Q1 2020 Earnings Call
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Ladies and gentlemen, this is the operator today's conference call will begin in five minutes I feel that's how I feel like she will again be placed on cool. Thank you for your patience.
Ladies and gentlemen that 50, operator to these conference calls will begin in five minutes until that time to align to again I just don't hold thank you for your patience.
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Good afternoon, and welcome to these earnings calls her Omeros Corporation at this time all participants are you noticing only know what I'm sorry to companies remarks, we will conduct a question answer session. Please be advised you school is being recorded at the company. So that's.
And your legal be available on companies that sites for one week from today I'll turn the call, but the journey for Williams Investor relation sport Omeros.
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.
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 on the risk factor section in the company's quarterly report on form 10-Q, which was filed today.
With the FCC and that risk factor section of the company's 2019 annual report on form 10-K for a discussion of these risks and uncertainties.
Dr., Greg Demopolis, Chairman and CEO bone marrow will take you through a corporate update and then my Jacobson, our Chief Accounting Officer will provide an overview of our first quarter financial results. We have some time reserved for questions. After the financial overview now I would like to turn the call over to Dr. Demopolis.
Thank you Jennifer and good afternoon, everyone. Oh, we appreciate you joining us for today's uptick.
Oh, we hope that all of you and your families are safe and healthy we would like to start by acknowledging and thanking all those on the front lives in those global battle against Sars Koby too.
Every day first responders in health care providers are risking their lives.
On the lives of their loved ones.
Oh patients with called at 19 into protect the rest of us from this disease.
We recognize and greatly appreciate their efforts and selflessness.
I don't know Merrells, our employees have remained a safe and healthy consistent with our governors guidelines most of our team members are working and functioning productively from home.
Our researchers who primarily work and the labs continue to do so.
Implementing appropriate precautions to ensure their safety and the safety of their coworkers.
Just a lot of all this is that the omeros team has been able to continue advancing our programs.
We'll begin with an update on our supplement our progress toward the drugs planned commercialization.
And our supplement is our fully human antibody targeting the lectin pathway of complement and specifically mask too.
Merrells exclusively controlled MASP, two and all therapeutics targeting be enzyme.
Our lead indication for an awful amount is about a pragmatic stem cell transplant associated thrombotic microangiopathy or transplant T. I may which has caused by endothelial injury.
Endothelial injury and cellular damage broadly.
Activate the lectin pathway of complement.
My blocking MASP, two which is the elect and pathways effect or enzyme nor sapolu mab inhibits the lectin pathway.
We resolve the historical data collection issue that we referenced during our last earnings call and we continue driving toward completing the submission of our rolling Biologics license application or B.L.A. foreign our supplement transplant, Tim and next quarter.
At the end of last year, we began our rolling B.L.A. with the submission of the Nonclinical sections.
We just submitted on schedule the first components of our chemistry manufacturing and controls or C. M C sections.
These include data on manufacturing analytical procedures and associated method validations.
As we reported during our last earnings call. We successfully completed manufacturing of all drug substance process validation lots that F.D.A. requires for the B.L.A. and now we also have successfully completed manufacturing of all of the required drug product.
Process validation lots.
The remaining CMC information and clinical sections are underway and constitute the final sections of RBL that.
Given our breakthrough therapy designation, we expect that F.D.A. will grant RBL, a priority review, which could further shorten the time to approval.
We are also pulling together the information for our European marketing authorization application, which will be submitted after we expect FDA approval.
And our supplement continues to increase its visibility and standing within the stem cell transplant community.
In February at the transplant and cellular therapy or TCT annual meetings in Orlando.
Omeros sponsored a continuing medical education session.
On thrombotic microangiopathy chaired by Dr., Sameer Collette medical director of Hematology and stem cell transplant clinical operations at city of hope.
The Speaker panel included Dr., Sergio Girl Deputy head of the Division of hematologic malignancies at Memorial Sloan Kettering Cancer Center.
Dr. Sinatra, Dell Professor of Pediatrics, and the division of bone marrow transplantation and immune deficiency at Cincinnati Childrens Hospital, and Dr., Chris standoff assistant Professor of clinical Pediatrics, and a bone marrow transplant specialist also at Cincinnati childrens.
Symposium was well attended and focused on transplant, Tim and potential therapies.
In mid June data from than our stop Lamar pivotal trial and transplant Tia may will be presented at the annual and now also virtual meeting of the European Hematology Association or yeah check.
Selected by conference leadership for a podium presentation. The data will be discussed by professor Alessandro run Balding of the University of Milan, and director of the Department of Hematology oncology.
Papa Giovanni 23 hospital.
Our interactions with opinion leaders continue to strengthen through advisory boards on our support of educational activities around transplant Tms.
Omarosa is also providing support for working group of the nation's leading transplanters who are developing for the first time guidelines for the diagnosis of transplant TDMA.
Commercial preparations continue as our rolling BLA submission nears completion.
We have developed in our supplemental value story and are conducting market research with transplant physicians administrators and payers.
We're finalizing our distribution and pricing strategies as well as our profiling activities to ensure a well designed.
And executed launch for in our supplemental been transplant Tms.
As part of those efforts, we recently hired our national sales head from jazz Pharmaceuticals, our National Director of Medical Science liaison from Amgen and our advocacy lead who joined US as a practicing health law attorney and was previously at Amgen and Fred Hutchinson.
Cancer Research Center.
As we did for Omidria. These new leaders are helping us build a top tier seasoned team to launch and our supplement.
In addition to transplant TDMA were also assessing expansion of in our supplemental into other endothelial injury syndrome, such as diffuse alveolar hemorrhage graft versus host disease and others.
Our efforts here are supported by our opinion leader advisors and the recent focus on endothelial injury associated with Cobot 19 has underscored the importance of mask too and the lectin pathway and the pathophysiology of diseases caused by into theater.
Ill injury.
Well, we're focused on obtaining approval for in our supplement and transplant may. We also have two phase three programs for in our supplemental.
One in Nigeria in a property and the other an atypical hemolytic uremic syndrome or a to us.
Consistent with FDA guidelines and with recommendations of the independent data safety monitoring committee for Omeros regarding ongoing clinical trials during that Cobot 19 pandemic study sites are conducting trials in a manner consistent with local guidelines and or regulations.
To maintain safety of study patients and investigators.
As a result at some sites new patient enrollment has slowed well previously enrolled patients are continuing the trials.
For our them as high Gan Phase three trial, we had already implemented procedures for home infusion of nurse off limits and our expanding this capability across additional sites.
Other measures to protect the safety of our clinical trial participants such as remote monitoring visits and access to local laboratory facilities are also in place at a good number of these sites.
The primary endpoint in the Artemus I again trial is change in proteinuria at 36 weeks.
Based on discussions with FDA, we have the ability to receive full regulatory approval for in our supplemental and gain a profit the based on assessing proteinuria rather than also needing to wait one to two years longer to assess the change in gillam area LER filtration rate.
We also are able and the protocol is written.
To assess the proteinuria endpoint in each of two different populations.
In the overall patient population with more than one gram of proteinuria per day and in the subset of patients with at least two grams of proteinuria per day.
Either population.
Can yield accelerated or full approval.
To the best of our knowledge and our supplement is singularly unique among the drugs in development for Jana prophecy and its ability to receive full approval on proteinuria alone.
We continue to target data read out on the proteinuria primary endpoint from the Artemus High again trial next year.
A manuscript authored by Professor John Bair, and others at the University of Lester describing the beneficial effects of in our supplement GA vasculitis associated in the Freitas a rapidly progressive Gillam Merial enterprise was accepted for peer reviewed publication will soon be published.
A second manuscript is also undergone review and is expected to be published soon.
Authored by Omeros, Iga Nephropathy academic leadership Committee members.
Comprised of international thought leaders the manuscript presents our phase two clinical data.
Turning now to our commercial product Omidria net sales in the first quarter were $23.5 million.
This is below our historical run rate and is due to the nationwide hiatus and elective surgery, such as cataract surgery as part of the Cobot 19 related public health emergency.
The net effect of the cobot 19 elective surgery shutdown on first quarter Omidria revenues is that of the five weeks.
Potential sales in March we were able to recognize sales from only one of those five weeks.
For context March typically accounts for about 45% of total first quarter revenues.
As a result, our net loss for the first quarter of 2019 was $29 million or 53 cents per share.
This includes noncash expenses of $6.4 million or 12 cents per share.
As of March 31, 2020, we had $54 million of cash and investments available for general operations.
We also have an accounts receivable base line of credit with Silicon Valley Bank.
The line of credit enables us to borrow up to the lesser of 85% of our outstanding eligible accounts receivable balance or $50 million.
We have not borrowed under this line of credit.
Historically Q1 is the slowest quarter of the year for cataract surgery Omidria sales traditionally ramp up significantly in March and as I. Just noted typically account for about 45% of total first quarter revenues.
Given the first quarter effects of cobot 19 on cataract surgery.
We're pleased with the Q1 revenue performance by Omidria.
Further good news is that coated 19 related restrictions on elective surgery have begun lifting.
So far hospitals and ambulatory surgery centers in 36 states have already resumed ordering omidria from the wholesalers.
Most centers are beginning with unlimited number of procedures and we'll continue expanding to meet the substantial backlog of patients waiting for surgery.
In the states, where cobot 19 related restrictions have not yet been lifted elective surgery is expected to be among the first activities reinstated.
We've been working closely with our accounts to prepare for the impending increase in cataract surgery and the anticipated increase in demand for Omidria.
Our conversations with top opinion leaders and surgeons indicate that as soon as possible. They will lengthen their surgical days to operate into evenings and that they will also expand the number of weekly operating days to include weekends to manage the bad.
Backlog in the pent up demand of patients awaiting surgery, which we expect could surpass historical levels.
Prior to the Cobot 19 related shutdown of cataract surgery physicians and facility adoption of Omidria.
Remained on its upward trajectory.
In Q1, there were 62 first time omidria buyers evenly split between hospitals and data sees.
This represents a 17% quarter over quarter increase and the number of new Omidria accounts.
We also are expanding our customer base to include large private equity groups as consolidation of surgical practices and facilities continues in Q1 alone. We signed two large private equity groups to new contracts, representing more than 55000 cat or.
Procedures annually.
And we're currently working to secure Omidria use across several other large see groups as well.
The growth in our customer base has also been helped by our recently received six picks J code for Omidria, which is now fully implemented.
Our J code has improved reimbursement standardizing payment across Medicare Medicare advantage, Medicaid and commercial insurance plans.
Under pass through Medicare part B is uniformly reimbursed at Atlas, 6% by CMS and in addition, we continue expanding reimbursement across Medicare advantage and commercial payers.
The increasing uptake of Omidria by surgeons and facilities has been further accelerated by the growing volume of peer reviewed publications documenting the expanding benefits of omidria.
Compelling clinical data continue to drive physician adoption as the value story for Omidria strengthens and solidifies.
Omidria is the only F. da approved product that prevents miosis and reduces post operative pain. It's prevention of inter operative floppy Iris syndrome reduction in complication rates and avoidance of the need for steroids add to the many reasons that surgeons are increasingly using.
On midea for their patients.
Two additional studies demonstrating the benefits and safety profile of Omidria were recently published in the peer reviewed journal of cataract and refractive surgery.
The first article detailed the results of a retrospective study that found that patients who received omidria had significantly lower incidences of sight threatening system macular edema breakthrough I writers and pain.
Paired to a controlled group receiving conventional Perry operative steroids.
The second presented the data by with Jeff da concluded that Omidria is safety use in children.
Expanding the FDA approved label to all cataract surgery patients.
This randomized double mass study and 72 pediatric patients showed that Omidria was not only safe and children ages zero the three years undergoing cataract surgery.
But also resulted in statistically significant lower pain scores.
As we previously discussed another recent publication in the journal of Cataract and refractive surgery demonstrated that omidria reduces the need for fentanyl.
A highly potent and addictive opioid.
During cataract surgery, while simultaneously delivering improved outcomes.
Lower validated pain scores and fewer complications.
To assess the effect of Omidria on post operative opioid use.
An analysis of claims data over a three year period was performed by IBCM Watson health.
Claims data were evaluated from 219000 patients 65 years of age or older who underwent cataract surgery.
To avoid potential confounding by recent opioid use or dependence all patients were required to have no opioid use during the six months prior to surgery.
Filled opioid prescriptions in the Omidria treated group were compared to those in the non Omidria treated group the findings were remarkable.
Patients who received omidria during surgery received fewer opioid pills during the two days and seven days post surgery than patients who did not receive omidria.
The median reduction seen was 56% specifically 20 pills versus 45 pills at two days with a P value of 0.0 on five and 33% 40 pills versus 60 pills at seven days with a P value of 0.0 to nine.
Sensitivity analyses yielded similar outcomes underscoring the strength of the results.
These data provide further evidence that omidria not only reduces the need for intra operative fentanyl, but also decreases the use of post operative opioids.
The value proposition and clinical need for Omidria are two of the reasons why we remain optimistic about continued separate payment for Omidria beyond September thirtyth of this year.
Which applies specifically and only to Medicare part B beneficiaries.
Published data and physician experience with the product support our ongoing legislative and administrative effort.
The Lockdowns in response to Cobot 19 have created a number of hardships for families across the nation, not the least of which has been increasing opioid addiction.
The non opioid prevent addiction in the nation or the no pain Act is a bill introduced in both chambers of Congress with increasingly strong bipartisan support.
If enacted it would provide separate payment for opioid sparing treatments such as Omidria for at least five years.
And would fix the disincentives that keep practitioners from prescribing non opioid treatment alternatives and surgical settings.
Just last Friday of bipartisan letters signed by 16 members of the house of Representatives, many of whom serve on energy and Commerce Committee of jurisdiction over CMS was submitted to the house Democratic and Republican leadership requesting the inclusion of the no pain act in the upcoming.
Cares 2.0 legislation.
Other administrative and legislative efforts are also progressing.
While we remain optimistic that separate payment will continue we're also working through scenarios to ensure that omidria will be a viable product that improves patient outcomes, regardless of insurance payer.
And that returns value to our shareholders, even without separate payment from CMS for Medicare part B beneficiaries.
Let's now turn to the rest of our pipeline starting with our complement related development programs beyond our supplements.
Almost 906 is our fully human antibody targeting mask to the enzyme believed to be the key activator and premier drug target in the alternative pathway.
Together with in our supplemental RMS nine of six is a major part of our complement franchise.
Among the broad range of alternative pathway disorders that our potential indications for all of 96.
Our initial focus is on PAREXEL nocturnal hemoglobin urea or Pn age.
We've completed the human dose enable toxicology studies, which show no adverse effects, even at the highest doses tested.
The manufacturing scale up process to support the remainder of the development program is well underway.
We remain on track to submit a clinical trial application this quarter and expect to dose the first subjects in our phase one trial in the first part of next quarter.
Rounding out our complement franchise, our our longer acting second generation MASP, two antibody as well as orally available small molecule inhibitors of MASP, two and MASP three.
These are all part of our strategy for lifecycle management of our complement franchise.
We are targeting the initiation of clinical trials in 2022 for the longer acting second generation MASP two antibody RMS 10 29.
Almost five to seven our phosphodiesterase or PD seven inhibitor program is also advancing.
We're planning the phase two program for a mess five to seven.
Which is currently focused on nicotine addiction.
In addition, we continue to make progress on our other development programs were increasingly excited about our GPCR program and GPR 174 in particular.
In which we're working to bring to the clinic as soon as possible.
We have shown that GPR 174 controls a new cancer immunity access that the receptor is linked to the tumor microenvironment and that GPR 174 can suppressed the bodies anti tumor response.
Tumors ability to protect itself from the body's tumor killing mechanisms is directly linked to the tumor microenvironment and has proven to be a major hurdle for cancer therapies to date, including checkpoint inhibitors.
Despite this limitation sales of checkpoint inhibitors exceeded $20 billion last year.
We are developing inhibitors of GPR 174, which represent a wholly new immunotherapy approach to overcoming the challenges inherent in the tumor micro environment.
And ex vivo and Invivo animal studies are GPR 174 inhibitors show substantial promise in doing just that.
They also acts synergistically with inhibitors of the adenosine pathway another important immuno oncology target.
We expect that our GPR 174 inhibitors could be administered a single agent.
Or in combination with adenosine pathway and or checkpoint inhibitors to enhance the efficacy.
Of those other agents.
With that I'll turn the call over to Mike for an overview of our first quarter financial results, Mike Yes. Thanks, Greg.
As Greg noted a media and total revenues for the first quarter were $23.5 million and are not loss was $29 million or 53 cents per share.
This includes noncash expenses of $6.4 million or 12 cents per share.
As of March 30, Onest 2020, we had $54 million of cash cash equivalents in short term investments available for general operations.
We also have an accounts receivable base line of credit, which allows us to borrow up to the lesser of 85% of our available accounts receivable and $50 million.
Here are some additional details regarding our first quarter results compared to the fourth quarter of last year.
Our revenue for the first quarter was significantly affected by the called the 19 pandemic.
As Greg mentioned in early March Omidria sales began to decrease due to the anticipate anticipated shutdown of elective procedures, including cataract surgery.
The impact of this shutdown on Q1 revenues this significant.
Given that approximately 45% of first quarter revenues occur in March.
Given the impact on cataract surgery from the club at 19 related elective surgeries shutdown.
Effectively recorded revenues from only one week out of the five weeks in March.
Cost and expenses for the first quarter were $47.2 million, a decrease of 9.9 million from the fourth quarter of last year.
As you May recall, we completed manufacturing of five drug substance lots at Lonza during the fourth quarter at a cost of 12.6 million.
During the first quarter, we successfully completed the drug product process validation lots at better our fill finished partner.
That like our successful drug substance slots will satisfy the FDA requirement for our be law.
This drug product will be used in our ongoing clinical trials of the softening lab and be available for commercial sell falling anticipate approval in transplant Tms.
The financial result of these two activities is a net savings of approximately $12 million and our two one research and development costs compared to the fourth quarter of last year.
As a reminder, until we receive approval furnace top allomap in transplant TDMA.
All CMC related cost that would normally be included in inventory are being expensed as incurred.
Going forward, we did not expect to incur similar costs until we build additional commercial inventory for Necitumumab in late 2020.
Interest expense for the current quarter was 5.1 million $5.9 million and inline with our expectations.
Looking ahead to the second quarter of 2020, as we mentioned earlier, our Midwest sales in April were light due to the shutdown related to call the 19.
Beginning the first week in May ask season hospitals in over 70% of the states began to perform cataract surgery again.
But we cannot currently estimate how quickly surgical volume will return to historical levels and the overall impact on a midyear revenues.
Having said that we understand that there's a significant backlog cataract surgery cases that need to be performed.
And we expect that demand to drive historically high numbers of cataract surgery and likely omidria use as this backlog is worked through.
Our research and development expenses for the second quarter should be slightly higher than the first quarter of 2020.
As DNA costs are expected to increase each quarter across the remainder of the year as we prepare for the launch and our supplement.
With that I'd like to turn the call back over to Greg Greg. Thanks, Mike, Let's open the call to questions.
As a reminder to ask a question you will need to our one of your telephone keypad, Dan that Star then the number one of your telephone keypad. David. Your question you May press. The pound. Please turn now will be composite can any aspect.
Your first question comes from the line.
Well that's from WBB. Your line is still open.
Hey, good afternoon, and thank you for taking the questions I only have two and I'll hop back in the Q.
On the imagery.
Obviously information that you're giving US you really can't provide estimates and I understand that and Youve just given us some color on backlog, but can you given the fact that youre. Your systems are going out there now in reaching to the clinicians to reaching out to the centers can you give us any idea of what steps. They are taking in terms of resumption.
Of.
Lens replacement and how that fits and as much colors, you can give on that would be greatly appreciated and then.
I've got one follow up question on our supplement please thank you.
Sure. Thanks, Steve.
With respect to Omidria and cataract surgery and how.
Surgeons are addressing this ramp up again of cataract surgery as I said at the groups are are starting in a controlled way.
As with all sort of re entry here across not only cataract surgery, but I think all parts of our lives.
The ramp up is is controlled at first their expectation.
Is that they will ramp that up and extend as I said.
The hours of the surgical day and extend the number of operating days to move into the weekends as well and the reason for that obviously is that these cataract in these patients have not resolved on their own.
These cataracts are still there and the absence of the ability to perform cataract surgery for the last six weeks has really just resulted in a backlog of these cases that will need to be performed I Wouldnt expect I think we would all expect that.
Does that backlog gets worked through.
So similarly would the utilization of Omidria. So as I've said, we are expecting.
They ramp up.
And potentially numbers that surpass.
Historical levels, both clearly and cataract surgery and then.
As a result of that.
In the utilization of Omidria.
And just just following up on on Omidria, obviously because.
It's obviously, where your revenue sources for right now.
With that with these procedures.
I'd like to know what youre getting feedback on because it's not like the procedures were done by someone else are not using omidria, what kind of feedback you're getting from the clinicians because obviously this is something that they need to return to justice desperately as has the patient. So what can you tell us there.
Yes, as I said I think that.
I think that the surgeons are expecting that theyre going to have to work and our frankly looking forward to working longer hours and they are more days and they are to increase their weekly surgical volumes.
This has hurt.
Cobot 19 has has hurt small businesses and when you think about.
Surgical practices largely those are small businesses.
And.
That that backlog needs to be addressed.
And those surgical cases need to be done.
And.
And correspondingly surgical revenues.
Need to be accessed.
Okay.
Again, thank you for that color because obviously this is these are just these are dislocated time, so as much as we can draw into it for modeling purposes. It is great and greatly appreciated.
No supplement view, you basically talked about that progress you've made this quarter in terms of regulatory what.
Given the disruptions that everyone has seen in the fact that this is one of those situations where in your particular case, you've been methodically preparing your submission what can you tell us about.
How the Cove it has affected your submission.
And specifically, how you've been able to do anything as far as workarounds or anything else as far as that kind of color and one follow up after that thank you.
Well remember that we were fortunate in that we had completed the clinical trial prior to the outbreak of Coven 19. So cobot 19 really had no effect on our clinical trial. Similarly.
We had announced last quarter that we had manufactured drug process.
Our drug substance lots and process validation lots ahead of schedule.
And by doing that it turns out we also.
Precluded the effect of cobot 19 on that manufacturing and similarly on on our drug product so all of that.
Looks great. We continue to push forward and we're quite pleased with the progress we're making as I said.
A lot of the company has been working remotely but working.
Very efficiently very productively remotely and we remain.
Focused.
On getting.
The BLM completed.
Next quarter.
Okay, and last and I'll hop back into queue. Thank you on the pump on just just to go back on the manufacturing.
You now or in a position for your first indication to be able to whenever you just whenever you do get facility in approval and launch you're able to address that requirement.
Almost instantaneously given the fact that you have done manufacturing and you are now in the feel of the fill finish process. So that you can deal with and go out there in administered to patients patients whenever you do get approval and thank you and I'll hop back in the Q.
Yes, the manufacturing that we did the process validation lots can be used commercially and so we have our commercial supply ready for launch.
That is that is ready to go so yes.
In short.
Great. Thanks again.
Thank you.
Your next question comes from delight, Brandon Folkes from Cantor Fitzgerald. Your line is now open.
Hi, Thanks, taking my question again, congratulations on the progress in the quarter.
Greg can you maybe talk about where that you are seeing the mapping studied pool Korean novartis anyway, just given the paper coming out of China, and then Matt.
Q pathway and then secondly, secondly can you just elaborate a bit more on you'll live is you have for financing right around as you move forward on this diplomat.
Any update in Canada, where do you think the note pain Act will come through just given way.
Yes legislative priorities have been shifted recently thank you.
Okay. Thanks High brand and I think I want to make sure can you repeat the first question for me because it was a little was a little muffled. So I just want to make sure I heard it.
Okay, and can you confirm whether or not going to enable any of your product all being steady for the potential use in karina virus.
Okay understood understood.
Look I'll answer it this way.
We are aware of the public information linking cobot 19 in the lectin pathway, specifically MASP two.
But I think those data are publicly available those are clear to us in fact.
We had identified the connection between KOVA 19, the lectin pathway and specifically MASP two prior to it being made publicly available.
So I hope that answers. Your your first question. Your second question I think was directed to Omidria and what we think the likelihood of the no pain Act.
Being.
Passed in two law.
Is that correct.
That is great great.
Yes, yes look.
It's interesting I think that.
A lot of.
Individuals might assume that all of the oxygen in Washington, DC is sort of sucked out of the room.
By Cobot 19, and that that's in large part a true statement.
What what is important there to understand however is that the number of vehicles.
Moving through Congress.
Has actually increased substantially with Covance 19.
And for a provision or bill like the no pain Act.
One of the most important components in getting that successfully through as I understand the group, that's leading that which is.
Voices for non opioid choices.
Is that you have vehicles men you have to have a vehicle.
Two which to attach the provision and given the increasing number of vehicles I think frankly, the likelihood of seeing that bill passed increases with cobot 19, I think that there is as I as I said earlier there is some.
Inefficient support and importantly, bipartisan support bipartisan support in both Chambers of Congress in the house and the Senate and on the committees of jurisdiction and in the house those committees of jurisdiction would be energy and commerce and ways and means.
As in the Senate, It's the Finance Committee.
So when you look at the support of that you are seeing for this bill out of both chambers.
You do see.
Key members.
And leadership of of those specific.
Committees.
And so I think all of that bodes well again, no one can guarantee what's going to happen but.
Clearly when you look at the effects of coded 19 on psychological issues in general and addiction specifically.
You see kind of horrendous results.
Or impact on on those psychological disorders, and again on addiction, and I think thats recognized so I think we're well positioned I think the study that was just done that we did with IBM Watson on what 219000 patients I think make said kind of abundant.
Lee clear that not only does omidria reduce the need for intra operative opioids, but clearly with statistical significance and clinically meaningfully reduces the need for post operative opioids.
So I think you know, we're well positioned I think the bill.
Certainly as deserving and I believe.
The groups that are really pushing that I have have positioned us well and we're optimistic.
Great. Thank you very much.
Thanks Brent.
I'm showing no further questions at this time I would now like to turn the conference back to Dr. Demopolis for closing remarks.
Thank you operator, and thank you again, everyone for taking the time to listen.
We're pleased with our progress across our programs and I personally.
I'm, particularly proud of what our team has accomplished given the unprecedented global challenges posed by cobot 19th.
Again, we wish you and your family's good health and all of US settle Merrells. Appreciate your continued support have a good afternoon.
This concludes today's conference call. Thank you all for joining you may now disconnect.
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