Q4 2020 Omeros Corp Earnings Call
Ladies and gentlemen, this is the operator todays conference call and once again.
And until that time.
We continue to hold and thank you for your patience.
Thank you you're on mute.
And enjoy the conference begins.
[music].
Good afternoon, and welcome to todays earnings call and for.
Corp.
At this time all participants are in a listen only mode. After the company's remarks, we will conduct a question and answer session.
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 over to Jennifer Williams Investor Relations folks.
<unk> four O Maris.
Good afternoon, and thank you for joining the call today, Dr. Greg Demopoulos, Chairman and CEO of all Narrows would take with you through a corporate update and then Mike Jacobsen, Our Chief Accounting Officer will provide an overview of our fourth quarter financial results. We have some time reserved for questions. After the financial overview 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 companys actual results to differ materially. Please refer to the special note regarding forward looking statements and the risk factors section.
And the company's annual report on form 10-K, which was filed today with the SEC for a discussion of these risks and uncertainties.
And now I would like to turn the call over to Dr. Democracy.
Thank you Jennifer and good afternoon, everyone. We appreciate you joining us for today's call.
And I will start today with.
And our supplement and our supplement is our fully human antibody targeting mask to the effector enzyme of the lectin pathway of complement.
And January FDA accepted our BLA for priority review for the treatment of hematopoietic stem cell transplant associated thrombotic microangiopathy or Ta TMA.
Priority reviews Shortens Fda's review period from 10 months to six months as a result of the Paducah date is July 17th.
We have continued working closely with the FDA during the review of our BLA.
As we prepare for the anticipated approval and commercial launch of and our supplemental for Ta TMA.
We're very excited to have recently welcomed naughty and dock to our senior leadership team as Chief commercial officer.
Naughty and brings an impressive breadth and depth of leadership General management and launch experience on places like Alder on which was acquired by Lundbeck Abbvie Novartis and Pfizer.
A valuable addition to our Melrose Nordea is already contributing to what we expect will be a successful launch of and our supplement and the continued growth of Omidria.
As those who have followed our progress and know we have been executing for well over a year on our launch strategy for and our soft <unk> and Ta TMA and.
And launch readiness activities continued to progress throughout the fourth quarter of 2020.
Our sales leadership team has already been hired and is comprised of talented individuals with deep experience and stem cell transplantation hematology and oncology.
With strong engagement from the transplant community our disease education efforts are successfully driving increased awareness of Ta TMA.
And market research demonstrates our growing understanding within the transplant community of the central role of the lectin pathway and the pathophysiology of Ta TMA.
As part of our and our supplementary launch activities. We have also been focused on securing appropriate reimbursement.
During the fourth quarter, we completed the filing and presentation and required to obtain a new technology add on payment or and tap.
Established by CMS and.
And tap as a special payment methodology that applies to new medical technologies, such as in our supplemental.
That will be administered and the hospital and patient setting.
And tap provides an additional payment of hospitals above Medicare standard all inclusive DRG payment.
We believe that and our supplemental qualifies for an untapped designation and we look forward to the posting of the untapped interim rule next quarter.
As part of our reimbursement efforts. We also applied and have received preliminary support from CMS for ICD 10, procedural and diagnostic codes for and our supplemental.
Across the untapped designation and ICD and codes. We are closely collaborated with key transplant societies and organizations and we appreciate the strong support that these groups have provided.
They include the center for international Blood and marrow transplant research.
The American society of transplant and cellular therapy or TCT.
The American society of hematology, the pediatric transplantation and cellular therapy consortium.
B and the match National bone marrow donor program, the European Society for bone blood.
Blood and marrow transplantation or BMT.
And the Ta TMA guidelines working group, which consists of some of the most respected transplant physicians and the U S and Europe.
After 2020 annual meeting of the American Society of Hematology on Melrose presented on the pharmacodynamics of nurse thoughtful amount and humans and primates.
The presentation was subsequently published and the peer reviewed journal blood.
<unk> also had a significant presence at the 2021 TCT annual meeting in February including both a podium presentation by doctors Hammer Colette of city of hope on the pivotal clinical trial results with non <unk> and Ta TMA as well as a well and.
Tended on Merrell sponsored continuing medical education symposium focused on improving outcomes and Ta TMA.
Later this month at the annual leave BMT meeting and our supplement and Ta TMA again will be the focus of podium and other presentations.
Now, let's turn to the work, we're doing with <unk> and COVID-19.
While continuing to execute on launch preparations for Ta TMA.
We recognize the role that and our supplement can play and.
And our obligation to participate and fighting the current global pandemic.
For these reasons, we continue advancing our thoughtful and mab as a treatment for critically ill COVID-19 patients.
We've previously discussed the similarities between Ta TMA and COVID-19.
Both our endothelial injury syndromes, meaning endothelial injury is that the pathophysiological core of each.
<unk> and our collaborators were among the first to recognize the importance of endothelial injury and COVID-19.
Key to treating COVID-19, now widely confirmed by leading research groups internationally.
The lectin pathway of complement is activated by cellular damage and microbes.
And COVID-19, the select and pathway activation occurs very early and the disease process.
Further mask to the effector enzyme of the lectin pathway is directly bound and activated by the nuclear capsid and spike proteins on the Sars Covid two virus.
The collective result of all of these events and COVID-19 is that very early and the disease.
<unk> and pathway is activated which then leads to hyperinflation.
Hyper inflammation and hyper coagulation or clotting, all of which are addressed by inhibition of masks to with and our Sop from map.
Following the first cohort of six critically ill COVID-19 patients and Bergamo, Italy, we have continued treating patients with <unk> under compassionate use to date nine more in Italy, and four and the U S.
Prior to receiving and our supplemental all of these patients were innovated some for as long as two weeks and had multiple comorbidities.
All had failed other therapies, including anti Virals targeted anti inflammatory therapeutics convalescent plasma and steroids.
These were all severely ill patients and.
And following treatment with our supplement the laboratory improvements and clinical outcomes are consistent with those seen in the initial cohort of Bergamo patients and published and immuno biology.
Of note the and our supplement treated patients for whom serology data are available show appropriately elevated levels of antibodies against Sars Covid two.
And these devin straight as expected.
And that and our sample a mab does not interfere with the patient's adaptive immune response, which is important for fighting infection.
This is one of the significant advantages of nurse thoughtful them out over other potential therapeutics for COVID-19, and.
Including other complement inhibitors day.
Data collection is wrapping up a manuscript detailing the findings and clinical outcomes on the second cohort of Bergamo patients is and preparation and we look forward to sharing those data soon.
Long term sequela or complications from COVID-19, and are now widely recognized.
Longitudinal controlled study recently published in Jama network, followed patients for up to nine months.
And shows that about 30% of even mild COVID-19 cases have significant and persistent problems.
To this point evaluation of the initial cohort of Bergamo patients at five to six months after treatment with <unk> supplement demonstrated no clinical or laboratory evidence of long term sequela.
We are considering now studying the role of and our supplement not only and preventing but also in treating long term sequela of COVID-19.
The interest in our supplement for the treatment of COVID-19 is growing internationally and.
In addition to advancing discussions with U S government agencies and advisors to the New administration, we are on talks with regulatory authorities in Europe.
And our global health care organization regarding potential funding manufacturing support and or additional clinical trials for and our supplement or and the treatment of COVID-19 patients.
Now part of the ice by Covid trials sponsored by quantum Leap health care collaborative and funded in part by BARDA with sites across the country and our supplemental dosing in this study is expected to begin very soon.
The ice by Covid trial utilizes and adaptive platform design intended to increase trial efficiency by minimizing study patient numbers and duration.
And our supplement is the only complement inhibitor invited to participate in the I spy trial.
In addition to our work within our supplemental and COVID-19, and Ta TMA, we have two ongoing phase III programs for and our supplemental and one in Iga nephropathy, and the other and atypical hemolytic uremic syndrome or <unk>.
Our phase III Artemis <unk> trial, evaluating and our supplement for the treatment of Iga Nephropathy now has over 120.
Sites activated worldwide.
While the pace of enrollment slowed some with the COVID-19 pandemic.
We expect to see enrollment to accelerate as pandemic restrictions ease.
We also are working with a leading CRO to bring the Artemis <unk> trial to additional geographies, including China.
Regulatory applications are underway and once completed we expect that this geographic expansion will significantly accelerate the pace of enrollment.
For example, Iga nephropathy is highly prevalent and China.
Approximately 25% of all dialysis patients in China reportedly of Iga nephropathy.
Even without the easing of Covid restrictions internationally, we expect that expansion across additional geographies will help the Artemis <unk> trial to closeout enrollment.
And we look forward to reading out the trials proteinuria data next year.
To the best of our knowledge and our supplement is the only drug in development for Iga nephropathy that can obtain full approval on proteinuria data alone.
As in Ta TMA and COVID-19, a growing body of research conducted by multiple international groups of leading experts increasingly supports.
The central role of the lectin pathway, and Iga nephropathy and more generally.
And progressive renal diseases as a whole.
In addition to the lectin pathways central role and producing <unk> inflammation.
Endothelial injury, and thrombotic Microangiopathy had been recently identified and glomerular capillaries. These.
These TMA lesions are seen and 10% to 15% of Iga nephropathy cases and are associated with a greatly accelerated path to end stage renal disease.
Lectin pathway activation has also been shown to play a key role and the development of tubular interstitial inflammation and fibrosis. The final common pathway to kidney scarring.
There are no drugs approved to prevent this kidney scarring and to date chronic kidney disease has been widely considered untreatable.
The data suggest that inhibition of the lectin pathway by and our supplement could possibly be a treatment not only for Iga nephropathy, but more broadly.
For progressive and chronic kidney diseases as a whole.
As part of this increased understanding about the central role of the lectin pathway and kidney disease last October.
The annual meeting of the American Society of Nephrology on Merrell sponsored a symposium featuring presentations by international experts on progressive and chronic renal disease.
Our focus of the symposium was the mechanism and rationale for lectin pathway inhibition as a treatment for renal disease and provided an overview of the phase III clinical trial results of <unk> and Iga nephropathy.
While preparing to expand the indications explored for and our soft from a map.
We also are planning ahead to lifecycle management for our mass II and lectin pathway franchise.
We expect our second generation longer acting masked two antibody RMS 10, and 29 to enter the clinic early next year.
We are targeting for this antibody once monthly or less frequent subcutaneous dosing.
We're also advancing our program of small molecule <unk> two inhibitors for oral administration.
The role of the lectin pathway across a rapidly growing set of indications is increasingly recognized and understood within the complement community.
And we look forward to making our mass two inhibitors and all of their forms available to help patients.
Yes.
Like our mast two platform our other complement program on mass 906 is advancing quickly.
And that's 906 is our mass three inhibitor.
And we're building a broad and exclusive intellectual property position directed to mastery, which is the key activator and we believe the premier target in the alternative pathway.
Unlike our lectin pathway inhibitor and our supplemental for which we have had to blaze. The trail two indications given that our broad intellectual property position around the lectin pathway has effectively kept others from pursuing lectin pathway inhibitors. The alternative pathway has been successfully targets.
And by other agents across multiple indications.
So a successful phase one clinical program.
<unk> that on that 906 blocks alternative pathway activation has a good likelihood of translating to efficacy and those same and other diseases linked to the alternative pathway.
In September we began our phase one placebo controlled double blind single ascending and multiple ascending dose trial.
The trial is running on schedule and we continue to expect initial data readout from our phase one trial for <unk> 906 next quarter.
Now, let's turn to Omidria, our commercial ophthalmic drug used and cataract and lens replacement surgery.
The extension of pass through status for Omidria expired as scheduled.
On October one 2020.
And CMS packaged reimbursement for the drug within the ambulatory payment classification for cataract surgery.
Given that Omidria was and package.
It met all criteria for separate payment under CMS has established policy to pay separately and the ambulatory surgery centers or <unk>.
For non opioid pain management surgical drugs.
This was confirmed by CMS in December 2020, making separate payment for Omidria.
Effectively retroactive to October one.
We anticipate that CMS will continue its policy to pay separately for non opioid pain management surgical drugs as it has done since 2019.
Because CMS has already determined on omidria qualifies under the policies objective criteria, we expect that Omidria will continue to be separately reimbursed when used and the ASC setting.
Given that CMS did not issue its decision to restore separate payment for Omidria until December utilization of the drug and the fourth quarter was limited.
Net revenues from the sale of Omidria and the fourth quarter, we're still $10 $6 million, reflecting both customer demand and fourth quarter units sold.
Our net loss for the fourth quarter was $37 3 million or <unk> 60 per share.
Of which three and $5 million or <unk> <unk> per share were non cash charges.
As of December 31, 2020, we had available for general operations of $135 million of cash cash equivalents and short term investments and up to an additional $50 million through our accounts receivable based line of credit.
And the first quarter of 2021, we have seen a sustained and continuing recovery and the number of purchasing facilities as well as and daily average sales volume.
To accelerate uptake of Omidria. Among ASC is one of our areas of focus has been establishing partnerships with ASC chains and groups of Alc's owned and operated by private equity groups.
And we're pleased with our progress.
As we have experienced with Omidria January and most of February are historically slow months.
For ups Almac surgical procedures in general.
March However is one of the strongest months for cataract surgery volumes and we look forward to seeing how omidria sales closeout the current quarter.
CMS is confirmation that omidria qualifies for separate payment and <unk> was a significant milestone for <unk>.
We also continue to expand reimbursement among Medicare advantage and commercial payers and.
In addition, the coalition for non opioid choices has continued to lead a large broad based alliance, including the American Medical Association. The ambulatory Surgery Center Association. The American Association of colleges of nursing and the National Safety Council.
To pass into law, the non opioids prevent addiction, and the nation Act or the no pain Act.
With strong bipartisan and leadership support and both chambers of the 116th Congress. The note <unk> sponsored.
Numbered 63, and the house of Representatives, and 25 or a quarter of all U S. Senators.
A large majority of those sponsors have remained and office for the new 117th Congress and we expect support for the Bill to continue to grow.
And the no pain act is expected to be reintroduced in the Senate.
This week and in the house soon thereafter.
I think we all agree that opioid addiction continues to ravage or country and this tragedy has only worsened during COVID-19.
In December the U S centers for disease control reported that the rate of overdose deaths has accelerated throughout the pandemic rising.
38, 4% during the year, leading up to May 2020.
Driven primarily by abuse of this synthetic opioid fentanyl.
As you might recall and 2019, the journal of cataract and refractive surgery published the results of a 60 patient prospective double masked controlled study demonstrating that use of omidria in cataract surgery reduced the need for intraoperative fentanyl.
Nearly 80%, while concurrently decreasing pain scores by approximately 50%.
And a subsequent prospective double masked randomized controlled study and 112 is using a similar design and generating similar results.
Showed that again omidria reduced both fentanyl use and pain scores.
And a manuscript detailing these data is being submitted for publication.
Consistent with previously published clinical data showing that omidria significantly reduces the incidence of sight threatening cystoid macular edema, while precluding the need for perioperative steroids, and new studies, showing that omidria significantly decreases retinal thickness and macular edema and cataract surgery.
Has been selected for podium presentation at the upcoming 2021 annual meeting of the American Society of cataract and refractive surgery.
Now, let's look quickly at our phosphodiesterase seven program on that five to seven.
Here again, we control abroad, and exclusive intellectual property position. This one covering pds and <unk> inhibitors for the treatment of addiction and compulsion.
As well as movement disorders.
Having successfully completed a phase one clinical trial continued clinical development and this program is subject to allocation of financial and other resources, which are currently prioritized for other programs.
We will close our program update today with GP or $1 74 for cancer immunotherapy.
<unk> hundred 74 is and immuno suppressive G protein coupled receptor.
Around which <unk> is also building abroad and exclusive intellectual property position.
We have found that and mouse tumor models <unk> 174 deficiency enhances T cell proliferation.
And tumor, killing phenotypes, leading to markedly reduced tumor growth.
Importantly, <unk> 174 is activated by products of the tumor micro environment, specifically phosphatidylserine on Lysophosphatide, all sharing our PFS and <unk>.
These molecules are released during processes associated with tumor growth include.
Including the proliferation and depth of tumor cells and tumor associated immune cells.
Cell death is also caused by radiation and chemotherapy, commonly used to treat cancer and we believe that <unk> 174 inhibition will be necessary to maximize the tumor killing immune responses. Following these frontline cytotoxic therapies.
Because the mechanism of action of <unk> hundred 74 separate from those of clinically validated checkpoint molecule <unk> four and PD one.
Combination with a <unk> 174 inhibitor should improve response rates observed with existing checkpoint inhibitors, such as your boy and Keytruda.
Furthermore, <unk> 174, and the identity and receptors utilized the same immunosuppressive cyclic A&P signaling pathway and we have found in multiple in vitro systems that combined inhibition of <unk> 174, and adenosine receptors Synergistically enhances T.
Cell activation and tumor killing phenotypes.
We plan to publish these data and the near future and our team is aggressively developing both small molecule and antibody inhibitors of <unk> 74 to unlock the potential.
Of what we view as a very exciting new cancer immunotherapy target.
With that I'll turn the call over to Mike for an overview of our fourth quarter financial results.
Thanks, Greg.
And as Greg noted, our midway and total revenues for the fourth quarter were $10 6 million or net loss for the quarter was $37 $3 million or <unk> 60 per share and non cash expenses were $3 $5 million or <unk> <unk> per share.
Reoccurring non cash expenses are usually around six $5 million to $7 million or 12 to 13 per share.
During the fourth quarter, we recognized non cash income tax benefit of $4 $2 million related to the issuance of our 2026 conferred on convertible unsecured notes.
Recognizing this benefit reduced our overall non cash expenses by seven cents per share.
As of December 31, 2020, we had $135 million of cash cash equivalents and short term investments.
Bailable for general operations.
We also have on accounts receivable baseline of credit, which allows us to borrow up to $50 million based on 85% of our available accounts receivable borrowing base less certain reserves.
Here are some additional details regarding our fourth quarter, 'twenty and 'twenty results compared to the third quarter.
Of last year.
Third quarter of.
2020 on revenues for the fourth quarter were severely affected by the uncertainty around the.
Bel ability at separate payment for Omidria following the October 1st exploration of pass through reimbursement.
During the period from mid September through December, 2nd and which time CMS confirmed that omidria qualifies for separate payment in the eight <unk>.
Sales to our wholesalers were greatly reduced once CMS announced confirmation of separate payment sales improved and then we entered the holiday season. Some customers also weighted for their respective regional Medicare administrative contract.
Or Mac, who posted on its website cms's decision and reimbursement details from midyear.
Verifying cms's decision to pay separately for Omidria.
By the end of January of 'twenty, one all Max had posted the correct omidria reimbursement information and were appropriately reimbursing for the use of the drug.
During the fourth quarter, we reduced our previously reported reserve for wholesale of returns as you may recall and the third quarter, we recorded an $8 $7 million return reserve due to the uncertainty surrounding omidria reimbursement.
Subsequent to receiving separate payment we reduced this reserve by $5 $7 million as the imagery and drug product at our wholesalers is now expected to be fully utilized.
The remaining $3 million is being recognized through incremental purchases and the first quarter of 2021 is a S sees increased their usage of Omidria and restock for the product. They returned to US following the exploration of reimbursement on October one 2020.
Our fourth quarter gross to net deductions, excluding return reserves were generally consistent with prior quarters.
Costs and expenses for the fourth quarter were $44 $4 million or $7 $1 million less than the third quarter.
The relatively higher expenses in Q3 were primarily due to an outgoing $5 million technology license payment.
Made during that quarter to ensure that all mass nine O six can be manufactured for potential commute commercial use without impediment.
Interest expense for the current quarter was $8 million and included a full quarter of interest on the 'twenty and 'twenty six convertible notes. This was in line with our expectations.
As we mentioned earlier, we record an income tax benefit of $4 $2 million related to the issuance of the 'twenty and 'twenty six convertible notes. This was recorded in the fourth quarter rather than in the third quarter due to inter period income tax allocation rules.
Looking ahead, we assume separate payment by CMS for Omidria and the a S sees will continue and.
Any change to that reimbursement will require a fundamental revision to CMS as broader policy to pay separately for non opiate pain management drugs used during surgery.
Accordingly, we are confident that a midyear revenues will increase significantly and the first quarter of 'twenty, one compared to the fourth quarter of 2020 and.
And as previous ASC customers continue resuming their use of omidria and as the ranks of new customers continues to grow.
We expect our research and development expenses for the first quarter of 2021 will be slightly higher than in the fourth quarter of 2020, as we continue our ongoing <unk> phase III programs.
And Manny if manufacturer additional commercial drug supply.
In preparation for the expected market launch and subsequent sales growth and our Sop and map for the treatment of Ta TMA.
As we've previously explained manufacturing costs are generally expensed as incurred.
Rather than included as inventory.
Until regulatory approval is highly assured.
SG&A costs are expected to increase from the first quarter and across the year driven a good part by the hiring of non <unk> focused field sales staff and.
And Ta TMA launch preparations.
With that I'll turn the call back over to Gregg Hey, Greg Thanks, Mike.
Operators, let's please open the call to questions.
And ladies and gentlemen, as a reminder to ask a question and that is start and one on your telephone.
First question.
And then.
Steve Zach Debbie.
Debbie.
Hey, good afternoon, and Greg and thanks for taking the questions just one and a follow up on after that please.
Can you give more clarity on <unk>.
On midyear, because one of the things that <unk> done.
And then I'm reading into this is specifically that you received reimbursement.
Authorization as of December but December was a short month, given the holidays and everything else. So can you be more specific and how many weeks you actually had.
And for selling for Omidria and.
I'll give you a follow up after that please.
Thanks, Steve well as you point out CMS restored separate payment for Omidria and early December.
So youre right I mean this this quarter was it was a relatively short quarter we.
A lot of the.
Customers ASC is and and H O P DS.
Just like anyone else don't like uncertainty and.
And the fourth quarter.
And was filled with uncertainty with respect to omidria reimbursement until up until CMS decided.
And confirmed.
That it would be restoring separate payment in early December once that happened I think as Mike pointed out sale.
Sales again picked up but it is as you understand.
During the holiday season and surgical procedures.
Largely grind to a halt so.
That likely affected sales, but we're quite pleased with what we saw on the fourth quarter and were.
Again pleased with what we're seeing as our progress and and Q1.
Okay.
Thank you for that a more detailed explanation and go.
Bank tuner supplement on.
And it was I think.
Time early last week, where and Francis Collins, basically started going out there and I remember memorialized thing specifics around the long haulers and and I think it was just about 1.15 billion for long haul or investigation and long haul or resourcing over the next three years can you give us more detail.
About how you're proposing to look at nor supplement specifically for long haulers, because obviously I know that youre looking at it specifically for the treatment of serious patients, but what can you tell us and as much detail on the on the long haul or side and why that would make sense and I'll jump back in the queue. Thank you sure.
Well first we are aware of the NIH initiative as you said, it's a $1.15 billion initiative to look effectively at the sequela.
Of Covid, so looking at the long term sequela and complications.
Of patients whose initial symptoms.
Symptomatic disease has resolved. So this this is as I think I mentioned in the prepared comments.
And area of.
Increasing recognition and concern.
And what we do know about the patients treated with our supplemental.
Is that those patients for whom we have data which includes the entire first cohort.
Of the Bergamo patients show no evidence of sequela, and when I say no evidence I mean, no laboratory or clinical evidence of sequela and.
And for other patients that we have treated for whom we have data.
Again, we have not seen any evidence of long term so quality. So it's interesting.
Again, we're not talking about large numbers.
But when you look at the percentage of.
Patients across the spectrum for those who have.
And Covid.
Those percentages are pretty hot.
So perhaps one would have expected that you would have seen some signal of long term, so quality and the patient is treated with our supplement but we have not seen any.
So again this is an interesting area, we believe that the long term sequela.
Or a good part of them.
And are tied to endothelial injury.
Which again matches I think quite well the mechanism of action of nurse thoughtful amount and specifically the pathophysiology tied to the lectin pathway.
So we see an opportunity here.
And again, we're familiar with that initiative and.
And as I said earlier, we are considering looking not only at.
Potentially preventing those sequela, but are also treating those sequela.
Well great. Thank you for thank you for that detail and obviously, we're looking forward to what happens and the results. So let me jump back into queue. Thank you again.
Thanks, Steve.
And your next question comes from the line of Alice and metal King with UBS.
And thank all businesses and so Paulo.
And then.
Okay and then.
Questions.
We have been from it does flow trials and <unk>.
And with <unk>.
And keeping the dealer channel.
And we will.
Anthony Scali involvement and west.
And by the pump on that.
And could you expand on licensing.
And yes.
Hi, Dan Charles and.
And.
How do you feel.
Sure.
Potential enrollment and <unk>.
Sure Thanks al as well.
As we've seen in other trials not just in the Iga trial, and meaning not just and <unk> trial, but as you point out and other trials.
Trials that are are largely are in good part hospital based and are experiencing.
Challenges and enrollment just because of.
A specific hospital restrictions around page.
Patient access and also around screening et cetera.
So we are continuing as I think I mentioned to expand the number and the geographic regions from which we are drawing patients.
But we also look to the easing of these COVID-19 restrictions to help accelerate that enrollment.
I think though again as I mentioned, even without we aren't counting on.
Those restrictions being lightened or removed we are continuing to approach. This as if those restrictions will stay in place.
And that's why we're increasing the number of sites and expanding those geographic regions from which we're drawing.
Does that answer your question.
Yes, Thank you and why.
And Jamie I think.
And David the disease itself.
Starting with Sangamo.
And this problems and involvement with <unk>.
Awesome.
No.
And I cant absolutes are always dangerous statements, so I'm not going to say absolutely no or across all patients now, but that certainly is not is not a primary driver and this is really just it's really just hospital specific restrictions and the ability to access these patients.
And enrolled these patients screen these patients and.
And and treat these patients.
Great. Thanks, and then I have one follow up each day.
And.
And data from two alternative pathway inhibitor and <unk>.
And in 2021.
And then novartis job on P. J T J and then.
And this chart.
Todd.
Can you explain what youll be looking for and Mark based on policy.
And <unk>.
Sure.
Sure I think what we'll be looking for is of course, the level of proteinuria reduction that those drugs deliver.
We have a.
A good level of confidence.
And that the driver and Iga nephropathy, and as the more recent data and our showing even more broadly and progressive and chronic renal diseases as a whole that the real driver is the lectin pathway. The alternative pathway is is subsequently.
<unk> up regulated.
In response to the initial activation of the lectin pathway.
So from our perspective and from the I think the perspective of many Iga experts with whom we work is that the the initiating event or the real driver is the lectin pathway. If you inhibit the lectin pathway.
The response will be significantly better and I think our data have really borne that out when you look at the data with nurse thoughtful and map.
Versus what other.
And what other drugs have have made public and.
Round level of proteinuria reduction and our.
Supple on map related proteinuria reduction is a multiple.
What other drugs have been able to deliver and that's really pretty and that's E.
I Shouldnt say pretty uniform that's uniform.
So I think that that is why also.
And our supplement is the only drug that can obtain as far as we know.
Full approval on proteinuria alone and that is really a reflection of the magnitude and the rapidity of proteinuria reduction that we see with nurse thoughtful and map so well, we'll be looking at obviously proteinuria reduction.
And we will also be very interested to see egfr.
And what's happening.
And with Egfr and there are there are drugs and companies with drugs that have reported out on stabilization of Egfr et cetera.
Often they don't report and what happens with proteinuria.
And I think you really need to look at both.
Of those components to understand what the drug is really doing.
So.
Uh huh.
And I think let me stop there and see if you have any other question about that.
Okay, that's great. Thanks, Craig.
Thanks Alice.
Your next question comes from.
And so right Robert.
With H C Wainwright.
Okay.
Thanks, very much for taking my questions just wanted to touch quickly on the non stop on that I spy program involvement and.
And what you expect and terms.
Readout from ice spy and specifically what the context of that would be what the nature of that data is likely to be.
Given the fact that there are multiple cash.
And it's being assessed within that program. If you could provide us with more of a framework on what we should legitimate and we expect from ice buy and how long, it's going to take to yield data.
Sure.
<unk>.
So.
I think first.
You have to understand that that trial is really independent of.
And our thoughtful and map and independent and I am sorry independent of <unk> other than the provision of and our supplement.
So it is a it really is an investigator sponsored trial.
So what we do is provide the drug and they run the study is as they have have designed.
It is as you pointed out.
And adaptive.
And a platform trial, so that they run five arms, one of those being a control arm and I believe for actives.
And <unk> is the only complement inhibitor.
That has been invited or.
And <unk>.
I expect we'll be invited too.
To participate in that trial.
The readout is really one.
<unk>.
Length of stay and the hospital mortality rate all of the things that you would expect and a trial like that the patients that we're treating there may not be quite as sick as those that were treating through compassionate use as you know and compassionate use we're treating really.
Now only patients who are intubated and have failed all other therapies I mean, we're really kind of treating the uncurable at this point and.
And those patients securing the uncurable, but I think and in this study they're going to be patients as you can see and their protocol, who are hospitalized and requiring oxygen support.
So it would be reasonable to expect therefore, given this kind of clinical readouts that if <unk> has a positive impact on length of stay and the hospital that's been proven to be and approvable endpoint. The FDA has granted <unk> on the basis of such an endpoint before.
That at least hypothetically, it's not out of the question for this to be sufficient evidence on which the FDA could grant and the wait or non stop on that and COVID-19 based on the may be effective criteria.
Sure.
And mortality as well or a reduction in mortality I will say and I, probably should've mentioned this earlier that the I Spy group. The quantum group is working very closely.
With FDA on that trial.
So.
They are in close communication so.
The objective of that trial is to find a drug or drugs.
That are effective and COVID-19, and that is the single objective.
So I would expect and I think I'm pretty confident in saying that of course, our success and that program.
Should lead to making.
A successful drug.
More widely available to the general population.
Okay, and then just a couple of very quick ones from me.
Sure.
<unk>.
And that's 906.
And post phase one clinical development I was just wondering if you anticipate once the drug transitions into the next stage of development prioritizing subcutaneous administration or if you're going to pursue both subcutaneous as well as intravenous administration.
I'm sorry that was your question around 906 nine.
Yes, certainly in our phase one trial.
And we're looking at both.
Subcutaneous and intravenous and.
Intravenous as the reference point, but the objective is clearly to move that program through clinical development as a subcutaneous administration and again subcutaneous administration that we're targeting once monthly or less frequent administration well, let me see if.
And if Steve has any comments.
To add to that.
Yes.
No Greg I think you summed it up well.
It could go either way.
Depending on the phase one results.
Okay, and then lastly, what would you expect clinical development timelines as you originally.
Wait them out for oil and that's $5 seven and GTR $1 74 at those two programs to continue to be impacted in any way in terms of the timing of initiation of future studies.
And the COVID-19 pandemic or do you anticipate that those two programs could advance even if the pandemic continues to persist as as it currently is today.
And I want to make sure that on.
And tracking on the programs that you you mentioned, we have not given any timeline previously around <unk> 174, entering the clinic. So I just I want to make sure that I'm answering your question.
Yes, no I think the question is not so much in terms of getting guidance and more in terms of whether you considered the pandemic to be impacting the forward progress on those programs at all.
Yes, it really depends on it really depends on.
Which way we go with respect to.
Indication trial design et cetera, I mean, obviously, if COVID-19 is remaining with us for an extended period of time all of those factors will be brought in to our discussions and decisions about about how we proceed.
I think the best way to answer that would be our objective would certainly be to avoid as best as possible and he obstacles and clinical development.
Thank you.
Thank you.
Your next question comes from the line of and Jeff Jim from with Bank of America.
Good afternoon, everyone. This is Jason on for Geoff Great. Thanks, So much from taking our call question on the commercial launch preparations for and our supplement.
Thanks, so much for the color I'm curious what do you envision to be the greater.
Bottlenecks or hurdles here just trying to think ahead to when you anticipate and inflection in terms of uptake and then as the second part of the question.
To the extent that you can can you talk a little bit about your pricing considerations and kind of longer term thinking about a number of different other income.
Indications and complement.
And then how that shapes your thinking.
Sure.
And Jason with respect to bottlenecks.
Look I think that that our.
<unk> team has really been all over this.
And they are really very well prepared and very well equipped to commercialize on our <unk> and Ta TMA.
There are on a number of advantages that you understand specifically.
The relatively small number of sites that perform these procedures, meaning the relatively contained group of.
And our sales force that's needed to do that it's accessing the facilities. It's accessing the key opinion leaders really all of that.
And our Med affairs team has been.
Very successful in doing and.
And I would say we have the broad support.
Key opinion leaders not just in the U S but internationally.
So with respect to bottlenecks.
There are always things that will come up.
As you know that we will have to deal with but I think the groundwork that has already been laid and the preparations and frankly the expertise.
And <unk>.
The commercial team we have.
And not just broadly, but even specifically and this area of transplantation.
And I really think is pretty tremendous so I think anything that does arise that team will be able to address quickly. So you know.
We're always looking we're always aware, but we like the way things are headed with respect to pricing.
And we haven't given any guidance on pricing.
Other than to say that Ta TMA is an ultra orphan indication.
Certainly these patients.
Appear otherwise to do.
Quite poorly.
And when Ta TMA is severe.
So if you think about the health economics.
<unk>.
<unk> like <unk> in this setting I think those are significant.
And but certainly we're looking at that.
I think also there may even be some.
Rough comparables.
I think as you know Soliris has been used <unk> and map has been used off label.
Uh huh.
Intermittently and <unk>.
Ta TMA.
And so again I think our I think there are some data points out there, but our reimbursement team and our commercial team are working through all of those and the objective is to make the drug available to patients.
At at a at.
At a price that works for everyone.
Got it thank you very much for the color and candor.
Alright, Jason Thanks.
And our next question comes from the line of Serge Belanger with Needham and company.
Good afternoon, just a couple of questions on Omidria.
On.
Greg based on the CMS decision from last December.
It was granted for calendar year 2021, but do you.
Expect it provides basis for all long term.
Reimbursement solution for the product.
And have you made any changes to the commercialization strategy Corp.
And here for 2021.
Hi, Serge thanks.
<unk>.
Yes, we do see it as a long term and here's why.
It is true that when CMS.
Issued.
And their determination or their confirmation of separate payment for Omidria. It came and the farm of the 2021 calendar year, Oh, PPS and ASC final rule right and that's an annual that's an annual vehicle.
For CMS.
But with that.
That is very different now than us, meaning on barrels being required to reapply.
For this exclusion under that policy of paying separately for non opioid pain management surgical drugs. So the determination has been made that we meet the objective criteria.
That is now done.
So what would CMS have to do to change that.
Really CMS would have to change the policy revise generally as a policy.
So this isn't something that and the same way that CMS can revisit any of their policies through the annual rulemaking and comment period.
And that can occur for any of their policies and a year.
But you also have to take a look at the specific policy and see that it has remained in effect.
With CMS since 2019, it hasnt changed so we do not expect it to change and the near future.
So I see and others I know that's a subtle distinction.
Because.
Because there is this idea that well it's for calendar year 2021, but CMS is not required to revisit this next year.
They are not required to revisit any policy and we do not need to reapply for it.
Great. So now that you have more visibility and the reimbursement.
The product does that change your commercialization strategies and do you invest more in.
And expand the sales force to grow that.
Net revenue line.
It's a good question I think we've got a sufficient sales force currently to manage.
To manage all all territories across the country and to manage them well. The team I think is really one of the premier sales forces for.
The ASC or the surgical setting so ASC H O P D call point.
So we're quite quite happy with what we're doing there with respect to the strategy. It really hasn't changed I mean, I mentioned, one thing that we are doing I think and the prepared comments, which is that we are specifically working now with.
ASC chains and.
And and <unk>.
Private equity groups that control large numbers of assays and the reason for that and the.
Focus there and putting together partnerships with those groups is very clear they control very large numbers.
<unk>.
Cataract surgery, so cataract surgery volume annual volume is controlled and.
And in good part by those ASC chains and buy those growing.
Private equity groups. So that's that is part of our strategy, but I think generally we're seeing this as a.
<unk>.
Omidria has been.
Appropriately recognized.
Meeting the exclusion as a.
As a non opioid pain management surgical drug.
And therefore qualifies and will continue to qualify for separate payment and the ASC. So we're pushing ahead now the other thing that we are doing is watching very closely what's happening and D. C with respect to the no pain Act.
Right I mean this is a.
This is a bill that really enjoys.
Broad based and strong bipartisan and bicameral support including and leadership of the key committees in the house and key committee and the Senate.
So this this is one of those rare I think.
Examples where you really can engender bipartisan strong bipartisan support this is talking about opioid abuse and.
And the way to to prevent or treat that and one of the ways is to prevent the wide use of opioids during surgical procedures and we've gone through before what the risks are to those patients. So I won't go through it again other than to say that cataract surgery.
<unk> in particular.
At significant risk.
And of long term opioid use disorder following exposure to opioids inter operatively. So it's the right approach the important part of the no pain Act is that it would expand separate payment from.
From a S cheese to also include H O P DS.
Now the majority of cataract procedures 80, plus percent are performed and afcs.
But it would also be nice to have the same.
Access to drugs like Omidria.
And readily available and it's already available hospitals are making use of omidria, but it would be it would be I think very helpful for them to have the same access that AFC is out and that no pain Act would would enable that for a five year peer.
<unk> renewable on a five year.
Revolving basis.
Great. Thank you congrats on the progress.
Thanks Serge.
Your next question comes from line of and argued.
Argue.
Brian <unk> with <unk>.
Wedbush Securities.
Good afternoon, and thank you for taking our questions. This is andreas on for we on them and south of Us most.
Most of our questions are already have.
So just a quick follow up from from the previous so theres been a noticeable trend growth and elective surgical procedures shifting to BCS setting how do you guys see this trend impacting future sales of Omidria, and then for and their supplemental.
Do you guys plan on bond hosting a commercial day for investors just to give us and analysts to give us and ideas.
Your thoughts on on how to.
Go ahead with that launch thank you.
Sure.
And answer to your first question certainly.
There is being a ship there is a shift underway and has been underway for quite a while.
From <unk> to <unk> for elective surgical procedures, and that's really as you understand.
Very well.
Cost efficiencies associated with with ASC.
Certainly.
Net.
And that I think.
Wood and you are to the benefit of.
Omidria right I think again.
And the idea there is.
<unk> is as quick turnover of cases.
High volumes running through those assays.
Omidria really does allow that right it takes away.
On a significantly diminishes that those risks are complications that can slow procedures down and really slowed down.
Surgical volume throughput.
So, yes, I see certainly.
The shift to asses.
Further enhancing.
The utilization of Omidria.
With respect to your second question, Yes, we are considering.
And analyst day, and that would address the science and the commercial aspects.
Of.
Of the.
Indications for <unk>, and obviously with a focus on Ta TMA and our launch preparations there.
Okay. Thank you and congrats on the progress.
Thank you.
Your next question comes from the line and Brandon Folkes with Cantor Fitzgerald.
Alright, Thanks for taking my questions and congratulations on all the progress and the quarter and.
Brent maybe just hey, great.
Maybe just on the I spy, obviously I heard what you said earlier.
Two investigator sponsored trial, but do you have a sense of whether we may see data and tend to what they are looking at.
And I guess the July do per day for diplomat and.
The reason I ask it.
And my next question is.
How should we think about North America.
Commercial supply and let's say.
That's it from that show good results and this high spot data readout that it sounds like you're all looking at it and the patient sites I assume it's the larger patient population and.
What should we think about in terms of the dynamics of that.
And I find data readout and wanting can be very quickly and from the Kevin to take and very soon.
So from that Ta TMA and <unk>.
And launch from you guys.
Okay right.
Right. Thanks, Thanks, Brendan and I understand the question.
And I apologize in advance for the somewhat circular response, and I'm going to give you but.
With respect to where we have data is really dependent upon how quickly the I spy.
Trial enrolls and.
And as I understand it.
The patients that are enrolled are sort of evenly distributed across the active treatment arms. So I think they have been enrolling well.
And getting updates on their enrollment and they've certainly ramped up and are and are enrolling well and in fact, I would I would say probably.
If not the best probably want one of the best enrolling trials that we have seen.
But I think it's going to depend on how quickly they do that and then how quickly they look at data they do have a.
And data monitoring committee.
Safety Committee as well and they'll be looking at those data.
So we'll have to we'll have to see how quick that read outcomes.
And we're hoping that read.
The readout will come pretty quickly from that study, but again.
And that's largely out of our ore is effectively out of our hands out of our control.
Let me.
Let me answer the question about how we would address.
Drug supply across a ta TMA launch assuming the drug is approved.
And and and Covid and that's a great question.
Obviously, our initial plans were really focused on Ta TMA.
And we initially manufactured and generated a drug supply to be sufficient for an ultra orphan indication.
And as the data have continued to come in and not just clinical data, but frankly.
Non clinical data as well either out of out of research laboratories.
And the U S at some of the top sites as well as as well as our complement.
Research laboratories at the University of Cambridge.
At all.
All arrows point, I think to the lectin pathway and to the role of mast two and COVID-19, it's very interesting how all of the day to fit together is that has happened we've had to think.
And quite quite seriously and and plan, how we would manage.
Having to supply potentially drug for both and.
And even drug for.
Potentially other clinical trials that that some might want to run using our drug again, what we don't want to do is cannibalize the ta TMA of drug supply because that too is an indication where mortality rates are high.
We're trying to balance that one of the clear answers as increased manufacturing and that's why I think on a number of calls and and our discussions with Gov.
Government agencies, whether they'd be in the U S and or ex U S. R.
Manufacturing is front and center and <unk>.
Those discussions because that support would be needed to make and our supplement broadly available.
That does that help.
Brandon.
Operator.
Yes.
And I need it and so.
Okay.
Alright, well I hope that answered his question.
And there are no further questions at this time I would now like to turn the call over to Ed.
Doctor and keep Marpol.
Closing remarks.
Thank you operator and thanks.
Everyone again for taking the time to listen in.
As we look across our programs and our supplement of Omidria on mesh 906, <unk> hundred 74, and others and it's clear that our team has really made tremendous progress.
2021 has continued to build on the successes from 2020 and.
And we look forward to updating you on pending milestones.
Until then all of US on <unk> appreciate your continued support and.
And we hope that you and your families are remaining safe and healthy.
Have a good evening. Thank you.
This concludes today's conference call and thank you for your participation you may now disconnect.
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