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spk02: Good morning. My name is Joseph and I will be your conference operator today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals first quarter 2022 investor update call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you'd like to ask a question at this time, simply press the star followed by the number one on your telephone keypad. If you'd like to withdraw your question, Press the star and then the number one on your telephone keypad. Thank you. Matt Roche, Director of Investor Relations. You may begin your conference.
spk07: Thank you, Joseph. Good morning and thanks for joining us for our first quarter 2022 investor update. Our press release issued this morning can be found on our website. It is called an accompanying slide to include four building statements. Such statements involve risks and uncertainties that may cause actual results to differ materially. Discussion of these statements and risk factors is available on the current Safe Harbor Statement slide, as well as under the Heading Risk Factors in our annual report on Form 10-K for the year ended December 31, 2021, and in our future SEC filings. All forward-looking statements speak as of the date of this presentation, and we undertake no obligation to update such statements. Also included are non-GAAP financial measures which should be considered only as a supplement to, not a substitute for or superior to GATT measures. To the extent applicable, please refer to the tables at the end of our press release for reconciliations of these measures to the most directly comparable GATT measures. During today's call, Tom LaCourte, our CEO, will review our strategic priorities and provide an update on the commercial performance of LINDSES. Mike Schetzlein, our Chief Medical Officer, will discuss our pipeline, and Shrovan Ahmadi, our Chief Financial Officer, will review our financial results and guidance. Today's webcast includes slides, so for those of you dialing in, please go to the events section of our website to access the accompanying slides separately. With that, I will turn the call over to Tom.
spk04: Thanks, Matt. Good morning, everyone, and thanks for joining us today. I'm delighted to announce our Q1 results this morning. Maintaining last year's momentum, we're off to a tremendous start this year, as demonstrated by the continued strong LINSA's performance, the initiation of IW3300 and CNT104 clinical studies, and another quarter of delivering profitability and positive cash flow from operations. At Ironwood, we remain committed to advancing the treatment of GI diseases and redefining standard of care for GI patients. We're focused on driving value for our shareholders by bringing important medicines to our patients. I believe the progress we made across the organization in the first quarter demonstrates the steps we're taking to become the leading GI healthcare company in the U.S. Now, I'll begin with a brief overview of our strategic priorities on slide six. Our strategy starts with maximizing LINZUS. We continue to be excited by the performance of LINZUS, which has delivered another quarter of double-digit demand growth. And we believe there's more opportunity ahead. Beyond LINZUS, we're making progress on our clinical trials and remain on track with previously shared data readout timing. We're focused on strengthening our pipeline. through our in-license and acquisition of innovative GI assets, which we believe will position our company for continued growth. And finally, we continue to deliver sustained profits and cash flow. We ended the first quarter with approximately $593 million in cash and cash equivalents on the balance sheet, and we continue to execute on our board-authorized share repurchase program. Through the end of March, we have repurchased $118 million in our common stock. We see these achievements in the first quarter as important progress that we believe will support continued growth and success for our company. Now, let's turn to some additional details on the commercial performance of Linza starting on slide seven. It's hard to believe that 2022 represents year 10 of Linza being on the market. Linzess has grown from being the first in class GCC agonist becoming the number one prescribed branded treatment in the U.S. for adults with IBSC and chronic idiopathic constipation. As you can see on the slide, Linzess is the leader in the category with 83% share and 75% total prescription share with gastroenterologists in the branded IBSC and chronic constipation market. Linzess is also the leader in the combined branded and generic IVS and chronic constipation market, with 43% total prescription share. Most important, we're proud to have supported nearly 4 million unique patients with Linzess since the launch of the brand in 2012. Building that last year's momentum, Linzess prescription demand increased an impressive 11% year-over-year in the first quarter of 2022, as shown on slide 8. continuing the stretch of five consecutive quarters of double-digit prescription demand growth. In addition, 98 prescriptions have grown as a percent of total retail prescriptions, with an all-time high of 21% at the end of Q1. This has also helped increase the average prescription size of Linzess for roughly 43 days. Slide 9 provides a bit more color on what we believe are the key drivers of Linzess demand over the long term. It starts with a strong clinical profile. Lynn says, has FDA-approved labeling demonstrating the improvement of overall abdominal symptoms of bloating, pain, and discomfort in adults with IBSC. And we're committed to helping both patients and providers understand the importance of treating these symptoms beyond constipation. Additionally, the American College of Gets Hydrology Guideline strongly recommends GCC agonists, including Linzess, to treat IBSC symptoms and recognize the high quality of evidence supporting Linzess. Moving to patient activation, Linzess continues to lead the IBSC and chronic constipation branded prescription market in direct-to-consumer promotion, with the goal of educating more appropriate adult patients to seek care for IBSC versus continuing the frustrating cycle of self-managing with OTC therapies. In April, we, together with our partner, AbbVie, launched our newest consumer campaign, which performed extremely well in market research. Of course, patient activation is not possible without the care of physicians and other healthcare professionals. At Ironwood, we are a GI healthcare company with an experienced and highly skilled sales force focused on broadening the use of Linzess with gastroenterologists and high-volume primary care physicians for appropriate patients. In addition, our investment in payer access is helping support clinical decisions by healthcare practitioners. We are proud that after many years, LINZUS has class-leading payer access and is widely available on commercial and Medicare Part D formularies. When looking at key plans, LINZUS is preferred on the top 10 commercial plans and is covered or better on the top 7 Medicare Part D plans. That meant most patients who have access to LINZUS get chosen by their healthcare professional. Finally, we believe we can expand the clinical utility of LensDust through key lifecycle management initiatives, including our ongoing pediatric program. Over time, we continue to refine our marketing mix and investment in the brand to support brand growth and improve brand margins and cash flow generation. We remain focused on the levers that we believe will drive continued demand growth and, in turn, generate profits and cash flow. Looking ahead, we're excited about continuing to maximize Linzess, advancing our clinical programs, strengthening our financial position, and growing Ironwood's leadership position within GI. In a few weeks, we will be presenting eight abstracts at the Digestive Disease Week meeting, or DDW, two of which are oral presentations highlighting our commitment to advancing the science as we strive to deliver better therapies for patients suffering from GI diseases. In particular, we'll be presenting new data on the clinical utility of the abdominal score, which is important to help physicians better understand the symptoms most important to patients suffering from functional GI disorders. We look forward to DDW and sharing data on lenaclidide, as well as preclinical IW3300 data with the brightest minds in the GI community. I would like to say a big thank you to all Ironwood employees who have laid the groundwork for continued momentum and strong execution against strategic priorities as we continue to help make a remarkable impact on patient lives. I would now like to hand the call over to Mike, who will discuss Thanks, Tom.
spk07: I'll start with the Lenaclotype pediatric program on slide 11. The clinical studies are ongoing, and we continue to expect the functional constipation study in six to 17-year-olds to read out in the second half of this year. The study is utilizing a 72-microgram dose and evaluating the safety and efficacy of Linacafib over a 12-week period in comparison to placebo. With spontaneous family, this is the primary endpoint. This is an exciting opportunity to potentially expand the clinical utility of Linacafib and, assuming positive data and FDA approval, bring a new treatment option to this patient population. As there are currently no FDA-approved prescription pediatric therapies for functional constipation. Next, we're advancing IW3300, a guanylate cyclase C agonist and a wholly-owned ironwood assay for the potential treatment of visceral pain conditions, such as interstitial cystitis, bladder pain syndrome, and endometriosis. The single ascending dose study completed in the first quarter of this year, the test of safety and tolerability in healthy volunteers. Based on a successful completion of that study, we're now planning to kick off the multiple ascending dose study in quarter two. Consistent with prior guidance, we expect to start Phase 2 proof-of-concept study at the end of this year. That will focus on pain benefits of IW3300 for patients suffering from interstitial status and bladder pain syndrome. We're currently working to finalize the study design. We recently had an advisory board meeting on this program, and the urologists we spoke with were really excited about the preclinical evidence for IW3300 and relief of visceral pain in a number of preclinical models. And lastly, CMP104. Core Pharmaceuticals is currently conducting a clinical study of CMP104, and the data is on track to be out in 2023. The study is evaluating the safety, colorability, pharmacodynamics, and efficacy of CMP104 in patients 18 to 75 years of age with PBC who are unresponsive to erythrocalva. The endpoints include pharmacodynamic outcomes, such as a change in alkaline phosphatase, which has been the foundation of prior product approvals. The real compelling feature is the objectivity of the immunological outcomes for this study, as well as the specificity of the therapy. The current diagnosis of PBC includes a positive antimicrobial antigen, which is the immune response to the target of this therapy, the PDCE2 antigen. So clinically, we're identifying the right patients to treat in this study. We're currently leveraging our expertise and reputation in the GI community to help CORE advance the study. We're thrilled to collaborate with CORE on CMP104, which we believe has the potential to significantly shift the treatment paradigm in PBC away from symptom management and be the first disease-modifying therapy for PBC patients. With that, I'll now turn it over to Shravan to review our financial performance.
spk06: Thanks, Mike. And good morning, everyone. I would like to provide a few updates this morning. First, I'll highlight our first quarter performance. Then I'll discuss our capital allocation strategy. And finally, I'll review our 2022 guidance. Please refer to our press release for our detailed financial information. I'll start on slide 13. When vast U.S. net sales were $232 million in the first quarter of 2022, an 8% increase compared to the first quarter of 2021. Net sales growth was driven by continued strong prescription demand, partly offset by net price erosion. In Q1, we experienced more modest net price erosion than anticipated due to a one-time gross-to-net benefit. From time to time, we may have one-time adjustments related to contracts or estimates as a normal part of the gross-to-net process that can have a quarterly impact, but that does not alter our full-year expectations. Therefore, for the full year, we continue to expect Linvest's U.S. net sales growth in the low-sing digits, driven by double-digit prescription demand growth. Turning to Linvest's brand profitability, Commercial margin in the first quarter of 2022 was 74%, compared to 73% in the first quarter of 2021. Moving to Ironwood revenues, in the first quarter of 2022, Ironwood revenues were $98 million, up 10% year-over-year, primarily driven by U.S.-Linzess collaboration revenues of $94 million. Turning to income tax expense, During the first quarter of 2022, Ironwood recorded $17.7 million of income tax expense, the majority of which was non-cash, as Ironwood continues to use net operating losses to offset taxable income for federal purposes and in many states. As a reminder, Ironwood has significant net operating loss carry-forwards from prior years, and therefore the majority of our income taxes will be a non-cash expense as we use our net operating Moving to Ironwood's profitability, gap net income was $39 million, and adjusted EBITDA was $58 million in the first quarter of 2022. Before moving on, I'd like to point out that beginning in the first quarter of 2022, we adopted ASU 2020-06, the new convertible debt accounting standard, which has the effect of decreasing our non-cash interest expense and increasing the number of shares used in the computation of our diluted earnings per share. It's important to note that the adoption of this accounting standard does not affect cash flows or adjusted EBITDA. Please refer to our public filings for additional information on this change. Now, moving to cash and capital allocation priorities. In the first quarter, we generated $64 million in cash flow from operations and ended the quarter with $593 million in cash and cash equivalents. We continue to execute on our board-authorized share repurchase program of up to $150 million that runs through the end of this year. Through March 31st, we have repurchased $118 million of shares, and we've repurchased an additional $16 million of shares through April 30th of 2022. Lastly, we have neglected to settle the $121 million 2022 convertible note that matures on June 15th in cash. With a strong balance sheet and disciplined approach to capital deployment, we're well-positioned to create value for our patients and shareholders by maximizing one's assets and actively pursuing innovative, highly differentiated GI assets to bolster our portfolio. Next slide. our 2022 guidance on slide 14. We are reiterating our full-year 2022 financial guidance as we remain confident in the continued strength of Linzess with expectations of double-digit prescription demand growth. While we had a strong performance in Q1 due to the previously mentioned one-time net price benefit, we continue to expect U.S. Linzess net sales growth in the low single digits for the year. As such, we continue to expect Ironwood revenue of $420 to $430 million, which includes approximately $10 million in royalty and other revenues, and adjusted EBITDA of greater than $250 million. Looking ahead, we remain focused on advancing our three strategic priorities. We have built a strong foundation, and we are excited about the opportunities ahead of us to improve the lives of GI patients and deliver shareholder value. I want to close by thanking all of our employees, patients, caregivers, and advocates for their shared dedication to advancing and supporting therapies for GI disorders. Operator, you may now open up the line for questions.
spk02: At this time, I would like to remind everyone, in order to ask a question, press star and the number one on your telephone keypad. We'll pause for just a moment to compile a Q&A roster. Your first question comes from the line of Eric Joseph. Your line is open.
spk00: Hi, good morning. This is Hannah on for Eric. Thanks for taking the questions. So just first on the pediatric opportunity for lenoxapide, you have the trial currently going on with data expected towards the end of this year. Can you talk a little bit about your expectations for the study? What would you consider as a win or label expanding data or label expansion enabling data with respect to SVM? And then on the potential design of a phase two proof of concept study for IW3300, just wondering, in general, if we might see any changes in the product candidate, either near term or down the line? Because while you're initially evaluating a suppository formulation, are there any plans to revisit that? And also, if so, what are the steps to making that happen? Thanks for taking the question.
spk06: All right, well, good morning, Hannah. Thank you for your questions. I'll hand it over to Mike Schetzlein to answer them specifically.
spk07: Yeah, thanks for the question. So the PEDS program, as you may know, was developed on the back of a Phase II study. So we did a Phase II study. It actually enrolled about 173 or so pediatric subjects between the age of 6 and 17. And those recruitment criteria for those are their own criteria. So they include the patients having to have less than three bowel movements per week based on their own criteria. So that's the inclusion criteria. Roughly when patients come into the pediatric studies, and it's not too different in the adult studies, they come in roughly with about two or so SPMs per week. So that's like the baseline. So we're looking obviously for clinical improvement and oftentimes we see somewhere a number of one to two, increase of one to two SPMs per week as a clinically meaningful benefit for patients. They're kind of the metrics, but please don't lose sight of the fact that there's currently nothing approved for pediatric functional constipation. So we really feel like there's a great opportunity, obviously data permitting, to have a discussion with the agency. Because clearly from that Phase 2 study, we did see a dose-dependent increase in the criteria around constipation, including SPMs as well as the The Bristol stool scale scored as well for stool consistency. So certainly with that data in hand, we look at the data obviously carefully with our partners at the – and look for a good discussion with the agency. But we're on track to do that in the second half of this year. So hopefully that answers that question. Maybe I'll stop there to see if that answers the PEAS question before I go to the 3,300 question. Yes, that is a good question. Okay, so for IW3300, again, we're real excited about that program because, you know, for the first time we're going to be able to test this hypothesis that's been in the medical and scientific community for decades, which is a cross-talk hypothesis. So you know sort of clinically when people have left arm pain, people worry about cardiac pain, right? That's sort of like this neuronal plasticity or this neuronal overlap that happens in all of us. That often happens in the pelvic organs. And that's what we discovered with IW3300, is as a really potent visceral hypersensitivity agent, in all the preclinical models we tested, it reduced that visceral sensitivity. And so given the colonic action of lenacletide that we know of, we're first testing the rectal administration of IW3300 just to ensure we have the adequate dose to prove this hypothesis because we'll know with the rectal administration that we're getting adequate exposure. So we certainly feel like we can achieve the dose we need the cross-talk hypothesis proves to be valid to show a real clinical improvement in the pain sensation in bladder pain syndrome patients because there's a lot of epidemiologic data that sort of correlates with IBS and bladder pain syndrome. So we think based on that, the proof-of-concept study is targeting this repository. We've always had the vision that an oral therapy would be useful in this population and probably preferred. The current chemistry really supports the opportunity for an oral formulation. Again, we're just testing the suppository because of the need to sort of prove the hypothesis in clinical subjects in order to make sure we get adequate exposure. A real interesting sideline, though, is that we've discussed this with urologists. Since there really are no good therapies currently available for bladder pain syndrome, they've actually looked positively even at the rectal formulation. So we have gotten that feedback. We do appreciate your point. But from a longer-term vision, there certainly is an opportunity for an oral formulation.
spk00: OK, great. That's very helpful. Thanks for taking my question.
spk02: Your next question. comes from the line of David Ansellum. Your line is open.
spk05: Hey, thanks. So just had a couple of questions. First, regarding business development and M&A, can you just give us a refresher on how big of a transaction you could theoretically do and what is the extent to which you would lever up? execute on a transaction. So that's number one. And just to talk philosophically about how you think about raising capital. And then secondly, I just wanted to get a refresher on the critical path items for an OTC version of linaclitide. I know it's something that's been talked about in the past, but just a refresher on, you know, what needs to happen to get to a point where there could be a low-dose OTC version of the product. Thank you.
spk06: Great. Well, thank you, David. There was some background noise, so I'll just – I think the first question is running around BD and our approach to BD and size and scale of it. The second one was around OT. staging items before we can actually achieve that. Is that correct?
spk05: That is correct. Yeah. Sorry about the background noise. Yes.
spk06: Yeah, no problem. I just want to make sure we got the questions right. Mike, why don't you address the OTC point first, and then, because I think that's probably a little simpler than the PD-1, and I'll answer that.
spk07: Yeah, so we're having ongoing discussions with our partner, AbbVie, because obviously we think there could be a huge opportunity for an OTC version of Linvest, given the fact that we have an extensive safety and tolerability database to show the drug is extremely safe and well-tolerated, as well as highly efficacious. So, we've initiated those discussions and we're progressing. We think there's an opportunity because there are regulatory metrics in that space in terms of other things like Miralax and OTC. So, we definitely think there's an opportunity. We think it may evolve around the concept of occasional constipation because you know as things transition to OTC, you've got to put them in patient-friendly language and have obviously an extensive safety database. So we think based on those precedents, based on the current data we have with Adalyn's and the medical need sort of out there, we think there's a huge opportunity. We are initiating those discussions and things are going well, and we can give you more details as they materialize.
spk04: Mike, maybe you could take – hi, this is Tom. Maybe you could take a minute and talk a little bit about the whole issue of the box learning and why that's kind of a key step as we move forward. The team's made tremendous progress already. Kind of what is the path forward to get that result?
spk07: Yes, certainly. So obviously, again, as I mentioned, the safety and tolerability is a key element for the OTC approach. And as you know, last year, we had a great milestone event with the agency in the removal of a large majority of what was the warning and contraindication present on the prior LNZEFS label. So the prior label actually included all pediatric population subjects 18 and under. Through the last years of our post-marketing studies in pediatric patients, we've generated a significant amount of data in pediatric patients, primarily along the ages of age 2 to 18. As you know, we've done a study in IBS patients from 7 to 17. We've done a study in functional constipation in patients 6 to 17, and we've also recently completed a functional constipation study in 2- to 5-year-olds. We submitted all that data to the agency, and in their review, when we submitted that, we also proposed a modification to the warning and contraindication. And the agency was very supportive, and that's what got the current label, which really only restricts in two years and below age category. Please note, we're currently not approved for pediatric patients. This was actually based on the warning language that was originally proposed in the label that was based on preclinical data, not clinical data. So with this delivery of clinical data in the two-year-olds to 18-year-olds, we were able to drastically remove a lot of the language in that population, but it still remains for two and below. And we think that's critical, obviously, because the goal eventually is to remove the entire warning. And we do think, going forward, as we generate more data in the pediatric population, we'll have ongoing discussions with the agency, and we do look at that as quite possible because the real point here is that we've now disproven what was a theoretical risk based on preclinical data at launch with the significant amount of pediatric data we have, which was that pediatric patients might be sensitive to GCC agonists and have an adverse event with over secretion or dehydration and really bad, morbid diarrhea. And we have not seen that in pediatric patients. In fact, what we've seen is that the doses needed in pediatric subjects are actually akin to what we use in adults. That's why the dose we're focusing on in the functional constipation study is actually 72 micrograms for that phase three program.
spk06: Great. And with respect to our business development activities, I'd say we're very focused on creating value here for shareholders at Ironwood. The bar for pursuing a transaction, from our perspective, is very high. As you're pretty much well aware, David, in this environment, from a market perspective, capital and cash preservation is very important. We feel very... We take this stewardship of the fact that we have $250 million this year or so, even doubt that we're going to produce roughly $600 million of cash on our balance sheet. We want to be good stewards of all of that. And look, I think our approach is to be value investors. If we can find opportunities in a market that's potentially dislocated to create value, we'll do it. But I think it requires – it's got to really work for us. And I think you've seen commentary from other CEOs during the recent two weeks of earnings calls talking about where expectations are from sellers and how they potentially haven't moderated yet. And so I would just point you to that. From a size and scale perspective, I would also say, look, it really just depends whether or not we see value. It depends on opportunity set and whether or not we think we have the right capabilities to execute.
spk04: I think the other thing Trevor might want to comment and maybe Mike comment, we're seeing a lot of opportunities and attractive opportunities. I mean, C&P 104 is a classic example of a potential game changer in a very high unmet need market where we could really make a difference in the marketplace and certainly to make a difference for ironwood so i think we're encouraged with what we're seeing you know trevin has done a tremendous job with uh you know dealing with the capital markets and his expertise in the capital markets and i think you know the bottom line is you've got as streven mentioned is the bar is high and we just want to make sure we're being making very good thoughtful moves as we proceed great very helpful thanks guys thanks david
spk02: Your next question comes from the line of Tim Chang. Your line is open.
spk03: Hi, thanks. Could you talk a little bit more about this pediatric study? How many patients have you enrolled in this pediatric study? And I'm sort of wondering, you know, assuming the data is positive, would this data – would you go to the FDA and see if the data – could be leveraged to remove the black box warning from your current label in the pediatric setting? And I know it's pediatric patients less than two years of age that the black box refers to.
spk07: Yeah, so thanks for the question. Good clarification. So the current study that I'm addressing that we think can increase the clinical utility for LINDESC is the study in functional constipation in 6- to 17-year-olds. And it is a Phase III study that we designed in collaboration with the FDA with the ultimate goal of potentially submitting an SMDA for approval of functional constipation in 6- to 17-year-olds. So that is the goal. That study is currently ongoing. It's a large study because it actually includes some safety data in IBS patients, so roughly about 460 patients. A lot of details are on clincharles.gov. It's actually a 12-week study, and it's looking at the change from baseline in spontaneous bowel movements over a 12-week period using the weekly sort of average SPM frequency. And again, it's a change from baseline. So it's compared to their baseline, which is a two-week running period where they obviously have to be established with their own criteria of less than three SPMs per week. So we do think that if we could have a clinically meaningful effect and a statistically positive effect in that study, that there is a very real opportunity to have an with the agency for a label change to include an indication of functional constipation in pediatric patients. Now, that's data permitting. The study's still ongoing. We'll pull all that together in the latter half of this year. We also obviously will have to have discussions with AbbVie, but we're clearly on the same page strategically with AbbVie with that approach. That's the current focus on the functional constipation component. How that relates to the warning, we already don't have the six to 17-year-olds in the current warning, like in the current, what was the early boxed warning language. As you mentioned, and as I clarified, that only pertains to two years and below population. So we will aggregate all of our pediatric data on board to have further discussions to ultimately get that part of the label removed. All pediatric data helps, but we'll likely need to have data in the less than two-year-olds to have that discussion for complete removal.
spk03: Okay. No, that helps. Thanks for the answer, Mike.
spk02: Thank you. Your next question comes from Boris Peker. Your line is open.
spk01: Great. Many of my questions have been asked and already answered, but maybe just a little more on Linzess. I'm just curious, how much room do you think there is to cut on marketing expenses without significantly impacting revenue? I mean, is that a discussion that you're having with AbbVie in the current kind of environment?
spk06: Yeah, so Tom, do you want to try and answer that one?
spk04: Yeah, Boris, I mean, that is an ongoing discussion. You know, we have continued to throttle back, particularly on professional promotion, which is, you know, the second biggest expense line, you know, on the brand P&L. And the thing that's remarkable is the strength of the market leader position is still enabling customers the brand to grow, even though we've dramatically pulled back on personal promotion, we constantly evaluate that and we'll be taking another look at it probably mid-year to see will we continue to kind of throttle back on that expense. And I think the other piece is we're also looking at the media buy. One of the real advantages of having Appy as a partner is they have such strength with regard to media discounts, which has really helped the bottom line, but we'll continue to look at that as well. So I think there's opportunity to continue to expand the margins and make a more profitable brand, and we'll continue to refine that with our finance colleagues across the two organizations.
spk01: Great. Thank you for taking my question.
spk02: There are no further questions at this time, and that concludes today's conference call. You may now
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