Ironwood Pharmaceuticals, Inc. (IRWD) Earnings Call Transcript & Summary

All right. Good evening, and thanks again for joining us for the annual JPMorgan Healthcare Conference. I'm Eric Joseph, senior biotech analyst at the firm. Our next presenting company is Ironwood Pharmaceuticals, and it's my pleasure to welcome the CEO, Mark Mallon, to tell us a little bit about the company. Before I hand it over, I just want to remind folks that they can ask a question that I will ask on their behalf in the Q&A session after the presentation. [Operator Instructions] So with that, Mark, thanks again for sharing some of your time with us. Take it away.

Great. Thanks, Eric, and thanks to all the participants. I also want to say thanks to JPMorgan for hosting the event. I have to say they've done a great job in transitioning from an in-live event to this virtual platform. We had a great day today, having a chance to meet with a number of important investors and other important partners. So we're very pleased with our first day here at the conference. So thanks so much. I understand that all of you have got a chance to potentially download or at least have the presentation access -- or access to it. I will call out the numbers as they go along as best I can. And as Eric said, we'll have a chance for Q&A following the presentation. So if we move to Slide #2. This is the safe harbor statement. I'll be making some forward-looking statements as part of this presentation. And I just wanted to remind you of that and ask that you see our SEC filings for more information on Ironwood Pharmaceuticals. So if we now move to Slide 3. Our vision continues to be and is clearly to become the leading GI health care company in the U.S. We define that as our mission as redefining the standard of care for patients suffering from GI diseases, right? And in doing that, we're looking to make a huge difference in their lives but also importantly to be able to drive share -- value for our shareholders by bringing important medicines to these patients and building a growing and successful business. Over the next 20 minutes, I want to explain why we believe that we can do this, right? In fact, we're one of the few companies that we think can really lead in the GI health care area. We have the expertise, the experience and the capabilities to make it happen, and we'll take the next few minutes to bring you through our thinking on this. So if we move to Slide #4. This is just a quick recap of 2020. This was a challenging year, I think, obviously, to say the least, given the pandemic and many other challenges with a tough external environment. And we also did have pipeline disappointments in the case of Ironwood internally with 2 of our late-stage assets having negative results. But despite these, we really were able to deliver on some outstanding business results. First and foremost, our key commercial asset that we're in partnership with AbbVie, LINZESS, we achieved $930 million in sales, significantly above our guidance for the year, and 10% net sales growth year-on-year versus 2019. And we'll talk -- I'll say a few words on why we've been able to see such good success for that. We also took work -- we had a priority to develop our GI pipeline. As I said, we did have a couple of late-stage disappointments. But I would say we also moved with speed once we had that information -- the results from those studies to quickly reallocate resources to make sure we're really optimizing the work of our company. And we conducted a full assessment of the opportunities that we had both in the context of the disappointments but also in the context of the great results we're having with LINZESS in our outstanding GI capabilities and basically considered sort of all of our strategic options and made -- recommitted ourselves to focusing on GI. And I'll take you through that and what that means in a moment. I also want to note we did get approval for our sNDA for abdominal symptoms in IBS-C. This is important new data for physicians and patients, and we're really excited to have that delivered in 2020. And then finally, we continue to deliver strong profit and cash, in fact ahead of expectations. Again, we ended the year with cash and cash equivalents of about $350 million, significantly increasing over the 2019 close of $177 million. So it gives you a sense of the ability of our organization to really generate important profit and cash for reinvestment in the business and for creating value for our shareholders. So if we move now on to Page 5. I just want to highlight a couple of more points related to 2020, and then we'll focus on how we're going to move forward. So clearly, the LINZESS performance was very resilient. In fact, I would say beyond resilient. It was really actually quite strong. As I mentioned before, we've reached 10% net sales growth overall. This was driven by an all-time high in volume units for the brand, which was 7% growth versus the previous year. We hit all-time highs with new brand prescriptions. So new patients continue to get on the brand despite the limitations and access patients had at different points during the year because of the pandemic. We saw an increase in our 90-day prescriptions as a percentage of the total business, approaching 20%, also an all-time high. And we had guided for the year that we expected price to be stable. But in fact, we did actually have some appreciation of price, which altogether contributed to this outstanding net sales performance that you can see in the chart to the right-hand bottom side on this page. Now if we move over to Slide 6. I will mention to you that the Board and the management team took time to really look at all strategic options for the company and what would be the best path forward, considering the success of LINZESS but also the changes in our pipeline. And we basically reconfirmed ourselves to focus on GI as the best option for Ironwood. We came to this conclusion for a couple of reasons. First of all, the unmet needs in GI remain very significant. Second of all, we completed a very exhaustive and comprehensive review of new assets coming through the lab -- the pipelines of companies in the industry that are working in the GI space. And we see a number of examples of innovation that we think we could play a role in bringing to patients. And so there's definitely opportunities to meet these needs and to make a difference for patients. And finally, we believe we continue to be in a unique position to help companies that have innovative assets but then don't have the commercial development capabilities to really bring them to fruition to make sure that they can reach their full potential and in doing so, creating value for patients and for our shareholders. So for -- with the unmet needs, with the innovation coming into the market and with our unique position to have success, drive success from a development perspective and a commercial perspective, we really think staying focused on GI is the right thing to do. And of course, this is all on top of what we're doing with LINZESS, which in and of itself is a fantastic position to begin with in GI and represents already a major source of growth, value for our shareholders and for Ironwood and also, of course, makes a huge difference for many, many patients suffering from IBS-C and chronic constipation. Now we also have said that we're going to continue to consider transformative transactions. We've had this position since we launched the new Ironwood with our focus on GI, and we're going to continue to be open to those types of transactions, whether those could be inbound ideas or we also, on a regular basis, are considering the ideas ourselves and whether there's things that we should be pursuing. So that is -- really has set, I think, a clear direction for us as we head into 2021. Moving on to Slide 7. What does it mean to say that we're going to have a GI-focused strategy and really continue to aim to be the leader in the GI marketplace? How are we going to do that? We basically set 3, I think, very clear priorities. The first is to maximize LINZESS. I often say LINZESS, LINZESS, LINZESS. This is an amazing medicine, making a huge difference for many hundreds of thousands of patients in the U.S. and beyond the U.S. And so we've got to make sure that we leave no stone unturned with our partner to really maximize this product. We're going to talk a little bit more about the opportunities. I see a couple of things that we can do to further strengthen the growth of LINZESS. We've got some innovative commercial model opportunities that we're going to be pursuing, and we're going to be making a very robust assessment of the -- of life cycle opportunities that we could have for LINZESS. And we'll -- I'll say a word about that in a moment. The second priority, as I mentioned, is to build an innovative GI pipeline. And one important focus that we're adding to our work in this space is really having a very keen focus on serious and organic GI diseases. And I'm going to take a moment to explain to you what we mean by organic diseases and what are the criteria that we evaluate -- we'll be evaluating any potential business development opportunities. And then finally, we will continue to prioritize sustaining our profits and generating a positive cash flow as we've done since we launched the new Ironwood. If we move to Slide 8. We can see here a simple picture of our capital allocation strategy that we're using to support our overall priorities and to achieve our overall vision for Ironwood. I think the first thing to say about our approach to capital allocation is that we're always looking for where the highest return opportunities are. That's where we want to put our capital. The first place we're going to look is obviously to continue to maximize LINZESS. This is where our biggest opportunity is in the near term. We will then also look for opportunities to add -- build an innovative pipeline. Now we're going to set a very high bar, as you'll see when we explain how we approach this because these opportunities do have to deliver value to shareholders, but that would be a second area of focus for our capital. And then the third is we'll also be ready to look at whether returning capital to shareholders is -- also could be, at certain times, a high return opportunity. We believe that in many cases that maximizing LINZESS and investing in the pipeline will be the right ways to best maximize return to shareholders. But if there are cases we're going to stay open to and consider where and when it might be that returning capital to shareholders is the best investment. And most likely, we'll be doing that through share repurchases. If we now move to Slide 9. We'll dive a little bit more into each of these pillars. So the first one to talk about is maximizing LINZESS and if we move right away into Slide #10. I think this slide really almost speaks for itself. LINZESS is really in a uniquely strong position in the IBS-C and chronic constipation market. Basically, we are the #1 medicine brand by pretty much any measure you could have. We're #1 prescribed product in this category. We have the highest market share with a 40% market share each achieved in 2020. We have the best access, 75% combined, unrestricted access across Medicare Part D and commercial. And we're #1 in both physician and patient satisfaction. This really -- all of these together really puts us in a position where we've been able to achieve the great growth that we've had this year and the 10% growth in net sales and the $930 million in net sales in 2020. But more importantly, it gives us a position which we can continue that growth in '21 and beyond. And so to put some -- a primer as to what we think is possible in '21 and in the context of the momentum that we've had coming out of 2020, I wanted to basically walk through sort of our initial guidance for 2021 for Ironwood. I should say that we expect 2020 to come in at the high end of our revenue range that we gave guidance for. This is -- it was $370 million to $385 million. So based on the really outstanding performance of LINZESS, we will be in the high end of that range. And you can see, as a reminder, that we participate in a 50-50 profit share with our partner, AbbVie. And that means that basically, we'll be getting about over -- just over $300 million in profits from the collaboration in the U.S. with AbbVie behind LINZESS. And so as -- with this momentum going into '21, we're very confident that we can continue to deliver high single-digit volume demand growth. This will be driven by our ongoing execution in personal promotion, in maintaining access and in consumer -- our consumer marketing programs but also through a couple of innovative, new commercial strategies that I'll talk about in a moment. We do expect in '21 that we will see some price erosion, mid-single-digit price erosion. This is due to competitive dynamics and some changes in the payer mix, rebates and mix. And so this will lead to still strong growth of 3% to 5% in net sales in 2021. Now if we move on to Slide 12. I want to actually talk about the levers that we have to drive that success next year and beyond. And the product is already clearly on a track to $1 billion in net sales as we've just achieved $930 million in the last year. So we can be confident that we will, in fact, exceed $1 billion. The question is by how much can we exceed. And that's what the team is really focused on. And we have 4 levers that we're going to be using in '21 and beyond to really make sure we can really maximize the opportunity that is in LINZESS. The first thing is that we've really got to do everything we can to enhance the HCP and patient experience, in particular their communication with each other, and really getting patients to explain to physicians their symptoms and how it's impacting their life, really getting physicians to ask the right kind of questions so that patients that really would benefit because of the -- abdominal pain, abdominal discomfort and constipation symptoms would really benefit from LINZESS. And we'll, of course, use our traditional tools. But on top of that, we're going to be adding virtual selling capabilities. In 2020, we were very quick to establish virtual detailing capabilities within our sales force. All of the representatives have been trained on that. They're building their capabilities and experience in 2020. Probably by the end of the year, we'll have about half a call per day on average being delivered virtually. And we aim to see that increase in '21 as the team continues to build this capability. We think this is a really important capability in the future as physicians expect that up to 30% of the interactions with sales representatives will be on a virtual basis. And so we've got to make sure that we can be successful with this new capability. A second critical opportunity for us is telehealth. IBS-C and chronic constipation are very good conditions to be treated via the telemedicine platforms. These are easy for patients to describe to their physicians. And in LINZESS, you have an ideal medicine for a telemedicine or telehealth platform. Physicians are confident in the product. It has a very good safety and tolerability profile. And both the patients and physicians can be very confident in its efficacy. And that was evidenced by earlier in the year when we had the sort of peak of office closures, and telemedicine was really a primary way that the patients were getting their medicines. Up to half of our new-to-brand prescriptions were coming through a telemedicine channel, and it continues to be a high-level proportion even as the offices began to open up. So we've piloted this year our own telemedicine platform as part of our consumer campaign. The first step in that process is getting people to our website. We've had a remarkable increase in 2020, thanks to the consumer campaign and the integration of some telehealth principles, where we're now seeing between 400,000 and 500,000 visitors every month to our websites. The next challenge that we've been exploring and building our learning really how to do this is to get these people to a medical -- telehealth platform where they can actually get their conditions diagnosed. They can get the appropriate treatment plan from physicians and with LINZESS as a market leader that will -- in and of itself will create opportunities for the brand. So that's the really focus on maximizing the experience and the impact we can have on prescribers and patients. We have to continue to communicate about our new abdominal symptom data that I had mentioned. We just got that into the label last year. So it's still relatively new, and it's an important information to continue to communicate, both the physicians and patients. We have had -- always had very strong overall access. We've got to maintain that as a key lever and driver for the brand while managing the impact on net price. And then finally, we want to really look to continue expanding the clinical utility of LINZESS with a real focus on assessing what options we have for life cycle management. We -- I think many of you are aware that LINZESS has patent or intellectual property exclusivity -- market exclusivity through first quarter of '29, which is a very long runway for us to continue to invest in the product both on the commercial side but also through life cycle management, and we're currently advancing efforts to explore new indications, treatment -- treating new populations and other options for life cycle management with LINZESS. Now if we move to 13. I provided -- we provided you a little bit more information on how we're thinking about basically what we're calling our hybrid selling model. This is one that -- basically where we're using both traditional personal promotion but also virtual selling to really maximize the impact of representatives. And then also, we share a little bit more information on telehealth initiatives, which we piloted this year, but we'll continue to invest in '21 and beyond. Now moving on to the innovative pipeline. Just to say a few words on how we're evolving and thinking about this and our plans for '21 and beyond. So first of all, as I said, we did a very comprehensive view of the landscape in GI and identified over 100 assets, innovative assets in the clinics today in development. Many of these compounds are with smaller companies, companies that don't have the necessary commercial and development capabilities to fully realize the full benefit of these assets. And these assets are primarily in what we would call organic diseases. This is in contrast to functional GI diseases. What do we mean by organic diseases? These are diseases that have really well-understood pathophysiology, well-understood mechanisms. And most importantly, there are well-defined markers for impact of the disease and impact of treatments of the disease so it can be really clear, the impact of a new medicine on a particular disease. The benefit of this is that we should be able to design studies smartly that are potentially shorter, potentially more efficient, involving less patients and give really clear answers so that we can make the quick decisions, right decisions, both getting products that are positive to markets quickly but also stopping fast those that are not going to achieve the necessary characteristics. As I said, we've identified over 100 assets in the GI space, so a lot of potential targets for us across more than 25 disease areas. And in particular, we've identified 8 that are listed here that are most interesting to us because these have some of the highest unmet needs, and we're seeing a lot of progress in understanding the disease, the pathway, the potential targets and where companies that have been able to put together new enemy or enemies that could be used -- or potential medicines for treatment of these conditions. And this is where we're going to be focusing our work in '21 and beyond. So I think it's a very exciting picture for us going forward to rebuild our pipeline. But it's important that we really maintain sort of a rigorous standard and a high bar when making investments in business development and that we stay laser-focused, ensuring that wherever we would make investments in acquiring an asset, that is going to deliver shareholder value. And so we've set up these principles to guide us in evaluating each asset we might look at. The first is that we're going to primarily focus on diseases and medicines that are managed by gastroenterologists. We want to try to avoid assets or diseases that really are moving into the primary care space, which is highly competitive and expensive. And so we want to stay focused on where we have our strengths, which is a group of customers that are matched with our resources and size. We're going to focus, as I said, on organic GI diseases, where mechanisms are really well understood and we should have the opportunity to be -- to accelerate our clinical development programs and be very cost-efficient as we're doing that and then really improving potentially the overall success rates. We want to focus on innovation. In particular, we define innovation as first-in-class or clearly differentiated opportunities. And again, this is to increase the probability of success as we go to commercially launch a product. We are going to -- and this is an evolution from where we've been in the first 18 months to explore innovative, earlier-stage clinical assets. The key here is again emphasizing products that have a chance to be first-in-class or differentiated. And we are going to -- although we'll be going earlier, we're going to stay focused on clinical assets, so assets that have some information on efficacy or safety in man. And then finally, any of these assets, we need to be able to, as we're developing and launching them, maintain our ability to deliver profits and cash as we have been doing. And overall, when we put this together, we think this will give us the best chance to choose and basically execute against assets that really will be at a price and have a return that will create value for shareholders. But we're not only focusing on the external opportunity because we do have a tremendous amount of experience in an important category of drugs, which is the GC-C agonist. These products, we've -- obviously, it's the basis for LINZESS. Linaclotide is the GC-C agonist. And we have a lot of experience in using these products to treat hypersensitivity in visceral pain. And so we have -- I'm pleased to say we have a product that we've been advancing in the preclinical setting, Ironwood-3300, that is ready -- we're ready to take into Phase I development for the treatment -- potential treatment of visceral pain conditions. Now we have really strong clinical data for this asset. It's a peptide that is more potent than linaclotide and more stable. We've looked at it in a number of very important pelvic conditions where visceral pain plays an important role. For example, we've got preclinical data in endometriosis-induced vaginal hypersensitivity. We've got a number of models looking at pain relief in bladder preclinical hypersensitivities models. And these areas really give us confidence that this potential medicine could make a big difference in an area of high unmet need, in particular in interstitial cystitis in the bladder pain syndromes and in endometriosis. And when you combine what we know about this category of drugs, the safety profile that they have, the experience that we've had and success that we've had with linaclotide in treating abdominal pain and hypersensitivity in the GI tract, we're very excited by these preclinical data in these other conditions that -- where hypersensitivity and visceral pain play an important role. And this is going to be an opportunity to test an important biological concept, which is the -- or hypothesis, which we call cross-talk or we refer to as cross-talk. And this will be the first time we'll be testing this in humans although there is a lot of data again to support the success both from a preclinical standpoint and from assessing biologic processes in humans. And this is that condition -- a process where pain or damage in one organ basically causes a response in a nearby organ because of the common neural pathways. And so we're going to be able to test whether Ironwood-3300 when deployed in the colon, which will trigger the GC-C cascade and the GMP -- triggering GMP in the colon, dampening the firing of afferent nerves and then triggering a corresponding effect in the nerves in the target organ, in this case would be focusing on the bladder to attack, as I said, interstitial cystitis and the bladder pain syndrome. We are in a position to do, we think, a very fast proof-of-concept and get a very clear answer. We're at a very cost-effective approach. If successful, this could be a really important medicine. We'd look certainly potentially to bring a partner involved to help bring it to these markets. And so in a sense, this is a chance to really leverage the capability that we've built up in this area of GC-C agonists and in treating visceral pain and doing it in a very cost-efficient and smart way and basically is another opportunity to create value for our shareholders. And finally, I just want to remind everybody that Ironwood really does have a leading set of capabilities within GI and -- the capabilities and expertise. And this is as indicated by the number of successful partnerships we've had over the years not just with LINZESS but with products like Nexium and Cologuard and most recently with GIVLAARI, which is -- we work together with Alnylam to basically identify appropriate acute hepatic porphyria patients that are being managed by gastroenterologists, getting them identified over to the Alnylam team so that we can -- they can get on this important new medicine. And we've had a great deal of success in helping Alnylam identify these patients. So tremendous examples of success leveraging capabilities across the value chain in GI. And I'll now bring the presentation to close and we'll move to questions by just summarizing the financial results that we've had in 2020 and remind people of sort of -- give our latest guidance for 2020 and just say a few words about the future. So moving to Slide #20 (sic) [ #33 ]. This highlights something we've already referenced, this really excellent financial performance that we had in 2020. You can see on the left-hand -- right -- side of the slide how Ironwood revenue has grown, driven by -- primarily by the great performance of LINZESS in the U.S., the last 2 quarters coming in with greater than $100 million a quarter in revenue for Ironwood. And then on the right-hand side, you can see the growth, as I mentioned, in cash and cash equivalents, up to -- we estimate about $350 million by the end of 2020, so great value being created both from a revenue standpoint and from a cash generation standpoint. And I also wanted to remind people of just the tremendous transformation that Ironwood has been through from a financial perspective. Third quarter 2020 was the sixth consecutive quarter of profitability. And you can see looking basically at the first 3 quarters of 2018, 2019 and 2020, what kind of a transformation we've undergone, where we've gone from a GAAP net income loss of just over $200 million in 2018 in the first 3 quarters of that year to $63 million in net income in 2020, so I think a pretty remarkable transformation. Just closing 2020 out and by updating our guidance or basically giving the latest view as we are getting all the final data for 2020 in, you can -- as I've mentioned already, we've exceeded both the guidance at the beginning of the year and even from the guidance for 2020 for net sales growth with 10% growth and $930 million in sales. You can see the total revenue. As I said, it's going to be in the high end of our range that we had communicated of $370 million to $385 million. And finally, significant uplift versus original guidance of $150 million in adjusted EBITDA. I think by any measure, a really successful financial year. So I'll close by saying we really believe that Ironwood is poised to continue to deliver value through growth and innovation. We have -- of course, the first foundation of that growth is going to continue to be LINZESS. We're on track to exceed $1 billion. And our challenge to ourselves is how much more than $1 billion we can do. We have between now and until first quarter of 2019 to really maximize LINZESS. We've got some commercial innovation that we're going to be applying starting next year that we think can make a real difference. On top of that, we have our second growth platform, which is our life cycle management opportunities for LINZESS that we're working and identifying and confirming this year. And then beyond that, you saw the great set of potential opportunities across a number of serious organic GI diseases where Ironwood, we think, has a unique position to smartly work with potential partners to find the most innovative medicines that can make a difference for patients and generate real value for shareholders. Putting these 3 platforms together, we really believe we've got a future to, one, become the leader in GI health care but deliver strong, sustained growth for years to come. So thank you, everyone. Thank you, Eric, and we look forward to taking any questions.

Great, great. Thanks, Mark, for the presentation and overview. Just a first question from me, really just to pick up on this. It's really strong performance by LINZESS in the fourth quarter and for the full year. And you're seeing benefit obviously from increased volume, which I think is sort of in line with your expectation at the top of the year but also stronger-than-expected price. And as we look to 2021, you're anticipating again some erosion, you think, on net price. And so I guess just how to kind of reconcile those 2 trends when it comes to net price. Are you being a little -- perhaps a little overly conservative in terms of 2021 guidance? Anything in the way of new pressure from payers that you are anticipating going forward.

I'm going to ask our CFO, Gina, to give her thoughts on that. And I can assure you that we're certainly always trying to be ambitious at Ironwood, but Gina, share your thoughts on pricing.

Sure. Thanks, Mark. Maybe I'll start with just 2020 because I think if I give a little bit of color on what transpired during the 2020 year, it will help you understand the guidance that we've provided for 2021. And when we started 2020, we had guided to net stable price. And we were really excited about that guidance especially coming off a few years of price erosion. We were able to provide that guidance because we made some very thoughtful plan design changes, which we thought would still provide affordable access for our patients -- broad affordable access for our patients without significantly decreasing demand. Now we were obviously able to realize that. And not only were we able to stabilize price, we actually saw some modest price appreciation throughout the year and for the full year. And that was due to a few different things. So one, just to point out, there's a little bit of apples-to-oranges in the '19 to 2020 comparison. We had a few adjustments to gross to net that were unfavorable in 2019 that didn't repeat in 2020, nothing significant, nothing like we saw a few years back. But year-over-year, it does add to some price. So payers routinely approach us for adjustments, higher rebates, et cetera. They've done that in the past, they did it in 2020, and I'm sure they'll continue to do it again in 2021 and beyond. But in the past, when we finalized those discussions, a lot of times, the rebates, the higher rebates were effective almost immediately. And this time, when we completed those discussions, we will not see the impact of the majority of those discussions until 2021. So that's why you'll see the price erosion in 2021 as opposed to 2020. And then lastly, I might just add that in the beginning and the early days of COVID, we talked a little bit about just monitoring the net price and being concerned about the many Americans -- unemployed Americans and those Americans potentially losing their health insurance and moving from commercial plans to Medicaid plans. As that happens, those patients would carry -- our Medicaid carries higher rebates, which is a lower net price to us. We didn't see that materialize in 2020, but we are just continuing to monitor that for 2021, given where we are in the pandemic.

Of course, yes.

And yes, maybe just to wrap it up. I'm sorry to go on for too long, but I just want to reiterate that LINZESS does have a long runway and we continue to believe that it will grow through demand. So a core strategy for us is affordable payer access, and we think we have the right balance.

Yes. I mean we are several years into launch. It's hard to say we're in a launch with LINZESS right now, right? I'd be curious to sort of get your characterization in terms of where we are in the product cycle for LINZESS and, in particular, sort of where things stand in terms of brand awareness, market penetration currently. And sort of what some of the levers are tools -- some of which you've described so far have really continued the volume trend.

I think, Eric, I'll ask Tom to comment on that. I think he's well-situated to comment on the position of the product. Or maybe you can build on the information I shared in the presentation, Tom, and give a bit more flavor on where we're at with LINZESS and what's possible going forward.

Yes. And I think, to Mark's point earlier, I mean this is -- as you know, this is a large population, highly symptomatic. And as well as LINZESS has done, we've really still only scratched the surface. And we're continuing to tap into new sources of business as we move forward. And this is where the marketing mix really becomes powerful particularly when we face something like the pandemic, where -- as Mark mentioned, this is really almost an ideal drug for things like telemedicine as well as virtual detailing but telemedicine, where patients and physicians can talk, they can be diagnosed, they can be managed. And because of our strong payer access, they can be pulled through. And so as we think about what's driving that growth, it continues to be driving broader awareness of who is the appropriate patient and actually motivating patients to self-identify and describe their problem. And the more we can do that, obviously, this drug is going to continue to thrive. I think the other piece, too, I don't want to exclude the fact that we're going to continue to strive to broaden the clinical utility of the drug. Obviously, the additional indications -- or excuse me, additional abdominal symptom claim is a very powerful tool to broaden physician's view of who the appropriate patient is but also broaden the pool of patients, the ability to self-identify and describe these symptoms. And Mark mentioned a little bit about the telemedicine platform which is becoming a very powerful vehicle and, I think, an area of great interest to us that we're going to continue to learn about and leverage to our advantage and most importantly, to bring better care to so many suffering Americans right now. So I think we're well positioned for ongoing success. And to Gina's point, the most important driver is volume growth and demand growth, which is where we're myopically focused today.

Have your competitors sort of kept pace with you on the telemedicine and virtual detailing side? I know that there are different product profiles and so forth. But just you've leveraged -- you've adapted well in this space. I'm wondering sort of whether your competitors have kept pace with you.

Well, there is and there should be...

Go ahead, Tom.

I'm sorry, Mark.

Please go ahead, yes.

There is an advantage of being the market leader, right? And we've had a very, very successful consumer campaign. I mean just to put -- Mark kind of mentioned this, we're seeing 400,000 and 500,000 patients every month come to the website, looking for help. And obviously, being able to tap into that and pull those patients through is critically important. And obviously, we're working with the best vendors there and the best technologies, and we're going to continue to advance it. And I think we're very enthusiastic about that opportunity.

Got it, got it. Now we're actually just coming up to the end of the session here for time. So I'm going to have to hold back on some of these questions, unfortunately. But anyway, thanks so much again for your time this afternoon, Mark, Tom, Gina. We really appreciate it. And thanks, everybody, for tuning into the webcast this afternoon. Everybody, have a wonderful evening.

Thanks, Eric.

Thanks, Eric.

Thank you.

And thanks to all of the participants.