Ironwood Pharmaceuticals, Inc.
Q2 2018 Earnings Call Transcript

Published: 6 Aug 2018

[Operator:]

Good day, ladies and gentlemen, and welcome to the Ironwood Pharmaceuticals Second Quarter 2018 Investor Update Conference Call. [Operator Instructions]. As a reminder, this conference is being recorded. I would now like to introduce your host for today's conference, Meredith Kaya. Ma'am, you may begin.

[Meredith Kaya:]

Good morning, and thanks for joining us for our second quarter 2018 investor update. Our press release crossed the wire earlier this morning and can be found on our website, web-mac. Today's call and accompanying slides include forward-looking statements. Such statements involve risks and uncertainties that may cause actual results to differ materially. A discussion of these statements and risk factors is available on the current Safe Harbor statements Slide as well as under the heading Risk Factors and our quarterly report on Form 10-Q for the quarter ended March 31, 2018, and in our future SEC filings. Our forward-looking statements speak as of the date of this presentation, and we undertake no obligation to updates such statements. Also included are non-GAAP financial measures, which should be considered only a supplement to and not a substitute for or superior to GAAP measures. For a reconciliation, please refer to the table at the end of our press release. Joining me for today's call are Peter Hecht, Chief Executive Officer; Tom McCourt, Chief Commerical Officer; Chris Wright, Chief Development Officer; and Gina Consylman, Chief Financial Officer. Mark Currie, Chief Scientific Officer will also be available during the question-and-answer portion of the call. We'll be referring to slides available via the webcast, for those of you dialing in, please go to the events section of our website to access the webcast slides. With that, I'll turn the call over to Peter.

[Peter Hecht:]

Thanks, Meredith. Good morning, everyone, and thanks for joining us. The second quarter was an eventful period for Ironwood. We demonstrated continuing commercial execution with our market leader LINZESS, delivered on multiple aspects in our pipeline and made significant progress towards separating the company into two nimble, focused, more productive and better positioned organizations. We also announced this morning that we have terminated our U.S. licensing agreement with AstraZeneca, following a review of the test market data. Let me comment briefly on the plans for separation and the listen to our decision. The upcoming separation is an important step in our company's journey, 1 that we believe is the best way to accelerate growth, expedite new therapeutics to patients and unlock value for shareholders. We're designing both companies to have strong financial profiles at the launch and to be set up for sustaining growth in addition and market leadership. We anticipate the capital structures of each new [indiscernible] will be built from a combination of cash on hand, various financing tools and potential partnerships that we are exploring. With that said, I would like to be clear that we do not expect ongoing funding between the two companies following the separation. Turning to lesinurad, Tom will provide more details shortly. I would just like to take a moment to commend him and the team for their passion and commitment to these products and to patients and for driving with agency to a well-informed data-driven decision. The decision to terminate was not taken lightly but we are confident it is the right decision and it enables us to allocate capital to the highest return opportunities and to drive growth. With that, let me turn the call over to Tom to provide more detail.

[Thomas McCourt:]

Thank you. As Peter mentioned, we had a strong second quarter with many key advancements made across our business including continued LINZESS growth and multiple developments within the pipeline. Chris and I will discuss these in more detail but I would like to begin by commenting on the lesinurad decision. In early 2018, we initiated a robust study to explore a comprehensive set of marketing mix options for lesinurad in select test markets. Our objective was to find a path for value creation for lesinurad based on scaled investments and/or an optimized marketing mix to drive higher promotional response. After assessing lesinurad market test results in late July, we concluded that the data did not show the level of response needed to support further investment by Ironwood. Therefore, we believe that it's in the best interest of our business and our shareholders to terminate our agreement and focus on creating high-value through our existing GI portfolio opportunities. We're working to maintain appropriate availability of lesinurad for patients and physicians during the termination period. The full lesinurad team has broad sound expertise and creative commercial skills to support this franchise over the past few years and I'm grateful for the tremendous effort that everyone on our team has put behind this product. Looking ahead, following the completion of separation expected in the first half of next year, new Ironwood will become a profitable company, exclusively focused on its industry-leading capabilities and G.I. diseases with multiple first in category assets, each with long expected IP coverage and the potential to help millions of patients with serious and chronic disorders. Now turning to LINZESS. Performance was strong during the second quarter with prescription volumes up 14% year-over-year. Early in the second quarter, we launched the new highly successful yes, LINZESS BDC campaign, which was a driving force behind this growth. As a branded prescription market leader in this category, we believe LINZESS has a long runway before reaching its full potential and with millions of patients still suffering, we're critically assessing ways to expand the number of appropriate patients treated with LINZESS. This includes the recently initiated Phase IIIb trial, studying the effect of linaclotide on bothersome abdominal symptoms including bloating, discomfort and pain associated with IBS-C. Survey data suggest that as many as 2/3 of adult IBS-C sufferers experience symptoms such as abdominal bloating and discomfort every week and as a common reason patients -- common reason patients seek care. If successful, the Phase IIIb trial creates an opportunity to deliver a more impactful promotional message that will activate more patients to demand LINZESS and provide physicians with an even more compelling reason to prescribe LINZESS for their patient's. Our delayed-release program is a new product opportunity that has the potential to be a vicryl [ph] non-opiod pain relieving agent for millions of patients suffering from all forms of IBS. We recently reached agreement with the FDA regarding trial design and endpoints and are now in the process of finalizing the Phase IIb protocol. When linaclotide's global presence continues to grow as well. Astellas is commercializing LINZESS in Japan for adults of IBS-C and the brand continues to grow nicely. And it is becoming an important component of Ironwood revenue. In China, we and our partner AstraZeneca anticipate approval of linaclotide later this year with plans to launch shortly after. Moving to 3718. Our captured retentive by West local sequestrant being developed for the treatment of persistent gout. We have recently initiated our pivotal Phase III program. The primary endpoint will evaluate the reduction of heartburn severity with key secondary endpoints including improvement in weekly hyper in severity, regimentation and sleep disturbance. Data from these trials are positive, are expected to support this potential approval. Persistent Gerd affects an estimated 10 million Americans who continue to suffer from heartburn and vegetation despite receiving treatment of PPIs, the current standard of care. If approved, we believe 3718 has the potential to dramatically improve the bothersome symptoms experienced by these patients. As there is limited number of FDA approved treatment options currently available, this advancement in care compliments our promotion of LINZESS, our pipeline and could create a huge opportunity for us commercially here at Ironwood. With that, I'll turn the call over to Chris.

[Christopher Wright:]

Thanks, Tom. As Peter outlined, it's an exciting time for sGC franchise. Our two teams are doing a superb job of advancing clinical trials of innovative products that aim to treat highly progressive and serious diseases. We currently have four Phase II trials ongoing. Praliciguat is currently being studied for the treatment of diabetic neuropathy and for heart failure and preserve or HFpEF. And we expect to see data from both studies in the second half of 2019. Olinciguat is currently being studied for the treatment of sickle cell disease and for achalasia. In June, we were pleased to receive orphan drug designation for olinciguat for the treatment of patients with single cell disease. We also recently closed enrollment in our single dose proof of mechanism achalasia study and expect to report top line data in the coming months. In addition to our development programs, the teams are making significant advances in our preclinical sGC tissue targeted programs. We expect to initiate a Phase I study with IW-6463 in early 2019. 6463 has been shown to cross the blood brain barrier in preclinical models and represents a potentially significant opportunity in certain serious CNS diseases. I'll become a more precise in the targeting of specific organs, we are having success in preclinical programs that target either the lung or the liver. We see encouraging data and are advancing some exciting programs. As the leader in cGMP pharmacology, the future of our sGC franchise is promising. We intend to advance our pipeline to develop medicines that can address the unmet needs of patients suffering from a variety of serious and orphan diseases. I will now pass the call over to Gina.

[Gina Miller:]

Thanks, Chris and good morning, everyone. Over the next few minutes, I will be detailing our second quarter financial highlights and updating 2018 financial guidance. Please refer to our press release for the detailed financial information. Ironwood revenues increased 25% year-over-year to $81 million in the second quarter, driven primarily by continued LINZESS sales growth and margin expansion as well as growing API sales to Astellas, our partner in Japan. LINZESS net sales were $192 million, up 14% year-over-year. The LINZESS U.S. brand collaboration generated $115 million in commercial profit, reflecting a commercial margin of 60%. Linaclotide API sales to Astellas were $9 million during the second quarter and generated approximately $5 million in gross profit. Other revenue including linaclotide royalties copromotion and net sales for DUZALLO and ZURAMPIC totaled $3 million. Total operating expenses were $121 million including $39 million in R&D and $68 million in SG&A. The increase in operating expenses this quarter compared to the same quarter last year is primarily due to cost associated with our planned separation. GAAP net loss for the quarter was $49 million or $0.32 per share, non-GAAP net loss was $43 million or $0.28 per share. With regard to the lesinurad decision, as there are a few financial components that I would like to briefly review. As a result of our decision to terminate the lesinurad licensing agreement, we expect to save approximately $75 million to $100 million in full year 2019 operating expenses most of which will be within SG&A. We plan to reduce our workforce by approximately 125 employees, primarily consisting of our field day sales employees. We estimate that this will result in aggregate charges of approximately $10 million to $13 million, primarily in 2018, nearly all of which is cash. In the second quarter, we wrote down approximately $2 million related to lesinurad inventory and purchase commitments. We also expect to record an intangible asset impairment of $150 million and a gain our fair value remeasurement of contingent consideration of $30 million in our third quarter 2018 financial statements. To review and update our full year 2018 financial guidance, we reiterate the following

[Operator:]

[Operator Instructions]. Our first question comes from Jamie Rubin of Goldman Sachs.

[Divya Harikesh:]

This is Divya Harikesh on behalf of Jamie Rubin. I have 1 question. With the termination of the lesinurad program and the rationale makes a lot of sense, do you feel you have -- Peter this is for you, do you have enough in your pipeline or the pieces in place to drive growth for Ironwood go? How are you thinking about capital allocation going forward? And looking for potential strategic BD opportunities? Or do you think you have all the pieces in place within Ironwood Co at this point in time?

[Peter Hecht:]

Thanks for the question, Divya. We feel great about the assets we have on hand. I think you're asking about post-separation...

[Divya Harikesh:]

Post separation as you think about the GI franchise?

[Peter Hecht:]

That company has a great foundation. It's set up to be a market leader in the G.I. and G.I. primary care space with 3 market-leading or first or only in category products that have long pat life and durability in each case out to 2030 or beyond and the opportunity to help millions of patients and the products go really terrifically well together both in terms of their strategy and their commercial fit. We think that's a great foundation for growth and the opportunity for attracting further assets.

[Operator:]

And our next question comes from David Leibowitz with Morgan Stanley.

[David Lebowitz:]

Would you be able to run us through the IW-3718 trial and quantify for us what we should be looking for as a benefit that would signal a successful trial?

[Christopher Wright:]

This is Chris. Thank you for question. So the two pivotal studies that we're executing on currently involve dramatize control trial looking at 1500 milligrams of 3718 with a treatment period of 8 weeks. And so we've been looking for the main endpoint, there's a 45% reduction in the heartburn, looking at responder rates so that's individuals that had our response in 4 of 8 weeks as well as the last -- one of the last two weeks in the eight-week period but also looking at a number of other measures including a change from baseline in heartburn, a regurgitation, heartburn three days and also a sleep disturbance.

[Peter Hecht:]

David, it's also important to mention that this is on top of PPI. So these are patients who have suffered from gerd, chronically from both, primarily heartburn but also regurgitation have been treated with PPI's but continue to suffer. And what we've certainly saw in the IIb trial was a significant improvement in both heartburn as well as regurgitation. So as I think about this marketplace, this is a really painful disruptive disease and each advancement in care that we've seen in this marketplace creates a significant commercial opportunity.

[David Lebowitz:]

So will all PPIs be taken into the trial?

[Christopher Wright:]

There is no restrictions on a particular PPI in the study so they'll continue on their standard of care therapy and has to be stable and then we'll add on either placebo or IW-3718.

[David Lebowitz:]

One more question. On the changes relating to lesinurad, going forward, how could we expect SG&A to change and R&D for that matter after all the restructuring charges and are completed?

[Gina Miller:]

David, this is Gina. Thanks for your question. The SG&A expenses should -- you'll see a reduction in approximately $75 million to $100 million beginning in 2019, and we typically provide our guidance for the next year in February of each year. And we do expect most of the savings to take place within SG&A less so from R&D perspective.

[Operator:]

And our next question comes from Jeff Makem with Barclays.

[Jason Zemansky:]

This is Jason on for Jeff. I'm just curious, two quick questions, for the LINZESS franchise, if you could comment a little bit more on the efforts underway to really build the market, I appreciate that kind of this was a little bit overshadowed by the decision to terminate the agreement. And then as far as gout goes, looking at your test markets, I'm curious could you shed a little bit more light on to what it was that came out of that test that was really instrumental in driving your decision? And perhaps, what was there that perhaps was not there beforehand that you didn't see during the development of the franchise that could have informed the decision?

[Peter Hecht:]

Let's take the gout decision first. As far as what we saw over the last 18 months as you know we've been on the market roughly 18 months, we saw a nice opportunity here both in the market and we clearly saw lesinurad as an advancement in care. We initially launched with ZURAMPIC which we really saw as a market primer for DUZALLO. As we launched DUZALLO, the update was quite a bit slower than we expected and we were really struggling to evaluate or understand why the market was or why the product was so slow. So we wanted to really understand what kind of promotional offer will really be required to really accelerate its growth. And so we had -- identified a number of test markets in which we had varying levels of promotion both on the consumer side as well as the physician side. And as we invested in and pushed it hard, we certainly saw some promotional response but it just wasn't adequate to look at a product that we could -- that we were confident that we could continue to invest in and grow. So I think the big piece -- the big 3 takeaways is one, we like to market, the uptake was slow and as we pushed it harder, the growth just didn't accelerate to justify ongoing advancement. As far as lesinurad -- or as far as LINZESS is considered, I mean we still see ourselves in growth mode and this is a very strong alignment with our partner Allergan that we're going to continue to invest in this market, it continues to grow very nicely, keep in mind we've treated little over 2 million patients but there's another 30 million Americans out there that are continuing to suffer. And we're looking at other ways in which we can activate patients and motivate physicians to treat patients more broadly. And we're focusing on really 3 areas

[Operator:]

And our next question comes from Ying Huang with Bank of America Merrill Lynch.

[Ying Huang:]

First one on the R&D program for the HFpEF IW-1973, you decided to discontinue the low and medium dose and only continue to trialing HFpEF with high dose. I was wondering what led to that decision? And then secondly, since now you're discontinuing the lesinurad commercialization program, do you have any intention to go out and then seek other potential commercial opportunities for your sales force to utilize?

[Peter Hecht:]

Chris, can you take the first.

[Christopher Wright:]

Sure so with regard to the HFpEF study changes, we are -- we felt that as we move forward into the two different companies [indiscernible] and the new Ironwood that we wanted to focus primarily on accelerating time to POC data and on that basis, we made the changes in the study that were mentioned.

[Thomas McCourt:]

It serves us -- how we look at the utilization of the sales force on we report. Obviously, this decision will impact the workforce that we have both internally and externally. So we certainly see that being downsized to some degree. As far as how we look at future opportunities, the core business is very tight, we will continue to focus in GI assets, primarily that both gastroenterologist and primary care physicians utilize, and we continue to evaluate a number of candidates that could be an additional very nice fit into the current portfolio.

[Operator:]

And our next question comes from Eric Joseph of JP Morgan.

[Eric Joseph:]

Just a couple from last year. Just wondering if you could provide or let us know how we should be thinking about commercial margin in the second half of the year for LINZESS? And also, what sort of your latest thoughts on longer-term commercial margin, if it's still around 70% peak long-term and what sort of the leverage are to get there? And I have a follow-up on delayed release.

[Gina Miller:]

This is Gina. I'm happy to take the first part of your question regarding the LINZESS margin. As you saw for the quarter, it was about 60%, which was up nicely year-over-year. And well we continue to fluctuate quarter-to-quarter, we do expect it to increase over time and we are still guiding to the greater than 70% by 2020.

[Eric Joseph:]

Got it. And on the DR2 formulation, I was just wondering if you can provide a bit of color around the commercial opportunity there? And how that's distinct from what's currently addressed by the branded constipation or diarrhea products including LINZESS, [indiscernible] et cetera? And what in the Phase IIb, what allowances are made for use of those therapies either in combination with DR2 or as rescue therapy?

[Thomas McCourt:]

Yes. This is Tom. As we think about the commercial opportunity, this is almost a pure pain drug that will treat not only lower abdominal pain but also bloating and discomfort. And as you know, other than linaclotide, there really isn't many -- there really isn't an effective treatment for lower abdominal pain. So the fact that we have a drug that clearly demonstrates an approval abdominal pain, which we believe we can amplify by delivering it into the colon and avoid any effect that bowel have it really is a very, very unique opportunity that would be attractive to tents and millions of patients. Basically, all forms of IBS, they're recognizing you also have to treat that bowel habit. So this will be the primary treatment for relieving abdominal symptoms and they use another therapy that would either manage their constipation our diarrhea. And again, it certainly could be used on top of LINZESS to amplify the pain affect but we see this as just a much, much broader drug that can relieve pain. As you know, it's very well-tolerated and it's quite safe. So we really like this opportunity as we move forward.

[Peter Hecht:]

Eric, did you have a specific person about the design of the Phase IIb study and use of [indiscernible] meds that Chris should take, I wasn't sure about that.

[Eric Joseph:]

Yes, Peter. That's exactly right. I'm just wondering in the Phase IIb, whether the plan is to study DR2 at least in some patients on background meds either constipation or diarrhea OTC branded? How?

[Christopher Wright:]

That's exactly the approach so individuals ought to be on stable doses of their regular medicines for either constipation or diarrhea and will add on top of that the DR -- of an appetite DR and access for effects on pain and obviously look to see if there is any changes in bowel habits as well.

[Peter Hecht:]

We're quite pleased to progress the conversation with the FDA on this. It's a novel category and it's taken some time to get good alignment and understanding on the right way to advance the medicine. But it's a great opportunity for patients and we're very excited to be able to move forward now.

[Operator:]

And our next question comes from Irene Koffler with Mizuho.

[Irina Koffler:]

I was just wondering if there is going to be any change to the staggered board when you spin-off the R&D company? That's question 1. And then maybe you can update us on the progress of your partnering discussions for the early stage assets in the R&D company?

[William Huyett:]

This is Bill Huyett. Taking notes in turn, we'll be announcing the governance structure broadly including board membership and board structure over the coming months based on the designs for the new companies and things we've heard from all of our investors over the past few months. With respect to the partnership discussions, they are ongoing. As you might imagine, the crystallization of the strategy for the R&D company has led to modifications and improvements and simplifications in some cases of our licensing discussions. We're broadening them not only on the HFpEF and DM, we have discussed in the few prior calls but also some of the other compounds that Chris discussed earlier. So these discussions have been energized by the separation process.

[Irina Koffler:]

If I could add a follow-up, which is about SG&A expense. So I noticed that guidance didn't change for SG&A expense for the year but yet you're cutting elements of the gout program and the staff. So why wasn't that piece lowered as well?

[Gina Miller:]

This is Gina. We did take a look at the SG&A guidance and decided to keep it the same as we had originally guided to in February because while we expect some savings related to the gout franchise, we are incurring additional costs related to the separation.

[Operator:]

And our next question comes from Boris Peaker with Cowen.

[Boris Peaker:]

First, I want to ask about the capsules you mentioned that there was a significant uptick in those. I'm just curious is that cannibalizing the original formulation? And also, with the uptake of capsules, is there some stocking associated with it?

[Thomas McCourt:]

You're talking about the expenditures...

[Boris Peaker:]

Yes. Yes.

[Thomas McCourt:]

Okay, I think there is two things here. As you mentioned, as the petard of the prescription grows, obviously, that has an effect on the total prescription volume. So that's a reason why we're seeing the actual unit sold as a -- obviously clear indicator of growth and that's where the 14% year-over-year growth comes from. The second and Gina can comment more specifically on this, what we did see some drawdown in inventory for the quarter below where it has been in the past, which obviously had some effect on revenue but I think net-net, we saw this as a very strong quarter and it was the growth and the financials have been almost solely or largely driven by demand. Gina, if you want to comment further on the inventory?

[Christopher Wright:]

Thanks, Tom. Actually sounds correct that we saw a modest change in the inventory but certainly, we're within our normal range and there is not a lot to add, there was a nice volume uptake that would, that corresponded nicely with the increase in net sales for the quarter.

[Boris Peaker:]

Great. And my second question. I'm just curious, for the gerd drug, which is obviously going with the new Ironwood, with what was the rationale with keeping us with new Ironwood instead of just keeping it with the RND call?

[Thomas McCourt:]

Yes, I think this was largely a commercial decision. Because it fits so well with our current portfolio. I mean when you look at the prescriber base, Boris, on this, if it's exact same prescriber base across gastro and primary care, which we learned a lot about if you remember when we promoted Nexium, when we first launched the company as far as understanding this prescriber base. And then in addition, obviously, the delayed race that appetite again overlaps prescriber base almost habitually perfectly. So you think about how much more productive a single sales reps would be basically selling 3 drugs to 1 doc and we wanted to keep the continuity together. Keep in mind, we will still have a very strong development team with the new Ironwood organization as well as a regulatory and medical affairs group are really the best in the industry particularly in GI. And I think -- we think we're very well poised to subsist with 3718 in the marketplace.

[Operator:]

And our next question comes from Michael Morabito with Crédit Suisse.

[Michael Morabito:]

This Michael Morabito. The first question I had is, just wanted to get more clarity on the licensing plans for the sGC's. Now that you've mentioned that you plan on having nonoverlapping boards between the two companies, do you still intend to license both of those products ex-US prior to spinning out the new Iron de co and prior to data reading out? [Technical Difficulty] From those trials? And secondly, just specifically for Peter, at what point will you be able to provide investors with the guidance on, which company you plan to remain with if either one?

[William Huyett:]

Michael, it's Bill. On your first question, we intend to outlicense 1973 praliciguat. Our intent when we first discussed it was perhaps inappropriate by some scented on ex-US, as we focused the strategy of the RND company on severe rare orphan diseases, it's become quite clear to us that a full licensing of that compound is the right prayer forward. On the others, we are entertaining a variety of ideasx U.S. and for the United States. All designed to make sure that each molecule, which is greatest potential and then I was shareholder schedule line share of the value for doing that.

[Peter Hecht:]

And with respect to the question on me Michael. Be financed substantial force into the leadership team for both of the new codes and actually, they are making great progress in getting up and going within the context of our current company. And I would say my role is an important 1 here to make sure that we continue as a unified team to execute on our 2018 operating plan, deliver on our goals as 1 company and execute on a high-quality separation as a unified team. So I'm sticking with to that and serving in my current role with great pleasure. I do expect to consider future roles at some point near term and we'll update you on that and CEOs for both companies and boards as soon as we get them clarified.

[Michael Morabito:]

Okay. And I just have 1 quick follow-up also, do you have any new guidance on when you do anticipate becoming -- do you anticipate on Ironwood becoming cash flow positive prior to spinning out RNDco?

[Gina Miller:]

Michael, this is Gina. Our current guidance is that new Ironwood will become a profitable company in its first year of launch. Clearly, we don't expect that for the RND co company initially and then the other guidance related to do our fourth quarter of this year and whether we would positive cash flow or not, and the only change to that guidance is that we are now guiding to a negative cash flow in the fourth quarter just due to the restructuring costs that we expect to incur.

[Operator:]

[Operator Instructions]. Our next question comes from Tim Chang with BT IG.

[Timothy Chiang:]

I just have one question just on linaclotide release. Is it possible that post your discussion with the FDA on this trial, you would also know patients that have been on linaclotide or? Could it be possible that you might even have the linaclotide arm to compare the delayed for these benefits to the standard product that you have?

[Christopher Wright:]

It's Chris Wright. Thanks for the question. So currently, the trial design does not involved including the linaclotide and that may be something that we want to look at a later phase to understand how this on top of linaclotide has impacts but right now, we're focused on understanding how DR2 impacts pain across all subtypes of IBS.

[Timothy Chiang:]

Okay. And maybe just 1 follow-up. Peter, obviously you're putting much more of your focus on LINZESS, I think this is a good decision, dropping lesinurad. Could you talk a little bit on just about how you see the product evolving over the next 2 to 3 years. Obviously, that number of additional trials to try to maximize the value of the product, how do you see your relationship with Allergan as well? Do you see this relationship getting stronger over the next 2 to 3 years?

[Peter Hecht:]

We continue to be very excited about really LINZESS as a foundational product for growth for Ironwood today and for new Ironwood. It's really still in the early stages of growth. It was long runway and many years to go. We have IPX exclusivity out for quite a long ways, you'll see in our announcement this quarter, we just settled the second ANDA out in 2030. And it's the clear market leader with long way to go and will. It's a very high margin product and it's benefiting a great many people but with a huge number of. Who frankly still haven't even heard of that work. So I think Tom and the commercial team have tremendous opportunity to continue to open up new categories and new section segments of the market and grow the category for many, many years to come. You've heard from as well abdominal symptoms claim and how we think that can be a helpful catalyst for growth, you heard about DR and really what's a really completely different product concept for abdominal pain. I think there's a really long way to go and you have to light Allergan and our partnership is now 10 plus years and continues to be very strong and in an order was continues to strengthen over time know each other better and trust and work together over every function in the company. Are expected to continue to grow and strengthen over time. I don't see any reason not to. we're very well aligned across strategy and investment. So I think there's every reason to be bullish about the current and prior years.

[Operator:]

And our next question comes from Patrick Fraser [ph] with Behringwerke capital.

[Unidentified Analyst:]

At a recent congressional hearing, HSS said that we may need to move towards the system without rebates with their PDFs and drug companies just negotiate fixed-price contracts. Can you tell us where do you think the system like this is feasible? And secondly, how do you see such a system effect the formula to position of LINZESS, particularly as a new competition enters market over the next few years?

[Thomas McCourt:]

I think there is probably three pieces to this question. First, on the rebate front, I mean there's still comes back to negotiating to a net price. The question is who do we negotiate with? And that's largely determined by the value proposition we have for the brand. And we have said from the date we walked into this marketplace, I would number 1 priority was to secure products is across all peer groups will enable us to drive broad and long-term demand. So I think this is going to continue to evolve. I think the people will be debating what the right model is but I think at the end of the day, it really comes back to a patient with an unmet medical need and advancement in care, our value proposition for the brand and I think that's something we've been able to consistently establish with our partner. I think the other piece as well as the emerging competitive, I think again, one of the advantages of being the category later in the market leader and we are in a situation where continuing to raise the bar with regard to the profile of the brand, the clinical utility brand, dosing options, I think it's going to be challenging for emerging competitors to enter the market. It was a lot of how the enter the market now than it was five years ago and I think we're going to continue to see that particularly in GI and primary care. So I think what we need to focus on is really continuing to make sure we're optimizing our value proposition for the payer, work with the payer, make should we price responsibly and almost all cost make sure we have broad access and reimbursement for our patients and docs.

[Unidentified Analyst:]

I have one other question actually on a separate front. Do you expect SG&A expenses to be up or down in 2019 given the savings from existing gout?

[Gina Miller:]

This is Gina. We are planning to provide guidance for the two new companies in February of next year for when we typically provide our year-end update.

[Unidentified Analyst:]

I just have one more question regarding the spirit. Investors often ask us about how this will unlock value. Can you tell us about what examples the board provided where business splits a mock value? And second, can you tell us what changes if any plan are planned for the antitakeover positions in either R&D co or new Ironwood?

[William Huyett:]

This is Bill. The board reviewed a number of separations inside and outside by a former in reaching its decision that this would be clearly value creating for the shareholders and the scenes from all those with the simplicity focus of the strategies of the 2 companies and the resulting organizations and cost structures. And without commenting on the individual examples, we're already starting to see as we develop our separation plans and the organizations that will deliver on the strategies, the sorts of things that we and the board discuss as part our separation process. With respect to the board governance, membership, our board is working closely on with us and at the selection of the board members with the termination of the governance practices of the companies and it will be announcing those over the coming months.

[Operator:]

And our next question comes from [indiscernible].

[Unidentified Analyst:]

This is Julian. How should we be thinking about recent approval of something in the context of 3718?

[Thomas McCourt:]

I guess why don't I take that, the system, the novelty here isn't so much coast of Lent, it's the delivery system. The thing that we -- you have to keep in mind is, in order for this to work to be able to minimize socket shape exposure bio, the bile acid sequestrant has remained in the stomach and basically, the ties of the bio. The challenge would just well call is your stomach empties every one point five hours worked so you really only have a very brief coverage our bile as soon as it's very much like an acid where I can treat the acid in the stomach but as soon as the stomach empties and it feels back up again, you still have acid in bio. So the real novelty here is this gas return of formulation of colesevelam that enables the success of this therapy.

[Operator:]

Thank you. This concludes today's Q&A session. I would now like to turn the call back over to Peter Hecht for closing remarks.

[Peter Hecht:]

Thanks, Imani and thanks everybody for your time this money. We'll be here and available all day if you have follow-up questions. If you do, please just reach out to Meredith or to Gary here in our offices. Thanks again.

[Operator:]

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