The following discussion and analysis of our financial condition and results of
operations should be read in conjunction with our financial statements and
related notes and the related Management's Discussion and Analysis of Financial
Condition and Results of Operations included in this Annual Report on Form

10-K.



  49






Forward-Looking Information



The following discussion and analysis of our financial condition and results of
operations should be read in conjunction with our consolidated and combined
financial statements and the notes to those financial statements appearing
elsewhere in this Annual Report on Form 10-K. This discussion contains
forward-looking statements that involve significant risks and uncertainties. As
a result of many factors, such as those set forth under "Special Note Regarding
Forward-Looking Statements" and "Risk Factors" in Item 1A of this Annual Report
on Form 10-K, our actual results may differ materially from those anticipated in
these forward-looking statements.



Overview



We are a clinical-stage biopharmaceutical company harnessing the power of
soluble guanylate cyclase, or sGC, pharmacology to discover, develop and
commercialize breakthrough treatments for serious and orphan diseases. Our focus
is enabling the full therapeutic potential of next-generation sGC stimulators.
Our strategy rests on a solid scientific foundation that is enabled by our
people and capabilities, external collaborations and a responsive capital
allocation approach.



We operate in one reportable business segment-human therapeutics.

Separation from Ironwood Pharmaceuticals


On April 1, 2019, Ironwood Pharmaceuticals Inc., or Ironwood, completed the
separation of its sGC business, and certain other assets and liabilities, into
us as a separate, independent publicly traded company by way of a pro-rata
distribution of our common stock through a dividend distribution of one share of
our common stock, with no par value per share, for every 10 shares of Ironwood
common stock held by Ironwood stockholders as of the close of business on
March 19, 2019, the record date for the distribution, which we refer to herein
as the Separation. As a result of the Separation, we became an independent
public company and commenced trading under the symbol "CYCN" on the Nasdaq
Global Select Market on April 2, 2019.



In connection with the Separation, on March 30, 2019, we entered into certain agreements with Ironwood to provide a framework for our relationship with Ironwood following the Separation, including, among others, a Separation Agreement, a Tax Matters Agreement, and an Employee Matters Agreement.





In addition, in connection with the Separation, on April 1, 2019, we entered
into a Development Agreement, an Ironwood Transition Services Agreement, a
Cyclerion Transition Services Agreement and an Intellectual Property License
Agreement with Ironwood.



On April 2, 2019, we issued 11,817,165 shares of our common stock, or the
Private Placement Shares, to accredited investors for gross proceeds of $175
million (net proceeds of approximately $165 million) pursuant to the Amended and
Restated Common Stock Purchase Agreement. We received the funds associated with
the sale of the Private Placement Shares on April 2, 2019.



Our historical consolidated and combined financial statements for the periods
prior to the Separation have been derived from Ironwood's combined financial
statements and accounting records and are presented in conformity with United
States Generally Accepted Accounting Principles, or U.S. GAAP.



Our consolidated and combined financial statements reflect our financial
position, results of operations and cash flows of the business that were
transferred to us in the Separation. The historical financial statements may not
be indicative of our future performance and do not necessarily reflect what our
results of operations, financial condition and cash flows would have been had we
operated as a separate, publicly traded company for the periods presented prior
to the Separation. The consolidated and combined financial statements prior to
the Separation included herein do not reflect any changes that occurred in our
financing or operations as a result of the Separation from Ironwood.



Financial Overview



Research and Development Expense.Research and development expenses are incurred
in connection with the discovery and development of our product candidates.
These expenses consist primarily of the following costs: compensation, benefits
and other employee-related expenses, research and development related
facilities, third-party contracts relating to nonclinical study and clinical
trial activities. All research and development expenses are charged to
operations as incurred.



  50






The core of our research and development strategy is to harness the power of sGC
pharmacology to develop therapies for serious and orphan diseases. Our portfolio
of programs includes:



Olinciguat is a once-daily, orally administered vascular sGC stimulator that is
well suited for the potential treatment of sickle cell disease, or SCD. We are
conducting a dose-ranging Phase 2 study, STRONG-SCD, that is expected to enroll
up to 88 patients from both US and ex-US sites. This study is designed to
explore a broad range of tolerated doses and optimize our understanding of the
therapeutic potential of olinciguat in SCD. We expect topline data from this
study in mid-2020.



In June 2018, the U.S. Food and Drug Administration, or the FDA, granted Orphan
Drug Designation to olinciguat for the treatment of patients with SCD. Orphan
Drug Designation provides marketing exclusivity for seven years from the date of
the product's approval for marketing and contributes to a significant reduction
in development costs.



Praliciguat is an orally administered, once-daily systemic sGC stimulator that
was evaluated in two recently completed Phase 2 proof-of-concept studies: a
dose-ranging study in 156 adult patients with diabetic nephropathy, and a study
in 196 adult patients with heart failure with preserved ejection fraction
(HFpEF), CAPACITY-HFpEF. On October 30, 2019, we released topline results from
these studies.



In CAPACITY-HFpEF, the study did not meet statistical significance on its
primary endpoint of improved exercise capacity from baseline as compared to
placebo, measured by cardiopulmonary exercise testing. There was clear evidence
of drug exposure and pharmacological activity as judged by expected reductions
in blood pressure. Praliciguat was generally well tolerated. We are
discontinuing development of praliciguat in HFpEF.



The study of praliciguat in participants with diabetic nephropathy also did not
meet statistical significance on its primary endpoint of reduction in
albuminuria from baseline as compared to placebo, measured by urine albumin
creatinine ratio. However, there was a trends toward improvement across the
total intention-to-treat study population. Praliciguat was generally well
tolerated. As previously announced, we intend to out-license praliciguat for
late-stage global development and commercialization.



IW-6463 is an orally administered central nervous system-penetrant sGC
stimulator that, because it readily crosses the blood-brain barrier, affords an
unprecedented opportunity to expand the utility of sGC pharmacology to serious
neurodegenerative diseases. . On January 13, 2020 we released positive top line
results from our first-in-human study of IW-6463. IW-6463 was generally well
tolerated in healthy human adults. The study demonstrated IW-6463 penetration
across the blood-brain-barrier at levels expected to be pharmacologically active
as well as a mild reduction in blood pressure providing evidence of peripheral
pharmacological activity. The Company intends to continue development activities
for IW-6463. In December 2019 we initiated an ongoing translational pharmacology
study in elderly subjects. Topline data from this study is expected in mid-2020.



Discovery Research. Our discovery efforts are primarily focused on identifying,
designing and developing sGC stimulators for serious and orphan diseases. sGC
stimulation is a powerful mechanism that can broadly regulate blood flow,
inflammation, fibrosis and metabolism. In diseases that are localized to
specific organs or tissues, we believe that our organ-targeting strategy will
maximize the efficacy of sGC pharmacology in these organs while reducing the
potential for dose-limiting hemodynamic effects sometimes observed with sGC
stimulation. Our initial focus is on the liver and the lung due to the clear
role of nitric oxide signaling in diseases with high unmet need that affect
these organs. Additional discovery efforts are ongoing and aimed at further
expanding the potential of sGC stimulation in disorders of the CNS.



The following table summarizes our research and development expenses related to
our product pipeline, as well as employee and facility related costs allocated
to research and development expense, for the years ended December 31, 2019 and
2018. These product pipeline expenses relate primarily to external costs
associated with nonclinical studies and clinical trial costs, which are
presented by development candidates.



  51






                                               Years Ended December 31,
                                               2019                2018
                                                    (in thousands)
Product pipeline external costs:
Praliciguat                               $     13,344       $      17,814
Olinciguat                                      13,064               6,603
IW-6463                                          4,278               2,603
Discovery research                               1,293               2,248
Total product pipeline external costs           31,979              29,268
Personnel and related internal costs            40,008              37,029
Facilities and other                            23,153              21,419
Total research and development expenses   $     95,140       $      87,716




Securing regulatory approvals for new drugs is a lengthy and costly process. Any
failure by us to obtain, or any delay in obtaining, regulatory approvals would
materially adversely affect our product development efforts and our business
overall.



Given the inherent uncertainties of pharmaceutical product development, we
cannot estimate with any degree of certainty how our programs will evolve, and
therefore the amount of time or money that would be required to obtain
regulatory approval to market them. As a result of these uncertainties
surrounding the timing and outcome of any approvals, we are currently unable to
estimate precisely when, if ever, our discovery and development candidates will
be approved. We invest carefully in our pipeline, and the commitment of funding
for each subsequent stage of our development programs is dependent upon the
receipt of clear, supportive data.



The successful development of our product candidates is highly uncertain and subject to a number of risks including, but not limited to:

· The duration of clinical trials may vary substantially according to the type

and complexity of the product candidate and may take longer than expected.

· The FDA and comparable agencies in foreign countries impose substantial and

varying requirements on the introduction of therapeutic pharmaceutical

products, which typically require lengthy and detailed laboratory and clinical

testing procedures, sampling activities and other costly and time-consuming


   procedures.



· Data obtained from nonclinical and clinical activities at any step in the

testing process may be adverse and lead to discontinuation or redirection of

development activity. Data obtained from these activities also are susceptible

to varying interpretations, which could delay, limit or prevent regulatory


   approval.



· The duration and cost of discovery, nonclinical studies and clinical trials may

vary significantly over the life of a product candidate and are difficult to


   predict.



· The costs, timing and outcome of regulatory review of a product candidate may

not be favorable, and, even if approved, a product may face post-approval


   development and regulatory requirements.



· The emergence of competing technologies and products and other adverse market


   developments may negatively impact us.




As a result of the factors listed above, including the factors discussed under
the "Risk Factors" in Item 1A of this Annual Report on Form 10-K, we are unable
to determine the duration and costs to complete current or future nonclinical
and clinical stages of our product candidates or when, or to what extent, we
will generate revenues from the commercialization and sale of our product
candidates. Development timelines, probability of success and development costs
vary widely. We anticipate that we will make determinations as to which
additional programs to pursue and how much funding to direct to each program on
an ongoing basis in response to the data from the studies of each product
candidate, the competitive landscape and ongoing assessments of such product
candidate's commercial potential.



  52






General and Administrative Expense. General and administrative expense consists
primarily of compensation, benefits and other employee-related expenses for
personnel in our administrative, finance, legal, information technology,
business development, communications and human resource functions. Other costs
include the legal costs of pursuing patent protection of our intellectual
property, general and administrative related facility costs, insurance costs and
professional fees for accounting and legal services. Certain costs associated
with our Separation from Ironwood are included in these expenses. We record all
general and administrative expenses as incurred.



Critical Accounting Policies and Estimates





Our discussion and analysis of our financial condition and results of operations
is based upon our consolidated and combined financial statements prepared in
accordance with U.S. GAAP. The preparation of these financial statements
requires us to make certain estimates and assumptions that may affect the
reported amounts of assets and liabilities and disclosure of contingent assets
and liabilities at the date of the consolidated and combined financial
statements, and the amounts of expenses during the reported periods. Significant
estimates and assumptions in our consolidated and combined financial statements
include those related to allocation of expenses, assets and liabilities from
Ironwood's historical financial statements for the periods prior to the
Separation, impairment of long-lived assets; income taxes, including the
valuation allowance for deferred tax assets; research and development expenses;
contingencies and share-based compensation. We base our estimates on our
historical experience and on various other assumptions that are believed to be
reasonable, the results of which form the basis for making judgments about the
carrying values of assets and liabilities. Actual results may differ materially
from our estimates under different assumptions or conditions. Changes in
estimates are reflected in reported results in the period in which they become
known.



We believe that our application of accounting policies requires significant
judgments and estimates on the part of management and is the most critical to
aid in fully understanding and evaluating our reported financial results. Our
significant accounting policies are more fully described in Note 2, Summary of
Significant Accounting Policies, of the consolidated and combined financial
statements elsewhere in this Annual Report on Form 10-K.



All research and development expenses are expensed as incurred. We defer and
capitalize nonrefundable advance payments we make for research and development
activities until the related goods are received or the related services are
performed. See Note 2, Summary of Significant Accounting Policies, of the
consolidated and combined financial statements appearing elsewhere in this

Annual Report on Form 10-K.



Results of Operations



For the period prior to the Separation, our consolidated and combined financial
statements include an allocation of expenses related to certain Ironwood
corporate functions, including senior management, legal, human resources,
finance, information technology and quality assurance. These expenses were
allocated to Cyclerion based on direct usage or benefit where identifiable, with
the remainder allocated pro-rata based on project related costs, headcount or
other measures. We considered the allocation methodologies used to be a
reasonable and appropriate reflection of the historical Ironwood expenses
attributable to us. The expenses reflected in the consolidated and combined
financial statements may not be indicative of expenses that will be incurred by
us in the future. After the Separation, we began performing these corporate
functions using internal resources or purchased services, certain of which are
being provided by Ironwood under the transition services agreement. The
following discussion summarizes the key factors we believed are necessary for an
understanding of our consolidated financial statements.



  53






                               Years Ended December 31,              Change
                                 2019              2018           $           %
                                             (dollars in thousands)

Revenue from related party   $       4,507      $        -     $  4,507       100 %
Cost and expenses:
Research and development            95,140          87,716        7,424         8 %
General and administrative          34,404          27,536        6,868    

   25 %
Total cost and expenses            129,544         115,252       14,292        12 %
Loss from operations              (125,037 )      (115,252 )     (9,785 )       8 %

Interest and other income            2,029               -        2,029    

  100 %
Net loss                     $    (123,008 )    $ (115,252 )   $ (7,756 )       7 %




Revenue from related party. The increase in revenue from related party for the
year ended December 31, 2019 compared to the year ended December 31, 2018 is the
result of services performed under the Development Agreement for Ironwood, which
was entered into in connection with the Separation.



Research and Development Expense.  The increase in research and development
expense of approximately $7.4 million for the year ended December 31, 2019
compared to the year ended December 31, 2018 was primarily related to an
increase of approximately $3.0 million in employee-related expenses as compared
to the pre-Separation allocation costs from Ironwood, including approximately
$2.5 million related to one-time costs associated with a workforce reduction, an
increase of approximately $1.7 million in facilities and operating costs
allocated to research and development, and a net increase of approximately $2.7
million in external research costs. The net increase in external research costs
was primarily due to an increase of approximately $6.5 million associated with
olinciguat due to increased enrollment and site activity for the STRONG-SCD
Phase 2 study as well as supporting ancillary studies, toxicology and
manufacturing, and an increase of approximately $1.7 million associated with
IW-6463 studies, partially offset by a decrease of approximately $4.5 million
associated with praliciguat due to the timing of study activities which ceased
enrollment and closed out by the end of 2019 and a decrease of approximately
$1.0 million in discovery research.



General and Administrative Expense.  The increase in general and administrative
expenses of approximately $6.9 million for the year ended December 31, 2019
compared to the year ended December 31, 2018 primarily was driven by increases
of approximately $5.8 million in stock-based compensation as compared to the
pre-Separation allocation from Ironwood, approximately $2.8 million in other
employee-related costs, and approximately $1.0 million in facilities and other
operating costs. These increases were partially offset by a net decrease of
approximately $2.9 million in consulting fees and other professional services
expenses.



Interest and other income.  Interest and investment income increased by
approximately $2.0 million for the year ended December 31, 2019 compared to the
year ended December 31, 2018 due to $1.9 million of interest generated on excess
operating funds from investments in U.S. government money market funds and
overnight repurchase agreements and the recognition of approximately $0.1
million of net sublease income. There was no investment and sublease income for
the year ended December 31, 2018 because there was no cash allocated to
Cyclerion and no lease directly attributed to Cyclerion prior to the Separation.



Liquidity and Capital Resources





Prior to the Separation, the primary source of liquidity for our business was
cash flow allocated to Cyclerion from Ironwood. Transfers of cash to and from
Ironwood have been reflected in net parent investment in the historical combined
balance sheets, statements of cash flows and statements of changes in
stockholders' equity (deficit). Ironwood's cash has not been assigned to us for
any of the periods prior to the Separation presented in the consolidated and
combined financial statements because those cash balances are not directly
attributable to us. Post Separation, transfers of cash to and from Ironwood
related to the Transition Service Agreements, Development Agreement and
provisions of the Separation Agreement, have been reflected in the consolidated
and combined statement of cash flows.



  54






After giving effect to the completion of the Separation on April 1, 2019, we
raised approximately $165 million net of direct financing expenses with the
closing of the private placement on April 2, 2019. Subsequent to the Separation,
we no longer participate in Ironwood's centralized cash management or receive
direct funding from Ironwood.



On December 31, 2019, we had approximately $94.9 million of unrestricted cash
and cash equivalents. Our cash equivalents include amounts held in U.S.
government money market funds. We invest cash in excess of immediate
requirements in accordance with our investment policy, which requires all
investments held by us to be at least "AAA" rated or equivalent, with a
remaining final maturity when purchased of less than twelve months, so as to
primarily achieve liquidity and capital preservation.



Our ability to fund our operations and capital needs will depend on our ongoing
ability to generate cash from operations and access to capital markets and other
sources of capital, as further described below. We anticipate that our principal
uses of cash in the future will be primarily to fund our operations, working
capital needs, capital expenditures and other general corporate purposes.



Going Concern



Based on our development plans and clinical stage patient testing and our timing
expectations related to the progress of our discovery research programs, we
expect that our existing cash and cash equivalents as of December 31, 2019, will
be sufficient to fund our planned operating expenses and capital expenditure
requirements through at least the first quarter of 2021. We have based this
estimate on assumptions that may prove to be wrong, particularly as the process
of testing drug candidates in clinical trials is costly and the timing of
progress in these trials is uncertain.



Cash Flows



The following is a summary of cash flows for the years ended December 31, 2019
and 2018:



                                               Years Ended December 31,                 Change
                                                 2019              2018            $              %
                                                               (dollars in thousands)

Net cash used in operating activities $ (102,215 ) $ (97,503 ) $ (4,712 )

            5 %

Net cash used in investing activities $ (6,715 ) $ (3,438 ) $ (3,277 )

           95 %
Net cash provided by financing activities   $      211,571      $  100,941
   $  110,630            110 %



Cash Flows from Operating Activities


Net cash used in operating activities totaled approximately $102.2 million for
the year ended December 31, 2019. The primary uses of cash were our net loss of
$123.0 million, changes in assets of approximately $0.1 million and changes in
liabilities of approximately $2.2 million. The changes in assets resulted
primarily from increases in related party accounts receivable of approximately
$1.5 million, prepaid expenses of approximately $1.1 million, and other assets
of approximately $0.6 million, partially offset by a decrease in the operating
lease right of use asset of approximately $3.1 million. The changes in
liabilities resulted primarily from decreases in accrued research and
development costs of approximately $3.1 million, accrued expenses of
approximately $1.6 million and accounts payable of approximately $0.3 million,
partially offset by increases in operating lease liabilities of approximately
$2.7 million and related party accounts payable of approximately $0.1 million.
These uses of cash were partially offset by non-cash items including share-based
compensation of approximately $19.6 million, depreciation and amortization
expense of approximately $2.7 million, and loss on disposal of property and
equipment of approximately $0.8 million.



  55






Net cash used in operating activities totaled approximately $97.5 million for
the year ended December 31, 2018. The primary uses of cash were our net loss of
$115.3 million and changes in other current assets of less than $0.1 million.
These uses of cash were partially offset by non-cash items of approximately
$14.0 million, including approximately $12.5 million in share-based compensation
expense and approximately $1.5 million in depreciation and amortization expense
of property and equipment, changes in assets of $0.4 million resulting primarily
from decreases in prepaid expenses and other assets of approximately $0.4
million and $0.1 million, respectively, and changes in liabilities of
approximately $3.3 million resulting primarily from increases in accounts
payable, accrued research and development costs, and accrued expenses and other
current liabilities of approximately $1.0 million, $0.3 million and $2.0
million, respectively.



Cash Flows from Investing Activities





Cash used in investing activities for the year ended December 31, 2019 totaled
approximately $6.7 million, resulting from purchases of property and equipment,
primarily leasehold improvements, of approximately $6.9 million, partially
offset by proceeds from the sale of property and equipment of approximately
$0.2
million.


Cash used in investing activities for the year ended December 31, 2018 totaled approximately $3.4 million, resulting from the purchase of property and equipment, primarily laboratory equipment.

Cash Flows from Financing Activities


Cash provided by financing activities for the year ended December 31, 2019 was
approximately $211.6 million, primarily as a result of approximately $164.6
million in net proceeds from the private placement, approximately $46.5 million
of cash transferred to us from Ironwood prior to Separation when Ironwood
managed our cash and financing arrangements, and approximately $0.5 million from
proceeds from the exercises of stock options and the employee stock purchase
plan.



Cash provided by financing activities for the year ended December 31, 2018 was
approximately $100.9 million, resulting from the cash transferred to us from
Ironwood based on changes in our cash used for operations.



Funding Requirements


We expect our expenses to increase as we advance the preclinical activities and clinical trials of our product candidates. In addition, as a result of the Separation, we expect to continue incur additional costs associated with operating as a public company. Our expenses will also increase as we:

· continue advancing our product candidates into preclinical and clinical


   development;



· seek regulatory approvals for any product candidates that successfully complete


   clinical trials;



· may potentially hire additional clinical, quality control and scientific


   personnel;



· enhance our operational, financial and management systems and

· maintain, expand and protect our intellectual property portfolio.


We believe that our existing cash, cash equivalents and restricted cash as of
December 31, 2019 will enable us to fund our operating expenses and capital
expenditure requirements through at least the first quarter of 2021. We have
based this estimate on assumptions that may prove to be wrong, and we could
exhaust our available capital resources sooner than we expect.



  56





Because of the many risks and uncertainties associated with research, development and commercialization of product candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on, and could increase or decrease significantly as a result of, many factors, including the:

· scope, progress, results and costs of researching and developing our product


   candidates, and conducting preclinical studies and clinical trials;



· costs, timing and outcome of regulatory review of our product candidates;

· costs of future activities, including medical affairs, manufacturing and

distribution, for any of our product candidates for which we receive marketing


   approval;



· cost and timing of necessary actions to support our strategic objectives;

· costs of preparing, filing and prosecuting patent applications, maintaining and


   enforcing our intellectual property rights and defending intellectual
   property-related claims; and



· timing, receipt and amount of sales of, or milestone payments related to or

royalties on, our current or future product candidates, if any.


A change in any of these or other variables with respect to the development of
any of our product candidates could significantly change the costs and timing of
the development of that product candidate. Further, our operating plans may
change in the future, and we may need additional funds to meet operational needs
and capital requirements associated with such operating plans.



Until such time, if ever, as we can generate substantial product revenue, we
expect to finance our cash needs through a combination of public or private
equity offerings, debt financings, collaborations, strategic alliances or
licensing arrangements with third parties. As discussed under the "Risk Factors"
in Item 1A of this Annual Report on Form 10-K, to preserve the tax-free
treatment of the Separation, we may be barred, in certain circumstances, for a
two year period following the Separation, from engaging in certain capital
raising transactions. To the extent that we raise additional capital through the
sale of equity or convertible debt securities, your ownership interest may be
materially diluted, and the terms of such securities could include liquidation
or other preferences that adversely affect your rights as a common shareholder.
Debt financing and preferred equity financing, if available, may involve
agreements that include restrictive covenants that limit our ability to take
specified actions, such as incurring additional debt, making capital
expenditures or declaring dividends. In addition, debt financing would result in
increased fixed payment obligations.



If we raise funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us.


If we are unable to raise additional funds when needed, we may be required to
delay, reduce or eliminate our product development or future commercialization
efforts, or grant rights to develop and market product candidates that we would
otherwise prefer to develop and market ourselves.



Contractual Commitments and Obligations





Tax-related Obligations


We exclude assets, liabilities or obligations pertaining to uncertain tax positions from our summary of contractual commitments and obligations as we cannot make a reliable estimate of the period of cash settlement with the respective taxing authorities. As of December 31, 2019, we had no uncertain tax positions.





Other Funding Commitments



As of December 31, 2019, we had, and continue to have, several ongoing studies
in various clinical trial stages. Our most significant clinical trial spending
is with clinical research organizations, or CROs. The contracts with CROs
generally are cancellable, with notice, at our option and do not have any
significant cancellation penalties.



Transition from Ironwood and Costs to Operate as an Independent Company


Our consolidated and combined financial statements for the period prior to the
Separation reflect our operating results and financial position as it was
operated by Ironwood, rather than as an independent company. As a result of the
Separation, we have incurred additional ongoing operating expenses to operate as
an independent, publicly traded, company. These costs include the cost of
various corporate headquarters functions, incremental information
technology-related costs and incremental costs to operate stand-alone
accounting, legal, human resources and other administrative functions. We also
incur non-recurring expenses and non-recurring capital expenditures.



  57






As an independent company, our information technology operating costs may be
higher than the costs allocated in the historical combined financial statements.
In addition, we will incur non-recurring expenses and capital expenditures to
establish independent information technology systems.



We have entered into a Transition Services Agreement with Ironwood that will
provide us with certain services and resources related to corporate functions
for an initial term of up to two years from the date of the Separation (as
applicable). This Transition Services Agreement will help us to operate our
business independently prior to establishing stand-alone infrastructure. During
the transition from Ironwood, we will incur non-recurring expenses to expand our
infrastructure.



It is not practicable to estimate the costs that would have been incurred in
each of the periods presented in the historical financial statements for the
functions described above. Actual costs that would have been incurred if we
operated as a stand-alone company for the periods prior to the Separation would
have depended on various factors, including organizational design, outsourcing
and other strategic decisions related to corporate functions, information
technology and back office infrastructure.



Off-Balance Sheet Arrangements


We do not have any relationships with unconsolidated entities or financial
partnerships, such as entities often referred to as structured finance or
special purpose entities, that would have been established for the purpose of
facilitating off-balance sheet arrangements (as that term is defined in
Item 303(a)(4)(ii) of Regulation S-K) or other contractually narrow or limited
purposes. As such, we are not exposed to any financing, liquidity, market or
credit risk that could arise if we had engaged in those types of relationships.
We enter into guarantees in the ordinary course of business related to the
guarantee of our own performance.



New Accounting Pronouncements


For a discussion of new accounting pronouncements see Note 2, Summary of Significant Accounting Policies, of the consolidated and combined financial statements appearing elsewhere in this Annual Report on Form 10-K.

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