Q2 2022 Omeros Corp Earnings Call
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Good afternoon and welcome to today's earnings call for Omeros Corporation.
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 company's request and a replay will be made available on the company's website for one week from today.
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I'll turn the call over to Jennifer Williams, Investor Relations for 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. These statements are based on management's beliefs and expectations as of today only and are subject to change. Thank you for joining us today.
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 10Q, which was filed today with the SEC, and the risk factor section of the company's annual report on Form 10K for a discussion of these risks and uncertainties. Now I would like to turn the call over to Dr. Greg Zimopulos, Chairman and CEO of Omeros. Thank you.
Thank you, Jennifer, and good afternoon, everyone. We appreciate you joining us for today's call.
Weíll start with a corporate update and an overview of our second quarter 2022 financial results followed by a more detailed financial summary. Joining me on the call today are Mike Jacobson, Nadia Dott, Kathy Melfi, and Steve Whitaker, our respective heads of finance, commercial, regulatory, and clinical.
We'll start with an update on our MASP2 program and specifically, narsoplamab in stem cell transplant associated thrombotic microangiopathy or TATMA.
In the first quarter of this year, we had a Type A post action meeting with the FDA UDivision for our Biologics License Application, or BLA.
Following the receipt of the official minutes of that meeting, we decided in consultation with our regulatory and legal advisors.
to pursue formal dispute resolution.
The dispute resolution process allows a sponsor to appeal a decision made at the division level to a higher deciding authority, which in our case is the Office of New Drugs or OND.
As previously reported, our dispute resolution request was submitted to FDA in June .
The request comprised a detailed briefing document that we believe presents to O&D a compelling case across all of the components.
clinical data, regulatory history, regulatory precedent, and literature.
that Narsoplamab should be approved for use in TATMA based on our BLA as originally filed.
Following the submission of that briefing package as part of FDA standard procedures for dispute resolution, we met with OND last month.
The deciding official was well prepared and familiar with our BLA and with our briefing package.
We were joined at the meeting by several leading experts in stem cell transplantation.
At that meeting, FDA does not typically provide any indication of how the dispute resolution will be decided, and our meeting was no exception.
We are currently awaiting a decision which, unless OND determines it requires additional time, should be rendered this month.
Once received, we'll share FDA's decision publicly with our shareholders and the investor community.
Let's turn now to narsoplamab for the treatment of IgA nephropathy.
We continue to advance enrollment in our Phase III Artemis-Igan trial, and the nine-month proteinuria data are scheduled to read out by mid-next year.
We look forward to making those data publicly available.
Our Narsoplamab Phase III trial in atypical hemolytic uremic syndrome, or AHUS, is also ongoing, but as weíve previously reported, its prioritization and as a result, its resource allocation is below those of our other complement programs.
We're also evaluating narsoplamab as a potential therapeutic both for acute severe COVID-19 for long COVID, also known as post-acute sequelae of SARS-CoV-2 infection or PASC.
As new variants of SARS-CoV-2 continue to emerge and vaccines and the current antivirals are proving.
less effective than hoped.
The need for better COVID-19 therapeutics remains.
and arguably continues to grow.
Narsoplamab was part of the iSPI COVID-19 platform trial sponsored by Quantum Leaf Healthcare Collaborative which has evaluated now multiple agents as potential therapies for COVID-19.
To date, no agent in the iSPI trial has been publicly reported to show a benefit over standard of care.
We continue to look forward to quantum's disclosure of the narsoplamab results.
The important role of complement and specifically the central role of the lectin pathway in both acute COVID and PASC.
is increasingly the focus of publications from leading research groups internationally.
The O'Meara's team is in the UK at the University of Cambridge and in Seattle.
recently added
groundbreaking work to this effort.
publishing manuscripts by Ali et al. in Frontiers in Immunology and by Lynch et al. in Clinical and Translational Medicine.
Together, these publications describe our discoveries related to the pathophysiological mechanism of severe COVID-19.
specifically that patients with severe COVID-19 early in disease
Show marked complement consumption.
which is driven by lectin pathway hyperactivation.
Itís this hyperactivation of the lectin pathway that leads to secondary hypocomplementemia and loss of complement mediated protection against infection.
The result is increased risk of clinically severe infections, which are known to be a common cause of morbidity and death in COVID-19.
So where does Narsoplamab fit in?
Well, narsoplamab inhibits this complement consumption and restores complement function and bactericidal activity.
thereby preventing risk of secondary infection.
We have now evaluated longitudinal serum samples from over 400 acute severe COVID-19 patients from multiple UK government funded consortia.
at ICU admission effectively.
All sera of patients with severe COVID-19 showed elevated levels of MASP2-C1 inhibitor complex, which is a marker of lectin pathway functional activity.
low CH50 levels, a measure of overall complement functional activity.
residual elevated levels of the enaflatoxins
C3A, and C5A.
A subset of these patients had very low antibody levels at ICU admission.
meaning that complement activation and consumption in acute COVID-19 are antibody independent.
Collectively, these data indicate that the lectin pathway is the key driver of complement hyperactivation in acute COVID-19.
Based on these data, we're developing a multiplex high-throughput assay platform as a commercially available tool for hospitals and physicians to reduce morbidity and mortality by identifying COVID-19 patients at risk for becoming severely ill.
The clear implication is that these identified patients
would then benefit from treatment with narsoplamab as soon as the consumptive biomarker profile is seen.
Let's now discuss more broadly our MASC2 program, which as of this week has two molecules in clinical trials.
Narsopilumab and OMS-1029 are long-acting second-generation MASP2 antibodies.
The first two subjects have now been dosed in our Phase 1.
Trial evaluating OMS 1029.
Dosing for OMS 1029 is expected to be once monthly to once quarterly, delivered subcutaneously or intravenously.
Designed to be complementary to Narsoplamab, OMS 1029 should enable us to pursue lectin pathway-driven indications for which longer duration dosing would be a particular advantage.
We're also making good progress on our small molecule MASC2 inhibitors.
These will be orally administered and we are working to add an oral MASSP2 inhibitor to our clinical portfolio as soon as possible.
Now letís turn to Omidria and a high-level overview of our financial results for the quarter.
As previously discussed, last December , O'Meara's completed the strategic divestiture of its commercial ophthalmic drug Omidria to Rainer Surgical.
The transaction with Rainer required us to reclassify all historical Omidria revenue and expenses as discontinued operations and to record the royalties earned as a reduction from the Omidria contract royalty asset on our balance sheet.
Our Royalty Rate for US Net Sales of Omidria is currently 50%.
which equates to more than 70% of the operating profit.
For the second quarter, Rainer reported Omidria net sales of $34.5 million, a new all-time high.
This eclipses our previous high of $34.2 million for quarterly Omidria revenues and represents a 25% increase over Rainer's net sales of Omidria for the first quarter of 2022.
Our 50% royalty on Rainer Net sales for the quarter was $17.2 million.
Given the required reclassification of Omidyria revenues and expenses, our revenues for the second quarter were reported as zero and our net loss from continuing operations was $41.7 million compared to $50.2 million in the prior year quarter.
Our overall loss for the current quarter was $30.8 million, or 49 cents per share, compared to $28.6 million, or 46 cents per share in the second quarter of last year.
Our non-cash expenses were $3.7 million or 6 cents per share for the current quarter and $3.9 million or 6 cents per share for the prior year quarter.
As of June 30, 2022, we had $122.6 million in cash and investments on hand available to support ongoing operations.
So in total, our change in cash and investments from the end of the second, of the, I'm sorry, of the first quarter to the second quarter is a decrease of $19.7 million.
In addition, we have an additional $14.5 million of receivables representing primarily royalties to be paid to Omeros by Rainer for Omidria sales for May and June .
Omidyria royalties are received monthly by Omeros within 60 days of being earned.
We also have $150 million at the market sales agreement, which we have not used.
During the quarter, we continued to work closely with Rainer to ensure a smooth transition of the product, the teams, and all operations with minimal disruption to customers.
The transition has gone well and we expect to complete it this quarter.
We're encouraged by the quarter over quarter growth in Omidria sales.
We expect that the positive momentum will be further boosted by the proposed 2023 rule governing the Outpatient Prospective Payment Systems.
issued by CMS last month and reconfirming.
that Omidria qualifies for separate payment under the non-opioid pain management exclusion when used in ambulatory surgical centers or ASCs.
We appreciate CMS's commitment to continue providing access to Omidria for Medicare patients and their physicians.
We're also pleased that as part of the proposed rule, CMS solicited public comment on potentially expanding the exclusion beyond the ASC setting to pay separately for non-opioid surgical drugs in hospital outpatient departments or HOPDs.
We support this expansion as approximately 20 percent of cataract procedures are performed in HOPDs.
And cataract surgery patients deserve access to omidria regardless of whether they undergo surgery in an ASC or in an HOPD.
Under the terms of the Rainer transaction, Omeros is also eligible to receive a $200 million milestone should, before 2025, separate payment be secured for Omidria for a continuous period of at least four years.
Congressional passage of the Non-Opioids Prevents Addiction in the Nation Act, or the No Pain Act, would trigger this milestone payment for O'Meara's.
The No Pain Act would provide separate payment for non-opioid pain management drugs like Omidria in both the ASC and HOPD settings.
Leading the charge, Voices for Non-Opioid Choices continues to advance the No Pain Act and has assembled an impressive coalition of major medical societies, patient advocacy groups and prevention and recovery organizations across the country in support of the legislation.
The bill has strong bipartisan and bicameral support with sponsors and co-sponsors now numbering
49 in the Senate and 113 in the House of Representatives, roughly equally split between Democrats and Republicans.
These Senators and Representatives include chairpersons and key members of relevant committees.
representing a diverse group of congressional caucuses.
Passing the No Pain Act is the right thing for patients and for the country, and we expect that given the bill's broad-based and bipartisan support in both chambers.
The No Pain Act has a good likelihood of becoming law in this Congress or early in the next.
Looking at the sales trajectory for Omidria, we expect that the drug will continue to provide us with meaningful cash flow from royalties in both the near and long term.
The non-dilutive Omidria revenue stream helps to defray significantly.
the costs of developing our pipeline programs including our complement franchise of MASK2 and MASK3 inhibitors.
Just as we have done for MASP2, we continue to build a dominant intellectual property position around MASP3, the key activator of the complement system's alternative pathway.
Let's...
Now turn to OMS906, our lead MAST3 inhibitor.
Having successfully completed a Phase 1 study in healthy subjects, weíre preparing to initiate enrollment in a trial evaluating OMS906 in patients with paroxysmal nocturnal hemoglobinuria, or PNH, who have an unsatisfactory response to the C5 inhibitor ravulizumab.
In late July , OMS906 received orphan drug designation from FDA for the treatment of TNH.
The benefits of which include seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and waiver of certain administrative fees.
Awareness of our OMS 906 program is growing within the scientific community.
We'll be presenting preclinical data on OMS906 at the European Meeting on Complement in Human Disease later this month in Bern, Switzerland.
And the results of our Phase I trial have been submitted for presentation at a major Congress later this year.
We expect that OMS906 could hold significant advantages over other agents approved or in development for alternative pathway related disorders.
These advantages are expected to include decreased infection risk and a convenient dosing profile.
with administration as infrequently as once monthly to once quarterly.
importantly.
Unlike other targets in the alternative pathway, MASC-3 does not appear to be an acute phase reactant.
An acute phase reactant increases in circulating concentration in response to inflammation in the body.
That inflammation can be as simple and common as the flu.
the result is that dosing of a drug targeting an acute phase reactant might no longer be effective.
resulting in breakthrough disease.
Because MAS3 is not an acute phase reactant, background inflammation has no effect on its concentration or on the dosing of OMS906.
greatly mitigating that risk of disease breakthrough.
Given these expected advantages, we're focused on obtaining efficacy data with OMS 906 as quickly as possible.
So, in addition to initiating our Phase 1b study of OMS906 and PNH patients who have had an unsatisfactory response to ravulizumab.
Weíre expanding our OMS906 program to include trials evaluating OMS906 in treatment-naive PNH patients and in C3 glomerulopathy patients as well as in one or more related indications.
We're making good headway on this and are targeting data that demonstrate efficacy of OMS 906 in these diseases by early 2023.
The importance of alternative pathway inhibition is well understood.
as is the commercial viability of agents successfully inhibiting the alternative pathway. If we demonstrate efficacy of OMS906 in alternative pathway diseases like PNH and like C3G.
the safety dosing and or biological advantages that I just described prove to be accurate.
which we expect they will.
the value created around OMS906 should be compelling.
Although we continue to prioritize our complement clinical programs over those of our phosphodiesterase, or PDE7 inhibitor program OMS 527.
Discussions are ongoing to access third-party funding to continue development of OMS 527 for addictive disorders.
in addition to our work in addiction.
Researchers at Emory University are evaluating in clinically predictive primate models the potential of our PDE-7 inhibitors to improve L-DOPA induced dyskinesias.
More than 50% of Parkinson's patients develop dyskinesias following prolonged L-DOPA treatment.
Our existing patents broadly cover this indication and we look forward to seeing the final dyskinesia data early next year.
If positive, we expect that we would have another viable and large commercial opportunity for OMS 527.
Iíll close the update today with our immuno-oncology programs in which weíre evaluating a number of novel molecules to treat cancers.
To date, immuno-oncology primarily has been focused on cell surface checkpoints.
We're taking a different approach.
developing intracellular target inhibitors that optimize T cell conditioning to yield both potent tumor killing
and a more sustained anti-tumor response.
Our technology involves a combination of inhibitors of GPR174, adenosine receptors, and other targets.
to limit the negative impact of certain pathways on T cell function.
We believe that our novel approach has the potential to improve response rates for patients receiving either engineered or native T cell therapies for liquid and solid tumors.
And we're continuing to explore the application of this technology to improve human CAR T cell therapies.
Across these landscapes of both therapeutics and adoptive T cell therapies, we are building broad patent protection.
With that, Iíll hand the call over to Mike Jacobson, our Chief Accounting Officer, for a more detailed description of our second quarter financial results. Mike?
Thanks Greg!
As Greg briefly discussed, on December 23rd, Rainer acquired Omidrean Associated Business Operations.
The sale required us to restate our financial statements for all prior periods into two components.
One, continuing operations and the second, discontinued operations.
This means that all historical and mid-year revenue and operating expenses are shown in a single line on our income statement as discontinued operations.
All of our other activities are included in continuing operation.
The immediate transaction includes royalties on worldwide sales.
O'Mara will continue to receive royalties of 50% on net sales of Omidria in the U.S. until the early of either January 1, 2025, or the payment of the $200 million milestone.
Thereafter, we will receive a 30% royalty on US net sales for the duration of the relevant patent terms, which extend out to at least 2033.
We will also receive a 15% royalty.
on any non-US net cells of omidria over the life of the relevant test.
From an overall standpoint, considering the US royalties and our reduction in operating expenses —
We will receive more than 70% of the US operating profit when royalties are 50%
and over 40% when the royalty is at 30%.
Turning to our actual results, our net loss for the second quarter was $30.8 million or $0.49 per share.
This compares to a $33 million loss, or 53 cents per share, for the first quarter of this year.
Our non-cash expenses for the quarter were $3.7 million or $0.06 per share.
As of June 30, 2022, we had $122.6 million of cash, cash equivalents, and short-term investments available for general operations.
This is a 19.7 million.
power decrease
from our report at the end of March.
of this year. We also have $14.5 million in royalty and trade receivables which will be fully collected by the end of this month.
In addition, we have the at the market sales agreement that allows us to sell from time to time up to $150 million of our common stock.
Costs and expenses from continuing operations for the second quarter were $41.7 million, which was an increase of $2.2 million from the first quarter.
We continue to gate our Nafapamab sales and marketing spend until the timing of the FDA approval is clear.
Additionally, we continue to expense any Nursoplamib manufacturing costs.
until timing of approval in the US is certain.
Interest expense for the second quarter was $5 million and consistent with the previous year quarter.
Now let's look at discontinued operations.
In the second quarter, the actual royalties earned from Avidria's sales were $17.2 million and an increase of $3.4 million from the first quarter of this year.
The royalties earned were recorded as a reduction in the Omidria contract royalty asset on our balance sheet.
Additionally, we recorded $10.8 million of income in discontinued operations in our income statement, recognizing for accounting purposes the interest earned on the Emidria contract royalty asset.
and re-measurement adjustments.
Now let's look at the expected third quarter results.
We expect overall operating costs from continuing operations in the third quarter of 2022 to increase modestly from those of the second quarter, due primarily to the timing of some planned research and development activities.
Interest expense for the third quarter should be consistent with the second quarter at approximately five million dollars.
Income from discontinued operations should be in the $8 to $9 million range.
With that, I'll turn the call back over to Greg.
Thanks Mike. Operator, would you please open the call to questions.
We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad.
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At this time, we will pause momentarily to assemble our roster.
The first question comes from Greg Harrison with Bank of America. Please go
Hey, good afternoon. Thanks for taking the question. So, on the NARS-OPLOMAB-I-GAN program, will you announce when the trial is fully enrolled? I'd assume that may be close.
That's the nine-month data will be in mid next year. And then where would you expect to see Narsoplamab used in this indication? Is there a certain group that could be more amenable or are you expecting broad use and how does the existence of one or maybe even two approved therapies by the time you would launch impact your strategy?
Yes, I don't expect that we will be announcing when enrollment is complete, but I think...
She's made your correct Greg in that we are close.
With respect to where we would use it, I mean, I think that the data that weíve shown so far look to be generally applicable across IgA nephropathy in general. The bulk of our data, as you know, having seen the Phase 2 data, are in high protein spillers. So those who are spilling more than 2 grams.
per day of protein.
But, you know, I think again, we are...
We are guardedly optimistic that the applicability of the product will be brought.
But again, let's see the data. Steve, any additional comments? I guess I'd say that...
It's important to remember that.
despite the fact there would be potentially two other products on the market at that time, that the improvements we've shown have been greater than what they reported, and this does look like a first-line therapy at least for a large member of patients.
other products on the market at that time that the improvements we've shown have been greater than what they reported and this does look like a first line therapy at least for a large number of patients. Thank you.
To Steve's point, as you look, the magnitude of proteinuria reduction with Narsoplamib
shown to date has been a multiple of whatís been shown by other products. But again, letís look at the data and then I think that will help guide us.
Okay, great. Thanks for taking the question.
Thanks Greg.
The next question comes from Steve Brozak with WBB.
Please go ahead.
Thanks for taking the questions. There are two I've got. One, I know you can't say anything about FDA, but I do want to know about items around Narceplamab, for instance, drug availability and anything else that you can give us any kind of clarity on around Narceplamab, and I've got a question on Emidria after that. Thank you.
Sure. With respect to drug availability, Steve, we have sufficient drug for a successful launch.
preparations.
are in place for a successful launch. So I think with respect to all of the components to which you're referencing, I think we're in good shape. But let me ask Nadia if she'd like to add anything to that.
Well stated, Greg. We are watching that carefully and continue to sharpen our plans, including making sure that supply is ready at time of launch.
Thank you. Okay. On Omidria, you know, you've talked obviously about the guidelines that CMS has brought up and the No Pain Act. But can you really itemize what does that mean for patients? What does that mean for the use of Omidria and specifically around how the clinicians would use this, how patients would receive this? And I'll hop back in the queue afterwards. Thank you. Thank you.
Okay. On Omidria, you know, you've talked obviously about the guidelines that CMS has brought up and the No Pain Act, but can you really itemize what does that mean for patients? What does that mean for the use of Omidria and specifically around how the clinicians would use this, how patients would receive this? And I'll hop back in the queue afterwards. Thank you. Sure. Well, first...
there is the currently extant
non-opioid alternative exclusion.
under which Omidria is being separately paid in the ASC.
and that has been in place CMS
put that in place in 2019.
and it has remained in place really without change since that time. So we expect that that is a policy particularly given the current opioid crisis.
frankly, the opioid epidemic.
The expectation is that that policy would continue well into the future. What the No Pain Act would do is secure that
separate payment for non-opioid
alternatives used during surgery, so during surgical procedures, of which omidria would be included.
for a period of five years, renewable by Congress, and it would expand.
the separate payment from the ASC's.
to include procedures performed in HOPDs. Now, for cataract surgery, thatís important. I think as I mentioned during the prepared comments, about 20 percent of cataract procedures somewhere around there, maybe a little less, the shift continues to move toward ASCs. But letís say thatís 20 percent of the total procedures are performed in HOPDs.
And what weíre most interested in, and again, what we very much appreciate CMS recognizing and moving to ensure is that patientsÖ
physicians.
should have access to omidria.
drugs like omidria. Whether they choose to use it or not should be a decision made by the physician in consultation with his or her patient.
but the access should be absolutely preserved.
Thatís what the current policy of CMS does in the ASCs. We think thatís important to expand to the HOPDs as well so that patients who have cataract procedures performed in the HOPDs have the same access.
to the quality of care that patients have in ASCs. And we were really quite heartened by CMS's request for comments on the potential of expanding the non-opioid exclusion from the ASCs to include HOPDs as well.
Thank you for that explanation.
Let me hop back in. Thank you. All right. Take care Steve
The next question comes from Hannah Eddy Oye with J.P. Morgan. Please go ahead. A question from Dan
Hi, good afternoon. This is Hannah on for Eric Joseph. Thanks for taking the questions. So first with regard to the Artemis-Igans study, can you just speak to the role of SGLT2 inhibitors in the trial? Some physicians that we've talked to have noted that these are currently considered standard of care in the indication. Do you have or do you allow for the enrollment of patients currently on SGLT2 inhibitors in the study?
And then secondly, given reductions in proteinuria may not necessarily translate to long-term kidney function improvement, can you just reiterate what gives you confidence in proteinuria as an end point for registration? And then also, is that the only end point of focus, or would you have to show some level of preserved kidney function? And I have a follow-up after that. Thank you.
Sure. With respect to SGL2s, those are not. Those are excluded from the clinical trial.
with respect to your question about...
kidney function.
We are also looking at EGFR as really are all products in development for IgA nephropathy.
The question is how will that EGFR be used? In the setting of a regular approval on Protonuria, which based on our discussions with FDA, we will be able to make a new decision. The question is how will the FDA be used? In the setting of a regular approval on Protonuria, we will be able to make a new decision.
and our Sopla Mab can achieve.
I believe itís the only one that can achieve regular approval on proteinuria alone. If that were to, and that is based on the rapidity and magnitude and the reduction of the proteinuria seen in our earlier studies.
But let's say that regular approval is obtained, then eGFR data really becomes a safety endpoint, meaning eGFR data is obtained, then eGFR data is obtained, then eGFR data is obtained, then
is EGFR remaining stable, ensuring that EGFR does not meaningfully fall off.
In the event of an accelerated approval, which is similar to what colitis is, colitis is drug received, EGFR then becomes the confirmatory endpoint in the, or the primary endpoint in the confirmatory trial. For more information, visit www.engvid.com
And that is, again, a possibility for us as well, depending on the magnitude of protein area reduction. With respect to, is EGFR a meaningful solution?
endpoint, and does it correlate with proteinuria? Yes, the answer to both of those is yes. The data clearly show Dr. Leslie Inkerís data, which have been published, I think, now to publications or more on that, that there is very good correlation between EGFR improvement and proteinuria reduction. Steve, again, Iíll look to see if youíve got anything you want to add to that.
I don't have anything. Thanks, Greg. All right.
The next question comes from Ram. Please go ahead.
Hi, this is Mitchell on for ROM. Thank you for taking your questions.
The first question I just wanted to ask, I know you can't comment much on the formal dispute resolution, but if there was an adverse decision, would you be able to appeal if that were the case?
Hi, Mitchell. Yes, I mean, again, youíre right, we donít want to comment on ongoing discussions. But if we had a negative opinion, which I hope and I frankly am optimistic will not be the case, but letís say that did occur, yes, we do have the ability to appeal higher within the agency. Weíre all in this together. Weíre all in this together. Weíre all in this together.
Okay, great. And then thinking about the principal sales related activities that Rayner is engaging in, could you talk about those and how they can spur an uptake of Omidria and how high do we think that sales could potentially go in the near term? MyOmidria-
And then thinking about the principal sales related activities that Rayner is engaging in, could you talk about those and how they could spur the uptake of Omidria, and how high do we think that sales could potentially go in the near term? Sure.
Well, the sales force that Rainer has is the sales force that was within Omeros selling Omidria. So this is what we believe, and I think Rainer shares this belief, is really a
one of, if not the premier
ambulatory surgery center detail forces in ophthalmology. So this is a group that's really outstanding at selling omidria and frankly it's a drug that has great benefits and has not been shown to have any safety issues. So that's also helpful in the sales process.
But I think that clearly separate payment.
And the continued relative certainty of separate payment plays an important role there, right? Because what physicians and what ASC administrators do not want to do is have to change protocols or procedures or directions in regulation.
And the continued relative certainty of separate payment plays an important role there, right? Because what physicians and what ASC administrators do not want to do is have to change protocols or procedures frequently.
And in the time period where we had omidria reimbursement, then omidria reimbursement was taken away for some discrete period of time, that creates discomfort.
and it creates disruption within the ASCs and the management of those procedures.
So, I think certainly having continued separate payment or relative certainty of separate payment is very helpful. I think also Rainer is highly focused on the sales of Omidria and I expect and I know that they are thinking, again, donít ñ I canít speak for them, but I understand that they are considering further expanding the sales force to further drive.
sales. And then again, it's their ability to...
to generate sales ex-US. That is also appealing to us. And there we receive 15% royalty on net sales.
So I think Rainer is doing a really wonderful job of pushing forward the product. I think the other part of your question was where do we think sales can go?
I'd like to withhold comment there, but I certainly, other than to say I think it's a multiple of what they currently are.
Great. Thank you so much for the detail. Appreciate it. You're welcome.
The next question comes from Brandon Folks with Cancer Fitzgerald.
All right, thanks for taking my question. Maybe just on OMS 906.
Should we think of you focusing on either the treatment naive patients or the patients with the unsatisfactory response to the C5 inhibitors going forward depending on data or should we think of you bringing both of those indications forward? And then similarly, can you just help us think through the impact of the different routes of administration and how they may impact the ultimate addressable market just between that once quarterly IV, the once monthly and maybe the sub-q? Thank you. Thank you.
Sure, hi Brendan. I'll answer part of that and then I'm going to hand it off to Steve for additional comment.
I'll answer part of that and then I'm going to hand it off to Steve for additional comment. But first of all with...
with respect to the target indication. The reason that we begin or began with a...
with patients on Ravielizumab is it allows access to PNH patients, right? Most patients are currently receiving some sort of treatment in the PNH community. So this allows us to access patients. We have now been able to find patients who are PNH patients and treatment naive. The advantage of that.
is the efficacy signal can be obtained much more quickly than waiting to take a ravulizumab patient and take them off ravulizumab as we transition to narsoplamab. So thatís the advantage. Where we see the market I think isÖ
largely agnostic.
We believe that there are meaningful advantages, as I think I detailed in the prepared comments. We think those are important.
one, infection, two, dosing convenience or infrequency of dosing, and then the third is the difference between an acute phase reactant as a target and a target like MASC3 that is not an acute phase reactant.
All of those are meaningful and I would underscore the acute phase reactant.
difference which we think is a very meaningful difference.
So Steve, let me turn it to you and see your thoughts on this.
Thanks, Greg.
Um, I
I might differ a little bit from you on one point. The treatment naives are clearly very rapid, you can show it very rapidly, but in the study that we're going to look at Ravelizumab, we can see data or we can see efficacy in that relatively quickly when we start the combination therapy as well. And so we certainly aren't dependent on one population or the other to see the efficacy. As Greg said, we believe this will be very strongly competitive in the market.
And once we see efficacy in PNH, that will give us very...
even higher confidence than we have now, that this will be applicable across a wide variety of alternative pathway diseases. So our thinking isn't limited to PNH or to C3 glomerulopathy. Seeing rapid efficacy in these indications will certainly open up.
or give us even higher confidence that this will be effective in a wide variety of diseases. And finally as far as the sub-Q vs. IV go.
goes. At least I've talked to several physicians about this. You can hear different opinions on what they think patients want, but I can tell you that there's great enthusiasm for both routes of administration. Both would be well accepted.
with the dosing frequency that we were proposing. Exactly.
Right, and you know part of this Brendan is when you look at MASC2.
There's no predicate.
because of our IP position around the lectin pathway and Masp2 specifically.
So most don't really understand what is the potential for a MASSP2 inhibitor.
until we get Narsoplamab across the finish line, which we hope to do quickly, that will answer that question.
but in the alternative pathway space.
there are alternative pathway inhibitors on the market.
And so it's pretty well understood.
what the market opportunity is for those, what you need to show to be effective.
And I think that that sets up very nicely for OMS 906. When we demonstrate efficacy, Steve says in one indication...
or two indications, then I think it becomes pretty clear that the applicability of OMS 906 is really across all of those alternative pathway indications that have been identified and for which other drugs are currently approved.
And then the question becomes, okay, so what are the differentiators between OMS-906 and those other drugs? And I think those are what we highlighted in the prepared comments. Those are what I think weíve talked about again just in this exchange. And I think you really need to look at those because I think those become quite important.
So the question is, is 906 effective as an alternative pathway inhibitor, yes or no? We believe that all of the data we have to date...
certainly, certainly weigh on, yes it is.
But letís see. Weíll have data, I think, soon enough that will answer the question. And then that question, once answered, becomes broadly applicable.
Was there a follow-up Mr. Polk's?
All right.
This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Gregory Demopoulos for any closing remarks.
Thank you, operator, and once again, thank you everyone for joining us today. Weíll continue to keep you updated on our progress. As always, we appreciate your continued support, and have a good evening.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
has now concluded. Thank you for attending today's presentation. You may now disconnect.
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