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Momenta Pharmaceuticals Inc (MNTA)
Q2Â 2019 Earnings Call
Aug. 02, 2019, 8:30 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good day, ladies and gentlemen. And welcome to the Momenta Pharmaceuticals Second Quarter 2019 Earnings Conference Call. [Operator Instructions] Also as a reminder, this conference call is being recorded.
At this time, I'd like to turn the call over to your host to Patty Eisenhaur, Vice President of Investor Relations and Corporate Communication. Please go ahead.
Patty Eisenhaur -- Vice President of Investor Relations and Corporate Communications
Thank you, Dalham and good morning, everyone. And thank you for joining us today for Momenta's conference call to discuss financial results and operational highlights for the second quarter of 2019. Today's call is being webcast and you can view the slides we will be presenting in the Investor section of our website at momentapharma.com.
Joining me on the call with prepared remarks are Craig Wheeler, President and Chief Executive Officer; and Michelle Robertson, Chief Financial Officer. Young Kwon, our Chief Business Officer; and Santiago Arroyo, our Chief Medical Officer, will be available for the Q&A portion of the call. Following our remarks, we will open up the call to questions.
Before we begin, I'd like to mention that our call will contain forward-looking statements about our financial outlook, business plans and objectives, and other future events and developments, including statements about the use, efficacy, safety, potency, tolerability, dosing, convenience and market potential in reception of our products and product candidates, including their potential as best-in-class agents, development timelines and strategies, development of our product candidates, including the design, timing and goals of clinical trials and availability, timing and the announcement of data and results.
Hypotheses regarding certain effects of our product candidates and clinical studies, the timing of regulatory filings, regulatory approvals, market formation and launches of our product candidates and products, potential competition and revenues for our products, accounting treatment for payments from our collaborators, accounting treatment related to payments to be made by Momenta, our current and potential future collaboration and non-GAAP operating expense guidance, including our anticipated collaborative revenues and restructuring charges.
These statements are subject to risks and uncertainties that may cause actual results to differ materially from those projected. These risks and uncertainties include those described in the slide entitled Cautionary Note regarding forward-looking statements included in the presentation accompanying this call and under the heading Risk Factors in our quarterly report on Form 10-Q for the quarter ended March 31, 2019 filed with the Securities and Exchange Commission, as well as other documents that we may file from time to time with the SEC. Any forward-looking statements speak only as of today's date and we assume no obligation to update any forward-looking statements made on today's call.
On the call, we will also discuss second quarter 2019 non-GAAP operating expense. Please see the presentation accompanying the call for further information and reconciliation of this measure.
With that, I will now turn the call over to Craig.
Craig A. Wheeler -- President and Chief Executive Officer
Thank you, Patty, and good morning, everyone. 2019 continues to be a year of execution from Momenta and I am happy to report is going well. On today's call, I'll update you on the progress we have made across our clinical programs and share some details with you on our newest M281 trial in warm autoimmune hemolytic anemia. Then I'll provide a brief update on and highlight some changes in our legacy generic programs, which we retained post restructuring. Following my remarks, our CFO Michelle Robertson will discuss our second quarter 2019 financial results and reiterate our guidance for 2019. Following closing remarks, we'll open the line to your questions.
I'll begin today's update with our FcRn program, M281 or nipocalimab, the name we have recently adopted for our antibody. As a reminder, our FcRn inhibitor offers potential in the three broad areas of medicine. First, the receptors control of antibody levels provides a strong therapeutic rationale across a range of autoimmune diseases with high unmet need.
Second, the FcRn receptors role in the transfer of antibodies across biologic boundaries, specifically across the placenta from mother to fetus during pregnancy, opens potential for our agent to treat a range of alloantibodies driven fetal maternal diseases.
Third, again depending on FcRn ability to control antibody levels, is the agents potential in role and product immunogenicity. Specifically by reducing alloantibodies to AAV gene therapy, potentially enabling reduced dosing or reducing for these products. We are pursuing all of these broad areas with nipocalimab. Our thesis is supported by what we believe is a best-in-class profile strengthened by strong clinical results to date. Our Phase 1 study supports our belief that nipocalimab has the potential to demonstrate superior safety, efficacy, and dosing versus standard-of-care agents including steroids, immunosuppressants, and IVIg as well as many of the other agents being developed in this class.
We are pursuing a multipronged development strategy. First, in IgG-mediated autoimmune disease, in our Phase II Vivacity Myasthenia Gravis study we are on track, with the vast majority of our sites open and about a third of the patients recruited, showing strong progress toward our 60 patient target. This study is looking at several dosing levels and dosing intervals to allow us to fully evaluate the optimal dose, which allow us to maintain the strong reduction in IgGs we observed in Phase I and maximize 281s potential efficacy, while extending dosing intervals to ease the burden for the patients. We believe, we will be able to achieve once monthly dosing with this trial. This trial will also provide a comprehensive dosing dataset that will allow for a more informative label for physicians. Finally, if our potency advantage translates to better efficacy, the bigger effect size may allow us to run a smaller Phase 3 study. We continue to anticipate top line proof-of-concept data in the second or third quarter of 2020.
Yesterday, we announced that the FDA has accepted IND application to evaluate nipocalimab in a second autoimmune indication, warm autoimmune hemolytic anemia, and they have granted us fast track designation in this indication. Hemolytic anemia is a severe, debilitating -- debilitating disease characterized by the destruction of red blood cells due to the presence of pathogenic IgG auto antibodies. This loss of erythrocytes results in severe anemia, weakness and fatigue. As the disease progresses without safe and effective treatment, serious complications can develop diminishing patient's quality of life, and putting them at risk for premature death. Data indicates up to 8% of patients may die prematurely with those experiencing active and uncontrolled hemolysis most at risk.
The unmet need in this indication is significant, as there are roughly 45,000 patients in the U.S. with most diagnoses occurring in adulthood and no approved therapies. Patients with severe hemolytic anemia are at some point admitted to an ICU, where the current standard of care includes, rescue blood transfusions, corticosteroids, immunosuppressants and removing the spleen, all of which are associated with significant side effects and impact the patient's quality of life. For those admitted to an ICU during severe anemia, mortality rates as high as 30% had been observed. We believe, nipocalimab's ability to rapidly reduce circulating IgG with ameliorate the physical and laboratory manifestations of hemolytic anemia.
Our trial, which we have launched, is a randomized double-blind placebo-controlled multicenter adaptive Phase 2/3 study to investigate the safety, efficacy and tolerability of nipocalimab in patients with primary and secondary hemolytic anemia. In this study, patients will be randomized 1 to 1 to 1 to receive bi-weekly or monthly IV infusions versus placebo. The trial is expected to enroll 90 patients on a 24-week treatment period, with a primary endpoint that was agreed with the FDA and is based on hemoglobin level change from baseline.
Secondary endpoints include markers of hemolysis and fatigue. Clinical sites are currently being activated and patient recruitment is under way. The adaptive nature of this study will allow for modification of the study, based on interim analysis of the data. The strategy allows for greater flexibility and efficiencies in study design, which can benefit patients in diseases with large unmet need, as the most amounts of useful data is collected and maximized. As such, if successful, we believe this Phase 2/3 trial could serve as a pivotal study in hemolytic anemia, potentially enabling us during the first treatment to patients with this disease. We anticipate topline data by the end of 2021.
The FDAs fast track designation assures us that we will have frequent communication with the agency, which could lead to an earlier drug approval and access for patients. This designation reflects the collaborative and constructive dialogue we have had with the agency as we develop this program and highlights the significant unmet need of this patient population. One of our goals for this product is to provide a patient friendly dosing model. It's why we're focused on both once monthly IV dosing, as well as investing in a Sub-Q version. Today, I'm pleased to announce the results of a Phase 1 trial on another aspect of dosing, infusion time, which we believe will be of great benefit to patients.
We have recently completed nipocalimab infusion study to support significant reductions in infusion rates versus our current two hour infusion rate. The study has demonstrated that nipocalimab can be administered rapidly with infusion times as low as 7.5 minutes for the 30 mg per kilogram dose and 15 minutes for the 60 mg per kilogram dose. Notably nipocalimab's safety and tolerability profile continue to look strong in this trial, adding another 30 subjects to our safety database. We are very pleased with these results. The data continue to support our best-in-class profile and it makes the entire program easier to run and recruit, as it reduces the burden on patients and facilities. We have incorporated a shorter infusion time in the design of the hemolytic anemia study, and a further protocol amendment to include it in the MG study as well.
Our third ongoing clinical indication is in Hemolytic disease of fetus and newborn, or HDFN. This is the first fetal maternal disease that we pursuing. Our antibody's ability to maintain full receptor occupancy enables total blockage of pathogenic alloantibodies and autoantibodies from passing through the placenta from the mother to the fetus. To date, key clinical sites in the U.S. and Europe for the Unity HDFN study have been activated, and patient enrollment is under way. We are aiming to enroll a total of 15 pregnant women and expect this study to read out in 2021.
Additionally, we announced earlier this week that the FDA granted nipocalimab fast track status in HDFN as well. This designation is designed to facilitate the development in this rare indication and to escalate the ultimate review of our BLA for nipocalimab. With fast track designation, we are eligible for more frequent meetings and communications with the FDA with respect to our development in HDFN.
Given the high unmet need in the body of data that we were aiming to generate, we further believe, that there may also be a pathway to accelerated approval. Notably, if the HDFN trial is successful, we will be the only FCRN targeted agent that has demonstrated it can be used safely in women of childbearing age, who become pregnant, another critical element for the broad label we're developing.
Between the lowering of systemic IDG observed in our Phase 1 study, and its ability to block placental transfer of pathogenic allo and autoantibodies as well as the drug itself, we believe nipocalimab has the potential to transform the treatment landscape in HDFN and in fetal maternal disorders more broadly. We know FCRN is a widely followed and competitive space. I hope our progress continues to demonstrate the value of our strategy to develop a best-in-class profile through purposeful design of our molecule and a carefully designed development program to demonstrate both the molecules potential and create a broad label for the product. We believe, there is enormous commercial opportunity for nipocalimab, which we will continue to pursue as we advance this clinical program.
Turning now to M254, our hyper-sialylated IgG program. As we've outlined, IVIg has a mammoth footprint in autoimmune disease. It is a supply constrained $4.5 billion market across some 60 indications. This success comes even though IVIg carries a significant treatment burden for patients due to the very high doses needed to demonstrate efficacy as a single dose of IVIg can require two or more days to administer, and can result in serious adverse events. Our pre-clinical data does show our enzymatic sialylation can produce an effect upto 10 times more potent than IVIg in multiple animal models. If we can achieve this benefit in humans, we could administer a fraction of the dose and achieve the same effect. This would transform this market in terms of safety, tolerability, patient convenience, lower overall use of resources and possibly even improved efficacy.
We are currently evaluating M254 in a four part Phase 1/2 study designed to identify a dose equivalent -- that is equivalent to the clinical standard of 1,000 mgs per kg IVIg dose. We have completed part A, the single ascending dose I'm evaluating M254 in healthy volunteers and advanced into Part B, our single ascending dose arm evaluating M254 in patients with Immune thrombocytopenic purpura or ITP.
M254 is likely to be our first novel program to achieve proof-of-concept with top line data expected in the first half of 2020. If its successful, we believe we have this molecule could unlock tremendous market potential. We're evaluating a wide range of clinical strategies to exploit the attributes of this molecule. Beyond the enhanced potency and safety, we believe are possible. Lower dose of IVIg required would alleviate the global supply issues we have today, enabling the market to grow potentially significantly.
Lastly I will touch on M230, our novel program developed in collaboration with CSL. M230 is a recombinant Fc multimer that works by antagonizing the activating Fc gamma receptor system and blocking immune complex mediated tissue damage. It is currently being evaluated in an ongoing Phase 1 dose escalation study. CSL has made the decision to shift to evaluating the potential use of a subcutaneous formulation, which we expect to extend the Phase 1 timelines. CSL is the lead development party here, but we co-fund 50% and we'll share 50/50 in U.S. profits with them. In addition, we're eligible for attractive ex-U.S. royalties and milestone payments. We'll keep you updated as we learn more, but continue to believe this program has significant potential.
While I won't spend time on our research programs today, in past calls, we have described the broad potential of the platforms behind our lead clinical programs. The reallocation of resources away from our legacy generic business has allowed us to more fully invest in our early stage research, where we have several exciting opportunities we are advancing, and we look forward discussing these programs in more depth with our investors in the future.
Now, turning to our legacy products for an update. We continue to refocus our business more exclusively on our novel drug portfolio. As part of this effort, I have two issues to discuss with you on today's call. First, on Enoxaparin. As you all know, we have been carrying costly litigation expense related to our complex generics for LOVENOX. In the last quarter, we, together with our partner, Sandoz announced that we reached a comprehensive resolution with Amphastar Pharmaceuticals to settle all pending patent litigation. As a result of the settlement, we paid Amphastar $21 million at the end of the second quarter, and we will recover $36 million on the bond that we posted, which will be reflected in the third quarter.
More importantly, this settlement eliminates the majority of our ongoing litigation expense and allows us to increase -- our increase our focus on operational execution of the business. We do have one ongoing third-party litigation, which is still active related to Enoxaparin. But the settlement of an Amphastar related cases significantly reduces our litigation costs and risks.
We are also announcing today, that we have made the decision to cease ongoing development activity on M923 or biosimilar to HUMIRA. We have previously said that we would not be taking this program forward ourselves. While we were hopeful that we could secure a commercial partner for this program, and we did have interest as we pursued the path, the market opportunity has changed significantly with recent settlements, ensuring that up to eight players will be launching at once. As such, we have been unable to secure a commercial partner for this program, and believe it is prudent to cease ongoing investment in M923 at this time.
As a result of this decision, we have notified our manufacturing partner GSK that we will not utilize our originally scheduled 2020 manufacturing runs. We have not made any decisions at this time on our 2022 manufacturing runs. However, these trigger the take-or-pay provisions of our contract, which requires us to pay GSK a contractually agreed to fee at the time the runs in 2020 and 2022 would have been completed. Together, they require us to incur a onetime charge in our Q2 financials as reported. It is worth noting that any and all payments that we are required to make to GSK are beyond our projected timing of our clinical readouts in 2020, and therefore, are not expected to impact our cash runway to proof-of-concept.
I also want to emphasize that the decision to discontinue activities on M923 will save us approximately $100 million in anticipated cost to launch the product, which can now be allocated to our promising novel programs. Michelle will cover the accounting details for these liabilities in her section of the call. Together with our executive leadership team, I'd like to acknowledge and thank the M923 team for their contributions and dedication to this program. They have accomplished much to bring this product forward, and many of these achievements and learnings will contribute to our ongoing work.
Finally, we are maintaining our investment plan with M710 our proposed biosimilar to EYLEA. Our partner Mylan is currently enrolling patients in the Phase 3 study to this product, and we continue to believe that we have the opportunity to launch in the U.S. as early as 2023. We are currently in the lead for developing this asset and believe M710 could bring in significant revenue to support our expanding novel pipeline and we look forward to keeping you updated here as this trial progresses.
With that, I'll now turn the call over to Michelle to review the second quarter 2019 financial results, and then I'll close with some final comments.
Michelle Robertson -- Chief Financial Officer
Thanks Craig. Good morning, everyone. We reported a net loss for the second quarter of $114 million compared to a net loss of $70 million for the same quarter last year. The increase was primarily due to onetime operating expenses which I will discuss shortly. Revenue for the second quarter totaled $5 million, compared to $14 million for the same period in 2018. Product revenue, which includes profit-share from Sandoz' sales of our Glatopa products was $3 million compared to the $12 million for the same period in 2018. The decrease was largely due to continued market competition in Glatopa.
Research and development revenue was $2 million, an increase from $1 million in the same quarter of 2018. The increase was primarily due to higher revenue recognized from the collaborative upfront payment as part of our biosimilars collaboration with Mylan, offset in part by lower reimbursable expenses. Second quarter total GAAP operating expenses were $122 million, compared to the $84 million for the same period in 2018. The second quarter GAAP operating expenses included onetime expenses of $64 million, including the emphasized settlement we announced in June and our contract manufacturing obligation with GSK, our supplier of M923. Note, the GAAP operating expense associated with the GSK obligation is non-cash event this quarter.
Second quarter R&D expense increased to $32 million when compared to $31 million in the same period in 2018. The increase was primarily due to cost related to our nipocalimab and M254 clinical trials, partially offset by our cost savings following our workforce reduction in the fourth quarter and lower lease costs. Second quarter G&A expense increased to $47 million, compared to $23 million in the same period in 2018. This increase was primarily due to the $21 million paid to Amphastar. Other operating expenses in the quarter included a $43 million charge related to our take-or-pay minimum purchase obligations under our development activity related to M93. We incurred these charges as we have cancelled manufacturing runs scheduled for 2020 and may not use manufacturing runs scheduled for 2021, 2022. We'll be making payments on this obligation beginning in late 2020 and then in 2022.
For the second quarter of 2019, our non-GAAP operating expense was $118 million. As a reminder our non-GAAP operating expense is defined as total operating expenses less stock based compensation, less restricting cost and less collaborative reimbursement revenues. Subsequent in the second quarter and related to the restructuring, we have amended our lease at 320 Bent Street, greatly reducing our footprint at this location. This will save us $63 million over the remaining term of the lease through February 2027. Finally, we ended the second quarter with $380 million in cash, cash equivalents, marketable securities and restricted cash released in the third quarter of 2019, compared to $449 million in available funds at December 31, 2018.
Turning now to our guidance for 2019. We are providing average, quarterly non-GAAP operating expense guidance of $45 million to $55 million for the remaining of the year. As a reminder, we expect fluctuations in cost quarter-to-quarter as our studies get under way and more patients are enrolled.
I'll turn the call back over to Craig for closing remarks.
Craig A. Wheeler -- President and Chief Executive Officer
Thanks, Michelle. As you've heard, we are well-capitalized to achieve our goals and milestones for 2019 and beyond. We continue to focus on enrolling patients in our clinical trials in MG, HDFN and our newly initiated study in hemolytic anemia. Based on our progress, we expect to have sufficient cash to fund the company beyond the 2020 clinical readouts for nipocalimab and M254. We are also continuing our productive discovery efforts and we'll share updates with you in the future, as we work to identify a new early development candidate by the end of the year.
Thank you again for joining us, and I'll now turn the call back over to the operator to get the Q&A under way.
Questions and Answers:
Operator
[Operator Instructions] Our first question comes from Derek Archila from Stifel. Please go ahead.
Derek Christian Archila -- Stifel, Nicolaus and Company -- Analyst
Hey, thank you operator, and good morning. Craig, just a few questions from us. I mean, first on the wAIHA study. So first-off, is this is global program, or is this just U.S.? And understanding the population, are you looking at adults and children, or one or just one of those groups. And then also, I think you talked about some interim results. So is there a possibility of seeing data before 2021?
Santiago Arroyo -- Senior Vice President, Development and Chief Medical Officer
Yeah, the study is a global study. We will be doing an interim analysis, but the interim analysis will be blinded. The only thing that we will know on the interim analysis is that, if the study continues or not continues. There will be -- it is possible through the interim analysis, one dose arm will be terminated, but sponsor we will not know that it would all be blinded. That is very important. This study needs to be proposed. We consider this study pivotal. So we need to maintain the study integrity. And because of that, we'll not be able to have interim results.
Craig A. Wheeler -- President and Chief Executive Officer
Also the population adults in...
Santiago Arroyo -- Senior Vice President, Development and Chief Medical Officer
The population would be adults only.
Derek Christian Archila -- Stifel, Nicolaus and Company -- Analyst
Adults only, OK. And then I just wanted to see if he had any updates as far as your formulation work for subcutaneous version of nipocalimab. I know you briefly mentioned on the call, but I don't know if you have to add any color there?
Craig A. Wheeler -- President and Chief Executive Officer
Yeah, so, as we said before, that we actually have successfully formulated the product at the concentrations that make it a feasible injection. So it's kind of ready-to-go. What we're trying to figure out is when we're going to introduce it into the clinical trials. We were really, really excited about the fact that we can get it to our 30 mg per kg dose with a maximum of dosing. We could -- we showed we showed that we could actually safely dose it at 7.5 minutes, which is a very, very successful infusion. So it actually makes our 30 mg per kg dose quite attractive, and hopefully we can get to once monthly dosing there. And we think that dose with that sort of infusion actually could be beat frequent Sub-Qs. And so we will have that available. We intend to have that available at launch and we will figure out where to introduce that in the trials going forward.
Derek Christian Archila -- Stifel, Nicolaus and Company -- Analyst
Great. That's helpful. And then just last one for me. So are there any other plans to announce an additional indication from the nipocalimab in the next 12 to 18 months?
Craig A. Wheeler -- President and Chief Executive Officer
We're looking at a broad set of indications for this agent. So I don't think it's outside the possibility that we'll announce something in the next -- you know in the next 18 months. But I think we really want to see the results of the multiple trials we have going on now that would give us a better sense where we take it next.
Derek Christian Archila -- Stifel, Nicolaus and Company -- Analyst
Terrific. Congrats on the progress guys.
Craig A. Wheeler -- President and Chief Executive Officer
Thank you.
Operator
Thank you. Our next question comes from Danielle Brill from Piper Jaffray. Please go ahead.
Danielle Catherine Brill -- Piper Jaffray -- Analyst
Hi, guys. Good morning. Thanks for the question. A couple from me. So first, for HDFN, have you actually enrolled or dosed any patients yet in this trial, and will you press release or notify the Street when the first patient is enrolled? And then on wAIHA, how are you thinking about the competition for this indication? I think there are a couple other FcRn program that are also being evaluated, do you know where they are in development? Thanks.
Craig A. Wheeler -- President and Chief Executive Officer
Sure. So on HDFN, I can confirm that there are patients in the trial. While we have no significant plans to do announcements, because there's obviously a trial that we hope is a pivotal trial for us. We'll have to see as we go through the trial. On warm autoimmune hemolytic anemia, others have announced that they're going into it. Most notably, I think Alexion has plans to take their soon-to-be molecule into it. We don't know of anybody else that is actually into a Phase 2/3 what we consider potentially pivotal trials for us. And so we are in the lead in that indication. So we'd expect to be competitive. It's a large indication, and we expect that we have a very competitive agent there with the characteristics of our molecule.
Danielle Catherine Brill -- Piper Jaffray -- Analyst
Great. Thanks, Craig.
Craig A. Wheeler -- President and Chief Executive Officer
Sure.
Operator
Thank you. Our next question comes from Brandon Folkes from Cantor Fitzgerald. Please go ahead.
Brandon Richard Folkes -- Cantor Fitzgerald and Company -- Analyst
Hi, thanks for taking my question. Maybe just expanding on the prior question. Now that you've announced the three indications for 281 that you're going after, could you share your thoughts a bit more in-depth on a competitive landscape? Do you think could -- your partner could shape up into the anti-FcRn class?Thank you.
Craig A. Wheeler -- President and Chief Executive Officer
Sure. I'll go back to it. All right. I'm thinking about the strategy for this product. If you think about the breadth of opportunities in the three major broad areas as well as many, many diseases in each area. This is a tremendously fertile area for people to invest in, which is why you're seeing multiple programs. And we expect there will be multiple successful products here. We have designed our molecule with a high degree of intent to make sure that we have the high potency and the patient convenience. And so far, that's paid out in our trials. And so we're really looking for trying to get a label that will actually make us the agent of choice for physicians.
And the way we're going after that is thinking about how we choose our trials. You've noticed notice we're doing in fetal maternal, we're doing a research collaboration in gene therapy and then doing two trials so far in the autoimmune space to get broad application of it. But we're also designing our Phase 2 is to put a dosing information into the labels, so that physicians can -- you know decide how do they want to use the agents more broadly. We're actually working aggressively to make sure that we can get the agent able to be used safely in women of childbearing age by doing the fetal maternal. That fetal maternal actually opens that area, but also gives us a very strong label.
And so if you look at our dosing models, where we have done the infusion study to get we get shortest dosing, and we think we do have the shortest infusion dosing at this point of time versus our competitors. We think that we actually will have the best packaging label for clinicians to be able to use this. So, so far, everything's played out into that strategy. We're kind of thinking label backwards. As we look at competition, we see in the eye -- in the antibody space, we see our competitors using IgG 4 platforms, which have shown what seem to be toxicities, which means they cannot get to the level of IgG reduction that we can get to because of the toxicities of the programs. So they're using lower doses and seeing lower reductions.
And then, when you look at our Gen X, they're taking a different approach. There're a competitive binder. They have to get very very high doses to get even approach the kind of levels of IgG reductions that we can get, which means that we think we're going to be able to get better dosing against those agents. So we think, we're really well positioned in the space as the -- as the agents and the class develops.
Brandon Richard Folkes -- Cantor Fitzgerald and Company -- Analyst
Great. Thank you very much.
Craig A. Wheeler -- President and Chief Executive Officer
Certainly.
Operator
Thank you. Our next question comes from Eric Joseph from JPMorgan. Please go ahead.
Eric William Joseph -- JP Morgan -- Analyst
Hey, guys, thanks for taking the questions. Craig, I'm just wondering if you can provide a little more clarity on sort of where you see the greatest level of unmet need or commercial opportunity with nipocalimab and wAIHA given some pretty high response rates, I think with rituximab at least as reported in the literature and you know how we should be thinking about the treatment setting being studied here with nipocalimab in terms of patient severity or number of product therapies?
Craig A. Wheeler -- President and Chief Executive Officer
Sure. I'm going to turn that one over to Santiago.
Santiago Arroyo -- Senior Vice President, Development and Chief Medical Officer
Well, yes, as a reminder, in United States, there is no marketed product for this disease. As you were saying, rituximab is used often in this disorder. It is off-label. It has a good initial effect. Probably the number of reoccurrences is quite high. And we have to remind ourselves that rituximab is an fully immunosuppressant drug. Nipocalimab on the contrary, we believe that it will not be an immunosuppressant. As you know, it doesn't affect other IgG immunoglobulins. It doesn't affect cellular immunity. So it will be an important differentiator on the safety side, and we are also hoping to have better efficacy than the standard-of-care of label.
Eric William Joseph -- JP Morgan -- Analyst
Got it. That's helpful. And maybe just a follow-up on 254. I guess with the potential to significantly reduce IgG volumes with the candidate. Can you talk a bit about whether it's inevitable for subcute dosing and just generally whether you see much of a commercial advantage with an Fc formulated products relative to the present commercial landscape in IVIg? Thanks.
Craig A. Wheeler -- President and Chief Executive Officer
Yeah. So there's there's a number of questions in there. We do think that if we're at the same kind of ratios that there is a potential. Many people are trying to do Sub-Q with the current doses of a 1,000 mg per kg of IVIg. So it's feasible. It's still going to be a high volume, but it's feasible. And so we will be exploring that obviously in that competitive space. The real opportunity is around the convenience for patients. The shorter -- the shorter infusion times, the less burden on the healthcare resources. The fewer side effects, because you're giving much less protein. It really transforms and allows that market to grow, which is supply constrained.
The second piece of your question was around FcRns, and we do think FcRns will actually take some of the volume that is in the IVIg markets. But we do not think it will take all of it. We think this product has a long, long legs and will be around for a long time. So we think that they're both can actually work quite well together, because remember IVIg does more than just go after better at binding of FcRn. It also interacts with Fc gamma receptor receptors both activating and suppressing. And so -- so we actually think that there will be opportunities for both products even though they will interact with some of the diseases.
Eric William Joseph -- JP Morgan -- Analyst
Got it. That's very helpful. Thank you for taking my questions.
Craig A. Wheeler -- President and Chief Executive Officer
Sure. Thank you.
Operator
Thank you [Operator Instructions] Our next question comes from Tom Shrader from BTIG. Please go ahead.
Thomas Eugene Shrader -- BTIG -- Analyst
Good morning. Kind of a related question to the last one in the 254 trial. Do you match the infusion times of IVIg or do you match the protein per time or are you just -- what are you exploring in terms of reduced infusion times in this first trial?
Craig A. Wheeler -- President and Chief Executive Officer
Sure, I'll let Santiago answer that.
Santiago Arroyo -- Senior Vice President, Development and Chief Medical Officer
Yeah. We are currently not matching infusion times. Our infusion -- depending on the dose that we provide for 254, infusion time is much shorter.
Thomas Eugene Shrader -- BTIG -- Analyst
Okay. Can you tell us, in 281, where you've gotten with Sub-Q concentrations? How close are you to the full load?
Craig A. Wheeler -- President and Chief Executive Officer
Yeah. We haven't disclosed the concentration that we're at at this point in time so. So I don't want to disclose it at this point.
Thomas Eugene Shrader -- BTIG -- Analyst
Okay. And then one quick housekeeping question. The GSK manufacturing charge. It sounds like you're unsure about runs in 2021 and 2022, does that mean you could use it for another product? Is that part of the contract?
Craig A. Wheeler -- President and Chief Executive Officer
Yeah. There is flexibility in the contract, and so we're exploring. If there is opportunities to do other things that runs and that is exactly what we're thinking about.
Thomas Eugene Shrader -- BTIG -- Analyst
All right. Great. Thanks a lot, congratulations.
Craig A. Wheeler -- President and Chief Executive Officer
Sure. Thank you.
Operator
Thank you. As there are no further questions in the queue at this time, I'd like to turn the call back to Mr. Craig Wheeler, CEO for closing remarks.
Craig A. Wheeler -- President and Chief Executive Officer
Sure. Thank you, and I'll be brief. I just wanted to thank everybody for getting on the call. It's exciting progress for us and we're -- I'm pleased to say the team is really executing to -- according to plan and we're hoping to have more good news for you in coming quarters. So we look forward to talking to you. Thank you.
Operator
[Operator Closing Remarks]
Duration: 39 minutes
Call participants:
Patty Eisenhaur -- Vice President of Investor Relations and Corporate Communications
Craig A. Wheeler -- President and Chief Executive Officer
Michelle Robertson -- Chief Financial Officer
Derek Christian Archila -- Stifel, Nicolaus and Company -- Analyst
Santiago Arroyo -- Senior Vice President, Development and Chief Medical Officer
Danielle Catherine Brill -- Piper Jaffray -- Analyst
Brandon Richard Folkes -- Cantor Fitzgerald and Company -- Analyst
Eric William Joseph -- JP Morgan -- Analyst
Thomas Eugene Shrader -- BTIG -- Analyst
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