Q4 2021 Omeros Corp Earnings Call
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Good afternoon, and welcome to todays earnings call for <unk> Corporation.
At this time all participants are in a listen only mode. After the company's remark, 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 available on the company's website for one week from today.
I'll turn over the call to Jennifer Williams Investor Relations for <unk>.
Good afternoon, and thank you for joining the call today I'd like to remind you that some of the statements that will be made on the call today will be forward. Looking these statements are based on management's beliefs and expectations as of today only and are subject to change all forward looking statements involve risks and uncertainties that could cause the company's actual results to differ materially.
Please refer to the special note regarding forward looking statements and the risk factors section in the company's annual report on Form 10-K , which was filed today with the SEC for a discussion of these risks and uncertainties.
The call will include a discussion of certain non-GAAP financial measures. A reconciliation of these non-GAAP measures to the corresponding GAAP measures is included with <unk> earnings Press release included excuse me issued earlier today, which is available on the Investor Relations page of our website and has been furnished with the form 8-K, we filed with the SEC.
Earlier today now I would like to turn the call over to Dr. Gregg Moskowitz, <unk> Chairman and CEO .
Thank you Jennifer and good afternoon, everyone. We will start with a corporate update and a high level overview of our fourth quarter and.
And year end 2021 financial results, followed by a more detailed financial summary.
With me today here are Mike Jacobsen, Nordea dock, Cathy Melfi, and Steven Whittaker, our respective heads of finance commercial regulatory and clinical.
As publicly announced on December 23, 2021, <unk> completed the strategic divestiture of its commercial ophthalmic product omidria to Rainer surgical.
Rainer has a long heritage in ophthalmology and markets a portfolio of complementary ophthalmology products across more than 80 countries.
At the Transaction's closing <unk> received a $126 million in cash and.
In addition, during this first quarter of 2022.
<unk> is collecting all accounts receivable outstanding at the closing date.
Bringing the effective total cash received by <unk> to $165 million.
With cash on hand at year end. This brings our effective cash and accounts receivable at December 31, 2000 $21 million to $195 million.
<unk> will also receive a milestone payment of $200 million before 2025 separate payment for Omidria is secured for a continuous period of at least four years.
The immediate capital infusion of $165 million together with the ongoing royalty stream.
Should provide sufficient capital for <unk> to run through late 2023.
The $200 million milestone if achieved will substantially extend that run room.
Beyond the upfront payment and milestone on Merrell retains significant upside in the future growth of Omidria through royalties on both U S and ex U S net sales of Omidria.
In the U S <unk> receives 50% of net sales.
Approximately 70% of the operating profit.
From the closing date until the earlier of either January one 2025, or the payment of the $200 million milestone.
Thereafter, <unk> will receive 30% of U S net sales, which equates to over 40% of operating profits until U S patent expiration, which at present is 20% to 33.
And given pending patent applications might well be later.
Outside of the U S. <unk> will receive a royalty of 15% of net sales again with a long duration running until the expiration of all relevant regional or national patents.
Let's turn to our fourth quarter financials.
GAAP net income for the fourth quarter was $281 million or $4 48 per share, which includes a $306 million gain on the sale of Omidria.
As Mike will explain later the asset sale of Omidria involve the mandatory restatement of our financials, which changed the way we need to report our fourth quarter, Omidria and transaction related revenues and expenditures.
Provide you now with a high level overview of some key metrics of our fourth quarter financial results adjusted to exclude the accounting impact of the sale.
Overall fourth quarter net sales of Omidria totaled $32 $9 million or growth of 10% over the third quarter.
This represents a new quarterly record for Omidria sales and ambulatory surgery centers and.
And closely approaches and all time record for quarterly sales in both ASC and hospital outpatient departments. Despite the absence currently of separate payment by CMS.
<unk>.
<unk> recognized as revenue, all but $1 1 million of that $32 9 million total $38 million from direct product sales prior to the acquisition and $1 million from our 50% royalty on <unk> net sales in the remainder.
<unk> of Q4 following the acquisition.
Absent the sale of Omidria, our fourth quarter loss would have equaled two 3 million or <unk> 37 per share effectively unchanged from the prior quarter's loss and per share loss for.
Quarter noncash expenses were $6 3 million or <unk> 10 per share.
This too was effectively unchanged from the third quarter of 2021.
As of year end, we had $157 million of cash cash equivalents and short term investments and $38 million in accounts receivable.
This.
This combination really brings our effective cash and accounts receivable at year end to $195 million.
We also have a $50 million line of credit against our accounts receivable, which includes our royalty receivables from Rainer.
And we also have a $150 million at the market sales agreement, which we have not used.
We're pleased with Omidria is overall performance from the fourth quarter and expect Omidria sales to continue to grow throughout 2022.
And the transaction for Omidria.
Rainer acquired a great ophthalmic product, which will help rainer grow it's ophthalmology franchise.
Rainer now also has what we collectively believe is the premier surgical facility focused sales force in ophthalmology.
<unk> the transaction's economics are highly favorable, allowing monetization today, a substantial downstream revenues.
Eliminating significant costs and reducing risk, while maintaining roughly 40% to 70% of future operating profits.
<unk> plans to expand its U S and ex U S sales forces.
And to capitalize on synergies between Omidria and there are other ophthalmic products like intraocular lenses for cataract surgery, all of which should further accelerate sales of omidria.
Also rainer plans to launch Omidria in markets outside of the U S. Later this year.
Which we expect will bring substantial royalty revenues to <unk> from previously untapped regions.
Further we remain optimistic that <unk> will receive.
$200 million milestone payment.
But we are immensely proud to have conceived of developed and successfully commercialize them.
Drug that improves outcomes in cataract surgery, and already has been used safely and.
And more than 2 million cataract surgery procedures.
I am also tremendously proud of the Omidria sales force that came together as a cohesive unit launched a first of kind drug in ophthalmology and grew omidria to a $125 million a year product.
I know that under <unk> leadership that team will continue working hard to bring omidria to more and more patients who need it.
We believe the product is in very good hands with Rainer and we look forward to Omidria has continued expanding utilization and our ongoing economic participation in that growth worldwide.
Before leaving Omidria today I'd like to give you a brief update on the no pain Act a legislative effort led nationally by voices for non opioid choices and endorsed now by more than 80 major medical societies patient advocacy groups and prevention and recovery organizations.
Across the country.
The no pain Act, if past will provide long term separate payment for non opioid pain management drugs like Omidria and ambulatory surgery centers as well as in hospital outpatient departments.
The no pain Act now counts 44 Senators and 93 Representatives as co sponsors.
And is truly bipartisan.
Momentum around the Bill is growing and new co sponsors continue to sign an.
Sponsors are now focused on identifying the appropriate legislative vehicle to carry in the near term.
The no pain act across the finish line.
The divestiture of Omidria marks a significant transition for <unk> as an organization as well.
Omidria is a unique specialty pharmaceutical product.
Now <unk> is a pure biotech leading scientific advancement across our portfolio of product candidates in development assets, an immunology focused on the complement system and on immuno oncology.
And in addiction.
Here's an update on some of our programs.
Let's start with <unk>, our fully human monoclonal antibody targeting <unk> two the effector enzyme of the lectin pathway of complement.
On October 18th 2021, we announced receipt from FDA.
A complete response letter regarding our biologics license application or BLA for the treatment of hematopoietic stem cell transplant associated thrombotic microangiopathy or Ta TMA.
As we've previously disclosed FDA in its CRM.
Expressed difficulty interpreting our <unk> treatment effect, given the complexity and severity of both the disease.
And patient population.
Indicating that additional information would be necessary to support approval.
There were no safety or CMA CMC issues sighted.
So there is no bleed over to other indications in which <unk> is being evaluated.
In January after discussion with and input from our regulatory consultants, including former FDA Office and Division directors, we submitted a comprehensive response addressing in detail.
All of Fda's critiques in the CRO.
Accompanying that response was a request for a type a meeting.
To discuss our responses to the CRO.
The type a meeting was granted.
And held last month.
Which <unk> responded to each of fda's issues in the CRO.
We believe that the meeting was constructive we.
We currently are awaiting feedback from FDA and will provide further updates as we have more information and clarity.
We continue to believe that our BLA as submitted merits approval and that the data meet or exceed the threshold for substantial evidence of effectiveness.
In our supplement delivered a highly statistically significant outcome compared to the pre specified efficacy threshold. All secondary endpoints were also favorable several reaching statistical significance and the benefit risk balance heavily favors benefit.
We work closely with FDA throughout the clinical development process, followed fda's guidance on the design and conduct of our pivotal single arm trial as well as on the appropriate registration path and collaborated with FDA to create the novel primary endpoint.
The regulatory history, including agreements with FDA are well documented in meeting minutes and official communications.
Ta TMA is an orphan indication with no approved treatment and our goal is to bring in our supplement to some stem cell transplant patients for whom Ta TMA is a too often lethal complication.
During our ongoing interactions with FDA, we have continued to sharpen our launch plans and invest in Ta TMA disease education, we're confident that we'll be launch ready once <unk> is approved.
Also more publications and presentations from international experts continue to accumulate.
The manuscript detailing the findings from the pivotal trial and authored by a consortium of the trial's investigators is in the final stage of review by a peer reviewed journal.
A manuscript elucidating the role of the lectin pathway and masked two in Ta TMA was recently published in the peer reviewed journal experimental hematology and oncology.
In November a detailed summary of the successful treatment with <unk> and a 60 year old with Ta TMA was published.
In blood.
And there will be three presentations at the upcoming annual meeting of the European Society for blood and marrow transplantation later this month.
The first detail the findings of an international working group of experts in stem cell transplantation.
Establishing the first broad based diagnostic criteria for Ta TMA.
<unk> will be important in helping identify ta TMA and a greater number of patients early in the disease process.
The second describes the systematic literature review of the natural history of <unk> in adults, which makes clear that the beneficial effects seen with our supplement are substantially better than would be expected in untreated patients or.
Otherwise stated in the natural history of the disease.
And the third describes resolution of severe ta TMA within our <unk> treatment and a nine month old girl.
At Emory University, who had failed treatment with <unk>.
<unk> is also being evaluated in three other indications immunoglobulin, a or Iga nephropathy, atypical hemolytic uremic syndrome or <unk>.
And COVID-19.
Our phase III Artemis <unk> trial is enrolling internationally.
Despite the challenge of COVID-19 at hospital investigational sites enrollment has continued to progress.
And has even accelerated.
An investigational new drug application is under review by the Chinese FDA <unk> has identified and is working with over 15 Chinese investigational centers. So that Roland can begin as soon as possible after IMD clearance.
Iga nephropathy accounts for about 45% of primary glomerular disease in China.
The magnitude of its prevalence in that country will meaningfully accelerate further enrollment in the trial.
Multiple sites and other European South American and Asian countries are also coming online.
Proteinuria data are expected in the first part of next year.
As reported in our last earnings call and in our press release last November .
Results of nearly three year follow up in Iga nephropathy patients treated with our supplement demonstrate unprecedented effects on proteinuria reduction as well as egfr stabilization and improvement.
These data were presented by international renal experts at both the annual meeting of the American Society of Nephrology.
And at the World Congress of Nephrology, which took place just last week.
We look forward to seeing the phase III data.
Our phase III, our supplement trial in patients with H U S remains open as previously reported for commercial reasons, we've de prioritized that program.
Favre of other mask to unmask III inhibitor programs.
In our supplement is also being evaluated for the treatment of severe COVID-19, and the ice by COVID-19 platform trial sponsored by quantum leap healthcare collaborative.
Then our supplemental treatment arm of the trial has now concluded once all data are available they will be analyzed we look forward to a readout of the data once that analysis is completed.
Two manuscripts from <unk> laboratories at the University of Cambridge have been submitted for peer reviewed publication and detail some of our recent discoveries in the pathophysiology of COVID-19.
The first.
Covers the discovery of a profile of complement markers or broad complement dysfunction.
Seen in all patients examined.
During the acute phase of severe COVID-19.
The dysfunction appears to be driven by hyper activation of the lectin pathway.
In our supplement restores complement function in these severe COVID-19 patients well in patients not treated with <unk>, the broad complement dysfunction persists throughout hospitalization or until death.
The second manuscript demonstrates that the complement dysfunction in severe COVID-19 patients reported in the first manuscript result, an impairment of the adaptive immune response necessary to fight infection.
Leading to an increased risk of life threatening secondary infection.
Here again treatment within our Sop <unk> normalizes, the adaptive immune response.
Should restore the body's ability to prevent or fight secondary infection.
And to reduce COVID-19 mortality.
We look forward to both manuscripts being made available soon.
We expect that they will spur important discussion and future research.
Our mass to lifecycle management programs beyond in our supplement are also moving ahead quickly omm's $10 29 is our second generation and long acting <unk> two antibody.
Clinical trial application is planned for submission next quarter and Oems $10 29 remains on track to begin enrolling its phase one trial this summer.
We expect that <unk> $10 29, we will be able to be dosed subcutaneously or intravenously at a frequency of once monthly.
And perhaps even once quarterly.
We expect that all of them is $10 29 will allow us to pursue different.
And complementary sets of indications for this molecule.
Our planned for in our supplement.
In addition to Oems $10 29 for subcutaneous delivery, our small molecule mass II inhibitors continue to progress.
Designed for once daily oral administration, we look forward to moving a lead candidate when ready into the clinic.
Turning now to <unk> 906, which is our antibody targeting <unk> three.
Our phase one clinical work in healthy subjects is now complete.
And shows high levels suppression of alternative pathway activity.
Favorable pharmacokinetics.
And a good safety profile to date.
We're moving ahead with our phase one b trial in patients with paroxysmal nocturnal hemoglobinuria or <unk>, who have an unsatisfactory response to the C. Five inhibitor raviolis map.
A successful meeting was held between <unk> and the medicines and healthcare products regulatory agency or MH or.
To discuss the design and conduct of the phase one b trial and enrollment is expected to begin this summer we.
We expect that RMS 906, Unlike <unk> inhibitors will address both intra vascular and extra vascular hemolysis and PSNH and will have significant advantages over agents either on the market.
Or in development to treat <unk>.
And our phosphodiesterase seven or <unk> inhibitor program all of them as five to seven work is ongoing.
<unk> completed its phase one program in humans without a safety signal.
Given the resource constraints.
We had been limiting clinical activities. However, discussions are underway with an external funding source to accelerate clinical work.
If successful in accessing external financial support for the program.
We do plan to advance all of them as five to seven through additional clinical trials.
Finally, let's turn to our immuno oncology portfolio.
Part of our recent efforts have really revolved around methods to improve the potency and durability of adoptive T cell therapies are novel approach, which enforces memory phenotypes and cultured T cells through a previously unexplored pathway has.
<unk> marked tumor regression following transfer of expanded mouse T cells in an aggressive solid tumor model.
We continue to explore the universality of our approach in human car T and adoptive T cell therapy systems, and we believe our platform has the potential to improve markedly response rates for patients receiving either engineered or native T cells.
Therapies for liquid or solid tumors.
Furthermore, we continue to explore the effects of <unk> 174 inhibitors and other novel biologics in promoting anti tumor immune responses and overcoming the immunosuppressive tumor microenvironment.
With that I'll turn the call over to Mike Jacobsen, Our Chief Accounting officer for a more detailed discussion of our fourth quarter and year end financial results. Thanks, Greg.
As Greg briefly discussed on December 23rd Rainer acquired Omidria and the associated business operations, including the imagery of commercial and sales teams devoted to the product the.
The sale was accounted for as an asset sale.
Which required us to restate our financial statements into two components. The first being continuing operations in the second being discontinued operations for all of the historical periods presented.
This means that all imagery of revenue operating expenses and $306 million gain related to the sale of Omidria are shown in a single line on our income statement as discontinued operations.
All of our other activities are included in continuing operations.
I will provide more detail in a few minutes.
Also our Form 10-K provides additional details regarding the sale and I suggest you look there if you have any additional questions on the accounting treatment following our call today.
I would like to now summarize the deal and why we believe it is positive for <unk>.
We received an upfront payment of $126 million in December and retained all of our outstanding amid drea related accounts receivable.
Which amounted to $39 million as of the December 23rd closing.
We also have the opportunity to achieve an additional $200 million milestone payment.
Right to the achievement of long term separate payment from CMS.
The a major transaction includes royalties on all sales worldwide.
<unk> will continue to receive 50% of the net sales in the U S.
Until the earlier of either January one of 2025 or the payment of the $200 million milestone.
Thereafter, we will see 30% royalty on U S. Net sales for the duration of the <unk>.
Relevant patent terms, which will which extend to at least 2033.
We will also receive a 15% royalty on non U S. Net sales of Omidria over the life of the relevant patents.
From an overall standpoint, considering the U S royalties and a reduction in operating expenses.
We will receive approximately 70% of the U S operating profit when royalties are 50%.
And over 40% when the royalties or the royalty is 30%.
Turning to our actual results overall net income.
For the fourth quarter was $281 million or.
Or $4 48 per share.
The results include the $306 million gain on the sale of Omidria.
Without this gain our fourth quarter loss would have been 23 million or <unk> 37 per share.
This is consistent with the last quarter, where our net loss per share was $22 $7 million and <unk> 36 per share.
Our noncash expenses for this quarter were $6 3 million or <unk> 10 per share.
As of year end, we had $157 million of cash cash equivalents and short term investments available for general operations.
We also have $38 million in accounts receivable.
We are collecting this quarter.
As you May recall, we have an at the market sales agreement that allows us to sell from time to time up to $150 million of our common stock.
Fourth quarter sales from our merger are all included in discontinued operations as either sales or royalties.
On a GAAP basis, we recognized $30 8 million.
Of the sales as product revenue from pre closing sales of the midyear.
And $1 million as our 50% share of royalties on <unk> sales post closing.
Overall sales for Omidria in the fourth quarter, both pre and post closing was the $32 $9 million, an increase of $2 9 million or 10% over third quarter reported omidria revenues.
We are very satisfied with the overall fourth quarter sales of Omidria.
Sales in Afcs reached another all time high and overall sales for the quarter were nearly an all time high even though separate Medicare payment is not currently available in the hospital setting.
Together with <unk>, we are continuing to pursue a variety of options to ensure long term reimbursement for omidria.
On both the ASC and hospital setting as Greg mentioned earlier.
Achievement.
There would trigger the $200 million milestone payment to <unk>.
Continuing operating costs and expenses for the fourth quarter were $43 million.
This is an increase of $3 million from the third quarter.
Just due to the timing of additional in our supplemental clinical trial activities.
As Greg mentioned earlier in our call. We continue to gate on our supplemental sales and marketing spend until the timing of the FDA approval is clear.
As I've stated previously we do continue to expense in our supplement manufacturing costs until timing of approval in the U S is certain.
Interest expense for the fourth quarter was $4 $9 million and consistent with the previous quarter.
Net income from discontinued operations for the.
Year is $386 million and includes the $306 million gain on the sale of merger as well as the $80 million and net operating profit from our midyear prior to the sale to Rainer <unk>.
The gain on the sale of a midyear has two key components.
Up front cash payment of $126 million that we received upon closing in December .
And $185 million for the minimum expected net present value of future U S royalty payments.
These minimum expected future royalties are quite conservative for the following reasons.
One.
The objective and booking.
Yes.
Future royalty payments and ensure that no downward adjustment would need to be made to the assessment in the future.
Secondly.
The required accounting assessment of future royalties by definition is not fair not a fair value assessment.
Third.
The accounting assessment uses net present value with a double digit discount factor in the computation.
Another item for the assessment does not include any gain related to the $200 million milestone payment.
Because it's not yet.
Final certainty and five the assessment does not include any revenues from ex U S sales.
And lastly, the assessment includes a 20% effective tax rate.
And coming up with the amount and we expect most of that would be avoided through the use of our historic net operating losses.
Tax credit carryforwards.
Now, let's take a look at the first quarter 'twenty, two and the expected results.
Because we recorded $185 million future minimum amid where royalty payments on our balance sheet at closing in December of 'twenty one.
Cash received for royalty earned will primarily be recorded as a reduction in this omidria account royalty asset on our balance sheet.
Versus revenue in our income statement.
If and when we achieve the $200 million milestone event, we will record the payment as income from discontinued operations in our income statement.
I would also just our omidria contract royalty asset to reflect the reduction in expected.
Minimum future royalties earned as the royalty rate goes to 30%.
We expect overall operating costs in the first quarter of 2022 to remain essentially unchanged from those in the fourth quarter of 2021.
Interest expense for the fourth quarter should be consistent with the third quarter or approximately $5 million.
As we just discussed net income from discontinued operations should have minimal minimal amounts recorded as the imagery of royalties earned next quarter or in the first quarter will primarily be recorded as a reduction of the established omidria contract royalty asset value on the balance sheet.
With that.
I'll turn the call back over to Gregg Hey, Greg. Thanks.
Thanks, Mike Okay, operator, let's please open the.
The call to questions.
Thank you to ask a question you will need to press star one on your telephone to withdraw your question press the pound key.
Again, if you would like to ask a question press star one on your telephone.
Our first question comes from Eric Joseph with Jpmorgan. Your line is open.
Good evening, thanks for taking the questions.
Appreciating that you are still waiting feedback.
Our minutes from FDA, but.
Nevertheless, I'm wondering if you could just kind of walk us through some of the alternative scenarios going forward and Ta TMA with their south of that.
Would you be able to resubmit the BLA with.
The additional responses discuss the type a meeting.
Or if additional.
Clinical data are needed.
Would you look to conducted.
Additional study.
How do you prioritize that versus focusing on the ongoing programs. Thanks.
Thank you.
Let me take.
First answer to that and then I'll, probably ask others to to answer as well, but again I think it's obviously difficult for us to assess.
What we what we expect will need to do in the absence of the feedback from the last meeting as I said the last meeting we had with FDA, we felt was constructive.
And we.
We really went through each.
<unk>.
FDA has.
Stated issues.
And I think responded quite strongly to those.
And all really database.
With respect to.
Where we go and what we do I think we really need to see what comes back from FDA until then.
I would be.
I would be guessing and I'm not I'm sure. That's not what you want me to do but let me see I'll turn the question over to Cathy Melfi, our head of regulatory and Kathy do you want to add anything to that.
Again, just to reiterate that the <unk>.
Meeting, we have with that view is constructive waiting for their feedback and so we really can't speculate on what that might be but again just to reiterate that the data for <unk> and Ta TMA are strong and we feel that the BLA submitted merits approval, but right now.
We're still in a waiting game.
Thanks.
I think again.
Summing up.
We think that we should be able to resubmit with the data we have.
But we really need we need feedback and we need guidance and right now right now we're waiting for that is as Im sure you are.
Okay, great. Thanks for taking the questions and for the color. Thank you Sir.
Thank you. Our next question comes from Greg Harrison with Bank of America. Your line is open.
Hey, good afternoon, thanks for taking the question.
Hi, Greg Alright, Hey are you able to provide any other <unk>.
Details as to.
The additional information that was requested.
And maybe whether your response to the Crs contained any additional data or or if it was more.
Explaining your take on the.
The data that you provided in the initial BLA and then if you have any.
A description you could provide of that.
FDA has receptiveness to your arguments during that meeting.
Sure well first I would say that a lot of.
Our responses to these stated concerns from FDA.
I would characterize really is clarification.
The existing data.
And perhaps.
Re presentation of existing data to address.
Are those issues with respect to with respect to Fda's.
Response.
As you know, that's often very tough tough to read.
And I wouldn't want to speak for.
For FDA at this point other than to say.
We await we await their responses to what we think.
It was a very strong package and a very strong set of responses to those issues, but again, let me ask.
Steven Whittaker, our head of clinical or or again Kathy Murphy.
Please feel free to add anything you'd like here.
Greg I agree with you.
It's hard to read FDA, and we don't comment on FDA interactions anyway, but the data that we have a strong we had strong responses to each of the points. They raised and we addressed every point that was raised in the <unk>.
And.
In my view that the BLA does deserve.
Approval on deserve approval first round and certainly now with our responses.
That should clarify things for FDA in my view.
Yes.
And I would just reiterate is as we said when we received the <unk> that there were questions that really.
Got into that.
Characterize the complexity of the disease and the patient population. So it was important for us to provide some clarification until as Greg said a lot of it was really.
Re clarification of some of the data and we feel that our responses were strong and again the meeting was constructive.
Great. Thanks, if I could sneak one more in on another topic.
What are the steps.
Going forward now.
Then our staff on the arm is completed within the I spy trial.
Is there anything you can imply is too.
The efficacy, we could see or just the results in general just considering the length of time that our stock was included in the trial.
Steve would you like to.
Sure.
I doubt this will be a very satisfactory answer but this is as you know the ice by group is very hands off with the.
Providers are the drugs that are included in that trial.
Right now, we're just looking forward to that.
Getting the dataset so the full dataset and we can then.
Yeah.
At that point, all the analysis can be done and we can have.
Then we will publicly disclose the results.
I have to make sure I haven't I've never even talk to these people so.
Got it well thanks for answering the question sure.
Thank you. Our next question comes from Rob <unk> with HC Wainwright. Your line is open.
Thanks, very much for taking my questions.
I was wondering if you could elaborate on specifically what you expect the usage pattern of our supplement to be in Ta TMA. If it is approved and to what extent you anticipate.
Use might succeed the deployment of vacuous map.
So let me take.
I'll answer that maybe at the at the back and move forward.
With the approval of our supplemental that will be the only drug approved.
In stem cell TMA, so I think that that would make the use of really any off label drug for Ta TMA.
Difficult.
First.
So.
I think.
I think that becomes pretty clear.
With respect to usage pattern.
Yes, I will look to.
To Steve and to not yet too.
To answer that from clinical and perhaps a commercial perspective.
Sure I'll take the first crack from a clinical perspective.
<unk>.
Population. We studied I think as you all know is a high risk population that high risk population is actually a large population and these patients can deteriorate quickly and Phil I think that.
The.
With approval ourselves from them would be you.
Used in.
Substantial percentage of these patients because they do have so many of them have these risk factors I think two thirds had gvhd I'm going off the top of my head now and this data has been presented 80% had infections something like that so a very large number of these risk factors of the entire Ta TMA population and I think that that pace.
<unk> do poorly and can deteriorate so quickly physicians with an approved drug would want to use this pretty aggressively.
And the only thing I'll add is just a reminder, that the diagnostic code with also approved back in October and so prior to this we haven't had that for Ta TMA.
Which may make it even more difficult for off label use.
<unk> if approved would be the only one approved for Ta TMA.
So.
Yes, I think what you are hearing as we think.
Pattern of utilization.
Would be would be strong.
<unk> would be the only FDA approved product in that space.
And the data I think are pretty clear the one thing I would add is I think I mentioned.
The work that's being done by the expert.
<unk> of transplant.
Who are looking through their data and identifying.
Really criteria for diagnosis of Ta TMA and I think that's going to be helpful.
When that ultimately is solidified and published.
I think that.
That would likely increase.
The number of diagnoses or the frequency of diagnosis in Ta TMA remember this is still largely.
A condition.
That.
That.
Is used.
Where physicians use.
A number of different sets of criteria.
And I think that makes it a little more difficult a.
Unified consistent.
Set up of diagnosed diagnostic criteria I think will only serve to increase.
That that base and I think by extension utilization of nurse thoughtful about.
Great I was just wondering also if you had any further clarity regarding the timing of potential topline data released from the Artemis <unk> trial.
Even the commentary that enrollment has accelerated and if.
You think it might still be possible for us to see that data before the end of this year.
No I think realistically that's going to be in into as I said, the first part of next year.
Team's working very hard to do it.
No.
We are hospital based.
So enrollment is a function of being able to access those hospitals and in the setting of Covid.
That that can be quite a challenge so we're pretty pleased with the progression.
The enrollment that we've seen as I said.
When we look we've even seen acceleration.
But I think realistically ROM I would rather guide you.
Into 2023 for those data.
We're excited to see them.
Think that the phase two long term three year data, our nearly three year data.
Really demonstrate an unprecedented picture.
In effect not only on proteinuria.
But.
Estimated glomerular filtration rate or Egfr.
And I think what we're seeing with our sample a mab.
I know I, just called that unprecedented but I want to underscore it hasnt been seen with.
If any other drug.
So we are excited to see the data.
Renal experts are excited to see the data.
Believe me, we're pushing as hard as we can to get those out.
Thank you very much and then the last question is if you have any additional thoughts or perspective on the positioning of <unk> in COVID-19, given the rise not only if the omicron varian, but some variance in that lineage and the fact that multiple therapeutic antibodies that we're in.
Originally approved for use against Sars Kobe too do not appear to have retained significant binding activity versus omicron and.
What.
Potential opportunities this may create Kronos software mab as a novel non.
Sars Colby two binding antibody therapeutic within COVID-19.
Well, yes, and I think Ron what Youre pointing out was not unexpected to you or to many men when when you are targeting.
Spike protein or other parts of the virus and what we know is that this virus mutates like other viruses do but this virus seems to have a very elegant escape mechanism.
For mutation and largely driven by the spike protein.
So the advantage that we see here with <unk>.
Is that.
The effect the beneficial effect of <unk> would be <unk>.
Downstream.
From from that.
Specific virus or the spike protein and protein any of that the focus of our <unk> is not on the virus. The focus of <unk> is on the damage that the virus risks.
And thats the endothelial damage, so really and our thoughtful of map.
Is not subject would not be subject to the same limitations that the antivirals are.
And.
To be more specific isn't affected or shouldn't be affected by by the mutational changes in the virus all of those all of those virus.
Virus.
Mutations that you have noted all effect the endothelium and the same way.
And then create the disease and that's where our sample of map works now I mentioned some of the data and really.
I should underscore some of the discoveries.
That have come out.
Of our collective group here at <unk> and in our labs at Cambridge, and those I expect will be published soon.
Theyre already submitted but what those studies show I think will be.
We'll be illuminating.
For for many.
And I think.
Our focus which is part of your question we are looking at treatment.
But we're looking beyond treatment.
We're also looking at past or the <unk>.
Post acute sequela of Sars Covid two.
Pask or long long haul disease or long Covid. However, you want to refer to it.
I think that based on what we're seeing.
And are again, primarily in our Cambridge labs that.
The lectin pathway may very well be.
A driver.
Long COVID-19 .
We have to we have to do more work to to have that borne out but early on.
I think that looks pretty promising.
So we're not just focused on treatment.
We're looking at how we meaning treatment of the acute disease, we're focused as well on how we can treat.
The long COVID-19 or past.
Thank you.
Thanks, Rob.
Thank you. Our next question comes from Brandon Folkes with Cantor Fitzgerald. Your line is open.
Hi, Thanks for taking my question and congratulations on the progress maybe just a quick one from me just coming back to supplement in stem cell TMA just given your interactions at the <unk> meeting.
If the agency did come back and say.
We agree with your robust piece Resubmit do you expect an AD com to evaluate that data or do you expect.
Should you not have to do additional clinical work. Thank you.
Hi, Brendan.
I think again, we have no basis on which to make.
Any statement about a potential outcome other than to say that.
We have discussed Ad com.
More more than once with FDA during the review process.
And.
And the response was that an outcome would not be necessary.
But other than that I have no no basis to make any.
Any statement or guide you in anyway.
With respect to an outcome.
And Greg would you be able to maybe just elaborate if.
Do you feel an AD com could actually be a beneficiary beneficial infectious situation just given the reality of it.
This disease I think.
First company, we've seen where I think the company feel the FDA.
May is not fully understood disease.
Because it makes me decision.
Are you prepared to comment whether you think headcount if it would happen would actually be favorable.
Well Brandon are you trying to talk me into an AD com.
I just think it could be favorable could you a pleasant.
I would like to tell you.
I can tell you what happens when we lay the data out in front of expert transplant. Okay.
And that is a uniform.
Our valuation and then determination that what we have identified as responders.
Our responders and again I'll just underscore the uniformity.
<unk> of that.
That response.
Or that assessment.
To date.
<unk>.
Do I think that.
Experts understand the data.
Yes, I do and that's not surprising. This is a this is a complex disease and Ta TMA is a complicated disorder on top of a complex disease.
So.
Not surprising that that.
The experts.
We'll be able to interpret data that other.
Skilled people.
May have more difficulty.
Sorting out.
So I guess, let me let me start my answer there but.
We know we know how the data are viewed you see it yourselves I mean, youre going to see at <unk> BMT again.
Why why are we getting the requests for compassionate use.
So.
Let me stop there and see.
<unk>.
If you've got any follow up questions.
No that's okay I appreciate that I appreciate it.
Okay.
Thanks, Greg.
Thank you and we have a question from Serge Belanger with Needham Your line is open.
Hi, This is Robert on for Serge. Thanks for taking my question in terms of our supplement or is there any.
Scenario, where you don't move forward with it and in that scenario what becomes the next focus pipeline.
Well, one I think and how are you doing a search sorry. Thanks.
One I think look it is entirely premature to address any thought that we would not move forward with our supplement the data for in our supplemental that we see in that the experts are pretty clear.
And as I think Cathy you mentioned earlier and as I mentioned in our prepared.
In our prepared comments.
<unk>.
We believe and this is a.
Hey.
A shared belief we believe that.
And our thoughtful of map merits approval that it meets or exceeds the threshold for substantial evidence of effectiveness.
And.
All of the components. We believe are there so for us to abandon that.
Is really not even in our thought process or lexicon at this point we think.
The drug warrants approval, we think that we will get there with FDA and we're hoping we get there soon.
But again.
I can't comment other than to say, we're awaiting we're awaiting a response.
But.
With respect to what other things we have in the pipeline. In addition to Ta TMA and our supplement for Ta TMA.
We were focused on Iga nephropathy.
There is a list of other indications on our whiteboard that we are targeting not only with in our supplement but with our EMS $2 29.
As our long acting <unk>, two inhibitor and as I said, we really see a set of indications for <unk> four in our supplemental and we see a complementary set of indications for a long acting subcutaneously delivered or IV delivered.
<unk> $10 29.
And then we have another set of indications.
All tied to LMS, 906, which targets <unk>, three which we believe and others believe is the key activator.
The alternative pathway in the Premier target.
The alternative pathway and we're moving fast and hard on that as well as I said, we plan to be enrolling <unk> patients.
Summer with <unk> 900, <unk> so.
The franchise around complement for <unk>.
As is broad and it is deep.
And we see Ta TMA as as the first step there.
Certainly certainly not the last.
Thank you.
Thanks.
Thank you and I'm showing no further questions in the queue I would like to turn the call back to Dr. <unk> for closing remarks.
Thank you operator, and thanks again, everyone for joining us today.
We've discussed we're confident in our financial position and in the strength and value across our programs.
In our supplement we hope to bring our second product markets soon and we look forward to what 2022 holds for the rest of our pipeline as.
As always we appreciate your continued support and have a good evening. Thank you.
Thank you. This concludes today's conference call. Thank you for participating you may now disconnect everyone have a great day.
Okay.
Thanks.
Okay.
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