Q3 2019 Earnings Call
Ladies and gentlemen, today's conference is scheduled to begin shortly please contained a standby. Thank you for your patience.
After the company's remarks, we will conduct a question and answer session. Please be advised to this cosby.
The company's request and a replay will be available on the company's website.
One week from today.
I'll now turn the call over to Jennifer William Investor Relations from Merrill. Please go ahead ma'am.
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 on 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 in the company's quarterly report on Form 10-Q , which was filed today with the FCC and the risk factor section of the company's 2018 annual report on Form 10-K for a discussion of these risks and uncertainties.
Dr., Greg Demopolis, Chairman and CEO of Ameris will take you through a corporate update and then my Jacobson, our Chief Accounting Officer, who will provide an overview of our third quarter financial result.
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. We appreciate you joining us for todays update.
Omarosa accomplished a great deal last quarter, we submitted the first sections of our rolling B.L.A. foreigners problem out for the treatment of stem cell transplant associated T. M ATV and we're accelerating toward the anticipated completion of our B.L.A. submission in the first half of next year.
We announced positive results from the phase one trial in our or about five to seven program focused on addictions, and compulsion and continued to advance our clinical and preclinical pipeline.
In addition to all of that Omidria produced another quarter of record revenues.
Today, I'll start with Omidria and our quarterly financials.
So third quarter delivered record net sales of Omidria $29.9 million, an increase from 12% over the first quarter.
The growth in sales came from increased demand driven by a substantial increase in both the number of ordering accounts and the penetration within those accounts across all channels. They assays hospitals that'd be a and other government customers.
The company's net loss for the quarter was 16, and a half million dollars or 33 cents per share which include non cash charges of $6.3 million or 13 cents for sure.
As of September 32019, we had $27.3 million available for general operations, representing a cash burn of four and a half million dollars for the quarter.
We also have a 50 million dollar revolving line of credit facility with Silicon Valley Bank.
This line of credit enabled us to borrow up to 85% of our outstanding accounts receivable balance.
Subject to applicable reserves.
We have not yet borrowed under this line of credit.
Q4 is historically strong for Omidria sales and we expect Omidria revenues will set another record in the fourth quarter.
Consistent with previous sales growth, increasing physician demand and expanding payer coverage are expected to be a key drivers along with the implementation of the J code within various payer systems.
In Q3, our sales reflect continued execution of our strategy to penetrate a broadening base of accounts by driving demand from the top down specifically expanding our focus on private equity groups group purchasing organizations and academic hospitals.
We see significant pull through from the community of cataract Surgeons, who continue to generate strong data further reinforcing and expanding the clinical value of omidria cataract patients surgeons and administrators.
Publications documenting the substantial clinical benefits of Omidria continue to grow in number.
In an earlier quarterly call, we discuss the prospective randomized controlled clinical trial, showing that omidria prevents one of the major problems and cataract surgery.
Inter operative floppy Iris syndrome or Ifis.
We also discussed two independent studies, comparing omidria, two up enough rent and assessing the need for post operative steroids as well as the incidence of system macular edema or see a me a sight threatening complication of cataract surgery.
Across the total of approximately 2800 patients steroids were shown to be unnecessary.
When Omidria was used and the incidence of C.M. me was reduced three to 12 fold.
One of these two studies authored by Dr., Keith Walter of Wake Forest University was accepted for publication last month, and the journal cataract and refractive surgery.
Results of the other study conducted by Dr. deniers VESCO are expected to be published after Dr. Walter study and expand the benefit beyond CMB to include breakthrough I writers and pain.
Just last week. Another important study was published in the peer reviewed journal clinical ophthalmology, demonstrating the profound effect of omidria on reducing opioid use.
And this prospective well controlled clinical trial omidria in cataract surgery reduced use of the dangerous opioid fat know by nearly 80%.
Well also cutting visual analog scale or be I guess pain scores in half.
The author and the studies investigator Dr., Eric Donenfeld recent past President of the American Society of cataract and refractive surgery.
The expanding and compelling set a peer reviewed publications documenting the scope of omidria benefits that improve patient outcomes and safety are helping to drive sales across commercial med advantage CMS for Medicare part B and other government payers.
Regarding omidria as use with Medicare part B beneficiaries, we continue to enjoy separate payment from CMS until our drug scheduled pass through expiration on September 32020.
And we are working to ensure continued payment for this sector beyond that expiration date.
One Avenue is through continued efforts to qualify under CMS is non opioid exclusion.
CMS established its non opioid exclusion in response to a congressional mandate specifically the support act through.
Through the support our Congress means to ensure that there are no financial incentives within the outpatient prospective payment system or old P. P. S.
To use opioids, rather than non opioid pain medications.
The non opioid exclusion enable CMS to pay separately for a drug administered during surgery. When there is evidence showing using CMS has claims data.
That absence of separate payment limits utilization of the drug.
And for which peer reviewed published data demonstrate the drugs benefit of reducing opioid use.
As many of you are aware on November 1st CMS issued the 2020 LTPS final rule.
In that rule CMS, Despite congresses directive.
Did not grant the exclusion to a single additional product including Omidria.
Yet omidria and likely other products fits squarely within the congressional mandate of the bipartisan support Act.
The agency was provided with CMS his own utilization data for Omidria and clinically meaningful and statistically significant results from prospective well controlled peer reviewed published clinical trials.
CMS was also provided with the not yet published Donenfeld data and received an expert review of these data conducted by David Clark Professor of Anesthesiology, Perry operative and pain Medicine at Stanford University, and an international leader in pain management and opioid use disorder.
In his review.
Dr. Clark underscores the importance of Omidria and reducing fentanyl use in the at risk population of cataract surgery patients.
With these collective data.
Omidria clearly meets CMS his own criteria for its non opioid exclusion and warrants separate payment.
Lack of access to F.D.A. approved medications presents concerns beyond incentives to utilize opioid when access to Omidria is limited cataract surgeons often turned to non FDA approved products from compounding pharmacies.
The results can be tragic as we saw in Dallas, where 68 patients were blinded by a compounded product used during cataract surgery.
This event and other examples of the dangers of products from compounding pharmacies recently was brought to mainstream media.
When television hosts John Oliver at a 20 minutes segment about compounding pharmacies honest show last week Tonight.
As I said earlier, we see continued growth in utilization across all payer groups CMS commercial med advantage and the V.A.
On October Onest Omidria received a permanent J code, which enables us to expand to separate payment across commercial med advantage and Medicaid insurers as well as in the office setting.
Many of these previously would not reimbursed for Omidria under the drugs now retired C code.
With respect to CMS or Medicare part B, we will continue to advance our legislative and administrative efforts to secure separate payment for Omidria beyond September 32020.
We've overcome the same challenge before and we remain as committed as ever to ensuring that Medicare part B beneficiaries can continue to access the important and well published clinical benefits of Omidria.
As part of our broad based legislative administrative and clinical efforts additional clinical studies are underway.
We believe these collective efforts will be successful.
In fact bipartisan legislation is expected to be introduced in the house of Representatives. This week.
This bipartisan Bill was born out of a number of groups growing frustration with CMS is unwillingness to provide appropriate reimbursement and access to non opioid alternatives.
The build darex CMS to provide separate Medicare reimbursement in the hospital outpatient setting and in a asses for non opioid treatment like omidria.
That have demonstrated the ability to replace or reduce use of opioids in a clinical trial or through clinical data published in peer reviewed journal.
Separate payment would run for five years.
The similar companion Senate Bill is planned for introduction within the coming weeks.
Bipartisan members of Congress are paying attention to this issue.
And we expect that Omidria will continue to be appropriately reimbursed by CMS beyond September 32020.
Let's turn now from our commercial product to an update on our development pipeline.
Well start with in our supplemental bar antibody targeting MASP, two which is moving rapidly toward regulatory approvals.
In September of FDA agreed with our proposed schedule for the Rolling review of our B.L.A. front, our soft flameout for the treatment of stem cell transplant associated Tim <unk>.
Rolling review can accelerate the time to approval because it allows for F.D.A. to review the sections as they receive them.
Rather than waiting to begin its review until the entire B.L.A. has been submitted last.
Last month in line with the agreed schedule, we submitted to F.D.A., the nonclinical sections of the B.L.A., including toxicology pharmacology and pharmacokinetics.
The clinical sections of the B.L.A. are scheduled for submission next to be followed by the CMC sections.
Work to complete the remaining sections of the BLM.
Is on track for completion in the first half of next year.
We anticipate that FDA will grant to be law for nurse Hoplamazian a priority review.
Which would further shorten FDIC is overall review time.
In Europe , we recently received a positive opinion from the pediatric committee of the European Medicines Agency Oreo Matt.
A pediatric investigation plan or Pip outlining a development program for the investigational product and the pediatric population.
As a prerequisite to we amazed acceptance of a marketing authorization application our M&A.
Yeah Mays acceptance of the Pip now paves the way for submission of our EMEA furnace Hoplamazian stem cell Tms.
Yeah May will also allow us to defer completion of the pediatric plan until after approval of the EMEA.
Successful completion of the Pip makes nurse awful amount of eligible for up to two additional years of marketing exclusivity.
Although we have made does not have a rolling submission procedure.
We intend to harmonize the contents of both the M&A and be a law.
We plan to submit for European marketing approval soon after our via lay in the U.S. has been filed.
Our preparations for the anticipated commercial launch of nonstop limits in the U.S. in Europe are also progressing well as stated previously we have been working with thought leaders from the top transplant centers internationally to increase awareness of stem cell, Tim may and to establish common guidelines.
For the diagnosis and treatment of this often fatal complication of stem cell transplantation.
Recently, Omeros convened a group of top U.S. transplanters to discuss the current stem cell TDMA diagnostic paradigm and to begin establishing guidelines for treatment.
We anticipate that the new guidelines will help improve patient outcomes by enabling centers to identify and appropriately treat stem cell TDMA patients earlier.
We will have a significant presence at the upcoming American Society of Hematology meeting next month in Orlando.
There we will continue our educational campaign directed to increasing awareness of T. I may with a focus on its cause.
Endothelial damage.
Which is a known and strong activator of MASP, two and the lectin pathway.
Based on discussions with our advisors and other opinion leaders there is growing recognition of the substantial unmet need in stem cell Tms.
Last quarter I updated you on our payer interactions and value story creation for in our supplement.
In Q3, we continued to advance this effort working with payers physicians and transplant centers to evaluate the cost of stem cell Tms.
And the potential value that in our supplement can bring to both patients and the centers that treat them.
Based on these interactions and the data derived from them, we remain confident that in our supplemental will offer a strong value proposition.
As for the other commercial preparations are targeting work indicates that about 90% of the allogeneic tramp plants in the U.S. occur within the top 120, U.S. stem cell transplant centers.
With a top 25 of these centers, making up about 50% of U.S. allogeneic transplant.
This concentration within a relatively small number of centers allows us to focus our resources, bringing on the right expertise and market approach for non stop them out in this indication.
And we expect to begin building our focus to US sales force early next year.
Our commercial preparations in Europe indicate that there is a similar dynamic across the top Bu countries. Our team is doing the right things to prepare for a successful launch of nurse Hoplamazian for patients physicians centers Payors and our shareholders.
We're also advancing our phase three program for in our supplemental Jana prophecy overall enrollment in our phase three trial continues to accelerate that increasing number of sites across North America, Europe and other international catchments.
In addition to the general population of patients with at least one Gram of Proteinuria Daily. This trial is also enrolling a subset of patients with 24 hour proteinuria levels greater than two grams.
Either of these two populations can result in accelerated or full approval based on proteinuria production alone.
To the best of our knowledge in our supplemental is the only drug and development fried Jain of property that can obtain full approval on proteinuria alone.
The singular distinction would avoid the long timeframe required to collect DGF our data truncating the full approval process by as much as three years.
A manuscript prepared by Omeros Ism academic leadership Committee, which is comprised of world leaders and I Jana prophecy in renal clinical research detailing the clinical data from the phase two Iga Nephropathy program is expected to be published in a peer reviewed journal.
A report detailing the response to in our supplemental treatment by a patient with AIG vasculitis associate in the Freitas and rapidly progressive Guillain Barre alone or Freitas.
Has been submitted for publication.
In September we began enrolling patients in a separate study evaluating the pharmacokinetics and pharmacodynamics of subcutaneously administered stirred in our supplemental Eni GA nephropathy.
The study is also evaluating potential biomarkers in patients with this disease.
Which could aid in earlier diagnosis as well as an identification of patients most responsive to MASP two inhibition.
Chronic subcutaneous dosing of in our supplement as being used in our phase three trial for atypical hemolytic uremic syndrome or a choose this trial includes multiple sites across the us in Europe and is actively enrolling.
Now, let's turn to another component of our complement franchise RMS nine six our antibody targeting MASP three.
We along with others in industry and in the complement research community believed that MASP three is the key activator in premier drug target in the alternative pathway.
Potential indications for almost nine six include a broad range of alternative pathway disorders. Our initial focus is on paroxysmal nocturnal hemoglobin urea or pn age.
We expect RMS nine six to have significant advantages over other alternative pathway inhibitors currently on the market or in the development for Pn age.
The collective advantages of mastery inhibition include the ability to inhibit extra vascular homologous, while providing more potent inhibition of in Trivascular homologous.
A favorable safety profile and a more convenient route of administration with much lower frequency of self administered dosing.
On us 96, as expected to be dosed subcutaneously twice monthly or less frequently.
Toxicology studies and GMP manufacturing are underway and all the mess nine of six of slated to enter the clinic in the first half of next year.
As we continue to progress in our supplement LMS nine six we also are advancing our strategy for lifecycle management of our complement franchise as a whole.
We are developing both a longer acting second generation antibody as well as orally available small molecule inhibitors against mask to both of which we are targeting for clinical entry in 2021.
We also continue developing small molecule inhibitors of MASP three.
Moving to our phosphodiesterase seven or PD seven program to treat addictions and compulsion in September we reported positive results from our phase one trial in the double blind randomized study our drug was well tolerated and demonstrated good safety. It's PK profile was consistent.
With once daily dosing.
Our focus is nicotine addiction, and we are planning our phase two development program.
Tobacco use as the single largest preventable cause of death and disease in the U.S. with the national death toll of nearly half a million people.
The popularity of east cigarettes, especially among young people represents a newly emerging epidemic of nicotine dependent further underscoring the need for new treatments for nicotine addiction.
Let's close our pipeline discussion with an update on our GPCR program.
Last week, we announced that a team from a merrells along with academic collaborators from the University of Toronto were awarded the pre Galyon.
Canada researcher award for 2019 in recognition of the discoveries underlying omeros proprietary GPCR platform.
Validating the strength and importance of our GPCR program, the pre Galyon as North America's most prestigious award in the field, a pharmaceutical research and innovation.
As a result of our GPCR platform technology, we control 54, GPCR drug targets and corresponding compounds.
On our last quarterly call in August I indicated that we would soon share our data demonstrating the relevance of GPR 174 to cancer immunotherapy.
In September we announced a series of discoveries showing that GPR 174 controls a new access and cancer immunity.
While GPR 174 inhibition has significant potential as a solo anti cancer agent, we have shown that the combined and ambition.
Both GPR 174 in the adenosine pathway another key metabolic pathway that regulates tumor immunity.
Synergistically enhances cytokine production by T cells.
Dennis in pathway inhibitors of the focus of cancer immunotherapy development efforts by a number of companies.
It now turns out though that combined inhibition of both pathways and adenosine receptor antagonist combined with one of Omeros novel, GPR 174 inhibitors results in maximal enhancement of T cell response.
The importance of this lies in the tumor micro environment, where the tumor is able to suppress the bodys own immune response to kill the tumor.
This tumor immuno suppression.
As a major limitation on the efficacy of anti cancer agents, including checkpoint inhibitors, like keytruda or Opdivo, which work at best and only about 20% of patients today.
The data show that GPR 174 inhibitors could well shift this balance, making checkpoint inhibitors and other anti cancer drugs significantly more effective.
Our work with human cells, as well as new and exciting animal tumor model data will be presented later this month and Boston.
At the conference of the American Association for Cancer Research.
Next month, we are scheduled to present at a similar conference in Geneva.
The response from both a scientific community and industry to our GPR 174 program has been strongly positive and we look forward to bringing GPR 174 inhibitors to the clinic as soon as possible.
With that I'll turn the call over to Mike for an overview of our third quarter financial results.
Thanks, Greg.
As Greg noted a mid Ria and total revenues for the third quarter were $29.9 million and our net loss was $16.5 million or 33 cents per share.
This includes non cash expenses, the $6.3 million or 13 cents per share.
Here are some additional details regarding our third quarter results compared to the prior quarter.
Amid real once again achieved record sales total product revenue of $29.9 million compared to $26.8 million in Q2.
This is an increase of $3.1 million or 12%.
During the third quarter, our overall gross to net deductions were 28% remaining consistent with the second quarter.
Constant expenses for the third quarter were $4.9 million higher than in Q2 at $41 million.
Although approximately $4 million of that total represented noncash charges.
The increase was primarily due to scaling drug substance manufacturing at Lonza.
These process validation batches will form key components of the CMC portion of our B B allay filing for stem cell pmeight.
Third party manufacturing cost related to our own mess 96 program.
Also contributed to the increase.
Interest expense was in line with our expectations at $5.7 million.
And included $2.4 million of non cash interest.
As of September Thirtyth 2019.
We had $27.3 million of cash cash equivalents and short term investments available for general operations.
In addition, we have a three year $50 million revolving line of credit available Silicon Valley Bank.
Under the terms of the agreement.
We can generally borrow up to 85% of our outstanding accounts receivable.
Interest on any outstanding balance crews that the greater a 5.5% or the primary.
As Greg mentioned, we have not made any draws under this line of credit to date.
Now, let's take a look ahead to the fourth quarter of 2019.
With regard to revenue Q4 is historically a strong quarter from Midwest sales, we expect fourth quarter omitted revenues to once again set a record.
In the fourth quarter, our research and development expenses will primarily be related to supplement.
We expect research and development costs will increase in the fourth quarter due to continued manufacturer of drug substance to support our be a BLA filing for stem cell pmeight.
As I mentioned last quarter.
All development and manufacturing cost for insightful mab incurred prior to the U.S. Yoo approvals are expensed as research and development.
Selling general and administrative expenses for the fourth quarter of 2018.
Our expected to increase modestly from the third quarter total of 16.9 million.
Primarily due to incremental supplement sales and marketing activities.
Interest expense for the third and fourth quarter.
Interest expense for the fourth quarter should be in line with the third quarter at approximately 5.8 million.
With that I'll turn the call back over to Greg.
Alright, Thanks, Mike, Let's open the call two questions.
Ladies and gentlemen to ask a question you will need a press star one on your telephone to withdraw your question press the pound Keith.
Please standby will be compiled acuity roster.
And our first question comes from.
Ross you with H.C. Wainwright. Please proceed with your question.
Thanks, very much for taking my questions and congratulations on an excellent quarter.
I wanted to ask about when.
During the course of 2020, it might be possible for CMS to revisit the reimbursement status of Omidria and specifically the open yes inclusion are there specific time points during 2020 CMS formally do that.
Or is it on likely to occur more on an AD hoc basis, and then secondly, I wanted to ask about the status of the non supplement artemus trial. If you could just give us a sense of how many clinical sites are up and running and enrolling patients in that study and if possible.
Where you are with respect to the enrollment target there.
Finally, with respect to potential future applications for nor supplement and indeed other MASP two and MASP three inhibitor compounds, whether you has evaluated the possibility of applying these in the context of an indication called Neuromyelitis Optica spectrum disorder, and then my last.
Thank you.
Yeah. Thanks from.
First your question about CMS.
CMS uses its annual rulemaking.
As its formal vehicle.
To promulgated new rules within within the agency.
So the scheduling for that is is well known and and pretty regular.
This of course does not that include any other discussions potentially with CMS or any sort of legislative action as I mentioned.
The house is putting forth a bill introducing a bill expected to be this week.
The sponsors are co sponsors of that bill or bi partisan.
They are the right.
Group to be introducing such a bill and.
That that can happen at.
Any time.
The question that you had.
On.
And our software map and the enrollment.
We've got.
About 90 sites activated across us Europe and internationally in the Artemus trial, we continue to grow that number.
Enrollment has as I think I mentioned accelerated so it's ramping.
And we're pretty we're pretty pleased.
With the rate of enrollment at this point.
So your third question I believe was around the use of nurse awful amount.
In Optima optimized leidos optic ends is that correct.
That was Neuromyelitis optica, an abnormal ilyce, yes, okay policies that that is that is primarily on alternative pathway disorder as I understand that right.
And so I think we haven't looked at that with MASP two inhibition.
But certainly with our MASP three that is something that that we would look at.
Thank you.
The next question comes from Steve Brozak WBB. Please proceed with your question.
Hey, Greg Thanks for taking the questions Im just going to go into nor supplement you were very very detailed in terms of the rolling via lay submission.
But what do you think in terms of preparation by the clinicians and what kind of effect to do you see.
This taking place in transplant medicine, and I've got one more follow up question on no supplement but after that please.
Yeah, I mean, thanks, Steve I think certainly look.
There is no treatment for stem cell transplant associated Tim.
And we believe that.
Almost seven to one or supplement will be the first drug approved for that.
In fact, I think we're well on our way to getting there I think that the impact on that is going to be substantial I mean, this represents a clear unmet medical need a there is.
No satisfactory treatment.
With with current approaches so we're clearly hearing from our advisors, who represent a the premier.
Transplanters really in the world that what what almost seven to one or supplement will bring.
We'll be substantially so they're excited a they're excited to to be able to use it.
We're excited that we will be able we expect to be.
Able to make it available for their use and out of this it's going to be the patients who benefit I mean, it's very clear when you look at the narratives.
On these patients that we have.
These are patients who should not do well these are patients who should not survive and yet with in our sop limit they do survive.
And so that's a.
The impact of that I think is clear I think.
Obviously the.
The community views it that way and and we're looking forward as quickly as possible to making it available for patients.
Got it now.
Going to.
Broader picture.
Given the fact that this is obviously is important to drugs.
Hoping is and the fact that you have.
Different indications that are possible later on and also different geographical regions can you give us anything on partnering potential partnering thoughts on partnering that we should be looking out or thinking about.
I will hop back in the queue. Thank you yeah no. Thanks, Steve look we don't discuss our partnering discussions, but I mean, if look I don't think it would surprise anybody.
That given our programs given our assets I mean, even if you look at the ones. We were just discussing LMS seven to one or soft Lamar and our mass three program our nine six.
I don't think it would surprise anyone that there would be significant interest around those programs I think as I said.
I think a good number and industry and a good number and the and the complement research community view each of those targets as respectively. The premier targets in the Lexus and in the alternative pathways.
So.
We don't discuss it.
But you know look with the right partner.
That could make a lot of sense.
But I think.
Again.
Let's see how things all play out.
But we continue to March ahead, and we're very excited about both of those programs.
Great and thanks again for taking good questions.
You're welcome.
Thank you enter next question comes from Serge Belanger with Needham and company. Please proceed with your question.
Hi, Good afternoon, just a couple questions for me.
First Greg can you discuss the initial impact of J code implementation I know, it's only been a month and I guess other than streamlining their reimbursement process.
Just wanted to get a little more color on.
What others what segments of the market. This J code will allow you to penetrate a little better now.
Yes, Thanks search certainly I mean look it allows us to penetrate the commercial payers the med advantage payers. The Medicaid payers. It also allows us to as I said penetrate.
The in office setting.
All of those areas are significantly advantage for us with the J code.
It is it simplifies the billing.
We had seen initially or maybe some doubts that CMS, what appropriately reimbursed under the J code.
Those concerns have been quickly OLED and reimbursement is is running smoothly with the J code. So we think that overall this is going to be a significant enhancement.
For us because it does expand our user base and our and our payer base beyond just CMS part b.
Then when we looked.
Two years ago.
At or if you look at the data from two years ago around CMS and med part b of that sector of the market again with two year trailing CMS data.
Represented about 60% of our overall of our overall market for Omidria or I should say of our overall utilization of Omidria.
But over the past two years, we've expanded commercial we've expanded med advantage, we've expanded the V.A. system. We've expanded these other payors.
So that that percentage, although we don't have the CMS data because again CMS data trail by two years, but we expect that percentage has has dropped.
And so the national averages about 45% is med part b.
And we May again don't have the data to show it, but we may very well be tracking that.
Okay.
And then in terms of I guess, if you can just give us.
Maybe potential timelines and when you think there'll be a resolution of the permanent pass through reimbursement solution and if that doesnt materialize or when it does materialize is there the possibility that there could be.
Additional commercialized commercialization efforts behind this program to.
Drive further growth.
Sure.
That's.
That's the big question when.
Look there is unhappiness generally.
Not just with Omidria anymore, but generally in the industry, which frankly helps us significantly right. I mean, if you think about the last time, we faced this issue with CMS.
And we're now and were successful this was largely.
A very limited number of products one of them being omidria. The problem now expand much more broadly than omidria, which which is good I mean, it shows that there is a concerted frustration and.
And.
Eagerness to get this problem resolved a across multiple products multiple sectors and frankly, a multiple regions of the country, which translates to substantial bipartisan by cameral support and that's why you see the legislation that we.
Mentioned, that's coming out we expect that to be introduced a this week and as I think I mentioned previously the co sponsors of that are strong.
And this also shares the support of other groups one of those groups being voices for non opioid choices a very vocal group.
This problem needs to be fixed opioids are a big problem.
Continuing to.
Create financial Disincentives.
Two frankly use opioids over opioid alternatives makes no sense and it flies counter to this administrations.
Clearly stated and strong strong policy about trying to reduce opioid use.
So.
We think that with respect to timing you know look.
See the Congress is currently tied up with a focus on I think drug pricing.
I think that would probably have to clear, but certainly there's an emphasis to get this taken care of.
As quickly as possible and we'll see the Senate as I said is expected to bring forth. Its companion bill within the next couple of weeks.
And all of that I think makes pretty clear that indeed these by the way I want to be very clear these are not omeros.
Sponsored bills. These are not bills that omeros has put forth. These are bills that have been put forth wholly independent of us.
So these are all I think positive signs and look this just needs to get fixed so our objective of course as they get this fixed prior to the expiration of pass through.
But the idea that somehow.
With loss of of part B.
Yes, no separate payment that somehow omidria is mortally wounded I think.
Our our greatly so those assumptions are greatly overstated.
There are a lot of markets for Omidria and there are other things that we continue to look at but you know our objective now is too is to make this.
Consistently available for med part B patients I think will be successful.
And I think groups in Washington are are all mobilizing to fix this general problem.
Okay, and just one question on seven to one.
I think in your prepared comments you talked about you started enrollment and in a small pharmacokinetics pharmacodynamics study that will look at Biomarkers is that part of the overall regulatory strategy or is it just exploratory.
Oh, it's it's a it's largely a exploratory men, obviously, having a biomarker for mass to inhibition and response to mask to inhibition would be exceedingly helpful. For US. There currently is not but we think that that's a that's a reasonable.
Approach, we think it's it's a it's it's something that we can accomplish and if we do then I mean, you understand very well the implications of that you understand the implications of that not only in Nigeria, but in every other disease in which we are pursuing.
Math to inhibition.
So all of those things I've seen kind of plan, but sure I think a biomarker will be exceedingly helpful. And we think we'll have one.
Okay. Thanks for taking the questions.
Thanks surge.
Thank you and we have a follow up question from.
Selvaraju with HC Wainwright. Please proceed with your question.
Oh, yes, just a very quick one from me Greg do you anticipate any potential deployments of nor supplement.
Through the right to try program.
And if so what indications Mike this potentially occur thanks.
We don't at this time.
Rahm, we have our compassionate use program.
And that is how we're making the drug available to those who need it and can count access it in a clinical trial. So that that has been our approach that continues to be our approach I expect in the foreseeable future that will remain our approach.
Thank you.
Thank you.
Thank you.
This concludes our Q any session I'll now turn the call over to Dr. Demopolis for any further remarks.
All right well that wraps up the call for today. Thanks again, everyone for taking the time to listen it.
Clearly we're excited about the progress that we're making in 2019.
We look forward to further progress in 2020, and we'll continue to provide you with updates as we continue to execute on our mission.
To move these products forward and really do good for patients and their families.
Until then thanks again for listening and have a good afternoon.
Ladies and gentlemen. This concludes today's conference. Thank you for participating you may now disconnect.