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Operator
Ladies and gentlemen, thank you for standing by. My name is Sherrell, and I will be your conference operator today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals Q2 2023 Investor Update conference 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 would like to ask a question during this time, Simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to Matt Roach, Director of Investor Relations. Your line is now open.
Matt Roach
Thank you, Sherelle. Good morning and thanks for joining us for our second quarter 2023 investor update. Our press release issued this morning can be found on our website. 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 Statement slide, as well as under the heading Risk Factors in our annual report on Form 10-K in the year ended December 31, 2022, and in our subsequent 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 and not a substitute for or superior to GAAP measures. To the extent applicable, please refer to the tables at the end of our press release for reconciliation of these measures to the most directly comparable GAAP measures. During today's call, Tom McCourt, our Chief Executive Officer, We review our strategic priorities and our pipeline. And Shrevan Imani, our Chief Financial Officer, will provide an update on the commercial performance of Linzess, discuss the recent addition of apraglutide to our portfolio through our acquisition of VectorBio, and review our financial results and updated guidance. Andrew Davis, our Chief Business Officer, is available for the question and answer session following our prepared remarks. Mike Schatzlein, our Chief Medical Officer, is unable to attend today's call, as he's out for personal reasons unrelated to Ironwood's business. While we do not know how long Mike may be out, we will provide updates as appropriate. Today's webcast includes slides, so for those of you dialing in, please go to the event section of our website to access the accompanying slides separately. With that, I'll turn the call over to Tom.
Sherelle
Thanks, Matt. Good morning, everyone, and thanks for joining us today. I'm excited to provide an update on our progress on what has been a transformative quarter at Ironwood. First, I'm pleased to announce that we are increasing our full year LINZUS US NET sales and Ironwood revenue guidance based on the strong performance of LINZUS. Second, LINZUS received FDA approval to treat pediatric patients ages 6 to 17 years old for functional constipation, further expanding the clinical utility of the brand and its growth potential. Finally, we're excited to have completed the tender offer to acquire Vector Bio, including their key GLP-2 asset, epiglutide. If successful and approved, we believe epiglutide has the potential to become the new standard of care for patients suffering from short bowel syndrome with intestinal failure and achieve a billion dollars in peak net sales. We believe the continued success of lenses combined with our expanding pipeline as as well positioned to realize our vision of becoming the leading GI healthcare company. let's turn to slide six for a brief overview of our strategic priorities. First maximize lenses. Linzess continues to see robust prescription demand growth, profitability, and widespread acceptance among healthcare practitioners as a leading branded prescription treatment for adults with IBSC and chronic idiopathic constipation. In the second quarter, U.S. net sales and prescription demand both increased 9% year-over-year, demonstrating that the momentum of the brand remains strong. In June, Linzess received FDA approval for pediatric patients ages 6 to 17 for functional constipation, making Linzess the first and only prescription therapy indicator for the use in this population, which has a high unmet medical need and limited treatment options. We're extremely proud of this achievement for Ironwood, but more importantly for patients. Moving on to our second strategic priority, strengthen and progress our innovative GI portfolio. In addition to the impressive LINZUS performance in the second quarter, we also significantly enhanced our GR portfolio with the acquisition of ActiveBio. This acquisition fits squarely within our strategic framework, and we believe it represents a critical step for Ironwood to achieve our vision and deliver value to patients and shareholders. Our third strategic priority is to deliver sustained profits and generate cash flow. We expect the cash flow from Linzess will support a rapid de-levering to below two times total net debt to EBITDA ahead of the potential epiglutide commercial launch in 2025. As a GI-focused biopharma with strong cash flow generation, we believe we are well positioned to maximize Linzess growth and continue to advance our pipeline programs to create the next growth horizon for the company. Next, I'll review our pipeline programs, which you can see on slide 7. I'll start with an update on the timing of the top-line data for the STARS Phase III clinical program of afraglutide and short bowel syndrome intestinal failure, which continues to be our primary focus in the VECTIV-BIO pipeline and the expected value driver from the acquisition. We recently completed enrollment of the STARS phase three trial with 164 patients suffering from short bowel syndrome with intestinal failure. It is the largest GLP-2 study ever conducted in short bowel syndrome with intestinal failure. A big congratulations to the entire STARS clinical team and the entire organization for this tremendous accomplishment. Given the medical need and the interest of patients, We elected to enroll all screen patients that made it successfully through the star studies screening process in honor of their commitment to participate in the clinical trial, allowing for more global diversity, which we believe is beneficial to both patients and the global development program. We expect the addition of these patients will now result in a top line readout for the stars phase three in March 2024. In addition, apraglutide for short bowel syndrome and testicle failure receive fast-track designation, which is designed to expedite development of treatments for patients with limited treatment options and can lead to earlier drug approval and faster access. Apiglutide's FAST-TRACK designation further reinforces our conviction in the clinical development program based on the unmet medical need and the potential benefit for patients suffering from short bowel syndrome with intestinal failure, which remains on track for a potential launch in 2025. We look forward to providing additional updates as the study continues to advance. In addition to evaluating apiglutide for short bowel syndrome with intestinal failure, We are also evaluating the asset as a potential treatment for patients with graft-versus-host disease, or GBHD. Graft-versus-host disease is immunologically mediated and occurs in individuals with allogenic hematopoietic stem cell transplantation where donor immune cells react against the host recipient. The gastrointestinal tract is among the most common sites that is affected by GVHD and severe manifestations of GVHD if the gut portends poor prognosis in patients after stem cell transplant. We are currently executing a proof of concept phase two study, which is going well, and recently completed a preplanned interim analysis. The interim analysis supported continuing the study without any changes. Given the recent acceleration in recruitment of the study, we expect a complete recruitment in the near term, and we expect data on the complete study in the first quarter of 2024. Now, the CMP104 for the potential treatment of primary biliary cholangitis. The proof of concept study is ongoing, and given the strong science underlying this therapy, we plan to assess T cell response in patients dose with CMP104 in the second half of 2023. This will inform the timing of the top line data and potential option exercise. We expect to provide an update on the program at that time. We're excited about CMP104 because it is truly precision medicine and it introduces a potentially new game-changing asset for PBC patients. as there are no therapies on the market today that address the root cause of the autoimmune destruction of bile ducts in PBC. Moving to IW3300, a wholly owned ironwood asset for the potential treatment of interstitial cystitis and bladder pain syndrome. There is a significant unmet need in this area, as this chronic condition affects millions of America. Yet, there are very few treatment options currently on the market or in development. We are currently executing a proof of concept phase two study, which is progressing as planned. We're excited about this program as it is the first time the crosstalk hypothesis will be tested in humans. We are proud to be on the forefront of the clinical development in this area. Before I turn the call over to Shravan, I want to acknowledge all the Ironwood employees, including our newest colleagues who have joined us for Vector Bio who have continued the momentum and strong execution against their strategic priorities as we pursue our mission to help make a remarkable impact in patients' lives. Trevin, over to you.
Matt
Thanks, Tom. And good morning, everyone. I'm happy to provide additional details on what was a very exciting and transformative quarter for Ironwood, starting on slide nine. As Tom mentioned a few moments ago, both Linzess U.S. Net Sales and prescription demand grew 9% year-over-year. This strong growth was driven in part by a 15% increase in new-to-brand prescriptions year-over-year, reinforcing that patients and healthcare professionals continue to choose LensS in a growing market. We believe the strong demand momentum for LensS is a result of high treatment satisfaction with both patients and healthcare professionals, combined with the support of class-leading formulary access. guideline recommendations, and focused commercial execution. In addition, as previously mentioned, Linzess was granted a new indication in June for the treatment of functional constipation, which affects roughly six million patients ages six to 17 years old in the United States. Since the FDA approval, our talented sales team has been in the field educating customers. Thus far, feedback has been very positive, and healthcare professionals are excited by the ability to prescribe Linzess to help this new patient population. In early July, we also began promoting Linzess to pediatric gastroenterologists in specific geographies and will assess future promotional expansion based on market response from these efforts. We look forward to providing updates later in the year as we gain more insight into this opportunity, which will help inform optimal investment and the net sales potential in 2024. Moving on to our acquisition of Vective Bio on slide 10. We are thrilled to have apraglutide as part of our GI portfolio for the following reasons. We have high conviction in apraglutide's clinical program in the short bowel syndrome with intestinal failure based on its mechanism of action, designed for enhanced potency, extended half-life, and unique convenience of weekly dosing. as well as the compelling data-to-date. In addition, the novel design of the ongoing Phase III study is set up to evaluate efficacy in both short bowel syndrome with intestinal failure, patient populations, which are stoma and colon incontinuity. As a company with a strong network in the GI community, we believe Ironwood is best positioned to maximize the potential value of AfroGlutide for patients and shareholders by leveraging our existing expertise in clinical development, regulatory, medical affairs, and commercial execution, as evidenced by the blockbuster success of Linzess. We believe we will drive significant operating leverage through Ironwood's existing commercial capabilities to support a potential commercial launch in 2025, if approved. As I mentioned earlier, we believe Apple Gutide has the potential to achieve $1 billion in peak net sales and significantly expand the treated patients in short bowel syndrome with intestinal failure based on the asset's unique properties. This acquisition has the potential to create an attractive financial profile for Ironwood over the long term, with apriclutide providing a significant catalyst to extend Ironwood's growth horizon through the 2030s. Additionally, I'd like to provide a brief update on where we are with the VectiveBio transaction closing and the integration. As we previously announced at the end of June, we successfully completed the tender offer to purchase the outstanding ordinary shares of VectiveBio for $17 per share in cash, with 98% of the shares being tendered. Following the completion of the tender offer, we began collaborating with our new colleagues and integrating Ironwood and VectiveBio business operations, which is progressing well. we are taking the necessary steps to effect squeeze out merger under Swiss law to acquire the remaining 2% effective bio shares. We expect this process to be completed during the second half of 2023. We will provide additional updates and subsequent filings as steps in this process are completed. Next, I'll provide additional details on our financial performance for the quarter. As shown on slide 11, U.S. net sales were $270 million in the second quarter of 2023, an increase of 9% year-over-year. Net sales growth was driven by Linzess prescription demand growth of 9%. Second quarter net price was favorable as compared to our previously communicated full-year mid-single-digit net price erosion guidance due to favorable channel mix, turning to Linzess brand profitability. Commercial margins in the second quarter of 2023 were 71%, compared to 69% in the second quarter of 2022. Moving to Ironwood revenues. In the second quarter of 2023, Ironwood revenues were $107 million, driven primarily by U.S. and LINSS collaboration revenues of $105 million. Ironwood recorded $13 million of income tax expense in the second quarter, the majority of which was non-cash. We completed two restructurings in the second quarter of 2023. In April, as previously disclosed, we reduced our workforce by approximately 10% of our headquarters-based personnel. And in June, Ironwood commenced the elimination of certain positions in connection with the Vective Bio acquisition. Ironwood recorded $13 million of restructuring expenses and adjustments, primarily comprised of employee severance, benefits, and related costs in the second quarter. In the second quarter, Ironwood recorded $1.8 million in interest expense and other financing costs and generated $8.8 million in interest and investment income. Gap net loss was $1.1 billion, and adjusted EBITDA was a loss of $1 billion in the second quarter, driven by a one-time charge of approximately $1.1 billion related to Duke. acquired in-process research and development from the VectiveBio acquisition. In the second quarter, we generated approximately $35 million in cash flow from operations and ended the quarter with $175 million in cash and cash equivalents. The acquisition of VectiveBio was funded through proceeds from a revolving credit facility, cash on hand, and cash of VectiveBio. Moving forward. We continue to maintain our focus on generating sustained profits and meaningful cash flows, while now having the potential to extend our growth horizon through the 2030s. We expect to generate greater than $175 million in operating cash flows each year ahead of a potential apriclutide commercial launch, if successful and approved in 2025. Additionally, the acquisition of EktiveBio is expected to be accretive to earnings per share beginning in 2026, And assuming no additional business development activities, we expect adjusted EBITDA to return to greater than $250 million by the end of 2025. We anticipate total net debt to EBITDA for our revolving credit agreement of approximately three times by the end of 2023. And we expect cash flows from Linzess will support a rapid delevering to below two times total net debt to EBITDA out of a potential commercial launch in 2025. Moving forward, we will continue to prioritize investments to maximize the value of LINZ-S, progress our development portfolio, and manage our capital structure through debt paydown. We will maintain the flexibility to evaluate additional opportunities for capital development. Next, I'll review our updated 2023 guidance on slide 13. As a result of the continued strong performance of LINZ-S through the first half of the year, we are increasing our full-year U.S. LINZAS net sales and Ironwood revenue guidance. We now expect LINZAS U.S. net sales growth of between 6% and 8%, driven by continued strong prescription demand growth and an improved pricing outlook for the remainder of the year. Accordingly, we now expect Ironwood revenue between $435 to $450 million. We are also revising our adjusted EBITDA guidance to reflect the acquisition of ActiveBio. We now expect a loss of approximately $900 million, which includes a one-time charge of approximately $1.1 billion from the acquisition. Excluding the impact of the one-time charge, adjusted EBITDA is an approximate representation of our operating cash flows. To wrap up, We had a strong second quarter and first half of the year. We believe we have strengthened our position to become the leading GI healthcare company. We are well-positioned for continued growth, and we remain focused on maximizing one's efforts, strengthening and progressing our innovative GI portfolio, and delivering sustained profits and generating cash flow. We are excited about the several key development milestones ahead of us, and we'll continue to keep you updated on our progress in the second half of the year. 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.
Operator
At this time, I would like to remind everyone, in order to ask a question, press star then the number one on your telephone keypad. we will pause just for a moment to compile the Q&A roster. Your first question comes from the line of Tim Chang with Capital One. Your line is now open.
Tim Chang
Hi, thanks. I've just got a few questions. I think maybe the first question is on the improved pricing for Linzess. Could you just sort of comment on you know, what the dynamics are for Linzess in the second half of the year, you know, how things have changed a little bit from the first half of the year for Linzess?
Matt
Yeah, so thanks, Tim. Good to hear from you. So I think, you know, from a pricing perspective, the first few quarters, we've experienced favorable pricing relative to our initial guidance and expectations. And I think as we disclose, that's due to favorable channel mix. First half pricing trends have improved our outlook for the full year. And as you can imagine, when you have the volume of Linzess, a slight shift in the mix is going to have meaningful change. And so I think that's essentially where we're at.
Tim Chang
Got it. And then maybe just a follow-up on apraglutide. I mean, obviously, you've adjusted the timeline for the top-line readout. Is there any change and is it really just screening related? Is that the reason for the push out on the release of data?
Matt
Yeah. So, I think all we said is we... I think the key here, Tim, is that we elected and enrolled all the patients that made it successfully through the STARS study and the screening process. And so, as Tom mentioned, we have a commitment to those patients and a commitment to those sites. And in order to maintain the global diversity of the trial, we believe this is beneficial for the patients and our overall global development opportunity. And so we're excited that the trial enrollment is completed, and we've got 164 patients. And with that, I think we'll have something to report out the first quarter of next year.
Sherelle
Tim, this is Tom. I think, you know, this is a discussion that we had, obviously, with the VECTIV team. And, you know, the process of screening these patients is pretty robust and challenging. And we're asking patients to go through an awful lot during the screening process. So we felt obligated to really include them into the trial. We felt it was absolutely the right thing to do. We had good alignment with VECTIV on that. Plus, it certainly strengthens the overall diversity of the study as we think about a global program, as we think about the future filings of the product. So, we are absolutely delighted with where the program's at. Certainly, everything looks, you know, right where it needs to be, and I think we have great conviction and confidence in the clinical development program at this point.
Matt
And two final points on top of that, which is, one, you know, that it's an extra 20 patients in the trial and study. Notwithstanding the extra 20 patients, we still expect to have a 2025 launch, and there's no impact from our perspective on the timing of our commercial launch.
spk08
Okay. Got it. The details are very helpful. Thanks.
Operator
Your next question comes from the line of Boris Peeker with T.D. Cohen. Your line is now open.
Boris Peeker
Good morning, and congratulations on Strongland's S results.
Matt
Thanks, Boris.
Boris Peeker
I guess I just have two questions, one on Linzess and the other one on the GLP-2. So on Linzess, can you comment where the sales growth is coming from? Is there a particular demographic that you're seeing expansion, uptake, or maybe any kind of specific type physician, general practitioners versus GI docs? Or is this kind of across the board? And on the GLP-2 side, my question is, is What are your thoughts on the generic gap tax? Why we haven't seen one and when we may be seeing one?
Linzessa
Thanks. Andrew, why don't you kind of take the first practice? Yeah. So on that first question on Linzess, it's really across the board that we're seeing growth. And so we're excited by that. And as we said in the remarks, I think we're seeing continued growth in the market and we're continuing to see physicians choose Linzess when those patients present.
Sherelle
I mean... I think part of that, too, is certainly the pediatric indication was a strong endorsement of the overall profile of the drug, which I think has a significant halo effect. I'm sure we'll better understand what we think the upside potential is for pediatrics. It's still early. But Andrew and the team are really evaluating how promotional responsive this is to really understand how hard we can push or how hard we should push on the investment side. But I think this is, I mean, as you know, it continues to be a remarkable drug to see this kind of linear growth and even acceleration in growth, particularly with the new to brand. To see a 15% increase in new-to-brand at this point on the base business that we have, this is pretty remarkable.
Matt
Yeah, and so we're just seeing these new patients continue to care, and then I think the other piece is a strong profile remains the same, right, clinically. Huge patient satisfaction. I think the things that have made Linzessa a success over the last 11 years for us, I think have continued here. And then, Andrew, do you want to take a crack at the GADX question as well?
Linzessa
Yeah. So on generic GADX, I mean, tough to say what's going through another pharmaceutical manufacturer's mind on what they're doing strategy-wise. But at the end of the day, you know, peptides are not always easy drugs to make and easy drugs to bring to market. I think there's a number of kind of market dynamics for generic to make it challenging. So we haven't seen it yet. I think maybe not the most unexpected outcome for us at this
Sherelle
Yeah, and of course, I mean, as far as we're concerned, that's nothing but good news. You know, when you look at kind of work addicts and when you look at the profile of apraglutide with regard to its potency and its half-life, I mean, this really could be a significant advancement in care for patients.
Boris Peeker
Great. Well, congratulations again, and thanks for taking my questions.
Sherelle
Thanks, Boris. Thanks, Boris.
Operator
Your final question comes from the line of David Amsler from Piper Sandler. Your line is now open.
David Amsler
Hey, thanks. So on the GATEX generic question, I know it's hard to make. It's a peptide and all that. But I guess my question here is, to the extent that GATEX does lose exclusivity, how are you thinking about payer dynamics for apobutide? How are you thinking about pricing? for apraglutide. So just help us understand the commercial implications of a loss of excessivity for GATEX. And then secondly, for the Stargaze study in acute graft versus host, to the extent that you do have proof of concept, is that something you intend to take forward or is that something you'd look to partner out given that it's outside the GI realm? How are you thinking about that? Thank you.
Linzessa
Yeah. Andrew, why don't you start with the first one? So on the generic GATTX question, I think maybe it's a little bit early in where we are in terms of for us to specifically guide on price. But I think I can say that this is certainly something that we considered and modeled out when we did the transaction. So regardless of if there's a GATTX generic or there's not, I think we feel quite comfortable about the investment we've made here and the strong opportunity there is for Apple Glutide in the future.
Matt
And with respect to the Stargaze trial, look, I think where we're at is we just recently – complete the pre-planned interim analysis, and that's supported continuing the study without any changes. Where we are with the study and the recruitment, we'll probably, as Tom mentioned, we'll have something in the first quarter to kind of report out in terms of data. And at that point in time, I think, depending on where the trial is, I think we'll, and what the data says, we'll evaluate options.
Sherelle
Yeah, I think the big part here is, you know, where is the greatest opportunity for value creation? And obviously, that's something, you know, that we'll critically assess. I mean, I don't think we're at this point we're tied to any specific outcome. We'll evaluate. I think a lot of it has to do with what the profile ends up looking like as to, you know, how, you know, how assertive we would be in this space. but I think you know we're very data-driven, we're very evidence-driven, and we'll certainly make a good choice. This is a huge unmet medical need. Keep in mind the biggest problem here is the GI problems associated with this. When that occurs, obviously the GI community is involved and consulted, so they certainly would play a role.
spk01
even though they don't directly often care for these patients they're often consulted on these patients yes ladies and gentlemen that concludes today's call thank you all for joining you may now disconnect
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