Q1 2021 Omeros Corp Earnings Call
[music].
Good afternoon, and welcome to todays earnings call for ONEOK Corp. At this time all participants are in listen only mode. After the company's remarks, we will conduct a question and answer session. Please be advised that this call is being recorded at the comp.
See quest and a replay will be available on the company's website for one week from today.
And over the call the Jennifer Williams Investor Relations for on the House.
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 these statements are based on management's beliefs and expectations as of today 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 company's 2020 annual report 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 on merits.
Chairman and CEO.
Thank you Jennifer and good afternoon, everyone and we appreciate you joining us for today's call.
Our agenda begins with the corporate update as part of that will be joined by not any of that our chief commercial officer.
Mike Jacobsen, our Chief Accounting Officer will then provide an overview of our first quarter financial results.
We of reserve time for questions following the prepared comments.
We will start today's call with an update on our supplemental and our supplement is our fully human monoclonal antibody targeting masks to the effector enzyme of electric pathway of complement.
Our biologics license application or BLA for the treatment of hematopoietic stem cell transplant associated thrombotic microangiopathy or Ta TMA.
Was accepted by FDA for priority review and the Paducah date is July 17th.
As we recently shared of new ICD 10 diagnosis code for Ta TMA and two new ICD 10 procedural codes for the administration of <unk> have been approved the.
And the ICD 10 diagnosis code awarded by the centers for disease control and prevention of C. D. C will be effective October one 2021 consistent.
And with Cdc's annual schedule.
This code will allow physicians and others to more accurately code track and bill for Ta TMA.
And the diagnosis codes should also provide a competitive benefit and our supplement given that other therapies are currently used off label to treat Ta TMA.
This off label use has frequently been reimbursed because without a specific ta TMA diagnosis code the.
As off label therapies have been coded with diagnosis for which they are approved.
Now with the diagnosis code specifically for Ta TMA, it should become easier for payers to track and question use of off label therapies.
We expect and our supplement and will be the first drug approved specifically for the treatment of Ta TMA and if so its use would be uniquely on label for Ta TMA.
In addition, the centers for Medicare and Medicaid services or CMS granted to ICD 10 procedural codes that will allow providers to bill for the administration of and our supplement.
And the inpatient setting the.
These codes also become effective on October one 2021.
Throughout the application process and <unk> collaborated closely with key transplant societies and organizations, including the center for international Blood and marrow transplant research.
The American society of transplant and cellular therapy, the American society of hematology, the pediatric transplantation and cellular therapy consortium.
The the match National bone marrow donor program and the Ta TMA guidelines working group, which consists of some of the most respected transplant physicians and the U S and Europe.
And our supplement of is also a focus of attention and international Society meetings.
Selected for a podium presentation professor Alessandro of on Baldy of the University of Milan disc.
<unk> discussed the and our soft to the lab Ta TMA pivotal trial data in February.
At the annual meetings of the European Society for blood and marrow transplantation.
The conference also featured several other scientific presentations on our supplement and Ta TMA.
For the upcoming 2021 Congress of the European Hematology Association in June.
And our supplementary Ta TMA pivotal trial data again were selected for a podium presentation.
In addition, two manuscripts will soon be submitted one authored by investigators of the Ta TMA pivotal trial details of the trials results and the other authored by international experts on complement as well as by leaders and adult and pediatric stem cell transplantation elucidates the.
The role of mast, two and the lectin pathway and Ta TMA and other endothelial injury syndromes.
And our supplement of also continues to be used to treat critically ill COVID-19 patients.
And prior calls and presentations, we've highlighted the pathophysiological similarities between Ta TMA and COVID-19.
Youre, both endothelial injury syndromes.
We've also published results from the first cohort of and their supplement of treated COVID-19 patients and Bergamo, Italy.
All of whom recovered.
The survived and showed no clinical or laboratory evidence of long haul disease.
Results from the second cohort of critically ill COVID-19 patients and Italy are similarly impressive.
Data have been collected and we expect that they also will be published.
In addition to the severely on COVID-19 patients we've treated under compassionate use and our supplement as part of the nationwide <unk> by COVID-19 trials sponsored by quantum leap healthcare collaborative.
Partly funded by BARDA the.
Trial features and adaptive platform designed and intended to increase its efficiency by minimizing the number of study patients needed and the overall trial duration.
Dosing of patients with <unk> and the trial began in early March.
Work also continues at our laboratories at the University of Cambridge, and the <unk>, Cambridge Center for complement and inflammation research or Oc three IR.
The C. Three IR as part of the humoral immune correlates of COVID-19 consortium funded by U K research and innovation.
And the British and National Institute for Health Research.
We expect that soon a series of manuscripts will begin coming from most of the three IR directed to and our supplement of an electron pathway and.
COVID-19.
The rollout of COVID-19 vaccines continues to have its challenges.
Meanwhile, variance of the Sars COVID-19 two virus continue to grow and number.
Perhaps hastened by selective pressure, resulting from therapeutic approaches aimed at conferring passive immunity.
At the same time global 19 infections.
Hospitalizations and deaths continue mounting.
Many experts and the field believed that the key to and effective therapeutic is targeting the endothelial injury and associated complications like thrombosis and hyper of coagulation.
That reportedly are present across all COVID-19 variance to date.
This speaks directly to and our supplemental non.
Not only for acute COVID-19, but potentially also for debilitating aspects of long haul disease.
Discussions are ongoing with governments and the U S and internationally regarding funding.
And manufacturing support.
Beyond our work and endothelial injury syndromes, namely Ta TMA and COVID-19, we have two ongoing phase III programs for and our soft home out one and Iga nephropathy, and the other and atypical hemolytic uremic syndrome or H U S.
Our phase III Artemis <unk> trial is over a 120 sites already activated worldwide.
We're also expanding to additional geographies, including China, where Iga nephropathy is more prevalent than in other parts of the world.
We expect that this expansion will further accelerate progress and the Artemis <unk> trial and allow us to wrap up enrollment and readout proteinuria data and next year.
To our knowledge and our supplement is the only drug in development for Iga nephropathy that and kind of and obtain full or regular FDA approval on proteinuria data alone.
Now, let's look at our first quarter financial results as we discussed on our last call. Omidria recently was determined to qualify for separate payment by CMS when used in ambulatory surgery centers or afcs under Cms's policy that provides separate payment.
For non opioid pain management surgical drugs.
Net revenues from the sale of Omidria and the first quarter were $21 $1 million, a doubling over the previous quarter.
Sales of Omidria of continued to grow through the first part of the current quarter and are quickly approaching revenue levels in the afcs present before Omidria pass through status expired on September 30 of last year.
The revenues achieved and the first quarter were despite limited sales in January and part of February.
Caused by a delay on the part of Medicare administrative contractors or Macs and posting CMS is December action restoring separate payment for Omidria.
This delay created uncertainty regarding reimbursement among a good number of our customers who refrained from purchasing until the Max publicly confirmed the restoration of Omidria separate payment in late January.
Our net loss for the first quarter was $35 $1 million of <unk> 57 per share of which $4 $1 million of seven <unk> per share were noncash charges.
As of March 31, we had $105 million of cash cash equivalents and short term investments. We also have a $50 million of accounts receivable based on line of credit.
And an additional $150 million available through an at the market equity program.
Now the separate payment has been restored and the afcs, we remain committed to ensuring the cataract surgery patients and hospital outpatient departments or H O. P. DS are also able to access omidria.
The non opioids prevents addiction and the <unk> in the Nation Act or the no pain Act would do just that.
Mandating separate payment for non opioid surgical pain manage and drugs like omidria when used in either <unk> or H O P DS.
The no pain Act has been reintroduced in the Senate and already list 17 Senators as co sponsors.
We expect the house companion to the Senate Bill to be introduced within the next several weeks by its lead sponsors.
Democrat Representatives, Custer, and Seoul, and Republic, and Representatives Mckinley and Fitzpatrick.
The no pain Act has strong bipartisan support among congressional members and leadership as well as from medical societies, including the American Medical Association.
And counts as its supporters of number of very strong patient advocacy groups.
With that I'll turn the call over to <unk>, our chief commercial officer to provide and update on commercial activities for both of our supplement and Omidria not here.
Thank you Greg.
And exciting for three months from me with an error.
Out of the progress of the commercial team has been making with building momentum for Omidria. Following the December 2020, CMS decision for separate reimbursement and the ASC is as well as lifting our thoughtful of math launch readiness for our July of <unk>.
I'll begin with the significant progress with our <unk> launch readiness.
Talented regional hospital sales managers with deep experience and stem cell transplantation, hematology and oncology has been identified for each of our territories.
And they have existing relationships with top of transplant centers.
They will focus on account profiling and disease awareness education ahead of our anticipated SBA approval.
We are building a best in class Hematology oncology field force to ensure we hit the ground running at time of approval.
The field marketing and medical Science liaison team are already in place building relationships and key transplant centers of excellence providing.
Critical disease awareness education, and creating centers of specific plans to ensure rapid access to and our supplemental post approval.
Our national payer team has been engaging payers with disease state and Preapproval information exchange presentation.
Payers of reacting positively to and our supplement of clinical and safety profile we.
We have held advisory boards with hospital formulary decision makers and we've indicated the likelihood of managing our software and that treatment. According to the final label in fact, they highlighted and our Sop the mat strong efficacy data coupled with the good safety profile as the rarity and their field, particularly for a life threatening disease.
In addition to these engagement we have been executing of multichannel unbranded disease awareness campaign, driving online traffic to Eas threat Dot com a website directed to educating physicians and patients about EIF or endothelial injury syndrome. The.
The response has been impressive with over 11000 unique users to date.
Our market research with HFC T transplant physicians indicate a near unanimous belief that numerous biologically linked endothelial injury complications can occur post HSC team a recognition that has steadily increased since our disease education efforts began.
Respondents ranked th PMA is one of the most serious transplant complications 90% of transplants are surveyed correctly by the complement activation of playing a central role and endothelial injury syndrome importantly, they all recognize the fundamental role at the lectin pathway and then just the allele injury.
Overall, it is clear from our interactions of transplant or is that their understanding of the endothelial injury syndrome as central to Ta TMA is rapidly growing and that they believe and novel therapeutic option for the treatment of Ta TMA represents a significant unmet need.
The commercial team has also been focused on building omidria momentum with steady and sustained recovery following the uncertainty around reimbursement and the total number of Asp's ordering and the first quarter has increased by 43% over the fourth quarter driving of total ASC purchase volume increase of 274.
Percentage in the same period.
Our efforts with establishing partnerships with ASC chains and groups of ASC is owned and operated by private equity groups has been instrumental and building this momentum.
We successfully executed agreements with seven private equity groups and ASC chains and the first quarter.
We estimate the aggregate procedural volume from the affiliated facilities at nearly 300000 procedures annually or an additional 7% to 8% of the reported cataract market.
Presenting a significant opportunity for future Omidria growth.
Additionally, cataract surgeons favorable perception of Omidria and expectation to use of imagery and the future of continues to strengthen.
And our recently completed attitudes and usage market research study conducted with cataract surgeons on <unk>.
<unk> showed strong association with four key attributes that surgeons rated among the most important when prescribing of treatment for use during or following cataract surgery.
Specifically search and syndicated familiarity with our real world clinical data showing that Omidria decrease the complication rates prevents iris prolapse, and floppy Iris syndrome and that it decreases the use of pupil expanding devices.
These associations support of positive value proposition for Omidria the.
Complications and the use of additional devices and the surgery can lead to increased costs lower patient satisfaction and reduced throughput and the LR.
The surge of Allstate precedes the overall strong value proposition and atria offers.
Typically site of imagery, it's consistent outcomes and quality and markedly better safety profile and FTA approval of significant benefits over compounded product.
Impose unnecessary and often unknown risks on patients.
We believe that the growth we have seen since the fourth quarter of coupled with positive perceptions, among surgeons and ongoing efforts to expand reimbursement among commercial and Medicare advantage payers will continue to build strong momentum throughout the second quarter.
With that I will turn the call back over to Greg.
Thank you and Audi.
As not.
<unk>, we've seen omidria as momentum growing in 2020, one and we're excited about the work that Naughty and her team have been doing to prepare for a successful commercial market launch of nurse supplement.
Working to realize the full potential of our Master II program. We're also focused on lifecycle management beyond and our supplement.
The <unk> 10, and 29 is our second generation long acting <unk> two antibody.
Targeting once monthly or less frequent subcutaneous dosing of all of <unk> 10, and 29 is expected to enter the clinic and the first half of next year.
In addition, we continue to advance our small molecule masked two inhibitors designed for oral administration.
Our masks III program is also progressing well mass III is the key activator of the alternative pathway and we along with other leading complement researchers.
Believe that it's the premier target and the alternative pathway.
The phase one trial for our mass III inhibitor on match 906 remains on schedule.
It's a placebo controlled double blind single ascending and multiple ascending dose trial, we have completed dosing five cohort and expect a data readout later this quarter.
Let's turn now to all of them as five to seven of our <unk> seven inhibitor for the treatment of addiction and compulsions.
Having completed a successful phase one trial the clinical program is planned to continue advancing when additional resources are available.
In the meantime, a seminal paper detailing the mechanism of action of PD and <unk> inhibition and nicotine addiction will soon be published and the peer reviewed journal of neuroscience.
We'll wrap up the program update today with J P on 174 for cancer immunotherapy.
<unk> hundred 74 is an immuno suppressive G protein coupled receptor.
That is activated by products of the tumor microenvironment.
We're building a broad and exclusive intellectual property position around <unk> 174.
We also are aggressively developing both small molecule and antibody inhibitors of <unk> hundred 74 to unlock the potential of this exciting new cancer immunotherapy target.
And we've found the GP or 174 of deficiency and mouse models and enhances T cell proliferation, and tumor, killing phenotypes, leading to reduced tumor growth.
We believe that the <unk> hundred 74 inhibitor will be necessary to maximize tumor killing immune responses following radiation and chemotherapy all of which can cause cell death.
We also believe that inhibitors of <unk> hundred 74 could be combined with existing cancer immunotherapies like youre of Hawaii or Keytruda.
To improve their response rates.
In addition, we plan to publish data soon from our studies demonstrating that combined inhibition of <unk> 174, and adenosine receptors synergistically enhances T cell activation and tumor killing phenotypes.
With that I'll turn the call over to Mike for and for an overview of our first quarter financial results, Mike and thanks, Greg.
And as Greg noted of Missouri, and total revenues for the first quarter were $21 1 million or net loss for the first quarter was $35 $1 million or <unk> 57 per share.
This includes noncash expenses of $4 $1 million or <unk> <unk> per share.
As mentioned earlier pass through extension for Omidria expired on October one and 2020 and separate payment for Omidria and the Afcs wasn't announced until December.
The Max which of the regional reimbursement of administrators from Medicare Medicare part B.
And put the new reimbursement rules into their systems until well and the first quarter and many of our ASC customers were hesitant to use the Missouri until the tested the reimbursement process.
This negative negatively affected our January and February revenue.
As of March 31.
202, one we had $105 million of cash cash equivalents and short term investments available for general operations.
Also have the $50 million of 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 March and continuing into the second quarter, we have seen the steady increase and omidria sales to afcs and our weekly sell through to these customers are approaching levels seen prior to the loss and subsequent restoration of the separate payment.
Costs and expenses for the first quarter were $51 7 million and.
And increase of $7 $2 million from the fourth quarter of last year.
The increase was primarily due to additional in the supplement of commercial drug substance lots being produced at loans of our contract manufacturer.
Until we receive approval for and our Sop of them up and Ta TMA all CMC related costs that would normally be included and the inventory are being expensed as incurred.
Interest expense for the current quarter was $4 $4 9 million. This.
This is $3 $1 million less than in the fourth quarter of last year due to the January 1st adoption of ASU 2020.
<unk>, six which allows us to account for our convertible senior notes solely as debt and set of debt and equity.
Looking ahead, we assume separate payment by CMS for Omidria and the ASC and we'll continue consistent.
Consistent with CMS policy that has been in place since 2019.
We're confident that Omidria revenues will continue to increase as this as the customers ramp up their use of Omidria and our customer base continues to grow.
We expect our research and development costs to be similar and the second quarter to those and the first quarter.
Our cost for manufacturing of.
And our supplement commercial supply will decrease and the second quarter.
But our ongoing costs for our phase III clinical programs from the supplement and.
And the activities related to Oems nine of <unk> six and.
All of <unk>, 10, and 29 should increase.
As I noted just a few moments ago, we will continue to expense and a subtle about manufacturing costs rather than include them as inventory until regulatory approval is certain.
SG&A costs are expected to increase throughout the year low.
Largely to support and our supplement <unk> launch preparations and the hiring of our regional hospital sales managers.
Interest expense for the second quarter should be approximately $5 million.
With that I'll turn the call back over to Greg Greg.
Thanks, Mike, Let's open up the call operator to questions.
Yes, Sir.
Ladies and gentlemen, if you have a question at this time. Please press. The Star then the number of one key on your Touchtone telephone.
The question has been answered all of which to remove yourself from the queue.
Please press the pound key.
Our first question is from Steve Brozak from double UBB. Your line is open.
Yes, hi, and thanks for taking the question just one on the sales that you just posted on the Omidria can can you tell us how you feel about it because I'm just looking for a general feedback on everything and what's your thoughts on thanks, and I'll hop back in the queue.
Yeah, I'll answer that and then and then I'll I'll hand, it over to <unk> to respond as well and see if she has the same or different view, but I can tell you that.
I'm I'm pleased with those numbers, particularly given the.
And that the Max.
Had a delay and posting CMS is decision regarding separate payment until.
And until late in January.
No.
And that really did create some.
Understandable I think understandable discomfort among some of our some of our customers are a good number of our customers who wanted to make sure that the Max would in fact reimburse win.
And when billing was submitted.
So given that I think that the numbers were strong and I think of both nodding.
And Mike have also underscored you know those those numbers have continued to improve throughout this quarter. So we're feeling really quite good about it but now let me share if.
How naughty of use of that.
Yeah, Greg I completely agree just having started within the first quarter.
On the heels of the very challenging.
And of where reimbursement was lost.
And I'm really proud of the team because together we focus on the areas.
That had the best return, meaning focusing on the customers focusing on where we need it to make sure of the messages were received that reimbursement is restored and this kind of focus is building really strong momentum. So I'm extremely pleased and I am excited even as we said and this quarter four and EBIT.
The outcome.
Great. Thanks, again for taking the question.
Thanks, Steve.
Your next question is from Colin Bristow from UBS. Your line is open.
Good evening and tastes and taking the questions.
And on Novartis and N P zero to three.
And just get your view on the recent day, two and Iga nephropathy and how.
How do you see that we can create geo program. Thanks.
Well it started calling and it's a bit muffled and I may have I heard about the Iga.
Iga nephropathy and could you just repeat the first part.
I was just I was asking about the compound and their data is that and does that somebody is somebody who is helping me a bit with the question. So I just want to make sure that was that.
Was that the question.
Yes, sorry I didn't.
No it's okay no loss share.
Is that and pizza at G III just.
On the day to any REIT right from the program the efficacy bar.
Well first let me just say that all I know about the data.
What are are available publicly.
Which which is has some but not not in great detail, but what and.
I'm sure you'll know this number probably better than I, but but my recollection is that they showed about a 23 and 5% reduction in proteinuria and the patients treated with <unk> with their factor B inhibitor.
Is that is that does that align with your understanding Collin, yes, that's exactly right and the 90 day and point 23 per cent reduction.
Right.
Well again, I would point to what we've said about reduction with and our sample of map and.
Proteinuria and Iga nephropathy.
It appears that we're we're really playing in a very different level.
So the reports around other drugs and now including Novartis is factor B inhibitor are all sort of playing in that and that low to mid 20% reduction in proteinuria, but what we've seen and reported with and our supplement our number.
<unk> that are a multiple of that 50, 60, 70, 80 up to 90% reduction and some patients and proteinuria.
So I think it's.
I think.
And I saw those data.
I was quite heartened and.
And again I think.
Underscored our confidence and.
And our supplement.
Our ability to play a major role and Iga nephropathy, and again really really I think demonstrated the pretty clear distinction between what we're seeing within our supplemental and kind of what everybody else is seeing with there.
Specter of drugs.
So.
So let me stop there and see if that answered your question.
Yeah that was very helpful. Thank you.
Thanks Colin.
Your next question is from Geoff Meacham from Bank of America. Your line is open.
Hey, guys.
So much of the question.
I've got a couple but.
But one Greg on the on the nurse supplement the COVID-19 front.
Do you view the path for just given all the progress we've seen with vaccine, but I guess the question is does the.
Slowdown of new cases, and hospitalizations effect.
And of your view of the commercial potential for this indication and then I have a follow up.
That's a good question.
Zinc.
I think that the vaccines have been challenged I think the rollout. It has been challenged I think that we're finding just in the number of states that are turning back COVID-19 vaccines. They are having trouble in the stage getting their citizens.
The two one of you vaccinate.
And I think obviously.
Of the problems with some of the vaccines that have been very publicly publicly discussed.
Have created a bit of the concern on that and I also think that what we're seeing with the variance and the increasing number of variance is a real problem.
And.
The interesting thing about that is.
How are these variance coming about I mean, certainly the virus is is mutating independently, but but is there a component of this which is selective pressure.
And what could be causing that selective pressure well.
And some believe and I think with.
With reasonable scientific basis.
That the.
Selective pressure may and part be driven.
By these approaches and passive immunity, so convalescent plasma or some of the antibodies that are intended to confirm passive immunity.
I think.
I think as of distillate of everything I'm, saying.
Do I think COVID-19 is going to be not a problem and the near future. Unfortunately.
Don't subscribe to that I think this is going to be of problem not just in the U S but globally.
For years to come and.
And I think that you need of therapeutic I think vaccines wonderful they reduce the numbers are there.
The reduce the infectivity I think all of that is great.
And I don't think that we are ever going to get there collectively if we don't have a real therapeutic that addresses the problem and when you look at the at the variance.
It's it's pretty clear.
Endothelial injury, and the complications thereof, including the micro thrombosis and the hyper coagulation et cetera.
Those things are are consistent across the variance. So I think you've got to address it there.
At that level at the endothelial injury level and.
Just happens to turn out that that's what and our sample of Mab does.
So.
And again kind of bringing it all back around to your question.
You know unfortunately.
I think COVID-19 is going to be here to stay for a number of years and I think that frankly.
And our supplement looks to be a really good answer or certainly.
One of the best answers we've seen before.
For the treatment of critically ill COVID-19 patients and I think you know.
Again, Unfortunately, but the reality is those patients are still going to be there and be there and good numbers.
Got you Okay. That's helpful. Greg and then.
Either for you or for Naughty I, just wanted to talk a bit about the launch and and TMA.
And just help characterize the level of awareness today versus a year ago and.
The follow up is do you think the treatment guidelines or some sort of consensus building publication, maybe helpful or our physicians and your view likely the target at risk patients and an effective way and and and TMA. Thank you.
Let me hand that off and idea.
To answer your question and.
And I may add a little bit, but let's see Naughty of would you think you got it. Thanks.
So in terms of awareness and the team has been running.
And the attitudes and use of studies for a bit of time now we're actually on our third waves. The wheat track of awareness very closely and we're really pleased with the growth that we have seen wave over ways and.
Sales of course, you know the products that are out there and used for off label has.
Slightly higher awareness, but we are very pleased with the unaided awareness that we're seeing currently and you know in terms of the codes that we talked about that Greg talked about and the beginning this is truly going to help right now that there are dedicated diagnostic codes for Ta TMA.
That awareness and the consensus building will come together, because there's no way to track up until now.
What is P of TMA, what's off label.
And so would.
Sense of statement help our consensus paper, absolutely because if you look at the publications you do see a range.
But that's why we feel very strongly about the need to engage on disease education, and we see when our team and the field have the conversation about the signs and symptoms of the diagnostic criteria the.
And I like goes from I don't think I have any patients to I think I have of patient right now and the inpatient ward.
We view that is of critical part of preparing for launch and getting to the produce a day.
Let me ask Greg to comment on anything else that you'd like to add.
I think that answers the question pretty well I'm, just just to underscore something you said.
And <unk>.
To your question about consensus Jeff there is.
The study group that is consisting of really the the leading transplant and both the U S and Europe, who are doing just just what you are proposing which is they have come together as a group.
Two to better defined.
The entity that is Ta TMA.
And that will result in a publication I think that debt will help certainly two of line.
Transplant is around.
Around the world.
And what is the Ta TMA and.
And perhaps how best how best to approach treatment for that so I think certainly.
As you've identified that debt.
And that sort of alignment or consolidation.
It would be helpful and I think I think we're certainly headed toward that and I think could have that and a relatively short amount of time.
Okay, great. Thank you so much.
Jeff.
Your next question is from Roku on some of the Roger from H C. Wainwright. Your line is open.
Hey, guys. Thanks, a lot from the call and the questions.
Just a quick follow up on what you just said regarding the ICD codes could you perhaps comment on the potential magnitude of the impact and when do you think.
Its influence on the utilization may kicking.
Yes.
And then I'm going to hand this over the Naughty on just a moment, but I think just just from what I said.
And those those become effective on October one of 2021.
So we would.
The obviously to have an effect, starting then and that effect would continue to grow but let me let me see an idea of how do you view.
And the codes both for diagnosis and really for the for procedure, which allows for the reimbursement for administration of the drug which is also very important.
Yes.
And I've launched my fair share of products and when you are launching into an area that there are no established diagnosis codes, let alone cathedral of cards for the product that's half the battle and and and you don't know you know there's no guarantee whether these are going to be in place. When you get your opinion sort of approval that you have received.
This approval on both diagnostic and procedural codes and.
And that will be effective in October is a very big win for the launch.
And as I said, you know it'll help track actual ta TMA patients.
But it will also allow the prescribing and Theres Poplar Mab and positioning of the the billing obviously of these patients here on the hospital settings and the appropriate treatment centers. So.
And I consider that a very big win and something that we're very happy about in terms of the momentum that the launch will take once we are approved.
And there was also of grid that we had the support I think naughty of really the premier organizations in transplant and those of the deal with this complication of transplant and Ta TMA really internationally, which I think was.
Sort of underscores.
I think how people view of the.
And the importance of this and also.
Potentially the importance of nurse half of them out as the first approved.
Treatment of if we can reach that point of.
And for Ta TMA.
Awesome. Thank you so much for that and just a quick question on the COVID-19 study and the please excuse me feel already and so that in your prepared remarks, but when and when can we anticipate data from the I Spy study and maybe if you could comment on.
Now the assets and differentiate us from the rest of the drug and the study since it's the only the the only complement inhibitor involved and the study.
Yes, I can confirm that in our supplement of is the only complement inhibitor and the I spy trial and the only complement inhibitor that has ever been and the I spy trial with respect to when we can.
And <unk>.
Anticipate data that's pretty tough we are kept very much at arm's length from that study.
We are not involved in.
And the conduct of the study we were not involved and the design of the study that's really one of the requirements of that.
That the group.
Quantum.
Requires.
And it is it has to make it wholly independent of industry. So really all we do is provide provide the drug and.
And then we have to we have to wait.
To hear anything from them.
What what I do know.
Is that it has been enrolling.
And that are our arm has been enrolling cash.
To give you a number of patients that have been enrolled.
I think we'll just have to wait to see how that plays out I know that there are I believe that they are targeting.
Certainly this year.
For for data.
But run beyond that.
And kind of your guess is as good as mine at this point, we really are and I know that may sound like I'm I'm I'm stiff arming the question, but I'm not we really are kept in the dark and intentionally intentionally so.
Great. Thank you and I should've probably.
<unk> mentioned this on the beginning of the call them cheap filling in for Rob, but just the last thing from me.
On oil and that's 96 I know you provided some color on the press release, but.
Can we still anticipate data this quarter and lastly, maybe some color on the enrollment piece and the Iga nephropathy study with the <unk>.
So came on thank you so much.
Sure.
We do expect that we will have initial data release from the nine O. Six trial later this quarter of.
That trial as I said and in the comments is running on schedule and.
And so that is our expectation with respect to Iga.
You know we continue to enroll that study we had as we've discussed publicly.
We had some.
Slowdown due to COVID-19 and due to being able to enroll patients as a result of COVID-19 at these hospitals.
But that seems to have been lightening.
Meaning the COVID-19 restrictions and so enrollment is picking up again.
Also mentioned that we look to expand our geographic regions for enrollment and one of the areas. We're clearly targeting is China and that's because.
China has a very high prevalence of Iga nephropathy and in fact, my understanding is that one out of every four dialysis patients in China has Iga nephropathy.
So the these are big numbers, and we think that once we're up and running there. We can can move pretty quickly, but let me see.
Steve Whitaker here as well, let me ask Dave Steve do you have any other thoughts on that.
Yeah.
No.
And as well.
Good I think yeah, I think we're in good shape. There we're excited about the program.
To underscore the.
Question and.
About about the Novartis is factor B inhibitor.
All of the things, we see point too and our shop of them up and <unk>.
And nephropathy, having really a singularly unique role we just need to look at the data when the data are available and and.
And we expect and certainly hope that those data will confirm what we've already seen.
And when and when that occurs and if that occurs then I think that's really a game changer.
And Iga and potentially not only and Iga.
But across across renal diseases the mechanism.
At the <unk> level and at the two below interstitial level.
We're seeing we're seeing the dishes.
The.
This is a pathology and a mechanism of our drug that extends beyond the Iga nephropathy to again more broadly really these protein Europe renal diseases, and general and that's a very big deal.
Awesome. Thank you so much thanks, a lot for your time and patience with Oh. Thank you. Thanks for your question.
Your next question is from Jason Mccarthy from make simple your line is open.
And of this is Michael and which on the line.
Thanks for taking the question.
Okay.
Okay.
So I'd like to ask on Omidria sales, maybe if you could help quantify the magnitude of the impact that that lack of clarity on reimbursement had and the early part of the quarter like how much of the revenue is concentrated in March versus January February and was there any impact due to COVID-19 given the high <unk>.
Number of cases early in the quarter or was that kind of overshadowed by the reimbursement of Scott.
Okay.
Yeah, and understood that's difficult to quantify Michael really.
As you know January traditionally is one of the slower months for cataract surgery or for surgery, and general and that's due to the rollover of health care plans beginning in January but.
Those are still meaningful months January and the early part of February of <unk>.
And for Us and so.
I think the only way that I can really quantify that is to say that it has a meaningful effect. When you have a number of your.
Larger customers and stronger customers, who are waiting on the sidelines to confirm that the macs are really going to pay right. It's one thing for CMS to say.
Yes.
And we confirm that <unk> has and that Omidria has separate payment and.
And the <unk>, it's another to have your your billing reimbursed.
And so everybody you know a lot of lot of these folks wanted to sit that out until that was confirmed once confirmed things started to pick up as we said in February and March is traditionally one of our stronger months. So I think I think all and all.
And those those numbers are pretty telling.
And I think.
As is not ER, underscored and and as I said.
I think we certainly were pleased with.
With those results, but let me see again not yet do you have any other thoughts on that.
No I think you answered the answered it very well and I completely agree with it.
Okay.
Your next question is from Andrea <unk> from Wedbush Securities. Your line is open.
Thanks for taking our questions. This is andreas on coming on and the Santos.
A couple of a couple from us starting with the midyear.
The quick comments on on the number of cataract surgeries that you're seeing now compared to pre COVID-19 levels, and then I'll have a follow up thanks.
Yes, understood and and.
I think that Michael asked the same question and I may not have answered that so thank you for giving me another opportunity at that.
It's a little difficult again to tell what's happening there I think that COVID-19 certainly is having an effect its not having the same kind of effect it had last year or last summer.
Or frankly last spring when elective procedures were shut down.
But I think certainly there's there's still hesitation on the patient side I think also in the <unk> and and the H O. P. Dos there is still there is still.
Additional precautions that are are in place, which which reduced the throughput of these types of surgical procedures right. If theres a longer turnover time that is going to reduce the number of cases that you can run and any specific room on any given day.
So there is an effect.
We're not focused on it I guess it would be our best answer.
And as you can see the team has done a tremendous job of of driving Omidria utilization back and we are as I think you've heard a couple of times today, we're approaching the.
And the levels of utilization that we had prior to the loss of pass through and then restoration of separate payment by by CMS.
So we're not focused on it I'm sure. It's a factor I can't quantify for you.
How big of a factor how big of a factor that is.
Just the follow up to that what do you think is the kind of be going forward a bigger contributor to sales would be again.
And the surgeries of returning to cope pre COVID-19 levels or more about the debt.
Restored access.
About the what was the second.
Amit.
The restored access so I, just just trying to figure out which of yeah. Yeah, Yeah, I don't think and again I'll ask Naughty of her opinion on this is my opinion is that there's really no question about the.
It is the restore and access I don't think debt.
The COVID-19.
They continue to have have an effect, but that is going to pale in comparison to restored access and the restored access and the ASC is important.
Clearly, which we already have because cataract surgery is largely performed probably 80% roughly of cataract procedures are performed in the ASC.
On the no pain Act as we spoke about during the comments I think.
Has a straw.
The strong.
The strong opportunity to succeed.
It is really one of the only bills that you can point to and do you see right now that really has strong bipartisan bicameral support.
So if if both both sides and D C and and Congress wanted to agree on anything this is of tremendous opportunity for them and the numbers of co sponsors continue to grow as I mentioned on the Senate side at last count there were 17 and.
As soon as the bill drops and the house, meaning it is introduced.
The number of of bipartisan support or is there.
Will grow rapidly.
And just just so that it's very clear.
With the New Congress, the no pain act needed to be reintroduced so the.
The the previous Congress the the no pain Act had about 60.
House.
Ask house co sponsors.
Kind of split directly down the middle R&D.
And it had.
About 25 or 26 Senate sponsors again split directly of very closely directly down party lines. So bipartisan.
And the new Congress took over that bill needed to be re introduced and that's the process. That's that's been.
Undertaken currently remember that we are not.
And any way, leading or driving that process. This is really our voices for non opioid choices who is.
Who is the lead group for this with with multiple association.
Supporters and and advocacy.
The patient advocacy groups. So we're really watching this from the sidelines.
But it certainly looks to be again, gaining momentum and and.
And that would add separate payment and the H O P DS.
Any comments on that.
Yeah, just to build on on the one area that you know Greg already touched on is that we.
Really the the lack of reimbursement was the biggest hit to US yes, we look at the impact from that decision too early December when it was restored and you see a market change right and in the performance of Omidria and so while of course.
The COVID-19 and elective surgeries is looming.
We really view the restoration of reimbursement is the biggest factor and when I said earlier that the team has done a really exceptional job of very focused execution and with focus specifically on our biggest customers getting them back on board and and driving the depth of.
And the prescribing and overtime.
And over a short period of time work on it.
And the opportunity of increasing our breadth as well and that's really directly related to the restoration of reimbursement.
Great, Thank you and and.
Just the.
And following up on the supplement of and Iga, and so and Novartis.
And is advancing and factor being the phase III. Following the meeting the primary endpoint and phase two and their comments the mentioned GFR and approvable endpoint.
I do believe in the past and you've mentioned.
And your communications with the FDA that proteinuria.
Is it and the approvable end point for our enemies could you provide some color.
Around the Novartis is thinking and then.
And when it comes to.
Your expansion into China is the most of it we see that by the way I own. It doesn't look like they're going to be reading out the phase two this year of possibly because of some COVID-19 related delays et cetera is China the.
Extension of the China.
And you go.
And I believe that you'll you'll hit the 2022 timeline. Thanks.
The first and answer to the question about Egfr.
What what the.
Cardio renal division has been requesting.
For for most drugs and the Iga space.
The Egfr data for four full of regular approval, what they have indicated a willingness to provide accelerated approval on proteinuria data.
But the requirement then would be to look at really slope of Egfr over a two to three year period and.
And demonstrate that in fact that is that you are reducing the decline in the egfr relative to what would be expected and usually what's discussed is what would be expected our data that have come out of.
The Doctor Leslie inker.
And so.
So that's being used as as the reference and I think most groups are looking at that.
And I think that's again why.
Novartis is looking at proteinuria, but also is referencing egfr.
And our supplement.
As in a different situation.
Just on our discussions with the cardio renal division, we are able and this is really based on the magnitude and the rapidity of the reduction seen in proteinuria with and our supplement we are able to obtain full or regular approval on.
Proteinuria alone and again I believe in our supplement has been given this kind of singularly.
Nique opportunity now that that requires of course that the reduction in proteinuria.
As is substantial and and I would expect.
Meaningfully more substantial than what other what other drugs are showing but I think if you look at our proteinuria data as we discussed before certainly there's a difference there and.
Everybody else as I said is sort of delivering and the mid twenties.
The 'twenty three 'twenty five 'twenty seven.
It's very different and the proteinuria reductions that we've seen and reported with and our thoughtful of map. So assuming that that the phase III data look like what we have already.
Made public and all of the data that we have and we have made we have made public.
We would expect.
And that that would result, and a fall of regular approval at the same time. If you look at our design, we also are including Egfr.
Should for summaries, and we qualify for an accelerated approval and need the confirmatory data from Egfr for the regular approval. So all of that is built into our study, but we're very focused on proteinuria and.
And remember we have two separate groups right. The overall population which is.
Spilling protein it at.
Graham or more than a gram per day, and then the high protein spillers that are two grams or more of proteinuria of per day and really the what we have been able to.
Discuss and agree with with F. D. A is we can obtain full.
Meaning regular or accelerated approval and either of those populations.
So it's it's a it's a little our program is a little different but it I think warrants of those differences based again on what we've seen and proteinuria and again, the magnitude and rapidity of that proteinuria reduction.
And as the as the.
The study powered to measure the impact on EBITDA.
Yes, it is yes.
Yes. It is of Great and then just I know you gave a detailed explanation. We appreciate that and just a quick follow up on the.
Delays I guess to all of you honest as program and and the confidence you have behind reading out topline and 2022, the Chinese the Chinese expansion is the strategic universe of that thank you.
Right we are.
We are looking to China to provide.
Necessary patience too to get that done.
On the timeline that we've built but the timeline that we have built and the timeline that we are presenting publicly is one that that we think and expect that we can meet again with with the assumptions that you are identifying and I am of the identifying upfront.
Great Congrats on the progress guys. Thank.
Thank you very much thank you and dress.
Your next question is from Brandon Folkes from Cantor Fitzgerald. Your line is open.
Hello, everyone. This is carvey and footprint and today, we have a couple of questions here.
First can you talk about your most recent thinking.
Pricing of.
So the map and the TMT M&A given.
Given the products and development for other indications beyond <unk>.
Should we still assume you price price it to maximize the key.
The <unk> opportunity and.
It's the lawyers a good analog to look at here.
The second question can you talk about the manufacturing of north of Superman.
The approved in January we've seen a lot of capacity taken out by the vaccines. So any update on manufacturing capacity really helpful. Thank you.
Okay.
And the pricing question over to Naughty I'll, just make a comment that we really don't discuss our pricing plans, but I understand your question about are we looking at Ta TMA and and and.
Distillation and or are we looking more broadly at other indications when we're considering pricing of Ta TMA. So let me hand that over to nausea and diarrhea.
And what do you think.
Yeah and and as.
Alright, and said, we haven't given any guidance on pricing, but I can tell you that this is the very key piece of what the team is working on right. Now we are collecting insight doing a quantitative pricing work, but we're not only looking at Ta TMA. We're also looking at the other indications because.
As you know.
Indication based pricing of quite challenging so where we are.
And looking at all of those variables I will say, what's really critical is a solid value proposition and from everything that we've talked about and everything that we're encouraged by seeing and the attitude and usage study.
On the physician and the formulary decision makers and see a very solid value proposition for nurse thoughtful of mab between its clinical efficacy and safety profile. So on.
All of that is quite encouraging for us as we build the story.
In terms of analog it's difficult right you don't have the natural approved products for Ta TMA.
Pick analogs.
Or stratify and your analysis and of course, we're doing that and making sure that we've got a solid recommendation ahead of picking from.
Thank you and I do.
With respect to your question on manufacturing.
We have supply sufficient for launch.
And in retrospect it looks like.
The manufacturing that we've done and the additional launch that we manufactured.
And one point that might've seemed perhaps a little premature of of turned out.
Two two of served us well, so we certainly have supply of.
And for launch and well into launch of.
Of course.
The COVID-19 vaccines are putting a a bit of a crimp.
And available raw materials, but we have our manufacturing slots reserved we're able to access.
And those raw materials and in fact, our participation and the COVID-19 effort and.
Allow us.
And some preferential.
The treatment with respect to raw materials. So overall, we're feeling pretty good about our situation vis vis the manufacturing.
And I'm showing no further question at this time and would now like to turn the conference back in the Doctor Demopoulos.
Alright, Thank you operator, and thanks, everyone again for taking the time to join us.
<unk> heard today 2020, one is off to a strong start for <unk>. The next few months will be exciting as in our supplement of moves ahead to what the <unk> date for Ta TMA and we hopefully learn more from the ice by COVID-19 trial and share data from.
<unk> nine O six phase one trial.
In the meantime, all of US at <unk>. Appreciate your continued support and have a good evening. Thank you.
This concludes today's conference call. Thank you for participating you may now disconnect.
Yeah.
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