Q3 2023 Ironwood Pharmaceuticals Inc Earnings Call
Speaker 1: Thank you for standing by. My name is Aaron and I will be your conference operator for today. At this time I would like to welcome everyone to the Ironwood Pharmaceuticals Q3 2023 Investor Update Conference Call.
Thank you for standing by my name is Aaron and I will be your conference operator for today at this time I would like to welcome everyone to the Ironwood Pharmaceuticals, Q3, 2023, Investor update conference call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks.
Speaker 1: All lines have been placed on mute to prevent any background noise. After the speakers remarks, there will be a question and answer session. And if you would like to ask a question during that time, simply press star followed by the number one on your telephone keypad. If you'd like to withdraw your question, simply press star followed by the number one.
There will be a question and answer session and if you would like to ask a question during that time simply press star followed by the number one on your telephone keypad, if you'd like to withdraw your question simply press star followed by the number one again.
Speaker 1: I would now like to turn our call over to Matt Roach, Director of Investor Relations. Matt, please go ahead.
I would now like to turn our call over to Matt Roche Director of Investor Relations Ma'am. Please go ahead.
Speaker 2: Thank you, Erin. Good morning and thanks for joining us for our third quarter, 2023 investor update. Our press release issued this morning can be found on our website. Today's call and accompanying slides includes
Thank you Eric.
Morning, and thanks for joining us for our third quarter 2023 Investor update.
Press release issued this morning can be found on our website.
Today's call and accompanying slides include forward looking statements such.
Speaker 2: such statements involve risk-sidential certainties that may cause actual results to different materially. The discussion of these statements and risk factors is available on the current state proper statement slide as well as under the heading risk factors. Now annual report on form 10K, the year ended, December 31st, 2022, and in our quarterly report on form 10Q, for the second quarter ended June 30th, 2023, in our subsequent SEC filing.
Such statements involve risks and uncertainties that may cause actual results to differ materially.
These statements and risk factors is available on the current safe Harbor statement slide as well as under the heading risk factors.
Annual report on Form 10-K.
Ended December 31, 2022 and in our <unk>.
Quarterly report on Form 10-Q for the second quarter ended June 32023.
Subsequent SEC filings all.
Speaker 2: All four looking statements speak as a data this presentation. We undertake no obligation to update such statements.
All forward looking statements speak as of date of this presentation, we undertake no obligation to update such statements.
Speaker 2: 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 NABAR Pressure Leads for reconciliation of these measures to the most directly comparable GAAP measures .
Also included are non-GAAP financial measures, which should be considered only the tougher it too 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.
Speaker 2: During today's call, Tom McCourt, our Chief Executive Officer, will begin with a brief overview. Mike Schetzline, our Chief Medical Officer, will discuss our pipeline. And Shrevin Emani, our Chief Financial Officer, provide a commercial update and review our financial results in guidance.
During today's call Tom Mccourt, our Chief Executive Officer will begin with a brief overview, Mike <unk>, our Chief Medical Officer, who will discuss our pipeline and <unk> <unk>, our chief Financial Officer provide a commercial update and review our financial results and guidance.
Speaker 3: Today's webcast includes slides. So for those of you dialing in, please go to the event section of our website to access the accompanying slides separately. With that, I'll turn the call over to Tom. Thanks, Matt. Good morning, everyone. And thanks for joining us today. As we approach the end of the year, and look back on the progress we've made across our strategic priorities, we are pleased with the slides taken towards realizing our vision to become the leading GI healthcare company in the industry.
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 slide separately with that I'll turn the call over to Tom Thanks, Matt and good morning, everyone and thanks for joining us today.
As we approach the end of the year and look back on the progress we've made across our strategic priorities.
We are pleased with the strides taken towards realizing our vision to become the leading GI health care company in the industry.
Speaker 3: As you come to expect from us over the years, we continue to maximize Linsus by driving, robust demand growth, and expanding its clinical utility while generating strong cash flows. We are on track to deliver on our Linsus net sales guidance of growth between six and eight percent this year, and remain encouraged about the future growth potential of Linsus based on its continued strong performance in the third quarter.
As you've come to expect from us over the years, we continue to maximize linzess by driving robust demand growth and expanding its clinical utility while generating strong cash flows. We are on track to deliver on our linzess net sales guidance of growth between six and 8% this year and remain encouraged about the future growth.
Potential for Linzess based on its continued strong performance in the third quarter.
Speaker 3: But importantly this year, we have also strengthened and progressed our GI portfolio in areas of high unmet need.
But importantly, this year, we have also strengthened and progressed, our Gi portfolio in areas of high unmet need.
Speaker 3: Earlier this year, we acquired Vecta Bio, including its lead investigational asset, a Pregnant Eye, in development for the treatment of short-bottle syndrome with intestinal failure, which we believe has the potential to achieve a billion dollars in peak net sales and extend the growth horizon for our company into the 2030.
Earlier this year, we acquired effective bio, including its lead investigational asset are primarily tied in development for the treatment of short bowel syndrome with intestinal failure, which we believe has the potential to achieve a $1 billion in peak net sales and extend the growth horizon for a company into the 20 <unk>.
Speaker 3: We couldn't be more excited about the potential for pride with diet. And just a few weeks ago, at the United European Guest Centralology Week, we presented positive final 52-week data from the Phase 2 Stars Nutrition Study in short, Boston, New York, and Texas failure, and colon incontinuity, which were featured during a late-breaker oral presentation.
We couldnt be more excited about the potential for price with Hite.
Just a few weeks ago at the United European Gastroenterology week, we presented positive final 52 week data from the Phase two stars Nutrition study and short bowel syndrome woods intestinal failure and colon and continuity, which were featured during a late breaker oral presentation.
Speaker 3: We believe these days to highlight the potential for EPRAB who guide to be the best in class GLP2 analog for the whole spectrum of patients in short bowel syndrome and testful failure, including those with colon incontinuity and reinforces our high conviction for the Star's clinical program.
We believe these data highlight the potential for <unk> to be the best in class <unk> analogue for the whole spectrum of patients and short bowel syndrome looks at its heart failure, including those with colon in continuity and reinforces our high conviction for the stars clinical program in.
Speaker 3: In addition, we're also excited about the progress of CMP 104, a potentially disease-modifying therapy for the treatment of primary, biliary, colonitis or PBC.
In addition.
We're also excited about the progress of CMP, one O for a potentially disease modifying therapy for the treatment of primary biliary cholangitis or PBC.
Speaker 3: the design of the CMP 104 program and the structure of the licensed option agreement with core pharmaceuticals, are examples of our disciplined approach to building and progressing our development portfolio.
The design of the <unk> program and the structure of the license option agreement with core Pharmaceuticals are examples of our disciplined approach to building and progressing our development portfolio.
Speaker 3: The sound scientific rationale for CMP 104 and the specificity of the target, the PDCE2 antigen, provided an opportunity to review the early effect on T cell response. This assessment showed evidence of T cell responses in patients treated with CMP 104, which is very encouraging.
Sound scientific rationale for <unk> 104, and the specificity of the target. The P. D. C. E. Two antigen provided an opportunity to review the early effect on T cell response.
This assessment showed evidence of T cell responses in patients treated with <unk>, which is very encouraging.
Speaker 3: together, these positive developments across our pipeline, reinforce our confidence. In the tremendous opportunity we have in front of us, with multiple programs that have the potential to improve standard of care and improve quality of life for patients managing GI diseases. And we also have key upcoming data that will help clarify our path forward.
Together these positive developments across our pipeline reinforce our confidence and the tremendous opportunity we have in front of us with multiple programs that have the potential to improve standard of care and improve quality of life for patients managing Gi diseases.
We also have key upcoming data that will help clarify our path forward.
Speaker 3: Our commitment and optimism to develop and advance innovative GI assets is as strong as it's ever been. We believe the positive momentum across our GI pipeline programs, combined with the continued strong performance of Linzess, uniquely positions us on our mission to be the leader in GI.
Our commitment and optimism to develop an advanced innovative Gi assets is as strong as it's ever been we believe the positive momentum across our GI pipeline programs combined with the continued strong performance of Linzess uniquely positions us and our mission to be the leader in Gi.
Speaker 3: We're looking forward to a strong finish in 2023 and are very excited about the key catalyst ahead in 2024, which we believe will propel iron with growth and ability to create value for patients and show shareholders for the years to come.
We're looking forward to a strong finish in 2023 and are very excited about the key catalysts ahead in 2024, which we believe will propel iron was growth and ability to create value for patients and show its shareholders for the years to come I would now like to turn it over to Mike who will review our pipeline and more.
Speaker 3: I would now like to turn it over to Mike, who will review our pipeline in more detail.
Detail, Mike Thanks, Tom and good morning, everyone I'm delighted to provide an update on our pipeline programs, starting with <unk> tied in short bowel syndrome intestinal failure or spss on slide eight share best center with intestinal failure results from severe organ failure due to reduction in test cell function below the minimum.
Speaker 4: Thanks, Tom, and good morning, everyone. I'm delighted to provide an update on our pipeline programs, starting with apiglutide and short bowel syndrome with intestinal failure, or SBSIF, on slide eight.
Speaker 4: Sure, Bell Center for the Testinal Failure results from severe organ failure due to reduction in testinal function below the minimum necessary for normal nutrient and fluid absorption.
Necessary for our normal nutrient and fluid absorption leading to dependence on lifelong parental support or intravenous administration of fluid and nutrients to maintain healthy growth and survival.
Speaker 4: leading to dependence on lifelong parental support or intravenous administration of fluid and nutrients to maintain health, growth, and survive.
Speaker 4: SPSIS is associated with increased mortality, significant morbidity, high economic burden, and reduced quality of life.
<unk> is associated with increased mortality significant morbidity high economic burden and reduced quality of life.
Speaker 4: On slide 8, we highlight two distinct patient populations within SPSIS that have different metabolic needs. They are stoma and colon and continuity, often referred to as CIC.
On slide eight we highlight two distinct patient populations within Sps I asked that have different metabolic needs. They are stoma, and colon and continuity often referred to as CIC.
Speaker 4: Patients with stoma often have a higher degree of fluid loss and dehydration than those with colon incontinuity Since the lack of colon makes sufficient fluid reabsorption more challenging
Patients with <unk>, often have a higher degree of fluid loss and dehydration and those with colon and continuity since the lack of colon make sufficient fluid re absorption more challenging. These patients are often dependent on lifelong franchise support and may require parental support infusions for up to 10 to 15 hours a day.
Speaker 4: These patients are often dependent on lifelong parenteral support and may require parenteral support infusions for up to 10 to 15 hours a day for seven days a week.
For seven days a week.
Speaker 4: Patients with colon incontinuity typically require more nutritional support than absolute fluid volume. Colon incontinuity patients, due to the presence of a functional colon, may have a better opportunity to achieve enteral autonomy, which is the elimination of parenteral support altogether. SVSIF patients with CIC represent greater than 50% of the SVSIF market, and are a distinct patient population currently underserved by available treatment.
Patients with colon and continuity typically require more nutritional support to an absolute fluid volume.
Morning continuity patients due to the presence of a functional colon may have a better opportunity to achieve venture autonomy, which is the elimination of parental support altogether Sps.
<unk> patients with CIC represent greater than 50% of the SBS market and our distinct patient population currently underserved by available treatments.
Speaker 4: Now to slide nine. As Tom mentioned, we're excited about the positive final 52-week data from the Open Label Phase 2 STARS nutrition study.
Now to slide nine as Tom mentioned, we're excited about the positive final 52 week data from the open label Phase two stars Nutrition study starts nutrition is the first ever dedicated study designed to evaluate the clinical benefit of the <unk> and DLP two analogs, specifically in short bowel syndrome, which attests.
Speaker 4: STARS Nutrition is the first ever dedicated study designed to evaluate the clinical benefit of a GLP-2 analog specifically in short bowel syndrome with intestinal failure with colon incontinuity. As you can see on slide 10, parenteral support volume reduction reached a statistically significant 40% at week 24, and the effect was maintained with a 52% volume reduction at week 52.
<unk> failure with colon and continuity as you can see on slide 10 franchise support volume reduction reached a statistically significant 40% at week 24, and the effect was maintained with a 52% volume reduction at week 52.
Speaker 4: And as shown on slide 11, all patients were clinical responders defined as those achieving a parenteral support volume reduction of at least 20%.
And as shown on slide 11, all patients who are clinical responders defined as those achieving a parental support volume reduction of at least 20%.
Speaker 4: At week 52, 7 of the 9 patients or 78% achieved at least one day off parenteral support.
At week 52, seven of the nine patients or 78% achieved at least one day off parental support.
Speaker 4: At week 52, patients gained 2.1 days off parenteral support per week, compared to a mean of 5.2 days per week at baseline, a significant improvement which allows patients more independence.
At week 52 patients gained two one days off franchise support per week.
<unk> to a mean of five two days per week at baseline a significant improvement which allows patients more independence Africa.
Speaker 4: Amproglutide is found to be well-tolerated with an acceptable safety profile.
Africa type is found to be well tolerated with an acceptable safety profile.
Speaker 4: These data are strong testament to the durability of the effect of apiglutide on improving intestinal absorption and reducing parenteral support dependency in CIC patients and reinforces our high conviction in the phase three study.
These data are strong testament to the durability of the effect of Africa tied on improving intestinal absorption and reducing printer will support dependency in CIC patients and reinforces our high conviction in the phase III study.
Speaker 4: Moving to slide 12, the STARS phase 3 study is the largest GLP-2 trial ever conducted in SBS-YF with 164 patients and has been designed to evaluate efficacy in both stoma and colon and continuity patient population.
Moving to slide 12 stars Phase III study is the largest PLP to trial ever conducted in Sps I F. With 164 patients and has been designed to evaluate efficacy in both stoma and colon and continuity patient population.
Speaker 4: The STARS Phase III study's primary endpoint, which includes STOMA and CIC patients, is relative change from baseline in weekly parenteral support volume at week 24. We believe apiglutide has the potential to improve the standard of care as the only once weekly GLPT therapy for SBSIF. It's successful and approved.
<unk> Phase III studies primary endpoint, which includes settlement CIC patients is relative change from baseline in weekly pressure support volume at least 24, we believe Africa tight has the potential to improve the standard of care as the only once weekly COPD therapy for Sps AF is successful and approved.
Speaker 4: We're looking forward to the top line data expected in March 2024, and we'll keep you updated as the study continues to advance.
We're looking forward to the top line data expected in March 2024, and we will keep you updated as the study continues to advance.
Speaker 4: On slide 13 is an expanded view of our portfolio. In addition to evaluating apiglutide for short bowel syndrome with intestinal failure, we're also evaluating the asset as a potential treatment for patients with graft versus host disease, or GVHD.
On Slide 13 is an expanded view of our portfolio. In addition to evaluating <unk> for short bowel syndrome with intestinal failure. We're also evaluating the asset as a potential treatment for patients with graft versus host disease or gvhd.
Speaker 4: Graft-versus-host disease is immunologically mediated and occurs in individuals undergoing allogenic hematopoietic stem cell transplant, where donor immune cells react against the host recipient. The gastrointestinal tract is among the most common sites affected by GVHD. And severe manifestations of GVHD portend a poor prognosis in these patients.
Graft versus host disease is immunologically mediated and occurs in individuals' undergoing allogeneic hematopoietic stem cell transplant.
Donor immune cells react against the host recipient the gastrointestinal tract is among the most common sites affected by Gvhd and severe manifestations of gvhd for tend to poor prognosis. In these patients enrollment is completed and data is expected from this open label Phase II study in the first quarter of 'twenty four.
Speaker 4: Enrollment is completed and data is expected from this open label phase 2 study in the first quarter of 24.
Speaker 4: Now to CMP 104 for the potential treatment of primary biliary cholangiitis.
Now at the CMP <unk> for the potential treatment of primary biliary cholangitis PBC.
Speaker 4: TBC is a slowly progressive and debilitating rare disease driven by an autoimmune response to the PDCE2 antigen in which autoreactive T cells destroy the bile ducts, the underlying root cause of the disease. This may result in profound fatigue and pruritus, as well as other symptoms, and not uncommonly can lead to irreversible damage and scarring of the liver, ultimately requiring liver transplant.
PBC is a slowly progressive and debilitating rare disease, driven by an autoimmune response to the PTC two antigen.
Auto reactive T cells destroy the buybacks the underlying root cause of the disease. This may result in profound fatigue, and pruritus as well as other symptoms and not uncommonly can lead to irreversible damage and scarring and deliver ultimately requiring liver transplant.
Speaker 4: As Tom mentioned, given the strong science behind this clinical program, we had the opportunity to assess peripheral T cells. We completed an early assessment which showed evidence of favorable T cell responses in patients treated with CMP104, supporting the mechanistic rationale for this asset, which we believe could potentially impact disease progression in PBC.
As Tom mentioned, given the strong science behind this clinical program, we had the opportunity to assess peripheral T cells. We completed an early assessment, which showed evidence of favorable T cell responses in patients treated with CMT winner for supporting the mechanistic rationale for this asset, which we believe could potentially impact disease progression and <unk>.
Speaker 4: We're encouraged by the T cell response and we expect top-line data results in the third quarter of 24. As a reminder, the primary endpoint in Phase 2 study includes safety, tolerability, plus change in affluent fossils.
We're encouraged by the T cell response, and we expect topline data results in the third quarter of 24 as a reminder, the primary endpoint in phase III study include safety Tolerability plus change in affluent phosphatase were excited about CMT one of four because it is truly a precision medicine and introduces a potentially new.
Speaker 4: We're excited about CMP-104 because it is truly precision medicine and it introduces a potentially new game-changing therapy for PBC patients, as there are no therapies on the market that address the root cause of this progressive liver disease.
Game changing therapy for PBC patients as Sharon noted therapies on the market that address the root cause of this progressive liver disease moving.
Speaker 4: Moving on to IW3300, a wholly owned ironwood asset for the potential treatment of interstitial cystitis and bladder pain syndrome. There's a significant unmet need in this area, as this condition affects millions of Americans, yet there are very few treatment options currently on the market or in development. We're currently executing a proof of concept phase two study, which is progressing.
Moving onto IW 3300, a wholly earned ironwood asset for the potential treatment of interstitial cystitis bladder pain syndrome, there's a significant unmet need in this area as this condition affects millions of Americans. It there are very few treatment options currently on the market or in development. We are currently executing a proof of concept phase II study, which.
Speaker 4: We're excited about this program as it is the first time the crosstalk hypothesis will be tested in humans, and we're proud to be at the forefront of clinical development in this area.
Is progressing we're excited about this program as it is the first time the cross talk hypothesis will be tested in humans and we're proud to be at the forefront of clinical development in this area.
Speaker 4: Over the past couple of years, we've evolved Ironwood into a leading GI company with a robust pipeline that addresses serious organic GI diseases with high unmet patient need. We're looking forward to an exciting and potentially transformational year for Ironwood with several catalysts in 2024, highlighted by the top line data from the STARS phase three study in March in short bowel syndrome with intestinal failure and top line data from the ongoing phase two study in CMP 104 in the third quarter of 2024. With that, I'll turn it over to Shrevan to review.
Over the past couple of years, we've evolved ironwood into a leading Gi company with a robust pipeline that addresses serious organic gi diseases with high unmet patient need we're looking forward to an exciting and potentially transformational year for ironwood with several catalysts in 2024 highlighted by the topline data from the start phase III.
In March and short bowel syndrome, with intestinal failure and top line data from the ongoing phase II study in CMT one of four in the third quarter of 2024.
With that I'll turn it over to <unk> to review Linzess performance. Thanks, Mike and good morning, everyone. I'll begin on slide 15 in the third quarter Linzess delivered another quarter of impressive volume growth, increasing 8% versus the third quarter of 2022 <unk>.
Speaker 5: Thanks Mike, and good morning everyone. I'll begin on slide 15. In the third quarter, Linzess delivered another quarter of impressive volume growth, increasing 8% versus the third quarter of 2022.
Speaker 5: New-to-brand prescriptions were strong once again, growing 16% year over year, reinforcing that patients and healthcare professionals continue to choose Linzess in a growing market.
New to brand prescriptions were strong once again growing 16% year over year, reinforcing that patients and health care professionals continue to choose linzess and a growing market. We believe there is a significant opportunity to reach appropriate new patients drive additional prescription demand growth clean the roughly 6 million children and adolescents ages.
Speaker 5: We believe there is a significant opportunity to reach appropriate new patients, drive additional prescription demand growth, including the roughly 6 million children in adolescence ages 6 to 17 who suffer from functional constipation.
6% to 17, we suffer from functional constipation.
Speaker 5: Since the June FDA approval in this pediatric population.
Since the June FDA approval in this pediatric population, we have been promoting linzess pediatric gastroenterologists in specific geographies and will continue to assess future promotional expansion based on market response from these efforts and we have received great feedback so far. Additionally, at the recent North American Society for Pediatrics.
Speaker 5: We have been promoting Linzest to pediatric gastroenterologists in specific geographies, and we'll continue to assess future promotional expansion.
Speaker 5: based on market response from these efforts, and we have received great feedback so far. Additionally, at the recent North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition annual meeting, we met with a number of healthcare professionals who were excited by the ability to prescribe Blinzess to help this pediatric patient age group, which is very encouraging.
Gastroenterology, Hepatology and nutrition annual meeting.
With a number of healthcare professionals, who are excited by the ability to prescribe linzess to help this pediatric patient age group, which is very encouraging.
Speaker 5: We look forward to providing updates as we continue to gain more insights into this opportunity, which will help inform the investment level and net sales potential in 2020.
Look forward to providing updates as we continue to gain more insights into this opportunity, which will help inform the investment level and net sales potential in 2024.
Speaker 5: Next, I'll provide a brief update on the Vectiv bio transaction.
Next I'll provide a brief update on the vector bio transaction.
Speaker 5: The integration of Ironwood and Vective Biobusiness Operations is ongoing and progressing as planned. As we continue to integrate, we remain focused on ensuring business continuity, learning from our new colleagues, and progressing after Glutide Expedition.
Integration of Ironwood Invective bio business operations is ongoing and progressing as planned we can't as we continue to integrate we remain.
Focused on ensuring business continuity learning from our new colleagues progressing African tied expeditiously.
Speaker 5: As a reminder, third quarter financial results, notably operating expense and cash flows, include the first full quarter impact from the Vectiv Bio acquisition.
As a reminder, third quarter financial results, notably operating expense and cash flows include the first full quarter impact from the vector bio acquisition.
Speaker 5: We also continue to take the necessary steps to effect a squeeze-out merger, under Swiss law, to acquire the remaining 2% of outstanding vector bio share.
We also continue to take the necessary steps to effect, a squeeze out merger under Swiss law to acquire the remaining 2% of outstanding back to bio shares we.
Speaker 5: We expect this process to be completed by the end of this year and we will provide additional updates once this process is completed.
We expect this process.
By the end of this year and we will provide additional updates once this process is completed.
Next I'll provide additional details on our third quarter financial performance starting with Linzess.
Speaker 5: provide additional details on our third quarter financial performance starting with Linzess.
Speaker 5: As shown on slide 16, U.S. net sales were $279 million, an increase of 7% year-over-year, driven by strong Linzess prescription demand growth of 8% versus the prior year quarter, in line with her full-year guidance.
As shown on slide 16 U S. Net sales were $279 million, an increase of 7% year over year, driven by strong linzess prescription demand growth of 8% versus the prior year quarter in line with our full year guidance.
Speaker 5: Commercial margins, 72%, compared to 74% in the third quarter of 2020.
Marshall margins, 72% compared to 74% in the third quarter of 2022.
Speaker 5: Ironwood revenues were $114 million, driven primarily by U.S.-Linzess collaboration revenues of $110 million.
Ironwood revenues were $114 million, driven primarily by U S Linzess collaboration revenues $110 million.
Speaker 5: Ironwood recorded $18 million of income tax expense in the third quarter. The majority of which was non-cash. In addition, Ironwood recorded $10 million in interest expense and other financing costs and generated $2 million in interest investment.
Ironwood recorded $18 million income tax expense in the third quarter, the majority of which was noncash.
Ironwood recorded $10 million in interest expense and other financing costs and generate $2 million in interest investment income.
Speaker 5: Gap net income was $14 million and adjusted EBITDA was $49.
GAAP net income was $14 million and adjusted EBITDA was $49 million.
Speaker 5: In the third quarter, we generated approximately $33 million in cash flow from operations and ended the third quarter with $110 million in cash and cash equivalents, after repaying $75 million of the outstanding principal balance on our evolving credit facility in cash.
In the third quarter, we generated approximately $33 million in cash flow from operations and ended the third quarter with $110 million in cash and cash equivalents after repaying $75 million of the outstanding principal balance on our revolving credit facility in cash.
Speaker 5: as the end of September , the outstanding drawn balance on the revolver was $325 million.
And as the as.
At the end of September the outstanding drawn balance on the revolver was $325 million.
Speaker 5: Moving forward, we continue to maintain our focus on generating profits and meaningful cash flows. We will prioritize investments to maximize
Moving forward, we continue to maintain our focus on generating profits and meaningful cash flows we will prioritize investments to maximize the value of linzess.
Speaker 5: progress our development portfolio and manage our capital structure through debt pay down while maintaining the flexibility to evaluate additional opportunities for capital development.
<unk>, our development portfolio and manage our capital structure through debt pay down while maintaining the flexibility to evaluate additional opportunities for capital deployment.
Speaker 5: Next, I'll review our 2023 guidance on slide 17.
Next I'll review, our 2023 guidance on slide 17.
Speaker 5: We are reiterating our full year 2023 financial guidance as we remain confident in the continued strength of Flinders.
Reiterating our full year 2023 financial guidance as we remain confident in the continued strength of Linzess.
Speaker 5: We continue to expect to invest U.S. net sales growth of between 6 and 8 percent.
We continue to expect Linzess U S net sales growth of between six and 8%.
Speaker 5: Ironwood revenue between $435 and $450 million.
Ironwood revenue between 435 $450 million.
Speaker 5: and an adjusted EBITDA loss of approximately $900 million.
And an adjusted EBITDA loss of approximately $900 million.
Speaker 5: which includes a one-time charge of approximately $1.1 billion from the acquisition of ActiveFile.
Which includes a onetime charge of approximately $1 1 billion.
From the acquisition of bio.
Speaker 5: Excluding the impact of the one-time charge, adjusted EBITDA is an approximate representation of operating cash flow.
Excluding the impact of the onetime charge adjusted EBITDA is an approximate representation of operating cash flows.
Speaker 5: To wrap up, we are pleased with our third quarter results, and we are looking forward to a strong finish to the year. We are well-positioned for continued growth, and we remain focused on maximizing LINZS, strengthening and progressing our innovative GI portfolio, and delivering sustained profits and generating cash flow.
To wrap up we're pleased with our third quarter results and we are looking forward to a strong finish to the year.
We are well positioned for continued growth and we remain focused on maximizing linzess strengthening and progressing our innovative gi portfolio and delivering sustained profits and generating cash flow.
Speaker 5: We are excited about continued strong Linzess performance and to keep pipeline catalysts ahead of us.
We are excited about continued strong linzess performance and the key pipeline catalysts ahead of us, which we believe will help launch ironwood's next phase of growth.
Speaker 5: We believe we'll help launch Ironwood's next phase of growth.
Speaker 5: We'll close by thanking all of our employees, patients, caregivers, and advocates for their shared dedication to advancing and supporting therapies for GI disorders.
Want to close by thanking all of our employees patients caregivers and advocates for their shared dedication to advancing and supporting therapies for Gi disorders. Operator, you may now open up the line for questions.
Speaker 1: Thank you. And at this time, I would like to remind everyone that if you would like to ask a question today, press star followed by the number one on your telephone keypad and we'll pause for just a moment to compile the Q&A roster.
Thank you and at this time I would like to remind everyone that if you would like to ask a question today Press star followed by the number one on your telephone keypad and we'll pause for just a moment to compile the Q&A roster.
Our first.
Speaker 1: Question comes from the line of Jason Butler
<unk> comes from the line of Jason Butler.
Your line is live.
Speaker 6: hi thanks for taking the question and i think that's on the quarter uh...
Hi, Thanks for taking my question and congrats on the quarter.
Speaker 6: Just three for me. But first of all, I was asked, can you speak to what if any impact the label expansion had on the disaster in the quarter and what you're seeing into the fourth quarter? Second on Afro-Glutai, can you speak to how improvements in an actual autonomy can help by the pricing of a jury reimbursement?
Just three for me personal Linzess can you speak to what if any impact the label expansion had on linzess in the quarter and what youre seeing into the fourth quarter.
Second on <unk> can you speak to.
How improvements in actual autonomy can help by the pricing leverage and reimbursements.
Speaker 6: And then just last one, CMP104, can you speak to the magnitude of the T cell responses and how that might, you know, speak to the predictive value for clinical outcomes? Thanks.
Then just last night <unk> four can you speak to the magnitude of the T cell responses and how that might.
Speak to the predictive value for clinical outcomes.
Speaker 5: Yeah. So I'll answer the first one, Jason, and I'll hand him over to Mike to get the second and third. With respect to our 2023
Yeah. So I'll answer the first one Jason and I'll hand them over to <unk>.
To get the second and third.
With respect to our 2023 guidance.
Speaker 5: We're extremely excited to be able to offer Linzess as the first and only approved prescription therapy for pediatric patients suffering from functional constipation for patients ages 6 to 17.
We're extremely excited to be able to offer linzess is the first and only approved prescription therapy.
For pediatric patients suffering from functional constipation for patients aged six to 17.
Speaker 5: Our sales guidance of 68% for the full year includes any impact from the pediatric indication so it's in the guidance that we've already given.
Our sales guidance of 6% to 8% for the full year includes any impact from the pediatric indication. So it's in the guidance that we've already given.
Speaker 5: And as a reminder, I think we've stated this before, we've set minimal contribution from Pediatrics in 2023 as we focus on these promotional pilots.
And as you as a reminder, I think I think we've stated this before we expect minimal contribution from pediatrics in 2023, as we focus on these promotional pilot programs and as we kind of assess where we're at and we'll come back at the start of next year. When we give guidance for 2024 as to what we think the opportunity size really will be for next.
Speaker 5: And as we kind of assess where we're at, and we'll come back at the start of next year when we give guidance for 2024 as to what we think the opportunity size really will be for next year.
Year.
Speaker 4: Mike, you want to take the question? Yeah, I think the question was on the enteral autonomy for the apogruti program. I think it's an important question because patients who suffer from SBSIF and require parenteral support actually have a huge sort of economic burden with their disease because they have to connect themselves to this IV administration of fluid and nutrients, oftentimes, as we said, for multiple hours in a day for seven days a week.
Mike you want to take the question, Yes, I think that the question was on the enter autonomy for the Applegate type program I think it's an important question because patients who suffer from spss and require <unk> support actually have a huge sort of economic burden with their disease, because they have that Eddie.
At connect themselves to this IV administration of fluid and nutrients oftentimes as we said for multiple hours in a day for seven days a week so.
Speaker 4: Your question is on inter-autonomy, but we need to remember that even reducing that requirement by a day or two is a significant economic improvement because for these things to happen every day, it's a huge burden on the patient, but also a financial burden. Achieving inter-autonomy is where you remove completely the need for parenteral support. So that's why inter-autonomy in a way is curative related to parenteral support need because you no longer need to tether yourself to the IV fluid administration every day.
Your question is on enter autonomy, but we need to remember that even reducing that requirement by a day or two it was a significant economic improvement because for these things happen every day, it's a huge burden on the patient, but also financial burden achieving enter autonomy is where you re move completely the need for parenteral support so that's why enter autonomy.
In a way is curative related to parental support need because you no longer need to tether yourself to the IV fluid administration every day.
Speaker 4: So that's why we think it's a very important consideration in this population. It's also important to understand that prior products haven't really focused on the colon and continuity patient population. And with our approach, we think we have a great opportunity in that population to potentially achieve enteral autonomy.
So that's why we think it's a very important.
<unk> in this population, it's also important to understand that prior.
Products haven't really focused on the colon and continuity patient population and with our approach. We think we have a great opportunity in that population to potentially achieve enter autonomy.
Speaker 3: And lastly on the CM. Sorry. The other part of the question that I thought I heard was how did this lend to really the pricing opportunity? And obviously the value proposition here is very, very strong. One is Mike Pantin is really burdensome disease. These patients are very costly to manage.
And then lastly on the <unk> I'm sorry.
The other part of the question that I thought I heard.
It was hot has led to really the pricing.
Opportunity.
And obviously the value proposition here is very very strong one as Mike mentioned is really <unk>.
Some disease. These patients are very costly to manage.
Speaker 3: and there's certainly a price point out there are already established with the currently available therapy which is sizable.
And there's certainly a price point out there are already established.
With the currently available therapy, which is sizable so I think we're looking at bringing a.
Speaker 3: So I think we're looking at bringing a very strong clinical profile to the table that can basically manage probably a broader patient population in a more significant way, which obviously is going to put us in a pretty good position as far as where we would enter the market and how we would enter the market.
Very strong clinical profile to the table that can that they can basically manage probably a broader patient population and a more significant way, which obviously is kind of put us in a pretty good position as far as where we would enter the market and how we would enter the market and maybe Mike you can talk specifically about the T cells are yes sure.
Speaker 4: And maybe, Mike, you can talk specifically about the T-cells. Yeah, sure. So it's a good question. And I can tell you what we can tell you, OK, from a T-cell response magnitude. I mean, remember, as Tom alluded to this as well, the reason we did this deal was because of the strong science behind the clinical study and the chance to assess the potential opportunity by analyzing peripheral T-cells. And recall, there's a peripheral T-cell look for a disease that's confined to the liver and the bile.
So it's a good question and I can tell you what we can tell you. Okay from a T cell response magnitude I mean remember as Tom alluded to this as well. The reason we did this deal is because of the strong science behind the clinical study and the chance to assess that potential opportunity by analyzing peripheral T cells and recall this is a peripheral T cell or look for.
For a disease, that's confined to deliver in the biotech stocks. So we completed the early assessment, which showed evidence of T cell responses, which really support the mechanism mechanistic rationale for CMP, which we believe could potentially impact disease progression, but it is a very small unblinded review, which was to determine if we could see this effect on T cells.
Speaker 4: So we completed the early assessment, which showed evidence of T cell responses, which really support the mechanistic rationale for CMP, which we believe could potentially impact disease progression.
Speaker 4: but it was a very small, unblinded review, which was to determine if we could see this effect on T cells. So while we're encouraged by the early look and by the favorable findings, we do need to remember that as a reminder, the primary endpoint for the phase two has safety tolerability as well as ALKFAS. And we're really looking forward to that data set to better understand what these changes in the peripheral T cells mean on clinical endpoints.
So while we are encouraged by the early launch and by the favorable findings, we do need to remember that as a reminder, the primary endpoints for the phase II has safety tolerability as well as well as Amtrust and were really low.
Looking forward to that data set to better understand what these changes in the peripheral T cells named on clinical endpoints.
Thanks, Jason.
Thank you for the questions.
Speaker 1: Our next question is from the line of David Anselam with Piper Sandler.
Our next question is from the line of David insulin with Piper Sandler.
Your line is live.
Speaker 7: Hey, thanks. So just had a couple of commercially oriented questions on app blue tide. Can you just remind us of the size of the CIC?
Hey, Thanks, So just had a couple of commercially oriented questions.
On an absolute side can you just remind us.
The size of the CIC.
Speaker 7: patient subgroup relative to the the stoma subgroup. That's number one. Number two is what is the approximate if you have this patient footprint or number of patients that are on that are on GATEC?
<unk> subgroup relative to the.
The stoma subgroup.
Number one number two is what is the.
Approximate if you have this patient.
Footprint or number of patients that are on there on GATX.
Speaker 7: And what's your estimate of, you know, the patients, the number of patients over time that have cycled through it? That's number two. And then lastly, just later thoughts on, how are you thinking about pricing of the average blue tide to the extent that age in Eric of Gathex materializes. Thank you.
What's your estimate of.
The patients for the number of patients over time that have cycled through it.
That's number two and then lastly, just latest thoughts on.
How are you thinking about pricing of <unk> tied to the extent that a generic of GATX materializes. Thank you.
Speaker 5: All right, so I think I'll start on the first one, and then, Mike, you check me on this. Our estimates right now are that the market is essentially 50-50 between stoma patients and TIC patients. The overall market size globally is 17,000 patients.
Alright, so I think I'll start.
The first one and then Mike you got your check me on this.
Our estimates right now are that that market is essentially 50 50 between stoma patients and.
And CIC.
CIC patients.
The overall market sizes globally 17000 patients.
Speaker 5: And so, and it's roughly 50-50 between the two.
And so and it's roughly 50 50 between the two subsets.
Speaker 5: Number two, with respect to the patient footprint on GATAC, and the number of patients treated, I think our, again, this is all public information.
Number two with respect to the patient's footprint on GAAP tax and the number of patients treated I think are again. This is all public information.
Speaker 5: you know, to be checked, I think our understanding is that it's about 2,000 patients in the U.S. that have been treated by GAT.
To be checked I think our understanding is that it's about 2000 patients.
In the U S that have been treated by <unk>.
GATX.
Speaker 5: So that's the number that we have. And then third, David, on pricing, I think Tom already answered this question. I think we're going to, you know, the GATX already has a, you know, a number that's out there. With respect to the idea of
So thats the number that we have.
And then third David on pricing I think Tom already answered. This question I think we're going to.
Yes.
<unk> already has.
Yes.
A number thats out there with respect to the idea of.
Speaker 5: generic, you know, I think our view is we're going to come with a very interesting and compelling data package here hopefully in that we'll find out in a few months, but hopefully we'll have a compelling data package to bring to the market and and something that will be quite competitive. And then I think on top of that the idea of a generic, we don't really see the generic being that viable here, just there's not.
A generic.
Our view is we're going to come with a very interesting and compelling data package here hopefully in that won't find out in a few months, but hopefully we'll have a compelling data package to bring to the market.
And something that will be quite competitive.
And then I think on top of that the idea of a generic we don't.
Not really see the generic being that viable here just theres not.
Speaker 5: That much patient population, as you can see from Gasex only, having treated 2000 patients in the United States, it's not an asset for a disease state we think is heavily managed. And there isn't a lot of volume to go get from a massive reduction in price in this one. I think...
That much patient population as you can see from GATX only having trained 2000 patients in United States, its not an asset or a disease state. We think is heavily managed.
And there isn't a lot of volume to go get from.
A massive reduction in price in this one.
I think we also feel that there's probably.
Speaker 3: it's not a real high probability that we'll see a generic. Certainly there's been, you know, an end of file, but nobody's really acted on it. And obviously these, you know, you're gonna have to maintain a REMS program, et cetera. So this is a, and there's a lot of mechanics to be able to launch a generic and support the generic. So I do think that, you know, and I think when you look at,
Not a real high probability that we'll see a generic.
Certainly theres been.
No.
And the NDA filed but nobody's really acted on it and obviously youre going to have to maintain a rems program et cetera. So this is a.
And there's a lot of mechanics to be able to launch a generic.
And support the generic.
So I do think that and I think when you look at.
Speaker 3: you know, the fact that about 50% of patients discontinued therapy on Gattics, you know, within the first year, I think it speaks to the limitations of the drug. And I think, you know, having a drug, you know, move from like daily injections to once a week injections and a drug that's certainly more potent and longer acting, you know, really could help a broader patient population, particularly these CIC patients. Thanks, David.
The the fact that about 50% of patients discontinue therapy on <unk>.
Within the first year I think it speaks to the limitations of the drug and I think having a drug.
From like daily injections to once a week injections in a drug that's certainly more potent and longer acting.
Really could help a broader patient population, particularly the CIC patients.
Okay. Thanks, David.
Thank you.
Thank you for your question.
Speaker 1: Our next question is from the line of Boris Peaker with TD Cohen. Your line is live.
Our next question is from the line of Boris <unk> with TD Cohen.
Your line is live.
Speaker 8: Great, a couple of questions for me. First on 104, just curious why are entry disclosing the T cell data or maybe another way to ask it is.
Great.
<unk> for me first on one off for just curious why arent you are disclosing the T cell data or maybe another way to ask it is when will we see the actual T cell data and then.
Speaker 8: And then on the upper gluteide, if we look at zealence-glepogluid, they showed a 14% of patients become independent of front-bone nutrition. I'm just curious how important is that.
On the Africa tide I mean, if we look at Zealand cyclical type they showed a 14% of patients become independent of parental nutrition I'm just curious how important is that.
In terms of kind of assessing the <unk> data.
Yeah. Thanks, <unk> for your questions on.
Speaker 5: On the first question, I'll take it and then, again, obviously add additional color. I don't think we ever, I think our plan is always to run this trial to completion before we read out any results and we've always contemplated that being a 2024 event. I think at this point in time, we're able to say that we think we'll be able to.
On the first question.
I'll take it and then Mike again, obviously add additional color.
I don't think we ever.
Our plan is always to run this trial to completion before we readout any results and was always contemplated that being a 2024 event I think at this point in time, we're able to say that we think will be able to have a readout in the third quarter of 2024.
Speaker 5: have a readout in the third quarter of 2024 for the trial.
For the trial.
Speaker 5: And I think that's when you'll see a more complete data set around the primary end.
And I think thats when Youll see a more complete dataset around the primary endpoint.
Speaker 4: I might get on if there's anything else. I don't know if it gets better. All right, and then in the second question, do you want to take the second one? Yeah, so for the Antural Autonomy question, it's a good question. Clearly, it was Antural Autonomy achieved in the Cleppa program that's in the public domain.
Mike I don't know if there's anything else on it I think it's fair Alright, and then the second question do you want to take the second one yeah. So far they enter autonomy question. It's a good question.
Clear there was enter autonomy achieved clep a program that's in the public domain.
Speaker 4: And you may have seen from our presentation at the UEG meeting on the star nutrition data that we had enter autonomy achieved in the nutrition study as well. I'm gonna have to be a higher percentage in the 14% that a glipoglutide has published, but nonetheless it's a small open label study. So we're just looking forward to the face-tree data to better define those outcomes for the patient populations we have in the star study.
And you may have seen from our presentation at the <unk> meeting on the Sars nutrition data that we had entered autonomy achieved in nutrition study as well I'm going to have to be a higher percentage in the 14% that.
Tide has published but nonetheless, it's a small open label study. So we're just looking forward to the phase III data to better define those outcomes for the patient populations. We have in this <unk> study.
Great. Thanks for taking my question.
Thank you for your question.
Speaker 1: Ladies and gentlemen, once again, if you would like to ask a question on today's call today, remember it's star followed by the number one on your touch tone.
Ladies and gentlemen, once again, if you would like to ask a question on today's call today remember at Star followed by the number one on your Touchtone keypad. Our next question is from the line of Tim Chiang with capital one.
Speaker 1: Our next question is from the line of Tim Chang with Capital One.
Your line is live.
Speaker 9: Hey, thanks. Since we're almost done with 2023, and obviously you're doing still quite well with Lin-Dez. I sort of wanted to get your thoughts on how you sort of look at growth rates for Lin-Dez for next year. Obviously, you'll probably provide some guidance at the beginning of next year. But how do you guys think Lin-Dez is situated at this point?
Thanks.
We're almost done with 2023.
Obviously, youre doing still quite well with Linzess I sort of wanted to get your thoughts on how you sort of look at growth rates for Linzess for next year, obviously, probably provide some guidance at the beginning of next year, but.
How do you guys think Linzess is situated at this point.
Speaker 5: Thanks to him, good to talk to you. I think as we've said already, we're excited about the performance of Lundzass right now and the volume growth we've had in 2023. The fact that we're near 11 of the drug.
Thanks, Tim.
Talk to you I think as we've said already we're excited about the performance of Linzess right now and the volume growth. We've had in 2023 and the fact that we're near 11 of the drug still driving high single digit demand growth is just a great outcome.
Speaker 5: Still driving high single digit demand growth is...
Speaker 5: We think that there are a lot of untreated patients who are keen to be in a growing market, so we're excited about that.
Outcome and so we think that there are lot of unpaid untreated patients tend to be in a growing market. So we're excited about that.
Speaker 5: With respect to future guidance, I think we'll give guidance at the appropriate time, which is next year in the early part of like the OEC.
With respect to future guidance I think we will give guidance at the appropriate time, which is next year.
In the early part of it like we always do.
Speaker 3: Yeah, I think, you know, Jim is Tom. It's been really remarkable over the last three years.
John This is Tom.
<unk> been really remarkable over the last three years, how steady the growth year over year has been and certainly this year has actually been stronger than we've seen in a long time.
Speaker 3: How steady the growth year over year has been and certainly this year has actually been stronger than we've seen in a long time.
Speaker 3: And what's probably the most important lead indicator here is the volume increase in new to brand patient.
And what's probably the most important lead indicator here is the volume increase in new to brand patients.
Speaker 3: you know, we're at, you know, 15, 16% increase year over year, which is always probably the most the best predictor of future growth. So...
We're at 15, 16% increase year over year, which is always probably the most the best predictor of future growth. So.
Speaker 3: We're certainly not signing up for a 15% increased number for next year, but certainly it's looking very very strong and certainly We're still assessing the upside from the pediatric indication. There's no question. We're seeing some growth there And we really need to you know really understand kind of how much we should be investing in that growth opportunity, but I think
We're certainly not signing up for a 15% increase number for next year, but certainly.
Looking very very strong and certainly.
We're still assessing the upside from the pediatric indication. There's no question, we're seeing some growth there and we really need to really understand kind of how much we should be investing in that growth opportunity, but I think.
Speaker 3: Things look bright, and I think we're very confident in what we'll see next year.
Things look bright and I think we're very confident in what we'll see next year.
Speaker 9: Maybe just one trial up. And obviously, we all get a lot of questions about the Glipp ones, about the weight loss drugs. If you see any impact, I mean, is there any impact to lenses from these Glipp one drugs for weight loss?
Maybe just one follow up obviously.
<unk> get a lot of questions about the glib ones, but the weight loss drugs.
Any impact I mean is there any impact to linzess from.
Lift one.
Drugs for weight loss.
And Mike do you want to kind of take this.
Yeah I mean.
Speaker 4: Yeah, it's a fair question. And we do get questions on it as well on our side. I mean, because as you know, I mean, the Glipp ones are definitely being heavily used. And it's also true that obese patients also suffer from constipation quite regularly too. So there is a lot of concomitance. I mean, the actual impact, though, that you really want to get at, it's hard to nail that down at present. But we certainly appreciate the question. There may be some things there. We're looking into it, but we don't really have a direction right now to how the...
Yeah, It's a fair question and we do get questions on it as well on our side I mean, because as you know I mean, the eclipse lines are definitely.
In heavily used and it's also true that obese patients also suffer from constipation quite regularly too. So there is a lot of concomitant use I mean, the actual impact study you really want to get at it is hard to nail that down at present, but we certainly appreciate the question there may be some things there where we're looking into it but we don't really have that.
Direction right now to have that type of impact that.
Speaker 10: Okay, great. Thanks.
Okay, great. Thanks.
Speaker 1: Thank you for your question. And ladies and gentlemen, that will conclude today's iron would pharmaceuticals Q3 2023 investor update conference call. Thank you all for joining. You may now.
Thank you for your question and ladies and gentlemen that will conclude today's Ironwood Pharmaceuticals Pharmaceuticals, Q3, 2023 Investor update conference call. Thank you all for joining you may now disconnect.
Speaker 11: Please wait, the conference will begin shortly. Thank you.
Please wait the conference will begin shortly.
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