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Edited Transcript of MNTA earnings conference call or presentation 7-Nov-18 1:00pm GMT

Q3 2018 Momenta Pharmaceuticals Inc Earnings Call

CAMBRIDGE Dec 17, 2018 (Thomson StreetEvents) -- Edited Transcript of Momenta Pharmaceuticals Inc earnings conference call or presentation Wednesday, November 7, 2018 at 1:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Craig A. Wheeler

Momenta Pharmaceuticals, Inc. - President, CEO & Executive Director

* Michelle Robertson

Momenta Pharmaceuticals, Inc. - Principal Financial Officer, Principal Accounting Officer, CFO & Treasurer

* Santiago Arroyo

Momenta Pharmaceuticals, Inc. - Chief Medical Officer & Senior VP of Development

* Sarah Carmody

Momenta Pharmaceuticals, Inc. - Senior Director of IR & Corporate Communications

* Young T. Kwon

Momenta Pharmaceuticals, Inc. - Chief Business Officer, Senior VP of Corporate Development & Strategy

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Conference Call Participants

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* Brandon Richard Folkes

Cantor Fitzgerald & Co., Research Division - Analyst

* Danielle Catherine Brill

Piper Jaffray Companies, Research Division - VP & Senior Research Analyst

* Derek Christian Archila

Stifel, Nicolaus & Company, Incorporated, Research Division - Director & Senior Biotechnology Analyst

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Presentation

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Operator [1]

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Good day, ladies and gentlemen, and welcome to the Momenta Pharmaceuticals Third Quarter 2018 Earnings Call. (Operator Instructions) As a reminder, this call is being recorded.

I would now like to introduce your host for today's conference, Sarah Carmody, Senior Director of Investor Relations. Ma'am, you may begin.

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Sarah Carmody, Momenta Pharmaceuticals, Inc. - Senior Director of IR & Corporate Communications [2]

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Thank you, Heather. Good morning, everyone, and thank you for joining us today for Momenta's conference call to discuss results for the third quarter of 2018. Today's call is being webcast, and you can view the slides we will be presenting in the Investors section of our website at momentapharma.com.

Joining me on the call with prepared marks are Craig Wheeler, our President and CEO; and Michelle Robertson, our Chief Financial Officer. Also joining us today are Young Kwon, our Chief Business Officer; and Santiago Arroyo, our Chief Medical Officer, who will 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 development, including statements about our strategic plan and the restructuring resulting from our strategic review; the timing of regulatory filings; regulatory approvals; market formation and launches of our product candidates and products; the market potential and reception of our products and product candidates; potential competition in revenues for our products; development time lines and strategies; development of our product candidates, including timing of clinical trials and availability of data; hypothesis regarding certain effects of our product candidates in clinical studies; accounting treatment for payments from our collaborators; our goals and strategy; our current and potential future collaborations; 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 under the heading Risk Factors in our most recent quarterly report on 10-Q filed with the SEC as well as other documents we might 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 third quarter 2018 non-GAAP operating expense. Please see the presentation accompanying the call for further information and reconciliation of this measure.

With that, I'll turn the call over to Craig.

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Craig A. Wheeler, Momenta Pharmaceuticals, Inc. - President, CEO & Executive Director [3]

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Thank you, Sarah. I'll start today's call with an update on the status of the corporate restructuring that we announced on October. Then, I'll provide an update of our novel drug and biosimilar programs and recap some of the information that was announced at our recent R&D Day. Following my remarks, our CFO, Michelle Robertson, will discuss our second quarter financial results and provide guidance for the remainder of 2018. We'll then open the call for questions.

In early October, we announced our plans for corporate restructuring. The restructuring was done in order to reduce our level of involvement in biosimilar development and focus more of our resources to advance what has become a very attractive pipeline of novel drug candidates targeted at immune-mediated disorders. Since the announcement, we have taken steps to reduce our workforce by approximately 50%. A top priority has been to ensure a smooth transition for those departing the company as well as for those continuing on with Momenta. We are now well underway in the considerable efforts needed to relaunch the company after such an extensive reduction in force. We're now putting the processes in place to focus the company and function on a leaner scale going forward. I want to thank the Momenta team for all the hard work over the past few weeks. It's been a very difficult transition.

Looking forward, we have an exciting portfolio to develop, and I'll start with news on our 2 remaining biosimilar programs. First, M923, our wholly owned biosimilar to HUMIRA. Yesterday, we announced that we reached a global settlement with AbbVie on the HUMIRA patent at stake. We have a U.S. launch date in November of 2023 and have the ability to launch in the EU as soon as we are approved.

The settlement paves the way for our U.S. filing, which will happen this quarter. In addition, we plan to file in the EU in the first half of next year, and can be in the market in Europe as early as 2020. We have initiated discussions with potential commercialization partners for this product candidate. And we believe our settlement and filings will help us to find the ideal global partner for M923. We're excited about the potential launch of this product, however, there are significant manufacturing expenses ahead to enable us to market this product candidate, and we believe bringing a commercial partner onboard in the near term could meaningfully reduce our share of these expenses.

While we are continuing our biosimilar collaboration with Mylan, we only plan to continue investment in M710, a proposed biosimilar to EYLEA. Mylan's currently enrolling patients in a Phase III study for this product, and we believe it can launch in the U.S. as early as 2023. We are currently in the lead development of this asset and feel M710 could bring in significant revenue to support our expanding novel drug pipeline. We look forward to keeping you updated as this trial progresses.

There are ongoing discussions with Mylan to exit our participation in the further development of the other 5 programs that were part of the original collaboration agreement, including M834, a proposed biosimilar to ORENCIA.

Now on to our promising autoimmune novel drug pipeline. We were very excited to give you a closer look at these programs at our recent R&D Day in New York City. I'll start with M281, our promising FcRN program. To begin, I'll provide some perspectives on our full Phase I data set, which we presented at R&D Day. The Phase I data clearly demonstrates that M281 continues to exhibit best-in-class performance. The data show that M281 can achieve the highest level of IgG reduction and provide the most rapid reduction of IgG from baseline of any agent in the class. On the safety front, no SAEs occurred, and the total level and types of AEs in the study were similar for patients taking drug as for placebo across all single and multi-dose patients.

The trial also demonstrated that M281 can achieve and safely maintain full receptor occupancy of the FcRn receptor, a characteristic critical for dosing fetal-maternal indications. The study gave us everything we needed to advance with confidence into multiple Phase II trials, and the regulatory agencies agree. However, I do realize that some of the laboratory data we presented at the R&D Day raised some questions for our investors. So I want to provide you with our perspectives on these issues and highlight why we and the regulators have not flagged these issues as a concern.

I'll start with the CK elevation that was seen in 3 subjects of the 15 -- in the 15-milligram per kilogram or low-dose portion of the multiple-ascending dose study. CK, or creatinine kinase, is an important enzyme in cells that consume energy rapidly, for example, muscle cells. Clinically, CK is monitored as it can be a marker for muscle damage. There are 3 types of CK: muscle, cardiac and neurological. The 3 patients had elevated CK in our trial had only muscle CK elevations. And while we intend to continue to monitor CK in our future trials, we do not think it is drug related for the following reasons.

First, CK elevation in Phase I trials is common. A published meta-analysis shows that elevated CK levels occurs in over 11% of Phase I healthy volunteers. It was seen in 3 of 50 dosed in our trial. Transient muscle CK rises occur after exercise, which is a common cause for CK rises in Phase I patients. One of the volunteers in our trial with a high CK lab result admitted to exercising. Third, the CK rises seen in the trial did not show any dose dependency as it has only occurred at the low dose and the levels were variable across patients, and all elevations are transient and returned to normal. Fourth, there were no symptoms, such as myalgia, indicating muscle damage in any of the Phase I patients. The elevations were all considered mild by the investigator reporting them. Finally, I want to emphasize that the neuro pharm division of the FDA did not express any concerns regarding the elevation seen in the Phase I healthy volunteers study and has allowed us to move forward with a Phase II study in myasthenia gravis, an autoimmune disease involving muscles. All of these taken together leaves us to believe that the CK elevations were not related to M281.

The second observation in the Phase I safety data that I'd like to address is the asymptomatic reduction in albumin seen in the laboratory data. We saw linear reduction in the 60 mg per kg single-ascending dose and in the 15 and 30 mg multiple-dose cohorts. The reduction was about 20% to 25% when measured against the subject's individual baseline. Albumin reductions were not associated with edema or other adverse events and returned to normal within 2 to 3 weeks after the drug was discontinued.

Based on the data we have in hand, we hypothesized that lowering albumin is likely to be a class effect and is likely related to the drug. In our Phase I studies, M281 was dosed at significantly higher levels than our competitors' to allow us to reach and maintain full receptor occupancy so we can take advance of M281's best-in-class potency. As a reminder, we were able to achieve these dose levels because our molecule did not had any dose-limiting toxicities.

We believe the albumin drops we are seeing in our high-dose cohorts are acceptable for the following reasons: First, the albumin drop of 20% to 25% is seen only in our high-dose arms. It seems to be stable and resolves naturally after the drug is withdrawn, we believe, because the FcRn recycles both IgG and albumin. This class of drugs likely reduces the level of both when the receptor is blocked. Albumin, which is the most abundant protein in the body, plateaus a much lower reduction in IgG because of high and compensating production in the liver. Second, the drop was consistent across or most of those Phase I patients and our monkey studies, where much higher doses of drugs were used for over 6 months with no clinical symptoms related to albumin reduction.

Third, we believe that the reduction in albumin is dose-dependent, and if we were to extend the dosing of our molecule at doses similar to what our competitors are using, we would not see albumin levels outside of the normal range. That we are seeing it in our high dose is a testament to the safety and potency of our molecule, which allows us to drive IgG levels significantly lower than our competitors have been able to achieve.

Finally, there is no evidence that this level of albumin reduction is clinically relevant. Patients with genetic base introductions of albumin, who have much lower levels, typically show little to no symptoms. Symptoms are typically only evident in patients with liver disease, who have low levels of albumin but also significant complications from the liver disease itself.

As with the CK, regulators have reviewed all of our albumin data and have given the go-ahead to initiate trials of M281 in pregnant women with severe hemolytic disease of the newborn or HDFN. Pregnant women often have lower levels of albumin to start with. However, multiple agencies are comfortable enough with our data to allow us to move forward in this important indication. So far, Health Canada has accepted the CTA to initiate our Phase II trial. In addition, we just received a positive opinion to the Voluntary Harmonisation Procedure, or VHP, from the United Kingdom, Netherlands, Belgium, Spain to support initiation of our Phase II study.

As you'd expect, we'll continue to monitor a broad range of clinical laboratory values, including albumin and CK levels in our Phase II trial, but we don't expect either to present a significant toxicity issue. Our team will provide reference materials that support our analysis to investors who are interested. As a final point on our Phase I study, I want to re-emphasize that M281 continues to show its best-in-class potential with the ability to achieve full receptor occupancy with no dose-limiting toxicities now demonstrated in humans.

Looking ahead, we announced at R&D Day that we've embarked on a broad strategy to demonstrate the superiority of M281. We're working in 3 areas: autoimmune disease, fetal-maternal disease and supportive therapy for other agents, specifically AAV gene therapy, to allow this product to overcome alloantibodies and retain their efficacy. We announced our first 2 Phase II trials in autoimmune and fetal material and are commencing both this quarter.

Our first indication we've chosen is generalized myasthenia gravis, a debilitating, rare autoimmune disease mediated by pathogenic IgG autoantibodies and associated with severe morbidity and potentially life-threatening complications. We chose generalized MG because there remains a significant unmet medical need. Since our competitors have already released data showing that lowering IgGs have a therapeutic benefit in this disease, it is a perfect indication to demonstrate that our superior potency and toxicity profile can translate to better efficacy.

We have designed a very robust Phase II study that will evaluate approximately 60 patients with generalized myasthenia gravis. This study should allow us to demonstrate efficacy and safety and establish the clinical relationship between IgG reduction and efficacy.

We're also evaluating a wide range of dose paradigms to establish the optimal dose and dose schedule for maximum patient benefit for use in a Phase III study, which we believe will enable us to design a focused Phase III trial, which can be rapidly enrolled. We anticipate top line results from this study in 2020, assuming a successful pace of enrollment.

Our second M281 indication is HDFN. HDFN is a rare alloimmune disease caused by antibodies from the mother crossing the placenta and impacting the baby. In a process known as red cell alloimmunization, the mother develops antibodies, which target proteins on fetal red blood cells causing anemia in the fetus with associated potential fetal demise and significant infant morbidity. Based on publicly available data, we estimate that there are approximately 4,000 to 8,000 cases of HDFN per year in the U.S. with severe HDFN affecting the approximately 1,600 to 3,200 of these cases.

We chose HDFN as an indication for 2 important reasons. First, there remains a very high unmet medical need. There are no approved therapies, and current standard of care is invasive: intrauterine transfusions. Standard treatments are also not always available or effective, leading to a 20% rate of fetal mortality and significant morbidity in the neonates.

Second, we believe that M281's mechanism is the perfect match for this disease. By blocking FcRn, M281 can fully block the transfer of mom's autoantibodies to the fetus. In addition, M281 will also reduce the amount of antibodies against fetus red blood cells in maternal circulation. M281 showed in its Phase I clinical trial that a 30 mg per kg weekly dosing regime can maintain 100% receptor occupancy, which is essential for treating this disease, and we use this dose in our Phase II trial.

As for the timing of this trial, we have regulatory acceptance in Canada and, as I mentioned previously, received positive opinions to initiate in U.K., Spain, Netherlands and Belgium. We're working with the FDA and plan to file an IND in the U.S. as well, and we're targeting proof of concept in 2021 for this trial, assuming a successful rate of enrollment.

We have provided what we believe to be realistic time lines for both our generalized myasthenia and HDFN Phase II trials, however, we will look to accelerate the time lines wherever possible going forward. In particular, some of the regulatory agencies that we've been working with in HDFN have suggested the potential for accelerated filing depending on the outcome of the Phase II study.

Turning to M254, our hyper-sialylated IgG program designed to be a potential high-potency version of IVIg, which we also showcased at our R&D Day. We outlined our clinical development plan for M254. We plan to enter a single trial with dose ranging in normal volunteers and then progressing directly into patients with idiopathic thrombocytopenic purpura or ITP. ITP is a disease where IVIg is already approved as a treatment and can provide robust proof of concept because the platelet readout is rapid and a good indicator of efficacy. Therefore, we believe this trial can be completed quickly, and M254 has the potential to be our first novel autoimmune program to reach proof of concept.

This Phase I/II trial is a 4-part study, which should allow us to rapidly identify the relevant dose levels of M254 required in humans that show equivalent efficacy to IVIg. I won't go into the full design here, but it's on our website. And Santiago is here with me if you have questions following our prepared remarks.

Our main goal in this trial is to demonstrate that M254 has the potential to be up to 10x more potent than IVIg in humans. If successful, this program could transform IVIg therapy. The IVIg market is estimated to be a $4 billion market in autoimmune disease. It is a supply-constrained market, and it brings a very high burden for patients because of the large volumes that must be used to show efficacy. Our agent offers the possibility of a much more potent version of IVIg and, therefore, a lower dose. A more potent lower dose can bring better safety, tolerability, patient convenience, lower overall use of resources and possibly higher efficacy than IVIg.

We planned on initiating this study in the fourth quarter of 2018, but due to manufacturing delays at our contract manufacturer, we're now targeting the initiation of this Phase I/II proof of concept in early 2019. Importantly, and subject to the rate of enrollment, we are still targeting the 2020 time frame for proof of concept data. We're very excited about the potential of M254 and look forward to providing more information as we progress.

Lastly, on the novel drug portfolio, a quick update on M230, our novel drug program 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. The Phase I study designed to evaluate safety and tolerability of M230 in healthy volunteers is ongoing, and CSL anticipates this study will be completed in 2019. I look forward to keeping you updated as we move forward on this program as well.

Before I turn the call over to Michelle, I would like to discuss how we're thinking about financing the company. As we always are, we are evaluating the potential for additional public financing. However, I would emphasize that there are alternatives available to extend our runway, including multiple business development opportunities. These opportunities include identifying a commercial partner for M923, partnering some of our attractive research candidates or exploring ex U.S. collaborations for wholly owned development programs. We have added cash in the company to enable us to choose the right timing and sources of capital to fund these products in portfolio.

In closing, we have a lot to be excited about at Momenta from the broad potential of our promising novel drug programs and the further development and commercialization of our 2 late-stage biosimilar candidates. We're committed to aggressively executing our plans to drive these programs forward to deliver meaningful therapeutics to the patients who need them and value for our investors.

With that, I'd like to welcome Michelle to the executive team and to congratulate her on her new role as CFO. I'm looking forward to working with her as we advance our portfolio and both the company.

And with that, I'll turn the call over to Michelle to review the second quarter financials.

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Michelle Robertson, Momenta Pharmaceuticals, Inc. - Principal Financial Officer, Principal Accounting Officer, CFO & Treasurer [4]

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Thanks, Craig. Good morning, everyone.

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Craig A. Wheeler, Momenta Pharmaceuticals, Inc. - President, CEO & Executive Director [5]

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Third quarter.

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Michelle Robertson, Momenta Pharmaceuticals, Inc. - Principal Financial Officer, Principal Accounting Officer, CFO & Treasurer [6]

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We reported a net loss in the third quarter of $50 million compared to a net loss of $33 million for the same quarter last year. The net loss for the third quarter 2018 includes restructuring charges of approximately $16 million. Revenues in the third quarter totaled $15 million compared to $24 million for the same period in 2017. Third quarter 2018 revenue include approximately $14 million in product revenue, which was profit share earned from Sandoz's sales of our Glatopa products. In Q3 2017, we reported product revenue of approximately $11 million from Sandoz's sales of Glatopa 20 mg. The year-over-year increase in product revenues in the third quarter was primarily due to a nonrecurring deduction of a $5 million contractual commitment in 2017, offset by lower net sales, driven by market decline and Mylan's entry to the COPAXONE markets.

Research and development revenues decreased to $1 million from $13 million in the third quarter of 2018. The decrease was primarily due to a $10 million milestone payment achieved in the 2017 period and lower reimbursement expenses for our complex generic programs with Sandoz.

Third quarter total GAAP operating expenses were $67 million compared to $59 million in the same period in 2017. The third quarter GAAP operating expenses included $16 million in charges related to our restructuring in October.

Third quarter R&D expense decreased to $31 million compared to $38 million in the same period in 2017. The decrease was primarily due to reduced external R&D expenses for M923, offset by increases in spending for M281 and M230.

Third quarter G&A expense remained flat at $20 million compared to the same period in 2017. G&A expenses in third quarter 2018 include approximately $1 million in third-party costs associated with the company's strategic review.

Due to the strategic review, the company did not provide nonoperating -- non-GAAP operating expense guidance for the third quarter of 2018. For the third quarter 2018, our non-GAAP operating expense, excluding restructuring costs was $46 million. 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 with $282 million in cash, cash equivalents and marketable securities compared to $320 million at the start of the quarter.

Turning now to guidance. Today, we have provided updated non-GAAP operating guidance of approximately $230 million to $240 million for full year 2018 and $45 million to $55 million for the fourth quarter of 2018. 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.

We'll now open the call to questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) Your first question comes from Brandon Folkes with Cantor Fitzgerald.

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Brandon Richard Folkes, Cantor Fitzgerald & Co., Research Division - Analyst [2]

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First question is you noted that we may -- that you're going to publish the M281 data later this year. Is there anything in addition to what you presented at the Analyst Day that we may see there? And then secondly, can you just talk about the potential revenue synergies you may have on 281 if you do get an approval between HDFN and MG, just between the 2 indications?

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Craig A. Wheeler, Momenta Pharmaceuticals, Inc. - President, CEO & Executive Director [3]

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Sure. First, I'll start on M281, and Santiago is here. But the paper is basically going to provide all the data tables and everything supporting the conclusions that we presented. So I don't think it's anything really new that will be in that data. Santiago, anything?

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Santiago Arroyo, Momenta Pharmaceuticals, Inc. - Chief Medical Officer & Senior VP of Development [4]

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There is obviously more data on the paper, but nothing that will be significantly different from what we have already released.

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Craig A. Wheeler, Momenta Pharmaceuticals, Inc. - President, CEO & Executive Director [5]

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Yes, our goal at R&D Day was really to give you all the keys included out of it. You'll just have the whole dataset to be able to take a look at.

And then secondly, the second question was on revenue synergies between HDFN and MG. So one of the things that we've been thinking about broadly is the strategy with our molecule. And we've been working very hard for the last 4 years to be able to go into fetal-maternal disease, but we think there are obvious expansion benefits on autoimmune diseases as well. Because one of the big challenges in many auto diseases, and MG is one of them, is that there is certainly a peak of activity of MG. There's 2 peaks, one in elderly population, one in more younger population, which has a lot of women of child-bearing age. And that's a very difficult patient population to treat today because there actually has not -- get pregnant. They can pass that disease onto their fetuses, and it's -- and so they generally are avoiding pregnancy when they're being treated. If we can establish in fetal-maternal that we are safe for use in pregnant women, that opens up a pretty broad swath across the autoimmune diseases, where we should be able to be the preferred candidate for women of child-bearing age. And so that's where we really see the linkages because we'll be the only one who has that very comprehensive dataset showing the safety of the drug in pregnant women.

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Operator [6]

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Your next question comes from Danielle Brill with Piper Jaffray.

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Danielle Catherine Brill, Piper Jaffray Companies, Research Division - VP & Senior Research Analyst [7]

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I just wanted to expound a little bit more on the albumin reductions. We've had some investors ask us about the potential impact of this on the PK of highly protein-bound drugs. Is this something you discussed with the FDA?

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Santiago Arroyo, Momenta Pharmaceuticals, Inc. - Chief Medical Officer & Senior VP of Development [8]

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We not have any specific discussion on that. We believe that the change in albumin, which is relatively minor, will not have a major impact in most of the concurrent medications or antibodies. Again, that's something that we'll be working in the future to model. And if needed, we will replicate this study. We don't actually believe that we'll need a specific study to understand the direction again, because the effect on albumin is relatively minor.

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Craig A. Wheeler, Momenta Pharmaceuticals, Inc. - President, CEO & Executive Director [9]

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Yes, and as a reminder, there's -- because albumin is the most prevalent protein generated in the body, there's still an awful lot of albumin floating around in the bloodstream of these patients. So we will watch it, but as Santiago says, we don't anticipate any problems there.

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Operator [10]

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(Operator Instructions) Your next question comes from Derek Archila with Stifel.

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Derek Christian Archila, Stifel, Nicolaus & Company, Incorporated, Research Division - Director & Senior Biotechnology Analyst [11]

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So just to follow-up on Brandon's question. So on the publication that you guys are going to put out on M281, I'm just curious if there'll be any data around the albumin levels baseline for these patients and kind of where they fell in the normal range? And then I have 2 follow-ups after that.

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Santiago Arroyo, Momenta Pharmaceuticals, Inc. - Chief Medical Officer & Senior VP of Development [12]

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I believe we don't have a specific data on what are the baseline albumin levels. This is just a paper so there is not the complete dataset for that. So that would probably not be there.

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Craig A. Wheeler, Momenta Pharmaceuticals, Inc. - President, CEO & Executive Director [13]

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Yes. The one thing I would say to albumin. Albumin in the normal range is actually quite a wide range. And people vary quite a bit, which is why it's often measured against their own baselines.

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Derek Christian Archila, Stifel, Nicolaus & Company, Incorporated, Research Division - Director & Senior Biotechnology Analyst [14]

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Okay. And then the second question, just given the agreement with AbbVie, and can you just maybe talk about how that might accelerate negotiations with commercial partners for your biosimilar to HUMIRA? And then maybe just refresh us on the strategy. Is it the goal to find one global partner for that asset or several geographic partners?

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Craig A. Wheeler, Momenta Pharmaceuticals, Inc. - President, CEO & Executive Director [15]

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Sure. So I'll just start by saying, we think it actually enhances the opportunity quite substantially. Because now, there's no major legal expenses and there's guaranteed launch access dates. But Young Kwon, our Chief Business Officer, is actually here in the room, and I'm going to let him give a quick comment since he's leading that effort.

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Young T. Kwon, Momenta Pharmaceuticals, Inc. - Chief Business Officer, Senior VP of Corporate Development & Strategy [16]

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We have a few different options to pursue. I think that in the -- one approach is to find a single partner that would take the geographies worldwide, principally in the U.S. and Europe, although we also have the rest of world settlement as part of the agreement with AbbVie. I think the U.S. is obviously the largest market opportunity for HUMIRA, and so that's really the place where we are focusing our efforts to try and find that commercial partner.

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Derek Christian Archila, Stifel, Nicolaus & Company, Incorporated, Research Division - Director & Senior Biotechnology Analyst [17]

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Yes. Okay. And then just one last one on the clinical trial that you guys are looking to initiate. Have you talked about the cost of those programs and what to expect over the next couple of years? I mean, obviously, you're not going to provide guidance. But any sort of kind of rough guidance as far as the estimate for those types of trials would be helpful.

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Craig A. Wheeler, Momenta Pharmaceuticals, Inc. - President, CEO & Executive Director [18]

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Yes, we'd rather not give specific guidance at this point. We'll be coming out with a full year guidance at JPMorgan, so we'll have all of those numbers for you then.

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Operator [19]

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And I'm showing no further questions at this time. I'd like to turn the call back over to Craig Wheeler for closing remarks.

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Craig A. Wheeler, Momenta Pharmaceuticals, Inc. - President, CEO & Executive Director [20]

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Sure, and thank you. Thanks, everybody, for joining us this morning, and we look forward to keeping you updated on what's a pretty exciting pipeline coming out of the research labs here. So thanks very much, and we'll talk to you soon.

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Operator [21]

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Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program, and you all may disconnect. Everyone, have a wonderful day.