Q1 2026 Ironwood Pharmaceuticals Inc Earnings Call

May 7, 2026

Speaker #1: IRONWOOD PHARMACEUTICALS, first quarter 2026 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.

Operator 1: Pharmaceuticals Q1 2026 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. Thank you. I would now like to turn the call over to Gregory Martini, Chief Financial Officer. Please go ahead.

Speaker #1: If you would like to ask a question during this time, simply press star followed by the number 1 on your telephone keypad. If you would like to withdraw your question, press star 1 again.

Speaker #1: Thank you. I would now like to turn the call over to Greg Martini, Chief Financial Officer. Please go ahead.

Speaker #2: Good morning and thank you for joining us for our first quarter 2026 investor update. Our press release issued this morning can be found on our website.

Gregory Martini: Good morning, and thank you for joining us for our Q1 2026 investor update. Our press release issued this morning can be found on our website. Today's call and accompanying slides include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 for the year ended 31 December 2025, 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.

Speaker #2: Today's call and accompanying slides include forward-looking statements within the meaning of the private securities litigation reform act of 1995. Such statements involve risk, uncertainties that may cause actual results to differ materially.

Speaker #2: A discussion of these statements and risk factors is available on the current Safe Harbor Statements slide, as well as under the heading Risk Factors in our annual report on Form 10-K for the year ended December 31, 2025, and in our subsequent SEC filings.

Speaker #2: All forward-looking statements speak as of the date of this presentation, and we undertake no obligation to update such statements. All 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.

Gregory Martini: 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 reconciliations of these measures to the most directly comparable GAAP measures. During today's call, Tom McCourt, our Chief Executive Officer, will begin with a brief overview. Tammi Gaskins, our Chief Commercial Officer, will provide a commercial update, including discussion of the commercial opportunity for apraglutide in Short Bowel Syndrome with Intestinal Failure. Michael Shetzline, our Chief Medical Officer, will discuss our pipeline. I will review our financial results and guidance. Today's webcast includes slides. For those of you dialing in, please go to the Events section of our website to access the accompanying slides separately. With that, I'll turn the call over to Tom.

Speaker #2: 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 GAAP measures.

Speaker #2: During today's call, Tom McCourt, our Chief Executive Officer, will begin with a brief overview. Tammy Gaskins, our Chief Commercial Officer, will provide a commercial update, including discussion of the commercial opportunity for Aperglutide in short bowel syndrome with intestinal failure.

Speaker #2: Mike Shetzline, our Chief Medical Officer, will discuss our pipeline, and I 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.

Speaker #2: With that, I'll turn the call over to Tom.

Speaker #3: Good morning, everyone, and thanks for joining us today to review our first quarter 2026 financial guidance results and business updates. Earlier this year, we laid out our top priorities for 2026, which are maximizing Linzess, advancing Aperglutide, and delivering sustained profits and cash flow.

Tom McCourt: Good morning, everyone, thanks for joining us today to review our Q1 2026 financial guidance, results, and business updates. Earlier this year, we laid out our top priorities for 2026, which are maximizing LINZESS, advancing apraglutide, and delivering sustained profits and cash flow. We believe these priorities are key to achieving our goals of redefining standard of care for patients suffering from GI and rare diseases while maximizing shareholder value. During the Q1, we made significant progress on each of these priorities. First, LINZESS, which continues to be the prescription leader for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation in its 14th year on the market. We reported an outstanding Q1 financial performance with 97% year-over-year net sales growth for LINZESS, driven primarily by improved net price and supported by 5% prescription demand growth.

Speaker #3: We believe these priorities are key to achieving our goals of redefining standard of care for patients suffering from GI and rare diseases, while maximizing shareholder value.

Speaker #3: During the first quarter, we made significant progress on each of these priorities. First, Linzess. Which continues to be the prescription leader for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation, in its 14th year on the market.

Speaker #3: We reported an outstanding first quarter financial performance, with 97% year-over-year net sales growth for Linzess, driven primarily by improved net price and supported by 5% prescription demand growth.

Speaker #3: These first quarter results position us well to achieve our full year 2026 financial guidance. Which will return Linzess to blockbuster status. And we'll set a new all-time high for annual US net sales for the brand since launch.

Tom McCourt: These Q1 results position us well to achieve our full year 2026 financial guidance, which will return LINZESS to blockbuster status and will set a new all-time high for annual US net sales for the brand since launch. We are also continuing to make progress in bringing LINZESS to younger age groups. In Q1, the FDA accepted a supplementary new drug application for LINZESS for the treatment of functional constipation in patients 2 to 5 years of age. The application received a priority review with a PDUFA target action date set for 24 May 2026. At present, LINZESS is the only FDA-approved drug for the treatment of children 7 years and older with irritable bowel syndrome with constipation and for children 6 to 17 years old for functional constipation.

Speaker #3: We are also continuing to make progress in bringing Linzess to younger age groups. In the first quarter, the FDA accepted a supplementary new drug application for Linzess for the treatment of functional constipation in patients 2 to 5 years of age.

Speaker #3: The application received a priority review with a PDUFA target action date set for May 24, 2026. At present, Linzess is the only FDA-approved drug for the treatment of children 7 years and older with irritable bowel syndrome with constipation, and for children 6 to 17 years old for functional constipation.

Speaker #3: If approved, the indication in children 2 to 5 years old for the treatment of functional constipation would further broaden the clinically utility of Linzess in younger age groups.

Tom McCourt: If approved, the indication in children two to five years old for the treatment of functional constipation would further broaden the clinical utility of LINZESS in younger age groups, and we look forward to hearing from the FDA in the coming weeks. Also in Q1, we advanced our STARS-II confirmatory phase III clinical trial assessing apraglutide for the treatment in patients with short bowel syndrome with intestinal failure, including completion of the clinical site feasibility, and we remain on track for the clinical site initiation in Q2. This past weekend, we had a chance to present findings at Digestive Disease Week meeting in Chicago from the landmark survey, which underscored the need for therapies that address multiple dynamics dimensions of the burden of total parenteral nutrition based on real-world experience of patients suffering from short bowel syndrome with intestinal failure.

Speaker #3: And we look forward to hearing from the FDA in the coming weeks. Also in the first quarter, we advanced our STARS II confirmatory phase III clinical trial.

Speaker #3: Assessing Aperglutide for the treatment in patients with short bowel syndrome with intestinal failure, including completion of the clinical site feasibility and we remain on track where the clinical site initiation in the second quarter.

Speaker #3: This past weekend, we had a chance to present findings at Digestive Disease Week meeting in Chicago, from the landmark survey which underscored the need for therapies that address multiple dynamics that dimensions of the burden of total parenteral nutrition based on real-world experience of patients suffering from short bowel syndrome with intestinal failure.

Speaker #3: The survey identified the reduction in days of total parenteral nutrition as the top priority for patients. At DDW, we also presented an additional data from the long-term extension study of Aperglutide showing a long-term safety profile consistent with previous studies.

Tom McCourt: The survey identified the reduction in days of total parenteral nutrition as a top priority for patients. At DDW, we also presented additional data from the long-term extension study of apraglutide showing a long-term safety profile consistent with previous studies. Dr. Michael Shetzline, our Chief Medical Officer, will share more details of these data later in the call. Finally, in Q1, we delivered strong profits with $40.8 million in GAAP net income and $76.7 million in adjusted EBITDA. Looking ahead for the year, we believe the cash flows from LINZESS will continue to fund development and commercialization of apraglutide, if approved, while simultaneously reducing our debt. With that, I'll hand the call over to our Chief Commercial Officer, Tammi Gaskins, for a LINZESS commercial update and an overview of the opportunity in Short Bowel Syndrome with apraglutide. Tammi?

Speaker #3: Dr. Mike Shetzline, our Chief Medical Officer, will share more details of these data later in the call. Finally, in the first quarter, we delivered strong profits.

Speaker #3: With 40.8 million in GAAP net income and 76.7 million in adjusted EBITDA. Looking ahead for the year, we believe the cash flows from Linzess will continue to fund development and commercialization of Aperglutide if approved, while simultaneously reducing our debt.

Speaker #3: With that, I'll hand the call over to our Chief Commercial Officer, Tammy Gaskins, for a Linzess commercial update and an overview of the opportunity in short bowel syndrome with Aperglutide.

Speaker #3: Tammy?

Speaker #4: Thanks, Tom, and good morning, everyone. As Tom highlighted, the first quarter US net sales of 272.5 million dollars for Linzess represent a 97% increase compared to the first quarter of 2025.

Tammi Gaskins: Thanks, Tom, and good morning, everyone. As Tom highlighted, the Q1 US net sales of $272.5 million for LINZESS represent a 97% increase compared to the Q1 2025, driven by significantly improved net price and 5% year-over-year demand growth for LINZESS. Now I'd like to share some additional context on these results. To start, improved year-over-year net price in the Q1 2026 was driven primarily by two factors. First, net price benefited from elimination of inflationary rebates across channels, including Medicaid. We expect that this benefit from reduced inflationary rebates to persist throughout 2026, as captured in our full year LINZESS US net sales guidance.

Speaker #4: Driven by significantly improved net price and 5% year-over-year demand growth for Linzess. Now I'd like to share some additional context from these results. To start, improved year-over-year net price in the first quarter of 2026 was driven primarily by two factors.

[Company Representative 2] (Ironwood Pharmaceuticals): Looking ahead for the year, we believe the cash flows from LINZESS will continue to fund development and commercialization of apraglutide for brew while simultaneously reducing our debt. With that, I'll hand the call over to our Chief Commercial Officer, Tammi Gaskins, for a LINZESS commercial update and an overview of the opportunity in Short Bowel Syndrome with apraglutide. Tammy?

Speaker #4: First, net price benefited from elimination of inflationary rebates across channels, including Medicaid. We expect that this benefit from reduced inflationary rebates to persist throughout 2026, as captured in our full-year Linzess US net sales guidance.

Looking ahead for the year, we believe the cash flows from lindus will continue to fund development and commercialization of aberlite approved. Wild simultaneously, reducing our debt,

With that, I'll hand the call over to our chief commercial officer, Tammy Haskin.

Speaker #4: The second factor that contributed to improved net price in the first quarter was fareable time phasing of gross-to-net rebate reserves as compared to the first quarter of 2025.

Tammi Gaskins: The second factor that contributed to improved net price in Q1 was favorable time phasing of gross to net rebate reserves as compared to Q1 of 2025. Looking ahead in 2026, we expect reduced variability in sequential quarterly LINZESS US net sales than occurred in 2025 as a result of more consistent net price across channels in 2026. Additionally, we recognized $104.2 million in US brand collaboration revenue in Q1 of 2026. This represents a 169% increase compared to $38.8 million in Q1 of 2025. Now, in just a minute, Greg will speak to additional Q1 of 2026 financial results.

Tammi Gaskins: Thanks, Tom. Good morning, everyone. As Tom highlighted, the Q1 US net sales of $272.5 million for LINZESS represent a 97% increase compared to Q1 2025, driven by significantly improved net price and 5% year-over-year demand growth for LINZESS. Now I'd like to share some additional context from these results. To start, improved year-over-year net price in Q1 2026 was driven primarily by two factors. First, net price benefited from elimination of inflationary rebates across channels, including Medicaid. We expect that this benefit from reduced inflationary rebates to persist throughout 2026, as captured in our full year LINZESS US net sales guidance.

For a lenses commercial update and an overview of the opportunity, in short ball syndrome with aphro glutide Tami. Thanks Tom and good morning everyone. As Tom highlighted, the first quarter us, net sales

Speaker #4: Looking ahead in 2026, we expect reduced variability and sequential quarterly Linzess US net sales than occurred in 2025, as a result of more consistent net price across channels in 2026.

272.5 million for lindvest represent a 97% increase compared to the first quarter of 20225.

Driven by significantly improved that price and 5% year-over-year.

Speaker #4: Additionally, we recognize 104.2 million dollars in US brand collaboration revenue in the first quarter of 2026, which represents a 169% increase compared to 38.8 million dollars in the first quarter of 2025.

Now, I'd like to share.

Additional context from these results to start improved year-over-year. Net price in the first quarter of 2026 was driven primarily by 2 factors.

first net price benefited from elimination of inflationary rebates across channels, including Medicaid,

Speaker #4: Now, in just a minute, Greg will speak to additional first quarter 2026 financial results. Now moving on from Linzess performance, I would like to spend a few minutes on the anticipated commercial potential of Aperglutide for SBSIF.

We expect that this.

Benefit from in.

Tammi Gaskins: Now moving on from LINZESS performance, I would like to spend a few minutes on the anticipated commercial potential of apraglutide for SBS-IF. For some context, SBS is a severe organ failure condition resulting from surgical resection of a significant portion of the small intestine, leading to a dependence on parenteral support to meet patients' nutritional needs for survival. On average, SBS-IF patients require 10 hours a day, 6 days per week parenteral support with a severe quality of life burden. Parenteral support meets patients' nutritional needs for survival, but as highlighted by the LANDMARK survey, central line infections, fatigue, central line pain, and abdominal pain are all common, highly distressing challenges associated with parenteral support, thereby underscoring the need for therapies to address multiple dimensions of total parenteral nutrition.

Tammi Gaskins: The second factor that contributed to improved net price in the Q1 was favorable time phasing of gross to net rebate reserves as compared to the Q1 2025. Looking ahead in 2026, we expect reduced variability in sequential quarterly LINZESS US net sales than occurred in 2025 as a result of more consistent net price across channels in 2026. Additionally, we recognized $104.2 million in US brand collaboration revenue in the Q1 2026. This represents a 169% increase compared to $38.8 million in the Q1 2025. Now, in just a minute, Greg will speak to additional Q1 2026 financial results.

Reduced inflationary rebates to persist throughout 2026 as captured in our full year Linds Seuss. Net sales guidance.

Speaker #4: For severe organ failure condition resulting from surgical resection of a significant portion of the small intestine. Leading to a dependence on parental support to meet patients' nutritional needs for survival.

Speaker #4: And on average, SBSIF patients require 10 hours a day, 6 days per week of parental support. With a severe quality of life burden. Parental support needs patients' nutritional needs for survival, but is highlighted by the landmark survey central line infections, fatigue, central line pain, and abdominal pain are all common highly distressing challenges associated with parental support.

The second factor that contributed to improved net price in the first quarter was favorable time phasing of gross to net rebate reserves as compared to the first quarter of 2025. Looking ahead in 2026, we expect reduced variability and sequential quarterly wins as U.S. net sales occurred in 2025, as a result of more consistent net price across channels in 2026.

Additionally, we recognize 104.2 million dollars in US brand collaboration Revenue in the first quarter of 20226 represents a 169% increase.

Speaker #4: Thereby underscoring the need for therapies to address multiple dimensions of total parental nutrition. Now, data from the STARS phase III clinical trial, which is the largest phase III trial in SBSIF conducted to date, demonstrated a twofold relative PS volume reduction from baseline at 24 weeks with Aperglutide once weekly dosing, as compared to placebo.

Tammi Gaskins: Now, moving on from LINZESS performance, I would like to spend a few minutes on the anticipated commercial potential of apraglutide for SBS-IF. For some context, SBS is a severe organ failure condition resulting from surgical resection of a significant portion of the small intestine, leading to a dependence on parenteral support to meet patients' nutritional needs for survival. On average, SBS-IF patients require 10 hours a day, 6 days per week of parenteral support with a severe quality-of-life burden. Parenteral support meets patients' nutritional needs for survival, but as highlighted by the LANDMARK survey, central line infections, fatigue, central line pain, and abdominal pain are all common, highly distressing challenges associated with parenteral support, thereby underscoring the need for therapies to address multiple dimensions of total parenteral nutrition.

Compared to 38.8 million in the first quarter of 2025. Now, just a minute, Greg will speak to additional first quarter, 2026 Financial results.

Tammi Gaskins: Now, data from the STARS phase III clinical trial, which is the largest phase III trial in SBS-IF conducted to date, demonstrated a twofold relative PS volume reduction from baseline at 24 weeks with apraglutide once weekly dosing as compared to placebo. Importantly, these longer-term data have demonstrated that more patients continued to wean off PS with longer exposure to apraglutide. In our phase III long-term extension study called STARS Extend, approximately 1 in 5, or 20% of patients, achieved enteral autonomy as of January 2025. At DDW this week, we presented new data highlighting the long-term safety profile of apraglutide, which was pulled from the STARS clinical program. It includes the phase II STARS Nutrition trial, STARS phase III trial, and the ongoing open-label extension STARS Extend trial.

now, moving on from Linda's performance, I would like to spend a few minutes on the anticipated commercial potential of Aber tide for SBS if

For some context SBS is a severe, organ failure. Condition resulting from surgical reception of a significant portion of the small intestine

Speaker #4: Importantly, these longer-term data have demonstrated that more patients continue to wean off PS with longer exposure to Aperglutide. In our phase III long-term extension study called STARS EXTEND, , approximately one in five or 20% of patients achieved enteral autonomy as of January 2025.

leading to a dependence on Parental support to meet patients. Nutritional needs for survival and on average SPS if patients require 10 hours a day, 6 days per week of Parental support,

With a severe quality of life burden.

Speaker #4: At DDW this week, we presented new data highlighting the long-term safety profile of Aperglutide that was pulled from the STARS clinical program that includes the phase II STARS nutrition trial, STARS phase III trial, and the ongoing open-label extension STARS EXTEND trial.

Parental support needs patience, nutritional needs for survival, but is highlighted by The Landmark survey survey central line, infections fatigue, central line pain and abdominal pain are all common, highly distressing challenges associated with parental support.

Tammi Gaskins: Now, data from the STARS phase III clinical trial, which is the largest phase III trial in SBS-IF conducted to date, demonstrated a twofold relative PS volume reduction from baseline at 24 weeks with apraglutide once weekly dosing as compared to placebo. Importantly, these longer-term data have demonstrated that more patients continued to wean off PS with longer exposure to apraglutide. In our phase III long-term extension study called STARS Extend, approximately 1 in 5 or 20% of patients achieved enteral autonomy as of January 2025. At DDW this week, we presented new data highlighting the long-term safety profile of apraglutide, which was pulled from the STARS clinical program. It includes the phase II STARS Nutrition trial, STARS phase III trial, and the ongoing open label extension STARS Extend trial.

Thereby underscoring the need for therapies to address multiple dimensions of total parental nutrition.

Speaker #4: These data for Aperglutide showed a long-term tolerability and safety profile consistent with previous studies, low discontinuation rates due to treatment emerge in adverse events, and no new safety observations.

Tammi Gaskins: These data for apraglutide showed a long-term tolerability and safety profile consistent with previous studies, low discontinuation rates due to treatment emergent adverse events, and no new safety observations. Based on the clinical data generated to date, we believe that apraglutide has the potential to reduce volume and days on parenteral support for patients with SBS-IF. Turning from data, let's look at the market size. We estimate that there are roughly 18,000 SBS-IF patients across the US, Europe, and Japan. Within that patient population, we estimate that there are more than 8,000 patients in the US with SBS-IF who are dependent on parenteral support for 3 or more days a week. This group of patients dependent on parenteral support 3 or more days per week represents the total addressable SBS-IF market of more than $4 billion in the US.

Speaker #4: Based on the clinical data generated to date, we believe that Aperglutide has the potential to reduce volume in days on parental support for patients with SBSIF.

Now data from the Star says 3 clinical trial, which is the largest phase 3 trial in SPS. If conducted to date demonstrated a 2-fold relative, PS volume reduction from Baseline at 24 weeks with aberi Once weekly dosing has compared to placebo.

Speaker #4: Now, turning from data, let's look at the market size. We estimate that there are roughly 18,000 SBSIF patients across the US, Europe, and Japan.

Importantly, the longer term data has demonstrated that more patients continue to clean off the S with longer exposure to advertise.

Speaker #4: Within that patient population, we estimate that there are more than 8,000 patients in the US with SBSIF who are dependent on parental support for three or more days a week.

And our phase 3, long-term extension study called Stars, extend, approximately 1 in 5 or 20% of patients achieved entral, autonomy, as of January 2025.

At DDW this week, we presented new data highlighting the long-term safety profile of a Blue Tide.

Speaker #4: This group of patients, dependent on parental support three or more days per week, represents a total addressable SBSIF market of more than $4 billion in the US.

Tammi Gaskins: These data for apraglutide showed a long-term tolerability and safety profile consistent with previous studies, low discontinuation rates due to treatment emergent adverse events, and no new safety observations. Based on the clinical data generated to date, we believe that apraglutide has the potential to reduce volume and days on parenteral support for patients with SBS-IF. Now, turning from data, let's look at the market size. We estimate that there are roughly 18,000 SBS-IF patients across the US, Europe, and Japan. Within that patient population, we estimate that there are more than 8,000 patients in the US with SBS-IF who are dependent on parenteral support for 3 or more days a week. This group of patients dependent on parenteral support 3 or more days per week represents the total addressable SBS-IF market of more than $4 billion in the US.

Pulled from the STARS clinical program, that includes the Phase 2 STARS Nutrition trial, STARS Phase 3 trial, and the ongoing open-label extension STARS Extend trial.

Speaker #4: Based on Aperglutide's clinical profile and our market research, we believe that Aperglutide has the potential to increase the number of GLP-2 treated patients, extend days on therapy, and achieve greater than 700 the US.

Tammi Gaskins: Based on apraglutide's clinical profile and our market research, we believe that apraglutide has the potential to increase the number of GLP-2 treated patients, extend days on therapy, and achieve greater than $700 million in peak net sales in the US. With that, I'll turn the call over to Michael Shetzline, our Chief Medical Officer, to discuss apraglutide's ongoing clinical development. Michael?

These data for a blue tide showed a long-term, tolerability and safety profile. Consistent with previous studies low discontinuation rates due to treatment emergent Adverse Events and no new safety observations.

Speaker #4: With that, I'll turn the call over to Mike Shetzline, our Chief Medical Officer, to discuss Aperglutide's ongoing clinical development. Mike?

Based on the clinical data generated to date, we believe.

The appropriate tide has potential to reduce volume in DayZ on Parental support for patients with SPS.

Speaker #5: Thanks, Tammy. And good morning, everyone. As you've heard today, we're very excited about the opportunity to help our patients with SBSIF and have generated strong clinical data some of which Tammy highlighted through our STARS and STARS EXTEND trials.

Michael Shetzline: Thanks, Tammi, good morning, everyone. As you've heard today, we're very excited about the opportunity to help more patients with SBS-IF and have generated strong clinical data, some of which Tammi highlighted through our STARS and STARS Extend trials. Over the past few months, we've made significant progress as we move towards site initiation of our confirmatory phase III trial, STARS-II, this quarter. STARS-II is designed based on our interactions with the FDA to confirm and further support the positive data generated in the STARS phase III clinical trial. We plan to enroll 124 patients with SBS-IF in a 1-to-1 randomization. Enrollment will be for the overall SBS-IF patient population, which includes patients with both stoma and colon-in-continuity.

Now, turning from data. Let's look at

The market size.

We estimate that. There are roughly 18,000 SP.

Speaker #5: Over the past few months, we've made significant progress as we move towards site initiation of our confirmatory phase III trial, STARS II, this quarter.

if patients across the US Europe and Japan within that patient population, we estimate that there are more than 8,000 patients in the US with SPS if

Support for 3 or more days a week?

Speaker #5: STARS II was designed based on our interactions with the FDA to confirm and further support the positive data generated in the STARS phase III clinical trial.

Tammi Gaskins: Based on apraglutide's clinical profile and our market research, we believe that apraglutide has the potential to increase the number of GLP-2-treated patients, extend days on therapy, and achieve greater than $700 million in peak net sales in the US. With that, I'll turn the call over to Michael Shetzline, our Chief Medical Officer, to discuss apraglutide's ongoing clinical development. Michael?

This group of patients dependent on Parental support through or more days per week, represents the total addressable SPS if Market of more than 4 billion dollars in the US.

Speaker #5: We plan to enroll 124 patients with SBSIF in a one-to-one randomization enrollment will be for the overall SBSIF patient population. Which includes patients with both stoma and colon incontinuity.

Based on aberle clinical profile and our market research. We believe that AER. Glutide has the potential to increase the number of glp 2 treated patients.

Extend days on therapy and Achieve greater than 700 million Peak. Net sales in the US.

Speaker #5: Our primary endpoint for the study will be the same as our prior STARS phase III clinical trial. Evaluating relative parental support volume change from baseline for the overall population at week 24.

Michael Shetzline: Our primary endpoint for the study will be the same as our prior STARS Phase III clinical trial, evaluating relative parenteral support volume change from baseline for the overall population at week 24. Secondary endpoints, also to be measured at week 24 for the overall population, include clinical response, defined as a 20% reduction in parenteral support volume, number of days off parenteral support per week, and enteral autonomy. In designing the phase II trial, we've incorporated feedback from our prior FDA interactions and leveraged learnings from the positive STARS Phase III trial. In preparing for the STARS 2 trial, we've taken steps to refine and optimize the dose administration instructions. A key consideration in designing STARS 2 was the dose selection, which we intended to confirm the efficacy and tolerability demonstrated in STARS, with patients receiving 3.5 mg once weekly of apraglutide.

Michael Shetzline: Thanks, Tammy, and good morning, everyone. As you've heard today, we're very excited about the opportunity to help more patients with SBS-IF and have generated strong clinical data, some of which Tammy highlighted through our STARS and STARS Extend trials. Over the past few months, we've made significant progress as we move towards site initiation of our confirmatory phase III trial, STARS-2, this quarter. STARS-2 is designed based on our interactions with the FDA to confirm and further support the positive data generated in the STARS phase III clinical trial. We plan to enroll 124 patients with SBS-IF in a 1-to-1 randomization. Enrollment will be for the overall SBS-IF patient population, which includes patients with both stoma and colon-in-continuity.

Speaker #5: Secondary endpoints also to be measured at week 24 for the overall population include clinical response, defined as a 20% reduction in parental support volume number of days off parental support per week and enteral autonomy.

With that I'll turn the call over to Mike set. Sign our chief medical officer to discuss. Aeroglide ongoing clinical development. Mike, thanks for having me and good morning everyone. As you've heard today, we're very excited about the opportunity to help our patients with SBS, if and have generated strong clinical data, some of which Tammy highlighted through our stars and stars extend trials,

Speaker #5: In designing the phase II trial, we've incorporated feedback from our prior FDA interactions and leveraged learnings from the positive STARS phase III trial. In preparing for the STARS II trial, we've taken steps to refine and optimize the dose administration instructions.

Over the past few months, we've made significant progress as we move towards site, initiation of our confirmatory. Phase 3 trials, Stars, 2, this quarter.

star 2 is designed based on our interactions with the FDA to confirm and further support the positive data generated through Stars, phase 3, clinical trial,

Speaker #5: A key consideration in designing STARS II was the dose selection. Which we intended to confirm the efficacy and tolerability demonstrated in STARS. With patients receiving 3.5 milligrams once weekly of Aperglutide.

Michael Shetzline: Our primary endpoint for the study will be the same as our prior STARS Phase III clinical trial, evaluating relative parenteral support volume change from baseline for the overall population at week 24. Secondary endpoints also to be measured at week 24 for the overall population include clinical response, defined as a 20% reduction in parenteral support volume, number of days off parenteral support per week, and enteral autonomy. In designing the Phase II trial, we've incorporated feedback from our prior FDA interactions and leveraged learnings from the positive STARS Phase III trial. In preparing for the STARS-2 trial, we've taken steps to refine and optimize the dose administration instructions. A key consideration in designing STARS-2 was the dose selection, which we intended to confirm the efficacy and tolerability demonstrated in STARS, with patients receiving 3.5 milligrams once weekly of apraglutide.

We plan to enroll 124 patients with SBI Sif in a 1 to 1. Rand in enrollment will be for the overall SBS, if patient population, which includes patients with both stoma and colon and continuity.

Speaker #5: We're getting close to initiated clinical trial sites in anticipation of dosing our first patient and look forward to providing additional updates as we continue to progress.

Michael Shetzline: We're getting close to initiating clinical trial sites in anticipation of dosing our first patient and look forward to providing additional updates as we continue to progress. Before turning the call over to Greg, I'd like to take a few minutes to highlight our presence at DDW this week. As you've heard, we had the opportunity to present pooled long-term safety data on apraglutide, as well as new findings from the landmark survey, in which surveyed providers emphasized the importance of reducing patients dependent on total parenteral nutrition or TPN to improve quality of life, reduce line infections, and lower the risk of thrombosis. About 46% of the providers identified reducing the number of days per week on TPN as a priority attribute for future therapies, and an additional 30% prioritized reducing TPN hours per day.

Our primary endpoint for the study will be the same as our prior Stars. Phase 3, clinical trial evaluating relative parental support. Volume change from Baseline for the overall population at week 24.

Speaker #5: Before turning the call over to Greg, I'd like to take a few minutes to highlight our presence at DDW this week. As you've heard, we had the opportunity to present pooled long-term safety data on Aperglutide.

Speaker #5: As well as new findings from the landmark survey. In which surveyed providers emphasized the importance of reducing patients' dependence on total parental nutrition or TPN to improve quality of life, reduce line infections, and lower the risk of thrombosis.

Secondary end points also to be measured at week 24 for the overall population include clinical response. Defined as a 20% reduction in Parental support. Volume number of days, off parental support per week and entral. Autonomy.

Speaker #5: About 46% of providers identified reducing the number of days per week on TPN as a priority attribute for further for future therapies. And in additional 30% prioritized reducing TPN hours per day.

Speaker #5: Survey results also highlighted the significant burden associated with long-term TPN dependence among patients with SBS. Our development strategy is informed by what we're hearing from patients and the medical community.

Michael Shetzline: We're getting close to initiating clinical trial sites in anticipation of dosing our first patient and look forward to providing additional updates as we continue to progress. Before turning the call over to Greg, I'd like to take a few minutes to highlight our presence at DDW this week. As you've heard, we had the opportunity to present pooled long-term safety data on apraglutide, as well as new findings from a LANDMARK survey in which surveyed providers emphasized the importance of reducing patients dependent on total parenteral nutrition or TPN to improve quality of life, reduce line infections, and lower the risk of thrombosis. About 46% of the providers identified reducing the number of days per week on TPN as a priority attribute for future therapies, and an additional 30% prioritized reducing TPN hours per day.

Michael Shetzline: Survey results also highlighted the significant burden associated with long-term TPN dependence among patients with SBS. Our development strategy is informed by what we're hearing from patients in the medical community. The design of our STARS and STARS 2 clinical trials of apraglutide evaluate multiple dimensions of parenteral support dependence. These real-world insights from providers and patients will help us better target the outcomes that most impact SBS patient lives. Our strong presence at DDW this past week further highlights our commitment to developing life-changing therapies for people living with gastrointestinal and rare diseases through enhanced research and a deeper understanding of the challenges these patients face. With that, I'll turn it over to Greg to review our financial performance in the Q1. Greg?

In designing, the phase 2 trial. We've Incorporated feedback from our prior FDA interactions and leverage learnings from the positive star Space 3 trial in preparing for the Stars, 2 trial, we've taken steps to refine and optimize the dose Administration instructions. A key consideration in designing Stars too was to do those selections which we intended to confirm the efficacy and tolerability demonstrated in stars with patients receiving 3.5 milligrams once weekly of award Levy.

We're getting close to initiated clinical trial sites in anticipation of dosing. Our first patient, and look forward to providing additional updates as we continue to progress.

Speaker #5: The design of our STARS and STARS II clinical trials of Aperglutide evaluate multiple dimensions of parental support dependence. These real-world insights from providers and patients will help us better target the outcomes that most impact SBS patient lives.

Speaker #5: Our strong presence at DDW this past week further highlights our commitment to developing life-changing therapies for people living with gastrointestinal and rare diseases through enhanced research and a deeper understanding of the challenges these patients face.

Before turning the call over to Greg I'd like to take a few minutes to highlight our presence at DW. This week as you've heard, we had the opportunity to present pulled long-term safety data on aqua blue tide as well as new findings from The Landmark survey in which survey providers emphasize. The importance of reducing patients dependent on total parental, attrition or tpn to improve quality of life, reduce line infections and lower the risk of thrombosis.

Speaker #5: With that, I'll turn it over to Greg to review our financial performance in the first quarter. Greg?

Speaker #6: Thanks, Mike. And good morning, everyone. I'm happy to walk through the highlights of our very strong first-quarter financial performance, beginning on slide 12. In the first quarter, total revenue was $106.5 million.

Gregory Martini: Thanks, Mike, and good morning, everyone. I'm happy to walk through the highlights of our very strong Q1 financial performance, beginning on slide 12. In Q1, total revenue was $106.5 million. GAAP net income was $40.8 million, and adjusted EBITDA was $76.7 million. We ended Q1 of 2026 with $220.5 million of cash and cash equivalents on the balance sheet, as well as $105.8 million in accounts receivable, which we expect to collect prior to the 15 June convertible note maturity.

Michael Shetzline: Survey results also highlighted the significant burden associated with long-term TPN dependence among patients with SBS. Our development strategy is informed by what we're hearing from patients in the medical community. The design of our STARS and STARS-2 clinical trials of Apraglutide evaluate multiple dimensions of parenteral support dependence. These real-world insights from providers and patients will help us better target the outcomes that most impact SBS patient lives. Our strong presence at DDW this past week further highlights our commitment to developing life-changing therapies for people living with gastrointestinal and rare diseases through enhanced research and a deeper understanding of the challenges these patients face. With that, I'll turn it over to Greg to review our financial performance in Q1. Greg?

About 46% of the providers identified reducing the number of days per week, on tpn as a priority attribute for further for future therapies and in additional 30%, prioritize reducing tpn hours per day.

Speaker #6: GAAP net income was $40.8 million. And adjusted EBITDA was $76.7 billion. We ended the first quarter of 2026 with $220.5 million of cash and cash equivalents on the balance sheet.

Survey results also highlighted the significant burden associated with long-term TPN dependence among patients with SPS.

Speaker #6: As well as $105.8 million in accounts receivable, which we expect to collect prior to the June 15th convertible note maturity. As noted in prior updates, we plan to use cash on hand and cash flows generated throughout 2026 to reduce our total debt balance.

Our development strategies are informed by what we're hearing from patients in the medical community. The design of our STARS and STARS 2 clinical trials for BLU-682 evaluate multiple dimensions of parental support for dependents. These real-world insights from providers and patients will help us better target the outcomes that most impact SPS patient lives.

Gregory Martini: As noted in prior updates, we plan to use cash on hand and cash flows generated throughout 2026 to reduce our total debt balance and plan to repay the 2026 convertible note in cash at maturity in June. We also expect to end the year with approximately $300 million of total debt on the balance sheet, less than 1 times our expected 2026 adjusted EBITDA. Moving to financial guidance on Slide 13. We are reiterating our 2026 guidance at this time. This includes LINZESS US net sales of between $1.125 and $1.175 billion. We continue to expect low single-digit percentage LINZESS prescription demand growth. We expect Ironwood revenues of between $450 and $475 million, and we expect adjusted EBITDA of greater than $300 million.

Speaker #6: And plan to repay the 2026 convertible note in cash at maturity in June. We also expect to end the year with approximately $300 million of total debt on the balance sheet.

[Company Representative 1] (Ironwood Pharmaceuticals): Thanks, Mike, and good morning, everyone. I'm happy to walk through the highlights of our very strong Q1 financial performance, beginning on slide 12. In Q1, total revenue was $106.5 million. GAAP net income was $40.8 million, and adjusted EBITDA was $76.7 million. We ended Q1 of 2026 with $220.5 million of cash and cash equivalents on the balance sheet, as well as $105.8 million in accounts receivable, which we expect to collect prior to the 15 June convertible note maturity.

Speaker #6: Less than one times our expected 2026 adjusted EBITDA. Moving to financial guidance on slide 13. We are reiterating our 2026 guidance at this time.

A strong Presence at ddw this past week, further highlights our commitment, to developing life-changing therapies for people, living, with gastrointestinal, and rare diseases through enhanced research and a deeper understanding of the challenges. These patients face with that, I'll turn it over to Greg to review our financial performance in the first quarter. Greg, thanks Mike and good morning everyone. I'm happy to walk through the highlights of our very strong. First quarter financial performance, beginning on slide 12,

Speaker #6: This includes Linzess US net sales of between $1.125 and $1.175 billion. We continue to expect low single-digit percentage Linzess prescription demand growth. We expect Ironwood revenues of between $450 and $475 million.

In the first quarter. Total revenue was 106.5 million gaap net income was 40.8 million and adjusted Eva was 76.7 billion dollars.

The end of the first quarter of 2026 with 220.5 million of cash and cash equivalents on the balance sheet.

Speaker #6: And we expect adjusted EBITDA of greater than $300 million. In summary, 2026 is off to a great start. With strong Linzess performance, a significantly improved financial position relative to 2025, and the impending initiation of the STARS confirmatory STARS II confirmatory trial.

[Company Representative 1] (Ironwood Pharmaceuticals): As noted in prior updates, we plan to use cash on hand and cash flows generated throughout 2026 to reduce our total debt balance and plan to repay the 2026 convertible note in cash at maturity in June. We also expect to end the year with approximately $300 million of total debt on the balance sheet, less than 1x our expected 2026 adjusted EBITDA. Moving to financial guidance on Slide 13. We are reiterating our 2026 guidance at this time. This includes LINZESS US net sales of between $1.125 and $1.175 billion. We continue to expect low single-digit percentage LINZESS prescription demand growth. We expect Ironwood revenues of between $450 and $475 million, and we expect adjusted EBITDA of greater than $300 million.

Gregory Martini: In summary, 2026 is off to a great start, with strong LINZESS performance, a significantly improved financial position relative to 2025, and the impending initiation of the STARS-II confirmatory trial. We continue to make progress on executing on our strategic priorities as we strive to redefine the standard of care for patients living with GI and rare diseases. I'd like to close by thanking all of our employees, patients, caregivers, and advocates for their shared dedication to advancing life-changing therapies. Operator, you may now open up the line for questions.

Convertible note maturity.

As noted in Prior updates, we plan to use cash on hand and cash flows generated throughout 2026 to reduce our total debt balance.

Speaker #6: We continue to make progress on executing on our strategic priorities as we strive to redefine the standard of care for patients living with TI and rare diseases.

And plan to repay. The 2026 convertible note in cash at maturity, in June

Speaker #6: I'd like to close by thanking all of our employees, patients, caregivers, and advocates for their shared dedication to advancing life-changing therapies. Operator, you may now open up the line for questions.

we also expect to end the year with approximately dollars of total debt on the balance sheet, less than 1 times, our expected 2026 adjusted Ava,

Moving to financial guidance on slide 13.

We are reiterating our 2026 guidance at this time.

Speaker #7: 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.

Operator 1: Your first question comes from the line of Mohit Bansal with Wells Fargo. Please go ahead.

This includes Linda us, net sales of between 1.125 and 1.175 billion dollars.

Speaker #7: We'll pause for just a moment to compile the trainer roster. Your first question comes from the line of Mohit Bansal with Wells Fargo. Please go ahead.

To continue to expect low single digit, percentage lenses, prescription demand growth.

[Company Representative 1] (Ironwood Pharmaceuticals): In summary, 2026 is off to a great start, with strong LINZESS performance, a significantly improved financial position relative to 2025, and the impending initiation of the STARS 2 confirmatory trial. We continue to make progress on executing on our strategic priorities as we strive to redefine the standard of care for patients living with GI and rare diseases. I'd like to close by thanking all of our employees, patients, caregivers, and advocates for their shared dedication to advancing life-changing therapies. Operator, you may now open up the line for questions.

Speaker #8: Great. Thank you very much for taking my question. And congrats on all this progress. So one question I have is on Linzess. So Linzess has been very strong in first quarter of wondering, so the volume growth and improved pricing, it does seem like a very strong quarter.

Mohit Bansal: Great. Thank you very much for taking my question, and congratulations on this progress. One question I have is on LINZESS. LINZESS has been very strong in Q1 of 2026. Wondering, like, the volume growth and improved pricing, it does seem like a very strong quarter. Would love to understand, like how, what is your thought process on the guidance, given this quarter? Or is there any one-time item that we need to think about here?

We expect Ironwood revenues of between $450 and $475 million, and we expect adjusted EBITDA of greater than $300 million.

in summary 2026 is off to a great start with strong winds up performance, a significantly, improved financial position relative to 2025 and the impending initiation of the Stars confirmatory stars to confirmatory trial

Speaker #8: So would love to understand what is your thought process on the guidance given this quarter? Or is there any one-time item that we need to think about here?

We continue to make progress on executing on our strategic priorities. As we strive to redefine the standard of care for patients, living with TI and rare diseases.

Speaker #6: Yeah. Thanks, Mohit. I think overall we're very encouraged by the first quarter results. Prescription demand, as you noted, 5% in the first quarter is slightly above our full year commentary on low single digits.

Gregory Martini: Yeah. Thanks, Mohit. I think overall, we're very encouraged by the Q1 results. Prescription demand, as you noted, 5% in the Q1 is slightly above our full year commentary on low single digits. That is a dynamic that we did anticipate. The Q1 is in line with our expectations that are factored into our overall full year guidance. From an overall brand performance and improved net price, I would say again, Q1 was very much in line with our expectations. I think positions us very well for our full year guidance. One dynamic that we called out in the prepared remarks is we don't expect the same fluctuation or volatility in quarterly net sales for the rest of this year as we saw in 2025.

Operator: Your first question comes from the line of Mohit Bansal with Wells Fargo. Please go ahead.

I'd like to close by thanking all of our employees patients, caregivers and advocates for their shared dedication to advancing life-changing therapies operator. You may now open up the line for questions.

Speaker #6: That is a dynamic that we did anticipate. So first quarter is in line with our expectations that our factored into our overall full-year guidance.

At this time, I would like to remind everyone in order to ask a question. Press star, then the number 1 on your telephone keypad will pause for just a moment to compare the 3 in our office.

Speaker #6: And from an overall brand performance and improved net price, I would say, again, first quarter was very much in line with our expectations. I think positions us very well for our full-year guidance.

Mohit Bansal: Great. Thank you very much for taking my question, and congrats on all this progress. One question I have is on LINZESS. LINZESS has been very strong in Q1 2026. Wondering, the volume growth and improved pricing, it does seem like a very strong quarter. Would love to understand what is your thought process on the guidance given this quarter? Or is there any one-time item that we need to think about here?

The first question comes from the line of with well, please go ahead.

Speaker #6: And one dynamic that we had called out in the prepared remarks is we don't expect the same fluctuation or volatility in quarterly net sales for the rest of this year as we saw in 2025.

Good, thank you very much for taking my question and Direction all the progress. Uh, so uh, 1 question I have is uh, on Lindsay. So Lindsay has been very strong in first quarter of 26.

Speaker #6: So I would expect more consistency in the quarterly phasing of Linzess net sales for 2026, which puts us on a nice trajectory for the full year.

Gregory Martini: I would expect more consistency in the quarterly phasing of LINZESS net sales for 2026, which puts us on a nice trajectory for the full year.

[Company Representative 1] (Ironwood Pharmaceuticals): Yeah. Thanks, Mohit. I think overall, we're very encouraged by the Q1 results. Prescription demand, as you noted, 5% in the Q1 is slightly above our full year commentary on low single digits. That is a dynamic that we did anticipate. The Q1 is in line with our expectations that are factored into our overall full year guidance. From an overall brand performance and improved net price, I would say again, Q1 was very much in line with our expectations. I think positions us very well for our full year guidance. One dynamic that we called out in the prepared remarks is we don't expect the same fluctuation or volatility in quarterly net sales for the rest of this year, as we saw in 2025.

And wondering like, uh, so like, so the volume growth and improved pricing. Uh, uh, it does seem like, uh, very strong quarter. So would love to understand like, how, what is your thought process on the guidance given this quarter, or is there any 1 time item that we need to think about here?

Speaker #8: Very helpful. And if I may ask one on Aprilglutide as well, so I mean, in our chat at DDW, it does seem like there are a lot of patients who are on parenteral nutrition, and the expert mentioned that about 70% of them probably could be on could be SBS patients as they have patients.

Mohit Bansal: Very helpful. If I may ask one on the apraglutide as well. Well, I mean, in our chat at DDW, it does seem like there are a lot of patients who are on parenteral nutrition, and the expert mentioned that about 70% of them probably could be on SBS patients. In that context, first is like how underpenetrated the market is currently, when you talk about GATTEX. With the ICD-10 code and all, how do you expect this to improve in terms of penetration of these GLP-2s in this market? Thank you.

Yeah, thanks mohead. I think overall, we're very encouraged by the first quarter results uh, prescription demand. As you noted 5% in. The first quarter is slightly above our full year, uh, commentary on low single digits. Uh, that is a dynamic that we did anticipate. So first quarter is, in line with our expectations, uh, that our factored into our overall full year guidance.

Speaker #8: So in that context, first is how underparented the market is currently when you talk about GAATX. And with the ICD-10 code and all, how do you expect this to improve in terms of penetration of these GLP-2s in this market?

[Company Representative 1] (Ironwood Pharmaceuticals): I would expect more consistency in the quarterly phasing of LINZESS net sales for 2026, which puts us on a nice trajectory for the full year.

Speaker #8: Thank you.

Speaker #6: Yeah. Tammy, do you want to comment on that?

Gregory Martini: Yeah. Tammi, do you wanna comment on that?

Tammi Gaskins: Sure. Thanks for the question, Mohit. Just to sort of start at the top, as I mentioned in my remarks, we look at the total SBS-IF population across US, Europe, and Japan as about 18,000 patients. We've distilled that further based on research and the patient claims data codes that you talked about to identify about 8,000 plus patients who we see as most likely.

Speaker #7: Sure. Thanks for the question, Mohit. Just to sort of start at the top, as I mentioned in my remarks, we look at the total SBS population across US, Europe, and Japan as about 18,000 patients.

Mohit Bansal: Very helpful. If I may ask one on apraglutide as well. Well, so I mean, in our chat at DDW, it does seem like there are a lot of patients who are on parenteral nutrition, and the expert mentioned that about 70% of them probably could be on SBS patients, as their PS patients. In that context, first is like how under-penetrated the market is currently, when you talk about GATTEX. With the ICD-10 code and all, how do you expect this to improve in terms of penetration of these GLP-2s in this market? Thank you.

And from an overall, uh, brand performance and and Improvement price, I would say, again, first quarter was very much in line with our expectations, I think, positions, as very well for our full year guidance. Um, and 1 Dynamic that we, uh, had called about the prepared remarks is, we don't expect the same fluctuation or volatility in quarterly, net sales, uh, for the rest of this year. Uh, as we saw in 2025, so I would expect uh, more consistency in the quarterly phasing of lenses that sales 42026 which which puts us on a nice trajectory for the full year.

Very helpful. And if I may ask 1 on that as well, uh,

Speaker #7: And then we've distilled that further based on research and the patient claims data codes that you've talked about to identify about 8,000-plus patients who we see as most likely to be prescribed a GLP-2 therapy as based on the definition of having requiring parental support three or more days a week.

Well, so, I mean, in our chat, uh, at DDW, uh, it does seem like there are a lot of patients who are on parenteral nutrition, uh, and the expert mentioned that about 70% of them.

Tammi Gaskins: to be prescribed a GLP-2 therapy as based on the definition of having, requiring parenteral support 3 or more days a week. Now, within that, and the numbers that I reference from a total addressable market of $4 billion, that's looking essentially at that 8,000 patients times the price that we know for the currently available therapy, of GATTEX. Within that opportunity today, we estimate based on public disclosures and available claims data, that about 1,500 to 2,000 of those patients are on GATTEX at any given time. There's still significant opportunity to increase GLP-2 utilization overall, and we believe in the potential of a brand such as apraglutide to also help improve adherence or days on therapy, to really optimize treatment for those patients.

Speaker #7: Now, within that, and the numbers that I referenced from a total addressable market of 4 billion, that's looking essentially at that 8,000 patients times the price that we know for the currently available therapy of GAATX.

[Company Representative 1] (Ironwood Pharmaceuticals): Yeah. Tammy, do you wanna comment on that?

Tammi Gaskins: Sure. Thanks for the question, Mohit. Just to sort of start at the top, as I mentioned in my remarks, we look at the total SBS-IF population across US, Europe and Japan as about 18,000 patients. We've distilled that further based on research and the patient claims data codes that you talked about, to identify about 8,000 plus patients who we see as most likely to be prescribed a GLP-2 therapy as based on the definition of having, requiring Parenteral Support 3 or more days a week. Now, within that, and the numbers that I reference from a total addressable market of $4 billion, that's looking essentially at that 8,000 patients times the price that we know for the currently available therapy, of GATTEX.

Speaker #7: Within that, opportunity today, we estimate based on public disclosures and available claims data that about 1,500 to 2,000 of those patients are on GAATX at any given time.

Probably could be, could be, could be on. Uh, could be, could be, um, SBS patients SBS. I have patience. So, in that context, first is, like, how underprivileged the market is currently. Uh, when you talk about that x, uh, and uh, and with the ICD 10 code and all do, how do you expect this to improve uh in terms of penetration of uh of these uh glp Tools in this market? Thank you. Yeah. Hey, do you want to come in on that? Sure, thanks for the question Mohit. Um,

To sort of start at the top. As I mentioned in my remarks, we look at the total SBS, if population across us Europe and Japan is about 18,000 patients,

Speaker #7: So there's still significant opportunity to increase GLP-2 utilization overall. And And we believe in the potential of a brand such as Aprilglutide to also help improve adherence or days on therapy.

and then we've distilled that further based on research and the, uh, patient claims data codes that you've talked about

To identify about 8,000 plus patients, who we see as most likely.

Speaker #7: To really optimize treatment for those patients.

Speaker #8: Helpful. Thank you.

Mohit Bansal: Helpful. Thank you.

Requiring parental support 3 or more days a week.

Speaker #7: Your next question comes from the line of Amy Lee with Jeffrey. Please go ahead.

Operator 2: Your next question comes from the line of Amy Lee with Jefferies. Please go ahead.

[Analyst] (Jefferies): Hi, this is Kathy on for Amy. I just wanted to ask a quick question about your plans for lifecycle management for LINZESS after LOE. You've previously alluded to being able to pursue OTC for LINZESS. When can we get an update on that? Have you had any conversations with the FDA on any additional data that you would need to show? Thank you.

Speaker #9: Hi. This is Kathy on for Amy. I just wanted to ask a quick question about your plans for a lifecycle management for Linzess after LOE.

Now within that and the numbers that I rest reference from a total addressable Market of 4 billion. That's looking essentially at that 8,000 patients times.

Tammi Gaskins: Within that opportunity today, we estimate, based on public disclosures and available claims data, that about 1,500 to 2,000 of those patients are on GATTEX at any given time. There's still significant opportunity to increase GLP-2 utilization overall, and we believe in the potential of a brand such as apraglutide to also help improve adherence or days on therapy to really optimize treatment for those patients.

The price that we know for the currently available therapy uh of GAD techs.

Speaker #9: So you've previously alluded to being able to pursue OTC for Linzess. When can we get an update on that? And have you had any conversations with the FDA on any additional data that you would need to share?

Within that.

Opportunity.

Today.

Speaker #9: Thank you.

Speaker #6: Yeah. Thanks, Catherine. Mike, do you want to take over?

Gregory Martini: Thanks, Catherine. Mike, do you want to take over?

Speaker #8: Sure. That's a good question. I mean, we've always been impressed with the performance of Linzess. And the availability of it for patients. And we have a tremendously large safety database for Linzess use.

Michael Shetzline: Sure. That's a good question. I mean, we've always been impressed with the performance of LINZESS and the availability of it for patients, and we have a tremendously large safety database for LINZESS use. We do think that the product has an opportunity for OTC. We are ongoing engagement with AbbVie, our partner, with a plan for OTC. We'll continue to do that, and we look forward to updating you as we get more in the future.

We estimate based on public disclosure and available claims data that about 1500 to 2,000 of those patients are on gatex at any given time. So there's still significant opportunity to increase glp to utilization overall and we believe

Speaker #8: So we do think that the product is has an opportunity for OTC. We are ongoing engagement with AbbVie, our partner, with a plan for OTC.

in the potential of

Speaker #8: We'll continue to do that. And we look forward to updating you as we get more in the future.

Mohit Bansal: Helpful. Thank you.

a brand which is actively tied to also help improve adherence or days on therapy. Um to really optimize treatment for those patients

helpful.

Thank you.

Operator: Your next question comes from the line of Amy Lee with Jefferies. Please go ahead.

Speaker #7: Your next question comes from the line of Chase and Butler with Citizens GMP. Please go ahead.

Operator 2: Your next question comes from the line of Jason Butler with Citizens JMP. Please go ahead.

[Analyst] (Jefferies): Hi, this is Catherine on for Amy. I just wanted to ask a quick question about your plans for lifecycle management for LINZESS after LOE. You've previously alluded to being able to pursue OTC for LINZESS. When can we get an update on that? Have you had any conversations with the FDA on any additional data that you would need to show? Thank you.

Your next question comes from the line of in with Jeffrey. Please go ahead.

Speaker #8: Hi. Thanks for taking the questions. Just a couple on the STARS 2 trial. One, just a clarification point. Are you stratifying CIC and STOMA patients in STARS 2?

Jason Butler: Hi. Thanks for taking questions. Just a couple on the STARS 2 trial. One just a classification point. Are you stratifying CIC and stoma patients in STARS 2? What's your expectation for the proportion of those patients, those two different populations that will enroll in the trial? Just in terms of learnings from the first phase III trial, how specifically thinking about operationally, what are you doing to make sure your enrollment timelines remain on track? What's the overlap in sites versus what you used in the prior trial? Thank you.

Speaker #8: What's your expectation for the proportion of those patients, those two different populations that are enrolled in the trial? And then just in terms of learnings from the first phase three trial, how specifically, thinking about operationally, what are you doing to make sure you're enrollment timelines remain on track?

[Company Representative 1] (Ironwood Pharmaceuticals): Thanks, Catherine. Mike, do you want to take a go?

Hi, this is Kathy on for Amy. Um, I just wanted to ask a quick question about your plans for life cycle management for Olympus after Eloise. So, you've previously alluded to being able to pursue an OTC for Linzess. When do we get an update on that? And have you had any conversations with the FDA on any additional data that you would need to share? Thank you.

Speaker #8: And what's the overlapping sites versus what you used in the prior trial? Thank you.

Speaker #6: Thanks, Jason. Mike?

Gregory Martini: Thanks, Jason. Mike.

Thanks Katherine. Mike, do you want to take over? Sure, that's a good question. I mean, we, we've always been impressed with the performance of lenses and and the availability of the for patients and we have a tremendously large safety database for lenses use. So we do think that the product is, an has an opportunity for OTC. We have, we are ongoing

Speaker #9: Yeah. Thanks, Jason. So from a stratification, it's a good question. For the STARS 2 program, we're not formally stratifying. This was actually an outcome from our discussions with the agency.

Michael Shetzline: Yeah, thanks, Jason. From a stratification, it's a good question. For the STARS 2 program, we're not formally stratifying. This was actually an outcome from our discussions with the agency. It's clearly recognized by the agency and prescribers that CIC, colon-in-continuity, and stoma patients have a significant medical need and benefit from GLP-2 therapy. In our study, our endpoints now, both primary and secondary, are aligned with the overall population, which includes colon-in-continuity and stoma patients. However, we do need to show a benefit over the populations, so we'll actually track the recruitment of stoma and CIC patients.

As a plan for OTC, we'll continue to do that. Um and we look forward to updating you as we get more in the future.

Operator: Your next question comes from the line of Jason Butler with Citizens JMP. Please go ahead.

Speaker #9: It's clearly recognized by the agency and prescribers that CIC, colon and continuity, and STOMA patients have a significant medical need and benefit from GLP-2 therapy.

Jason Butler: Hi. Thanks for taking the questions. Just a couple on the STARS-2 trial. One, just a clarification point. Are you stratifying CIC and stoma patients in STARS-2? What's your expectation for the proportion of those patients, like, 2 different populations that will enroll in the trial? Then just in terms of learnings from a first phase III trial, how specifically think about operationally, what are you doing to make sure your enrollment timelines remain on track? What's the overlap in sites versus what you used in the prior trial? Thank you.

Speaker #9: So in our study, our endpoints now, both primary and secondary, are aligned with the overall population, which includes colon and continuity and STOMA patients.

Speaker #9: However, we do need to show a benefit over the populations. So we'll actually track the recruitment of STOMA and CIC patients. But again, to the point, there's no forced stratification.

Michael Shetzline: Again, to the point, there's no forced stratification, but we'll align to get a representative group for both CIC and stoma patients, as we've discussed with the agency. In regards to the operational execution, this SBS is a complex disorder, and we certainly did an excellent job in the original STARS program operationally. As you know, that was a very robust, largest SBS-IF study ever performed. We had a very well-executed trial, as demonstrated by the low placebo response and the 2x, as Tammi highlighted, the twice benefit in terms of differential support volume reduction. We're certainly leveraging that experience on the path forward to STARS 2, and we feel confident in our ability to execute STARS 2 as we did in the original STARS program.

Speaker #9: But we'll align to get a representative group for both CIC and STOMA patients as we've discussed with the agency. In regards to the operational execution, I think this SBS is a complex disorder.

[Company Representative 1] (Ironwood Pharmaceuticals): Thanks, Jason. Mike.

Your next question comes from the line of Chief in Brooklyn with citizens GMT. Please go ahead. Hi, thanks for taking the questions. Um, just a couple on the, the, the Stars 2 trial, um, wanted to clarification Point, are you stratifying? Um, CRC and Stow patients and start to, uh, what's your expectation for the, the proportion of of, of those patients, like, 2 different populations? That are all in the trial, and then, just in terms of learning from, from the first stage 3 trial, how, how, how about operationally, what are you doing to to to, uh, make sure that your enrollment timelines remain on track? Uh, and what's the overlap in sites versus what you use for the prior trial. Thank you.

Michael Shetzline: Yeah, thanks, Jason. Stratification's a good question. For the STARS-2 program, we're not formally stratifying. This was actually an outcome from our discussions with the agency. It's clearly recognized by the agency and prescribers that CIC, colon-in-continuity, and stoma patients have a significant medical need and benefit from GLP-2 therapy. In our study, our endpoints now, both primary and secondary, are aligned with the overall population, which includes colon-in-continuity and stoma patients. However, we do need to show a benefit over the populations, so we'll actually track the recruitment of stoma and CIC patients.

Speaker #9: And we certainly did an excellent job in the original STARS program operationally. As you know, that was a very robust, largest SBSIF study ever performed.

Speaker #9: We had a very well-executed trial, as demonstrated by the low placebo response. And the 2X, as Tammy highlighted, the twice benefit in terms of parenteral sport volume reduction.

Speaker #9: So we're certainly leveraging that experience on the path forward to STARS 2. And we feel confident in our ability to execute STARS 2 as we did in the original STARS program.

Speaker #9: We'll continue to use sites we have used in the original trial. We're looking at all the sites carefully. As you know, this is a rare disease.

Michael Shetzline: We'll continue to use sites we have used in the original trial. We're looking at all the sites carefully. As you know, this is a rare disease, so the number of patients per site is something we have to actively include, so we need to consider that in the calculus. But that's, as Tom mentioned, we did a lot of site feasibility already, and we're taking those learnings as we initiate sites and prepare to those patients in the near term.

Thanks Jason, thanks. Yeah, thanks Jason. So, from stratification, is a good question. Um, for the Stars 2 program, we're not formally stratifying. Um, this was actually an outcome from our discussions with the agency. It's clearly recognized by the agency and prescribers that cic colon and continuity and Stow patients. Have a significant medical need and benefit from glp to therapy. So, in our study, our end points. Now, both primary and secondary are aligned with the overall population which includes colon and continuity and Stow patients. However, we do need to show a benefit over the population.

Speaker #9: So the number of patients per site is something we have to actively include. So we need to consider that in the calculus. But that's as Tom mentioned, we did a lot of site feasibility already.

Michael Shetzline: Again, to the point, there's no forced stratification, but we'll align to get a representative group for both CIC and stoma patients, as we've discussed with the agency. In regards to the operational execution, I think this SBS is a complex disorder, and we certainly did an excellent job in the original STARS program operationally. As you know, that was a very robust, largest SBS-IF study ever performed. We had a very well-executed trial, as demonstrated by the low placebo response and the 2x, as Tammi highlighted, the twice benefit in terms of preferential split volume reduction. We're certainly leveraging that experience on the path forward to STARS-2, and we feel confident in our ability to execute STARS-2 as we did in the original STARS program.

Speaker #9: And we're taking those learnings into as we initiate sites and prepare to those patients in the near term.

So we'll actually track the recruitment of stone and cic patients, but again to the point, there's no 4 Strat but we'll align to get a representative group for both cic and Stella patience as we discussed with the agency.

Speaker #8: Yeah. I think the other piece there, the bottom line on this is, one, working with the sites where we know there's existing patients. And we certainly have a track record there.

Tom McCourt: Yeah, I think the other piece there, or the bottom line on this is, one, working with the sites where we know there's existing patients, and we certainly have a track record there. This is also opening up additional sites 'cause this is all about recruiting patients as fast as we can. You know, we're certainly gonna make the most of the sites we have relationships with, but we've identified a number of additional sites, you know, that we believe, we could also harvest patients from. I think we're excited to get rolling on this, and that'll be initiated in the upcoming weeks.

Speaker #8: But this is also opening up additional sites. Because this is all about recruiting patients as fast as we can. And we're certainly going to make the most of the sites we have relationships with.

Speaker #8: But we've identified a number of additional sites that we believe we could also harvest patients from. So I think we're excited to get rolling on this.

Speaker #8: And that'll be initiated in the upcoming weeks.

Michael Shetzline: We'll continue to use sites we have used in the original trial. We're looking at all the sites carefully. As you know, this is a rare disease, so the number of patients per site is something we have to actively include, so we need to consider that in the calculus. That's as Tom mentioned, we did a lot of site feasibility already, and we're taking those learnings as we initiate sites and prepare to dose patients in the near term.

Um, in regards to the operational execution, I think it this uh, SPS is a is a complex disorder and we certainly did an excellent job in, in the original Stars program operationally. As you know, that was a very robust. Largest SPS. If study ever performed we had a very, uh, well executed trial as demonstrated by the local sebo response and the 2x is Tammy, highlighted the twice, uh, benefit in terms of Parental support volume reduction. So, we're certainly leveraging that experience, uh, on the path forward, the Stars too, and we feel confident in our ability to execute Stars, too, um, as we did in the original

Speaker #6: Thank you.

Operator 2: Thank you. Your next question comes from the line of Chase Knickerbocker with Craig-Hallum. Please go ahead.

Speaker #7: Your next question comes from the line of Chase, Mr. Bucker, with Craig Collin. Please go ahead.

Speaker #6: Good morning. Thanks for taking the questions. Maybe just on guidance again, sorry. Tom or Greg, maybe just walk me through what went better than expected from a demand generation perspective in Q1.

Chase Knickerbocker: Good morning. Thanks for taking the questions. Maybe just on guidance again, sorry. You know, Tom or Greg, maybe just walk me through, you know, what went better than expected from a demand generation perspective in Q1? What are you keeping in mind or don't expect to recur to drive the decline in volume growth, you know, through the year that your guidance implies? Thanks.

[Company Representative 2] (Ironwood Pharmaceuticals): Yeah. I think the other piece there, or the bottom line on this is, one, working with the sites where we know there's existing patients, and we certainly have a track record there, but this is also opening up additional sites. 'Cause this is all about recruiting patients as fast as we can. You know, we're certainly gonna make the most of the sites we have relationships with, but we've identified a number of additional sites, you know, that we believe we could also harvest patients from. I think we're excited to get rolling on this, and that'll be initiated in the upcoming weeks.

Speaker #6: And then what are you keeping in mind or don't expect to occur to drive the decline in volume growth through the year that your guidance implies?

Speaker #6: Thanks.

Speaker #8: Yeah. Thanks, Chase. This is Greg. So I think as we gave our initial guidance for 2026, we had commented to the low single-digit prescription demand growth.

Gregory Martini: Yeah. Thanks, Chase Knickerbocker. This is Gregory Martini. I think as we gave our initial guidance for 2026, we had commented to the low single-digit prescription demand growth, and that is still our expectation for this full year. Part of the reason we had anticipated that we may see a slowing in growth relative to 2025 or for prior years is as we enacted this pricing change, we expected that there would be some response and impact to prescription demand. We were really focused on how we could maximize net sales overall over the remaining life cycle of brand. We didn't expect that all of that would happen in Q1. We thought this would happen progressively throughout the year.

Speaker #8: And that is still our expectation for this full year. And part of the reason we had anticipated that we may see a slowing in growth relative to 2025 or prior years is as we enacted this pricing change, we expected that there would be some response and impact to prescription demand.

Patients as fast as we can. And you know we we're certainly going to make the most of the sites we have relationships with. But we've identified a number of additional sites, you know that we believe uh we could also Harvest patients from. So I think we're, we're excited to get get rolling on this and that'll be uh, initiated in the upcoming weeks.

Jason Butler: Thank you.

Thank you.

Operator: Your next question comes from the line of Chase Mitchell-Walker with Craig-Hallum. Please go ahead.

Speaker #8: But we were really focused on how we could maximize net sales overall over the remaining lifecycle of brand. So we didn't expect that all of that would happen in the first quarter.

Chase Mitchell-Walker: Good morning. Thanks for taking the questions. Maybe just on guidance again, sorry. You know, Tom or Greg, maybe just walk me through, you know, what went better than expected from a demand generation perspective in Q1? What are you keeping in mind or don't expect to recur to drive the decline in volume growth, you know, through the year that your guidance implies? Thanks.

Your next question comes from the line of Chase maker blocker with Craig Colin, please go ahead.

Speaker #8: We thought this would happen progressively throughout the year. And I would say Medicaid, in particular, is one of those areas that we would expect to potentially have reduced growth in the second half of 2026 or later portions.

Gregory Martini: I would say Medicaid in particular is one of those areas that we would expect to potentially have reduced growth in H2 2026 or for later portions. That's really what's factored into the guidance and where the 5% was more in line with expectations to start the year.

Good morning. Uh, thanks for taking the question. Uh, maybe just on guidance again, sorry. Uh, you know, Tom McGregor maybe just walk me through, um, you know, what went better than expected from a demand generation perspective in q1?

[Company Representative 1] (Ironwood Pharmaceuticals): Yeah. Thanks, Chase. This is Greg. I think as we gave our initial guidance for 2026, we had commented to the low single-digit prescription demand growth, and that is still our expectation for this full year. Part of the reason we had anticipated that we may see a slowing in growth relative to 2025 or for prior years is as we enacted this pricing change, we expected that there would be some response and impact to prescription demand. We were really focused on how we could maximize net sales overall over the remaining life cycle of brand. We didn't expect that all of that would happen in Q1. We thought this would happen progressively throughout the year.

And then what are you keeping in mind, or don't expect to recur to drive the decline in volume growth, you know, through the year that your guidance implies?

Speaker #8: And so that's really what's factored into the guidance and where the 5% was more in line with expectations. To start the year.

Speaker #6: Got it. Helpful. Maybe just on kind of growth to nets. Through the year, obviously, there's been quite a bit of changes as far as calculation there over the last 24 months.

Chase Knickerbocker: Got it. Helpful. Maybe just on kind of gross to nets through the year. Obviously, there's been quite a bit of change as far as calculation there over the last 24 months. Can you just help us with how we should think about it sequentially, kind of balancing all the different drivers, including, you know, some of the dynamics later in the year with the redesign?

Speaker #6: Can you just help us with how we should think about it sequentially? Kind of balancing all the different drivers, including some of the dynamics later in the year with the redesign?

Speaker #8: Yes. Absolutely. So I would say the biggest takeaway is full year we feel very good about our overall forecast. The guidance we provided, which implies more than 30% increase in net sales relative to 2025.

Gregory Martini: Yes, absolutely. I would say, the biggest takeaway is full year, we feel very good about our overall forecast, the guidance we've provided, which implies a more than 30% increase in net sales relative to 2025. I think to your point, there were quite a few fluctuations in net price throughout the quarters in 2025. In 2026, we don't expect that same dynamic to occur because we now have more consistent, or less variability in net price across channels. We do expect more consistent net sales in each quarter in 2026 than occurred in 2025. From a growth rate perspective, the quarterly year-over-year comparisons could have some anomalies, I'd say, such as the 97% year-over-year in Q1. From a dollar value, we expect more consistency in 2026.

Thanks. Yeah, thanks chase. This is Craig. Uh, so I think as we gave our initial guidance for 2026, uh, we had commented to, uh, the low single digit prescription demand growth and that is still our, our expectation for this full year. Um, and part of the reason we had anticipated, uh, that we may see a slowing in growth relative to 2025, or or prior Years is as we, uh, enacted this pricing change. We expected that there would be some response, uh, and impact to prescription demand, but we were really focused on how we could maximize.

Speaker #8: I think to your point, there were quite a few fluctuations in net price throughout the quarters in 2025. In '26, we don't expect that same dynamic to occur.

[Company Representative 1] (Ironwood Pharmaceuticals): I would say Medicaid in particular is one of those areas that we would expect to potentially have reduced growth in H2 2026 or later portions. That's really what's factored into the guidance and where the 5% was more in line with expectations to start the year.

Speaker #8: Because we now have more consistent or less variability in net price across channels. So we do expect a more consistent net sales in each quarter in '26 than occurred in 2025.

Net sales overall over the remaining life cycle of brand. So we didn't expect that. All of that would happen in the first quarter. We thought this would happen progressively throughout the year. Um, and I would say Medicaid in particular, is 1 of those areas, uh, that we would expect to potentially have reduced growth in the second half of 2020.

Or for later portions. Um and so that's really what's factored into the guidance and

Chase Mitchell-Walker: Got it. Helpful. Maybe just on kind of gross to nets through the year. There's been quite a bit of change as far as calculation there over the last 24 months. Can you just help us with how we should think about it sequentially, kind of balancing all the different drivers, including, you know, some of the dynamics later in the year with the redesign?

Where the 5% was was more in line with expectations uh to start the year.

Speaker #8: From a growth rate perspective, the quarterly year-over-year comparisons, could have some anomalies, I'd say. Such as the 97% year-over-year in Q1. But from a dollar value, we expect more consistency in 2026.

[Company Representative 1] (Ironwood Pharmaceuticals): Yes, absolutely. I would say, the biggest takeaway is full year, we feel very good about our overall forecast, the guidance we've provided, which implies a more than 30% increase in net sales relative to 2025. I think to your point, there were quite a few fluctuations in net price throughout the quarters in 2025. In 2026, we don't expect that same dynamic to occur because we now have more consistent, or less variability in net price across channels. We do expect more consistent net sales in each quarter in 2026 than occurred in 2025. From a growth rate perspective, the quarterly year over year comparisons could have some anomalies, I'd say, such as the 97% year over year in Q1. From a dollar value, we expect more consistency in 2026.

Got it helpful. Um, maybe just some kind of growth and that's um through the year. Obviously there's been quite a bit of changes as far as calculation there, over the last 24 months, can you just help us with how we should think about it sequentially? Uh kind of balancing all the different drivers including um you know some of the Dynamics later in the year with the redesign

Speaker #6: Got it. And then just last from me on the expense side. 300 million on EBITDA is seeming like a pretty safe floor at this point.

Chase Knickerbocker: Got it. Just last for me on the expense side. You know, $300 million on EBITDA is, you know, seeming like a pretty safe floor at this point. Is there any incremental expense kind of outside of STARS 2 that we should be considering that could kind of materially drive spend, you know, sequentially from here?

Speaker #6: But is there any incremental expense kind of outside of STARS 2 that we should be considering that could kind of materially drive spend sequentially from here?

Uh, yes, absolutely. So I would say, uh, the biggest takeaway is full year, we feel, uh, very good about our overall forecast. The guidance we provided uh, which implies, uh, more than 30% increase in net sales relative to 2025

Speaker #8: Yeah. So I think you hit on the key point. As we initiate activities associated with STARS 2, we do expect our R&D expenses will ramp up throughout the remainder of 2026.

Gregory Martini: Yeah. I think you hit on the key point. As we initiate activities associated with STARS 2, we do expect our R&D expenses will ramp up throughout the remainder of 2026. To your point, we continue to believe we'll be able to deliver greater than $300 million of adjusted EBITDA for the year.

Speaker #8: But to your point, we continue to believe we'll be able to deliver greater than $300 million of adjusted EBITDA for the year.

I think, to your point, there were quite a few fluctuations in net price throughout the quarters in 2025 and 2026. We don't expect that same dynamic to occur, because we now have more consistent—or less variability—in net price across channels. So we do expect more consistent net sales in each quarter in 2026 than our current in 2025.

Speaker #6: Great. Thanks, Chase.

Chase Knickerbocker: Great. Thanks, guys.

Speaker #8: Thank you.

Gregory Martini: Thank you.

Speaker #7: Your next question comes from the line of Tom Rosenfeld with Incheon Health Research. Please go ahead.

Operator 2: Your next question comes from the line of Tom Rosenthal with Intron Health Research. Please go ahead.

Speaker #9: Good morning, everyone. Tom Rosenfeld, Claudia from Incheon here. Thank you for taking the questions. My first one is, can you talk us through the magnitude of the opportunity to invest in functional constipation in two to five-year-olds?

Tom Rosenthal: Good morning, everyone. Tom Rosenthal calling from Intron Health here. Thanks for taking the questions. My first one is, can you talk us through the magnitude of the opportunity to invest in functional constipation in 2 to 5-year-olds and whether you anticipate any material revenues from this label expansion in H2?

Chase Mitchell-Walker: Got it. Just last from me on the expense side. You know, $300 million on EBITDA is, you know, seeming like a pretty safe floor at this point. Is there any incremental expense kind of outside of STARS-2 that we should be considering that could kind of materially drive spend, you know, sequentially from here?

From a growth rate perspective, the quarterly year-over-year comparisons could have some anomalies. I'd say uh, such as the 97% year-over-year in q1. Um, but from a dollar value, we expect more consistency in 2026

Speaker #9: And whether you anticipate any material revenues from this labor expansion in H2?

Speaker #8: Yeah. Thanks, Dominic. I'm going to ask Tammy to speak to the opportunity we see with two to five-year-olds depending on approval.

Michael Shetzline: Yeah. Thanks, Tom. I'm gonna ask Tammi to speak to the opportunity we see with 2 to 5-year-olds pending an approval.

[Company Representative 1] (Ironwood Pharmaceuticals): Yeah. I think you hit on the key point is as we initiate activities associated with STARS-2, we do expect our R&D expenses will ramp up throughout the remainder of 2026. To your point, we continue to believe we'll be able to deliver greater than $300 million adjusted EBITDA for the year.

Got it. And then just last for me. Um, the expense side, you know, 300 million, um, IBA is, you know, seeming like a pretty safe floor at this point, but is there any incremental expense kind of outside of stars to that? We should be considering, uh, that could, uh, kind of materially Drive spend, um, you know, sequentially from here.

Speaker #10: Yeah. Thanks, Tom. First, we're very excited about the potential opportunity to expand and offer a potentially offer a prescription therapy for an additional pediatric patient population.

Tammi Gaskins: Yeah. Thanks, Tom. First, we're very excited about the potential opportunity to expand and offer a potentially offer a prescription therapy for an additional pediatric patient population. We do expect-

Speaker #10: We do expect that if approved, the two to five will support additional demand for Linzess overall. But we still see the adult IBSC/CIC population as the main driver of growth over the next few years.

Tammi Gaskins: That, if approved, the 2 to 5 will support additional demand for LINZESS overall, but we still see the adult IBS-C/CIC population as the main driver of growth over the next few years. Yes, all these additional pediatric indications add to supporting demand, but the real continued inflection will come from the adult population.

Chase Mitchell-Walker: Great. Thanks, guys.

Yeah, so I think I think you hit on the. The key point is, as we initiate, uh, activities associated with stars 2. We do expect our R&D expenses will ramp up throughout the remainder of 2026, but to your point, we continue to believe, we'll be able to deliver greater than 300 million of adjusted. But for the year,

[Company Representative 1] (Ironwood Pharmaceuticals): Thank you.

great, thanks.

Operator: Your next question comes from the line of Tom Rosenthal with Intra-Health Research. Please go ahead.

Thank you.

Your next question comes from the line of Tom Rosenthal with in health research. Please go ahead.

Tom Rosenthal: Good morning, everyone. Tom Rosenthal calling from Intrum here. Thanks for taking the questions. My first one is, can you talk us through the magnitude of the opportunity for LINZESS in functional constipation in two to five-year-olds and whether you anticipate any material revenues from this label expansion in H2?

Good morning everyone. I'm calling from

Speaker #10: So yes, all these additional pediatric indications add to supporting demand. But the real continued inflection will come from the adult population.

Uh thank you for taking the questions. Uh, my first 1 is, can you talk us through the main issues of the opportunity to invest in functional constipation in 2 to 5 year olds?

Speaker #9: Thank you. That's really helpful. And one more question, if I may. So as these reinvestments for the R&D commercial expenses was down 90% this quarter versus the prior year, is that around the right run rate we should assume going forward?

Tom Rosenthal: Thank you. That's very helpful. One more question, if I may. As the reimbursement for the Ironwood commercial expenses was down 90% this quarter versus the prior year, is that around the right run rate we should assume going forward?

And whether you have to pay any material revenues from this labor expansion in H2.

[Company Representative 1] (Ironwood Pharmaceuticals): Yeah. Thanks, Tom Rosenthal. I'm gonna ask Tammi Gaskins to speak to the opportunity, we see with 2 to 5-year-olds, pending an approval.

Tammi Gaskins: Yeah. Thanks, Tom. First, we're very excited about the potential opportunity to expand and potentially offer a prescription therapy for an additional pediatric patient population.

Yeah, thanks. Dominic, I'm gonna have Tammy to speak to the opportunity. Uh, we see with 2 to 5 year olds, uh, depending on approval.

Gregory Martini: Yes. If you recall, in Q1 2025, we completed a restructuring of our organization, which reduced the Ironwood portion of the selling effort for LINZESS. I would say Q1 2026 is more representative of a run rate for the remainder of this year in terms of those reimbursements.

Speaker #8: Yes. So if you recall in first quarter of 2025, we completed a restructuring of our organization. Which reduced the IronWood portion of the selling efforts for Linzess.

Tammi Gaskins: We do expect that, if approved, the 2 to 5 will support additional demand for LINZESS overall, but we still see the adult IBS-C population as the main driver of growth over the next few years. Yes, all these additional pediatric indications add to supporting demand, but the real continued inflection will come from the adult population.

Speaker #8: So I would say first quarter 2026 is more representative of a run rate for the remainder of this year in terms of those reimbursements.

Move the 2 to 5 will support additional demand for LINZESS overall, but we still, uh,

Speaker #9: Got it. Thank you very much.

Tom Rosenthal: Perfect. Thank you very much.

Speaker #8: Thanks, Dominic.

Gregory Martini: Thanks, Dominic.

See the adult ibsc, cic population, as the main driver of growth over the next few years.

Operator 1: We have no further questions at this time. Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

So yes, all these additional pediatric indications add to supporting demand, but—

The real continued inflectional come from the adult population.

Tom Rosenthal: Thank you. That's really helpful. One more question, if I may. As the reimbursement for the Ironwood commercial expenses was down 90% this quarter versus the prior year, is that around the right run rate we should assume going forward?

Thank you for helping 1, more question. If I may, uh,

so,

I'd be very busy for the oddly enough. Expenses was down 100% this quarter versus the prior year.

[Company Representative 1] (Ironwood Pharmaceuticals): Yes. If you recall, in Q1 2025, we completed a restructuring of our organization, which reduced the Ironwood portion of the selling efforts for LINZESS. I would say Q1 2026 is more representative of a run rate for the remainder of this year in terms of those reimbursements.

Is that around the right run run, run rate, we should assume going forward.

Tom Rosenthal: Perfect. Thank you very much.

Uh, yes. So if you recall in first quarter of 2025, we completed a restructuring of our organization, uh, which reduced the Ironwood portion of the selling efforts for Lynn zest. So, I would say first quarter, 2026 is more representative of a a run rate for the remainder of this year, in terms of those reimbursements,

[Company Representative 3] (Ironwood Pharmaceuticals): Thanks, Dominic.

Stop it. Thank you very much.

Stomach.

Operator: We have no further questions at this time. Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

You have no further questions at this time.

Ladies and gentlemen, that concludes today's call, thank you all for joining. You may now disconnect