Momenta Pharmaceuticals' (MNTA) CEO Craig Wheeler on Q3 2017 Results - Earnings Call Transcript

Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) Q3 2017 Earnings Conference Call November 1, 2017 10:00 AM ET

Executives

Sarah Carmody - Director, IR

Craig Wheeler - CEO, President and Executive Director

Scott Storer - CFO, Senior VP & Treasurer

Analysts

Morgan Williams - Barclays PLC

Tyler Van Buren - Cowen and Company

Dana Flanders - Goldman Sachs Group

Thomas Shrader - Stifel, Nicolaus & Company

Gregory Gilbert - Deutsche Bank AG

Operator

Good day, ladies and gentlemen, and welcome to the Momenta Pharmaceuticals Third Quarter 2017 Earnings Call. [Operator Instructions]. As a reminder, this conference call is being recorded.

I would now like to turn the conference over to Sarah Carmody, Director of Investor Relations. Ma'am, you may begin.

Sarah Carmody

Thank you, Ashley, and good morning, everyone. Thank you for joining us today for Momenta's conference call to discuss results for the third quarter of 2017. 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 remarks are Craig Wheeler, President and Chief Executive Officer; and Scott Storer, our Chief Financial Officer. 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 statements about the timing of regulatory filings; regulatory approvals; market formation and launches of our product candidates; the market potential of our products and product candidates; the Glatopa fill/finish manufacturer; legal proceedings time lines and strategic decisions; development of our product candidates, including timing of clinical trials and availability of data; the identity of our biosimilar candidates; accounting treatment for payments from our collaborators; our goal and strategy; our current and potential future collaborations; operating expense guidance; and spending projections.

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 most recent quarterly report on Form 10-Q 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 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 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.

Craig Wheeler

Thank you, Sarah, and welcome, everyone. I'll begin today's call with a discussion of our complex generic products, including the status of our Glatopa 40-milligram product candidate and our Glatopa 20-milligram product results. Then, I'll cover our biosimilars, including the announcement this morning on M834 and our novel drug programs. Scott will discuss our third quarter financial results and provide guidance for the fourth quarter, and then we'll open the call for questions.

Before I begin, I'd like to thank our Co-Founder and Chief Scientific Officer, Ganesh Kaundinya, for accepting my offer to take on the additional role of Chief Operating Officer at Momenta. Ganesh has been a key leader in our company since its inception. Over the last decade, I work side-by-side with Ganesh and of firsthand, his passion for the company. I have seen real growth in Ganesh over the past years as he had expanded on his world-class scientific leadership to take on some of our business opportunities and challenges as well. As our COO, it will allow him to play an even more integral role in our day-to-day business operations. I look forward to continuing to work with Ganesh to advance our portfolio of drug candidates and drive the company to achieve our goals for both our investors and the patients that benefit from our products.

I'll now discuss the status of our Glatopa 40-milligram product candidate. Sandoz's ANDA for Glatopa 40-milligram remains under active FDA review, and we have no outstanding questions from the office of generic drugs on the application. At this time, the ANDA remains on a compliance hold due to the warning letter received by Pfizer's McPherson plant where our Glatopa products are manufactured. We understand that Pfizer has made significant progress on the remediation of the majority of the observations cited in the warning letter and that the facility is prepared for reinspection. We believe that there are 3 potential outcomes following an FDA reinspection of the McPherson facility.

First, the FDA could lift the warning letter and change the compliance status of the facility, which would allow the FDA to grant marketing approval of Glatopa 40-milligram. Second, the FDA could change the status of the facility to a Voluntary Action Indicated, or VAI. VAI status would allow the FDA to grant marketing approval. Last, the FDA could decide the facility remediation is not complete and leave the warning letter in place. We believe a near-term positive outcome in the form of a lifting of the warning letter or a change to VAI status could still allow for the approval of launch of Glatopa 40-milligram in late 2017 or early 2018.

In the event than an FDA reinspection of the McPherson facility does not meet the requirements for compliance for VAI, we and Sandoz have identified a potential second source fill/finish manufacturer. This effort continues to progress and has the potential to allow for the approval of an alternate supplier in the second half of 2018 if needed.

As you know, the market for Glatopa continues to evolve. In early October, Mylan announced the regulatory approval and launch of the generic Copaxone 20- and 40-milligram products in the U.S. While we are disappointed that our 40-milligram product was not approved before Mylan, we remain confident in Sandoz's ANDA and their ability to compete effectively in the Copaxone market upon 40-milligram marketing approval. Given the size of the market for Copaxone 40-milligram and Sandoz's success in penetrating approximately 40% of the 20-milligram market with our Glatopa 20-milligram product, we believe there remains a meaningful market opportunity for multiple competitors in the GA market.

Now I'll discuss our Glatopa 20-milligram third quarter results. In the third quarter of 2017, we recorded $11 million in product revenues from sales of Glatopa 20-milligram. In the third quarter, we also received a $10 million milestone payment from Sandoz based on our 20-milligram product being the sole FDA-approved generic of Copaxone for 2 years after launch and reaching a certain level of contractually defined profits in the United States. Scott will discuss the accounting for this milestone as part of his financial update.

As you know, we do not provide revenue guidance for our marketed products, but I do want to give you some perspective on market dynamics. With the Mylan launch of both the 20-milligram and 40-milligram product, we do anticipate pressure on our 20-milligram revenue in the future quarters. As always, with a competing generic entering the market, we anticipate declines in both price and volume for our 20-milligram product. There will also be additional pressure in the market for customers to switch from the 20-milligram product to the 40-milligram product now that there's a lower price alternative to Teva's product on the market. For reference at the end of the third quarter, Glatopa 20-milligram captured approximately 40% of the 20% U.S. glatiramer acetate market. We're watching the market dynamics carefully as we prepare for our 40-milligram launch, which we expect will still provide a supportive revenue source for Momenta.

Before I move to biosimilars, one quick note on Enoxaparin. In July, the jury and the District Court of Massachusetts issued its verdict finding that Amphastar did infringe our patent covering the methods for the manufacture of Enoxaparin. They also found the 866 - 886 patent to be invalid and unenforceable. Post-trial motions and briefs have been filed, and we continue to evaluate our legal options at the Massachusetts District Court and a potential appeal to the Court of Federal Appeals. We expect a final Massachusetts District Court decision could come by the end of this year.

I'll now turn to biosimilars and start with our earlier announcement regarding M834, our biosimilar ORENCIA candidate. This morning, we announced that we received the initial top line results from the Phase I study and that M834 did not meet its primary pharmacokinetic endpoints. The Phase I study compared the pharmacokinetics, safety and immunogenicity of M834 to U.S. and EU-sourced ORENCIA in normal healthy volunteers. We're disappointed by the outcome of the study and are in the process of continuing to gather and fully analyze these data. At this time, it's too early for me to speculate on the future for this program, and we'll provide more information once we have adequate time to perform a comprehensive analysis of the full data set from the study and then we are close to Mylan to determine next steps for this program.

Turning to M710, our next biosimilar candidate, we continue to progress this program, and we and Mylan are targeting a first regulatory submission for M710 clinical development by early 2018. We expect to disclose the reference brand product closer to that time frame.

Lastly on biosimilars, I will discuss M923, our wholly owned biosimilar HUMIRA candidate. We continue to prepare for a first submission for marketing approval by the end of this year. In late September, AbbVie and Amgen announced that they reached a global settlement to terminate the litigation of certain patents between the 2 companies. This settlement allows Amgen to launch their biosimilar version of HUMIRA in the U.S. in January 2023. Amgen's litigation with AbbVie had been the first scheduled District Court challenge of certain HUMIRA patents and was set for 2019. Now that this litigation has been terminated, it is our view that U.S. market formation for biosimilar competition with HUMIRA is more likely to begin in late 2022 or 2023. This is when AbbVie's key Rockford formulation patent expires. It also provides time for other companies beyond Amgen to work to clear later-expiring patents through IPR, litigation or settlement. While we do not specifically discuss our legal strategy, I can say that subject to marketing approval on our ability to identify a new collaboration partner, we continue to expect M923 to be among the first to launch at U.S. market formation.

We continue to evaluate multiple potential collaboration partners. The complex HUMIRA patent estate and the recent Amgen settlement has understandably caused many companies active or interested in this space to reconsider their plans, timing and collaboration preferences. While we are continuing with discussions, I cannot predict timing for an M923 deal at this time.

Moving on to our novel drug pipeline. I'll begin with our lead novel candidate, M281, our recombinant anti-FcRn program designed to be a novel best-in-class monoclonal antibody for the treatment of patients with antibody-mediated diseases. The multiple-ascending dose portion of this trial is now complete, and we are pleased with the data to date and look forward to providing top line data from the multiple-ascending dose portion of the study before year-end.

Now to M230, our program in collaboration with CSL. It's a recombinant homogenous Fc trimer that antagonizes the activating Fc gamma receptor system and blocks immune complex-mediated tissue damage. This program remains on track, and CSL plans to enter the clinic in late 2017 subject to regulatory feedback. Development indications will be determined during the Phase I study as we evaluate the clinical profile of M230 in humans.

In September, we announced that we agreed to opt in to a 50-50 cost and U.S. profit share with CSL for the development and commercialization of all products developed under the CSL collaboration agreement, including M230. Under the 50-50 arrangement, Momenta will fund 50% of global R&D cost and 50% of the U.S. commercialization and manufacturing costs in exchange for a 50% share of U.S. profits. Non-U.S. royalties remain payable to Momenta, and over our milestones, it will be adjusted accordingly. We believe that the upfront and potential milestone payments from CSL both served as a validation of our autoimmune immunology research efforts and also provides us the financial flexibility needed to further invest in M230 and our other early-stage programs. M230's potential to block immune system activation through multiple mechanisms opens the door to a broad number of indications, and we are very pleased to be working with CSL to optimize this and potential future programs across this range of potential indications.

As a reminder, we do have opt-out rights under the co-funding arrangement should we decide that we have to limit our investments depending on our capital needs in the future. If at any time we choose to opt out, milestone payments and royalties would revert back to the prearrangement amounts.

Lastly, I'll comment on M254, our hyper-sialylated IVIg program designed as a potential high-potency version of IVIg. The program remains on track with an IND-enabling toxicology study this year and targeting the initiation of clinical trial in 2018.

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

Scott Storer

Thanks, Craig. Good morning, everyone. I will now review our financial results for the third quarter of 2017 and provide updated guidance for the remainder of the year. We reported a net loss for the third quarter of $33 million compared to a net loss of $18 million for the same quarter last year.

Revenues for the third quarter totaled $24 million compared with $29 million for the same period in 2016. Third quarter 2017 revenue included $11 million in product revenue, all of which was profit share earned from Sandoz sales of Glatopa 20 mg. This compares to $23 million in product revenue for the same period of 2016. The decrease in product revenues of $12 million was primarily due to higher sales deductions for Medicaid rebates and inventory price adjustments related to Mylan's entry into the Copaxone market. In addition, per our collaboration arrangement with Sandoz, the $10 million commercial milestone Momenta earned for the second year of Glatopa generic exclusivity was deducted from net profit prior to the calculation of Momenta's 50% profit share. Excluding these incremental deductions from Medicaid rebates, inventory price adjustments and the commercial milestone, Momenta's third quarter profit share earned would have been approximately $19 million, in line with historical averages.

Research and development revenues increased to $13 million from $6 million for the third quarter of 2016. The increase was primarily due to the $10 million commercial milestone we earned for Glatopa 20 mg generic exclusivity. Third quarter R&D expense increased to $38 million when compared to $32 million in the same period in 2016. The increase was primarily due to a $12 million increase in spending on M923, partially offset by lower spending on necuparanib, which was discontinued in 2016 and lower spend on M230 as those costs are now shared with CSL.

Third quarter G&A expense increased to $21 million from $16 million in the same period in 2016. The increase was due to an incremental $3 million in legal fees and approximately $1 million in personnel-related expenses driven by increased headcount and a higher share-based compensation expense. The company previously gave operating expense guidance as expected non-GAAP operating expenses for the third quarter of 2017 to be approximately $50 million to $60 million per quarter. Our non-GAAP operating expenses defined as total operating expenses less stock-based compensation and less collaborative reimbursement revenues. For the third quarter of 2017, our total operating expenses of $59 million less stock-based compensation of $5 million and less collaborative reimbursement revenues of $2 million totaled $52 million, which is at the low end of our guidance range. Finally, we ended the quarter with $423 million in cash, cash equivalents and marketable securities compared to $457 million at the start of the quarter.

Now turning to guidance. Today, we are updating our guidance and now expect non-GAAP operating expenses for the full year 2017 to be approximately $200 million to $210 million. This is $10 million to $20 million lower than full year spending guidance given last quarter. Specifically for Q4, we now expect non-GAAP operating expenses to be $43 million to $53 million. Our current full year spending projections include approximately $50 million of spending on M923, which was paid by Shire as part of the termination agreement and for which income was realized in Q4 of 2016. As a reminder, we continue to expect to recognize revenue for Mylan's $45 million upfront payment on a quarterly basis. In addition, collaborative reimbursement revenues are expected to be in the $0 million to $2 million range in the fourth quarter of 2017. Lastly, we expect to recognize the $50 million upfront payment from CSL revenue in the fourth quarter of 2017 after the completion of a predefined milestone in the CSL collaboration arrangement.

We will now open the call to questions. Operator?

Question-and-Answer Session

Operator

[Operator Instructions]. Our first question comes from Morgan Williams of Barclays.

Morgan Williams

So, I guess, first on Glatopa with respect to the McPherson site. Is the inspection currently scheduled? And then maybe if you could provide some color around how that process typically works and the usual timing there? And then as a follow-up, could you go into a little bit more detail around your thoughts on the current glatiramer acetate market, and then whether you think you'll be able to retain your 20-milligram Glatopa market share leading up to a potential 40-milligram approval and whether you think that we might see incremental generic approval ahead of yours? And if so, when you finally get to the market, do we just see immense pricing erosion from there?

Craig Wheeler

Sure. Thanks, Morgan. So first on the inspection, I really can't give any specific updates beyond what I've already said. My problem is I have to only be able to talk about what's been cleared through Pfizer and Novartis. And so one of the things I said in the past is, hopefully, we will see that inspection and our ability to get approved, but I don't know if I'll be able to talk anything specific until I get clearance for what I've already said. So I apologize for not being able to give you any more color on that. In terms of the market, I do think that Novartis is well positioned. Sandoz has done a very good job in terms of building the 20-milligram market share, so I would expect they have the ability to retain a fair amount of the volume.

However, I do expect the price to come down and I do expect that the 20-milligram share of the total glatiramer acetate market to start to decline further now that there's more cost to that, the 40-milligram version available and the 20-milligram competing generic product. So it's early days. We've heard some comments about Mylan's aggressive pricing in some accounts, but we really just don't know and won't know until we see the full quarter and how that all shapes out, how everything works in the 20-milligram market and how pricing evolves. And in terms of other approvals, we're optimistic that we'll still see an approval in the near term.

So it's my hope that we'll see our approval - the next approval in. We don't have any specifics on where other applications are. We do know what they've said publicly, ready to say that they're expecting to see further questions and Synthon has been very quiet and Pfizer has been very quiet. So we can't really predict, but I am hopeful that we'll see our entry into the market in the near term. I think it's going to be like any other generic market with a number of competitors and the behavior of those competitors that will set the price, and so it's hard for me to predict where the price will ultimately end up in this marketplace. It's in our hope we'll just get in as soon as possible, move the capture as much as we can.

Morgan Williams

And then maybe a quick follow-up just through your conversations with Sandoz. Have you heard of any accounts reaching out to Sandoz in response to potential proposals from Mylan with respect to kind of additional rebating or kind of adjusting price based on some competition from Mylan?

Craig Wheeler

Yes. Well, I think you should expect - this is a generic market race, so you should expect when there's a new entry into this market. Every account rebids essentially to come out, and they also have best price contract, and that's why you saw flowing through some of our late quarter numbers here, some of the price adjustments to the inventory. You would expect in the course it's happening that every accounts now looking at how they can actually get lower cost product by pitting the 2 generics against each other. So yes, that's happening and that would happen in any marketplace.

Operator

Our next question comes from Tyler Van Buren of Cowen & Company.

Tyler Van Buren

Just kind of related to Morgan's last question and the contracting. But it sounds like it's still a little bit too early to get a real good sense of what Mylan's doing with pricing and contracting, and that's probably due to the hidden discounts of the WAC. But I guess, it would be helpful to understand at what period of time or how much longer do you think it will take to really get a good understanding of their strategy with respect to discounts and contracting?

Craig Wheeler

Yes, it's a good question. I think, for us, being one step removed from it, we'll probably get a really good sense of it after the first quarter sales. Sandoz is in the mix on this and seeing it on an account-by-account basis, and so I'm sure they have a - they're a little closer to exactly what they're competing against as they're bidding on these contracts. But I would imagine by the next quarter call, I'd be able to give you a much better perspective on where everything falls. It's just early days. There's hidden numbers, but also there's negotiations ongoing at this point in time, as product enters the marketplace and competitors approach all of the different folks that are buying the product.

Tyler Van Buren

Great. And you briefly touched upon your thoughts on how the 20 mg and the 40 mg split will evolve. But with respect to the overall market opportunity and the sustainability of volumes glatiramer acetate in general, what's your thoughts on the impact that could have with potentially taking share some - from some of the other MS products as we see more glatiramer acetate products available?

Craig Wheeler

Yes, my sense is as the price comes down on this product, there will be a heavy incentive for some of the higher controlled insurance plans to put a step through on this product before they get other high-priced MS product. That's happened in every other therapeutic category. And the particular advantage here is that this drug still has the best data for early MS patients with the safety profile it has patients on this product for many, many years safely. And so with that kind of history and track record and a much lower price from the generics than you would see from the other MS brand products on the marketplace, I would not be at all surprised to see some step through reimbursement strategies that actually cause some increases in the volume here.

Tyler Van Buren

Great. And just last question on the proprietary immunology pipeline, which is really exciting on 281. Clearly, we have the multiple-ascending dose data here by year-end. Could you just review for us what we've seen so far with the single-ascending dose data and kind of what expectations are for this mad data release?

Craig Wheeler

Sure, and I'll go back to just a very high level for everybody on what we saw in the single-ascending dose. Our goal with this product was to be able to drive IgG levels down to where we know that - if current reduction plasmapheresis actually allow you to get resolution of a lot of players across multiple antibody-mediated diseases. And what we found with this product was that a single dose at 30 milligrams per kilogram, we were able to drive antibody levels down to between 20%, 25% and 30% across the full cohort in about 4 days. That's similar to the level you would get after two plasmapheresis, which we know is kind of a therapy that people get if they're already struggling with either IVIg or steroid therapies. So we're already in that range.

And the really nice thing that we saw was we saw that this effect persisted for about 4 weeks below 50% of normal IgGs. So that actually - I said both week can vary - at least in this data set, safely administer this and get to the levels we had targeted, which, to us, gives us [indiscernible] a good shot of getting efficacy that we're targeting. But also begins to allow us to think about chronic types of indications because we have the persistence of effect of the molecule with a single dose. So in a multiple dose, we're hoping to understand is, obviously, the safety we're looking at, keeping these levels down, but also the persistent so we can do in keeping that IgG levels down to give us a better sense of which indications we should go after and leave to the acute or chronic side.

Operator

Our next question comes from Dana Flanders of Goldman Sachs.

Dana Flanders

My first one here and I know you can't comment specifically on Pfizer's remediation plan, but maybe just more broadly. Are there examples or precedents of the FDA lifting a warning letter or moving a facility into VAI status if the remediation actions are not 100% complete? It seems to be a point of debate in the stock and just hoping maybe you could shed some light on precedent or historical examples there, and then I have a follow-up.

Craig Wheeler

Sure. It is our understanding from our consultants that this is absolutely not - would not be a first for FDA to do something like this. Very typically, when you have a warning letter because there are broad quality systems kind of questions, there are long lead items to take some time to actually resolve. And so it would not be uncommon for the FDA to look at a plant and determine that it is in control, meaning they feel that they could lift the warning letter because the quality system's in control, but that there are continued activities that they need to monitor, and they are for shift to voluntary action indicated, meaning that they're going to come back and look at those at a future date, but it's really up to the company to resolve them. So it would not be a precedent-setting move for them to actually make that kind of decision.

Dana Flanders

Okay, great. And then just secondly, on the ORENCIA study, I know you're still analyzing the data, but is there anything that you can elaborate on in terms of just what happened? I mean, presumably this is related to the reformulation. And then how does this setback shape your thinking on your broader biosimilar strategy or just other programs in development, if at all?

Craig Wheeler

Sure. It's really too early for me to comment. All we've seen at this point is the top line data, and so our technical teams are beginning to dig in to the full data set. We just wanted to make sure as soon as we knew this, we got to talk to you that the study has met its endpoints. So we're going to be looking at all aspects of trial conduct to the molecule itself to assay, et cetera, et cetera. So it's too early for me to say exactly what happened here. I don't think this impacts the rest of our biosimilar portfolio. In fact, it actually is a good example of why we feel it's important to have a portfolio of biosimilar products. These products all stand on their own. This is a complicated molecule. It's a fusion protein. But we've seen nothing that would actually question the broader biosimilar strategy.

Dana Flanders

Okay, great. And then just one last one, if I can. You obviously have a very attractive pipeline. Just how do you think about kind of the spend behind that pipeline in light of Mylan's approval and just flexibility heading into '18 with your - I know you have collaboration with CSL and just maybe your P&L flexibility given the changing kind of generic Copaxone market dynamics?

Craig Wheeler

Sure, thanks, and that's a good question. And I think it's obviously a lot of things that we have to think about as we see this evolving market. I mean, the good thing for us is that we have levers to pull in the company. So we'll be looking at things, for example, like additional partnership front partner programs if we needed to. We have the option to opt out of the CSL deal. If we opt out of it, we get all the cost out of our book, but we could use those milestones to fund other parts of our program.

We have the ability to potentially stagger some of our biosimilar programs. That staggering, by the way, make sense in any event depending upon the legal status of each of these biosimilar programs where you may want to try to resolve things by IPR before you file, you may want to file early to be able to get the patent in. And so there's all of those levers that we have to pull. We're also in a - at least in a recently healthy cash position at this point. So I would say that we're going to have to watch very carefully how this revenue stream evolves and then think about what strategic levers we have to pull in the company as we understand more of that.

Operator

[Operator Instructions]. Our next question comes from the line of Tom Shrader of Stifel.

Thomas Shrader

Pretty similar question. I just see if I get a little more detail. But as far as I understood your leg up in biosimilars is that you could be sure you were making the same thing than other people, so you could maybe explore more divergence, cell lines, things like that, look for advantages because you could be sure of what you were making. Was 834 an example of that? And can you comment - do you think this was a failure of analytics? Or is it a surprise in biology? I'm just curious where your sense comes from that this isn't impactful on other programs, just whatever you can say will be great.

Craig Wheeler

Sure. Without seeing all the data, it's hard for me to comment. But I will comment, I do not think it was a failure in analytics. I think our tools allow us to understand these molecules in a great amount of detail, and that's one of the reasons what we've said in the past that this is a very complex molecule. And so we still feel very confident in our analytics. And so we have to really understand what would happen in this trial. It's really hard for me to say because each of these programs is individual and stands on its own. But I do accept the fact that we choose to pick the riskier, more complex molecules, and there's things that even our analytics can't tell us what biologies and molecules.

Thomas Shrader

And can you say what was different? Is that too much detail for now?

Craig Wheeler

It is too much because I don't know at this point.

Operator

Our next question comes from the line of Gregg Gilbert of Deutsche Bank.

Gregory Gilbert

Craig, I was hoping you could at least provide some qualitative color on the pricing action on the 20 mg and whether it's consistent with one additional entrant or not at this point. And a broader question, any signs that the Gottlieb led FDA is shifting its focus or adding some focus on additional competition in the protein realm as it continues to work on getting the anti-backlog cleared and focused on more difficult small molecule and mixture products?

Craig Wheeler

Sure, thanks. So let me first tackle your first one, is that I don't think we know anything, except what I've told you, anecdotally, is that we do hear that Mylan is pricing aggressively in some of the accounts, but I don't want to overly emphasize that until I get a good view of the whole market and how the accounts settle out. So it's just too early for me to give you much more context than that as I really don't have my own prospectives fully developed on that. But we have heard the same thing. I'm sure that you have heard that there's been some accounts where there's aggressive pricing. In terms of the Gottlieb error, we do know that the FDA has placed a priority on making sure that there's competition in markets. And then Gottlieb has even said that his view is that multiple generic approves its goal, not a single generic approval.

We're also aware that there was a policy at the FDA as - we were involved in negotiating with the rest of the generic industry that when a generic product is held up as ours was for the warning letter, that the FDA to support competition in the market would accelerate the next competitor, and we believe that's what happened with Mylan is that they were next in queue. We were held up, and so their application was brought to the forefront and accelerated to get the market competition, which is another real big piece of Gottlieb's philosophy in the generic space. So I would - my personal belief is I wouldn't differentiate between types of molecules. I think that the barrier on the complex molecule is that the technology and the science and approach to it, but the FDA has got a stated philosophy now of trying to get multiple competitors into the market as early as they can.

Operator

And I'm showing no further questions at this time. I would now like to turn the call back to Craig Wheeler, CEO, for closing remarks.

Craig Wheeler

I just like to thank everybody for joining us on the call. And we will keep you updated as things evolve here, and I'll talk to you all next quarter. Thanks.

Operator

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