- Separation designed to unlock value, increase operational
performance and strategic flexibility, and tailor capital structure for
each business -
- Separation expected to result in two independent, publicly traded
companies -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotech company,
today announced that its Board of Directors has authorized an intent to
separate into two independent, publicly traded companies (Ironwood and
"R&D Co."). The separation is expected to be completed in the first half
of 2019 and is anticipated to be tax-free to Ironwood shareholders.
-
Following the separation, Ironwood anticipates being a profitable
company, building on its commercial success to-date to accelerate
growth of its in-market products and advance development programs
targeting treatments for gastrointestinal (GI) diseases, uncontrolled
gout, and abdominal pain.
-
R&D Co. will harness the pioneering work in cyclic guanosine
monophosphate (cGMP) pharmacology to advance an innovative sGC
pipeline expected to focus on the treatment of serious and orphan
diseases, led by Phase II clinical compounds praliciguat and
olinciguat (IW-1701).
Peter Hecht, chief executive officer of Ironwood said, "Today's
announcement marks a transformative milestone for Ironwood. Since our
founding 20 years ago, we have been driven by a simple mission: create
and commercialize innovative drugs that can change patients' lives and
generate value for our shareholders. Ironwood today markets three
commercial medicines, including LINZESS, a category leader, and is
advancing a deep pipeline of drug candidates targeting severe and high
unmet need diseases. We are pioneering two important areas:
commercializing products in categories with millions of potential
patients and innovating to discover and develop important new medicines.
The positive Phase IIb data from IW-3718, combined with the significant
progress within our sGC platform, including recent Phase IIa praliciguat
data, catalyzed our ability to separate into two focused, durable
businesses poised for long-term growth."
Terrance G. McGuire, Ironwood's chairman of the Board of Directors,
commented, "There has never been a more exciting time for Ironwood, and
our decision to separate these businesses underscores the strength of
our in-market and development portfolio developed by the team's
leadership and expertise. With our priority to maximize shareholder
value, our Board and management team regularly explore strategic
opportunities. This particular strategic review, which began in the fall
of 2017, included a focus on opportunities to best develop Ironwood's
strong commercial platform and its rich drug discovery and development
assets. Following a comprehensive review, the Board and management team
unanimously determined that a separation of these platforms into two
independent, publicly traded companies targeting differentiated markets
presents the best way to drive operating performance, accelerate growth
and unlock value."
Ironwood believes the planned separation will create, among other things:
-
two nimbler, more productive businesses with strengthened competitive
positions,
-
separate and distinct management teams focused on each business's
unique strategic priorities, target markets, and corporate development
opportunities,
-
specifically tailored capital allocation strategies for each company,
and
-
sharpened investment theses that attract a long-term shareholder base
suited to each business.
Creating Two Focused, Growth Companies
Ironwood
Ironwood's assets are expected to continue to include its three
in-market products and two development candidates targeting GI diseases
and abdominal pain. Ironwood anticipates being profitable with strong
revenue growth from its in-market products following the separation. It
also intends to develop and commercialize (if approved) its core
pipeline candidates. The in-market products include flagship product
linaclotide, which is available in the U.S. and over 30 countries
worldwide for the treatment of adults with irritable bowel syndrome with
constipation (IBS-C) and/or chronic idiopathic constipation (CIC) under
the brand names LINZESS® and CONSTELLA®. All of
Ironwood's current linaclotide collaborations are expected to remain
with Ironwood. Ironwood is expected to retain U.S. rights to the
lesinurad franchise for uncontrolled gout, including recently introduced
DUZALLO® (lesinurad and allopurinol) and ZURAMPIC® (lesinurad),
and continues to evaluate the optimal mix of investments for this
franchise. Additionally, Ironwood anticipates including IW-3718, which
is being evaluated for the treatment of persistent gastroesophageal
reflux disease (GERD) with Phase III trials expected to initiate in the
third quarter of 2018, and linaclotide delayed release which is being
evaluated for the treatment of abdominal pain associated with all forms
of IBS. These assets are expected to have strong intellectual property
coverage into the 2030s and are first-in-category therapies with the
potential to serve markets with millions of patients suffering from
serious and chronic disorders.
Following the separation, we believe Ironwood will:
-
be profitable beginning in 2019 with the ability to tailor capital
allocation to the growth of the commercial business,
-
drive revenue growth with a focus on expanding operating leverage,
-
use its distinctive skills in applying deep patient insights and
bringing differentiated therapies to patients,
-
employ more innovative consumer-led marketing techniques, such as
digital advertising, to effectively engage, educate, and motivate
patients and healthcare providers,
-
secure broad market access through greater payer appreciation of
product value,
-
continue highly effective linaclotide collaborations, and
-
execute on a multi-faceted business development strategy.
R&D Co.
R&D Co.'s assets are expected to initially include numerous sGC
stimulator programs targeting serious and orphan diseases, such as
praliciguat in Phase II for heart failure with preserved ejection
fraction (HFpEF) and for diabetic nephropathy, olinciguat in Phase II
targeting sickle cell disease and achalasia, and tissue-targeted sGC
stimulators, including IW-6463 in development for severe central nervous
system diseases and other discovery programs targeting severe liver and
lung diseases. sGC plays an important role in regulating many critical
physiological processes; dysregulation of sGC may play a role in
multiple serious diseases. Ironwood's sGC stimulators are believed to
harness the nitric oxide/sGC/cyclic guanosine monophosphate
(NO/sGC/cGMP) pathway by working synergistically with NO to improve
blood flow and metabolism and decrease inflammation and fibrosis. R&D
Co. is expected to develop and commercialize (if approved) drugs
treating serious and orphan diseases and to out-license drugs targeting
larger patient populations.
As an independent company, we believe R&D Co. will:
-
apply its core competency in NO/sGC/cGMP pharmacology,
-
rapidly advance its pipeline of clinical-stage assets, including
praliciguat and olinciguat,
-
accelerate drug development with more parallel programs and innovative
trial designs,
-
tailor its development approaches to serious and orphan diseases,
-
simplify its capital allocation decision-making process, and
-
enter strategic partnerships to achieve the full patient impact and
value creation in the diverse markets its products could serve.
Leadership, Employees, Name and Location
Ironwood plans to have separate Boards and management teams for each
business with specific details provided at a later date. The company
intends to transition employees to the new businesses as the
organization design is completed over the coming months. After
separation, the commercial business will continue to be named Ironwood
with the name of R&D Co. to be announced at a later date. Both
businesses are anticipated to be headquartered in Cambridge, MA.
Approvals
The proposed separation is subject to customary conditions, including
receipt of regulatory approvals, a favorable opinion with respect to the
tax-free nature of the transaction, and final approval of Ironwood's
Board of Directors. Ironwood may, for any or no reason and at any time
until the proposed separation is complete, abandon the separation or
modify or change its terms.
Guidance
Ironwood expects to incur charges related to the transaction. As a
result, Ironwood plans to provide an update on the impact of the
transaction charges on its 2018 financial guidance during the company's
second quarter 2018 investor update.
Centerview Partners LLC is acting as financial advisor to Ironwood, and
Ropes & Gray LLP is acting as legal counsel.
Conference Call
Ironwood will discuss today's announcement in more detail on its first
quarter 2018 conference call, scheduled for 8:30 a.m. Eastern Time
today, Tuesday, May 1, 2018. Individuals interested in participating in
the call should dial (877) 643-7155 (U.S. and Canada) or (914) 495-8552
(international) using conference ID number 9859406.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is a commercial biotechnology
company focused on creating medicines that make a difference for
patients, building value for our fellow shareholders, and empowering our
passionate team. We are commercializing two innovative primary care
products: linaclotide, the U.S. branded prescription market leader for
adults with irritable bowel syndrome with constipation (IBS-C) or
chronic idiopathic constipation (CIC), and lesinurad, which is approved
to be taken with a xanthine oxidase inhibitor (XOI), or as a fixed-dose
combination with allopurinol, for the treatment of hyperuricemia
associated with gout. We are also advancing a pipeline of innovative
product candidates in areas of significant unmet need, including
uncontrolled gastroesophageal reflux disease, diabetic nephropathy,
heart failure with preserved ejection fraction, achalasia and sickle
cell disease. Ironwood was founded in 1998 and is headquartered
in Cambridge, Mass. For more information, please visit www.ironwoodpharma.com
or www.twitter.com/ironwoodpharma;
information that may be important to investors will be routinely posted
in both these locations.
About LINZESS (linaclotide)
LINZESS® is the #1 prescribed brand for the treatment of
adult patients with irritable bowel syndrome with constipation (IBS-C)
and chronic idiopathic constipation (CIC), based on IQVIA data. Since
its FDA approval in August of 2012 and subsequent launch in December
2012, greater than 2 million unique patients have filled approximately
10 million prescriptions for LINZESS, according to IQVIA.
LINZESS is a once-daily capsule that helps relieve the abdominal pain
and constipation associated with IBS-C, as well as the constipation,
infrequent stools, hard stools, straining, and incomplete evacuation
associated with CIC. The recommended dose is 290 mcg for IBS-C patients
and 145 mcg for CIC patients, with a 72 mcg dose approved for use in CIC
depending on individual patient presentation or tolerability. LINZESS
should be taken at least 30 minutes before the first meal of the day.
LINZESS is contraindicated in pediatric patients less than 6 years of
age. The safety and effectiveness of LINZESS in pediatric patients less
than 18 years of age have not been established. In neonatal mice,
linaclotide increased fluid secretion as a consequence of GC-C agonism
resulting in mortality within the first 24 hours due to dehydration. Due
to increased intestinal expression of GC-C, patients less than 6 years
of age may be more likely than patients 6 years of age and older to
develop severe diarrhea and its potentially serious consequences. In
adults with IBS-C or CIC treated with LINZESS, the most commonly
reported adverse event was diarrhea.
LINZESS is not a laxative; it is the first medicine approved by the FDA
in a class called guanylate cyclase-C (GC-C) agonists. LINZESS contains
a peptide called linaclotide that activates the GC-C receptor in the
intestine. Activation of GC-C is thought to result in increased
intestinal fluid secretion and accelerated transit and a decrease in the
activity of pain-sensing nerves in the intestine. The clinical relevance
of the effect on pain fibers, which is based on nonclinical studies, has
not been established.
In the United States, Ironwood and Allergan plc co-develop and
co-commercialize LINZESS for the treatment of adults with IBS-C or CIC.
In Europe, Allergan markets linaclotide under the brand name CONSTELLA
for the treatment of adults with moderate to severe IBS-C. In Japan,
Ironwood's partner Astellas markets linaclotide under the brand name
LINZESS for the treatment of adults with IBS-C. Ironwood also has
partnered with AstraZeneca for development and commercialization of
linaclotide in China, and with Allergan for development and
commercialization of linaclotide in all other territories worldwide.
About ZURAMPIC (lesinurad) 200mg tablets
ZURAMPIC (lesinurad) works in combination with xanthine oxidase
inhibitors (XOIs) to treat hyperuricemia associated with uncontrolled
gout. ZURAMPIC is not recommended for the treatment of asymptomatic
hyperuricemia and should not be used as monotherapy. XOIs reduce the
production of uric acid; ZURAMPIC increases the excretion of uric acid.
Together, the combination of ZURAMPIC and an XOI provides a dual
mechanism of action that both decreases production and increases
excretion of uric acid, thereby lowering serum uric acid (sUA) levels in
patients who have not achieved target serum uric acid levels with XOI
treatment alone. ZURAMPIC selectively inhibits the function of
transporter proteins uric acid transporter 1 (URAT1) and organic anion
transporter 4 (OAT4), involved in uric acid reabsorption in the kidney.
The safety and efficacy of ZURAMPIC was established in three Phase III
clinical trials that evaluated a once-daily dose of ZURAMPIC in
combination with the XOI allopurinol or febuxostat compared to XOI
alone. The boxed warning for ZURAMPIC states that acute renal failure
has occurred with ZURAMPIC and was more common when ZURAMPIC was given
alone and reinforces that ZURAMPIC should be used in combination with an
XOI.
About DUZALLO (lesinurad and allopurinol)
DUZALLO (lesinurad and allopurinol) is a once-daily oral therapy that
contains lesinurad 200 mg plus allopurinol 300 mg; it is also available
in a lesinurad 200 mg plus allopurinol 200 mg dosage. DUZALLO is
approved by the FDA as a once-daily oral treatment for hyperuricemia
associated with gout in patients who have not achieved target serum uric
acid (sUA) levels with a medically appropriate daily dose of allopurinol
alone. DUZALLO is not recommended for the treatment of asymptomatic
hyperuricemia. Allopurinol is an XOI whose action differs from that of
uricosuric agents such as lesinurad. Allopurinol reduces the production
of uric acid (UA); lesinurad increases renal excretion of UA by
selectively inhibiting the action of URAT1, the UA transporter
responsible for the majority of renal UA reabsorption. The
dual-mechanism combination of DUZALLO can address both inefficient
excretion and overproduction of UA, thereby lowering sUA levels. DUZALLO
should be taken in the morning with food and water, and patients should
be advised to stay well hydrated when taking DUZALLO (about 2 liters of
liquid a day).
LINZESS Important Safety Information
INDICATIONS AND USAGE
LINZESS (linaclotide) is indicated in adults for the treatment of both
irritable bowel syndrome with constipation (IBS-C) and chronic
idiopathic constipation (CIC).
IMPORTANT SAFETY INFORMATION
|
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
LINZESS is contraindicated in patients less than 6 years of
age. In nonclinical studies in neonatal mice, administration of a
single, clinically relevant adult oral dose of linaclotide caused
deaths due to dehydration. Use of LINZESS should be avoided in
patients 6 years to less than 18 years of age. The safety and
effectiveness of LINZESS have not been established in patients
less than 18 years of age.
|
Contraindications
-
LINZESS is contraindicated in patients less than 6 years of age due to
the risk of serious dehydration.
-
LINZESS is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
Warnings and Precautions
Pediatric Risk
-
LINZESS is contraindicated in patients less than 6 years of age. The
safety and effectiveness of LINZESS in patients less than 18 years of
age have not been established. In neonatal mice, linaclotide increased
fluid secretion as a consequence of GC-C agonism resulting in
mortality within the first 24 hours due to dehydration. Due to
increased intestinal expression of GC-C, patients less than 6 years of
age may be more likely than patients 6 years of age and older to
develop severe diarrhea and its potentially serious consequences.
-
Use of LINZESS should be avoided in pediatric patients 6 years to less
than 18 years of age. Although there were no deaths in older juvenile
mice, given the deaths in young juvenile mice and the lack of clinical
safety and efficacy data in pediatric patients, use of LINZESS should
be avoided in pediatric patients 6 years to less than 18 years of age.
Diarrhea
-
Diarrhea was the most common adverse reaction in LINZESS-treated
patients in the pooled IBS-C and CIC double-blind placebo-controlled
trials. The incidence of diarrhea was similar in the IBS-C and CIC
populations. Severe diarrhea was reported in 2% of 145 mcg and 290 mcg
LINZESS-treated patients, and in < 1% of 72 mcg LINZESS-treated CIC
patients. If severe diarrhea occurs, dosing should be suspended and
the patient rehydrated.
Common Adverse Reactions (incidence ≥2% and greater than placebo)
-
In IBS-C clinical trials: diarrhea (20% vs 3% placebo), abdominal pain
(7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral
gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%).
-
In CIC trials of a 145 mcg dose: diarrhea (16% vs 5% placebo),
abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory
tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal
distension (3% vs 2%). In a CIC trial of a 72 mcg dose: diarrhea (19%
vs 7% placebo) and abdominal distension (2% vs < 1%).
Please see full Prescribing Information including Boxed Warning: http://www.allergan.com/assets/pdf/linzess_pi
ZURAMPIC Important Safety Information and Limitations of Use
|
WARNING: RISK OF ACUTE RENAL FAILURE MORE COMMON WHEN USED
WITHOUT A XANTHINE OXIDASE INHIBITOR (XOI)
-
Acute renal failure has occurred with ZURAMPIC and was more
common when ZURAMPIC was given alone
-
ZURAMPIC should be used in combination with an XOI
|
Contraindications:
-
Severe renal impairment (eCLcr less than 30 mL/min), end-stage renal
disease, kidney transplant recipients, or patients on dialysis
-
Tumor lysis syndrome or Lesch-Nyhan syndrome
Warnings and Precautions:
-
Renal events: Adverse reactions related to renal function have
occurred after initiating ZURAMPIC. A higher incidence was observed at
the 400-mg dose, with the highest incidence occurring with monotherapy
use. Monitor renal function at initiation and during therapy with
ZURAMPIC, particularly in patients with eCLcr below 60 mL/min or with
serum creatinine elevations 1.5 to 2 times the pre-treatment value,
and evaluate for signs and symptoms of acute uric acid nephropathy.
Interrupt treatment with ZURAMPIC if serum creatinine is elevated to
greater than 2 times the pre-treatment value or if there are symptoms
that may indicate acute uric acid nephropathy. ZURAMPIC should not be
restarted without another explanation for the serum creatinine
abnormalities. ZURAMPIC should not be initiated in patients with an
eCLcr less than 45 mL/min.
-
Cardiovascular events: In clinical trials, major adverse
cardiovascular events (defined as cardiovascular deaths, non-fatal
myocardial infarctions, or non-fatal strokes) were observed with
ZURAMPIC. A causal relationship has not been established.
Adverse Reactions:
-
Most common adverse reactions with ZURAMPIC (in combination with an
XOI and more frequently than on an XOI alone) were headache,
influenza, blood creatinine increased, and gastroesophageal reflux
disease
Indication and Limitations of Use for ZURAMPIC
ZURAMPIC is a URAT1 inhibitor indicated in combination with an XOI for
the treatment of hyperuricemia associated with gout in patients who have
not achieved target serum uric acid levels with an XOI alone.
-
ZURAMPIC is not recommended for the treatment of asymptomatic
hyperuricemia
-
ZURAMPIC should not be used as monotherapy
Please see full Prescribing Information, including Boxed Warning,
at: http://irwdpi.com/zurampic/ZURAMPIC_PI_and_Medguide_2017.pdf#page=1
DUZALLO Important Safety Information
|
WARNING: RISK OF ACUTE RENAL FAILURE
-
Acute renal failure has occurred with lesinurad, one of the
components of DUZALLO
|
Contraindications:
-
Severe renal impairment (estimated creatinine clearance [eCLcr] < 30
mL/min), end-stage renal disease, kidney transplant recipients, or
patients on dialysis
-
Tumor lysis syndrome or Lesch-Nyhan syndrome
-
Known hypersensitivity to allopurinol, including previous occurrence
of skin rash
Warnings and Precautions:
-
Renal events: Adverse reactions related to renal function,
including acute renal failure, can occur after initiating DUZALLO.
Renal function should be evaluated prior to initiation of DUZALLO and
periodically thereafter, as clinically indicated. More frequent renal
function monitoring is recommended in patients with eCLcr < 60 mL/min
or with serum creatinine elevations 1.5 to 2 times the value when
lesinurad treatment was initiated. DUZALLO should not be initiated in
patients with an eCLcr < 45 mL/min. Interrupt treatment with DUZALLO
if serum creatinine is elevated to > 2 times the pretreatment value or
if there are symptoms that may indicate acute uric acid nephropathy,
including flank pain, nausea, or vomiting. DUZALLO should not be
restarted without another explanation for the serum creatinine
abnormalities
-
Skin rash and hypersensitivity: Skin rash is a frequently
reported adverse event in patients taking allopurinol. In some
instances, a skin rash may be followed by more severe hypersensitivity
reactions associated with exfoliation, fever, lymphadenopathy,
arthralgia, and/or eosinophilia including Stevens-Johnson syndrome and
toxic epidermal necrolysis. Associated vasculitis and tissue response
may be manifested in various ways including hepatitis, renal
impairment, seizures, and on rare occasions, death. Hypersensitivity
reactions to allopurinol may be increased in patients with decreased
renal function who are receiving thiazide diuretics and DUZALLO
concurrently. DUZALLO should be discontinued immediately at the first
appearance of skin rash or other signs that may indicate an allergic
reaction, and additional medical care should be provided as needed
-
Hepatotoxicity: A few cases of reversible clinical
hepatotoxicity have been reported in patients taking allopurinol and,
in some patients, asymptomatic rises in serum alkaline phosphatase or
serum transaminase have been observed. If anorexia, weight loss, or
pruritus develops in patients taking DUZALLO, evaluation of liver
function should be performed. In patients with preexisting liver
disease, periodic liver function tests are recommended
-
Cardiovascular events: In clinical trials, major adverse
cardiovascular events (defined as cardiovascular deaths, nonfatal
myocardial infarctions, and nonfatal strokes) were observed with
DUZALLO. A causal relationship has not been established
-
Bone marrow depression: Bone marrow depression has been
reported in patients receiving allopurinol, most of whom received
concomitant drugs with the potential for causing this reaction. This
has occurred as early as 6 weeks to as long as 6 years after the
initiation of allopurinol therapy. Rarely, a patient may develop
varying degrees of bone marrow depression, affecting one or more cell
lines, while receiving allopurinol alone. Patients taking allopurinol
and mercaptopurine or azathioprine require a reduction in dose to
approximately one-third to one-fourth of the usual dose of
mercaptopurine or azathioprine
-
Increase in prothrombin time: It has been reported that
allopurinol prolongs the half-life of dicumarol, a coumarin
anticoagulant. The prothrombin time should be reassessed periodically
in patients receiving coumarin anticoagulants (dicumarol, warfarin)
concomitantly with DUZALLO
-
Drowsiness: Occasional occurrence of drowsiness was reported in
patients taking allopurinol. Patients should be alerted to the need
for caution when engaging in activities where alertness is mandatory
Adverse Reactions:
-
The most common adverse reactions in controlled studies (occurring in
2% or more of patients on lesinurad in combination with allopurinol
and at least 1% greater than observed in patients on allopurinol
alone) were headache, influenza, blood creatinine increased, and
gastroesophageal reflux disease
-
The most common adverse reactions identified during post-approval use
of allopurinol are skin rash, nausea, and diarrhea
Indication and Limitations of Use:
DUZALLO, a combination of lesinurad, a URAT1 inhibitor, and allopurinol,
a xanthine oxidase inhibitor, is indicated for the treatment of
hyperuricemia associated with gout in patients who have not achieved
target serum uric acid levels with a medically appropriate daily dose of
allopurinol alone.
-
DUZALLO is not recommended for the treatment of asymptomatic
hyperuricemia
Please see full Prescribing Information, including Boxed, at https://www.irwdpi.com/duzallo/DuzalloPIandMedguide2017.pdf#page=1
LINZESS® and CONSTELLA® are registered trademarks of Ironwood
Pharmaceuticals, Inc., and ZURAMPIC® and DUZALLO®are
registered trademarks of AstraZeneca AB. Any other trademarks referred
to in this press release are the property of their respective owners.
All rights reserved.
Forward Looking Statements
This press release contains forward-looking statements. Investors are
cautioned not to place undue reliance on these forward-looking
statements, including statements about the benefits of a potential
separation, including with respect to Ironwood's and R&D Co.'s
competitive position, attractiveness to investors and enhanced
operational, commercial and scientific effectiveness; the timing,
leadership, structure, including the division of assets among Ironwood
and R&D Co., and impact of a separation; capital allocation ; the
strategy, including the intended development and commercialization plans
for each of Ironwood and R&D Co., and potential corporate development
opportunities; the tax free nature of the separation; the market size,
commercial potential, prevalence, and the growth in, and potential
demand for, linaclotide, lesinurad and other product candidates (and the
drivers, timing and impact thereof), for each of Ironwood and R&D Co.,
as applicable; the potential indications for, and benefits of,
linaclotide, lesinurad and other product candidates, for each of
Ironwood and R&D Co., as applicable; the strength of the intellectual
property protection for linaclotide, lesinurad and other product
candidates; growth in LINZESS prescriptions; the number of potential
patients; the anticipated timing of preclinical, clinical and regulatory
developments and the design, timing and results of clinical and
preclinical studies; expected periods of patent exclusivity, durability
and life of the respective patent portfolios for linaclotide, lesinurad
and other product candidates; Ironwood's and R&D Co.'s financial
performance and results, and guidance and expectations related thereto
(including the drivers and timing thereof); and expectations related to
revenue growth for in-market products, commercial margin, cash flow and
profitability growth and LINZESS U.S. net sales. Each forward-looking
statement is subject to risks and uncertainties that could cause actual
results to differ materially from those expressed or implied in such
statement. Applicable risks and uncertainties include those related to
the possibility that we may not complete the separation on the terms or
timeline currently contemplated if at all, achieve the expected benefits
of a separation, and that a separation could harm our business, results
of operations and financial condition; the risk that the transaction
might not be tax-free; the risk that we may be unable to make, on a
timely or cost-effective basis, the changes necessary to operate as
independent companies; R&D Co.'s lack of independent operating history
and the risk that its accounting and other management systems may not be
prepared to meet the financial reporting and other requirements of
operating as an independent public company; the risk that a separation
may adversely impact our ability to attract or retain key personnel; the
effectiveness of development and commercialization efforts by us and our
partners; preclinical and clinical development, manufacturing and
formulation development; the risk that findings from our completed
nonclinical and clinical studies may not be replicated in later studies;
efficacy, safety and tolerability of linaclotide, lesinurad and our
product candidates; decisions by regulatory and judicial authorities;
the risk that we are unable to successfully commercialize lesinurad or
realize the anticipated benefits of the lesinurad transaction; the risk
that we may never get sufficient patent protection for linaclotide,
lesinurad and our product candidates or that we are not able to
successfully protect such patents; the outcomes in legal proceedings to
protect or enforce the patents relating to our products and product
candidates, including ANDA litigation; developments in the intellectual
property landscape; challenges from and rights of competitors or
potential competitors; the risk that our planned investments do not have
the anticipated effect on our company revenues, linaclotide, lesinurad
or our product candidates; the risk that we are unable to manage our
operating expenses or cash use for operations, or are unable to
commercialize our products, within the guided ranges or otherwise as
expected; and the risks listed under the heading "Risk Factors" and
elsewhere in Ironwood's Annual Report on Form 10-K for the year ended
December 31, 2017, and in our subsequent SEC filings. These
forward-looking statements (except as otherwise noted) speak only as of
the date of this press release, and Ironwood undertakes no obligation to
update these forward-looking statements.
Additional Information
Ironwood, its directors and certain of its officers may be deemed to be
participants in the solicitation of proxies from shareholders in
connection with the matters to be considered at the company's 2018
Annual Meeting of Shareholders. In connection with any such solicitation
of proxies from shareholders, the company filed a preliminary proxy
statement and a WHITE proxy card on April 16, 2018 and will file a
definitive proxy statement and WHITE proxy card, each with the U.S.
Securities and Exchange Commission (the "SEC"). SHAREHOLDERS ARE
STRONGLY ENCOURAGED TO READ ANY SUCH DEFINITIVE PROXY STATEMENT AND
ACCOMPANYING WHITE PROXY CARD WHEN THEY BECOME AVAILABLE AS THEY WILL
CONTAIN IMPORTANT INFORMATION. Information regarding the identity of
solicitation participants, and their direct or indirect interests, by
security holdings or otherwise, is set forth in the preliminary proxy
statement and will be set forth in the definitive proxy statement and
other materials to be filed with the SEC in connection with the
company's 2018 Annual Meeting of Shareholders. Shareholders will be able
to obtain any proxy statement, any amendments or supplements to the
proxy statement and other documents filed by the company with the SEC
for no charge at the SEC's website at www.sec.gov.
Copies will also be available at no charge at the company's website at www.ironwoodpharma.com.
If you have any questions regarding this information or the proxy
materials, please contact MacKenzie Partners, Inc., our proxy solicitor
assisting us in connection with the annual meeting, toll-free at
(800) 322-2885 or at (212) 929-5500 or via email to IRWD@mackenziepartners.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180501005896/en/
Ironwood Pharmaceuticals
Investors:
Meredith
Kaya, 617-374-5082
Vice President, Investor Relations and Corporate
Communications
mkaya@ironwoodpharma.com
or
Media:
Joele
Frank, Wilkinson Brimmer Katcher
Andi Rose / Mahmoud Siddig,
212-355-4449
Source: Ironwood Pharmaceuticals, Inc.
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