Q1 2020 Earnings Call

[noise], ladies and gentlemen, thank you for standing by L. welcome to the Ironwood Pharmaceuticals first quarter 2020, 2020, Investor update conference call.

Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Ironwood Pharmaceuticals First Quarter 2020 Investor Update. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0.

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Good afternoon, and thanks for joining asked for first quarter 2020, Investor Epee I press release Cross the wire. This afternoon and can be found on our website W.W.W. dot ironwood format Dot com.

Unknown Executive: Good afternoon, and thanks for joining us for our first quarter 2020 Investor Update. Our press release crossed the wire this afternoon and can be found on our website, www.ironwoodpharma.com. Today's call and accompanying slides include four forward-looking statements. Such statements involve risks and uncertainties that may cause actual results to differ materially. A discussion of these statements and risk factors is available on the current Safe Harbor Statement slide, as well as under the heading Risk Factors in our annual report on Form 10-K for the year ended December 31, 2019, and in our future SEC filings. All forward-looking statements speak as of the date of this presentation, and we undertake no obligation to update such statements. Also included are non-GAAP financial measures, which should be considered only as a supplement to and not a substitute for or superior to GAAP measures.

Today's call any company inside include forward looking statements such statements involved risks uncertainties that may cause actual result to defer materially a discussion d. statements in risk factors is available on the currency Harbor statement side as well as under the heading risk factors in our annual report on form 10, K. for the year ended December 31st 2000, a night.

Team and and our future at D.C. firing.

Oh forward looking statements speak after the data. This presentation, we undertake no obligation to update such statements.

Also included or Nongaap financial measures, which should be considered only as a supplement to and not a substitute for or superior to get measure.

Unknown Executive: 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, Mark Mallon will begin with an overview of the quarter, Tom McCourt will review our commercial and pipeline performance, and Gina Conselman will review our financial results and guidance. Meg Shetzline will also be available during the Q&A portion of the call, and we will be referring to slides via the webcast. For those of you dialing in, please go to the events section of our website to access the webcast slides. With that, I'll turn the call over to Mark.

Pretty extensive clickable please refer to the tables at the end never press release for reconciliation. So these measures to them as directly comparable got measure.

During today's call Mark now and will begin with an overview of the quarter <unk> commercial and pipeline performance and Gina consummate or your financial results in time.

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We will be refrain besides via the web cast for those of you dialing and please go to the events section of our website to access the web cast that but that altering the color to mark.

Thanks merits and thanks, everyone for joining us today.

Mark Mallon: Thanks, Meredith, and thanks, everyone, for joining us today. We hope you and your families are safe and healthy in these challenging and uncertain times. The Ironwood team is all in different locations today as we continue to work remotely. It has been just over one year since Ironwood launched as a GI-focused healthcare company. We've made significant progress towards achieving our mission of advancing GI treatment and redefining the standard of care for millions of patients in need. We enter 2020 with a strong foundation and continue this momentum in the first quarter, highlighted by double-digit Lincez prescription demand growth. The advancement of our 3718 Phase III Program for Refractory Goods and the completion of patient dosing in our 7246 Phase 2 trial for abdominal pain associated with IBSD in our fourth consecutive quarter of delivering profit. However, the first quarter was also marked by the beginning of an unprecedented time in the U.S. and around the world.

Hope you and your family the safe and healthy in these challenging in uncertain times. The I would team are all in different locations today as we continue to work remotely.

It is and then just over one years since we launched as a G.I. focus healthcare company, we've made significant progress towards achieving our mission of advancing G.I. treatments and redefining the standard of care for millions of patients a neat.

We entered 2020 with a strong foundation and continue this momentum in the first quarter highlighted by double digit Lin says prescriptions demand growth.

Management about 37, 18 phase three program for Refractor regard.

The completion of patient dosing in our 70 246 face to trial for abdominal pain associated with I.B.S.D. in our fourth consecutive quarter of delivering profits.

How are the first quarter was also marked by the beginning of an unprecedented time in the U.S. in around the world to cope with 19 pandemic as cause substantial disruption to our lives.

Mark Mallon: The COVID-19 pandemic has caused substantial disruption to our lives, the healthcare system, and the economy. Navigating this pandemic is a primary focus for all of us right now, and so we plan to spend a good portion of today's call discussing the impact that it's having on our business, the actions that we're taking in response, and our unwavering focus, especially during these times, to deliver on Ironwood's vision First and foremost, the health and well-being of Ironwood teammates and their families, as well as patients, healthcare providers, and our broader communities, is our primary focus. Both our headquarters and customer-facing employees have been working remotely since March 16th.

Health care system in the economy navigating this pandemic is a primary focus for all of US right now and so we plan to spend a good portion of today's call discussing the impact that is having on our business. The actions were taking response in our unwavering focus, especially during these times the deliberately I would vision admission.

First and foremost the health and wellbeing barring with teammates and their families as well as patient healthcare providers in our broader communities is that primary focus both our headquarters in customer facing employees I've been working remotely since March 16th we've developed comprehensive plans for employees to resume in person work practices and expect to begin implementing.

Mark Mallon: We've developed comprehensive plans for employees to resume in-person work practices and expect to begin implementing those plans as we determine it to be safe to do so and pending relevant health authority guidance. As demonstrated by our strong fourth-quarter performance, we believe Ironwood is well-positioned to face these challenging times, and we remain steadfast in our vision to become the leading U.S. GI health care company. We are announcing today that we continue to expect to generate greater than $105 million in adjusted EBITDA in 2020, as we previously announced as part of our 2020 financial guidance. We've decided to withdraw the remainder of our 2020 guidance until we have greater clarity on the impact that COVID-19 may have on our business. Before turning it over to Tom, I'll close by saying that I remain confident in Ironwood, both today and its future. G.I. These diseases affect an estimated 70 million Americans in the U.S., or one in every five Americans. Additionally, nearly two-thirds of Americans report being burdened by GI symptoms at least once per week. New, innovative therapeutic approaches to treat GI diseases are needed, and Ironwood is ready to lead this important work.

Those plans as we determine it to be safe to do so and pending relevant health authority guidance.

As demonstrated by a strong first quarter performance, we believe I would as well positioned to face these challenging times and we remain steadfast in our vision to become leading U.S.G.I. healthcare company.

We are announcing today that we continue to expect to generate greater than $105 million in adjusted EBITDA in 2020, as we previously announced as part of our 2020 financial guidance.

Added to withdraw the remainder of our 2020 got into until we have greater clarity on the impact that Kobe 19 may have on our business.

Before turning it over time, I'll close by saying that remain competent and I would well today and it future.

Yeah, I diseases effect, an estimated 70 million Americans in the U.S. or one in every five American nearly two thirds of Americans report being burdened by G.I. symptoms at least once per week, new innovative therapeutic approaches to treat your eye diseases are needed and everyone is ready to lead in this important space.

Mark Mallon: As we look ahead, our focus is on building sustainable, profitable growth and enhanced value creation. We are investing thoughtfully in our growing business, and our capital allocation strategy is aligned with our three strategic priorities. We continue to deploy our capital towards driving wind size growth, advancing our late stage pipeline, and delivering sustainable profits. As we mentioned when we provided our full year results, we are also exploring inorganic opportunities that we believe fit well within our strategy and can deliver significant patient and shareholder value. We remain disciplined and rigorous in our approach in this current environment and beyond. With that, I'll now turn it over to Tom.

We look ahead or focus on building a sustainable.

Profitable growth and enhance value creation, we're investing thoughtfully into our growing business in our capital allocation strategy is aligned with a three P.C. card, we continue to play our capital towards driving when says growth.

Dancing I late stage pipeline and delivering sustainable profits as we mentioned when we provided I fully results were also exploring inorganic opportunities that we believe fit well within our strategy and can deliver significant patient and shareholder value, we remain disciplined and rigorous in our approach in this current environment and beyond what's that Oh now turn it over to Tom.

Thanks for good afternoon after one.

Prescription demand grew 11%.

Quarter and impressive growth rate in our eight years since launch.

Thomas A. McCourt: Thanks, Mark. Good afternoon, everyone.

Thomas A. McCourt: Linzess prescription demand grew 11% year over year in the first quarter, an impressive growth rate in our eighth year since launch, and especially considering some of the headwinds that we typically face during the first quarter of each year as high detectable plans get reset. There was an increase in lymphedema during the first two weeks of the quarter, which we believe to be the result of patients docking to COVID-19. We also saw a meaningful increase in the number of 90-day prescriptions filled during the quarter, which we believe will help support patient compliance during this time. While it's early, and uncertainties regarding the impact of COVID-19 remain, we are encouraged by the continued growth that we're seeing in the second quarter, reinforcing our confidence in the brand.

And especially considered somebody headwinds that we typically face during the first quarter during each year as as high deductible planes get reset.

There was an increase in loses demand during the first two weeks or the quarter, which we believe it'd be the result of patience dock you do the covert 19.

We also saw a meaningful increasing the number of 90 d. prescriptions filled during the quarter, which we believe will help support pasting compliance during this time.

Well, it's barely in a certain views regarding the impact of corporate 19 remain.

Courage by the continued growth that we're seeing in the second quarter reinforcing or confidence in the brand.

This is established clear prescription market leadership within the category and remains they trusted brand amongst position.

Studies indicate that patient with chronic symptomatic disorders, such as I.B.S.C. are more likely to refill their prescription during this time because of the symptomatic nature, which serves as a regular reminder for patients to take their medication.

Thomas A. McCourt: Linzess has established clear prescription market leadership within the category and remains a trusted brand among physicians. Studies indicate that patients with chronic symptomatic disorders such as IBSD are more likely to refill their prescriptions during this time because of the symptomatic nature, which serves as a regular reminder for patients to take their medication. For many patients, refilling a Linzess prescription is often as easy as just calling the healthcare professional. Approximately half of all Linzess prescriptions are refilled. Meaning they are being filled by patients that are currently taking Linzess, and the majority of new prescriptions are for patients who have had some experience with Linzess. Estimates suggest approximately 10 to 14 percent of Linzess patients are new to the Linzess brand entirely. It is with this subset of patients that we are seeing the largest negative impact due to COVID-19 to date. There has been a sharp decline in patient visits to doctor's offices since mid-March due to the pandemic, and new patients are more likely to need to see their physicians to get a prescription.

So many patients <unk> prescription is often as easy as just calling the healthcare professional approximately half a total themselves prescription or <unk>.

Meeting there being billed by patients that are currently taking lives.

The majority of new prescriptions, our patients who have had some experience with Linda.

Estimates to just approximately 10% to 14% of windows patients are new to the lenses brand entirely.

It is with this subset of patients we're seeing the largest negative impact do the covert 90 today.

There has been a sharp decline and patient visits the doctor's offices mid March due to the pandemic.

New patients are more likely to you need to see the position to get a prescription.

We expect Rome, new patients starts to increase over time once more local markets begin to open patient visits increase.

In our fuel resume in person promotion.

Overall, the brand has continued to seek role in market share even in the base to these challenging market impacts.

Between mid March in mid April lenses outperformed as competitors within the prescription I.B.S.C., a chronic conservation category across keys demand metrics, including total volume growth.

Thomas A. McCourt: We expect growth in new patient starts to increase over time. Once local markets begin to open, patient visits increase, and our field resumes in-person promotion. Overall, the brand has continued to see growth in market share, even in the face of these challenging market impacts. Between mid-March and mid-April, Linzess outperformed its competitors within the prescription IBSC and chronic constipation category across key demand metrics, including total volume growth. The size of Linda's prescriptions and market share is now close to 40%. All of this further strengthens Linzess Prescription Market Leadership.

The size of Windows prescription and marketeer is now close to 40%.

All of this further strengthens lenses prescription market leadership.

And our again have implemented several initiatives to enable continued engagement with both healthcare practitioners and with patients during this time.

We believe these changes will be important today and into the future given the evolution of how to communicate with our customer.

First we implemented a broad tele medicine initiative.

Successful pilot program in 2018, we believe that lives the fitting brand for Tele medicine due to the prescription market leadership in the category, It's demonstrated African seeing safety profile.

Thomas A. McCourt: We have implemented several initiatives to enable continued engagement with both health care practitioners and with patients during this time. We believe these changes will be important today and into the future, given the evolution of how to best communicate with our customers. First, we've implemented a broad telemedicine initiative. Following a successful pilot program in 2019, we believe that Linzess is a suitable brand for telemedicine due to the prescription market leadership in the category, its demonstrated efficacy and safety profile, broad payer access, and physicians' confidence to diagnose and treat patients virtually. Second, our DTC campaign, Get Real, was launched in early April.

Up here right.

Imposition competence to diagnose and treat virtually.

Second Argh you campaign get real was launched in early April.

We are leveraging well T.V. and radio with the strong call to action for patients to recognize that they may be suffering from I.B.S.C.

Chronic disorder noxious occasional constipation.

In doing so we believe we can activate more patient.

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And third we've provided multiple new tools in the field for it so they can conduct details virtually.

Thomas A. McCourt: We are leveraging both TV and radio with a strong call to action for patients to recognize that they may be suffering from IBSD, a chronic disorder, not just occasional constipation. In doing so, we believe we can activate more patients to seek care and request LISF. And third, we provided multiple new tools to the field force so they can conduct details virtually. While these activities cannot replace in-person interaction, I've been impressed by the level and depth of engagement in many of these virtual details.

Well these activities cannot replace in person interaction.

Been impressed by the level in depth of engagement many of these virtual detail.

Turning to live does supply.

Again remain focused on maintaining the availability lenses per patient.

We have not seen any significant impact on our ability to manufacture and supply linked to the U.S. today.

Closely monitoring the situation.

Currently believe we have sufficient Linda supply on hand to meet the U.S. demand at this time.

Thomas A. McCourt: Turning to Linda Supply. We at Allergan remain focused on maintaining the availability of lenses for patients. We have not seen any significant impact on our ability to manufacture and supply lenses to the U.S. to date, and we're closely monitoring the situation. We currently believe we have sufficient Linzess supply on hand to meet U.S. demand at this time. Lastly, an important announcement: We just announced last week that the U.S. PTO issued notices of allowance for two patent applications covering the 72-microgram dose of Linzeth. If these patent applications proceed to grant, Do they expect to be issued in 2020 and expire in 2031? We believe these actions further speak to the strength of the innovation surrounding Lynda.

Athlete and importantly.

We just announced last week that the U.S.P.T.O. issued notices overload for to patent applications covering the 72 microgram built with Linda.

If these patent applications precede the grant.

Do they expect to be issued in 2020 and expire in 2031.

We believe these actions further speak to the strength of the innovation surrounding wind up.

Turning to our partnership with an island and good Laurie.

Which was approved in November of last year for the treatment of acute attic for a period or eight H.P.

Early results from our G.I. focus efforts regarding position identification of H.B. patient and recognition of glory as an effective treatment option is encouraging.

Thomas A. McCourt: Turning to our partnership with Anilin and Gablari, which was approved in November of last year for the treatment of acute hepatic failure, or AHP. Early results from our GI-focused efforts regarding physician identification of AHP patients and recognition of Govlari as an effective treatment option are encouraging. Even during these uncertain times, we continue to work closely with NILM to identify opportunities to support AHP patient identification and treatment with Givlaria for appropriate patients.

Even during these uncertain time, we continue to work closely with an island to identify opportunities to support H.B. patient identification and treatment with good Lori per per patient.

Moving towards you have pipeline.

3718724 to our key to driving the long term value for our business <unk>.

We believe but each of these product opportunities has the potential.

It helped me the unmet need millions of patients.

37, 18, or Castro retentive bio asked this question.

Thomas A. McCourt: Moving to our GI pipeline, 3718 and 7246 are key to driving long-term value for our business.

Currently in phase three trials for potential treatment of refractory occurred.

As of today, we have enrolled approximately 70% of patients into two trials <unk>.

Thomas A. McCourt: We believe that each of these product opportunities has the potential to help meet the unmet need of millions of patients. Starting with 3718, our gasser, retentive, bioassay, sequester, currently in phase 3 trials with potential treatment for refractory GERD. As of today, we have enrolled approximately 70% of patients into two trials, the majority of whom have completed the studies. However, over 90% of the 3718 clinical sites have suspended patient screening due to COVID-19. And so our ability to enroll new patients has been substantially impacted. However, the sites are continuing to monitor the patients who are already enrolled in the trials, which the sites can do remotely. The safety of those patients is our highest priority. Despite the current challenges, we are committed to completing the Phase 3 program. We no longer expect to report top-line data in the second half of 2020 and are now working to achieve top-line data as soon as possible in 2021.

The majority of cool have completed the study.

However over 90% of the some of the 37 18 clinical site.

<unk> patients screening due to cope with 19.

It's our ability to enroll new patient it's been substantially impact.

The sites are continuing to monitor the patients were already enrolled in the trials, which can which the sites can do remotely.

The safety of those patients is our highest priority.

Despite the current challenges we are committed to complete the page three program.

We no longer be spectra report top line data in the second half of 2020 and are now working to achieve top blind date as soon as possible and 2021.

We plan to share more information as we gain certainty.

<unk> medical need <unk> remains high we believe that 37 18 has the potential to improve both heartburn in regurgitation symptom.

Both of which are not completely resolved with P.P.I.N.

In other treatment option.

Turning out to 7246.

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Currently interface to trial for the treatment of patience with abdominal pain associated with I.B.S.D.

Thomas A. McCourt: We plan to share more information as we gain certain, The unmet medical need for refractory gird remains high. We believe that 3718 has the potential to improve both heartburn and regurgitation symptoms, both of which are not completely resolved with PPIs and other treatment options. Turning now to 7246, a delayed release formulation of Linaquatide currently in a Phase II trial for the treatment of patients with abdominal pain associated with IBSD. We now expect to deliver top-line results in the second quarter of 2020, earlier than our previous guidance of mid-2020.

We now expect to deliver top line result in the second quarter 2020.

Earlier than our previous guidance of made 2020.

Believe 7246, that's a potential it'd be a non opioid pain relieving agent.

Patients suffering from abdominal pain associated with certain G.I. diseases.

Are positive phase to I.B.S.D. results with that 7246 support this hypothesis.

As the data demonstrated that seven two parts to reduce the Domino pain similar to 290 micrograms of Linda.

With limited effect on ball function. Additionally.

Phase one dose escalating study showed that 70 246 did not affect well function healthy volunteers when taking up to 3000 micrograms once a day.

Thomas A. McCourt: We believe 7246 has the potential to be a non-opioid pain-relieving agent for patients suffering from abdominal pain associated with certain GI diseases. Our positive Phase 2 IBSD results with 7246 support this hypothesis, as the data demonstrated that 7246 reduced abdominal pain similar to 290 micrograms of Linzess with a limited effect on bowel function. Additionally, a phase one dose escalating study showed that 7246 did not affect bowel function in healthy volunteers when taken up to 3,000 micrograms once a day. If the Phase 2 IBSD data are positive, we plan to conduct an end of Phase 2 meeting with the FDA with the goal of initiating a Phase 3 program in IBSD in early 2021. With that, I'll turn it over to Gina.

If the phase to I.B.S.D. data are positive replanted conducting the entropy stewed meeting with the F.D.A. with the goal of initiating a phase three program and I.B.S.C. in early 2021, what's that Oh current it over to Gina.

Okay.

10 minutes I like I first quarter financial performance.

Another financial impact we might see as a result.

And share our expectations for the remainder of the year.

Part of our best friend detail financial information.

Trying with our first quarter results in the first quarter of 2020.

Revenues for 80 million.

16% increase your over here.

Yes.

71 million and U.S. collaboration revenue combined with 5 million entails.

As we complete the transition.

Responsibility overarching R.I.Q.S. partner.

Yeah for 172 million during the first quarter.

Increasing your over here.

Gina Conselman: Thanks, Tom. Over the next few minutes, I will highlight our first quarter financial performance, discuss some of the financial impacts we might see as a result of COVID-19, and share our expectations for the remainder of the year. Please refer to our press release for detailed financial information. Starting with our first quarter results, in the first quarter of 2020, total Ironwood revenues were $80 million.

The difference between that has pros and prescription demand growth.

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One has come or something.

Per second the first quarter, the higher commercial market.

I see 120 20 compared to the first quarter last year was driven by higher than test set sail.

Meetings, resulting from the field.

During the last two weeks at the corner.

Every not telling activities conducted by though I am one.

Are excluded from the U.S.

Gina Conselman: A 16% increase year-over-year. Revenues were driven primarily by $71 million in U.S. collaboration revenue, combined with $5 million in sales of API, as we complete the transition of manufacturing responsibilities over to our ex-U.S. partners. Linzess net sales were $172 million during the first quarter, a 7% increase year-over-year. The difference between net sales growth and prescription demand growth is primarily due to a decrease in inventory, partially offset by net price improvement. Linzess commercial margin was 73% in the first quarter; the higher commercial margin for the brand in Q1 2020 compared to the first quarter last year was driven by higher Linzess net sales and some cost savings resulting from the field force being remote during the last two weeks of the quarter. The remote selling activities conducted by both Ironwood and Allergan are excluded from the U.S. Windsor Commercial Collaboration.

Collaboration.

We expect.

And before spend and the second quarter.

It's time to feel it has already been no during the quarter.

It's hard.

Certain until we have more clarity about.

You know again, we activate in person promotion broadly.

No training to earnings.

Yeah.

3 million for the quarter not gotten that income by 7 million and adjusted to you, but I was 14 million during the first quarter of 2020.

Maybe a quarter then that lost across.

During the first quarter of 29 soon as we have yet to complete the separation from site Clarion.

And lastly, I feel quite <unk>, sometimes.

44 million cash from operation ending the corner with a cash balance that 231 million.

There's proposition comedian providing us with.

Our corpus without the need to raise additional fun during these highly uncertain times.

It was combined with the actions, let me check and 29 ancient reduced are expensive simplify our business and spread out our debt obligations. Further increases are confident in our financial position. During this time.

Gina Conselman: We expect a larger decrease in field force spend in the second quarter due to the amount of time the field has already been remote during the quarter. The total impact remains uncertain until we have more clarity around when we and Allegan will reactivate in-person promotion broadly. Now turning to earnings. Gap net income was $3 million for the quarter, non-gap net income was $7 million, and adjusted EBITDA was $14 million during the first quarter of 2020. And lastly, a few quick remarks on cash. We generated $44 million in cash from operations, ending the quarter with a cash balance of $231 million.

We didn't know any major disruption to our financial.

In the first quarter.

T area.

Cut in Los neatly impact our financial performance for the remainder of 2020 Arlington entering spend the money.

Hum highlighted we are encouraged by the demand growth, we're continuing to see however, we're monitoring for any impact the Kobe 19 aren't a man and clothing did have reduced in person promotion or potential changes and patient access to healthcare and reimbursement.

Millions of Americans, losing their jobs thing going on on unemployment. We've only this could ship the patient me Oh wait I'm commercial insurance, which currently represents approximately half of our business.

Towards Medicaid, which comes at a much higher class.

We have nothing much of this today, but we're monitoring it costly.

Combined with any pressure on demand due to lower.

Or otherwise, maybe thought and lower U.S. net sales in 2020, then originally expected.

That that we're confident in the long term called potential for the brand.

Gina Conselman: We believe this is a very strong position to be in, providing us with the capital to support our core business without the need to raise additional funds during these highly uncertain times. This, combined with the actions we took in 2019 to reduce our expenses, simplify our business, and spread out our debt obligations, further increases our confidence in our financial position during this time. We did not see any major disruptions to our financials as a result of COVID-19 in the first quarter. The two key areas that we believe could most meaningfully impact our financial performance for the remainder of 2020 are LINZEF and 3718. On LINZEF, as Tom highlighted, we are encouraged by the demand growth we are continuing to see.

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It is expected to resolve.

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It's funny I. Some of these costs are now expected completely into 2021.

Note that we do expect aggregate clinical trial expenses for three seven wanting to increase over the duration of things trials.

But potentially lower three seven money.

With expected cost saving associated with it <unk> sales force could result in favor ability to Iowa.

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Taking all of this consideration we're maintaining our four year 2020 guidance of expected adjusted even Oh greater than 105 million, we're focused on delivering profits.

Preliminary estimates alisa potential impacts a call that 19 until investing U.S. that fail.

Maybe partially offset by the cost saving trying to feel forcing remote and the cost of late.

237 money.

Which gives us confidence in our original of greater than 105 million on 2020 adjusted either.

Gina Conselman: However, we are monitoring for any impacts of COVID-19 on demand, including due to reduced in-person promotion or potential changes in patient access to healthcare and reimbursement. With millions of Americans losing their jobs and going on unemployment, we believe this could shift the patient mix away from commercial insurance, which currently represents approximately half of our business, towards Medicaid, which comes at a much higher rebate to us. We have not seen much of this today, but we are monitoring it closely.

We are withdrawing the remainder of our 2020 financial guidance at this time.

<unk> uncertainties around the potential for and magnitude any color 19 related impacts.

In closing we once every every that due to the action completed over the past year handling performing.

We believe ironwood's in a position as strange as me weather, the storm and strive to continue to grow our business and deliver shareholder value.

That I'll turn it back to Mark for some closing comment.

Thanks, Tina before we open up the call for today I'd like to take a moment to recognize the team here at Ironwood I've been incredibly impressed and proud of the organization it's ability to remain focused during these difficult times.

Gina Conselman: This, combined with any pressure on demand due to lower new-to-brand growth or otherwise, may result in lower U.S. net sales in 2020 than originally expected. However, with that said, we are confident in the long-term growth potential for the brand. On 3718, the delay in enrollment is expected to result in lower R&D spend in 2020, as some of these costs are now expected to be delayed into 2021. However, note that we do expect Aggregate Clinical Trial Expenses 43718 to increase over the duration of these trials.

It's not easy time to maintain a high level of execution on our business priorities, but the I would change managed to do just that and so I would like to say, thank you to everyone and ironwood than I ever been community and for their hard work and dedication to advancing our vision of becoming a leading G.I. focused healthcare company and so now like.

I think we're ready for questions and so finish up.

That's good we have any questions.

Sorry, if you have any question.

Yeah.

Gina Conselman: The potentially lower 3718 spend combined with expected cost savings associated with the remote field force could result in favorability to Ironwood's P&L in 2020. Taking all of this into consideration, we are maintaining our full year 2020 guidance of expected adjusted EBITDA of greater than $105 million. We are focused on delivering profits, and based on our preliminary estimates, believe the potential impact of COVID-19 on Lindus U.S. Net Sales may be partially offset by the cost savings from the field force being remote and the cost delays due to the impact on 3718 enrollment, which gives us confidence in our original guidance of greater than $105 million in 2020 adjusted EBITDA. We are withdrawing the remainder of our 2020 financial guidance at this time due to the continued In closing, we want to reiterate that due to the actions completed over the past year and the Linzess performance seen to date, we believe Ironwood is in a position of strength as we weather the storm and strive to continue to grow our business and deliver shareholder value. With that, I'll turn it back to Mark for some closing comments.

From the line of write her room.

Hi, This is like go ahead.

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Hi, This is Blair Cohen I I'm just a few questions for you do you think the prescriber patterns and changed dramatically as a result of the pandemic and then what what would you say.

Calm you want to take that one.

Sure I mean, no question there has been.

Nitpicking changes, particularly.

With the reduction in in office visits switch, which had been down almost 70 per cent based on the data we seen so far.

Well, we have been C. is E.E.E. migration to would tell it held tele medicine model, which you know a number of both primary care N.G.I. positions are embracing.

And in in the US you know we have been actively looking at at that capability for for some time, we've implemented Tele medicine program that is driven off our consumer campaign and we have been talking in working with health care professionals to see how we can help them and and how we can it.

Better enable this kind of capability.

I think moving forward you know in talking to a number of these physician yeah, they've recognize how much more efficient you know this these you know managing some of these patients can be through a tele medicine platform.

Even as you know patients will get more comfortable you know coming back to the office.

So I do think things will change.

I think you know I think we've gotta continue to adapt in overcoming serve patients in the most effective way.

Mark Mallon: Thanks, Gina. Before we open up the call for Q&A, I'd like to take a moment to recognize the team here at Ironwood. I've been incredibly impressed and proud of the organization's ability to remain focused during these difficult times. It's not an easy time to maintain a high level of execution on our business priorities, but the Ironwood team has managed to do just that. And so I would like to say thank you to everyone at Ironwood and in the Ironwood community for their hard work and dedication to advancing our vision of becoming a leading GI-focused healthcare company.

I think in one of the things that I mentioned is you know with I.B.S.D. and lived that you know, it's well poised to be able to be leverage you know in in that kind of remote console.

And we're seeing more and more of it and I think it's largely helping us to stay in the ongoing growth through the brand.

Awesome. Thank you and do you think the launch.

It's going to be affected by a company making.

I mean.

Huh.

Okay sure. Thanks, Mark I can't comment specifically, what I, what I can tell you is one as you know this is the this is a horrendous disease and this is an incredible breakthrough, which got US excited about playing a role in helping a an island bring this the patient that of course, you know our presence in the G.I. office.

Mark Mallon: And so now I'd like to, I think we're ready for questions. And so, Venetia, I'll ask you if you have any questions. Venetia, sorry, if you have any questions.

Operator: Um, yes, we do have a question from the line of Rathuram South.

You know was was a natural fit because this is where most of these patients or manage.

Operator: Hi, this is

Unknown Attendee: Hi, this is Blair Cohen on the phone. Just a few questions for you. Do you think prescriber patterns have changed dramatically as a result of COVID-19?

That being said, we we've identified a number of patients that are being actively pulled through the system. I think there there may be some short term impact, but everything I'm I'm hearing up from the the Pullthrough side the patient pull through site is you know, we're continuing to pull patient through we're getting paid.

Thomas A. McCourt: Transcribed by https://otter.ai Tom, do you want to take that one?

Thomas A. McCourt: Sure.

Thomas A. McCourt: I mean, no question there have been significant changes, particularly with the reduction in office visits, which have been down almost 70 percent based on the data we've seen so far. What we have been seeing is a migration to a telehealth and telemedicine model, which a number of both primary care and GI physicians are embracing. And, and, and thus, you know, we have been actively looking at that capability for some time.

Drug and I think we need to continue the stay the course, it's still early yeah to to kind of interpret that but I think certainly be an island team would be better equipped it to discuss more specifically answer kind of the the question on an actual demand.

Sure and then going to the taste three program per 37 18.

Thomas A. McCourt: a telemedicine program that is driven by our consumer campaign, and we have been talking and working with healthcare professionals to see, you know, how we can help them and how we can, you know, better enable this kind of capability. You know, and I think moving forward, you know, in talking to a number of these physicians, they've recognized how much more efficient this, at least, managing some of these patients can be through a telemedicine platform, even as, you know, I do think things will change. I think we've got to continue to adapt and overcome and serve patients in the most effective way. And I think one of the things that I mentioned is that with IBSD and LINZUS, it's well poised to be able to be leveraged in that kind of remote consultation. And we're seeing more and more of it. And I think it's largely helping us sustain the ongoing growth of the brand.

Do you see that that trial panning out originally you know plan.

You think like any of that the data results can be compromise because the the delay.

My can you take that.

Sure.

For the face to program you were at committed to complete interface tree program and recognized it it's a fairly large development program.

Up or you know 660 patients in the two clinical trials, we have had to your point impact in screening due to cope with 19 and like much of the industry that has really impacted or ability to continue to enroll at the rate we wanted to to meet our 2020 timeline.

However, we do have a very safe products, we administrating in that program called what's up man with a gastric retentive. So we do have an opportunity to do things remotely once I patients are enrolled so we have had a slow down for screening.

That has impacted enrollment, but we are very able to move patients through the study given the safe product and to visit schedule. Their patients had so we do think we can get get patients through to study and we're committed to completing the phase three and we'll be exploring all potential options in order to do so and that continues to work actively with that we continue to work.

Unknown Attendee: Awesome. Thank you. And do you think the launch of

Unknown Attendee: The launch of Givlari is going to be affected by COVID-19.

Thomas A. McCourt: Go ahead, Tom; you can take that, too. Okay, sure. Thanks, Mark.

Thomas A. McCourt: I can't comment on that specifically. What I can tell you is, one, this is a horrendous disease, and this is an incredible breakthrough, which got us excited about playing a role in helping Anilin bring this to patients. And of course, you know, our presence in the GI offices was a natural fit because this is where most of these patients are managed. That being said, we've identified a number of patients that are being actively pulled through the system. I think there may be some short-term impact, but everything I'm hearing from the pull-through side, the patient pull-through side, is, you know, we're continuing to pull patients through, we're getting patients on drugs, and I think we need to continue to stay the course. It's still early to kind of interpret that, but I think certainly the aniline team would be better equipped to more specifically answer the question about actual demand.

Actively with sites better understand to be initiation of screening and how that activity could best proceed. So that we can better in form the expected timeline to get the pre coded recruitment to define our ultimate end of study timeline as we get further updates regarding pets board will certainly can to share them with you.

Perfect and last question for me how critical do you think be allowance of claims it's for that 72 goes.

So you know obviously, we're very.

Quick answer on that I mean, we're we're very encouraged by this I think you know a large percentage of these do go on to to get issues expected. We remain very competent in R.I.P. and so you know we'll be monitoring and in watching his process continues.

Okay. Thanks, guys.

Yeah.

I take up.

Good afternoon guys.

Thanks for taking my questions with respect to the guided knowing that this environment is highly uncertain, but you know could you provide any additional color.

Unknown Attendee: Sure, and then we go to the Phase 3 program for 3718.

It was under lighting your they'll see below guidance and.

Unknown Attendee: Do you see that?

Unknown Attendee: That trial is paning out as originally planned.

No color on the rubber new trends early in the second quarter.

Unknown Attendee: Do you think any of the data or results could be compromised?

Good would you.

You have some additional huh.

Shocking happy to thanks for the question.

Unknown Attendee: All of those could be compromised because of the delay. Mike, can you take that? Sure.

Yeah, I can start with maybe just talking about.

Why we are comfortable riding be greater than 105 million.

Michael Shetzline: Yes, for the Phase III program. We're committed to completing the Phase III program and recognize that it's a fairly large development program. We have over, you know, 660 patients in the two clinical trials. We have had, to your point, an impact on screening due to COVID-19, and like much of the industry, that has really impacted our ability to continue to enroll at the rate we wanted to meet our 2020 timeline. However, we do have a very safe product we're administering in that program, Colosevelam with the gastric retentive, so we do have an opportunity to do things remotely once patients are enrolled. So, we have had a slowdown in screening that has impacted enrollment, but we are very able to move patients through the study given the safe product and the visit schedule that patients have.

No.

The previous skating plain items.

And one is that no one that's just a thought to a strong start and 2020.

But through keeps you as well.

And.

What you're getting to answer your question, we certainly have.

Uncertainty.

Three seven when a trial in romance and they reduced in person promotion.

Unfavorability, there and say well, we certainly don't alright.

You know and.

Thanks actually start trying to <unk>.

When we are back in the field and when the whole thing we can increase our trial in domain as well.

There's obviously uncertainty as to the severity and the duration of the cold at night in impact.

But any negative offsets from lensx commands and to be more specific on that the demand side, we are potentially monitoring.

Michael Shetzline: So, we do think we can get patients through the study, and we're committed to completing Phase III, and we'll be exploring all potential options in order to do so. And we continue to work actively with sites to better understand the reinitiation of screening and how that activity could best proceed so that we can better inform the expected timeline to get the pre-COVID recruitment to define our ultimate end-of-study timeline. And as we get further updates regarding the path forward, we'll certainly share them with you.

Changes from unemployment chest less disposable income for American, but we're also looking at it as potential price compression as well so if you're thinking about it from a commercial side indication that patient to to medicate for instance, it includes.

Higher rebate for us and I understand why not quite.

Given the uncertainty and I just wanted to me that that we're not getting to that once at the top line and then obviously are are I am like revenue.

However, I will say that while we have some capability.

Unknown Attendee: Perfect. And last question for me: how critical do you think the allowance of

We have some negative offset we conducted you know our ran up range a model and then the majority of those we are still expected to every thought into a minimum adjusting though 105 million per year.

Unknown Attendee: What level do you think the allowance of claims is for that 72 dose?

Thomas A. McCourt: So, you know, obviously, we are very, I think it's a quick answer to that. I mean, we're very encouraged by this.

Thomas A. McCourt: I think, you know, a large percentage of these do go on to have issues as expected. We remain very confident in our IP. And so, you know, we'll be monitoring and watching as the process continues. Perfect. Thanks, guys.

Well of course continue to monitor the update and provide regular updates.

<unk>.

Okay. That's very helpful and then just on.

So you get closer to the close of the transaction with that'd be good cause you have just curious on.

Operator: And your next question comes from the line of Jacob Hughes.

Any interaction too high with the T. man any potential changes to that to that relationship brother, that's on the marketing side or or otherwise.

Jacob William Hughes: Hi Jacob. Hey, good afternoon, guys. Thanks for taking my questions. With respect to the guidance, knowing that this environment is highly uncertain, but, you know, could you provide any additional color on whether there's anything underlining your adjustability guidance and, you know, any additional color on the revenue trends early in the second quarter? Geeta, would you... Do you have some additional thoughts?

So I'll say a couple of words in time, you can also add a a thoughts of so first thing when I say you know the Algarin team has continued to stay really very focused and our always strong collaboration has continued and I I think certainly come through with the execution and the results in the <unk>.

Gina Conselman: Sure, Mark. I'm happy to.

First quarter and even into the into the second quarter. So.

Gina Conselman: Thanks for the questions. So, you know, I can start with maybe just talking about them. Why we were comfortable providing the greater than $105 million EBITDA guidance while we were no longer reiterating the previous guidance line items. And one is that, you know, Linzess is just off to a strong start in 2020, not just in Q1, but through Q2 as well. And, and this is probably what you're getting to in your question. We certainly have uncertainty related to the 3718 trial enrollment and the reduced in-person promotion. We've seen some favorability there, and, well, we certainly don't prefer it.

Hmm majority of the people who have been in place and there's staying very engaged and we keep working on that.

As we also it said you know we've had very preliminary sort of discussions because they've they've been sensitive to closing we still not quite close so that we're getting very close now and so don't really have any updates on that they you know our interactions have been positive we expect that they will.

Be working to keep the momentum going and that would be working to keep everything moving forward the supposedly.

You know the as we said before the parameters of the arrangement our partnership basically kind of continue largely a as is the key decision making bodies of the joint development Committee in commercial committee and the rules sort of governing though so basically stay the same and so we're we're ready to go full steam ahead I don't know if Tom if you have anything else.

Gina Conselman: It is adding to our P&L. And, you know, based on when states actually start to enroll, it will determine when we are back in the field and when, hopefully, we can increase our trial enrollment as well. There's obvious uncertainty as to the severity and the duration of the COVID-19 impact, but any negative offsets from LINDSEC demand, and to be more specific on that, the demand side, we are potentially monitoring changes from unemployment, just less disposable income for Americans, but we're also looking at it as potential price compression as well. So if you're thinking about it from the commercial side and the patient's move to Medicaid, for instance, it includes a much higher rebate for us and, obviously, a lower net price.

<unk>.

Yeah, just a couple of things first is you know there's been a terrific partnership with for this.

As well as Alex <unk> and as we move forward is is I know bill Murray's working closely with Abby on the integration he's keeping us well informed a good portion of the team will stay intact.

Particularly on the yeah. The sales sales management side, the number of people in the brand teams.

Will be intact, which I think will aid in a smooth transition and also.

Gina Conselman: And given the uncertainty on that, it is one of the reasons that we're not guiding to the LINDSEC top line and, obviously, our Ironwood revenue. However, I will say that while we have some favorability, we have some negative offsets. We conducted, you know, or ran a range of models. And in the majority of those, we are still expected to achieve a minimum adjusted EBIT of $105 million for the year. We will, of course, continue to monitor the progress and provide regular updates to you at least each quarter.

We agree on an overall brand plan.

At the at the beginning of every year, which obviously, we'll see attack, which really identifies the the investment to be made into plan and it certainly the overall strategies that support the brand bull up from a commercial side as well as the development side in in 7246 is mark.

Mentioned, we've had some initial interactions with with Abby, which had been very very encouraging I'm very excited about the opportunity to work with them. They have some very remarkable capabilities, particularly in the area of patients support.

Mark Mallon: Okay, that's very helpful. And then, you know, as you get closer to the close of the transaction with Abby, could you please tell me about any interactions you've had with the team and any potential changes to that, to that relationship, whether that's on the marketing side or otherwise. So, I'll say a couple of words, and Tom, you can also add thoughts. The first thing I want to say is that the Allegren team has continued to stay really very focused, and our always strong collaboration has continued, and that, I think, certainly shows through with the execution and the results in the first quarter and even into the second quarter. So, you know, the majority of the people have been in place, and they're staying very engaged, and we keep working on that.

In in in G.I. disease with your mirror that I think we can learn a lot from it and I think will will further enable us the better serve our patients.

Okay.

Thanks, a lot guys push.

<unk> Thanks ticket.

The next question comes from the line of.

Hi.

Hi, how are you thinking the question.

Just to come from me first on the eastern stocking pattern, but you you noted and you think you're seeing some benefit in the first quarter here from can you can you qualify that for for US a bit is that sort of a bunch of an increasing number of 90 days prescriptions.

Mark Mallon: As we also said, you know, we've had very preliminary sort of discussions with Abbie because they've been sensitive to closing. We're still not quite closed, although we're getting very close now. And so, I don't really have any updates on that. They, you know, our interactions have been positive. We expect that they will, you know, be working to keep the momentum going, and that we'll be working to keep everything moving forward smoothly. You know, as we've said before, the parameters of the arrangement, our partnership, basically continue largely as is. The key decision-making bodies of the Joint Development Committee and the Commercial Committee and the rules that are governing those basically stay the same. And so, we're ready to go full steam ahead. I don't know if, Tom, you have anything else to add to that.

Prior quarters and are you anticipating any chips and channel inventory in second quarter or going forward in order to meet that pattern.

And then I have to follow up.

Tom you want to take take that yeah sure as far as the you know the increase that we thought we so we saw a bit of a surge.

You know for a couple of weeks in in total are axes, you know, which which came back down but we still you know we're still tracking it double digit growth year on year, but there was a pretty significant jump over a period of time. Yeah. We did also see this corresponding increase in a 90 days.

A larger percentage of the patients are requesting 90 days to make sure. They have their medication you know for an extended periods of time here.

So you know, but I think you know the overall trend line looks pretty stable from from what we saw you're finishing last year into this year and as you recall, we generally see a pretty significant dip.

Thomas A. McCourt: Yeah, just a couple of things. First, as you know, it's been a terrific partnership with Forrest and Dallas, as well as Allergen, now AbbVie. And as we move forward, as I know, Bill Murray's working closely with AbbVie on the integration, he's keeping us well informed, and a good portion of the team will stay intact. Particularly on the sales and sales management side, a number of people on the brand teams will be intact, which I think will aid in a smooth transition. And also, we agree on an overall brand plan at the beginning of every year, which obviously will stay intact, which really identifies the investment to be made in the plan and certainly the overall strategies that support the brand, both from a commercial side as well as the development side in 7246.

In the first quarter in in spite of all that the brand is just holding up remarkably well I'm, particularly with the rate of refills, which has been very encouraging as far as the channel.

It's you know obviously it you know it tends to fluctuate quarter to quarter. Obviously, that's been closely monitored to make sure that we don't have any stockout, but I don't <unk>, we certainly don't see any risk to the brand there.

We certainly do see quarter to quarter fluctuations.

In in.

In in the overall inventory, but we haven't seen anything dramatic over the last quarter to that we haven't seen before.

Thomas A. McCourt: As Mark mentioned, we've had some initial interactions with AbbVie, which have been very, very encouraging. I'm very excited about the opportunity to work with them. They have some very remarkable capabilities, particularly in the area of patient support in GI disease with Humira, that I think we can learn a lot from and that I think will further enable us to better serve our patients.

Okay, Okay got it.

I'm also curious to know whether at this point you have a sense of what the greatest sensitivities are too.

When that demand from the reduced in person promotion effort I know, it's no hard at this point to know where it went to new normal whoa, what it looks like beyond the pandemic, but I am curious to know whether you see any efficiencies on the commercial stayed inside.

Jacob William Hughes: Thanks a lot guys; I appreciate it. Thanks, Jacob.

Operator: And your next question comes from the line of Eric Joseph.

Eric Joseph: Hi, how are you? Thanks for taking the time to answer the questions. Just a couple from me. First, on the patient stocking pattern that you noted, and you think you're seeing some benefit in the first quarter here. Can you quantify that for us a bit? Is that sort of a reflection of an increase in the number of 90-day prescriptions compared to prior quarters? And are you anticipating any shifts in channel inventory in the second quarter or going forward in order to meet that pattern? And then I have a follow-up. Tom, you want to take that? Yeah, sure.

And still being able to grow prescription volumes or whether we should expect the powder. Another commercial spent sort of wrapping a backup on either side of yeah.

<unk>.

You can take a stab at that I might have a common to add as well.

Absolutely first of all it I think you know this is a very promotion really sensitive market.

Thomas A. McCourt: As far as the, you know, the increase that we saw, we saw a bit of a surge for a couple of weeks in total Rx, which came back down, but we're still, you know, tracking its double-digit growth year on year. But there was a pretty significant jump over a period of time. And we did also see this corresponding increase in 90 days. A larger percentage of patients are requesting 90 days to make sure they have their medication for an extended period of time here.

And there's there's no replacement for personal promotion I think you know we're doing a yeomans effort.

And in supporting patients and it also our customers remotely and virtually and I think we're putting a number of innovative playing such as it telling medicine in place, but as far as a personal promotion you know, we we pushed it hard in the first quarter to get out of the gates strong and the.

<unk> absolutely terrific job in in driving you know continuing to drive you double digit growth I think the other thing to keep in mind is you know, we constantly evaluate and refine the overall selling model with regard to or reach with regard to our frequency who's.

Thomas A. McCourt: So you know, but I think, you know, the overall trend line looks pretty stable from what we saw, you know, finishing last year into this year. And, as you recall, we generally see a pretty significant dip in the first quarter. And in spite of all that, the brand is just holding up remarkably well, especially the rate of refills, which has been very encouraging. As far as the channel goes, obviously, it tends to fluctuate quarter to quarter. Obviously, that's being closely monitored to make sure that we don't have any stock outs. We certainly don't see any risk to the brand there, but we certainly do see quarter-to-quarter fluctuations in the overall inventory, but we haven't seen anything dramatic over the last quarter or two that we haven't seen before.

Gonna make the calls that were in where it causes.

Estimate of that in in his you know we've changed it quite a bit overtime bowls with regard to the number of targets the frequency called as the sales force has become increasingly more efficient.

I I do I do not see a replacement for in office promotion personal promotion I think you know where it shouldn't you get back into the office too you know to continue to drive demanded broaden positions view of who the appropriate patient is.

So, but I don't see any dramatic change over overall sewing effort is we kinda reengaging customers. So you know market. If you have a couple of additional comments.

Eric Joseph: Okay, okay, got it. Um, and, um, I'm also curious to know whether at this point you have a sense of what the greatest sensitivities are to Linda's demand from the reduced in person promotion effort. I know it's, you know, hard at this point to know where and when the new normal is.

I just wanted to echo, what you're saying that one of the things I've I've been always been oppressed since I arrived in iron what is the.

You know, how quick and smart to the both Algarin and I were together have been at you know sort of continuous improvement in there commercial plants you know they're always looking at <unk> you know as we learn more about a particular positions, but the rest right at the rap or the district level or overall, that's what I understand.

Eric Joseph: What it looks like beyond the pandemic, but I am curious to know whether you foresee any efficiencies on the commercial spend side and still being able to grow prescription volumes, or whether we should expect a pattern of commercial spend sort of ramping back up on the other side of the pandemic.

How the market is evolving of.

Sources and keep and in both within.

Thomas A. McCourt: Tom, you can take a stab at that. I might have a comment to add as well. Absolutely.

Sort of finishing promotion and then also bound to between position promotion in consumer motion. So it's a team that very used to and it's been I think one of their strengths and sort of optimizing so but rest assured they're going to continue that and that'll be a focus and then the other thing I just really been pleased at the way. The team is sort of embracing come <unk> you know the new technology.

Thomas A. McCourt: First of all, you know, I think this is a very promotionally sensitive market, and there's no replacement for personal promotion.

Thomas A. McCourt: I think, you know, we're doing a yeoman's effort in supporting patients and also our customers remotely and virtually, and I think we're putting a number of innovative plans, such as telemedicine, in place. But as far as personal promotion is concerned, we pushed it hard in the first quarter to get out of the gate strong, and the sales force did an absolutely terrific job driving, you know, continuing to drive, you know, double-digit growth. I think the other thing to keep in mind is, you know, we constantly evaluate and refine the overall selling model with regard to our reach, with regard to our frequency, who's going to make the calls, and we're in constant assessment of that. And as you know, we've changed it quite a bit over time, both with regard to the number of targets and the frequency of calls, as the sales force has become increasingly more efficient.

In the you know the new <unk> openness I would say a physician bent in patients to you know leverage things like Hell medicine to get their healthcare needs met and and so I've had a chance to interact with the number of teams and sales people, they're all embracing working with the virtual a selling eight and.

Virtual meeting the capability. Some mentioned, we've got to to our own Tele Medicine program that week scaled up nationally and we're going to really be diving big and diving deep into the some of these changes to see how we can leverage them to the benefit of patience and ultimately the business. So I'm encouraged with the way that.

Responding and but rest assured we're going to continue to focus on <unk>, both for doing it as a efficiently as we can.

Thomas A. McCourt: I do not see a replacement for in-office promotion, personal promotion. I think, you know, we're itching to get back into the office to, you know, continue to drive demand and broaden physicians' view of who the appropriate patient is. So, but I don't see any dramatic change in our overall selling effort as we kind of re-engage with customers. So, you know, Mark, if you have a couple of additional comments.

Got it takes takes for that answer there maybe just one last 170 240 sector.

You you've moved up high mind, a little bit here would be expected just quarter, just any thinking all in terms of.

<unk>, when they're making and gathering sort of the last legs.

Mark Mallon: I just wanted to echo what you were saying in that one of the things I've always been impressed since I arrived in Ironwood is how quick and smart both Algren and Ironwood together have been at some sort of continuous improvement in their commercial plans. They're always looking at, as we learn more about particular positions, whether it's right at the rep or the district level or overall, as we understand how the market is evolving, adjusting resources and both within sort of physician promotion and then also balancing between physician promotion and consumer promotion. So it's a team that's very used to, and it's been, I think, one of their strengths to sort of optimize. So rest assured they're going to continue that, and that'll be a focus.

Patient data patient fall loves anything in a way of anything from the pandemic that might impact sort of the the integrity adelphia back that better that'd be.

Are they tend to treat population based assessment.

Quarter.

Mike you can you take that please.

Sure Yeah, we were pretty good.

Good opportunity and I.B.S.D., I think which speaks to the medical need within that patient population and clear need for pain therapeutic for patients suffering with abdominal pain I'd say the ability to enroll that I think really speaks obviously to that testament for the the patience into patient need but also you know the team did a great job.

Accelerate that so we weren't really impacted under recruitment site by cultivated we were able to to get patience in in dos and actually get pacing shout sort of that before so they'd really took over a much of the recruitment in clinical trials and then much of what we did after that is sort of data cleaning data management data validation and and all that so.

Mark Mallon: And then the other thing I've really been pleased with the way the team is sort of embracing some of the new technology and the new openness, I would say, of physicians and patients to leverage things like telemedicine to get their healthcare needs met. And so I've had a chance to interact with a number of teams and salespeople. They're all embracing working with the virtual selling aid and virtual meeting capability. As Tom mentioned, we've got our own telemedicine program that we've scaled up nationally. We're going to really be diving big and diving deep into some of these changes to see how we can leverage them to the benefit of patients and ultimately the business. So I'm encouraged by the way the team's responding.

<unk> on track and we remain on track and we're committed to delivering it you know that this quarter she mentioned.

Right after taking a question.

And again.

<unk>.

Okay go ahead, I was going to us we had any additional calls.

Yes.

Yes.

Extra question during this time please.

And your telephone.

And we do have a question from.

Oh, great I birth, Hello, how are you.

Good How're you doing good. It's the first question is I think that's maybe virgina, but I don't know maybe answered is you mentioned that there's a low revenue per patient on Medicaid versus private ensure I was wondering if you quantify that at all so is there a lower is their ability to get a 90 day scripts for Medicaid.

Mark Mallon: And rest assured, we're going to continue to focus on driving lint growth but doing it as efficiently as we can. Thanks for that answer there. Maybe just one last one on 7246. You've moved up timelines a little bit here with data expected this quarter. Anything at all in terms of impacts from the pandemic and gathering sort of the last legs of patient data, patient follow-ups, anything in the way of anything from the pandemic that might impact sort of the integrity, the fidelity of that data set? or the Intended Treatment Population, basically, as we've looked at data this quarter. Uh, Mike, can you take that, please? Sure. Yeah, we were pretty.

As as there is some private pay or just want to kind of understand that dynamic.

[noise] do you mind to start with any perspective and time also if you have something to add please.

<unk>.

Sure sure. It's a great question that's right. So we said that you know.

I think that's not our business.

Yeah, it's commercial and with a high unemployment.

I'm on two fronts that maybe it could lead to a large commands or maybe a possibility of those patients I think some commercial on Medicaid anything doesn't include hire me you know we haven't quantified. It we don't distinguish our you know detail out across the net between commercial Medicaid, but you know I'm quite complex hang it.

Michael Shetzline: Really a good opportunity in IBSD, I think, which speaks to the medical need within that patient population and clearly the need for a pain treatment for patients suffering with abdominal pain. So the ability to enroll that, I think, really speaks, obviously, to the testament of the patients and the patient need, but also the team did a great job to accelerate that. So we weren't really impacted on the recruitment side by COVID. We were able to get patients in at the dose and actually get patients out before COVID really took over much of the recruitment and clinical trials. And then much of what we did after that was sort of data cleaning, data management, data validation, and all that. So we've been on track, and we remain on track, and we're committed to delivering it this quarter, as you mentioned. Great

It's a significant difference between commercial on Medicaid that's you can imagine.

And can Medicaid patients fill 90 days scripts, just as easily as commercial or do they have any restrictions.

Oh I want to Mark why don't I take that are currently I you know if they can only access I believe they can only x. 30 days supply similar to you know Medicare patients had says it is assumed as a similar restriction with regard to the quantity that they can actually access.

But I, but I think it's important to underscore <unk> yeah. The fact that you know we have over 50% of or nearly <unk>. This is actually a Medicare part d., which has been very stable and you know the the patients that we are you know that are at risk our commercial patients, but it's something.

Obviously, we're monitoring very closely but from what we've seen so far the demand is holding up you know very well, but obviously, it's something that certainly poses a risk to the the price and volume of the brand.

Michael Shetzline: Great, thanks for taking

Operator: and again as a reminder... Commission, do we have any...

Operator: Okay, go ahead. I was going to ask if we had any additional calls. No questions.

Operator: Yes, if you would like to ask a question during this time, please press star 1 on your telephone. And we do have a question from Boris.

My last question is on 37 18.

Boris Peaker: Oh, great. Hi Boris. Hello, how are you? Good. How are you doing? Good.

Just want to know what percentage of total enrollment have you already enrolled in these phase three studies and in that context, just want to understand it turns of data quality what happens if a significant number of patients Miss follow up appointment sit there are some point, where you just take him out of the study or you just kind of except the missing.

Boris Peaker: So, the first question is, I think this may be for Gina, but I don't know who else wants to maybe answer it, is you've mentioned that there's a lower revenue per patient on Medicaid versus private insurers. I was wondering if you could quantify that, and also is there a lower ability to get a 90-day script for Medicaid as there is on private payers? I just want to kind of understand that dynamic. Gina, why don't you start with any perspective, and Tom, also, if you have something to add, please do.

Data, how how does that work.

I can you take that.

Sure. We have this time mentioned, we've greater now 72% actually of patients enrolled in the studies and you're right. I mean, we do have to closely monitor all our study said, which we do here regardless of cause it 19 or not but your point is valid that in the setting up code at 19.

Gina Conselman: Sure, sure. It's a great question. That's right.

Gina Conselman: So, we said that, you know, approximately 50% of our book of business or our patient mix is commercial. And with the high unemployment, we are concerned on two fronts that maybe it could lead to lower demand or maybe a possibility of those patients moving from commercial to Medicaid. And we said it does include a higher rebate. You know, we haven't quantified it yet. We don't distinguish or, you know, detail out the gross to net difference between commercial and Medicaid. But, you know, I'm quite comfortable saying it's a significant difference between commercial and Medicaid, as you can imagine.

And and some of the monitoring monitoring that takes place in the clinical program. It's important to make sure. We can do that remotely and again, it's an eight week treatment course, so we do have the opportunity to to schedule things and plan things and get things done remotely. The team has made a great effort to achieve all that to ensure day didn't take her.

Trial integrity patient safety, Yeah, clearly patient safety Smushed critical item on that list and the work diligently to ensure that with all our patience and all their studies. So we have had a very good success.

Thomas A. McCourt: And can Medicaid patients fill 90-day scripts just as easily as commercial ones, or do they have any restrictions?

Thomas A. McCourt: Mark, why don't I take that? Currently, you know, they can only access, I believe they can only access a 30-day supply, similar to, you know, Medicare patients who have a similar restriction with regard to the quantity that they can actually access. But I think it's important to underscore, you know, the fact that over 50% of, or nearly 50% of our business is actually in Medicare Part D, which has been very stable. And, you know, the patients that we are treating that are at risk are commercial patients. But it's something we're obviously monitoring very closely. But, you know, from what we've seen so far, demand is holding up very well. But, obviously, it's something that certainly poses a risk to the price and volume of the brand.

Containing that aspect of that data integrity and child safety. So we're really happy to be able to continue that in the 3718 program.

Great. Thank you very much for taking my question.

And we have no further questions.

Mm.

And we have no other question.

This time.

And just as color concludes today's conference call you may not disconnect Caroline.

Thomas A. McCourt: And my last question is on the 3718. I just want to know what percentage of total enrollment you have already enrolled in these Phase 3 studies. And in that context, in terms of data quality, what happens if a significant number of patients miss follow-up appointments? Is there some point where you just take them out of the study, or do you just kind of accept the missing data?

[music].

Yeah.

[music].

Boris Peaker: How does that work? Mike, can you take that? Sure.

Michael Shetzline: We have, as Tom mentioned, we have more, now 72% actually, of patients enrolled in the studies. And you're right, I mean, we do have to closely monitor all our studies, which we do regardless of whether COVID-19 or not. But your point is valid, that in the setting of COVID-19 and some of the monitoring that takes place in the clinical program, it's important to make sure we can do that remotely. And again, it's an eight-week treatment course, so we do have the opportunity to schedule things and plan things and get things done remotely. The team has made a great effort to achieve all that, to ensure data integrity, trial integrity, and patient safety. You know, clearly patient safety is the most critical item on that list, and we work diligently to ensure that with all our patients and all our studies. So we have had very good success in maintaining that aspect of data integrity and trial safety, so we're really happy to be able to continue that in the 3718 program. Great, thank you very much for taking my question.

Operator: And we have no further questions. I will turn the call back over to Mark for closing remarks. And we have no other questions at this time. And this does conclude today's conference call. You may now disconnect your lines.

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