovered survived and were discharged the.
And 2 deaths were a 76 year old who died from complications of his preexisting cardiomyopathy and the 68 year old who began in our supplement of dosing after being Intubated for 13 days.
As was done with the results from the first cohort of Bergamo patients we plan to publish the data from the second cohort and of peer reviewed journal.
We also are continuing our work at our laboratories at the University of Cambridge, and the <unk>, Cambridge Center for complement and the inflammation research or Oc 3 IR.
The data coming from Oc 3 IR uniformly support.
What we and others, leading the Covid research field worldwide have shown.
That the lectin pathway, and specifically mask to play and early and central role and the pathophysiology of COVID-19.
A manuscript detailing.
Detailing the rationale for inhibiting mast, 2 and the lectin pathway and severe COVID-19.
And was published last month, and the peer reviewed journal frontiers and immunology.
Additional work is underway, including identification of the cause of the increased incidence of concomitant bacterial viral and fungal infections, often seen with COVID-19 and.
And in our supplemental <unk> potential role and preventing them.
And we also plan to explore of the role of mass of 2 and the lectin pathway and the post acute sequela of Sars Covid 2 or pasque.
All of the clinical and non clinical data generated around in our supplement of and COVID-19 are further helpful and our ongoing discussions.
With U S and international governments regarding funding and manufacturing support for and our supplement.
Let's look now at our second quarter financial results.
Net revenues from sales of Omidria on the second quarter were $28.8 million a.
A $7.8 million increase compared to last quarter's revenues.
This represents 37% quarter over quarter revenue growth.
Our net loss for the second quarter was $28.6 million of 40, <unk> per share of which $3.9 million or <unk> <unk> per share were noncash charges.
As of June 30, we had $73.7 million and cash cash equivalents and short term investments.
We also have of $50 million line of credit based on our accounts receivable, which has not yet been used and an additional $150 million of available through and at the market facility.
Revenues have continued to grow largely as a result of the determination last December by the centers for Medicare and Medicaid services or CMS that omidria qualifies for separate payment when used in ambulatory surgery centers or <unk>.
CMS made this the termination under its policy to reimburse separately for non opioid pain management surgical drugs.
Q2, 2021 was the first full quarter.
The Medicare administrative contractors had the appropriate CMS reimbursement posted for Omidria and.
Wowing, our customers to be confident that separate payment had been restored for omidria.
As a result, we saw a corresponding growth and omidria sales throughout the second quarter and.
And we expect that momentum to continue.
Last month CMS issued the calendar year 2022 proposed rule for its outpatient prospective payment system or <unk>.
Here again CMS confirmed its December decision that omidria qualifies for separate payment under the agency's policy regarding non opioid pain management surgical drugs.
Given this endorsement by CMS and the tenure of the policy, which has been and effect since 2019, we anticipate no change and this policy and Cms's final low PPS rule to be issued later this year.
In short our expectation is that Omidria will continue to receive separate payment reimbursement by CMS.
When used and afcs throughout 2022 and likely beyond.
Legislatively, the non opioids prevent addiction, and the nation or the no pain Act continues to make headway and both chambers of Congress.
Now with 30 Senators and 46 Representatives co sponsoring the bill rosters that continue to grow.
The no pain Act has strong bipartisan and bicameral support and.
Including the leadership and team members on the committees of jurisdiction and both the house and the Senate.
Importantly, the Bill has also endorsed by major medical societies and public health organizations.
Including to name a few of the American Medical Association, The American Society of Anesthesiologists, and the American College of Surgeons. The American Association of colleges of nurses, the ambulatory Surgery Center Association.
The advanced Medical Technology Association or out of the med and the National Safety Council.
The no pain act when and if passed would provide separate payment for non opioid pain management drugs like omidria not only on Afg's.
But also and hospital outpatient departments.
With that non <unk>, our chief commercial officer will now provide and update on commercial activities for both the midyear and and our supplemental nausea.
Thank you Greg since our last call. We've continued to make significant strides with desktop and App launch readiness and sustained recovery of Omidria. Following the decision last December by CMS for separate reimbursement and the ASC.
Starting with Omidria and we're excited about delivering a 37% increase in revenue over last quarter, driven by strong growth and the ambulatory surgical centers, which is our largest segment representing about 86% of our total current business.
And separate payment has yet to the restored at the hospital segment.
Hospitals.
<unk> is roughly half of the levels of those prior to lots of separate payment, but it is still growing at 32% over the last quarter.
As I shared with you and May our efforts with establishing partnerships with ASC chains and groups of ASC is owned and operated by private equity groups has contributed to this overall momentum.
And the second quarter, we successfully executed agreements with and now Theyre P/e group and and ASC chain, bringing our total to 6 private equity groups and 3 chains more specifically, we drove the combined volume growth and these 2 categories of 58% quarter over quarter.
Additionally, cataract surgeons favorable perception of Omidria continues to strengthen as they gain more experience with its benefits.
We held 2 bits and advisory boards in conjunction with major ophthalmology Congresses in May and July gaining insights from different segments of physicians on <unk>.
Adrian benefits and reducing complication rates. We're excited by these groups as the most compelling reasons to use omidria and their centers spin.
Specifically omidria is the effect on the reduction of both intra operative and post operative cataract surgery complications, including a reduction of intra operative floppy Iris syndrome, or ifas, postoperative, cystoid, macular edema, or CME breakthrough iritis and postoperative pain, and all of which have been.
<unk> and published studies.
The advisors, who had significant experience with the major yet reported of clear distinction between surgery days, where the majority of their cataract surgeries utilized omidria during the procedure versus days without the summed it up as the day, just a smoother with less challenges.
The feedback from the Advisory Board is consistent with market research insights, we've been collecting as part of our work to evolve our message platform later this year the.
Surgeons, we interviewed share that there's potential for complications with every procedure, where at any time, the pupil and other words, the operated field and come down and size, making complications more likely we dug deeper into this insight as part of our quantitative positioning research and may and learned from search.
<unk> that omidria fulfills the role of of dependable partner to help surgeons achieve excellence more consistently.
Research and also revealed similar importance of Omidria is top benefits to those cited by our advisory board of attendees with comments, including.
Superior pupils stability lower complication rates such of CME breakthrough Iritis and Isis <unk>.
Long with reduced use of pupil expansion devices.
Overall surgeons and our market research studies were impressed with the imagery of extensive clinical trial and real world evidence.
We're excited about how these insights are helping to further refine the omidria message platform planned for late this year.
Turning now to <unk>, we're continuing to make strong progress with launch readiness and we've taken the extension of the FDA review time to further refine key launch strategies and go to market plans.
The hiring and training of our field transplant sales managers has been initiated talented sales managers with deep experience and stem cell transplantation, hematology and oncology have joined our existing field team, including our market development managers and medical science liaisons with the focus on.
The top transplant centers.
These centers represent 80% of the total U S. Allogeneic transplant volume. In addition to account profiling theyre focused on educating stakeholders on the signs and symptoms of Ta TMA as well as creating centers of specific plans to ensure rapid access to nurse top of the map post approval.
We continue our interactions with both inpatient and outpatient pharmacy decision makers, gaining valuable insights on minimizing barriers to access and product distribution at time of launch.
Our distribution model is ready and sharing vials can be shipped and received at patient sites of care generally within 24 hours, which is essential for life threatening disease, such as Ta TMA.
Last month, our team attended the advanced topics for oncology pharmacy professional of conference, where we met with pharmacy directors and Vice Presidents from 19 centers of excellence, 5 outpatient systems and for payers and gaining a better understanding of the pharmacy and Therapeutics committee processes at top of.
And on marrow transplant centers.
These decision makers indicated a willingness to add <unk> to P&C committee agendas and anticipation of FDA approval.
So as to ensure timely reviews after nurse top low map is on the market.
Overall their feedback is consistent with previous advisory Board comment there is no FDA approved product for Ta TMA and our staff will map offers a compelling profile for addition to their centers formulary.
Finally, we have further refined our pricing strategy with the focus on the optimal intersection between our supplement the strong value proposition and the point, where patient barriers to access would be minimized.
The consistent feedback we hear from our pricing market research and advisers is that in our supplement the efficacy.
Meaning significant response rates, coupled with significant improvement and a 100 day survival.
And their supplemental safety profile and this very sick population with no observed safety signal is a strong value proposition for a life threatening disease with no approved treatments.
And the other guy that we of course, the considering is the pricing of other complement inhibitors that are used off label in the syndication.
With our stakeholder insight based and data driven strategy, coupled with the experience that we've been bringing on board. We are poised to execute successfully and our supplement launch upon approval.
With that I'll turn the call back over to Greg.
Thank you and audio.
Now I'll provide an update on the rest of our pipeline our mask to lifecycle management programs beyond and our supplement.
And are also progressing well.
All of them S 10, and 29 of our second generation and long acting <unk> 2 antibody is slated to enter the clinic next summer.
We expect that all of them S 10, and 29 will be dosed subcutaneously.
With no greater frequency than once monthly.
The current plan is to conduct the combination phase 1 and phase II clinical trial accelerating our development timeline and.
In addition to all of MFS 10, and 29, we're advancing our small molecule <unk> 2 inhibitors.
These are being designed for once daily oral administration, and we look forward to their joining in our supplement and Oems 10, and 29 and the clinic.
Our masks 3 program is also on track and forging ahead.
While there are multiple alternative pathway targets currently in development C..3 of factor B factor D. <unk> controls exclusive intellectual property rights around masks III.
Mass 3 of the key activator of the alternative pathway and the enzyme responsible for the conversion of pro factor D..2 of mature of factor D.
Our master II inhibitor of <unk> 906 is being evaluated and a placebo controlled double blind single and multiple ascending dose phase 1 trial.
Last quarter, we announced preliminary results from the trial showing that <unk> 906 was well tolerated at all doses tested and given the pharmacokinetic and Pharmacodynamic data, we again expect no more frequent dosing and then once monthly subcutaneously.
Finally, let's turn to <unk> 174 of central plank of our immuno oncology platform.
<unk> hundred 74 is also part of our broad <unk>.
<unk> program.
The exclusively expressed on immune cells <unk> 174 controls of cancer immunity pathway.
Discovered biomarkers.
We're developing both small molecule and antibody inhibitors of <unk> hundred 74 is a novel immunotherapy agents and are building, a broad and exclusive of intellectual property position around those inhibitors as well as around the <unk> 174 target itself.
We've found the <unk> 174 of deficiency or exposure to <unk> 174 inhibitors.
Enhances tumor, killing phenotypes and T cells and.
Such as increased production of IL, 2 TNF interferon gamma and grant zombie.
And also reduces expression of certain immune checkpoint molecules.
Consistent with these observations tumor growth is attenuated and GP are 174 deficient mice.
We know the tumor cell death results and the production of immunosuppressive <unk> 174 stimulating molecules. So we believe that the <unk> 174 inhibitor will be necessary to maximize the tumor killing immune responses following commonly used radiation and chemotherapy.
<unk>.
We also expect that inhibitors of <unk> 174 could be combined with existing cancer immunotherapies to improve response rates.
For example, <unk> 174 inhibitors could be combined with <unk> or keytruda as well as with the emerging immunotherapies such as next generation and IL, 2 and identity and access of inhibitors.
And again improving response rates.
Beyond <unk> 174, we continue to advance other components of our immuno oncology platform, including our car T and adoptive cell therapy programs.
We expect that these programs both wholly new approaches around which we continue to build broad patent and the states could fundamentally change the immuno oncology landscape.
With that I'll turn the call over to Mike Jacobsen, Our Chief Accounting officer for an overview of our second quarter financial results.
Thanks, Greg.
And as Greg noted Omidria and total revenues for the second quarter were $28.8 million and increase of $7.8 million of 37% from the first quarter. Our net loss for the quarter was $28.6 million or <unk> 46 per share.
And this includes noncash expenses of $3.9 million or <unk> <unk> per share.
As of June 30th 2021, we had $73.7 million of cash cash equivalents and short term investments.
Both of general operations.
We also have a $50 million accounts receivable baseline of credit, which allows us to borrow up to 85% of our available accounts receivable borrowing base after certain reserves.
As you May recall in March we also entered into and at the market sales agreement that allows us to sell from time to time up to $150 million of our common stock.
During the second quarter, we had seen the steady increase and Omidria sales to ASC and our weekly sell through to these customers are at the levels seen prior to the October 1.2020 loss of separate payment.
Cost and expenses for the second quarter were $52.8 million and increase of $1.2 million from the first quarter of this year.
The increase was due to additional selling general and administrative costs as we continue to prepare for the planned U S launch and the supplement this.
This increase was partially offset by a decrease and research and development expenses due to the timing of and our software Mab manufacturing activities.
And as I stated previously we are expensing the supplement of manufacturing costs until we are certain that we will of.
Obtain marketing approval and the United States.
Interest expense for the current quarter was $4.9 million and consistent with the first quarter.
As Greg mentioned earlier, the reimbursement scenario for Omidria is continuing.
The strengthen who expect the me too Omidria revenues of further increase as the.
And our ASC customers ramp up their use of Omidria and our customer base continues to grow.
We expect overall research and development costs and the third quarter of 2021, 2 and increased compared to the quarter ended June 30, 'twenty, 1 due to increased medical affairs and clinical costs for Ta TMA and additional development costs related to oil and mess $10.29.
Right.
SG&A costs are expected to increase throughout the remainder of the year largely to support on <unk>.
<unk> launch preparations and the hiring of our regional hospital sales managers.
Interest expense for the third quarter should be consistent with the second quarter at $4.9 million.
With that I'll turn the call back over to Greg Greg. Thanks.
Thanks, Mike.
Operator, let's please open the call to questions.
Yes.
Okay. So as a reminder to ask the question you will need to press the star 1 on your telephone.
All of your question grasp on key again that is star 1 on your telephone please standby, while we compile the Q&A roster.
First question comes from the line of Geoff Meacham from Bank of America. Your line is open.
Hey, guys. This is Greg Harrison on for Geoff Thanks for taking the question.
And just wanted to get your.
Thoughts and expectations around.
When we may see data from the I spy trial.
Assuming that things go.
As you'd like them to how long do you think it would take too.
Before that readout and then what would your expectations be.
As far as the efficacy.
We would really.
Convincing that it makes sense to continue moving forward and that indication.
Hi, Greg Thanks, well first with respect to the timing of the I spy trial.
I know.
It may be not of satisfying answer.
We really don't have a good sense.
And where they are with enrollment.
They keep the sponsors not just of <unk>, but all sponsors involved and the trial.
At arms length, and they do that so that they can preserve the credibility of the trial.
They began enrolling and March.
And I.
And would expect that enrollment probably slowed down a bit.
Over the past.
Several months, but I would guess that recently.
That enrollment has picked up again.
And we talked about earlier and I think you know very well there.
The number of of new infections of COVID-19 are increasing the cash.
<unk> is how many of those are making it into the hospital.
And how many of those would meet the criteria for I spy.
And so.
Our hope is that we hear something soon there.
They do initially.
A cut of the data to see if if there is a lack of feasibility and.
And we Havent heard anything there.
But we really don't have have a good sense of when they'll completed as soon as we know we'll share that information.
With respect to what we would be looking for from efficacy to.
To make a determination as to how.
We would proceed with and our supplement.
Look I think we already have pretty substantial data.
Showing that in our supplemental.
As at least appears to be and the studies that we have done or have been done by others for us.
It appears to be.
And <unk>.
Quite effective.
And the.
Critically ill COVID-19 patients, so we're pretty confident and the strength of those data now what we need to do is see what comes out of I spy again.
The slightly different patient population the <unk>.
Patients enrolled and I spy or arent.
And are required to be of sick as those that we have treated both in the U S and and Italy outside of buy spot.
And also we're counting on and and I believe this is the case, but we're certainly counting on.
The rigor.
The trial of the rigor of the protocol and the management of that trial.
And to deliver.
And the data that we believe we would see within our supplemental so let me stop there and see if if you've got any question about that.
Okay.
No that's really helpful. Maybe just 1.
Follow up what what would be your ideal of path forward.
And COVID-19 commercially.
Okay.
There has been talk of government funding and.
Have you had any.
The talks with BARDA or NIH about that or do you think thats something that would be more likely to happen. After the end of the results from that study.
And so as we've said discussions with governments, both U S and international are ongoing.
What we do.
The main focus of our discussions.
Our manufacturing.
What we need to increase our manufacturing capabilities in order to support.
The use of nurse thoughtful of mab more broadly and.
COVID-19.
And I think that clearly is as the first priority for us and those discussions are ongoing as well as discussions around funding of of other opportunities be those clinical trials et cetera, but I think certainly.
And the.
The appropriate move here would be too.
To fund additional manufacturing and.
And scale up of manufacturing for and our supplement.
Because let's let's just say what if the data come back as we expect.
What will be the next step well the next step would be how do we make that drug more broadly available.
And I think we would be challenged given the requirements that we already have 4 and our supplement across Ta TMA, our ongoing Iga and <unk> studies and other other areas that we're moving forward.
So I think that needs to be that needs to be the focus of <unk>.
Assuming positive response and.
The I spy trial.
We would certainly look to be talking with.
FDA.
About and EUA or some other approach.
To make the drug available to patients who need it.
Great. That's very helpful. Thank you.
Thanks, Greg.
Next question comes from the line of Steve Brozak from W. BP. Your line is now open.
Hey, Thanks for taking the question.
And just 1 quick 1 given you on the last on the last question that was the specific reference to obviously unfortunately, the resurgence of Covid.
How do you believe the system is prepared.
Given COVID-19 and its resurgence and specifically vis vis the omidria in terms of clinical use now and I'll hop back in the queue after that.
Thanks, Steve.
Well look I.
I think with respect to and I expect what you're asking is.
Elective procedures and how those might be affected by a resurgence of COVID-19. So I'll answer that question if I'm off base. Please correct me, but I would think.
That.
We are we are through.
And that initial challenge that we had nationally with respect to PPE or the personal protective equipment, which was 1 of the major impediments and.
And.
In keeping elective procedures running and ambulatory surgery centers.
So I think.
My expectation, although I don't know this my expectation would be that we don't have those same challenges that PPE generally is readily available and so I would expect that a resurgence in COVID-19.
Could not meaningfully affect what's happening in the afcs.
With respect to elective procedures, and specifically with respect to cataract procedures now.
What I I can't assess.
As the.
The patients response rate will patients still want to undergo their elective procedures and the setting of COVID-19, but what we're seeing currently is that there appears to be very little.
Impact on on Omidria from from any sort of patient.
CERN around their safety and Afg's. So let me stop and see if that was even the question that you were you were asking our or was it something else.
No no that was that was actually the exact question and I. Appreciate the direct response look congratulations on this quarter and looking forward to obviously all of the progress that youre, making with spine. Thanks again.
Thanks, Steve.
Next question comes from the line of Ram <unk> from H C. Wainwright. Your line is now open.
Hi, Thanks, very much for taking my questions real quickly on <unk> and COVID-19 day.
And you anticipate being able to do any kind of anecdotal investigational work, specifically and patients infected with the Delta Barry.
That's an interesting question thanks, Rob.
I expect that and what's being enrolled and the I spy trial include those patients who have the delta of area I don't think that and 1 fact, I know that their enrollment criteria.
Our exclusion criteria do not include the the.
The Delta variant, meaning that they are not excluding.
Patients with the Delta variant, so I would expect very much the that the patients that are currently being enrolled and the I spy trial are in large part of delta ovarian patients.
Independent of that the mechanism of action of and our supplement and should be wholly independent.
Of the variant of the Sars Covid 2 virus right, what what in our supplement of addresses.
As the endothelial injury and really the.
And the resultant activation of the lectin pathway due to endothelial injury and that is that is going to be present and.
And and.
And the original virus and the Delta variant and the Lambda variant and I would expect really and any variant of the Sars Covid 2.
The virus, so I don't see any.
And any impact or or any.
Detrimental effect on the role of and our supplement and Sars Covid 2 writ large based on on the variant.
That's very helpful. Can you also of elucidate for us positive.
The audio and which <unk> already has approval and Ta TMA.
It would be the perspective on the use of.
The I spy study as potential basis for a regulatory approval either of yet EUA or some other out but probably the.
<unk>, specifically and COVID-19, do you have any sort of feedback or sense that this trial could be kind of on a standalone basis.
The foundation for a potential approval or if there is likely to be of need for additional clinical work can be done and how does potential approval of non software map and the non COVID-19 indication potentially impact the ease with which our software and that might get EUA.
Well first of all make the general comment that we don't discuss.
Our communications with FDA around specific programs I would also make the.
The broad statement that we would not and do not.
Promote or or push off label use of of any of our drugs.
Having said all of that I think of look if you have a positive outcome from the I spy trial that we would be and discussions with FDA about how to make that drug more broadly available for COVID-19 patients and I think that would be.
And the appropriate.
And and I think that.
I would hope that given the.
The collaborative.
Working relationships that we've had throughout the years with FDA.
Net.
And that we would all work to figure out how to do that.
With that let me stop and see if if Cathy Melfi, our head of regulatory has any additional comments on that.
Thanks, Thanks, Greg and yes, as Greg said without getting into specifics about discussions we have with regulatory agencies.
And I do think that.
Given the similarities that there are between COVID-19, and stem cell TMA and certainly speak the FDA about.
And we're taking that into account and the decisions they make and that sort of thing, but other than that and what Greg said.
And that's really all of that we can say for now.
Okay, Great and just 1 last question on the Artemis trial can you comment at all on enrollment status and any kind of updated timelines of topline data release, particularly in the context of the additional sites being brought online in China.
Yes, we don't.
Hi, Ron we don't give updates on enrollment.
We are continuing to target.
Target date.
Data.
At the latter part of next year, we have to see what happens with the number of factors.
Including Covid.
Whether that will have any effect, we know that COVID-19 slowed us down before that may slow us down.
As we expand sites and China will need to see how that goes but again, what we're targeting and.
And as data and the latter part of next year.
See if we'll see if we're able to hit that that is that is the objective.
Thank you.
Next question comes from the line of Brandon Folkes from Cantor Fitzgerald. Your line is now open.
Alright, Thanks for taking the question and congratulations on the good core tech.
Firstly, and maybe just on Omidria had with the new P. P and ASC contracts was there any stocking and the quarter what was that all demand.
And then secondly on the map.
And on pricing.
Are you still going on price and that's diplomat's and maximize the Ta and.
The opportunity or should the IRI data readout, the full exit from that comes to market with TMA.
And could this have the potential impact on how you view of pricing. Thank you.
Yes.
The sponsor to your first question.
And there was no stocking so I think that that should answer that Brandon.
And on your on your second question.
I think that.
Again.
The objective is to get in our supplement of approved.
And for Ta TMA and I think that we will continue to work through these other indications.
And how we handle those commercially.
And once we get to that point I don't know if that answered your question if not if not.
Come come with another and I'll try to answer it more directly.
No I think I think you did on crude I think asked.
The more directly and I was just.
If the answer of my day to come.
Re dock productivity that you sort of the compelling that you think you're definitely going to get approval of bad weather you may price.
And let's get more prevalent and more usage and Covid right.
Yes, my understanding is.
Sounds like the end of focus on the Ta TMA opportunity and.
And then address the next opportunities is that fair.
Yeah.
Yes, it is and I think I think Brendan specifically look the focus as you've said is on Ta TMA remember that the population and which we have studied.
And our thoughtful of map and COVID-19 is really the the critically ill population.
And that is a relatively smaller part of the overall COVID-19 subset and even.
A smaller part of the.
Of the hospitalized subset of COVID-19 patients so.
We need to look at the overall numbers.
And again I think best thing, we can do is focus on getting our supplement of approved for Ta TMA vs.
And these other problems would be would be nice to have and ones that we certainly would work to sort through but I would expect that.
That we would do that well.
Great. Thanks, so much and Greg I appreciate the extra color.
Thank you.
There are no further questions at this time I will now turn the call over back to the Doctor demand on this.
Okay, well, thank you operator and the.
Thank you again, everyone for taking the time to join us today.
We're pleased with <unk> progress across our commercial and development programs and we really like how the remainder of the year the milestones and our likelihood of achieving them are shaping up in the meantime, as always on all of US on <unk>. Appreciate your continued support of <unk>.
Good evening. Thank you.
This concludes today's conference call. Thank you for participating you may now disconnect.
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