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Momenta Pharmaceuticals Inc (NASDAQ:MNTA)
Q3 2019 Earnings Call
Oct 31, 2019, 8:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Ladies and gentlemen, thank you for standing by. And welcome to the Momenta Pharmaceuticals Third Quarter 2019 Earnings Conference Call. [Operator Instructions] Please be aware that today's conference is being recorded.

I would now like to hand the conference to your speaker today, Patty Eisenhaur, Vice President of Investor Relations and Corporate Communications. Please go ahead, ma'am.

Patty Eisenhaur -- Vice President of Investor Relations and Corporate Communication.

Thank you, 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 third quarter of 2019. Today's call is being webcast and will be available for replay on the Investors 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 also be available for the Q&A portion of the call. Following our remarks, we will open 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 but not limited to statements about the use, efficacy, safety, potency, tolerability, dosing, convenience and market potential and reception of our products and product candidates, including their potential as best in class agents.

Development design, time lines and strategies for our product candidates, the design, timing and goals of clinical trials and availability; timing and announcement data and results; hypotheses regarding certain actions and effects of our product candidates in clinical studies, the timing of regulatory filings, regulatory approvals and launches of our product candidates and products; potential competition in revenues for our products and product candidates; our overall goals and strategies, non-GAAP operating expense guidance, including our anticipated collaborative revenues and our cash and cash equivalents.

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 June 30, 2019, filed with the Securities and Exchange Commission as well as other documents 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.

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.

During 2019, our focus has been on execution of our clinical programs, as we advance our pipeline of novel therapeutics for rare, immune, mediated diseases toward proof of concept. Momenta is leveraging its rich protein engineering heritage and immune biology expertise to develop these programs, all of which act on a different mechanism of Fc biology to combat pathogenic antibodies, a key driver of auto and alloimmune diseases, specifically with nipocalimab, we are targeting the FcRn receptor, which is responsible for maintaining the long half-life of IgG antibodies in circulation and mediating the transfer of IgG across biologic membrane.

With M254, we have enhanced sialylation of IVIg with the goal to reduce required doses and IV infusion times, as well as improve on a difficult adverse event profile that accompanies IVIg as the standard of care for many IgG1 mediated autoimmune diseases. And with M230, we have designed an Fc Multimer. Essentially, three Fc regions joined together that bind the Fc gamma receptors without activating them, enabling the drug to prevent immune complexes from binding Fc gamma receptors and activating the immune system.

Today, we will focus on nipocalimab and M254, as both are expected to report proof-of-concept data next year. Importantly, both of these agents have the potential to offer significant benefit to patients and to reshape the treatment landscape for a range of rare and large market IgG mediated diseases.

I'll begin with nipocalimab, our FcRn targeted antibody. Based on our Phase 1 data, we believe nipocalimab has the potential to be a best-in-class agent with superior safety, efficacy and convenience versus standard of care drugs and other molecules in this class. We are pursuing three indications, myasthenia gravis and Warm Autoimmune Hemolytic Anemia in the autoimmune area and hemolytic disease of the fetus and newborn, or HDFM, in the field of fetal maternal medicine.

The first of the nipocalimab studies to read out will be Vivacity-MG, our Phase 2 study in myasthenia gravis, from which we expect to report top line proof-of-concept data in the second quarter or third quarter of 2020. This study is progressing nicely. Most sites are open, and the trial is enrolling patients as per plan. We expect these data will provide an important window on the optimal dose that could allow us to achieve a greater than 80% IgG reduction observed in Phase 1, while extending the dosing interval to ease the patient's burden.

Ultimately, we believe we will be able to achieve once-monthly dosing. And at the comprehensive dosing data generated from this multi-arm Phase 2, could provide a more informative label for physicians. Finally, if our potency advantage translates into enhanced efficacy, the bigger effect size may allow us to pursue a smaller Phase 3 study versus competitors.

Importantly, achieving success in this trial would be a strong indicator of potential success in other autoimmune diseases, given nipocalimab's mechanism for blocking FcRn. On last quarter's call, we introduced our Warm Autoimmune Hemolytic Anemia clinical programs. Hemolytic anemia is a severe debilitating disease characterized by the destruction of red blood cells due to the presence of pathogenic IgG autoantibodies. The loss of erythrocytes results in severe anemia, weakness and fatigue. The unmet need in this indication is significant.

There are roughly 45,000 patients in the US, with most diagnosis occurring in adulthood and no approved therapies. As high as 30% of patients with severe hemolytic anemia are admitted to an ICU, where the current standard of care includes rescue blood transfusions, corticosteroids, immunosuppressants and removal of the spleen, all of which are associated with significant side effects and negative quality of life consequences.

We believe nipocalimab will ameliorate the physical and laboratory manifestations of hemolytic anemia by blocking FcRn-mediated recycling of IgG and reducing circulating levels of antibodies, including the pathogenic autoantibodies that cause the disease. We have been granted Fast Track designation in this indication, representing a fast-to-market opportunity and potentially, we could be the first FcRn inhibitor launched in this indication.

We are exploring this indication with our newly branded Energy clinical trial, our randomized, double-blind, placebo-controlled, multi-center, adaptive Phase 2/3 study, designed to investigate the safety, efficacy and tolerability of nipocalimab in patients with primary or secondary hemolytic anemia. In this study, patients will be randomized one to one to one to receive biweekly or monthly IV infusions of nipocalimab versus placebo.

The trial is expected to enroll 90 patients on a 24-week treatment period. The primary endpoint is based on the change from baseline in hemoglobin level, with secondary endpoints including markers of hemolysis and a fatigue scale. Clinical sites are currently being activated and patient recruitment is under way. If successful, this adaptive Phase 2/3 trial could serve as a pivotal study in hemolytic anemia. We anticipate top-line data around the end of 2021.

Thanks to the fantastic results from our recently completed infusion study, we have incorporated a significantly shorter infusion time in this trial. Our infusion study established the safety and tolerability of a best-in-class IV infusion time as low as 7.5 minutes for 30 mgs per kg. The dosing performance that we are seeing brings us ever closer to our goal of providing a patient-friendly dosing for this high dose product. The short infusion time, coupled with what we hope will be our long dosing interval of once-monthly will enable us to provide a convenient IV both at home and in infusion centers.

I'd also like to update you on our plans for a subcu dosage form. We have developed stable, high concentration subcu formulation. And based on the potency we have seen to date, we expect it will be a low-volume administration. We plan to introduce the subcu form in a future trial, once we have established the dose from our Phase 2 MG study and with the goal that it will be available when we launched the product in MG.

Our third nipocalimab trial, Unity, is our first trial in fetal maternal medicine. An area like autoimmune disease has multiple potential diseases that could benefit from this therapy. This trial is in hemolytic disease of the fetus and newborn or HDFN, where a mother's alloantibodies cross placenta and attack the fetal red blood cells.

FcRn is the receptor that transfers antibodies from the mother's circulation to the fetal circulation. Nipocalimab's ability to maintain full receptor occupancy enables total blockage of pathogenic alloantibodies from passing the mother to the fetus. We believe nipocalimab can make a profound difference in this devastating class of fetal maternal diseases.

Studying HDFN requires a highly specialized clinical program. This trial is being conducted in specialty centers under a strict protocol to protect the health of both the mother and the baby. The HDFN program has received Fast Track designation from the FDA, a nod to the high level of unmet need in the area and the potential difference nipocalimab could make.

We are currently enrolling patients with the aim to have 15 patients -- a 15 patient study readout in 2021. The strong mechanistic evidence, including the lowering of systemic IgG observed in our Phase 1 study and its ability in our preclinical work to block placental transfer of both pathogenic antibodies and the drug itself, highlights nipocalimab's potential to transform the treatment landscape in HDFN.

We also believe that proof of concept in this indication would validate our approach in fetal maternal antibody disorders more broadly, given the common mechanisms of all of these diseases. There are few agents in today's pharmaceutical landscape that have such a broad multi-disease potential. We believe nipocalimab is a best-in-class molecule in the FcRn class, and have built a development program to highlight that best-in-class profile.

Data to date and the work we are now undertaking have demonstrated that it achieves the greatest IgG reduction of any agent, has a promising safety profile, short infusion times, and with the fetal maternal work we are doing, access to the broadest market, any agent in development. We believe there is enormous commercial opportunity here and look forward to updating you as we advance this clinical program forward.

I'll now turn to M254, our hypersialylated IgG program. IVIg today generates $4.5 billion in revenue across many indications despite a significant treatment burden for patients. Specifically, IVIg requires very high doses to demonstrate efficacy, which can require two or more days to administer and often leads to significant adverse events. Our preclinical data show our enzymatic sialylation of IVIgs could produce a product with up to 10 times more potency than IVIg.

Importantly, the much slower protein mode has the potential to significantly reduce the AE profile associated with IVIg. Yes, as we have demonstrated in our animal models, we can administer a significantly smaller equivalent dose and elicit an equivalent effect, we believe M254 could transform this market in terms of safety, tolerability patient convenience and treatment costs. Also of note, with increased potency, there is a possibility that by delivering higher doses, we may be able to enhance efficacy.

Understanding the dosing ratio in humans is critical, which drives the design of our first trial. We are currently evaluating M254 and a four-part Phase 1/2 study designed to evaluate dose equivalents with IVIg. We have completed Part A, a single ascending dose arm in healthy volunteers. And we have advanced into Part B, a single ascending dose arm, patients with immune thrombocytopenic purpura or ITP. M254 is likely to be our first -- the first of our novel programs to reach proof of concept in 2020, which we would plan to announce after completing Part B of the trial and the first cohort of our Part C crossover study to validate the dose we believe is appropriate. This product if successful, could transform the treatment landscape in today's over $4 billion supply constrained IVIg market.

We look forward to reporting preliminary data from this program in the first half of 2020. We also have much going on in our research group, such as in our SIFbodies and in novel biology. We're not quite ready to talk details about these programs publicly yet, but we will update you on our plans to do so in the New Year.

And with that, I'll turn the call over to Michelle to review the third quarter 2019 financial results.

Michelle Robertson -- Chief Financial Officer

Thanks, Craig. Good morning, everyone.

We reported a net loss for the third quarter of $45 million, compared to a net loss of $50 million for the same quarter last year. The decrease was primarily due to a non-cash gain we received as a result of our lease modification and lower restructuring costs.

Product revenue, which includes profit share earned from Sandoz's sales of our Glatopa products was $6 million compared with $14 million for the same period in 2018. The decrease was primarily due to continued market competition.

Research and development revenue was $840,000, a decrease from $1 million in the same quarter of 2018. The decrease was primarily due to lower reimbursable revenue for Glatopa expenses. Third quarter total GAAP operating expenses were $53 million compared to the $67 million for the same period in 2018. The third quarter GAAP operating expenses include a $14 million gain, reflecting a reduction in our lease liability and our related right-of-use asset, as a result of our amended lease at our 320 Bent Street location.

Third quarter R&D expense increased to $46 million compared to $31 million in the same period in 2018. The increase was primarily due to an increase in manufacturing and clinical trial costs in nipocalimab and M254, offset in part by lower personnel costs following the company's workforce reduction in the fourth quarter 2018 and lower lease costs.

Third quarter G&A expense was essentially unchanged at $20 million. For the third quarter of 2019, our non-GAAP operating expense was $46 million, which includes the $14 million gain resulting from the reduction of our lease liability. Our non-GAAP operating expense is defined as total operating expenses less stock-based compensation, less restructuring costs and less collaborative reimbursement revenues.

Finally, we ended the third quarter at $326 million in cash, cash equivalents and marketable securities compared to $449 million at the start of year. Our third quarter cash position includes the addition of $36 million, reflecting the release of the bond related to the Amphastar Enoxaparin Sodium Injection litigation.

Turning now to our guidance for the remainder of the year. We expect fourth quarter non-GAAP operating expense of $50 million to $60 million, higher than the $45 million to $55 million we previously provided. Accelerated manufacturing investments and increased legal expenses are expected to contribute to the higher spend.

Despite the anticipated increase in operating expense, we continue to expect our current cash and cash equivalents to take us through upcoming proof-of-concept readout. As a reminder, non-GAAP operating expense is defined as total operating expenses less stock-based compensation, less restructuring costs and less collaborative reimbursement revenues.

With that, I'll turn the call back over to Craig for closing remarks.

Craig A. Wheeler -- President and Chief Executive Officer

Thanks, Michelle. As stated, we are well capitalized to achieve our goals and milestones for the remainder of 2019 and beyond, as we head into 2020. We will continue to advance our ongoing clinical studies of nipocalimab and M254 proof of concept. We will continue to drive the progress of our research teams, as they work on SIFbody technologies and novel biology to identify additional opportunities for pipeline programs. And we look forward to the progress of M710, our biosimilar EYLEA program Mylan is leading, as we move toward market formation in the 2023 timeframe, as well as our M230 program that CSL is leading, which should have additional data sometime next year.

Thank you 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

Thank you. (Operator Instructions) And our first question will come from the line of Danielle Brill from Piper Jaffray. You may begin.

Danielle Brill -- Piper Jaffray -- Analyst

Hi, guys. Thanks for the questions. Craig, you said last quarter that you enrolled 20 patients, about 20 patients in MG trial. Curious if you could tell us how many additional patients were added in 3Q? And then for M254, you said the preliminary data will include Part B and the first cohort of Part C. Can you remind us what you're looking for in Part B to justify moving to Part C? And will you update the Street when you start Part C? Thanks.

Craig A. Wheeler -- President and Chief Executive Officer

Sure. Thanks for the question. First on, last quarter, I don't think we gave specific patient numbers. They were speculation by questioners on the numbers. But our trial enrollment continues as per plan. And so we are still confident in the guidance that we're giving is second, third quarter readout for that trial. And so, overall, it's going quite well. On Part B into Part C, Part B is a dose escalation in patients. And so what we're looking for is understanding the ratio of our drug to IVIg in terms of where the equivalent dose is. But because Part B has small cohorts, we have a Part C that has two doses that we would take forward choosing out of Part B to really confirm the dose that is the right dose in humans to understand the ratio between M254 and IVIg.

Danielle Brill -- Piper Jaffray -- Analyst

So, what is the ratio that you need to see in Part B to justify starting Part C?

Craig A. Wheeler -- President and Chief Executive Officer

Well, what we said in the past is that, this is a product that actually could be very, very beneficial at a lot of different dose ratios. And so if you look at that, if you look at the ratios, if we're in the 7 to 10 range, we need very little IVIg to be able to cover a lot of diseases that IVIg is treating today.

So, there's a lot of ways you can do it, including working to buy IVIg ourselves without supplier agreements and launching the product ourselves. There are places where we will more likely need a partnership with a large plasma supplier because the amount we'd have to buy. And I kind of quantify that in the 4 to 7 range, where there still would be a very, very powerful agent for anybody if we could reduce the volume by that much .

And above that, then we'd have to really see if it's more comparable to IVIg. Obviously, it's not having the effect. We would hope it would have. So, we kind of see all the way down from your 3 to 4, all the way down to 10, where we've seen in animal models is very attractive. But just potentially could be different strategies for us depending on the ratio because of the IVIg sourcing requirements .

Danielle Brill -- Piper Jaffray -- Analyst

I see. Very helpful. Thanks so much for the questions.

Craig A. Wheeler -- President and Chief Executive Officer

Sure. Thank you.

Operator

Thank you. And our next question will come from the line of Derek Archila from Stifel. You may begin.

Derek Archila -- Stifel, Nicolaus & Company -- Analyst

Great. Good morning, and thanks for taking my questions. And congrats on the progress. So just a couple of questions. So first, just following up on some of the comments regarding the subcu version. I guess, is it fair to say that we'll get some specifics on the subcu version by the end of 2020.

And then, just two questions on M254. So just a follow-up to the previous question. So when we get the data that you plan to present for Cohort B in the first part of Cohort C, what that data is going to look like? How should we interpret these results? Like how are you going to present it? And then beyond just sialylating IVIG, what other areas could you take this platform to create some value for the company? Thanks.

Craig A. Wheeler -- President and Chief Executive Officer

Sure. So let me just kind of go through those questions in order. Thanks very much for them. So first on comments of subcu, we really can't tell you exactly when we're going to come out with subcu. Our goal is to really truly understand dosing in this molecule. And you know that the trial design that we've had and we can go through it in more detail because Santiago is here, if you would like to go through more detail that we put in our Phase 2 mg study is really to complete the dosing model to understand duration of dosing and level of IgG drops.

So, we need that data to begin to plan to bridge to a we subcu. We will have a subcu. We have developed a formulation. We will have a subcu available at launch for MG. But I don't want to be predictive. It's interesting. I see all of the debate that's going on with all the different companies. We're talking about subcu, but subcu delivery is actually a very sophisticated form of delivery that you really need to understand your dosing intervals and dosing durations, et cetera.

And so we're going to be very, very careful to make sure we can optimize that potential for us. But you can assume that we have a high dose formulation. We've already talked about a high concentration formulation and with the potency that we've seen that we will have a very competitive subcu when we do introduce it

Okay. Second, on Cohort M254, Cohort C, that really will be the results of what we're seeing in terms of comparable dose equivalents to M254 and IVIg. So the goal of the trial, the whole goal of this trial is to be able to go forward in this indication and other indications with M254 at an appropriate dose. And so we're looking at trying to understand what that dose ratio was. And so that's what we'll be reporting in the patients and obviously, the safety data will come along with it. It's not powered nor designed to actually show any superiority. So, this is not a -- this is not a superiority trial. It is a dose equivalence trial to show the ratio change, and that's what we should see out of that study.

Finally, where can we take it? As we've talked about in the past, sialylation actually has effects that could actually extend the half-life of other molecules, particularly blood products and so we've been exploring those in the laboratory and have some pretty interesting opportunities going forward. But nothing that we're really ready to put into the clinic or development portfolio at this time. But we do think there is actually significant potential beyond M254 with sialylation technology.

Derek Archila -- Stifel, Nicolaus & Company -- Analyst

Great. Thanks, Craig.

Craig A. Wheeler -- President and Chief Executive Officer

Sure. Thank you.

Operator

Thank you. And our next question will come from the line of Eric Joseph from J.P. Morgan. You may begin.

Turner -- J.P. Morgan -- Analyst

Hey. Good morning. This is Turner [Phonetic] on for Eric. I'm just curious if the Vivacity-MG study was successfully amended to incorporate, reducing nipocalimab infusion times. And if so, have you received any real world feedback and if there are any safety or tolerability concerns there?

And then secondly, you have the extension study for MG currently ongoing. I think that's been open for a few months now. So, I'm just hoping if you could comment on the rate rollover into this study understanding it's early on. Thank you.

Craig A. Wheeler -- President and Chief Executive Officer

Sure. I'm going to turn that question over to Santiago Arroyo, our Chief Medical Officer.

Santiago Arroyo -- Senior Vice President, Development and Chief Medical Officer

Hi. Good morning. Yes, we have incorporated a quicker infusion rate in our myasthenia gravis study. And the open label study is going well and there haven't been any significant safety issues related to the ongoing trial, both trials .

Turner -- J.P. Morgan -- Analyst

Great. And then just the extension study, if there's been any, if you could comment on the rollover into the MG extension study?

Santiago Arroyo -- Senior Vice President, Development and Chief Medical Officer

Sorry?

Michelle Robertson -- Chief Financial Officer

Is it rolling into the long-term?

Craig A. Wheeler -- President and Chief Executive Officer

Yeah, we don't comment specifically on the number of patients.

Santiago Arroyo -- Senior Vice President, Development and Chief Medical Officer

No, we don't comment on that. But they are rolling as expected

Turner -- J.P. Morgan -- Analyst

Okay. Thank you.

Craig A. Wheeler -- President and Chief Executive Officer

Thank you.

Operator

And our next question will come from the line of Brandon Folkes from Cantor Fitzgerald. You may begin.

Bryan Brokmeier -- Cantor Fitzgerald -- Analyst

This is Bryan on for Brandon. Regarding the Warm Autoimmune Hemolytic Anemia indication. Can you help us get a better understanding of the patient population? You've talked to 45,000 patients in the US. But can you provide color on where these patients are being diagnosed and treated? And what percentage of the 45,000 patients would Momenta be able to reach? Would this be a hospital-based approach, targeting patients admitted to the ICU? Or would you look to get patients potentially on M281 before any ICU admission? Any color would be helpful. Thanks.

Craig A. Wheeler -- President and Chief Executive Officer

Sure. That's another great question for Santiago. So, I'll let Santiago take that one.

Santiago Arroyo -- Senior Vice President, Development and Chief Medical Officer

Yeah, we are including patients with primary and secondary Warm Hemolytic Anemia. Those patients are outpatients. We are not aiming for patients that are transfusion dependent on this study. And these patients are in hematology clinics. So that's what we are focusing our patient search for this study.

Bryan Brokmeier -- Cantor Fitzgerald -- Analyst

Great. Thanks.

Craig A. Wheeler -- President and Chief Executive Officer

Thanks, Bryan.

Operator

And our next question will come from the line of Tom Shrader from BTIG. You may begin.

Tom Shrader -- BTIG, LLC -- Analyst

Good morning. I had a question on 254 and your confidence to go it alone. And just your thoughts. IVIg periodically gets supply constrained, then you would be a competitor. Does that -- where are you? Do you feel like you need to be on the inside?

Craig A. Wheeler -- President and Chief Executive Officer

Tom, thanks for the question. I don't think it worries us. It actually gives us kind of -- a couple of strategic directions that we have to think about. And with a low dose, we don't need that much material without with the low ratio, right? We have 10 in humans. We don't need that much IVIg. And so there are -- it's a complex market with some very large players.

But there's lots of smaller players that we could potentially source IVIg from, if we have a very high potency versus IVIg. If we are in the range where we have to buy a lot of material, we're going to be in the range where we need to actually buy from one of the larger players, which means a partnership would probably much, much prefer. Also in those larger players with -- those larger players have massive plans for their IVIg. They could actually put this technology into their IVIg production plans and that would also give them a good cost advantage of making the product. So it really depends. We do have kind of a two-pronged strategy for that, but it really depends on what we see in the clinical trial.

Tom Shrader -- BTIG, LLC -- Analyst

And is 7 kind of a breakpoint? Is that reasonable?

Craig A. Wheeler -- President and Chief Executive Officer

Roughly, I mean I kind of use that as a guideline. And I think we'd have to look at, for each of those ratios what kind of partnership would get to supply versus what the opportunities were in big, in large partnerships. Both of these are, actually, if you think about very attractive opportunities for us, either on our own or partnerships because the opportunity to actually partner with one of the big guys when there's really three of them. And this would give anybody who got it, if we have those kind of ratios an advantage, could be a very attractive partnership for us.

Tom Shrader -- BTIG, LLC -- Analyst

And then very quickly on the wAIHA trial, are all the doses set or at some level could Vivacity change that?

Santiago Arroyo -- Senior Vice President, Development and Chief Medical Officer

No, the doses are set. We will do an interim analysis. And through that a decision will be made about stopping one of the dose arms.

Craig A. Wheeler -- President and Chief Executive Officer

Yeah, and Tom, we..

Santiago Arroyo -- Senior Vice President, Development and Chief Medical Officer

We will not announce it because it will be actually blinded to what happens. So there will be a late [Phonetic] decision and the trial will continue

Craig A. Wheeler -- President and Chief Executive Officer

Yeah. And Tom, what I was going to say, the part of the reason that we did an adaptive trial here is we wanted to get it going, before we get all the full results of the MG dosing study. So, we have a pretty good beat in terms of what the dosing behavior is. And so we actually chose two doses within the adaptive design of this trial.

Tom Shrader -- BTIG, LLC -- Analyst

Okay. Great. Thanks for the answers.

Craig A. Wheeler -- President and Chief Executive Officer

Sure. Thank you.

Operator

Thank you. (Operator Instruction) Our next question comes from the line of Douglas Tsao from H.C. Wainwright. You may begin.

Douglas Tsao -- H.C. Wainwright & Co. -- Analyst

Hi. Good morning. Thanks for taking the questions. Just, Craig, maybe if you could help clarify some of the timelines, if the wAIHA study is successful for nipocalimab, you think that you can file or that could be the basis for filing? So, could that be potentially on the market by the end of 2022?

Craig A. Wheeler -- President and Chief Executive Officer

I think it really is up to the results of the trial. We've designed this trial and powered this trial with enough patients that it could be an approvable study depending on the results, but the FDA obviously doesn't tell you that ahead of seeing the results. So if that were the case, if we see that the potency of a small will translate into the efficacy, we think it can in this disease, then yes. If we're looking at the trial results around the end of 2021, then it's possible to see it in about a year into the market. Yes.

Douglas Tsao -- H.C. Wainwright & Co. -- Analyst

And Craig, just -- and that would be ahead of the timeline for MG most likely?

Craig A. Wheeler -- President and Chief Executive Officer

Yes, it would, because MG will be a Phase 2, and then a Phase 3. So yes, it will be.

Douglas Tsao -- H.C. Wainwright & Co. -- Analyst

And then for M254, just curious if you will establish dose equivalents, would your plan to then -- and that would obviously be an ITP, would you plan then to move into other indications with potential registration studies? Or would you be then moving into additional sort of proof-of-concept studies and other indications?

Craig A. Wheeler -- President and Chief Executive Officer

We're still considering that. Obviously, having that knowledge of what the dose ratio is gives us a pretty good idea of what we will be able to accomplish because IVIg has paved that path. And so you can look at ITP, which is primarily an acute indication. You can begin to look to indications like CIDP, which is the largest indication where IVIg sells. And so we're exploring all of that right now. So, you could see us move directly into registrational types of studies or go directly into a phase -- short Phase 2 to a Phase 3, but we're not quite there to be able to talk about the specific designs yet.

Douglas Tsao -- H.C. Wainwright & Co. -- Analyst

Okay. And you expect after we get the proof-of-concept data next year, would be in a position pretty quickly to sort of come up a bit or communicate the development plan?

Craig A. Wheeler -- President and Chief Executive Officer

I'm looking at Santiago. He is nodding vigorously.

Douglas Tsao -- H.C. Wainwright & Co. -- Analyst

Okay. Great. Thank you so much.

Craig A. Wheeler -- President and Chief Executive Officer

Okay. Thank you.

Michelle Robertson -- Chief Financial Officer

You are welcome, Doug.

Operator

Thank you. And I'm not showing any questions at this time. I would like to turn the call back over to Craig Wheeler for closing remarks.

Craig A. Wheeler -- President and Chief Executive Officer

Okay, everybody. Thank you for joining us for our call today, and we look forward to updating you. We think we have a really exciting year ahead of us in 2020 with all of the different readouts that we have. So, we are really happy you are joining us on that journey. Thank you.

Operator

[Operator Closing Comments]

Duration: 36 minutes

Call participants:

Patty Eisenhaur -- Vice President of Investor Relations and Corporate Communication.

Craig A. Wheeler -- President and Chief Executive Officer

Michelle Robertson -- Chief Financial Officer

Craig A. Wheeler -- President and Chief Executive Officer

Santiago Arroyo -- Senior Vice President, Development and Chief Medical Officer

Michelle Robertson -- Chief Financial Officer

Danielle Brill -- Piper Jaffray -- Analyst

Derek Archila -- Stifel, Nicolaus & Company -- Analyst

Turner -- J.P. Morgan -- Analyst

Bryan Brokmeier -- Cantor Fitzgerald -- Analyst

Tom Shrader -- BTIG, LLC -- Analyst

Douglas Tsao -- H.C. Wainwright & Co. -- Analyst

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