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Omeros (OMER) Q4 2019 Earnings Call Transcript

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Omeros (NASDAQ: OMER)
Q4 2019 Earnings Call
Mar 02, 2020, 2:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

Good afternoon, and welcome to today's conference call for Omeros Corporation. [Operator instructions] 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 Omeros.

Jennifer Williams -- Investor Relations

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 in the company's 2019 annual report on Form 10-K, which was filed today with the SEC and the Risk Factors section also in the company's 2019 annual report for a discussion of these risks and uncertainties. Dr. Greg Demopulos, chairman and CEO of Omeros, will take you through a corporate update; and then Mike Jacobsen, our chief accounting officer, will provide an overview of our financial results. We have some time reserved for questions after the financial overview.

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Now I will turn the call over to Dr. Demopulos.

Greg Demopulos -- Chairman and Chief Executive Officer

Thank you, Jennifer, and good afternoon, everyone. We appreciate you joining us for today's update. As you likely saw, we issued a press release today on the data from our narsoplimab pivotal trial in hematopoietic stem-cell transplant-associated thrombotic microangiopathy or stem-cell TMA. I'll start today's call with a brief summary of our financial highlights and then immediately run through our narsoplimab data.

Net sales of OMIDRIA in the fourth quarter were $33.4 million, another new record. This represents a 52% increase, compared to the fourth quarter of 2018 and a 12% increase over last quarter. It's important to note here that wholesaler inventories at December 31, 2019 were consistent with those historically held at year-end by our wholesalers. Our net loss for the fourth quarter of 2019 was $29.2 million or $0.58 per share.

This includes noncash expenses of $6.3 million or $0.13 per share. This also includes a onetime charge of $12.6 million or $0.25 per share due to our accelerating into the fourth quarter, the successful manufacture of a set of five lots of narsoplimab at Lonza, including three process validation lots. These lots satisfy FDA's requirements for our BLA, and all of these lots will be available for commercial sale following approval. Under GAAP accounting, manufacturing costs incurred prior to regulatory approval, are expensed as R&D.

As a result, there will be almost no cost of good realized when these lots are sold. So when we net out the noncash expenses on the onetime manufacture of PV lots, our overall cash burn for the quarter was approximately $10 million. As of year-end, we had approximately $61 million of cash and investments available for general operations. We also have a $50 million accounts receivable based line of credit, which allows us to borrow up to 85% of our eligible accounts receivable.

Now let's get right to our MASP-2 antibody, narsoplimab and the data from our pivotal registration trial in stem-cell TMA patients. Enrollment in the pivotal trial was stopped with the agreement of FDA. FDA is satisfied that the number of patients enrolled and that the data generated are sufficient to submit our rolling biologics license application or BLA for this breakthrough therapy designated product, and the first sections were submitted to FDA last quarter. There is no approved treatment for stem-cell TMA, and our first objective for narsoplimab is to obtain approval for this often-lethal disorder as quickly as possible.

The data from our pivotal trial, which were summarized in today's press release speak strongly to the approval question. Before jumping into the data, I'd like to thank the patients, their families, the physician investigators and other caregivers who participated in our trial. Your efforts are sincerely appreciated, and together, I expect that we've significantly improved the lives of future stem-cell transplant patients. Now let's look at the data.

Two important aspects of our stem-cell TMA program are, one, the definition of the primary endpoint; and two, the threshold for meeting that endpoint. As we have previously discussed, Omeros worked with FDA reviewers to develop a clear definition of response that demonstrates meaningful benefit in the very old population that we studied. As described in detail in today's press release, the FDA-agreed definition of the primary endpoint provides a rigorous test of efficacy and patient benefit. The FDA-agreed response threshold of 15% demonstrates the severely ill nature of our patient population and their elevated risk of poor outcomes.

Patients in the trial had a high expected mortality rate with 93% of them having multiple risk factors, including the persistence of stem-cell TMA despite modification of immunosuppression, which itself was a criterion for entry into the trial. Graft-versus-host disease, significant infections, non-infectious pulmonary complications and neurological findings. 28 stem-cell TMA patients were enrolled in the trial and received at least one dose of narsoplimab. 54% of patients in this intent-to-treat population met the FDA agreed complete response primary endpoint and 65% of patients who received the protocol-specified treatment of at least four weeks of dosing were complete responders.

Both of these response rates are well above the FDA-agreed 15% threshold for efficacy. The 95% confidence interval for all patients is 34% to 72%. And for those who received at least the protocol-specified four weeks of dosing, the 95% confidence interval is 43% to 84%. In both populations, these translate to p-values less than 0.001.

The secondary endpoint of 100-day survival was equally impressive, 68% across all patients, 83% in the protocol specified treatment group and 93% in responders. Laboratory assessments of secondary efficacy endpoints also demonstrate meaningful and statistically significant improvement, with p-values less than 0.01 across all patients, unchanged from baseline for platelets, LDH and haptoglobin. Narsoplimab has been well tolerated across our development programs. In the stem-cell TMA trial the most commonly reported adverse events were diarrhea, nausea, vomiting, hypokalemia, neutropenia and fever, all common in stem-cell transplant patients.

Six deaths occurred during the trial. These were due to sepsis, progression of the underlying disease, and graft-versus-host disease, again, all common causes of death in this patient population. At the American Society of Hematology meeting in Orlando in December, we had the opportunity to discuss data from our trial with over 30 of the premier transplant physicians throughout the U.S. and Europe.

Similarly, at the recent Transplant & Cellular Therapy Conference, also in Orlando, data on narsoplimab in stem-cell TMA were shared, both at a continuing medical education symposium and with an advisory board comprised of some of the top transplant opinion-leaders in the U.S. Feedback on the clinical data was uniformly and highly positive. Complete clinical trial data will be presented by Dr. Miguel Perales, deputy chief of the Adult Bone Marrow Transplantation Service and director of the Adult Stem Cell Transplantation Fellowship at Memorial Sloan Kettering Cancer Center, at the upcoming annual meeting of the European Society for Blood and Marrow Transplantation in Madrid later this month.

Now let's discuss our progress on Chemistry, Manufacturing and Controls or CMC. In February of this year, Omeros met with FDA to discuss the CMC aspects of the narsoplimab BLA. At the meeting, FDA requested near-term manufacturing dates for narsoplimab so that FDA's preapproval inspections could be scheduled. FDA and Omeros also reached agreement on requirements for stability data and release assays for the BLA.

As previously mentioned, together with our manufacturing partner Lonza, we have completed successful manufacturing of the required process validation lots of narsoplimab to include in the BLA. These were completed ahead of schedule to accelerate the BLA timeline. All of the completed narsoplimab lots will be available for commercial use. Timing for submission of the CMC sections of our BLA remain on track.

The nonclinical sections of the rolling BLA were submitted to FDA last quarter. The remaining sections of our BLA, CMC and clinical are progressing well. The clinical sections of the BLA will include the standard clinical study reports and clinical modules. All clinical trial data have been compiled and are already in-house at Omeros.

As initially requested by FDA, in connection with our breakthrough therapy designation, Omeros is including in the BLA detailed narratives on all patients. These narratives supply additional historical information that was not collected in the clinical trial, such as the clinical course prior to participation in the clinical trial. Most of the historical data needed to round up the patient narratives have already been collected. Importantly, all data affecting our efficacy endpoints are already compiled in in-house at Omeros and are reflected in the efficacy data provided today.

We encountered an administrative delay in one country related to local law requirements for the collection of historical data on diseased patients, which prohibit any postmortem host collection or transfer of historical data until government authorization is received. That issue appears to be resolved and the process of historical data collection at that site has begun. The administrative delay, however, may cause our clinical submission to slip into the early part of the third quarter. We are assessing the logistics with several options to bring the full submission date in earlier.

Our preparations for the commercial launch of narsoplimab in stem-cell TMA also continue to progress. As we've reviewed on previous calls, the value story behind narsoplimab is strong. Our efficacy profile goes beyond a complete response number. The profile represents saving lives and reducing cost of care, including hospital admissions, intensive care unit stays and dialysis.

Feedback from U.S. and European transplant administrators and payers also stressed the importance of how narsoplimab use would fit within their current treatment paradigms as a 30-minute infusion administration is easy for them and would dovetail into their existing treatment framework for both the inpatient and outpatient settings. During 2020, we will continue to build out our commercial team to prepare for the anticipated U.S. launch.

These strategic hires will be timed around milestones to ensure that we are fully ready to launch narsoplimab for patients suffering from stem-cell TMA. Regarding our European marketing authorization application or MAA last quarter, we received a positive opinion from the pediatric committee of the EMA for our pediatric investigation plan or PIP for narsoplimab. This positive opinion was adopted by EMA's CHMP, a prerequisite to EMA's acceptance of an MAA through the centralized procedure. As we noted, successful completion of the PIP makes narsoplimab eligible for up to two additional years of marketing exclusivity, and EMA will also allow us to defer completion of the pediatric plan until after approval of the MAA.

We are currently focused on completing the BLA submission to the U.S. and we plan to complete the submission for European marketing approval after the BLA has been filed. While stem-cell TMA is our initial focus, this disorder is part of a constellation of endothelial injury syndromes, which include graft-versus-host disease, veno-occlusive disease or sinusoidal obstruction syndrome, diffuse alveolar hemorrhage, idiopathic pneumonia syndrome and others. All of these syndromes are thought to be caused by endothelial damage, which is known to activate the lectin pathway of complement.

MASP-2 is the effector enzyme of the lectin pathway, so narsoplimab could well be effective across endothelial injury syndromes, and we plan to evaluate narsoplimab in a number of them. Let's turn now to our Phase 3 program for narsoplimab in IgA nephropathy, which continues to progress. In our ARTEMIS-IGAN Phase 3 trial, we are enrolling both from the general population of patients with at least one gram of proteinuria daily and from the subset of patients with 24-hour proteinuria levels greater than two grams. We expect data readout next year.

A manuscript was prepared by Omeros' academic leadership committee, which is comprised of world leaders in IgA nephropathy and renal clinical research. The manuscript detailing the clinical data from the Phase 2 IgA nephropathy program is expected to be published in a premier peer-reviewed journal. Also a review article entitled MASP-2 Inhibition as Potential Strategy for IgA Nephropathy Management authored by Dr. Jonathan Barrett of University of Leicester, and Richard Lafayette of Stanford University will soon be published in the journal Drugs of the Future.

Chronic subcutaneous dosing of narsoplimab is being used in our Phase 3 trial for atypical hemolytic uremic syndrome or aHUS. The trial includes multiple sites in the U.S., Asia and Europe and is actively enrolling. As previously noted, the bulk of our narsoplimab-related resources are focused on stem-cell TMA and IgA nephropathy, and we expect this program to complete after both TMA and IgA. Now let's move on to OMIDRIA, our FDA-approved ophthalmic product.

As is evident from our fourth-quarter results, demand for OMIDRIA continues to grow, both across hospitals and ASCs. In ASCs, sales growth continues to be driven by increasing penetration in existing accounts and expansion to new accounts. Hospital sales in the fourth quarter were particularly strong, and for the first time since reintroduction, we saw a higher growth rate in hospitals than in ASCs. This is an encouraging development.

Hospitals represent not only a significant opportunity to grow OMIDRIA sales, they also allow us to demonstrate OMIDRIA's benefits and improved outcomes to future cataract surgeons training in these facilities. Overall, in the fourth quarter, we saw a greater than 10% growth in the number of purchasing accounts over the previous quarter. Fourth-quarter sales also benefited from the introduction of our new J-code, which became effective October 1. J-codes standardized the submission and payment of insurance claims across Medicare, Medicare Advantage, Medicaid and commercial insurance plans.

The early results indicate that our new J-code will be important to OMIDRIA's future, providing expanded reimbursement across all payers and sites of care. Numerous plans that previously would not cover OMIDRIA under our prior C-Code are now reimbursing under the J-code. The J code also provides separate coverage for OMIDRIA when used in the setting of the physician office, where a growing number of cataract procedures are performed. This is important for two reasons.

First, our previous C-Code was not reimbursed in the office setting. And second, this setting is one in which CMS is mandated to pay separately for OMIDRIA, independent of pass-through status. With respect to CMS, Medicare Part B and pass-through, the current pass-through reimbursement status for OMIDRIA is slated to expire on September 30 this year. We continue to pursue broad-based legislative and administrative efforts to secure payment for OMIDRIA beyond September 30, and we remain optimistic that we will be successful.

On the legislative side, The Non-Opioids Prevent Addiction in the Nation Act referred to as the NOPAIN Act was introduced in the fourth quarter in both the House of Representatives and the Senate. This bipartisan legislation is designed to remove payment disincentives put in place by CMS that currently restrict the ability of practitioners to prescribe non-opioid treatment alternatives in surgical settings. With seven Senate and 16 house bipartisan sponsors and cosponsors, the NOPAIN Act is gaining momentum. Supported by the congressional Bipartisan Opioid Task Force, the NOPAIN Act also enjoys strong advocacy from grassroots organizations led by voices for non-opioid choices; and is supported by a diverse coalition, including professional organizations of physicians and nurses and other groups fighting for common sense solutions to pain management.

If passed, the legislation would provide separate payment status for five years. And as an anecdotal compliment to the measurable legislative progress we're seeing, in the past several months, we've also witnessed a steady course of third-party advocates, columnists, physicians and think tank types, supporting OMIDRIA Medicare coverage. Some recent examples of pro-OMIDRIA pieces we've seen are in mainstream publications, such as Investor's Business Daily and the Washington Times, as well as in important healthcare and policy publications, where the policy makers get their news, such as Modern Healthcare, The Hill, Inside Health Policy, FierceHealthcare, Morning Consult, Helio and RealClearHealth. We are also pursuing administrative efforts to qualify OMIDRIA for continued separate payment under the non-opioid exclusion that was established by CMS in response to Congress's mandate under the SUPPORT Act.

The non-opioid exclusion enables CMS to pay separately for non-opioid pain management drugs administered during surgery that CMS would otherwise package under its Drugs as Supplies packaging policy. As CMS requested, we continue to generate evidence demonstrating that OMIDRIA falls squarely within the non-opioid exclusion. Including evidence that use of OMIDRIA is associated with lower use of opioids, both during and after surgery. Among other efforts, a team of data scientists, armed with IBM Watson technology are providing analytics on claims data, from a large number of cataract procedures and demonstrating that use of OMIDRIA in cataract surgery reduces the quantity of opioids prescribed postoperatively.

Further, as mentioned during our third-quarter update, Dr. Eric Donnenfeld, clinical professor of Ophthalmology at New York University and recent past President of the American Society of Cataract and Refractive Surgery, published a study in the peer-reviewed journal Clinical Ophthalmology, demonstrating that OMIDRIA resulted in a reduction in both fentanyl use and VAS pain scores. Another clinical trial is currently under way to demonstrate OMIDRIA's opioid-sparing abilities. With the growing volume of published data on the benefits of OMIDRIA, utilization of the drug continues to expand across Medicare Part B med advantage and commercial patients, as well as in the VA system and academic centers.

OMIDRIA is now on formulary in five of the top six and 11 of the top 17 academic centers for ophthalmology training, including the No. 1 ranked training program in the country, Bascom Palmer Eye Institute at the University of Miami. Of course, patient safety and reduced rates of surgical complications are a critical concern to surgeons, facility administrators and patients. In Dallas, lawsuits were filed against the surgeons, facilities and the compounding pharmacy because the surgeons had used a compounded product that caused a vision loss in at least 68 cataract surgery patients.

Recently, a large number of the cases were settled, underscoring that use of compounded products instead of FDA-approved products like OMIDRIA present not only grave physical risk to patients, but also serious financial risk to facilities, physicians and their surgical practices. OMIDRIA is the only FDA-approved product of its kind in the absence of separate payment for the drug, surgeons and facilities are relegated to using less safe, compounded products incurring significant potential financial liability. Now let's turn to OMS906, another major component of our complement franchise. OMS906 is our antibody targeting MASP-3.

We, along with others in the industry and in the complement research community believe that MASP-3 is the key activator and premier drug target in the alternative pathway. To understand the breadth of potential indications for OMS906, one need to only look at the indications pursued by other alternative pathway inhibitors. Our initial focus is on paroxysmal nocturnal hemoglobinuria or PNH, where we expect to have significant advantages or other complement inhibitors approved or in development. These include the ability to inhibit extravascular hemolysis, while providing more potent inhibition of intravascular hemolysis, a favorable safety profile and a more convenient route of administration with much lower frequency of self-administered dosing.

Preliminary toxicology results show no adverse effects even at the highest dose tested. OMS906 remains on track to enter the clinic next quarter. Beyond narsoplimab and OMS906, our strategy for life cycle management of our complement franchise is progressing nicely. Our longer-acting second-generation antibody against MASP-2 is planned for clinical entry in early 2022, followed by an orally available small molecule inhibitor against MASP-2.

We also are developing small molecule inhibitors of MASP-3. Now let's discuss briefly our phosphodiesterase 7 or PDE7 program to treat addiction and compulsions. In our Phase 1 trial, which completed last fall, our drug was well tolerated with good safety. Its PK profile was consistent with once-daily dosing taken with or without food.

Our focus is nicotine addiction, and we are planning our Phase 2 development program. Let's close our pipeline discussion with an update on our G protein-coupled receptor or GPCR program. Last quarter, Omeros presented data at conferences in Boston and Geneva, demonstrating a link between features of the tumor microenvironment and GPR174-mediated suppression of antitumor immune responses. We found that GPR174 is stimulated by phosphatidylserine, which is highly abundant in tumors.

Cell membranes exposing phosphatidylserine activate GPR174 on T cells, resulting in suppression of T cell functions, like the release of interleukin 2 and interferon gamma, both required for the effective killing of tumor cells. We have found that GPR174 deficient mice are more effective at controlling tumor growth in models of melanoma and colon cancer in the presence of an immune stimulating co-therapy. We currently are evaluating the impact of GPR174 inhibition in tumor models in mice reconstituted with the human immune system. Another product of tumor cell death found in high concentration in tumors is adenosine, which signals through immune cell GPCRs similar to GPR174.

These adenosine receptors, A2A and A2B, are thought to play a significant role in patient resistance to immune checkpoint inhibitors, such as OPDIVO KEYTRUDA and YERVOY. We have found that in the presence of phosphatidylserine and adenosine, inhibition of both GPR174 and adenosine receptors results in synergistic and complete restoration of the production of the tumor cell killers, IL-2 and interferon gamma. We are currently assessing the effects of the combined GPR174 and adenosine pathway inhibition in animal tumor models. With our proprietary GPR174 inhibitors and this new understanding of how tumors suppress the immune system, Omeros is well-positioned to bring novel and transformative cancer immunotherapy strategies to the clinic.

Before handing the call over to Mike for an overview of our fourth-quarter financial results, I'd like to welcome Kurt Zumwalt to our board of directors. Kurt is the former Treasurer of Amazon, obviously, accomplished with a strong network of financial context. He is also a really good guy and we look forward to working with Kurt and expect that he will play an important role in our ongoing growth. Mike?

Mike Jacobsen -- Chief Accounting Officer

Thanks, Greg. As Greg noted, OMIDRIA and total revenues for the fourth quarter were $33.4 million, and our net loss was $29.2 million or $0.58 per share. This includes noncash expenses of $6.3 million or $0.13 per share. The increase in our net loss from the prior quarter was driven by the accelerated and successful manufacture, a process validation and commercial lots of narsoplimab at Lonza, our CMO, to support the CMC portion of our BLA filing for stem-cell TMA.

This represents a onetime $12.6 million expense or $0.25 per share and will save us an equal amount if and when all of the lots are sold commercially following approval. After netting out the noncash expenses and the onetime manufacture of the narsoplimab lots, our overall cash burn for the fourth quarter was approximately $10 million. As of December 31, 2019, we had approximately $61 million of cash, cash equivalents and short-term investments available for general operations. We also have an accounts receivable based line of credit, which allows us to borrow up to $50 million based on 85% of our available accounts receivable borrowing base.

Here are some additional details regarding our fourth-quarter results compared to the third quarter. Our revenue for the fourth quarter increased $3.6 million from the third quarter and benefited from the introduction of the new J-code that became effective October 1, which replaced the previous C-code. We anticipate that the new J-code will help our overall reimbursement for procedures covered under Medicare Advantage and commercial insurance plans as we continue to move through 2020. Our fourth-quarter gross-to-net deduction was 27%, compared to 28% in the prior quarter.

Cost and expenses for the fourth quarter were $57 million or $16.6 million more than the prior quarter. Again, the increase was driven largely by at scale process validation and commercial lots at Lonza. The manufacturing of these batches accelerated its Q4 to align better with our BLA timeline, were all successfully manufactured and are expected to be used primarily for commercial supply. As you may recall, until we receive approval for narsoplimab in stem-cell TMA, all CMC-related costs would normally be included in inventory are as expensed as incurred.

Going forward, we do not expect to incur similar costs until we build additional commercial inventory for narsoplimab in the second half of 2020. Interest expense for the quarter was $5.8 million and in line with our expectations. Looking ahead to the first quarter of 2020 and beyond, we anticipate that our mid-year revenue will continue to increase during periods that we have permanent separate reimbursement. As Greg discussed earlier, we are pursuing both administrative and a legislative means to achieve permanent separate reimbursement and believe we will be successful.

That said, it should be noted that first quarter of the year has historically the fewest number of cataract procedures performed. Our research and development expenses for the first quarter will be down considerably from the fourth quarter. SG&A costs are also expected to increase across the year as we prepare for the launch of narsoplimab. We plan to hire medical affairs specialists in the second quarter and begin hiring sales representatives in the third quarter.

With that, I'd like to turn the call back over to Greg. Greg?

Greg Demopulos -- Chairman and Chief Executive Officer

Thanks, Mike. Let's open the call to questions.

Questions & Answers:


Operator

[Operator instructions] Our first question comes from the line of Steve Brozak with WBB. Your line is open.

Steve Brozak -- WBB Securities LLC -- Analyst

Great. Greg, thank you for taking the question. And obviously, congrats on the quarter and the year. Two questions.

The first one, going into narsoplimab, you've explained the decision that you made on the acceleration of manufacturing. Can you position this and give us as much color as you can on how this affects the rolling BLA and what it means and what the other parts are so that we can gauge how much you've completed and what you're looking at into the future?

Greg Demopulos -- Chairman and Chief Executive Officer

Sure. Thanks, Steve. Well, certainly, our objective is to get the product approved, which will require us submitting the BLA as quickly as possible, so what we wanted to make sure was that our manufacturing aligned as best as possible with that timeline. I think it demonstrates certainly high level of confidence that we have here around the potential for this product commercially and also, I think, for what we see as the likelihood of success in the approval process.

Steve Brozak -- WBB Securities LLC -- Analyst

Going back to, obviously, everything that you've spoken with FDA, one question I really wanted to just get some more sense of. On the clinicians, what kind of anecdotal information that did you come up with or did they provide to you? Because obviously, right now, you're collecting additional data. I'm just kind of curious to see what they were saying given how devastating the disease is.

Greg Demopulos -- Chairman and Chief Executive Officer

Sure. Thank you. Look, we've had a number of patients. Again, when you say anecdotally, remember that these anecdotal patients have all collectively formed a clinical trial with the data that we've just released.

But we've spoken publicly about the young Italian patient. We've spoken publicly -- or our experts in this field have spoken publicly about, I believe, patients in Spain and others. So I think that collectively, the anecdotal data have created the very strong data that we released today. And again, I mean, when you look at the response rate versus the FDA-agreed threshold, I think it's an impressive set of data that we have provided, and I think we've done it in full transparency.

So every piece of that, just about every piece, we're saving some of this for what comes out at EBMT as well. But I mean, I think that we've answered just about every question that anyone could have about the pivotal trial.

Steve Brozak -- WBB Securities LLC -- Analyst

No, no. Your point is well taken. A p-value of 0.0001 is not anecdotal. I get it.

OK. Let me ask one last question, and then I'll hop back on the queue. You had mentioned something that was really fascinating, how with OMIDRIA that you started to see hospitals starting to use it. And as much as you can, given the fact that hospitals do have residencies where that's a training ground for future clinicians in the field, what can you tell us about that? Because it's one of those things where I'm always kind of curious to see how it's being -- how the uptake is being taken there.

And then I'll hop back in the queue. Thank you.

Greg Demopulos -- Chairman and Chief Executive Officer

Sure. Thanks, Steve. Well, we've had a growth in hospital sales for a while. What we reported today was just that this was the first time that that growth had exceeded the growth in the ASCs.

The growth in overall across hospitals and ASCs was over 10% growth in new customers. I mean, I think that's an important statistic. That's telling you that we're not just expanding by drilling deeper into our existing customer base but that we're actually expanding the customer base. And in this case, by over 10%.

You're absolutely correct in your perception of how hospitals play into future growth. Hospitals are the sites where residents train and that's why we also provided the data that we provided, specifically, on the academic centers, where now five of the top six and 11 of the top 17 academic centers for ophthalmic surgery have OMIDRIA on formulary use. OMIDRIA -- and that now includes the No. 1 ranked center, which is Bascom Palmer.

And yes, the feedback we get is that the product is extremely helpful in the hospital setting with the residents and with the resident training. And as I think we all understand that what you do during your training, you often do when you leave training. And I think that this is why we find this increase in the hospitals so encouraging to the overall future of OMIDRIA.

Steve Brozak -- WBB Securities LLC -- Analyst

Great. Again, thanks and congrats and look forward to, obviously, 2020.

Greg Demopulos -- Chairman and Chief Executive Officer

Yes. Thank you, Steve.

Operator

Your next question comes from the line of Raghuram Selvaraju with H.C. Wainwright. Your line is open.

Edward Marks -- H.C. Wainwright -- Analyst

Good afternoon. This is Edward Marks on for Ram. Looking at OMIDRIA, I'm just wondering, has the likelihood of past reimbursement extension changed for the worse in recent weeks due to some potential budget constraints around coronavirus? Or do you not see this having any bearing on the process?

Greg Demopulos -- Chairman and Chief Executive Officer

Thank you. Yes, I don't think that has any bearing. I think that if anything, the growth of the support and the increase in momentum around our legislative and administrative efforts indicate quite the opposite. I think that when you look at, for example, the NOPAIN Act, and this is just one example, but when you look at the NOPAIN Act, you're seeing an increasing number of sponsors and cosponsors, both in the House and in the Senate.

And remember that it's not just quantity, even though that quantity is increasing in both chambers. And I should underscore, I know we spoke about this in the prepared comments, but this is truly a bipartisan bill. This has effectively equal support. So sponsors and cosponsors are effectively equally divided between both parties, and that is growing.

So it's not just the quantity though, but it's also: are your sponsors on key committees, both in the House and in the Senate. So I think that it certainly is helpful that this is the right policy. I mean, certainly, this is something that should be done. It's something that I think both parties -- one of the few things maybe that both parties in Congress agree on.

And so I think, in short, an answer to your question, I think it's quite the opposite. I think what we're seeing is movement toward getting this done as opposed to somehow another impediment placed in front of it.

Edward Marks -- H.C. Wainwright -- Analyst

That's certainly good to hear. And moving on to narsoplimab, do you have any additional color on when the ARTEMIS-IGAN trial will provide some top-line data? And specifically, would the FDA want to see this top-line data before they approve stem-cell TMA?

Greg Demopulos -- Chairman and Chief Executive Officer

First, we guided to next year, and we'll be able to dial that in a little better as we progress through this year. As I said, we had, what, I think 91 clinical trial sites open and running around IgA nephropathy and more coming online. We're quite happy with the increase in enrollment that we're seeing. And remember that we are going to be looking at both the general population and the subset of high-protein spillers, so those that are putting out one gram a day, those that are putting out two grams a day.

And I believe that we are the only company specifically looking at those high-protein spillers, and our data assessment will be on both of those groups. With respect to your second question, no, I do not think at all that there is any link whatsoever between TMA and the assessment of our TMA data for approval in the IgA data. And I think I understand your question. At least I think I do that you're wondering about the safety of the product.

And I think that we've established that pretty clearly. So no, I don't see any connection between those two. I think they'll be reviewed independently as the data are submitted.

Edward Marks -- H.C. Wainwright -- Analyst

OK. Yes, and you absolutely did have that question, right, so thank you for that detail.

Greg Demopulos -- Chairman and Chief Executive Officer

Yes. We have not seen a drug-related serious adverse event with narsoplimab.

Edward Marks -- H.C. Wainwright -- Analyst

OK. Two more quick ones here just on that program. You laid out the nice complete response, FDA threshold data. I'm wondering if there is an FDA-efficacy threshold for 100-day survival in stem-cell TMA.

Or is there no agreement with the FDA on this point so far?

Greg Demopulos -- Chairman and Chief Executive Officer

Can you repeat that last question? I'm sorry, it broke up.

Edward Marks -- H.C. Wainwright -- Analyst

Yes. So just wondering, what is the FDA-efficacy threshold for 100-day survival in stem-cell TMA, or do you not have agreement with the FDA on this point yet?

Greg Demopulos -- Chairman and Chief Executive Officer

No, it's a secondary endpoint. We're not going to need a threshold for that. I think it's pretty clear, though, the experts believe that these patients should have had a less than 20% 100-day survival. And what you're seeing are the data that we generated, what I believe it's 65% in all patients, 83% in the protocol-specified four dose and 93% in the response group.

So those numbers are, however, you turn them or look at them or cut them, those data are extremely impressive. And when you, again, balance the benefit risk here, as I mentioned, we really have not seen a meaningful safety signal with narsoplimab.

Edward Marks -- H.C. Wainwright -- Analyst

Right. And then just a last quick question. I'm wondering how many patients you expect to be on narsoplimab through your work with myTommorrows' program.

Greg Demopulos -- Chairman and Chief Executive Officer

Yes. It's a question, one, that I'm not going to answer right now. It's a compassionate-use program that we have running with myTommorrows. And that sort of information, we're just generally not putting out there for reasons that you would understand.

Edward Marks -- H.C. Wainwright -- Analyst

Absolutely. Well, that's all from me. Thank you. I appreciate all the details and congrats on the data.

Greg Demopulos -- Chairman and Chief Executive Officer

Thank you very much.

Operator

Your next question comes from the line Serge Belanger with Needham & Company. Your line is open.

Tian Sun -- Needham and Company -- Analyst

Hey, thanks. This is Tian on for Serge. I just had a couple of questions. So the first one is about the pass-through status.

So as we approach the expiration in about six months, how do you expect the sales for OMIDRIA to trend beyond September, if there isn't any -- there's no extension? Should we expect something more in line to what we saw in 2018 or potentially a little bit better now that it's a more established product in the hospital and the ASC settings?

Greg Demopulos -- Chairman and Chief Executive Officer

Right. I would agree with what you just said. We would not expect to see the same sort of decrease that we saw when the original pass-through came up at the end of 2017. So this is a product now that has significantly more data published around it.

We would expect the sales to continue to ramp, we think, through the next couple of quarters, and we'll have to see. We're not placing all of our bets on an extension of pass-through. We think that that will be successful, but you would also expect that we have built multiple backup plans to that one and that expectation would be correct.

Tian Sun -- Needham and Company -- Analyst

OK, great. Thanks. And then just on the impacts and the penetration of the J-code, can you just describe a little bit more in detail in terms of the penetration that you've seen on the commercial, the Medicaid, Medicare Advantage payers so far? And how do you expect this trend to play out in 2020 and beyond?

Greg Demopulos -- Chairman and Chief Executive Officer

Right. We have seen, as I said, an increase of plans reimbursing under the J-code, that we're not reimbursing under the C-code. And that's cutting across Med Advantage and commercial plans. We would expect that that trend will continue to increase as physicians continue to contact their payers and as more and more of these Med Advantage and commercial payers are reimbursing, both regionally and nationally for OMIDRIA.

Tian Sun -- Needham and Company -- Analyst

Great.

Greg Demopulos -- Chairman and Chief Executive Officer

So that would include both not only the number of plans reimbursing, but the amount that they do reimburse.

Tian Sun -- Needham and Company -- Analyst

Great. And then lastly, just on OMS721, is there any feedback or update from the FDA as far as the priority review status? Is that something that you're still thinking about for six-month review?

Greg Demopulos -- Chairman and Chief Executive Officer

Sure. Let me turn that question over to our chief regulatory officer, Cathy Melfi.

Cathy Melfi -- Chief Regulatory Officer

Sure. Hi. Thanks for the question. Regarding priority review, again, that's something that's determined at the time of filing.

We'd certainly apply for it, and we've spoken to FDA about it. And given our Breakthrough Therapy designation, FDA has agreed that typically we would be granted a priority review. So again, we're expecting it, but it wouldn't be official until we have the submission and the final ruling by the FDA.

Tian Sun -- Needham and Company -- Analyst

Great. Thank you for the details.

Operator

Your next question comes from the line of Brandon Folkes with Cantor Fitzgerald. Your line is open.

Brandon Folkes -- Cantor Fitzgerald -- Analyst

Hi, thanks for taking my questions, and congratulations on the quarter and the data. Could you just help us think about the timeline from here to approval for narsoplimab in terms of news flow that we will see from our side? I know you talked about a potential for the clinical submission in the early part of 3Q 2020. What else should we expect between now and year-end?

Greg Demopulos -- Chairman and Chief Executive Officer

Well, with respect to the timeline, first thing we'll need to do is complete the clinical section, as well as the CMC sections and submit those to FDA. Once that's been filed, as you know, Brandon, the FDA has six months from the date of filing. But you've also recently seen that FDA has acted more quickly in some situations than that. So we'll have to see how all of those pieces come together for the full timeline.

Our priority in addition to getting this submitted is to submit a quality BLA, and one that will not come back with questions that would be time-consuming. So we want to make sure we submit a quality product. I fully expect we will -- based on the data that we have and the work by this team that has already gone into it, I have really no doubt about that, and we'll just see how that timeline moves following filing.

Brandon Folkes -- Cantor Fitzgerald -- Analyst

Great. Thank you, and congratulations again.

Greg Demopulos -- Chairman and Chief Executive Officer

Thank you, Brandon.

Operator

And I'm showing no further questions at this time. I would now like to turn the conference back to Dr. Demopulos.

Greg Demopulos -- Chairman and Chief Executive Officer

Thank you, operator. And that wraps up our call for today. Thank you, again, everyone, for taking the time to listen in. We're proud of what we accomplished as a company in 2019 and are very appreciative of our shareholders for their interest and support.

At the heart of everything we do at Omeros is really a devotion to improving the lives of patients and their families. Our employees really do live that mission each day, and I'd like to thank them and all our advisors and collaborators for their collective contributions to our success last year and to our expected continued successes in 2020. As always, we appreciate your support and have a good evening.

Operator

[Operator signoff]

Duration: 55 minutes

Call participants:

Jennifer Williams -- Investor Relations

Greg Demopulos -- Chairman and Chief Executive Officer

Mike Jacobsen -- Chief Accounting Officer

Steve Brozak -- WBB Securities LLC -- Analyst

Edward Marks -- H.C. Wainwright -- Analyst

Tian Sun -- Needham and Company -- Analyst

Cathy Melfi -- Chief Regulatory Officer

Brandon Folkes -- Cantor Fitzgerald -- Analyst

More OMER analysis

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