What changed in this filing

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Item 1A. Risk Factors

2021-11-04 compared with 2021-08-05 · 37 added, 50 removed, 808 unchanged (10% of the section changed)

59 unchanged sentences

In addition, the U.S.

FDA-approved label for LINZESS contains a boxed warning about its use in pediatric patients.

LINZESS is contraindicated in pediatric patients up to six years of age based on nonclinical data from studies in neonatal mice approximately equivalent to human pediatric patients less than two years of age.

There is also a warning advising physicians to avoid the use of LINZESS in pediatric patients six to less than 18 years of age.

This warning is based on data in young juvenile mice and, at the time of approval, the lack of pediatric clinical safety and efficacy data.

FDA-approved label for LINZESS contains a boxed warning describing the risk of serious dehydration in pediatric patients less than two years of age and a contraindication against its use in these patients.

The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established.

We and AbbVie have established a nonclinical and clinical post-marketing plan with the U.S.

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Certain third-party payors also require prior authorization for, or even refuse to provide, reimbursement for our products, and others may do so in the future.

Our business would be materially adversely affected if we and our partners are not able to receive

approval for reimbursement of our products from third-party payors on a broad, timely or satisfactory basis;

Our business would be materially adversely affected if we and our partners are not able to receive approval for reimbursement of our products from third-party payors on a broad, timely or satisfactory basis;

if reimbursement is subject to overly broad or restrictive prior authorization requirements;

or if reimbursement is not maintained at satisfactory levels or becomes subject to prior authorization.

In addition, our business could be adversely affected if government healthcare programs, private health insurers, including managed care organizations, or other reimbursing bodies or payors limit or reduce the indications for or conditions under which our products may be reimbursed.

In addition, our business could be adversely

affected if government healthcare programs, private health insurers, including managed care organizations, or other reimbursing bodies or payors limit or reduce the indications for or conditions under which our products may be reimbursed.

Moreover, as discussed further below, changes in insurance coverage or reimbursement levels by governmental authorities, private health insurers and other third-party payors, or in the type of such coverage held by patients, as well as the impacts to healthcare access or administration (including, for example, limitations on medications or procedures deemed “non-essential,” reduced interaction between patients and physicians, and increased unemployment), due to the COVID-19 pandemic may materially harm our business and commercialization efforts.

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CONSTELLA was first launched in certain European countries for the symptomatic treatment of moderate to severe IBS-C in adults in the second quarter of 2013 and our partner, AbbVie, is currently commercializing CONSTELLA in a number of European countries, including the United Kingdom, Italy and Spain.

LINZESS was first

launched in Japan for the treatment of IBS-C in adults in the first quarter of 2017, and for the treatment of chronic constipation in adults in the third quarter of 2018, and our partner Astellas Pharma, Inc., or Astellas, is currently commercializing LINZESS in Japan.

In addition, LINZESS was first launched in China for the treatment of IBS-C in adults in November 2019, and our partner AstraZeneca AB (together with its affiliates), or AstraZeneca, is currently commercializing LINZESS in China (including Hong Kong and Macau).

LINZESS was first launched in Japan for the treatment of IBS-C in adults in the first quarter of 2017, and for the treatment of chronic constipation in adults in the third quarter of 2018, and our partner Astellas Pharma, Inc., or Astellas, is currently commercializing LINZESS in Japan.

In addition, LINZESS was first launched in China for the treatment of IBS-C in

adults in November 2019, and our partner AstraZeneca AB (together with its affiliates), or AstraZeneca, is currently commercializing LINZESS in China (including Hong Kong and Macau).

The pricing and reimbursement strategy is a key component of our partners’ commercialization plans for CONSTELLA in Europe and LINZESS in Japan and China.

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however, they are limited in the number of in-person details they are able to conduct due to containment and mitigation measures related to the COVID-19 pandemic.

We monitor the impact of the COVID-19 pandemic in the territories where our customer-facing employees are engaged in in-person work practices, and in some cases, we have paused or delayed in-person work practices as a result of the impact of the COVID-19 pandemic in those territories, and may do so again in the

Customer-facing employees who are not providing in-person services continue to support their customers virtually through telephone and web-based technologies.

Headquarters employees are expected to have the option to work remotely through late 2021.

We may delay, stop or otherwise limit in-person work in the future pending relevant health authority guidance and additional safety or other considerations.

We may delay, stop or otherwise limit in-person work in the future pending relevant

health authority guidance and additional safety or other considerations.

T he virtual support we continue to provide to customers may not be as effective as in-person efforts, and our in-person efforts may be limited and/or limited in their effectiveness.

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FDA requirements, including those governing the testing, manufacturing, labeling, packaging, storage, advertising, promotion, sale, distribution, recordkeeping and submission of safety and other post-market information.

There is also a boxed warning advising physicians to avoid the use of LINZESS in pediatric patients six to less than 18 years of age.

This warning is based on data in young juvenile mice and, at the time of approval, the lack of pediatric clinical safety and efficacy data.

The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established.

We and AbbVie have established a nonclinical and clinical post-marketing plan with the U.S.

FDA to understand the safety and efficacy of LINZESS in pediatric patients, and clinical pediatric programs in IBS-C and

functional constipation are ongoing.

FDA to understand the safety and efficacy of LINZESS in pediatric patients, and clinical pediatric programs in IBS-C and functional constipation are ongoing.

Our ability to expand the indication or label information for LINZESS to pediatrics will depend on, among other things, our successful completion of pediatric clinical programs.

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Additionally, we cannot be certain of the duration or extent to which the COVID-19 pandemic may impact operations of regulatory authorities in jurisdictions around the world, and any reduction in resources dedicated to review and approval of products in applicable jurisdictions could delay or otherwise impact approval or other regulatory decisions or actions.

Further, regulatory approval in one jurisdiction does not ensure

regulatory approval in another, but a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory processes in others.

If linaclotide is not approved for all indications or patient populations or with the label requested, this would limit the uses of linaclotide and have an adverse effect on its commercial potential or require costly post-marketing studies.

Further, regulatory approval in one jurisdiction does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory processes in others.

If linaclotide is not approved for all indications or patient

populations or with the label requested, this would limit the uses of linaclotide and have an adverse effect on its commercial potential or require costly post-marketing studies.

Risks Related to Our Growth Strategy

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It is possible that none of the product candidates we may in-license or acquire will be approved for commercial sale or be otherwise commercially viable, which would impair our ability to grow.

Furthermore, we may have little or no insight or

control over the development and commercialization of any product that we in-license outside the licensed territory.

If other licensees do not effectively develop or commercialize any such product outside the licensed territory, our reputation or the reputation of any such product may be impacted.

Furthermore, we may have little or no insight or control over the development and commercialization of any product that we in-license outside the licensed territory.

other licensees do not effectively develop or commercialize any such product outside the licensed territory, our reputation or the reputation of any such product may be impacted.

Our failure to successfully develop and commercialize additional product candidates or approved products would impair our ability to grow and/or adversely affect our business.

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Although we have entered into such arrangements with respect to the development and commercialization of linaclotide worldwide, there can be no assurance that we will be able to do so in the future with respect to other products or product candidates that we either develop internally or in- license or that we will be able to gain the interest of potential partners;

establish and maintain development,

manufacturing, marketing, sales or distribution relationships on acceptable terms;

that such relationships, if established, will be successful or on favorable terms;

establish and maintain development, manufacturing, marketing, sales or distribution relationships on acceptable terms;

that such relationships, if established,

will be successful or on favorable terms;

or that we will gain market acceptance for such products or product candidates.

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Additionally, changes in regulatory requirements and guidance may occur, and we may need or otherwise determine to amend clinical trial protocols to reflect these changes.

Each protocol amendment would require institutional

review board review and approval, which may adversely impact the costs, timing or successful completion of the associated clinical trials.

Each protocol amendment would require institutional review board review and approval, which may adversely impact the costs, timing or successful completion of the

associated clinical trials.

If we or our partners terminate or experience delays in the completion of any clinical trials, the commercial prospects for our products or product candidates may be harmed, and our ability to generate product revenues will be delayed.

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Healthcare reform efforts have been and may continue to be subject to scrutiny and legal challenge.

For example, courts temporarily enjoined a new “most favored nation” payment model for select drugs covered under Medicare Part B that was to take effect on January 1, 2021 and would limit payment based on international drug price and the Centers for Medicare and Medicaid Services subsequently indicated that the rule will not be implemented without further rulemaking.

For example, courts temporarily enjoined regulations that would implement a new “most favored nation” payment model for select drugs covered under Medicare Part B that was to take effect on January 1, 2021 and would limit payment based on international drug price and the Centers for Medicare & Medicaid Services subsequently issued a notice of proposed rulemaking to rescind and remove the regulations.

As another example, revisions to regulations under the federal anti-kickback statute would remove protection for traditional Medicare Part D discounts offered by pharmaceutical manufacturers to pharmacy benefit managers and health plans.

18 unchanged sentences

These agreements govern the separation and distribution and the relationship between us and Cyclerion going forward, including with respect to potential tax-related losses associated with the separation and distribution.

In addition, the development agreement provides for the performance of services by Cyclerion for our benefit for a period of time.

If Cyclerion is unable to satisfy its obligations under these agreements, we could incur losses or operational challenges or difficulties and may not have sufficient resources available for such services.

120 unchanged sentences

Prior to the year ended December 31, 2019, we incurred net losses in each year since our inception in 1998.

As of June 30, 2021, we had an accumulated deficit of approximately $1.0 billion.

As of September 30, 2021, we had an accumulated deficit of $979.0 million.

We cannot be certain that sales of our products, and the revenue from our other commercial activities will not fall short of our projections or be delayed, particularly in light of the negative financial impact that the COVID-19 pandemic may have on our business in the future.

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Our indebtedness could adversely affect our financial condition or restrict our future operations.

As of June 30, 2021, we had total indebtedness of $520.7 million and available cash and cash equivalents of $492.7 million.

As of September 30, 2021, we had total indebtedness of $520.7 million and available cash and cash equivalents of $574.3 million.

Our indebtedness, combined with our other financial obligations and contractual commitments, could have important consequences on our business, including:

58 unchanged sentences

The COVID-19 pandemic has impacted, and is expected to continue to impact, our business and operations in a number of ways and there are significant uncertainties surrounding the extent and duration of such impacts.

Factors that will influence the impact on our business and operations include the duration and extent of the outbreak, the duration and extent of imposed or recommended containment and mitigation measures, periodic spikes in infection rates, new strains of the virus that cause outbreaks of COVID-19, the broad availability of effective vaccines, and the general economic consequences of the pandemic.

Factors that will influence the impact on our business and operations include the duration and extent of the outbreak, the duration and extent of imposed or recommended containment and mitigation measures, periodic spikes in infection rates, new strains of the virus that cause outbreaks of COVID-19, the broad availability of effective vaccines, the rate of vaccinations, and vaccine mandates and the general economic consequences of the pandemic.

Addressing the impacts of the COVID-19 pandemic has, and likely will for an extended period, required significant time and has diverted the attention of our management, other employees and our board of directors.

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McCourt, our chief executive officer;

John Minardo, our senior vice president and chief legal officer;

John Minardo, our senior vice president, chief legal officer and secretary;

Jason Rickard, our senior vice president and chief operating officer;

and Michael Shetzline, our senior vice president, chief medical officer and head of drug development.

Mark Mallon, our former chief executive officer, resigned from his position as chief executive officer and a member of our company’s board of directors, in each case effective March 12, 2021.

Effective upon Mr.

Mallon’s departure, Mr.

McCourt began serving as our interim chief executive officer, and in June 2021, Mr.

McCourt was appointed as our permanent chief executive officer and as a member of our board of directors.

In addition, Gina Consylman, our former chief financial officer, resigned from her position as senior vice president and chief financial officer, effective July 2, 2021.

and Michael Shetzline, our senior vice president, chief medical officer and head of research and drug development.

Gina Consylman, our former chief financial officer, resigned from her position as senior vice president and chief financial officer, effective July 2, 2021.

Effective upon Ms.

2 unchanged sentences

Consylman’s permanent successor.

These and any additional transitions in our senior management team or other key employees, or the unavailability of any such persons for any reason, can be inherently difficult to manage and may disrupt our operations or business or otherwise harm our business, for example due to the diversion of our board and management’s time and attention and a decline in employee morale.

This and any additional transitions in our senior management team or other key employees, or the unavailability of any such persons for any reason, can be inherently difficult to manage and may disrupt our operations or business or otherwise harm our business, for example due to the diversion of our board and management’s time and attention and a decline in employee morale.

In addition to the competition for personnel, the Boston area in particular is characterized by a high cost of living.

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We also rely to a large extent on information technology systems to operate our business, including to deliver our products.

We have outsourced elements of our confidential information processing and information technology structure, and as a result, we are managing

independent vendor relationships with third parties who may or could have access to our confidential information.

We have outsourced elements of our confidential information processing and information technology structure, and as a result, we are managing independent vendor relationships with third parties who may or could have access to our confidential information.

Similarly, our business partners and other third-party providers possess certain of our sensitive data.

The secure maintenance of this information is critical to our operations and business strategy.

Despite our security measures, our large and complex information technology and infrastructure (and those of our partners, vendors and third-party providers) may be vulnerable to attacks by hackers or breached due to employee, partner, vendor or third-party error, malfeasance or other disruptions.

Despite our security measures, our large and complex information technology and infrastructure (and those of our partners, vendors and third-party

providers) may be vulnerable to attacks by hackers or breached due to employee, partner, vendor or third-party error, malfeasance or other disruptions.

We, our partners, vendors and other third-party providers could be susceptible to third party attacks on our, and their, information security systems, which attacks are of ever-increasing levels of sophistication and are made by groups and individuals with a wide range of motives and expertise, including organized criminal groups, hacktivists, nation states and others.

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Incorporated by reference to Exhibit 3.2 of Ironwood Pharmaceuticals, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2009, filed with the SEC on March 30, 2010 .

S econd Amended and Restated Executive Severance Agreement, June 22, 2021, between Ironwood Pharmaceuticals, Inc.

and Thomas McCourt.

Incorporated by reference to Exhibit 10.1 of Ironwood Pharmaceuticals, Inc.’s Current Report on Form 8-K/A, filed with the SEC on June 24, 2021.

Certification of Chief Executive Officer pursuant to Rules 13a-14 or 15d-14 of the Exchange Act .

16 unchanged sentences

Ironwood Pharmaceuticals, Inc.

August 5, 2021

November 4, 2021

/s/ THOMAS MCCOURT

2 unchanged sentences

(Principal Executive Officer)

August 5, 2021

November 4, 2021

/s/ RONALD SILVER

3 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors