- Transaction Advances Ironwood’s Vision of
Becoming the Leading GI Healthcare Company -
- Adds apraglutide, Next Generation, Synthetic
GLP-2 Analog in Phase 3 for Short Bowel Syndrome with Intestinal
Failure (SBS-IF); Potential to become Best-in-Class for SBS-IF
-
- Orphan Drug Designation Received for
Treatment of Adult Patients with SBS-IF; Topline Results of Phase 3
Trial Expected by the End of 2023 -
- Ironwood to Commence All-Cash Tender Offer to
Acquire All Outstanding Shares of VectivBio for $17.00 per Share
-
- Ironwood to Host Conference Call and Webcast
Today at 8:30 a.m. ET -
Ironwood Pharmaceuticals, Inc. (“Ironwood”) (Nasdaq: IRWD), a
GI-focused healthcare company, and VectivBio Holding AG
(“VectivBio”) (Nasdaq: VECT), a clinical-stage biopharmaceutical
company pioneering novel, transformational treatments for severe
rare gastrointestinal conditions, today announced that they have
entered into a definitive agreement for Ironwood to acquire
VectivBio for $17.00 per share in an all-cash transaction with an
estimated aggregate consideration of approximately $1 billion, net
of VectivBio cash and debt (the “Transaction”). The acquisition
price represents a premium of 80% relative to the volume-weighted
average share price over the previous 90 trading days. The
Transaction was approved by both the Ironwood and VectivBio Boards
of Directors and the Transaction Agreement was entered into on May
21, 2023. The Transaction is conditioned upon, among other things,
the tender of shares representing more than 80% of VectivBio’s
issued and outstanding shares and other customary conditions.
Orbimed, Forbion and Versant Ventures, and VectivBio’s directors
and officers, jointly representing 28.6% of VectivBio’s
shareholdings, entered into tender and support agreements pursuant
to which such supporting shareholders agreed, among other things,
to tender their shares in the tender offer.
Headquartered in Basel, Switzerland, VectivBio is a
clinical-stage biotechnology company focused on the discovery and
development of treatments for severe, rare conditions, including
Short Bowel Syndrome with Intestinal Failure (SBS-IF) and acute
Graft versus Host Disease (aGvHD). SBS-IF is a severe malabsorptive
condition requiring ongoing I.V. administration of fluids and
nutrients and is associated with significant morbidity and
mortality, high economic burden, and an impaired quality of life. A
substantial number of SBS-IF patients remain dependent on chronic
parenteral support, and there is considerable unmet need in this
patient population, which has an estimated addressable population
of 18,000 adult patients across the U.S., Europe, and Japan1. aGVHD
is an immunologically mediated disease occurring in individuals
undergoing allogeneic hemopoetic stem cell transplantation (HSCT)
where donor immune cells react against the host recipient. The
gastrointestinal system is among the most common sites affected by
acute GVHD, and severe manifestations of aGVHD of the gut portends
a poor prognosis in patients after HSCT.
VectivBio’s lead investigational asset, apraglutide, is a
next-generation, GLP-2 analog which has shown compelling data to
date and is currently in Phase 3 with plans for topline readout by
year’s end. Apraglutide has the potential to be the best-in-class
GLP-2 therapy for the treatment of SBS-IF based on its potency and
pharmacological properties, unique convenience of weekly dosing,
and Phase 3 study designed to evaluate clinical benefit for both
SBS-IF stoma and colon-in-continuity patients. If successful and
approved, Ironwood believes apraglutide presents an opportunity to
reach $1 billion in peak net sales.
This Transaction has the potential to strengthen Ironwood’s
innovative portfolio and pipeline to advance the treatment of GI
diseases and redefine the standard of care for GI patients. With
its proven track record, Ironwood is well-positioned to leverage
its expertise in clinical development, regulatory pathways, medical
affairs and commercial execution to progress and maximize the
potential value of apraglutide for patients, physicians and
shareholders.
“The acquisition of VectivBio, including its compelling asset,
apraglutide, is an ideal strategic fit with Ironwood,” said Tom
McCourt, chief executive officer of Ironwood. “With the success of
our blockbuster product, LINZESS, we have built a strong GI
commercial function, healthy cash flow generation, and meaningful
EBITDA. We are confident that with our GI expertise, commercial
capabilities, and robust balance sheet, we are well-positioned to
continue developing apraglutide, with the goal of getting it into
the hands of the patients who need it the most and potentially
generate significant and sustainable value for shareholders.”
“We are delighted to enter into this agreement with Ironwood to
advance the development and commercialization of innovative
therapies targeted at GI and rare diseases, which is the mission of
VectivBio,” said Luca Santarelli, M.D., chief executive officer and
founder of VectivBio. “Ironwood’s capabilities and established
track record in GI make it the ideal company to bring apraglutide,
if approved, to patients suffering from SBS-IF and other serious GI
conditions. We believe this Transaction represents the best outcome
for our patients and shareholders.”
Strategic and Financial Benefits
The acquisition of VectivBio and its lead investigational asset
apraglutide provides a significant opportunity to accelerate the
next growth horizon for Ironwood. The Transaction has the potential
to deliver meaningful strategic and financial benefits,
including:
- Strengthens and complements Ironwood’s portfolio. Today,
Ironwood has a blockbuster asset in LINZESS, a strong GI commercial
function, and an exciting pipeline of development assets. Ironwood
believes that this transaction will further strengthen its
portfolio and pipeline, with the potential to meaningfully
accelerate its growth horizon. With approximately 18,000
addressable adult patients suffering from SBS-IF across U.S.,
Europe and Japan, apraglutide, if successfully developed, has
significant revenue potential given its orphan drug designation for
the treatment of adult patients with SBS-IF, compelling data to
date, convenient weekly dosing and potential expansion into
additional GI conditions, including aGvHD.
- Leverages Ironwood’s existing infrastructure. Ironwood
has strong expertise in clinical development, regulatory pathways,
and medical affairs, as well as a robust commercial infrastructure.
Additionally, Ironwood also has existing relationships within the
gastroenterologist community, and a knowledgeable specialty
salesforce that currently addresses a significant portion of
apraglutide’s potential prescriber base. Ironwood intends to
leverage its proven expertise from LINZESS’s successful
commercialization and ongoing lifecycle management to maximize the
apraglutide opportunity.
- Supports long-term profitability and cash-flow
generation. Apraglutide is a late-stage clinical asset with the
potential to reach $1 billion in peak net sales if successfully
developed and approved. The addition of apraglutide provides
another high-growth potential revenue stream, diversifies
Ironwood’s portfolio and pipeline, and potentially extends
Ironwood’s growth horizon through the 2030s.
- Compelling financial profile. Ironwood anticipates the
pro forma company will remain positioned to deliver sustained
profits and cash flows. Ironwood expects to generate greater than
$175 million in operating cash flows each year on a pro forma basis
ahead of apraglutide commercial launch. The Transaction, assuming
successful commercialization of apraglutide, is expected to be
accretive to earnings per share beginning in 2026.
Transaction Terms and Closing
Under the terms of the Transaction Agreement, Ironwood will
commence a tender offer to purchase all of VectivBio’s outstanding
ordinary shares for $17.00 per share in cash. The closing of the
tender offer will be subject to certain conditions, including the
tender of more than 80% of the total number of VectivBio’s
outstanding shares, the expiration of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act, certain shareholder
approvals and other customary closing conditions (the “Offer
Conditions”). VectivBio’s Board of Directors recommends that
VectivBio shareholders tender their shares in the tender offer. The
Transaction, which was approved by each company’s Boards of
Directors, is expected to close in the second half of 2023, subject
to the Offer Conditions. Assuming the closing of the tender offer
and Ironwood holding at least 90% of the outstanding shares of
VectivBio, Ironwood expects to acquire any shares of VectivBio not
tendered into the tender offer through a merger of VectivBio with
and into a subsidiary of Ironwood for the same per share
consideration as will be payable in the tender offer.
Orbimed, Forbion and Versant Ventures, and VectivBio’s directors
and officers jointly representing 28.6% of VectivBio’s
shareholdings, entered into tender and support agreements pursuant
to which such supporting shareholders agreed, among other things,
to tender their shares in the tender.
VectivBio will covene an extraordinary general meeting of
shareholders on June 26, 2023 for the purpose of obtaining certain
shareholder approvals in connection with the Transaction.
Ironwood expects to finance the acquisition with cash on hand
and funds drawn through a four-year, $500 million revolving credit
facility entered in connection with the Transaction.
Ironwood expects to provide updated full year 2023 adjusted
EBITDA financial guidance upon closing of the transaction.
Advisors
Citi, J.P. Morgan Securities, LLC, RBC Capital Markets, LLC, and
Wells Fargo Securities, LLC are serving as financial advisors to
Ironwood on the transaction.
Financing for the transaction has been provided by Citibank,
N.A., Citizens Bank, N.A., JPMorgan Chase Bank, N.A., Royal Bank of
Canada, and Wells Fargo Bank, National Association.
Latham and Watkins LLP and Advestra AG are serving as legal
advisors to Ironwood.
Centerview Partners LLC and BofA Securities, Inc. are serving as
financial advisors to VectivBio, and Cooley (UK) LLP and Homburger
AG are serving as legal advisors to VectivBio.
Conference Call Information
Ironwood will host a conference call and webcast today at 8:30
a.m. Eastern Time on Monday, May 22, 2023 to discuss the
Transaction. Individuals interested in participating in the call
should dial (888) 330-2384 (U.S. and Canada) or (240) 789-2701
(international) using conference ID number and event passcode
4671230. To access the webcast, please visit the Investors section
of Ironwood’s website at www.ironwoodpharma.com at least 15 minutes
prior to the start of the call to ensure adequate time for any
software downloads that may be required. The call will be available
for replay via telephone starting at approximately 11:30 a.m.
Eastern Time on May 22, 2023, running through 11:59 p.m. Eastern
Time on June 5, 2023. To listen to the replay, dial (800) 770-2030
(U.S. and Canada) or (647) 362-9199 (international) using
conference ID number 4671230. The archived webcast will be
available on Ironwood’s website for 14 days beginning approximately
one hour after the call has completed.
About Ironwood
Ironwood Pharmaceuticals (Nasdaq: IRWD), an S&P SmallCap
600® company, is a leading gastrointestinal (GI) healthcare company
on a mission to advance the treatment of GI diseases and redefine
the standard of care for GI patients. We are pioneers in the
development of LINZESS® (linaclotide), the U.S. branded
prescription market leader for adults with irritable bowel syndrome
with constipation (IBS-C) or chronic idiopathic constipation (CIC).
Under the guidance of our seasoned industry leaders, we continue to
build upon our history of GI innovation and challenge what has been
done before to shape what the future holds. We keep patients at the
heart of our R&D and commercialization efforts to reduce the
burden of GI diseases and address significant unmet needs.
Founded in 1998, Ironwood Pharmaceuticals is headquartered in
Boston, Massachusetts.
We routinely post information that may be important to investors
on our website at www.ironwoodpharma.com. In addition, follow us on
Twitter and on LinkedIn.
About VectivBio AG
VectivBio is a global clinical-stage biotechnology company
focused on transforming and improving the lives of patients with
severe rare conditions. Lead product candidate apraglutide is a
next-generation, long-acting synthetic GLP-2 analog being developed
for a range of rare gastrointestinal diseases where GLP-2 can play
a central role in addressing disease pathophysiology, including
short bowel syndrome with intestinal failure (SBS-IF) and Acute
Graft-Versus-Host Disease (aGVHD).
VectivBio is also advancing its modular, small molecule CoMET
platform to address a broad range of previously undruggable
Inherited Metabolic Diseases (IMDs). CoMET leverages innovative
chemistry, based on a proprietary stabilized pantetheine backbone,
to restore fundamental cellular metabolism in pediatric populations
with IMDs characterized by a deficit of energy metabolism caused by
the depletion of functional Coenzyme A (“CoA”). Candidates from the
CoMET platform are initially being evaluated in methylmalonic
acidemia (MMA), propionic acidemia (PA), and other organic
acidemias.
About Apraglutide
Apraglutide is an investigational new drug that is a
next-generation, long-acting synthetic GLP-2 analog being developed
for a range of rare gastrointestinal diseases where GLP-2 can play
a central role in addressing disease pathophysiology, including
short bowel syndrome with intestinal failure (SBS-IF) and Acute
Graft-Versus-Host Disease (aGVHD).
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 LESS THAN 2 YEARS OF AGE
LINZESS is contraindicated in patients
less than 2 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.
Contraindications
- LINZESS is contraindicated in patients less than 2 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 2 years of
age. In neonatal mice, linaclotide increased fluid secretion as a
consequence of age-dependent elevated GC-C agonism resulting in
mortality within the first 24 hours due to dehydration. There was
no age-dependent trend in GC-C intestinal expression in a clinical
study of children 2 to less than 18 years of age; however, there
are insufficient data available on GC-C intestinal expression in
children less than 2 years of age to assess the risk of developing
diarrhea and its potentially serious consequences in these
patients. The safety and effectiveness of LINZESS in patients less
than 18 years of age have not been established.
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
LINZESS® and CONSTELLA® are registered trademarks of Ironwood
Pharmaceuticals, Inc. Any other trademarks referred to in this
press release are the property of their respective owners. All
rights reserved.
Additional Information and Where to Find it
The description contained in this press release is for
informational purposes only and is not a recommendation, an offer
to buy or the solicitation of an offer to sell any shares of
VectivBio’s ordinary shares. The tender offer for VectivBio’s
outstanding ordinary shares described in this report has not
commenced. At the time the tender offer is commenced, Ironwood will
file or cause to be filed a Tender Offer Statement on Schedule TO
with the U.S. Securities and Exchange Commission (the “SEC”) and
VectivBio will file a Solicitation/Recommendation Statement on
Schedule 14D-9 with the SEC related to the tender offer. The Tender
Offer Statement (including an Offer to Purchase, a related Letter
of Transmittal and other tender offer documents) and the
Solicitation/Recommendation Statement will contain important
information that should be read carefully before any decision is
made with respect to the tender offer. Those materials will be made
available to VectivBio’s stockholders at no expense to them. In
addition, all of those materials (and any other documents filed
with the SEC) will be available at no charge on the SEC’s website
at www.sec.gov.
Cautionary Statement Regarding Forward-Looking
Statements
Certain statements in this press release may constitute
“forward-looking statements”. Forward-looking statements may be
typically identified by such words as “may,” “will,” “could,”
“should,” “expect,” “anticipate,” “plan,” “likely,” “believe,”
“estimate,” “project,” “intend,” and other similar expressions.
These forward-looking statements are subject to known and unknown
risks and uncertainties that could cause our actual results to
differ materially from the expectations expressed in the
forward-looking statements. Although Ironwood and VectivBio believe
that the expectations reflected in the forward-looking statements
are reasonable, any or all of such forward-looking statements may
prove to be incorrect. Consequently, no forward-looking statements
may be guaranteed and there can be no assurance that the actual
results or developments anticipated by such forward looking
statements will be realized or, even if substantially realized,
that they will have the expected consequences to, or effects on,
Ironwood, VectivBio or their respective businesses or
operations.
Factors which could cause actual results to differ from those
projected or contemplated in any such forward-looking statements
include, but are not limited to, the following factors: (1) the
risk that the conditions to the closing of the transaction are not
satisfied, including the risk that Ironwood may not receive
sufficient number of shares tendered from VectivBio stockholders to
complete the tender offer prior to the outside date set forth in
the definitive agreement and the receipt of required regulatory
approvals; (2) litigation relating to the transaction; (3)
uncertainties as to the timing of the consummation of the
transaction and the ability of each of VectivBio and Ironwood to
consummate the transaction; (4) risks that the proposed transaction
disrupts the current plans and operations of VectivBio or Ironwood;
(5) the ability of Ironwood and/or VectivBio to retain and hire key
personnel; (6) competitive responses to the proposed transaction;
(7) unexpected costs, charges or expenses resulting from the
transaction; (8) potential adverse reactions or changes to business
relationships resulting from the announcement or completion of the
transaction; (9) the prospects, including clinical development,
regulatory approvals, and commercial potential of apraglutide; (10)
Ironwood’s ability to achieve the growth prospects and synergies
expected from the transaction, as well as delays, challenges and
expenses associated with integrating VectivBio with its existing
businesses; and (11) legislative, regulatory and economic
developments. The foregoing review of important factors that could
cause actual events to differ from expectations should not be
construed as exhaustive and should be read in conjunction with
statements that are included herein and elsewhere, including the
risk factors included in VectivBio’s Annual Report on Form 20-F for
the year ended December 31, 2022, Ironwood’s Annual Report on Form
10-K for the year ended December 31, 2022 and Ironwood’s other
filings with the SEC (which may be obtained for free at the SEC’s
website at http://www.sec.gov). VectivBio and Ironwood can give no
assurance that the conditions to the transaction will be satisfied.
Neither VectivBio nor Ironwood undertakes any intent or obligation
to publicly update or revise any of these forward-looking
statements, whether as a result of new information, future events
or otherwise, except as required by law.
___________________________ 1 Rights to apraglutide in Japan
have been exclusively licensed to Ashai Kasei Pharma Corporation
(AKP)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230522005306/en/
Ironwood Pharmaceuticals
Media: Beth Calitri, 978-417-2031
bcalitri@ironwoodpharma.com
Investors: Greg Martini, 617-374-5230
gmartini@ironwoodpharma.com
Matt Roache, 617-621-8395 mroache@ironwoodpharma.com
VectivBio Investors: Patrick Malloy, 847-987-4878
Patrick.Malloy@VectivBio.com
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